• The Journal of KAIRB
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• v.5 no.2
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• pp.33-42
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• 2023

In the conduct of multicenter clinical trials, multiple reviews by multiple Institutional Review Board (IRB) result in unnecessary duplication of efforts, delays and increased expenses of the trials, placing unavoidable burdens on not only investigators and sponsors but also IRBs. During the coronavirus disease 2019 pandemic periods, as the need of multicenter clinical trials for its therapeutics and vaccines increased, a centralized IRB became more important than before in order to efficiently conduct the multicenter trials without unnecessary multiple reviews. Accordingly, government-supported central IBR as a new centralized IRB has launched to foster multicenter clinical trials while to avoid unnecessary reviews and delays and to reduce burdens of all stakeholders. However, there are still barriers to be overcome and problems to be solved in the central IRB. In this review, we introduce background and history of the central IRB and try to propose some strategies or solutions against the barriers and problems.

• Korean Journal of Radiology
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• v.22 no.12
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• pp.1938-1945
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• 2021

Breast radiologists are increasingly seeing patients with axillary adenopathy related to COVID-19 vaccination. Vaccination can cause levels I-III axillary as well as cervical lymphadenopathy. Appropriate management of vaccine-related adenopathy may vary depending on clinical context. In patients with current or past history of malignancy, vaccine-related adenopathy can be indistinguishable from nodal metastasis. This article presents imaging findings of oncology patients with adenopathy seen in the axilla or neck on cross-sectional imaging (breast MRI, CT, or PET-CT) after COVID-19 vaccination. Management approach and rationale is discussed, along with consideration on strategies to minimize false positives in vaccinated cancer patients. Time interval between vaccination and adenopathy seen on breast MRI, CT, or PET-CT is also reported.

• Anatomy and Cell Biology
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• v.56 no.1
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• pp.1-8
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• 2023

From the era of pre-historic times, the ancient Indians and the Greeks highlighted the importance of body and organ donations thereby emphasizing the need for anatomical sciences in medicine through the use of effective dissections for the same. However, after the Renaissance, there was a surge in dissections throughout the world, particularly in Europe, as a result of which various laws were enacted by governments concerning the procurement of bodies for the purpose of scientific dissections, which were later promulgated throughout the world through various anatomical acts. The situation in India was quite similar to that of Britain until its independence in 1947, after which different Indian states formulated their own anatomy acts that had their own merits and pitfalls. Hence, this literature review serves to highlight the various acts throughout history and would serve as a guide to emphasize the future perspectives of formulating a centralized unified anatomy act for the Indian nation that could possibly be the need of the hour.

• Journal of Preventive Medicine and Public Health
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• v.31 no.2 s.61
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• pp.265-274
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• 1998

To investigate the change of nitric oxide(NO), copper, and zinc in serum on smoking and alcohol ingestion in young adults, this study was performed in a cross-sectional study in 127 healthy men in Korea who had HBsAg(-), HCVAb(-), and no symptomatic liver, heart, gastrointestinal, chronic diseases, and inflammatory sign(lower than 10,000 white blood cell count in CBC). At the men's entry into the study, blood samples were drawn from each subject and immediately centrifuged for analysis of NO, copper, and zinc. Each man completed a questionnaire that provided information on smoking, alcohol intake and present and past medical history NO was analyzed by HPLC(Green et al., 1982), copper and zinc by atomic absorption spectrophotometer with air-acetylene flame and total cholesterol(TC) by Spectrum EPX. Smoking(number of cigarettes per day and pack-year) and alcohol intake was grouped fertile. Copper was adjusted for age and zinc and for age and TC. NO, copper, and zinc on smoking and alcohol ingestion were analyzed in general linear models, respectively. NO, copper and zinc in serum did not show statistical differences between non-smoking and high-smoking group and no-alcohol intake and high-alcohol intake group. This study suggested that copper, zinc, and NO was not. good biological marker for early effect by smoking and alcohol intake in young adults. However, selection bias should be considered in evaluation of this result. A large prospective study will be needed in advance on usefulness of copper, zinc, and NO as a marker for risk factors and early change of atherosclerosis.

• The Journal of Internal Korean Medicine
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• v.19 no.1
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• pp.97-113
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• 1998

BACKGROUND The purpose of this study was to investigate disability of the patients after stroke, clinical applicability and usefulness of the FIM in evaluating the functional abilities and to assess the characteristics of the patients after stroke. And this study examined difference by predictive factors on the treatment outcome. METHOD The study was composed of 31 stroke patients who were within 1 week after stroke and had been treated in hospital more than 4 weeks. Improving rate was measured by using the Functional Independence Measure(FIM), and the correlation was analyzed between Motor FIM and Cognitive FIM. We analyzed significant meaning statistically in the mean value of FIM. RESULT 1. There was no significant meaning statistically in the mean value of FIM that was between both at admission and after 2 weeks. But there was proportional correlation between both at admission and after 4 weeks, and significant meaning statistically. 2. There was proportional correlation between both FIM and Motor FIM, and significant meaning statistically. But there was no significant meaning statistically between both FIM and Cognitive FIM. 3. There was no significant meaning statistically between both FIM and sex, age, side of weakness, stroke subtype, hypertension, hypercholesterolemia, diabetes mellitus, heart disease, starting point of rehabilitation therapy and past history of cerebral vascular accident. While dysarthria affected functional recovery in stroke patients, and significant meaning statistically. CONCLUSION 1. FIM appeared to be a valid and reliable method to measure the functional abilities of the patients after stroke. 2. Only one thing between Motor FIM and score didn't influence FIM score. 3. Dysarthria affected functional recovery in stroke patients, and it is the statistically significant factor.

• Tuberculosis and Respiratory Diseases
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• v.69 no.2
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• pp.124-128
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• 2010

Septic pulmonary embolism is the process in which an infected thrombus becomes detached from its site of origin and lodges in a pulmonary artery, and is usually associated with infective endocarditis, especially right-sided, or infection-associated with indwelling catheters, peripheral septic thrombophlebitis, and periodontal diseases, etc. Here, we report a case of septic pulmonary embolism associated with tricuspid valve infective endocarditis. A 23-year-old female was admitted to our hospital, due to fever, sore throat, and myalgia. In her past medical history, she had undergone a surgical operation for closure of a ventricular septal defect, but was informed that the operation resulted in an incomplete closure. The initial chest radiograph demonstrated multiple rounded, parenchymal nodules in various sizes; several nodules had central lucency suggesting cavitations. Echocardiography demonstrated a large vegetation attached to the septal tricuspid valve leaflet, extending from right ventricular inflow tract to outflow tract. Computed tomography of thorax revealed bilateral peripheral nodules and wedge-shaped consolidation at various sizes, mostly accompanied by cavitations.

• Journal of Preventive Medicine and Public Health
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• v.45 no.1
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• pp.14-20
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• 2012

Objectives: The aim of this study was to evaluate and quantify the risk of both individual and combined health behaviors on premature mortality in middle aged men in Korea. Methods: In total, 14 533 male subjects 40 to 59 years of age were recruited. At enrollment, subjects completed a baseline questionnaire, which included information about socio-demographic factors, past medical history, and life style. During the follow-up period from 1993 to 2008, we identified 990 all-cause premature deaths using national death certificates. A Cox proportional hazard regression model was used to estimate the hazard ratio (HR) of each health risk behavior, which included smoking, drinking, physical inactivity, and lack of sleep hours. Using the Cox model, each health behavior was assigned a risk score proportional to its regression coefficient value. Health risk scores were calculated for each patient and the HR of all-cause premature mortality was calculated according to risk score. Results: Current smoking and drinking, high body mass index, less sleep hours, and less education were significantly associated with all-cause premature mortality, while regular exercise was associated with a reduced risk. When combined by health risk score, there was a strong trend for increased mortality risk with increased score (p-trend < 0.01). When compared with the 1-9 score group, HRs of the 10-19 and 20-28 score groups were 2.58 (95% confidence intervals [CIs], 2.19 to 3.03) and 7.09 (95% CIs, 5.21 to 9.66), respectively. Conclusions: Modifiable risk factors, such as smoking, drinking, and regular exercise, have considerable impact on premature mortality and should be assessed in combination.

• Tuberculosis and Respiratory Diseases
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• v.41 no.5
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• pp.521-530
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• 1994

Background : The past studies on prediction formulas of pulmonary function parameters in healthy nonsmoking Korean adults have been performed in relatively small number of subjects and the reported results were restricted on a few parameters. Also there was no systematic investigation into the effect of smoking on pulmonary function parameters in smokers who have no respiratory symptoms. Therefore we attempted to establish prediction formulas of pulmonary function parameters and examined the effect of smoking on pulmonary function parameters. Methods We analyzed the result of parameters derived from the forced expiratory spirogram in 1,067 nonsmoking subjects from June in 1990 to December in 1991. They consisted of 306 males and 761 females and had neither respitatory symptoms nor history of respiratory disease. We derived prediction formulas by multiple linear regression method from their age, heights, and weights in each sex. To examine the effect of smoking on pulmonary function parameters, we classified 383 smoking men into three groups according to the past amount of smoking as follows : i.e. group of smokers who have smoked below 10 pack-years, 10-20 pack-years and above 20 pack-years. Regarding each group of past smoking as an independent dummy variable, we analyzed pulmonary function parameters including nonsmoking men as a baseline by multiple linear regression. We evaluated the smoking effect on pulmonary function parameters according to estimated p-value. Result : 1) Prediction formulas for pulmonary function parameters in each sex were derived. 2) The past smoking less than 10 pack-years does not give any effect on pulmonary function parameters. The past smoking of 10~20 pack-years showed significant negative correlation with $FEV_1$/FVC and FEF 25~75%, and the smoking above 20 pack years showed negative correlation with $FEV_1$ and $FEV_1$/FVC. Conclusion : We have got prediction formulas of pulmonary function parameters which is driven from forced expiratory spirogram in nonsmoking Korean adults by multiple linear regression from age, heights and weights of subjects. The past smoking more than 10 pack-years showed negative correlation with some pulmonary function parameters of airflow obstruction.

• Journal of The Korean Society of Clinical Toxicology
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• v.14 no.2
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• pp.92-99
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• 2016

Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

• Journal of Preventive Medicine and Public Health
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• v.32 no.3
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• pp.347-354
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• 1999

Objective: This paper examines the possible toxicity to immune system in farmers chronically exposed to pesticides. Methods : We compared 43 male farmers exposed to pesticides with 29 male residents who had neither past nor current pesticides exposure. The selected variables for studying immunotoxicity were WBC, CD3, CD4, CD8, CD19, CD56, IgG, IgA, IgM, and IL-2. As part of the baseline questionnaires for the immunotoxicity, subjects were asked about kinds of farming, posticides exposure and medical history. Results : None of the variables for studying immunotoxicity showed statistically significant difference between the two groups. Although the results were not statistically significant, CD4 and the CD4/CD8 ratio decreased and CD8 increased. These effects showed a dose response change with exposure level. In the exposed group, the values of CD3, CD4, CD4/CD8 and CD19 decreased and those of the CD8 and CD56 increased compared to the non-exposed group. Also there was higher prevalence of self-reported disease in the exposed group compared to the non-exposed group. Conclusions: Although statistically significant differences in indices of immunotoxicity in farmers exposed to pesticides were not shown, the results suggest that pesticides may decrease immune function. More advanced test methods for immunotoxicity need to be developed and tested in larger population to detect immunotoxic effects of pesticides.