• Journal of Nutrition and Health
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• v.43 no.6
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• pp.653-660
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• 2010

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

• Nutrition Research and Practice
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• v.5 no.1
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• pp.3-10
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• 2011

Women's nutrition has received little attention in nutrition programming, even though clinical trials and intervention trials have suggested that dietary improvement or supplementation with several nutrients may improve their health, especially in low-income settings, the main focus of this paper. Most attention so far has focused on how improvements in maternal nutrition can improve health outcomes for infants and young children. Adequate vitamin D and calcium nutrition throughout life may reduce the risk of osteoporosis, and calcium supplementation during pregnancy may reduce preeclampsia and low birth weight. To reduce neural tube defects, additional folic acid and possibly vitamin $B_{12}$ need to be provided to non-deficient women before they know they are pregnant. This is best achieved by fortifying a staple food. It is unclear whether maternal vitamin A supplementation will lead to improved health outcomes for mother or child. Iron, iodine and zinc supplementation are widely needed for deficient women. Multimicronutrient supplementation (MMS) in place of the more common iron-folate supplements given in pregnancy in low-income countries may slightly increase birth weight, but its impact on neonatal mortality and other outcomes is unclear. More sustainable alternative approaches deserve greater research attention.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.26 no.1
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• pp.104-117
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• 2013

Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• IMMUNE NETWORK
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• v.22 no.5
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• pp.37.1-37.16
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• 2022

Autoimmune diseases are caused by a dysfunction of the acquired immune system. In a subset of autoimmune diseases, B cells escaping immune tolerance present autoantigen and produce cytokines and/or autoantibodies, resulting in systemic or organ-specific autoimmunity. Therefore, B cell depletion with monoclonal Abs targeting B cell lineage markers is standard care therapy for several B cell-mediated autoimmune disorders. In the last 5 years, genetically-engineered cellular immunotherapies targeting B cells have shown superior efficacy and long-term remission of B cell malignancies compared to historical clinical outcomes using B cell depletion with monoclonal Ab therapies. This has raised interest in understanding whether similar durable remission could be achieved with use of genetically-engineered cell therapies for autoimmunity. This review will focus on current human clinical trials using engineered cell therapies for B cell-associated autoimmune diseases.

• Korean Journal of Acupuncture
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• v.26 no.1
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• pp.27-40
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• 2009

Background : Qigong is an energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong-neither itself nor its postulated mechanism of action-are within the paradigm of modern Western medical science, its effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990s, Qigong papers in the Korean Literature are increased. The articles on Korean traditional medicine had been published more than those on physical education or nursing etc. However, since the majority of the trials determine questionnaire, it was difficult to determine the efficacy of a specific intervention. The methodological quality of the trials was generally low (Jadad score: mean, 1.3; range, 1 to 4), questioning their reliability. Conclusions : More profound studies for Qigong are needed. Further rigorous clinical trials with more objective outcome measures that include sham procedures should be performed. Specifically, we think it should be clinical studies and qualitative research methods for evaluation are needed.

• Biomolecules & Therapeutics
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• v.28 no.1
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• pp.34-44
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• 2020

Mesenchymal stem cells (MSCs) have been proposed as an alternative therapy to be applied into several pathologies of the nervous system. These cells can be obtained from adipose tissue, umbilical cord blood and bone marrow, among other tissues, and have remarkable therapeutic properties. MSCs can be isolated with high yield, which adds to their ability to differentiate into non-mesodermal cell types including neuronal lineage both in vivo and in vitro. They are able to restore damaged neural tissue, thus being suitable for the treatment of neural injuries, and possess immunosuppressive activity, which may be useful for the treatment of neurological disorders of inflammatory etiology. Although the long-term safety of MSC-based therapies remains unclear, a large amount of both pre-clinical and clinical trials have shown functional improvements in animal models of nervous system diseases following transplantation of MSCs. In fact, there are several ongoing clinical trials evaluating the possible benefits this cell-based therapy could provide to patients with neurological damage, as well as their clinical limitations. In this review we focus on the potential of MSCs as a therapeutic tool to treat neurological disorders, summarizing the state of the art of this topic and the most recent clinical studies.

• The Journal of Korea Robotics Society
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• v.15 no.4
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• pp.404-412
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• 2020

Typically everyday human life tasks involve at least two people moving objects such as tables and beds, and the balancing of such object changes based on one person's action. However, many studies in previous work performed their tasks solely on robots without factoring human cooperation. Therefore, in this paper, we propose cooperative robot for table balancing using Q-learning that enables cooperative work between human and robot. The human's action is recognized in order to balance the table by the proposed robot whose camera takes the image of the table's state, and it performs the table-balancing action according to the recognized human action without high performance equipment. The classification of human action uses a deep learning technology, specifically AlexNet, and has an accuracy of 96.9% over 10-fold cross-validation. The experiment of Q-learning was carried out over 2,000 episodes with 200 trials. The overall results of the proposed Q-learning show that the Q function stably converged at this number of episodes. This stable convergence determined Q-learning policies for the robot actions. Video of the robotic cooperation with human over the table balancing task using the proposed Q-Learning can be found at http://ibot.knu.ac.kr/videocooperation.html.

• BMB Reports
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• v.53 no.8
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• pp.400-412
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• 2020

The world has witnessed unimaginable damage from the coronavirus disease-19 (COVID-19) pandemic. Because the pandemic is growing rapidly, it is important to consider diverse treatment options to effectively treat people worldwide. Since the immune system is at the hub of the infection, it is essential to regulate the dynamic balance in order to prevent the overexaggerated immune responses that subsequently result in multiorgan damage. The use of stem cells as treatment options has gained tremendous momentum in the past decade. The revolutionary measures in science have brought to the world mesenchymal stem cells (MSCs) and MSC-derived exosomes (MSC-Exo) as therapeutic opportunities for various diseases. The MSCs and MSC-Exos have immunomodulatory functions; they can be used as therapy to strike a balance in the immune cells of patients with COVID-19. In this review, we discuss the basics of the cytokine storm in COVID-19, MSCs, and MSC-derived exosomes and the potential and stem-cell-based ongoing clinical trials for COVID-19.

• Journal of Nutrition and Health
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• v.38 no.2
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• pp.117-124
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• 2005

We investigated the effects of prolonged exposure in hot environmental condition and ingestion of fluid on various physiological variables including plasma glucose, lactate, the rating of perceived exertion (RPE), and heart rate as well as golf putting performance. Six male professional golfers were voluntarily participated in three different putting trials which were separated by seven days of time interval period. Three different putting trials were conducted at either 20℃ or 32℃, or 32℃ + Fluid ingestion. Performing 32℃ + Fluid ingestion trial, all subject ingested sport drink as much as their body mass was decreased. For each experiment, all subjects were undertaken total 48 putting, which separated by four x 12 putting in four different time points (i.e., Rest, 1 hr, 2 hr, and 3 hr). Plasma glucose concentration was significantly decreased with hot ambient condition but it was almost fully recovered by fluid ingestion. Plasma lactate concentration was significantly higher when subjects were exposed in hot environmental condition, and it did not change with fluid ingestion. There was a no different in putting performance and psychological fatigue level (performed by GRID test) at any environmental conditions. The RPE, commonly used for evaluating of physical fatigue level, was significantly dropped by fluid ingestion which indicates lower physical fatigue level. In addition to this, heart rate (HR) was also significantly decreased after fluid ingestion. Based on these results, it was concluded that the ingestion of fluid during prolonged exposure in hot ambient condition decrease the degree of physical fatigue levels and heart rate, which will possibly improve the golf performance when exposed in extreme weather condition in summer. (Korean J Nutrition 38(2): 117～124, 2005)