1.A Multimodal Ensemble Deep Learning Model for Functional Outcome Prognosis of Stroke Patients
Hye-Soo JUNG ; Eun-Jae LEE ; Dae-Il CHANG ; Han Jin CHO ; Jun LEE ; Jae-Kwan CHA ; Man-Seok PARK ; Kyung Ho YU ; Jin-Man JUNG ; Seong Hwan AHN ; Dong-Eog KIM ; Ju Hun LEE ; Keun-Sik HONG ; Sung-Il SOHN ; Kyung-Pil PARK ; Sun U. KWON ; Jong S. KIM ; Jun Young CHANG ; Bum Joon KIM ; Dong-Wha KANG ;
Journal of Stroke 2024;26(2):312-320
Background:
and Purpose The accurate prediction of functional outcomes in patients with acute ischemic stroke (AIS) is crucial for informed clinical decision-making and optimal resource utilization. As such, this study aimed to construct an ensemble deep learning model that integrates multimodal imaging and clinical data to predict the 90-day functional outcomes after AIS.
Methods:
We used data from the Korean Stroke Neuroimaging Initiative database, a prospective multicenter stroke registry to construct an ensemble model integrated individual 3D convolutional neural networks for diffusion-weighted imaging and fluid-attenuated inversion recovery (FLAIR), along with a deep neural network for clinical data, to predict 90-day functional independence after AIS using a modified Rankin Scale (mRS) of 3–6. To evaluate the performance of the ensemble model, we compared the area under the curve (AUC) of the proposed method with that of individual models trained on each modality to identify patients with AIS with an mRS score of 3–6.
Results:
Of the 2,606 patients with AIS, 993 (38.1%) achieved an mRS score of 3–6 at 90 days post-stroke. Our model achieved AUC values of 0.830 (standard cross-validation [CV]) and 0.779 (time-based CV), which significantly outperformed the other models relying on single modalities: b-value of 1,000 s/mm2 (P<0.001), apparent diffusion coefficient map (P<0.001), FLAIR (P<0.001), and clinical data (P=0.004).
Conclusion
The integration of multimodal imaging and clinical data resulted in superior prediction of the 90-day functional outcomes in AIS patients compared to the use of a single data modality.
2.Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies
Yong Wha MOON ; Seung Ki KIM ; Keun Seok LEE ; Moon Hee LEE ; Yeon Hee PARK ; Kyong Hwa PARK ; Gun Min KIM ; Seungtaek LIM ; Seung Ah LEE ; Jae Duk CHOI ; Eunhye BAEK ; Hyesun HAN ; Seungjae BAEK ; Seock-Ah IM
Cancer Research and Treatment 2023;55(3):766-777
Purpose:
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
Materials and Methods:
Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.
Results:
Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.
Conclusion
This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.
3.Decrease of glycogen synthase kinase 3β phosphorylation in the rat nucleus accumbens shell is necessary for amphetamineinduced conditioned locomotor activity
Joong-Keun SHIN ; Wha Young KIM ; Haeun RIM ; Jeong-Hoon KIM
The Korean Journal of Physiology and Pharmacology 2022;26(1):59-65
Phosphorylation levels of glycogen synthase kinase 3β (GSK3β) negatively correlated with psychomotor stimulant-induced locomotor activity. Locomotor sensitization induced by psychomotor stimulants was previously shown to selectively accompany the decrease of GSK3β phosphorylation in the nucleus accumbens (NAcc) core, suggesting that intact GSK3β activity in this region is necessary for psychomotor stimulants to produce locomotor sensitization. Similarly, GSK3β in the NAcc was also implicated in mediating the conditioned effects formed by the associations of psychomotor stimulants. However, it remains undetermined whether GSK3β plays a differential role in the two sub-regions (core and shell) of the NAcc in the expression of drug-conditioned behaviors. In the present study, we found that GSK3β phosphorylation was significantly lower in the NAcc shell obtained from rats expressing amphetamine (AMPH)-induced conditioned locomotor activity. Further, we demonstrated that these effects were normalized by treatment with lithium chloride, a GSK3β inhibitor. These results suggest that the behavior produced by AMPH itself and a conditioned behavior formed by associations with AMPH are differentially mediated by the two sub-regions of the NAcc.
4.Updated clinical guideline for human papillomavirus vaccine: the Korean Society of Gynecologic Oncology guidelines
Hyun-Woong CHO ; Kyung-Jin MIN ; Sang-Hoon KWON ; Kidong KIM ; Sunghoon KIM ; Seok Ju SEONG ; Yong Jung SONG ; Keun Ho LEE ; Shin-Wha LEE ; Jeong-Won LEE ; Woong JU ; Young Tae KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2021;32(6):e94-
Since the human papillomavirus (HPV) vaccine guidelines were developed by the Korean Society of Gynecologic Oncology (KSGO) in 2011, 2016, and 2019, several recent studies on the efficacy and safety of HPV vaccines in middle-aged women and men have been reported. Furthermore, there has been an ongoing debate regarding the efficacy of the HPV vaccine in women with prior HPV infection or who have undergone conization for cervical intraepithelial neoplasia (CIN). We searched and reviewed studies on the efficacy and safety of the HPV vaccine in middle-aged women and men and the efficacy of the HPV vaccine in patients infected with HPV and those who underwent conization for CIN. The KSGO updated their guidelines based on the results of the studies included in this review.
5.Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial
Eun-Jae LEE ; Sun U. KWON ; Jong-Ho PARK ; Yong-Jae KIM ; Keun-Sik HONG ; Sungwook YU ; Yang-Ha HWANG ; Ji Sung LEE ; Juneyoung LEE ; Joung-Ho RHA ; Sung Hyuk HEO ; Sung Hwan AHN ; Woo-Keun SEO ; Jong-Moo PARK ; Ju-Hun LEE ; Jee-Hyun KWON ; Sung-Il SOHN ; Jin-Man JUNG ; Hahn Young KIM ; Eung-Gyu KIM ; Sung Hun KIM ; Jae-Kwan CHA ; Man-Seok PARK ; Hyo Suk NAM ; Dong-Wha KANG ;
Journal of Stroke 2020;22(1):108-118
Background:
and purpose Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage (PICASSO) trial that demonstrated the non-inferiority of cilostazol to aspirin and superiority of probucol to non-probucol for cardiovascular prevention in ischemic stroke patients (clinicaltrials.gov: NCT01013532). We aimed to determine whether on-treatment HDL-C changes by cilostazol and probucol influence the treatment effect of each study medication during the PICASSO study.
Methods:
Of the 1,534 randomized patients, 1,373 (89.5%) with baseline cholesterol parameters were analyzed. Efficacy endpoint was the composite of stroke, myocardial infarction, and cardiovascular death. Cox proportional hazards regression analysis examined an interaction between the treatment effect and changes in HDL-C levels from randomization to 1 month for each study arm.
Results:
One-month post-randomization mean HDL-C level was significantly higher in the cilostazol group than in the aspirin group (1.08 mmol/L vs. 1.00 mmol/L, P<0.001). The mean HDL-C level was significantly lower in the probucol group than in the non-probucol group (0.86 mmol/L vs. 1.22 mmol/L, P<0.001). These trends persisted throughout the study. In both study arms, no significant interaction was observed between HDL-C changes and the assigned treatment regarding the risk of the efficacy endpoint.
Conclusions
Despite significant HDL-C changes, the effects of cilostazol and probucol treatment on the risk of cardiovascular events were insignificant. Pharmacologically altered HDL-C levels may not be reliable prognostic markers for cardiovascular risk.
6.Clinical guideline for 9-valent HPV vaccine: Korean Society of Gynecologic Oncology Guideline
Kyung Jin MIN ; Sang Hoon KWON ; Kidong KIM ; Sunghoon KIM ; Hyun Jung KIM ; Seok Ju SEONG ; Yong Jung SONG ; Keun Ho LEE ; Shin Wha LEE ; Jeong Won LEE ; Suk Joon CHANG ; Woong JU ; Young Tak KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2019;30(2):e31-
In 2016, 9-valent human papillomavirus (HPV) vaccine has been newly introduced in Korea, thus the need to develop recommendations for the vaccine has raised. Until we decide to develop a guideline, no further studies on the bi-valent or quadri-valent HPV vaccine have been announced. We searched and reviewed the literatures focused on the efficacy of 9-valent HPV vaccine, the ideal age of 3-dose schedule vaccination, the efficacy of 9-valent HPV vaccine in middle-aged women, the efficacy of the 2-dose schedule vaccination, the safety of 9-valent HPV vaccine, the possibility of additional 9-valent HPV vaccination, and cross-vaccination of 9-valent HPV vaccine. So, Korean Society of Gynecologic Oncology (KSGO) developed a guideline only for 9-valent HPV vaccine.
Appointments and Schedules
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Female
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Humans
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Korea
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Male
;
Papillomavirus Vaccines
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Vaccination
7.Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement.
Shin Wha LEE ; Taek Sang LEE ; Dae Gy HONG ; Jae Hong NO ; Dong Choon PARK ; Jae Man BAE ; Seok Ju SEONG ; So Jin SHIN ; Woong JU ; Keun Ho LEE ; Yoo Kyung LEE ; Hanbyoul CHO ; Chulmin LEE ; Jiheum PAEK ; Hyun Jung KIM ; Jeong Won LEE ; Jae Weon KIM ; Duk Soo BAE
Journal of Gynecologic Oncology 2017;28(1):e12-
Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement.
Committee Membership
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Consensus*
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Delivery of Health Care
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Drug Therapy
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Endometrial Neoplasms
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Evidence-Based Medicine
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Female
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Humans
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Insurance
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Korea*
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Mass Screening
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Sarcoma
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Standard of Care
8.Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients.
Heawon ANN ; Ki Hyon KIM ; Hyun Young CHOI ; Hyun Ha CHANG ; Sang Hoon HAN ; Kye Hyung KIM ; Jin Soo LEE ; Yeon Sook KIM ; Kyung Hwa PARK ; Young Keun KIM ; Jang Wook SOHN ; Na Ra YUN ; Chang Seop LEE ; Young Wha CHOI ; Yil Seob LEE ; Shin Woo KIM
Infection and Chemotherapy 2017;49(3):205-212
BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. RESULTS: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. CONCLUSION: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.
Delivery of Health Care
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Diarrhea
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Drug-Related Side Effects and Adverse Reactions
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Dyspepsia
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Exanthema
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HIV
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HIV-1
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Humans
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Hypersensitivity
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Korea
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Male
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Myocardial Ischemia
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Pharmacoepidemiology
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RNA
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RNA-Directed DNA Polymerase
9.Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea.
Young Ok BAIK ; Seuk Keun CHOI ; Jae Woo KIM ; Jae Seung YANG ; Ick Young KIM ; Chan Wha KIM ; Jang Hee HONG
Journal of Korean Medical Science 2014;29(4):494-501
The safety, tolerability and immunogenicity of an oral cholera vaccine (OCV) was assessed in adult Korean male through an open-label, non-comparative clinical study. Two doses of vaccine with an interval of 2 weeks were given to 20 healthy subjects. A total of 7 adverse events occurred in 6 subjects. However, no clinically significant change was observed in electrocardiograms, vital signs, physical examinations, and clinical laboratory tests. The immunogenicity of OCV was evaluated by serum vibriocidal assay where anti-Vibrio cholerae O1 and O139 antibodies were measured at day 0, 14, and 28 of vaccine administration. The antibody titers ranged from < 2.5-5,120 for V. cholerae O1 Inaba, < 2.5-10,240 for V. cholerae O1 Ogawa and < 2.5-480 for V. cholerae O139. In addition, the fold increase in antibody titers ranged from 1-4,096 for O1 Inaba, 1-8,192 for O1 Ogawa, and 1-384 for O139. The seroconversion rate was 95% and 45% for O1 and O139 antibodies, respectively. Our study clearly shows that administration of two doses of OCV at a 2 week-interval increases an appropriate level of antibody titer in the serum of healthy Korean adult males (Clinical Trial Number, NCT01707537).
Administration, Oral
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Adult
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Antibodies, Bacterial/*blood/immunology
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Antibody Formation
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Cholera/*prevention & control
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Cholera Vaccines/adverse effects/*immunology
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Creatine Kinase/blood
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Humans
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Male
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Republic of Korea
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Toothache/etiology
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Vibrio cholerae O1/immunology
10.Erratum: Addition of Author's Affiliated Institute and Correction of the Author's Name. Corrected: Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea.
Yeong Ok BAIK ; Seuk Keun CHOI ; Jae Woo KIM ; Jae Seung YANG ; Ick Young KIM ; Chan Wha KIM ; Jang Hee HONG
Journal of Korean Medical Science 2014;29(8):1182-1182
We found errors in our published article.

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