• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.181-186
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• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• The Journal of Korean Obstetrics and Gynecology
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• v.21 no.3
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• pp.75-89
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• 2008

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• Korean Journal of Clinical Oncology
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• v.14 no.2
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• pp.108-115
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• 2018

Purpose: This study aimed to compare the results of treatment with adjuvant trastuzumab for 9 months versus 12 months in human epidermal growth factor 2 (HER2)-positive breast cancer patients. The primary endpoint was disease-free survival. Secondary endpoints included cardiac safety, tolerability, and overall survival. Methods: The study included 60 non-metastatic HER2-positive breast cancer patients. All study patients underwent surgery, received adjuvant chemotherapy, radiotherapy and hormonal therapy if indicated. Thirty patients were randomized in each group. Group I patients received adjuvant trastuzumab for 12 months, while group II patients received adjuvant trastuzumab for 9 months. Patients were assessed by clinical examination and Echocardiography during treatment. Results: After median follow-up of 12 months, 90% of the patients in group I were disease free and 83.3% of patients in group II were disease free (P=0.402). All studied population in both groups I and II were alive at the end of the 1-year follow-up period after the completion of adjuvant trastuzumab treatment thus overall survival is 100%. Conclusion: Trastuzumab is tolerable and its side effects are reversible. Nine months of adjuvant trastuzumab treatment is more cost effective than the standard 12 months.

• The Journal of Korean Academic Society of Nursing Education
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• v.29 no.3
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• pp.203-224
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• 2023

Purpose: This study aimed to evaluate the effectiveness of simulation-based education on communication and clinical judgment in nursing students and nurses. Methods: A systematic review and meta-analysis were conducted in accordance with the PRISMA guidelines. Seven databases were searched to obtain articles published in Korean or English. Of 12,864 articles reviewed, 36 were included in a systematic review and 23 in a meta-analysis. To estimate the size of the effects of simulation-based education, a meta-analysis was performed using the R package meta program. The risk of bias was assessed using RoB 2.0 and ROBINS-I. Results: The effect sizes (ES) of simulation-based education on communication and clinical judgment were ES=0.77, 95% confidence interval (95% CI)=0.43 to 1.12 on communication-related variables and ES=1.84, 95% CI=1.03 to 2.65 on clinical judgment. Conclusion: Simulation-based education for nursing students and nurses is useful for improving their communication and clinical judgment. Thus, it is necessary to develop and apply simulation-based education programs for nursing students and nurses to improve their abilities in communications and clinical judgment.

• International Journal of Heart Failure
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• v.6 no.1
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• pp.1-10
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• 2024

Heart failure (HF) stands as a prevalent chronic ailment, imposing a substantial burden on global healthcare systems due to recurrent hospitalizations, intricate management, persistent symptoms, and polypharmacy challenges. The augmentation of patient safety and treatment efficacy across various care stages, facilitated by a multidisciplinary HF team inclusive of a clinical pharmacist, emerges as paramount. Evidence underscores that the collaborative engagement of a physician and a clinical pharmacist engenders proficient and secure management, forestalling avoidable adversities stemming from drug reactions and prescription inaccuracies. This synergistic approach tailors treatments optimally to individual patients. Post-discharge, the vulnerability of HF patients to re-hospitalization looms large, historically holding sway as the foremost cause of 30-day readmissions. Diverse strategies have been instituted to fortify patient well-being, leading to the formulation of specialized transitional care programs that shepherd patients effectively from hospital to outpatient settings. These initiatives have demonstrably curtailed readmission rates. This review outlines a spectrum of roles assumed by clinical pharmacists within the healthcare cohort, spanning inpatient care, transitional phases, and outpatient services. Moreover, it traverses a compendium of studies spotlighting the affirmative impact instigated by integrating clinical pharmacists into these fields.

• Journal of Korean society of Dental Hygiene
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• v.16 no.2
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• pp.205-214
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• 2016

Objectives: The purpose of the study is to investigate the current status and radiographic safety management in Korea. Methods: A self-reported questionnaire was completed by 200 dental hygienists in Jeonbuk province from September 1, 2014 and October 31, 2014. The questionnaire consisted of general characteristics of the subjects, radiation knowledge, radiation safety management, and radiation exposure anxiety. Data were analyzed using SPSS 18.0 program. Results: Duration of clinical experience(r=0.142) and number of daily radiation shot(r=0.145) showed a positive correlation to radiation safety management, and a nrgative correlation to use of intraoral films and digital devices(r=-0.587). A logistic regression analysis was performed in order to evaluate the influence on radiography knowledge. The results showed that the factors had significant influences on the age group over 41 years old(OR 7.25; 95% CI 1.30-40.43) and those who took a position above team leader(OR 0.23; 95% CI 0.59-0.90). Conclusions: It is very important to have the safety management toward dental intraoral imaging and radiograpgic shot in the dental hygienists. Continuous efforts should be emphasized on radiographic safety management and behavior.

• Fisheries and Aquatic Sciences
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• v.24 no.1
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• pp.10-18
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• 2021

Norovirus (NoV) prevalence was investigated in 100 sewage samples collected from 35 individual septic tanks around the drainage basin of Jaran Bay, Korea in January, May, and July of 2017. Genotypes and diversity of NoV strains detected in sewage samples were also assessed using the conventional RT-PCR and phylogenetic analysis. NoV GI or GII were detected in 22 (22.0%) and 24 (24.0%) samples, respectively. Thirteen genotypes were identified with three dominant genotypes (GI.9, GII.5 and GII.17) and GII.17 showed relatively higher prevalence during the survey period. GII.17 strains were clustered into recombinant type variant or NoV GII.17 Kawasaki variant. NoV GII.17 strains were considered emergent epidemic variants with widespread circulation. NoV surveillance strategy should include both environmental (sewage) and clinical data to reveal minor NoV genotypes likely cause of asymptomatic or underreported infections in the local population.

• Biomolecules & Therapeutics
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• v.13 no.4
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• pp.199-206
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• 2005

Cell therapy (CT) is a group of techniques to treat human disorders by transplantation of cells which have been processed and propagated independent of the living body. Blood transfusion and bone marrow transplant have been the primary examples of cell therapy. With introduction of stem cell (SC) technologies, however, CT is perceived as the next generation of biologies to treat human diseases such as cancer, neurological diseases, and heart disease. Despite potential of cell therapy, insufficient guidelines have been implemented concerning safety test and regulation of cell therapy. This review addresses the safety issues to be resolved for the cell therapy, especially SC therapy, to be successfully utilized for clinical practice. Adequate donor cell screening must preceed to ensure safety in cell therapy. In terms of SC culture, controlled, standardized practices and procedures should be established. Further molecular studies should be done on SC development and differentiation to enhance safety level in cell therapy. Finally, animal model must be further installed to evaluate toxicity, new concepts, and proliferative potential of SC including alternative feeder layer of animal cells.

• Journal of Korean Academy of Nursing Administration
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• v.22 no.3
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• pp.239-250
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• 2016

Purpose: The aim of this study was to examine effects of patient safety culture and burnout on safety management activities with a focus on clinical experience of nurses in general hospitals. Methods: Self-administered questionnaires were given to nurses in a general hospital in C Province, and 107 questionnaires were used for final analysis. Collected data were analyzed using SPSS/WIN 21.0 Program for t-test, ANOVA, Pearson correlation coefficients, and multiple regression. Results: The highest score as perceived by general hospital nurses for patient safety culture was for 'Immediate superior/Manager' (3.84), for burnout, the highest score was for 'Emotional exhaustion' (4.13), and for safety management activities, the highest score was for 'Prevention of infection' (3.96). Patient safety culture and safety management activities perceived by general hospital nurses showed significant positive correlations (r=.35 p<.001). The correlations between burnout and safety management activities perceived by the nurses showed significant negative correlations (r=-.37, p<.001). Results of hierarchical regression analysis conducted to identify factors that affect safety management activities showed that patient safety culture (${\beta}=.40$ p<.001) was effective for controlling safety management activities. Conclusion: The findings indicate a need to build a patient safety culture that fits the characteristics and situations of various hospitals.

• Safety and Health at Work
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• v.1 no.1
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• pp.80-86
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• 2010

Objectives: We investigated the genotoxicity of two chemicals, methyl formate and 2-methylbutane, using male ICR mice bone marrow cells for the screening of micronucleus induction. Although these two chemicals have already been tested numerous times, a micronucleus test has not been conducted and the amounts used have recently been increased. Methods: 7 week male ICR mice were tested at dosages of 250, 500, and 1,000 mg/kg for methyl formate and 500, 1,000, and 2,000 mg/kg for 2-methlybutane, respectively. After 24 hours of oral administration with the two chemicals, the mice were sacrificed and their bone marrow cells were prepared for smearing slides. Results: As a result of counting the micronucleated polychromatic erythrocyte (MNPCE) of 2,000 polychromatic erythrocytes, all treated groups expressed no statistically significant increase of MNPCE compared to the negative control group. There were no clinical signs related with the oral exposure of these two chemicals. Conclusion: It was concluded that the two chemicals did not induce micronucleus in the bone marrow cells of ICR mice, and there was no direct proportion with dosage. These results indicate that the two chemicals have no mutagenic potential under each study condition.