• Infection and chemotherapy
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• v.50 no.4
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• pp.301-310
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• 2018

Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

• Archives of Plastic Surgery
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• v.46 no.6
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• pp.566-571
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• 2019

Background In Western nations, hidradenitis suppurativa (HS) typically affects the apocrine gland-bearing skin of people of African origin, women, smokers, and individuals with obesity. The clinical characteristics of HS in Korea and Japan, however, are reportedly different from those in the West. We therefore hypothesized that wet earwax is associated with HS because most East Asian people are genetically predisposed to produce dry earwax. Methods The medical charts of 53 Japanese patients with HS were reviewed retrospectively. Results Unlike the results of surveys conducted in Western nations, most of our patients were men (72%), whose buttocks were the most commonly affected site. Apocrine gland-bearing areas, such as the axilla, were affected less often. The proportion of HS patients with wet earwax was 51%, which was substantially higher than that found in the general Japanese population. Moreover, when patients with gluteal HS were excluded, the proportion of patients with wet earwax became even higher (68%). Conclusions Although the etiology of HS is unknown, our survey indicated that HS in apocrine gland-bearing skin, such as the axillary and anogenital areas, may be associated with wet earwax. As this study was conducted in a limited clinical setting, a nationwide, multicenter survey is warranted to clarify the clinical characteristics of HS in Japan.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.11
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• pp.4917-4920
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• 2016

For advanced non-small-cell lung cancer (NSCLC) cases, a platinum-based regimen is the first-line chemotherapy treatment. The excision repair cross-complementing group 1 (ERCC1) plays an important role in DNA repair and has been related to resistance to platinum chemotherapy. This study aimed to investigate the effects of the ERCC1 (C118T) polymorphism on treatment response in 26 Thai advanced NSCLC patients receiving first line platinum-based chemotherapy during January to July 2015 at King Chulalongkorn Memorial Hospital (KCMH). DNA was extracted from peripheral blood lymphocytes and the single nucleotide polymorphism of ERCC1 was genotyped using a real-time PCR method with the TaqMan assay. The distribution of C/C, C/T and T/T genotypes was 57.7 %, 34.6 % and 7.7 %, respectively. The response rate to platinum-based chemotherapy in the wild type (C/C) of ERCC1 (C118T) was better than with the variant types (C/T and T/T) but the difference was not statistically significant (29.7% vs 9.1%, P=0.274). The results showed that a genetic polymorphism in ERCC1 might influence patient response to platinum-based chemotherapy. Further multicenter studies are now required to confirm the results of our study.

• Journal of Korean Critical Care Nursing
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• v.13 no.3
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• pp.75-85
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• 2020

Purpose : This study aimed to identify the prevalence and risk factors of cognitive impairment in survivors discharged from the intensive care unit (ICU). Methods : This secondary analysis study utilized data from a multicenter prospective cohort of post-ICU patients. We analyzed the data of 175 patients enrolled in the primary cohort who completed the cognitive function evaluation three months after ICU discharge. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) scale. The cut-off points for cognitive impairment were < 23 for face-to-face evaluation and < 18 for telephone evaluation. Results : The prevalence of cognitive impairment three months after ICU discharge was 32.6%. Significant risk factors for cognitive impairment were age ≥ 60 years (OR=10.52, 95% CI=3.65~30.33, p<.001), education < high school graduation (OR=2.53, 95% CI=1.07~6.01, p=.035), unplanned ICU admission (OR=4.01, 95% CI=1.45-11.14, p=.008), and delirium in the ICU (OR=4.33, 95% CI=1.08-17.23, p=.038). Conclusion : ICU nurses should use preemptive strategies to reduce post-ICU cognitive impairment of patients with risk factors. It is necessary to frequently assess and detect early delirium in critically ill patients, while attempting various non-pharmacological interventions.

• Journal of Preventive Medicine and Public Health
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• v.36 no.4
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• pp.373-376
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• 2003

Objectives : Peripheral blood-buffy coat fractions (N=14,956) have been stored at $-70^{\circ}C$ in the headquarter of the Korean Multicenter Cancer Cohort (KMCC), since 1993. To study the future molecular etiology of cancers using specimens of the cohort, properly stored specimens are necessary, Therefore, the DNA-viability of the bully coat samples was investigated. Methods : Buffy coat fraction samples were randomly selected from various collection areas and years (N=100). The DNA viability was evaluate from the UV-absorbent ratios at 260/280nm and the PCH for $\beta$-globin was performed with genomic DNA isolated from the buffy coat. Results : PCR products were obtained from 85 and 98% of the C and H area-samples, respectively, using 50 or $100{\mu}l$ of the buffy coat. There were significant differences in the yields of the PCR-amplifications from the C and H areas (p<0.05), which was due to differences in the homogenization of the buffy coat fractions available as aliquots. The PCR-products were obtained from all of the samples (N=7) stored at the C area-local confer, but the other aliquots stored at the headquarter were not PCR-amplified, Therefore, the PCR products in almost all the samples, even including the DNA-degraded samples, were obtained. In addition, an improvement in the DNA isolation, i,e. approx. 1.6 fold, was found after using extra RBC lysis buffer. Conclusions : PCR products for $\beta$-globin were obtained from nearly all of the samples. The regional differences in the PCR amplifications were thought to have originated from the different sample-preparation and homogenization performance. Therefore, the long term-stored buffy coat species at the KMCC can be used for future molecular studies.

• Journal of Periodontal and Implant Science
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• v.53 no.4
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• pp.306-317
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• 2023

Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of Gastric Cancer
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• v.23 no.3
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• pp.499-508
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• 2023

Purpose: Despite scientific evidence regarding laparoscopic gastrectomy (LG) for advanced gastric cancer treatment, its application in patients receiving neoadjuvant chemotherapy remains uncertain. Materials and Methods: We used the 2019 Korean Gastric Cancer Association nationwide survey database to extract data from 489 patients with primary gastric cancer who received neoadjuvant chemotherapy. After propensity score matching analysis, we compared the surgical outcomes of 97 patients who underwent LG and 97 patients who underwent open gastrectomy (OG). We investigated the risk factors for postoperative complications using multivariate analysis. Results: The operative time was significantly shorter in the OG group. Patients in the LG group had significantly less blood loss than those in the OG group. Hospital stay and overall postoperative complications were similar between the two groups. The incidence of Clavien-Dindo grade ≥3 complications in the LG group was comparable with that in the OG group (1.03% vs. 4.12%, P=0.215). No statistically significant difference was observed in the number of harvested lymph nodes between the two groups (38.60 vs. 35.79, P=0.182). Multivariate analysis identified body mass index (odds ratio [OR], 1.824; 95% confidence interval [CI], 1.029-3.234; P=0.040) and extent of resection (OR, 3.154; 95% CI, 1.084-9.174; P=0.035) as independent risk factors for overall postoperative complications. Conclusions: Using a large nationwide multicenter survey database, we demonstrated that LG and OG had comparable short-term outcomes in patients with gastric cancer who received neoadjuvant chemotherapy.

• Korean Journal of Radiology
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• v.21 no.7
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• pp.869-879
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• 2020

Objective: To evaluate the performance of a convolutional neural network (CNN) model that can automatically detect and classify rib fractures, and output structured reports from computed tomography (CT) images. Materials and Methods: This study included 1079 patients (median age, 55 years; men, 718) from three hospitals, between January 2011 and January 2019, who were divided into a monocentric training set (n = 876; median age, 55 years; men, 582), five multicenter/multiparameter validation sets (n = 173; median age, 59 years; men, 118) with different slice thicknesses and image pixels, and a normal control set (n = 30; median age, 53 years; men, 18). Three classifications (fresh, healing, and old fracture) combined with fracture location (corresponding CT layers) were detected automatically and delivered in a structured report. Precision, recall, and F1-score were selected as metrics to measure the optimum CNN model. Detection/diagnosis time, precision, and sensitivity were employed to compare the diagnostic efficiency of the structured report and that of experienced radiologists. Results: A total of 25054 annotations (fresh fracture, 10089; healing fracture, 10922; old fracture, 4043) were labelled for training (18584) and validation (6470). The detection efficiency was higher for fresh fractures and healing fractures than for old fractures (F1-scores, 0.849, 0.856, 0.770, respectively, p = 0.023 for each), and the robustness of the model was good in the five multicenter/multiparameter validation sets (all mean F1-scores > 0.8 except validation set 5 [512 x 512 pixels; F1-score = 0.757]). The precision of the five radiologists improved from 80.3% to 91.1%, and the sensitivity increased from 62.4% to 86.3% with artificial intelligence-assisted diagnosis. On average, the diagnosis time of the radiologists was reduced by 73.9 seconds. Conclusion: Our CNN model for automatic rib fracture detection could assist radiologists in improving diagnostic efficiency, reducing diagnosis time and radiologists' workload.

• Korean Journal of Radiology
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• v.22 no.5
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• pp.697-705
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• 2021

Objective: To investigate the feasibility and the accuracy of the coronary CT angiography (CCTA)-derived Registry of Crossboss and Hybrid procedures in France, the Netherlands, Belgium and United Kingdom (RECHARGE) score (RECHARGECCTA) for the prediction of procedural success and 30-minutes guidewire crossing in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). Materials and Methods: One hundred and twenty-four consecutive patients (mean age, 54 years; 79% male) with 131 CTO lesions who underwent CCTA before catheter angiography (CA) with CTO-PCI were retrospectively enrolled in this study. The RECHARGECCTA scores were calculated and compared with RECHARGECA and other CTA-based prediction scores, including Multicenter CTO Registry of Japan (J-CTO), CT Registry of CTO Revascularisation (CT-RECTOR), and Korean Multicenter CTO CT Registry (KCCT) scores. Results: The procedural success rate of the CTO-PCI procedures was 72%, and 61% of cases achieved the 30-minutes wire crossing. No significant difference was observed between the RECHARGECCTA score and the RECHARGECA score for procedural success (median 2 vs. median 2, p = 0.084). However, the RECHARGECCTA score was higher than the RECHARGECA score for the 30-minutes wire crossing (median 2 vs. median 1.5, p = 0.001). The areas under the curve (AUCs) of the RECHARGECCTA and RECHARGECA scores for predicting procedural success showed no statistical significance (0.718 vs. 0.757, p = 0.655). The sensitivity, specificity, positive predictive value, and the negative predictive value of the RECHARGECCTA scores of ≤ 2 for predictive procedural success were 78%, 60%, 43%, and 87%, respectively. The RECHARGECCTA score showed a discriminative performance that was comparable to those of the other CTA-based prediction scores (AUC = 0.718 vs. 0.665-0.717, all p > 0.05). Conclusion: The non-invasive RECHARGECCTA score performs better than the invasive determination for the prediction of the 30-minutes wire crossing of CTO-PCI. However, the RECHARGECCTA score may not replace other CTA-based prediction scores for predicting CTO-PCI success.