1.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
Objective:
This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2).
Methods:
We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load.
Results:
A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed.
Conclusion
The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.
2.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
Objective:
This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2).
Methods:
We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load.
Results:
A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed.
Conclusion
The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.
3.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
Objective:
This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2).
Methods:
We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load.
Results:
A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed.
Conclusion
The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.
4.A bifid ureter originating from separate major calyx and renal pelvis with dual calyceal systems: a case report
Yuri SEU ; Hyun Jin PARK ; Jin Seo PARK ; Yong‑Suk MOON ; Hongtae KIM ; Mi-Sun HUR
Anatomy & Cell Biology 2024;57(3):476-480
Present case report describes a case of bifid ureter arising directly from separate calyces and renal pelvis of the kidney. Incomplete ureter duplication on the left side in a 78-year-old male cadaver was found during an anatomy class.These ureters converged in a Y-shaped pattern just above the level of the anterior superior iliac spine. In the coronal section of the kidney, the anterior ureter arose from a renal pelvis that was divided into two major calyces in the lower two-thirds of the kidney. On the other hand, the posterior ureter was directly connected to a major calyx in the upper third of the kidney, without the formation of a renal pelvis. This anatomical variation has implications for diagnostic approaches, especially in the use of imaging techniques by urologists for the insertion of stents in the treatment of phyelonephritis.
5.Longitudinal profile of routine biomarkers for mortality prediction using unsupervised clustering algorithm in severely burned patients: a retrospective cohort study with prospectively collected data
Jaechul YOON ; Dohern KYM ; Jun HUR ; Yong-Suk CHO ; Wook CHUN ; Dogeon YOON
Annals of Surgical Treatment and Research 2023;104(2):126-135
Purpose:
Burn injury has high clinical heterogeneity and worse prognosis in severely burned patients. Clustering algorithms using unsupervised methods to identify groups with similar trajectories in heterogeneous disease patients can provide insight into mechanisms of disease pathogenesis. This study analyzed routinely collected biomarkers to evaluate mortality prediction, find clinical meanings for these or their subtypes, and evaluate patterns.
Methods:
This retrospective cohort study included patients aged >18 years, between July 2012 and June 2021. All eligible patients received fluid resuscitation and survived for at least 7 days. Characteristics of clinical interest to the physician at 4 clinically important time points were evaluated.
Results:
Eligible patients were divided into 4 subgroups according to these time points: from 1st week to 4th week. Total of 1,249 patients admitted within 2 days after burns and receiving fluid resuscitation were included. Mean Harrell’s C-index of pH was the highest (0.816), followed by platelets (0.807), creatinine (0.796), red cell distribution width (RDW, 0.778), and lactate (0.759). Longitudinal profiles among biomarkers were different.
Conclusion
The main predictors were pH, platelets, creatinine, RDW, and lactate. Creatinine and RDW showed consistent patterns. The other markers varied according to patient condition. Thus, these markers could provide clues into underlying mechanisms and predict mortality.
6.Multiple Organ Failure Resulted from Chromic Acid Burn
Myongjin KIM ; Jaechul YOON ; Dohern KYM ; Jun HUR ; Yong-Suk CHO ; Wook CHUN
Journal of Korean Burn Society 2022;25(1):1-4
This case is about 68-years old male patients who was exposed to hexavalent chromic acid on whole body. After the accident, he was transferred to burn center and received massive fluid resuscitation. Despite of the resuscitation, renal failure had pro -gressed and pulmonary dysfunction happened subsequently. Pulmonary dysfunction had aggravated that ECMO was required on hospital day 3, the patient had been transferred to other hospital that could manage the condition of the patient. Soon after the transfer, the patient died. We report this case because the acute chromic acid poisoning lead to multiple organ failure including renal impairment.
7.Variant muscle fibers connecting the orbicularis oculi to the orbicularis oris: case report
Norio KITAGAWA ; Joe IWANAGA ; R.Shane TUBBS ; Hongtae KIM ; Yong-Suk MOON ; Mi-Sun HUR
Anatomy & Cell Biology 2022;55(4):497-500
The orbicularis oculi (OOc) is a sphincteric muscle of the eyelids, whereas contraction of the orbicularis oris (OOr), another sphincteric muscle, causes narrowing of the lips. Facial muscle fibers normally blend with adjacent muscles. However, muscle fibers connecting the various facial muscles that have different actions and that are located at distant sites, such as the OOc and the OOr have been rarely reported. Herein, we report a rare case of connecting fibers between the inferior margin of the OOc and the OOr. These connecting fibers were blended with the OOr between the inserting fibers of the levator labii superioris and levator anguli oris. Contraction of such variant muscles might affect typical facial expressions.
8.Effects of Antioxidant on Oxidative Stress and Autophagy in Bronchial Epithelial Cells Exposed to Particulate Matter and Cigarette Smoke Extract
Jung HUR ; Chin Kook RHEE ; Yong Suk JO
Tuberculosis and Respiratory Diseases 2022;85(3):237-248
Background:
We evaluated the effect of particulate matter (PM) and cigarette smoke extract (CSE) on bronchial epithelial cell survival, as well as oxidative stress and autophagy levels. Moreover, we aimed to assess the effect of the antioxidant N-acetylcysteine (NAC) on the adverse effects of PM and CSE exposure.
Methods:
Normal human bronchial epithelial cells (BEAS-2B cells) were exposed to urban PM with or without CSE, after which cytotoxic effects, including oxidative stress and autophagy levels, were measured. After identifying the toxic effects of urban PM and CSE exposure, the effects of NAC treatment on cell damage were evaluated.
Results:
Urban PM significantly decreased cell viability in a concentration-dependent manner, which was further aggravated by simultaneous treatment with CSE. Notably, pretreatment with NAC at 10 mM for 1 hour reversed the cytotoxic effects of PM and CSE co-exposure. Treatment with 1, 5, and 10 mM NAC was shown to decrease reactive oxygen species levels induced by exposure to both PM and CSE. Additionally, the autophagy response assessed via LC3B expression was increased by PM and CSE exposure, and this also attenuated by NAC treatment.
Conclusion
The toxic effects of PM and CSE co-exposure on human bronchial epithelial cells, including decreased cell viability and increased oxidative stress and autophagy levels, could be partly prevented by NAC treatment.
9.2021 Clinical Practice Guidelines for Diabetes Mellitus in Korea
Kyu Yeon HUR ; Min Kyong MOON ; Jong Suk PARK ; Soo-Kyung KIM ; Seung-Hwan LEE ; Jae-Seung YUN ; Jong Ha BAEK ; Junghyun NOH ; Byung-Wan LEE ; Tae Jung OH ; Suk CHON ; Ye Seul YANG ; Jang Won SON ; Jong Han CHOI ; Kee Ho SONG ; Nam Hoon KIM ; Sang Yong KIM ; Jin Wha KIM ; Sang Youl RHEE ; You-Bin LEE ; Sang-Man JIN ; Jae Hyeon KIM ; Chong Hwa KIM ; Dae Jung KIM ; SungWan CHUN ; Eun-Jung RHEE ; Hyun Min KIM ; Hyun Jung KIM ; Donghyun JEE ; Jae Hyun KIM ; Won Seok CHOI ; Eun-Young LEE ; Kun-Ho YOON ; Seung-Hyun KO ;
Diabetes & Metabolism Journal 2021;45(4):461-481
The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.
10.2021 Clinical Practice Guidelines for Diabetes Mellitus in Korea
Kyu Yeon HUR ; Min Kyong MOON ; Jong Suk PARK ; Soo-Kyung KIM ; Seung-Hwan LEE ; Jae-Seung YUN ; Jong Ha BAEK ; Junghyun NOH ; Byung-Wan LEE ; Tae Jung OH ; Suk CHON ; Ye Seul YANG ; Jang Won SON ; Jong Han CHOI ; Kee Ho SONG ; Nam Hoon KIM ; Sang Yong KIM ; Jin Wha KIM ; Sang Youl RHEE ; You-Bin LEE ; Sang-Man JIN ; Jae Hyeon KIM ; Chong Hwa KIM ; Dae Jung KIM ; SungWan CHUN ; Eun-Jung RHEE ; Hyun Min KIM ; Hyun Jung KIM ; Donghyun JEE ; Jae Hyun KIM ; Won Seok CHOI ; Eun-Young LEE ; Kun-Ho YOON ; Seung-Hyun KO ;
Diabetes & Metabolism Journal 2021;45(4):461-481
The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

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