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Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.209-244
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    • 2020
  • TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

A Study on Industry-specific Sustainability Strategy: Analyzing ESG Reports and News Articles (산업별 지속가능경영 전략 고찰: ESG 보고서와 뉴스 기사를 중심으로)

  • WonHee Kim;YoungOk Kwon
    • Journal of Intelligence and Information Systems
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    • v.29 no.3
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    • pp.287-316
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    • 2023
  • As global energy crisis and the COVID-19 pandemic have emerged as social issues, there is a growing demand for companies to move away from profit-centric business models and embrace sustainable management that balances environmental, social, and governance (ESG) factors. ESG activities of companies vary across industries, and industry-specific weights are applied in ESG evaluations. Therefore, it is important to develop strategic management approaches that reflect the characteristics of each industry and the importance of each ESG factor. Additionally, with the stance of strengthened focus on ESG disclosures, specific guidelines are needed to identify and report on sustainable management activities of domestic companies. To understand corporate sustainability strategies, analyzing ESG reports and news articles by industry can help identify strategic characteristics in specific industries. However, each company has its own unique strategies and report structures, making it difficult to grasp detailed trends or action items. In our study, we analyzed ESG reports (2019-2021) and news articles (2019-2022) of six companies in the 'Finance,' 'Manufacturing,' and 'IT' sectors to examine the sustainability strategies of leading domestic ESG companies. Text mining techniques such as keyword frequency analysis and topic modeling were applied to identify industry-specific, ESG element-specific management strategies and issues. The analysis revealed that in the 'Finance' sector, customer-centric management strategies and efforts to promote an inclusive culture within and outside the company were prominent. Strategies addressing climate change, such as carbon neutrality and expanding green finance, were also emphasized. In the 'Manufacturing' sector, the focus was on creating sustainable communities through occupational health and safety issues, sustainable supply chain management, low-carbon technology development, and eco-friendly investments to achieve carbon neutrality. In the 'IT' sector, there was a tendency to focus on technological innovation and digital responsibility to enhance social value through technology. Furthermore, the key issues identified in the ESG factors were as follows: under the 'Environmental' element, issues such as greenhouse gas and carbon emission management, industry-specific eco-friendly activities, and green partnerships were identified. Under the 'Social' element, key issues included social contribution activities through stakeholder engagement, supporting the growth and coexistence of members and partner companies, and enhancing customer value through stable service provision. Under the 'Governance' element, key issues were identified as strengthening board independence through the appointment of outside directors, risk management and communication for sustainable growth, and establishing transparent governance structures. The exploration of the relationship between ESG disclosures in reports and ESG issues in news articles revealed that the sustainability strategies disclosed in reports were aligned with the issues related to ESG disclosed in news articles. However, there was a tendency to strengthen ESG activities for prevention and improvement after negative media coverage that could have a negative impact on corporate image. Additionally, environmental issues were mentioned more frequently in news articles compared to ESG reports, with environmental-related keywords being emphasized in the 'Finance' sector in the reports. Thus, ESG reports and news articles shared some similarities in content due to the sharing of information sources. However, the impact of media coverage influenced the emphasis on specific sustainability strategies, and the extent of mentioning environmental issues varied across documents. Based on our study, the following contributions were derived. From a practical perspective, companies need to consider their characteristics and establish sustainability strategies that align with their capabilities and situations. From an academic perspective, unlike previous studies on ESG strategies, we present a subdivided methodology through analysis considering the industry-specific characteristics of companies.

Contamination of operator's clothing by aerosols during scaling (스케일링 시 에어로졸에 의한 술자의 의복 오염도)

  • Kang, Kyung-Hee;Kim, Ye-Jin;Min, Ji-Yeon;Park, Seul-Gi;Woo, Ju-Hee;Goong, Haw-Soo
    • Journal of Korean Academy of Dental Administration
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    • v.5 no.1
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    • pp.31-37
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    • 2017
  • Recently interest in infection control is increasing in hospitalsnfection control has become more important in the overall health care practiceental hospital also requires thorough infection control. There are various kinds of vectormedical clothing. Contaminated clothing of a hospital staff can be a vector of nosocomial infecton. actual case of nosocomial infecton caused by contaminated medical clothing, nursing students were measuring contamination levels of uniforms and pathogenic microorganism wdetected in front of the uniform and pocket. There is also a high risk of exposure to contamination in the dental hospital. We conducted a study to enhance awareness about infection and proper clothing management by comparing before and after contamination of clothing caused by aerosols produced during scaling. Subjects were scaling operators' uniforms in the department of dental hygiene, K University located in Daejeon. Before scaling, the uniform was sterilized by autoclavecaling was performed times in the same place (an average of 60 minutes per person, a total of 180 minutes). ive parts of the uniform (sleeves, chest, belly, thigh, edge of pants) contracted Rodak-plate for 15 seconds. After incubating the contacted Rodak-plate at 37℃ incubator, contamination levels by measuring the number of colonies. As a result, all parts increased number of colonies. ontamination order chestedge of pants thigh belly sleeves. Increase rate of colonies was also high in the order chest edge of pants thigh belly sleeves. This study showed seriousness of clothing contaminationcaused by aerol produced during scalingcontamination of clothing can be a path to nosocomial infecton. According to th study, infection control for clothing as well as dental instruments should be implemented and thorough infection control training needed for dental staff. In further researches, practical infection prevention supplementing clothing management method.

Suicide Method, the Recent Stressors, Psychiatric Diagnosis of Suicide Attempters and Suicide Completers (자살시도자와 자살 사망자의 자살 방법, 스트레스 요인 및 정신과적 진단)

  • Sea Hyun O;Jihye Ahn;Seo Jihyo;Hyerin Gu;Minjeong Kim;Hyeyeon Jang;Seog Ju Kim
    • Sleep Medicine and Psychophysiology
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    • v.29 no.1
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    • pp.15-20
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    • 2022
  • Objectives: Suicide is the major public mental health concerns all over the world. The comparison of suicide attempters and suicide completers could be the fundamental evidence for the suicide prevention. The aim of this study is to explore the differences between suicide attempters and suicide completers in terms of the stressors, suicide methods, and psychiatric diagnosis. Methods: Two types of secondary data were collected for the analyses. Data of the suicide attempters (n = 680) were gathered by intensive reviewing the medical records of Samsung Medical Center, Seoul, Republic of Korea. Data of suicide completers (n = 11,722) were collected by the psychological autopsy data which were gathered by Korean Foundation for Suicide Prevention. Suicidal methods, psychiatric disorders and stressors before suicidal attempt were compared between suicide attempter and completers. Results: Suicide completers were older and male predominant compared to suicidal attempt. Hanging or gas intoxication were more commonly used in the suicide completion, while wrist cutting or drug intoxication were more common in suicide attempters. All types of stressors were found to be high in suicide completers than suicide attempters. However, the proportion of economic and physical stress were greater in suicide completers, while the proportion of family stress were greater in suicide attempters. According to the recorded diagnoses, the rates of depressive disorders, sleep-wake disorders, substance-related disorders were higher in suicide completers, while the rates of anxiety disorders and trauma- and stressor-related disorders, bipolar and related disorders and somatic symptom disorders were higher in suicide attempters. However, after controlling the gender and age, there were no significant differences in diagnosis between suicide attempters and suicide completers. Conclusion: These findings implicate that suicide attempters and completers differed in suicide methods and type of stress. The results suggests that economic stressors, physical illness might raise the risk of suicide completion.

Detection of Salmonella spp. in Seafood via Desalinized DNA Extraction Method and Pre-culture (전배양과 탈염과정을 포함하는 DNA 추출법을 이용한 분자생물학적 방법으로 수산물 중 오염된 Salmonella spp.의 검출)

  • Ye-Jun Song;Kyung-Jin Cho;Eun-Ik Son;Du-Min Jo;Young-Mog Kim;Seul-Ki Park
    • Journal of Food Hygiene and Safety
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    • v.38 no.3
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    • pp.123-130
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    • 2023
  • Salmonella spp. are prevalent foodborne pathogens that are infective at relatively low concentrations, thus posing a serious health threat, especially to young children and the elderly. In several countries, the management and regulation of Salmonella spp. in food, including seafood, adhere to a negative detection standard. The risk of infection is particularly high when seafood is consumed raw, which underscores the importance of timely detection of pathogenic microorganisms, such as Salmonella. Accordingly, this study aimed to develop a combined pre-treatment and detection method that includes pre-culture and DNA extraction in order to detect five species of Salmonella at concentrations below 10 CFU/mL in seafood. The effectiveness of the proposed method was assessed in terms of the composition of the enrichment (pre-culture) medium, minimum incubation time, and minimum cell concentration for pathogen detection. Furthermore, a practical DNA extraction method capable of effectively handling high salt conditions was tested and found to be successful. Through polymerase chain reaction, Salmonella spp. Were detected and positively identified in shellfish samples at cell concentrations below 10 CFU/g. Thus, the proposed method, combining sample pre-treatment and cell culture with DNA extraction, was shown to be an effective strategy for detecting low cellular concentrations of harmful bacteria. The proposed methodology is suitable as an economical and practical in situ pre-treatment for effective detection of Salmonella spp. in seafood.

Relationships of Peripheral Inflammatory Marker With Suicide Attempt History (자살시도력과 말초혈액의 염증 지표 간의 연관성)

  • Su-Hyun Oh;Seung-Jun Kim;Sang-Ho Shin;Hong-Seok Oh;Jae-Chang Lee;Woo-Young Im;Na-Hyun Lee
    • Korean Journal of Psychosomatic Medicine
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    • v.31 no.2
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    • pp.165-172
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    • 2023
  • Objectives : The purpose of this study is to determine whether there is a significant difference in the neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio according to the history of suicide attempt in patients with psychiatric diseases. Methods : A medical record review was conducted on patients who had been hospitalized in Konyang University Hospital since 2021-03-01 to 2023-02-28 to collect demographic and clinical characteristics. T-test for continuous variables and Chi-square test for categorical variables were performed to determine demographic differences according to the history of suicide attempt, and the ANCOVA test was performed to compare the average value of peripheral inflammatory marker according to the history of suicide attempt with gender and age as covariates. One-way variance analysis was performed to determine whether the number of suicide attempt causes significant difference of the peripheral inflammatory marker. Results : The final analysis target of this study was 266 patients, 101 had history of suicide attempt, and 165 had no history of suicide attempt. The neutrophil-to-lymphocyte ratio (p<0.001) and platelet-to-lymphocyte ratio (p<0.001) were higher in patients with the history of suicide attempt than patients without the history of suicide attempt, but the neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio were not significantly increased depending on the serial increase of number of suicide attempts. Conclusions : This study suggests that peripheral inflammatory markers are meaningful and easily accessible indicators for predicting the risk of suicide attempt in psychiatric patients. We expect that prospective follow-up study will be conducted with more subjects and controlled potential confounding variables.

Physiological and Psychological analysis of musculoskeletal symptoms (근골격계질환에 대한 물리적/심리적요인에 대한 연구)

  • Donghyun Park;Sung Kyu Bae
    • Korean Journal of Culture and Social Issue
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    • v.9 no.spc
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    • pp.107-122
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    • 2003
  • The object of this study is to evaluate the prevailing physical and psychosocial conditions regarding occupational low back injury. This study consists of two parts. In the first part of the study, analytic biomechanical model and NIOSH guidelines are applied to evaluate risk levels of low back injury for automobile assembly jobs. Total of 246 workers are analysed. There are 20 jobs having greater back compressive forces than 300kg at L5/S1. Also, there are 44 jobs over Action Limit with respect to 1981 NIOSH guidelines. The relationship between psychosocial factors and low back injury was examined in the second part of the study. A battery of questionnaires concerning the psychosocial stress based on PWI (Psychosocial Well-being Index) and musculoskeletal pain symptoms at low back was completed by 246 workers at the same plant. Results showed that 207 out 246 workers experienced the symptoms and 27 workers were diagnosed as patients. Two groups(low stressed, high stressed) based on PWI score had no significant relationships with both symptoms and results of diagnosis. The relationships between physical work load and psychosocial stress were also analysed. Specifically, some postural factors(vertical deviation angle of forearm, horizontal deviation angle of upperarm, vertical deviation angle of thigh, etc) were highly correlated with psychosocial stress. The results illustrated that PWI scores were associated with some physical workloads. However, psychosocial stress levels couldn't be well related with the pain symptom as well as the actual incidence of low back injury since pain or discomfort regarding low back injury were more complex than that of other musculoskeletal disorders.

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Effectiveness of statin treatment for recurrent stroke according to stroke subtypes (뇌졸중 재발에 대한 스타틴 치료의 뇌졸중 아형에 따른 효과성)

  • Min-Surk Kye;Do Yeon Kim;Dong-Wan Kang;Baik Kyun Kim;Jung Hyun Park;Hyung Seok Guk;Nakhoon Kim;Sang-Won Choi;Dongje Lee;Yoona Ko;Jun Yup Kim;Jihoon Kang;Beom Joon Kim;Moon-Ku Han;Hee-Joon Bae
    • Journal of Medicine and Life Science
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    • v.21 no.2
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    • pp.40-48
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    • 2024
  • Understanding the effectiveness of statin treatment is essential for developing tailored stroke prevention strategies. We aimed to evaluate the efficacy of statin treatment in preventing recurrent stroke among patients with various ischemic stroke subtypes. Using data from the Clinical Research Collaboration for Stroke-Korea-National Institute for Health (CRCS-K-NIH) registry, we included patients with acute ischemic stroke admitted between January 2011 and July 2020. To evaluate the differential effects of statin treatment based on the ischemic stroke subtype, we analyzed patients with large artery atherosclerosis (LAA), cardio-embolism (CE), and small vessel occlusion (SVO). The primary outcomes were recurrent ischemic stroke and recurrent stroke events. The hazard ratio for outcomes between statin users and nonusers was compared using a Cox proportional hazards model adjusted for covariates. A total of 46,630 patients who met the inclusion criteria were analyzed. Statins were prescribed to 92%, 93%, and 78% of patients with LAA, SVO, and CE subtypes, respectively. The hazards of recurrent ischemic stroke and recurrent stroke in statin users were reduced to 0.79 (95% confidence interval [CI], 0.63-0.99) and 0.77 (95% CI, 0.62-0.95) in the LAA subtype and 0.63 (95% CI, 0.52-0.76) and 0.63 (95% CI, 0.53-0.75) in CE subtype compared to nonusers. However, the hazards of these outcomes did not significantly decrease in the SVO subtype. The effectiveness of statin treatment in reducing the risk of recurrent stroke in patients with LAA and CE subtypes has been suggested. Nonetheless, no significant effect was observed in the SVO subtype, suggesting a differential effect of statins on different stroke subtypes.

Literature Review on Applying Digital Therapeutic Art Therapy for Adolescent Substance Addiction Treatment (청소년 마약류 중독 치료를 위한 디지털치료제 예술치료 적용을 위한 문헌연구)

  • Jiwon Kim;Daniel H. Byun
    • Trans-
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    • v.16
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    • pp.1-31
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    • 2024
  • The advent of digital media has facilitated easy access for adolescents to environments conducive to the purchase of narcotics. In particular, there's an increasing trend in the purchase and consumption of narcotics mediated through Social Network Services (SNS) and messenger services. Adolescents, sensitive to such environments, are at risk of experiencing neurological and mental health issues due to narcotic addiction, increasing their exposure to criminal activities, hence necessitating national-level management and support. Consequently, the quest for sustainable treatment methods for adolescents exposed to narcotics emerges as a critical challenge. In the context of high relapse rates in narcotic addiction, the necessity for cost-effective and user-friendly treatment programs is emphasized. This study conducts a literature review aimed at utilizing digital platforms to create an environment where adolescents can voluntarily participate, focusing on the development of therapeutic content through art. Specifically, it reviews societal perceptions and treatment statuses of adolescent drug addiction, analyzes the impact of narcotic addiction on adolescent brain activity and cognitive function degradation, and explores approaches for developing digital therapeutics to promote the rehabilitation of the addicted brain through analysis of precedential case studies. Moreover, the study investigates the benefits that the integration of digital therapeutic approaches and art therapy can provide in the treatment process and proposes the possibility of enhancing therapeutic effects through various treatment programs such as drama therapy, music therapy, and art therapy. The application of art therapy methods is anticipated to offer positive effects in terms of tool expansion, diversification of expression, data acquisition, and motivation. Through such approaches, an enhancement in the effectiveness of treatments for adolescent narcotic addiction is anticipated. Overall, this study undertakes foundational research for the development of digital therapeutics and related applications, offering economically viable and sustainable treatment options in consideration of the societal context of adolescent narcotic addiction.

Dietary Behavior Related to Salty Food Intake of Adults Living in a Rural Area according to Saline Sensitivity (농촌 지역의 중년이후 성인의 염분 민감도에 따른 짠 음식 섭취 관련 식행동)

  • Kim, Mi-Kyoung;Han, Jang-Il;Chung, Young-Jin
    • Journal of Nutrition and Health
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    • v.44 no.6
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    • pp.537-550
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    • 2011
  • This study was conducted to identify behavioral characteristics of salty food intake according to saline sensitivity of adults living in a rural area. Anthropometry and blood pressure were measured and salt intake-related dietary behavior was surveyed by questionnaires through interviews with 402 subjects aged ${\geq}$ 40 years in Chungcheongbuk-Do, Korea. The percentages of overweight and obese among the subjects were 37.8% and 3.8% respectively. Mean blood pressure of the subjects was in the normal range, but the distribution of subjects who were normotensive, high normal, and hypertensive was 48.7%, 17.7%, and 33.6% respectively. Approximately 27% of all subjects habitually consumed salty food, which was the smallest group, followed by 38.1% normal and 35.1% not-salty food. However, 34.6% of the eldest group of ${\geq}$ 65 years consumed salty food. The saline insensitive group showed a higher percentage of irregular meals, overeating, speed-eating, an unbalanced diet, a preference for fried food, and habitual intake of salty foods. These subjects recognized the risk for eating salty food, but they lacked the will to reduce their salty food intake. Compared to spouses and family members, experts such as doctors, nurses, and dieticians were the most influential for reducing the salty food intake of subjects. Saline sensitive group had relatively better control over salty food intake at every meal, eating out, and even when eating salty food that the spouse preferred. The saline sensitive group ate more frequently vegetables and fruits, whereas the saline insensitive group ate more frequently hot spicy foods. In conclusion, the results suggest that it is necessary to establish a social atmosphere toward reducing salt intake at the level of the government and food industry and to set action plans to be available for nutrition education programs to reduce salt intake nationwide.