• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• 무역상무연구
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• 제44권
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• pp.213-238
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• 2009

This thesis examines the problems faced in the clearance procedures of Korea's e-customs system for which improvements are necessary, and suggests various ways of overcoming those problems. Practical implications regarding the advancement of Korea's e-customs system are as follows. First, the substructure of the e-customs clearance system, which is the basis for the establishment of a global single window, should be developed into a more modern and advanced system. Second, additional improvements in the law are required to render the broad array of Internet-based export and import documents legally binding. Third, customized services should be provided in order to improve the operating efficiency of the e-customs clearance system. Fourth, the reputation of Korea's e-customs clearance system should be raised via the strengthening of a cooperative system between concerned parties, including exporters and importers. This innovative approach to systematic improvements will come about when we can simplify current customs clearance procedures and establish a fairer customs inspection administration regime. Additionally, when we review the methods intrinsic to our customs system, we must emphasize the urgency of proper completion of related systems and arrangements in the trade business and similar fields.

• 구강회복응용과학지
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• 제29권4호
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• pp.384-390
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• 2013

가철성 국소의치의 장착 과정을 적절하게 시행하였다면 장착 후의 문제들을 최소화할 수 있으나, 그럼에도 불구하고 기능, 심미, 발음상의 문제나 불편감 등의 문제들이 발생할 수 있다. 가철성 국소의치 장착 후 1주일 이내에 점검을 위한 약속이 이루어져야 한다. 환자들에게 의치를 사용하는 동안 겪었던 문제들에 대해 질문하고 구강조직과 의치를 철저히 검사해야 하며, 검사 과정 동안에 조직 손상 등을 발견할 수도 있다. 그리고 그 원인을 진단하고 적절한 치료를 시행하여 이러한 문제들을 해결하도록 해야 한다.

• Communications for Statistical Applications and Methods
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• 제23권6호
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• pp.497-515
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• 2016

Modern processes often monitor more than one quality characteristic that are referred to as multivariate statistical process control (MSPC) procedures. The MSPC is the most rapidly developing sector of statistical process control and increases interest in the simultaneous inspection of several related quality characteristics. Most multivariate detection procedures based on a multi-normality assumptions are independent, but there are many processes that assume non-normality and correlation. Many multivariate control charts have a lack of related joint distribution. Copulas are tool to construct multivariate modelling and formalizing the dependence structure between random variables and applied in several fields. From copula literature review, there are a few copula to apply in MSPC that have multivariate control charts, and represent a successful tool to identify an out-of-control process. This paper presents various types of copulas modelling for the multivariate control chart. The performance measures of the control chart are the average run length (ARL) and the average number of observations to signal (ANOS). Furthermore, a Monte Carlo simulation is shown when the observations were from an exponential distribution.

• The Korean Journal of Pain
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• 제34권4호
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• pp.487-500
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• 2021

Background: Although the erector spinae plane block has been used in various truncal surgical procedures, its clinical benefits in patients undergoing spinal surgery remain controversial. The aim of this meta-analysis was to evaluate the clinical benefits of erector spinae plane block in patients undergoing spinal surgery. Methods: We searched the Cochrane Library, PubMed, EMBASE, and China National Knowledge Infrastructure for randomized controlled trials comparing the erector spinae plane block with a nonblocked control for spinal surgery. Results: Twelve studies encompassing 696 subjects were included in our systematic review and meta-analysis. We found that the erector spinae plane block decreased postoperative pain scores and opioid consumption in the postoperative and intraoperative periods. Moreover, it prolonged the time to the first rescue analgesic, reduced the number of patients who required rescue analgesia, and lowered the incidence of postoperative nausea and vomiting. However, it did not exhibit efficacy in decreasing the incidence of urinary retention and itching or shortening the length of hospital stays, or the time to first ambulation. Conclusions: Erector spinae plane block improves analgesic efficacy among patients undergoing spinal surgery compared with nonblocked controls; however, there is insufficient evidence regarding the benefits of erector spinae plane block for rapid recovery.

• 대한암한의학회지
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• 제25권2호
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• pp.1-11
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• 2020

Objectives: The effectiveness of acupuncture on cancer pain is relatively well established, while there have been few clinical studies on pharmacopuncture on that. This research was aimed to investigate a trend of pharmacopuncture treatment for cancer pain and to propose information for further research. Methods: Clinical studies on pharmacopuncture for cancer pain were collected from 5 Korean medical databases. And the studies were analyzed by classifications of cancer, chief complaints, interventions, treating skills, additional treatments, treatment session, outcome measures, results and adverse effects. Results: The literatures were 8 case reports and 1 randomized controlled trial. Interventions were pharmacopunctures of soyeom, mountain ginseng, Harpagophyti Radix, snake venom, Trionycis Carapax, bee venom, Aconitum Ciliare Decaisne. Treatment skills, procedures, and indications of each pharmacopuncture were different. An adverse effects of bruising, bleeding, mild chilling, sore throat and pain were mentioned on snake venom and bee venom treatment. Conclusions: An appropriate interventions and treatment skills should be selected according to the type of cancer pain. And treatment procedures to ensure safety must be developed.

• PNF and Movement
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• 제12권2호
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• pp.51-61
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• 2014

Purpose: This study aimed to review articles related to PNF and easily provide information to readers who have difficulty reading papers or using PNF in clinics without a background in statistical knowledge. Methods: We used PubMed to collect papers on international studies and we conducted a search on April 28, 2014. Keywords used for the PubMed search were "PNF" and "Proprioceptive Neuromuscular Facilitation". The search results identified 765 papers that had been published since 1954. To target the papers for review, we selected 66 papers, excluding papers that were not published in online journals and papers that were written in a second language. Results: The reviewed papers consisted of studies that addressed basic principles and procedures, combined with other interventions, including PNF stretching concepts, and other diseases with PNF concepts. The articles related to basic procedures and principles reported on optimal contraction intensity, patterns, and irradiation. The articles related to stretching and strengthening reported on stretching the hamstring muscles in healthy subjects, in combination with other interventions such as neuromobilization, clinical massage, kinesio taping, and water immersion. The articles related to specific diseases reported on stroke, low back pain, athletic injury, total knee replacement, etc. Conclusion: In the 66 articles reviewed for this study, there was little evidence that PNF has therapeutic value. However, in future research on the application of PNF, investigators could conduct a more in-depth analysis of this topic and present more objective and useful information on the therapeutic benefits of PNF.

• Clinical Endoscopy
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• 제56권6호
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• pp.716-725
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• 2023

Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy is technically challenging. For example, scope insertion, selective cannulation, and intended procedures, such as stone extraction or stent placement, can be difficult. Single-balloon enteroscopy (SBE)-assisted ERCP has been used to effectively and safely address these technical issues in clinical practice. However, the small working channel limits its therapeutic potential. To address this shortcoming, a short-type SBE (short SBE) with a working length of 152 cm and a channel of 3.2 mm diameter has recently been introduced. Short SBE facilitates the use of larger accessories to complete certain procedures, such as stone extraction or self-expandable metallic stent placement. Despite the development in the SBE endoscope, various steps have to be overcome to successfully perform such procedure. To improve success, the challenging factors of each procedure must be identified. At the same time, endoscopists need to be mindful of adverse events, such as perforation, which can arise due to adhesions specific to the surgically altered anatomy. This review discussed technical tips regarding SBE-assisted ERCP in patients with surgically altered anatomy to increase success and reduce the risk of adverse events associated with ERCP.

• 한국간담췌외과학회지
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• 제27권2호
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• pp.131-140
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• 2023

During minimally invasive liver resection (MILR), the Pringle maneuver aims to minimize blood loss and provide a clear operative field, thereby identifying intrahepatic structures and facilitating safe parenchymal transection. Several techniques for using the Pringle maneuver in MILR have been described. This review presents various methods which have been reported in the literature. A systematic literature search used the MEDLINE/PubMed database from its earliest records to August 2022 using appropriate search headings and keywords. The primary outcome was identifying techniques for performing hepatic inflow occlusion during laparoscopic/robotic hepatectomy. Inclusion criteria consisted of publications describing technical steps to obtain hepatic inflow occlusion during minimally invasive hepatectomy. A literature search identified 23 relevant publications, and the full texts were examined. The techniques described in the reports can be broadly categorized into three groups: (1) the Rummel-tourniquet technique, (2) vascular clamp use, and (3) the Huang Loop technique. Various techniques have been used in MILR to achieve inflow confinement successfully. The authors prefer the modified Huang Loop technique because it is inexpensive, reliable, and quick to apply or release. Hepatobiliary surgeons are advised to familiarize themselves with these MILR techniques, which have proven effective and safe inflow occlusion.

• Nuclear Engineering and Technology
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• 제55권11호
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• pp.4083-4095
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• 2023

Currently, various research institutes in Korea are conducting research to develop a safety case for deep geological repository for high-level radioactive waste (HLW). In the past, low and intermediate-level waste (LILW) was approved by a regulatory body by performing a post-closure safety assessment, but HLW has different disposal characteristics and safety objectives are different. Therefore, in the case of HLW, safety assessment should be performed based on these changed conditions, and specific procedures are also under development. In this paper, the regulatory status of prior research institutes, feature, event and process (FEP) and scenario development cases were investigated for well-organized FEP and scenario development methodologies. In addition, through the results of these surveys, the requirements and procedures necessary for the FEP and scenario development stage during the safety assessment of repository for HLW were presented. These review results are expected to be used to identify the overall status of previous studies in conducting post-closure risk assessment for HLW repository, starting with identifying regulatory requirements, the most basic element.