• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.60-67
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• 2021

Electroencephalography (EEG) is used for the diagnosis of epilepsy and testing the brain function. Clinical technologists are responsible for recording EEG without artifacts in accordance with the international 10~20 electrode system. Training on these techniques requires practical education. In the case of EEG, however, it is difficult for trainees to find the correct location of the electrode. Therefore, this study compared the time spent to locate the electrode attachment between traditional tape and the newly developed band. The time spent for sitting position patients using the band (196.7±61.8s) was 1084.3 s faster than the tape (1,281.0±457.4s) (P<0.001). Furthermore, the spend time spent for lying position patients using the band (200.2±49.3s) was 1217.7s faster than the tape (1417.9±482.3s) (P<0.001). Measurements using the band showed fewer differences due to various factors, such as position, practical experience, and gender. The newly developed band can locate the correct electrode attachment position quickly and efficiently, which has been a difficult problem in EEG practical education. In addition, this band is expected to be applied widely by new clinical technologists in the clinical field. Nevertheless, more study will be required to verify the accuracy of the location of the attaching electrode.

• Journal of Yeungnam Medical Science
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• v.10 no.1
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• pp.1-17
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• 1993

고빈도 환기법은 최근에 개발되어 임상에 응용되면서 호흡생리학, 마취학, 집중치료의 학등의 분야에서 호흡부전의 새로운 치료법으로 관심이 집중되고 있는 환기법이다. 현재까지 고빈도 환기법중 고빈도 양압 환기와 제트 환기는 비교적 많은 연구가 되고 있고 임상적으로 사용되고 있으나 고빈도 진동 환기법은 제한적으로 사용되고 있다. 앞으로 고빈도 진동 환기법에 대해서도 더 많은 연구가 되어야 할 것이다. 또한 최근 개발되고 있는 고빈도 흉벽 진동 환기와 체표면 진동 환기에도 관심을 기울이면 호흡부전 환자의 치료에 바람직한 새로운 환기법이 될 수 있을 것으로 기대된다. 현재 고빈도 환기법의 몇몇 적용형태는 기관지-늑막루등의 폐압손상으로 인한 병변의 치료외에도 기관수술, 흉부수술, 뇌수술에서 수술부위의 움직임을 최소화시키면서 충분한 가스교환율 이룩할 수 있어서 효과적으로 이용되고 있다. 그러나 응급심폐소생술, 폐쇄성 폐질환, 성인 또는 영아 호흡곤란증후군등과 같은 질환에서의 적용은 더 규명되어져야겠다. 고빈도 환기법의 여러가지 문제점중 적절한 환기빈도의 결정, 충분한 습도를 공급하는 장치, 고빈도 환기의 정확한 감시장치의 개발등은 앞으로 우선적으로 해결해야 할 문제점이다. 또한 임상에 더욱 효과적으로 응용될 수 있는 새로운 환기법이 되기 위해서는 고빈도 환기법의 호흡생리와 안정성등에 관한 연구도 병행되어야겠다.

• 건강소식
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• v.30 no.6 s.331
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• pp.32-33
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• 2006

건강 나이라는 개념을 정리하여 대중적으로 알리기 시작한 사람은 미국 시카고 프리츠크의대의 마이클 로이젠 교수이다. 그는 2만 5,000여 건의 임상 연구를 토대로 질병, 습관, 유전, 환경 등 인간 수명에 영향을 미치는 125가지 기준을 선정하여 건강 나이 계산법을 만들었다. 우리나라에서는 서울백병원 가정의학과 김철환 박사가 미국의 자료와 우리나라의 임상 자료를 토대로 우리 실정에 맞는 '건강 나이 측정법'을 고안하여 보급하였다.

• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.581-594
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• 2013

A group sequential design can end a clinical trial early if a confirmed efficacy or a futility of study medication is found during clinical trials. Adaptation can adjust the design of clinical trials based on accumulated data. The key to this methodology is considered to control the overall type 1 error rate while maintaining the integrity of clinical trials. The estimation would be more complex and the sample size calculation will be more difficult if the clinical trials have repeated measurement data. Lee et al. (2002) suggested a repeated observation case by using the independent increments properties of the interim test statistics and investigated the properties of the proposed confidence interval based on the stage-wise ordering. This study extend Lee et al. (2002) to adaptive group sequential design. We suggest test statistics for the adaptation as redesigning the second stage of clinical trials and induce the stage-wise confidence interval of parameter of interests. The simulation will help to confirm the suggested method.

• The Korean Journal of Applied Statistics
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• v.27 no.1
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• pp.13-20
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• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

• Journal of the Korea Convergence Society
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• v.9 no.11
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• pp.161-167
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• 2018

A clinician's skills in a dental clinic are an important factor in removing the risk factors of patients. Although many universities have conducted educational programs, there has been a limitation on repeated practice because of the limited space and equipment. In dental radiography, there are various intraoral radiographic techniques. Since proficiency in radiography is an important factor in obtaining accurate radiographs, repeated practice and skill learning are important at the pre-clinical stage. However, the recent amendment of diagnostic radiation has caused difficulties in repeated practice on the human body. This study aims to develop a clinical simulator for intraoral radiography that enables repeated practice and self-directed learning without any restriction by utilizing the augmented reality technology to foster clinical skills for dental hygienist.

• Journal of Music and Human Behavior
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• v.10 no.2
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• pp.1-33
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• 2013

The aim of this study was to systematically review the latest clinical trials in music medicine and medical music therapy for pediatric patients. Thirteen databases were searched to obtain randomized controlled/crossover design studies published between the year 2000 and 2012 in English language. Out of 1012 articles retrieved in the initial search, fifteen studies were identified based on an exclusion criteria. Overall, selected articles involved children 1 month to 18 years, sample size of 11 to 150, and total participants of 987. Studies were classified and compared as music medicine or music therapy studies through a systematic synthesis assessing general characteristics, methodological quality, measured outcomes, types of interventions and the study results. Seven music medicine and eight music therapy studies measured seven dependent variables using thirty-six different measurement tools with a large heterogeneity in the selection, type, and method of music interventions. Evaluation of the methodological quality revealed that many studies did not provide a full report of the research method, and did not meet some or most methodological standards, such as randomization, allocation concealment, double or partial blinding, and intention to treat analysis. Although overall research results were positive if not significant, poor methodological quality and heterogeneity in design and intervention strategies raise the question of research bias and trustworthiness issues. The systematic review concluded that music may have a valuable clinical effect in addressing the physical and psychosocial needs of hospitalized children, although more rigorous, homogeneous and replicable studies are greatly needed.

• Korean Journal of Clinical Laboratory Science
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• v.51 no.1
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• pp.78-85
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• 2019

Membrane proteins are involved in many common diseases, including heart disease and cancer. In various disease states, such as cancer, abnormal signaling pathways that are related to the membrane proteins cause the cells to divide out of control and the expression of membrane proteins can be altered. Membrane proteins have the hydrophobic environment of a lipid bilayer, which makes an analysis of the membrane proteins notoriously difficult. Therefore, this study evaluated the efficacy of two different methods for optimal membrane protein extraction. High-speed centrifuge and reagent-based method with a -/+ filter aided sample preparation (FASP) were compared. As a result, the high-speed centrifuge method is quite effective in analyzing the mitochondrial inner membranes, while the reagent-based method is useful for endoplasmic reticulum membrane analysis. In addition, the function of the membrane proteins extracted from the two methods were analyzed using GeneGo software. GO processes showed that the endoplasmic reticulum-related responses had higher significance in the reagent-based method. An analysis of the process networks showed that one cluster in the high-speed centrifuge method and four clusters in the reagent-based method were visualized. In conclusion, the two methods are useful for the analysis of different subcellular membrane proteins, and are expected to assist in selecting the membrane protein extraction method by considering the target subcellular membrane proteins for study.

• The Korea Beekeeping Bulletin
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• s.229
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• pp.14-17
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• 1999