• Title/Summary/Keyword: Risk Excluded

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Association between Serum Cystatin C and Vascular Complications in Type 2 Diabetes Mellitus without Nephropathy

  • Kim, Hye Jeong;Byun, Dong Won;Suh, Kyoil;Yoo, Myung Hi;Park, Hyeong Kyu
    • Diabetes and Metabolism Journal
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    • v.42 no.6
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    • pp.513-518
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    • 2018
  • Background: Recent studies have correlated serum cystatin C (CysC) with vascular complications, but few studies have investigated this correlation in diabetes patients without nephropathy. This study aimed to evaluate if higher serum CysC levels increase the risk for vascular complications in type 2 diabetes mellitus patients with normal renal function or mild renal impairment. Methods: A total of 806 consecutive patients with type 2 diabetes mellitus who were admitted to the diabetes center of Soonchunhyang University Hospital for blood glucose control were retrospectively reviewed. Patients with nephropathy were excluded. Subjects were categorized into quartiles of serum CysC levels (Q1, ${\leq}0.65mg/L$; Q2, 0.66 to 0.79 mg/L; Q3, 0.80 to 0.94 mg/L; and Q4, ${\geq}0.95mg/L$). Results: The proportion of patients with diabetic retinopathy (DR) (P for trend <0.001), coronary heart disease (CHD) (P for trend <0.001), and stroke (P for trend <0.001) increased across the serum CysC quartiles. After adjustment for confounding factors, the highest serum CysC level remained a significant risk factor for DR (odds ratio [OR], 1.929; 95% confidence interval [CI], 1.007 to 4.144; P=0.040). Compared with Q1, a significant positive association was observed between serum CysC and CHD in Q2 (OR, 7.321; 95% CI, 1.114 to 48.114; P=0.012), Q3 (OR, 6.027; 95% CI, 0.952 to 38.161; P=0.020), and Q4 (OR, 8.122; 95% CI, 1.258 to 52.453; P=0.007). No associations were observed between CysC and stroke after additional adjustment for confounding variables. Conclusion: Serum CysC levels are independently associated with DR and CHD, suggesting that CysC may be useful for identifying type 2 diabetes mellitus patients without nephropathy who are at high risk for vascular complications.

Bioprosthesis in the Mitral Position: Bovine Pericardial versus Porcine Xenograft

  • Han, Dong Youb;Park, Sung Jun;Kim, Ho Jin;Jung, Sung-Ho;Choo, Suk Jung;Chung, Cheol Hyun;Lee, Jae Won;Kim, Joon Bum
    • Journal of Chest Surgery
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    • v.55 no.1
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    • pp.69-76
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    • 2022
  • Background: While the use of bioprosthetic valves for mitral valve replacement (MVR) is increasing, very few studies have compared bovine pericardial and porcine valves in the mitral position to help guide bioprosthetic selection. Methods: In the present study, patients who underwent MVR using bovine pericardial valves were compared with those who underwent MVR with porcine bioprostheses between January 1996 and July 2018. Those with prior MVR, infective endocarditis, congenital mitral valve disease, or ischemic mitral regurgitation were excluded. The primary outcomes were structural valve deterioration (SVD) and mitral valve reoperation from any cause, and death was regarded as a competing risk. Competing risk analysis and propensity score-matching were used for comparisons. Results: Among the 388 patients enrolled, pericardial and porcine bioprostheses were implanted in 217 (55.9%) and 171 (44.1%), respectively. Propensity score-matching yielded 122 pairs of patients that were well-balanced for all baseline covariates. No significant differences were observed between the groups in unadjusted (p=0.09) and adjusted overall survival (hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.72-1.76; p=0.60). Competing risk analysis revealed no significant differences in the risks of mitral reoperation (HR, 1.07; 95% CI, 0.50-2.27; p=0.86) and development of SVD (HR, 1.57; 95% CI, 0.56-4.36; p=0.39) between the groups. Matched population analysis confirmed similar results regarding reoperation (HR, 0.99; 95% CI, 0.40-3.22; p=0.98) and SVD (HR, 1.39; 95% CI, 0.41-4.73; p=0.60). Conclusion: No significant differences in survival or valve durability were observed between bovine pericardial and porcine bioprosthetic MVR. These findings require further validation through studies with larger sample sizes.

Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools (자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석)

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • 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.

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A Study on Determinants of Export Payment Terms in Korean Small & Medium Enterprises (한국 중소기업의 수출대금결제방식 결정요인에 관한 연구)

  • Choi, Kwang-Ho
    • Korea Trade Review
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    • v.43 no.2
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    • pp.159-180
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    • 2018
  • The purpose of this study is to contribute to the efficient selection of SMEs' trade settlement system through the empirical analysis of determinants of the payment method of SMEs in Korea. In the previous study, external factors, internal factors, settlement characteristics, transaction goods, transaction amount factors and risk management factors were used. Questionnaires were excluded from analysis, and the number of validated samples collected was 155. To conduct the study, all empirical analyses were verified at the significance level p <.005. Statistical analysis was performed using the SPSSWIN 18.0 program. Analysis results found the payment method used in the company was based on the year of establishment, export items, transaction area, type of transaction, and size of company. Empirical analysis showed that factors influencing the choice of the letter of credit are external factors, internal factors, the risk management factors, and the transaction amounts, etc. Results of this study are as follows: First, the effects of external factors, internal factors, settlement characteristics, and transaction amounts were significant. Hypothesis testing of collections trading methods has not been adopted in all areas presented. In order to utilize the research results, we conducted the study and comparison of the payment method of the income.

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Moxibustion for Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis (전립선 비대증에 대한 뜸치료의 효과 : 체계적 문헌고찰과 메타분석)

  • Bae, Go-eun;Lee, Seung-hwan;Hong, Jin-woo;Lee, In;Kim, So-yeon;Choi, Jun-young;Han, Chang-woo;Yun, Young-ju;Park, Seong-ha;Kwon, Jung-nam
    • The Journal of Internal Korean Medicine
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    • v.39 no.3
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    • pp.372-388
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    • 2018
  • Objective: This study evaluates the effectiveness and safety of moxibustion for benign prostatic hyperplasia (BPH). Methods: Using the keywords "benign prostatic hyperplasia", "benign prostatic hypertrophy", "benign prostatic enlargement", "prostatic hyperplasia", and "moxibustion", we searched papers in numerous databases, including National Discovery for Science Leaders (NDSL), Korean Traditional Knowledge Portal (KTKP), Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Sharing Service (RISS), PubMed, Embase, and CENTRAL. The search range included randomized controlled trials (RCTs). Papers not matched with inclusion criteria were excluded. The methodological quality of each RCT was assessed using the Cochrane risk-of-bias tool. Where appropriate, meta-analyses were performed. Results: Initially, 77 studies were found. Of these, 11 duplicate studies were removed and 27 were excluded following title and abstract screening. After the remaining 39 papers were scanned, 13 RCTs were selected and analyzed. Among these 13 RCTs, five compared moxibustion therapy and oral medication, seven compared moxibustion plus acupuncture therapy and oral medication, and one compared moxibustion plus acupuncture therapy and sham-moxibustion. The meta-analysis showed positive results for the use of moxibustion therapy in terms of International Prostate Symptom Score (IPSS), Quality Of Life (QOL), Maximum Flow Rate (Qmax), Prostate Volume (PV), and the efficacy rate. The meta-analysis showed positive results for the use of moxibustion plus acupuncture therapy in terms of IPSS, QOL, and the efficacy rate. Conclusions: This meta-analysis of clinical trials suggests that moxibustion is effective intreating BPH patients. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

Prognosis in the Patients with Prolonged Extracorporeal Membrane Oxygenation

  • Kim, Tae-Hun;Lim, Cheong;Park, Il;Kim, Dong-Jin;Jung, Yo-Chun;Park, Kay-Hyun
    • Journal of Chest Surgery
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    • v.45 no.4
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    • pp.236-241
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    • 2012
  • Background: Prolonged usage of extracorporeal membrane oxygenation (ECMO) may induce multi-organ failure. This study is aimed to evaluate prognostic factors in the patients with ECMO. Also, the prognosis of ECMO with Kidney Injury Network Scoring system is studied. Materials and Methods: From May 2005 to July 2011, 172 cases of ECMO were performed. The cases of perioperative use of ECMO were excluded. Renal failure patient and younger than 15 years old one were also excluded. As a result, 26 cases were enrolled in this study. Male patients were 15 (57.7%), and mean age was $56.57{\pm}17.03$ years old. Demographic data, ECMO parameters, weaning from ECMO, and application of continuous renal replacement therapy are collected and Acute Kidney Injury Network (AKIN) scores were evaluated just before ECMO and day 1, day 2 during application of ECMO. Results: Venoarterial ECMO was applied in 22 cases (84.6%). The reasons for applications of ECMO were cardiac origin in 21 (80.8%), acute respiratory distress syndrome in 4, and septic shock in 1 case. Successful weaning from ECMO was achieved in 15 cases (57.7%), and survival discharge rate was 9 cases (34.6%). Mean duration of application of ECMO was $111.39{\pm}54.06$ hours. In univariate analysis, myocarditis was independent risk factors on weaning failure. Using the receiver operating characteristic curve, level of hemoglobin on 24 hours after ECMO, and base excess on 48 hours after ECMO were showed more than 0.7. AKIN score was not matched the prognosis of the patients with ECMO. Conclusion: In our study, the prognosis of the patients with myocarditis was poor. Hemoglobin level at first 24 hours, and degree of acidosis at 48 hours were useful methods in relating with prognosis of ECMO. AKIN scoring system was not related with the prognosis of the patients. Further study for prognosis and organ injury during application ECMO may be needed.

Clinical Characteristics of Bacteremia in Children with Cancer (단일기관에서 소아암 환자에서 화학요법 중 발생한 균혈증의 임상 양상)

  • Chang, Mi Sun;Sung, Ki Woong;Kim, Yae Jean
    • Pediatric Infection and Vaccine
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    • v.18 no.2
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    • pp.201-206
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    • 2011
  • Purpose : Bacteremia is one of the most common causes of morbidity and mortality in children with cancer. The aim of this study was to evaluate the clinical features of bacteremia in pediatric cancer patients. Methods : We retrospectively analyzed bacteremia episodes occurred in pediatric cancer patients at Samsung Medical Center from January 2008 to December 2010. We excluded bacteremia episodes after hematopoietic stem cell transplantation. Results : A total of 141 blood cultures were positive in 121 patients. Thirteen cultures due to contamination were excluded. For analysis, 128 bacteremia episodes in 108 children were included. Gram-positive organisms accounted for 46.9% (60/ 128) and gram-negative organisms for 53.1% (68/128). The source of bacteremia was identified in 21.1% of episodes. Bacteremia due to catheter related infection was observed in 9.4% of episodes (12/128 episodes) and gram-positive organisms were isolated in 75% of episodes (9/12). There were 10 cases (7.8%) of bacteremia associated with septic shock and gramnegative organisms were isolated in 80% of episodes (8/10). Relapses were documented within 30 days in 2 patients who cleared bacteremia which was confirmed after negative blood cultures. Mortality associated with bacteremia was not observed. Conclusion : Continuous monitoring is needed to maintain the tailored strategies to manage pediatric cancer patients with neutropenic fever who are at high risk of developing bacteremia in each institution.

A Comprehensive Analysis of the Association of Psoas and Masseter Muscles with Traumatic Brain Injury Using Computed Tomography Anthropometry

  • Cho, Hang Joo;Hwang, Yunsup;Yang, Seiyun;Kim, Maru
    • Journal of Korean Neurosurgical Society
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    • v.64 no.6
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    • pp.950-956
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    • 2021
  • Objective : Psoas and masseter muscles are known markers of sarcopenia. However, the relative superiority of either muscle as a marker is unclear. Therefore, this study analyzed the two muscles in patients with a prognosis of traumatic brain injury (TBI). Methods : Patients with TBI visiting a regional trauma center between January 2017 and December 2018 were selected, and their medical records were reviewed. TBI patients with an abbreviated injury score (AIS) of 4 or 5 were selected. Patients with an AIS of 4 or 5 at the chest, abdomen, and extremity were excluded. Patients with a hospital stay of 1 to 2 days were excluded. Both muscle areas were measured based on the initial computed tomography. The psoas muscle index (PMI) and the masseter muscle index (MMI) were calculated by dividing both muscle areas by height in meters squared (cm2/m2). These muscle parameters along with other medical information were used to analyze mortality and the Glasgow outcome scale (GOS). Results : A total of 179 patients, including 147 males (82.1%), were analyzed statistically. The mean patient age was 58.0 years. The mortality rate was 16.8% (30 patients). The mean GOS score was 3.7. Analysis was performed to identify the parameters associated with mortality, which was a qualitative study outcome. The psoas muscle area (16.9 vs. 14.4 cm2, p=0.028) and PMI (5.9 vs. 5.1 cm2/m2, p=0.004) showed statistical differences between the groups. The PMI was also statistically significant as a risk factor for mortality in logistic regression analysis (p=0.023; odds ratio, 0.715; 95% confidence interval, 0.535-0.954). Quantitative analyses were performed with the GOS scores. Bivariate correlation analysis showed a statistically significant correlation between PMI and GOS scores (correlation coefficient, 0.168; p=0.003). PMI (p=0.004, variation inflation factor 1.001) was significant in multiple regression analysis. The masseter muscle area and MMI did not show significance in the study. Conclusion : Larger PMI was associated with statistically significant improved survival and GOS scores, indicating its performance as a superior prognostic marker. Further analyses involving a larger number of patients, additional parameters, and more precise settings would yield a better understanding of sarcopenia and TBI.

Environmental Impact Assessment and Evaluation of Environmental Risks (환경영향평가와 환경위험의 평가)

  • Niemeyer, Adelbert
    • Journal of Environmental Impact Assessment
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    • v.4 no.3
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    • pp.41-48
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    • 1995
  • In former times the protection of our environment didn't play an important role due to the fact that emissions and effluents were not considered as serious impacts. However, opinions and scientific measurements meanwhile confirmed that the impacts are more serious than expected. Thus measures to protect our earth has to be taken into consideration. A part of these measures in the Environmental Impact Assessment (EIA). One of the most important parts of the EIA is the collection of basic datas and the following evaluation. Experience out of the daily business of Gerling Consulting Group shows that the content of the EIA has to be revised and enlarged in certain fields. The historical development demonstrated that in areas in which the population and the industrial activities reached high concentration there is a high necessity to develop strict environmental laws and regulations. Maximum values of the concentration of hazardous materials were fixed concerning the emission into and water. Companies not following these regulations were punished. The total amount of environmental offences increased rapidly during the last decade, at least in Germany. During this development the public consciousness concerning environmental affairs increased as well in the industrialized countries. But it could clearly be seen that the development in the field of environmental protection went into the wrong direction. The technologies to protect the environment became more and more sophisticated and terms as: "state of the art" guided more and more to lower emissions, Filtertechnologies and wastewater treatment for example reached a high technical level-but all these sophisticated technologies has one and the same characteristic: they were end-of-the pipe solutions. A second effect was that this kind of environmental protection costs a lot of money. High investments are necessary to reduce the dust emission by another ppm! Could this be the correct way? In Germany the discussion started that the environmental laws reduce the attractivity to invest or to enlarge existing investments within the country. Other countries seem to be not so strict with controlling the environmental laws which means it's simply cheaper to produce in Portugal or Greece. Everybody however knows that this is not the correct way and does not solve the environmental problems. Meanwhile the general picture changes a little bit and we think it changes into the correct direction "End-of-the-pipe" solutions are still necessary but this word received a real negative touch and nobody wants to be brought into connection with this word received a real negative touch and nobody wants to be brought into connection with this word especially in connection with environmental management and safety. Modern actual environmental management starts in a different way. Thoughts about emissions start in the very beginning of the production, they start with the design of the product and modification of traditional modes of production. Basis of these ideas are detailed analyses of products and processes. Due to the above mentioned facts that the public environmental consciousness changed dramatically a continous environmental improvement of each single production plant has to be guarantied. This question is already an important question of the EIA. But it was never really checked in a wholistic approach. Environmental risks have to be taken into considerations during the execution of an EIA. This means that the environmental risks have to be reduced down to a capable risk-level. Environmental risks have to be considered within the phase of planning, during the operation of a plant and after shut down. The experience shows that most of the environmental relevant accidents were and caused by human fault. Even in highly protected plants the human risk-factor can not be excluded during evaluation of the risk-potential. Thus the approach of an EIA has to regard technical evaluations as well as organizational thoughts and the human factor. An environmental risk is a threat to the environment. An analysis of the risk concerning the organizational and human aspect however never was properly executed during an EIA. A possible solution could be to use an instrument as the actual EMAS (Environmental Management System) of the EC for more accurate evaluation of the impact to the environment during an EIA. Organizations or investors could demonstrate by an approved EMAS or even by showing their installment of EMAS that not only the technical level of the planned investment meets the requested standards but as well the actual or planned management is able to reduce the environmental impact down to a bearable level.

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Human Health Risk, Environmental and Economic Assessment Based on Multimedia Fugacity Model for Determination of Best Available Technology (BAT) for VOC Reduction in Industrial Complex (산업단지 VOC 저감 최적가용기법(BAT) 선정을 위한 다매체 거동모델 기반 인체위해성·환경성·경제성 평가)

  • Kim, Yelin;Rhee, Gahee;Heo, Sungku;Nam, Kijeon;Li, Qian;Yoo, ChangKyoo
    • Korean Chemical Engineering Research
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    • v.58 no.3
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    • pp.325-345
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    • 2020
  • Determination of Best available technology (BAT) was suggested to reduce volatile organic compounds (VOCs) in a petrochemical industrial complex, by conducting human health risk, environmental, and economic assessment based on multimedia fugacity model. Fate and distribution of benzene, toluene, ethylbenzene, and xylene (BTEX) was predicted by the multimedia fugacity model, which represent VOCs emitted from the industrial complex in U-city. Media-integrated human health risk assessment and sensitivity analysis were conducted to predict the human health risk of BTEX and identify the critical variable which has adverse effects on human health. Besides, the environmental and economic assessment was conducted to determine the BAT for VOCs reduction. It is concluded that BTEX highly remained in soil media (60%, 61%, 64% and 63%), and xylene has remained as the highest proportion of BTEX in each environment media. From the candidates of BAT, the absorption was excluded due to its high human health risk. Moreover, it is identified that the half-life and exposure coefficient of each exposure route are highly correlated with human health risk by sensitivity analysis. In last, considering environmental and economic assessment, the regenerative thermal oxidation, the regenerative catalytic oxidation, the bio-filtration, the UV oxidation, and the activated carbon adsorption were determined as BAT for reducing VOCs in the petrochemical industrial complex. The suggested BAT determination methodology based on the media-integrated approach can contribute to the application of BAT into the workplace to efficiently manage the discharge facilities and operate an integrated environmental management system.