• The Korean Journal of Applied Statistics
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• v.23 no.6
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• pp.1067-1080
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• 2010

A number of methods have been developed to determine sample sizes in clinical trial, and most clinical trial organizations determine sample sizes based on the methods. In contrast, determining sufficient sample sizes needed for experiments using microarray chips is unsatisfactory and not widely in use. In this paper, our objective is to provide a guideline in determining sample sizes, utilizing reproducibility of real microarray data. In the reproducibility comparison, five methods for discovering differential expression are used: Fold change, Two-sample t-test, Wilcoxon rank-sum test, SAM, and LPE. In order to standardize gene expression values, both MAS5 and RMA methods are considered. According to the number of repetitions, the upper 20 and 100 gene accordances are also compared. In determining sample sizes, more realistic information can be added to the existing method because of our proposed approach.

• Journal of Sasang Constitution and Immune Medicine
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• v.12 no.1
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• pp.10-23
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• 2000

Four-constitutional theory proposed by Dr. Lee, Je-ma has been evolve for last 100years by his followers. One of the major progresses was the emergence of constitutional acupuncture proposed by Dr. Kwan Doh-won. Constitutional acupuncture included the new pulse diagnostic method to determine the body type, pulse diagrams and corresponding acupuncture method called five element acupuncture in which five-element points in 12 meridian channels are used. Dr. Sa-ahm proposed five-element acupuncture three and a half hundred years age. Conjunction of Dr Lee's theory to Dr. Kwan proposed eight constitutions with eight pulse diagrams. He also adopted eight acupuncture prescriptions out of twenty-four Sa-ahm's acupuncture prescriptions. The author, Dr. Yom Tae-hwa, proposed more inclusive theory of 24 constitutions with 24 diagnostic pulse diagrams in Las Vegas International Acupuncture Convention in 1986. This article reviews history of constitutional medicine briefly. Each step of theoretical evolution from four-constitutional theory to twenty-four-constitutional theory is explained. By understanding the theoretical connection between twelve meridian channels based on five-element theory and four-constitutional theory in the article, one will easily accept the emergence of twelve of twenty four constitutional theory. Next, the article is focused on four subcategories under Sao-Yin constitution, which are one-sixth of 24 constitution. in this section classification, pulse diagnostic method, pulse diagram acupuncture prescriptions and herbal prescriptions are explained in detail. Then, clinical trial reports of acupuncture treatment and/or herbal formulas for such constitutions are attached for the rest part of the article. the purpose of this paper is to present the new hypothesis with the result of preliminary clinical trial hoping that additional clinical reports from other practitioners in this field triggers well-designed clinical study in future.

• Journal of Physiology & Pathology in Korean Medicine
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• v.29 no.2
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• pp.115-126
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• 2015

The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the proposals for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. Among them, we analyzed the methodological proposals from the clinical research papers that were published in the KM related fields. Various proposals for improving the problems in KM clinical studies are as follows. First, KM clinical research should be designed based on understanding for the theory, backgrounds, paradigms and worldviews of KM. In addition, considering the model validity, KM clinical research model should include the diagnosis, interventions and outcomes measurement methods reflecting the characteristics and real practice in KM. The internal validity and external validity should be also taken into account. One of the most important thing is to identify the contents about various and complex 'real practice' in KM. A prospective observational study was suitable for the purpose of this study. Finally, we suggested a few improvement directions for RCTs studies in KM. First, we would be able to improve the quality and the internal validity in KM clinical research using the checklists of CONSORT(Consolidated Standards for Reporting Trials) Statement and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture). Second, we could use various clinical research methods and the modified research of RCTs such as PCT(pragmatic clinical trial) to reflect the characteristics of actual KM practice. Consequently, we would be able to improve the external validity. Third, the KM diagnosis and outcomes measurement methods should be developed based on an actual KM practice and it should reflect a real practice. The 'pattern identification(辨證)' is the core to KM diagnosis. But in order to be applied to the clinical research, the pattern identification(辨證) should be objectified and standardized. Future KM clinical research model should reflect the characteristics and a real practice in KM. In addition, it should include the advantage of rigorous RCTs research.Specially, the diagnosis, interventions and outcomes measurement methods in KM clinical research should reflect this view.

• Journal of Preventive Medicine and Public Health
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• v.41 no.5
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• pp.339-344
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• 2008

Objectives : The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. Methods : The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. Results : It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Conclusions : Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

• Journal of Korean Medicine for Obesity Research
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• v.7 no.2
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• pp.27-37
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• 2007

Background Clinical practice guidelines (CPG) are systematically developed statements to assist practitioners and patients on healthcare decisions. They provide recommendations for the average patient, which should take into account individual clinical judgment and the patient's values and expectations. Ephedra has sympathomimetic effect and has been used for weight loss worldwide. However, its safety is controversial especially in autonomic and cardiovascular systems. Therefore, the need of appropriate CPG for ephedra prescription in obesity was advocated in Korean Traditional Medicine. Methods The committee comprised of specialists of obesity, oriental herbology, oriental cardiology, constitutional medicine. The committee collected all relevant references about adverse effect and safety of ephedra in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study and observational study from international and domestic databases and paper journals. 11 English- and 5 Korean-language references were gathered and categorized by PICO (Patient, Intervention, Comparison, Outcome) method. We could not complete strength of recommendation which should be clarified according to the evidence grade estimation. Result The first version of CPG for ephedra prescription in obesity was issued by Korean Oriental Association for Study of Obesity. It includes topics of introduction, pharmacokinetics, side effects and adverse events, constitutional aspect and recommendations for dose, indication and contraindication. Conclusion There should be periodic upgrade of this CPG from now on. Although there are some drawbacks in this version of CPG, it has significance as the first CPG in Korean Traditional Medicine.

• Genomics & Informatics
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• v.1 no.2
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• pp.65-74
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• 2003

Data mining differs primarily from traditional data analysis on an important dimension, namely the scale of the data. That is the reason why not only statistical but also computer science principles are needed to extract information from large data sets. In this paper we briefly review data mining, its characteristics, typical data mining algorithms, and potential and ongoing applications of data mining at biopharmaceutical industries. The distinguishing characteristics of data mining lie in its understandability, scalability, its problem driven nature, and its analysis of retrospective or observational data in contrast to experimentally designed data. At a high level one can identify three types of problems for which data mining is useful: description, prediction and search. Brief review of data mining algorithms include decision trees and rules, nonlinear classification methods, memory-based methods, model-based clustering, and graphical dependency models. Application areas covered are discovery compound libraries, clinical trial and disease management data, genomics and proteomics, structural databases for candidate drug compounds, and other applications of pharmaceutical relevance.

• Journal of the Korean Data and Information Science Society
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• v.24 no.6
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• pp.1349-1357
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• 2013

In clinical research, sample size determination is one of the most important things. There are parametric method using t-test and non-parametric method suggested by Kim and Kim (2007) based on Wilcoxon's rank sum test for determining sample size in non-inferiority trials. In this paper, we propose sample size calculation method based on placements method suggested by Orban and Wolfe (1982) and using the power calculated by Kim (1994) in non-inferiority trials. We also compare proposed sample size with that using Kim and Kim (2007)'s formula and that of t-test for parametric methods. As the result, sample size calculated by proposed method based on placements is the smallest. Therefore, proposed method based on placements is better than parametric methods in case that it's hard to assume specific distribution function for population and also more efficient in terms of time and cost than method based on Wilcoxon's rank sum test.

• Tissue Engineering and Regenerative Medicine
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• v.15 no.6
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• pp.673-697
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• 2018

BACKGROUND: Cartilage tissue engineering (CTE) aims to obtain a structure mimicking native cartilage tissue through the combination of relevant cells, three-dimensional scaffolds, and extraneous signals. Implantation of 'matured' constructs is thus expected to provide solution for treating large injury of articular cartilage. Type I collagen is widely used as scaffolds for CTE products undergoing clinical trial, owing to its ubiquitous biocompatibility and vast clinical approval. However, the long-term performance of pure type I collagen scaffolds would suffer from its limited chondrogenic capacity and inferior mechanical properties. This paper aims to provide insights necessary for advancing type I collagen scaffolds in the CTE applications. METHODS: Initially, the interactions of type I/II collagen with CTE-relevant cells [i.e., articular chondrocytes (ACs) and mesenchymal stem cells (MSCs)] are discussed. Next, the physical features and chemical composition of the scaffolds crucial to support chondrogenic activities of AC and MSC are highlighted. Attempts to optimize the collagen scaffolds by blending with natural/synthetic polymers are described. Hybrid strategy in which collagen and structural polymers are combined in non-blending manner is detailed. RESULTS: Type I collagen is sufficient to support cellular activities of ACs and MSCs; however it shows limited chondrogenic performance than type II collagen. Nonetheless, type I collagen is the clinically feasible option since type II collagen shows arthritogenic potency. Physical features of scaffolds such as internal structure, pore size, stiffness, etc. are shown to be crucial in influencing the differentiation fate and secreting extracellular matrixes from ACs and MSCs. Collagen can be blended with native or synthetic polymer to improve the mechanical and bioactivities of final composites. However, the versatility of blending strategy is limited due to denaturation of type I collagen at harsh processing condition. Hybrid strategy is successful in maximizing bioactivity of collagen scaffolds and mechanical robustness of structural polymer. CONCLUSION: Considering the previous improvements of physical and compositional properties of collagen scaffolds and recent manufacturing developments of structural polymer, it is concluded that hybrid strategy is a promising approach to advance further collagen-based scaffolds in CTE.

• Journal of Korea Multimedia Society
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• v.15 no.6
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• pp.805-813
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• 2012

In this paper, we have designed and developed a middleware for an effectively approaching database to the existed brain disease clinical research system. The brain disease clinical research system was consisted of two parts i.e., a register and an analyzer. Since the register collects the registration data the analyzer yields a statistical data which based on the diverse variables. The middleware has designed to database management and a large data query processing of clients. By separating the function of each feature as a module, the module which was weakened connectivity between functionalities has been implemented the re-use module. And image data module used a new compression method from image to text for an effective management and storage in database. We tested the middleware system using 700 actual clinical medical data. As a result, the total data transmission time was improved maximum 115 times faster than the existing one. Through the improved module structures, it is possible to provide a robust and reliable system operation and enhanced security functionality. In the future, these middleware importances should be increased to the large medical database constructions.

• Journal of the Korean Data and Information Science Society
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• v.27 no.2
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• pp.499-510
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• 2016

It is very important to select relevant variables in regression models for survival analysis. In this paper, we introduce a penalized variable-selection procedure in multi-level frailty models based on the "frailtyHL" R package (Ha et al., 2012). Here, the estimation procedure of models is based on the penalized hierarchical likelihood, and three penalty functions (LASSO, SCAD and HL) are considered. The proposed methods are illustrated with multi-country/multi-center bladder cancer survival data from the EORTC in Belgium. We compare the results of three variable-selection methods and discuss their advantages and disadvantages. In particular, the results of data analysis showed that the SCAD and HL methods select well important variables than in the LASSO method.