• Title/Summary/Keyword: Act of Clinical Research

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Current Status of Ophthalmic Optometry Laboratory Personnel in Korea, Japan, and the United States (한국, 일본, 미국 안과검사인력의 현황)

  • Okhwan, Jeon;Junbeom, Park;Dae Jin, Kim;Dae Eun, Kim;Cheol, Moon;Bon-Kyeong, Koo
    • Korean Journal of Clinical Laboratory Science
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    • v.54 no.4
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    • pp.285-292
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    • 2022
  • The education and training system, the ISCO (International Standard Classification of Occupations), and the legal systems of Japan and the United States consider all ophthalmic optometry laboratory personnel as ophthalmologists. They encompass optometrists, orthoptists, optometric technicians, and ophthalmic medical technicians. Data retrieved from the KOSIS (Korean Statistical Information Service) revealed that the number of opticians associated with the department of ophthalmology in 2022 could be appraised by classifying their medical institutions; contrarily, the number of clinical laboratory technologists could not be assessed. However, the current research investigated a general tertiary hospital and determined that clinical laboratory technologists outnumber opticians. Classification in Korea is based on ophthalmic optometry laboratory personnel, ISCO, ISCED (International Standard Classification of Education), the medical service act, the act on medical service technologists, and the higher education act. These results cannot be compared to the optometrists evaluated in the United States. Ophthalmology is a suitable profession for optometric technologists and technicians who perform under the instructions of ophthalmologists and optometrists. The field of eye healthcare would be benefitted by assigning the management based on their qualification according to the requirement of the job title, such as 'Clinical Optometry Technologist' to be given to clinical laboratory technologists and opticians who work in the ophthalmic optometry laboratories after obtaining a private qualification endowed by the Korean Ophthalmological Society and the Korean Optometry Society.

Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore

  • Tun, Tin;Sim, Xander
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.1
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    • pp.68-80
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    • 2021
  • An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors' facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.

Data-Linking Infrastructure for the Health Technology Assessment (의료기술평가 기반으로서의 데이터 연계)

  • Park, Chong Yon
    • The Journal of Health Technology Assessment
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    • v.6 no.2
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    • pp.81-87
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    • 2018
  • With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidence-based Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

Enhancement of Anti-tumor Immunity by Administration of Macrolepiota procera Extracts (큰갓버섯 추출물의 종양면역 증진 효과)

  • Han, Kyung-Hoon;Kim, Doh-Hee;Song, Kwan-Yong;Lee, Kye-Heui;Kang, Tae-Bong;Yoon, Taek-Joon
    • Korean Journal of Pharmacognosy
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    • v.43 no.1
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    • pp.32-38
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    • 2012
  • To examine the potentiation of Macrolepiota procera extracts (MPE-4) to act as adjuvant enhancing the tumor specific anti-tumor immune response, tumor vaccine prepared by boiling (HK vaccine) admixed with MPE-4 and immunized in mice. Vaccination of mice with HK vaccine in combination with MPE-4 resulted in higher inhibition in tumor metastasis compared with the mice of HK vaccine alone treatment against live syngeneic tumor cell challenge. The splenocytes from mice immunized HK vaccine mixed with MPE-4 was able to elicit a stronger cytotoxic T lymphocyte (CTL) response as compared with HK vaccine alone. In addition, the splenocytes from MPE-4 admixed HK vaccine immunized mice secreted a higher concentration of Th1 type cytokine such as IFN-${\gamma}$, and GM-CSF. Furthermore, the adoptive transfer of splenocytes from mice immunized HK vaccine and MPE-4 led to a more robust anti-tumour response than the HK vaccine alone. Overall, these results indicate that MPE-4 is a good candidate adjuvant of anti-tumor immune response.

The Characteristic of Research Regulation in Recent Japanese Medical World (최근 일본의 의학계 연구규율의 특색)

  • Song, Young-mi
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.173-206
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    • 2019
  • This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

A Study on the Management of benzo[a]pyrene according to the Level of Acute Toxicity (벤조피렌의 급성독성 수준에 따른 관리적 방안 연구)

  • Kim, Mina;Lee, Seungkil;Lee, Yongsik;Cho, Samrae;Kim, Dukhyun
    • Journal of Environmental Health Sciences
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    • v.44 no.2
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    • pp.153-159
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    • 2018
  • Objectives: This study was carried out to determine $LD_{50}$ of benzo[a]pyrene to decide the possibility to designate them as toxic substance on the Act on the Registration and Evaluation, etc. of Chemical Substances, and to suggest that they should be managed in what level on the Chemical Control Act. Methods: Based on the result of a preliminary study, 300 mg/kg was set as the middle dose. A highest dose of 2,000 mg/kg and a lowest dose of 50 mg/kg were selected based on the OECD TG 423. Benzo[a]pyrene was orally administered once to female and male SD rats at dose levels of 50, 300, 2,000 mg/kg (body weight). All animals were monitored daily for clinical signs and mortality over 14 days. Also testicular spermatid count, motility and etc. were examined as well. Results: Under the condition of this experiment, $LD_{50}$ of benzo[a]pyrene was assumed to be >2,000 mg/kg. In the lesion according to autopsy, there were no specific symptoms in the control and experimental groups. At 2,000 mg/kg, a decrease in the sperm motility was observed. Benzo[a]pyrene should be designated to be toxic substance as the material assumed to be reproduction-toxicity on the Act on the Registration and Evaluation, etc. of Chemicals. Therefore we should abide by legal procedures determined by Chemicals Control Act in treating it. Conclusion: Considering the significant result that sperm motility in the experimental group was inferior to that in the reference group, we suggest that benzo[a]pyrene be designated as a toxic substance.

Altered Gravity and Immune Response (중력 변화의 면역계에 대한 영향)

  • Jang, Tae Young;Kim, Kyu-Sung;Kim, Young Hyo
    • Korean journal of aerospace and environmental medicine
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    • v.28 no.1
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    • pp.6-8
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    • 2018
  • It is essential to study the effects of hypergravity on the human body in the research field of aerospace medicine. Previous studies have shown that hypergravity could act in a harmful way to the human body. However, recent studies have shown that moderate degree of hypergravity can act in a beneficial way to the human body. The authors have in particular been studying the effects of hypergravity on immune diseases, especially allergic asthma and rhinitis. Therefore, this review paper will introduce the results of recent studies on hormetic (health promotion) effect of hypergravity. In addition, this review paper also examines the mechanism by which hormetic effect of hypergravity could be possible. Furthermore, we will also discuss how to apply these hormetic effects in clinical practice.

Gametocyte Clearance in Uncomplicated and Severe Plasmodium falciparum Malaria after Artesunate-Mefloquine Treatment in Thailand

  • Tangpukdee, Noppadon;Krudsood, Srivicha;Srivilairit, Sriripun;Phophak, Nanthaporn;Chonsawat, Putza;Yanpanich, Wimon;Kano, Shigeyuki;Wilairatana, Polrat
    • Parasites, Hosts and Diseases
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    • v.46 no.2
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    • pp.65-70
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    • 2008
  • Artemisinin-based combination therapy (ACT) is currently promoted as a strategy for treating both uncomplicated and severe falciparum malaria, targeting asexual blood-stage Plasmodium falciparum parasites. However, the effect of ACT on sexual-stage parasites remains controversial. To determine the clearance of sexual-stage P. falciparum parasites from 342 uncomplicated, and 217 severe, adult malaria cases, we reviewed and followed peripheral blood sexualstage parasites for 4 wk after starting ACT. All patients presented with both asexual and sexual stage parasites on admission, and were treated with artesunate-mefloquine as the standard regimen. The results showed that all patients were asymptomatic and negative for asexual forms before discharge from hospital. The percentages of uncomplicated malaria patients positive for gametocytes on days 3, 7, 14, 21, and 28 were 41.5, 13.1, 3.8, 2.0, and 2.0%, while the percentages of gametocyte positive severe malaria patients on days 3, 7, 14, 21, and 28 were 33.6, 8.2, 2.7, 0.9, and 0.9%, respectively. Although all patients were negative for asexual parasites by day 7 after completion of the artesunate-mefloquine course, gametocytemia persisted in some patients. Thus, a gametocytocidal drug, e.g., primaquine, may be useful in combination with an artesunate-mefloquine regimen to clear gametocytes, so blocking transmission more effectively than artesunate alone, in malaria transmission areas.

A Review on the Practical Feasibility of Phrases 'Under the Instruction of Physicians or Dentists' Specified in the Definition on the Medical Service Technologist Etc Act: Focused on Radiological Technologist (의료기사 등에 관한 법률 중 '의사 또는 치과의사의 지도 아래' 문구의 타당성에 대한 고찰: 방사선사를 중심으로)

  • Joo, Young-Cheol;Lim, Cheong-Hwan;Lim, Woo-Taek;Hong, Dong-Hee;Jung, Hong-Ryang;Kim, Eun-Hye;Yoon, Yong-Su;Jung, Young-Jin;Choi, Ji-Won;Yoo, Se-Jong
    • Journal of radiological science and technology
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    • v.44 no.5
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    • pp.535-543
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    • 2021
  • The purpose of this study is to investigate various opinions on changes and revisions in the Medical Technician Act, to compare the curriculum of radiological technologist and physicians or dentists, and to compare the definitions and scope of work of radiological technologist in Korea and abroad. From the information, The goal is to review whether the phrase 'guidance of a doctor or dentist' specified in the definition of the 'Act on Medical Technicians, etc.' is realistically appropriate. radiological technologist receive specialized college education on radioligical science & medical imaging. The training hours for radiolgical science student are greater than medical students. In addition, radiological technologists are continuously developing their competencies for new knowledge and skills through continuing education in clinical fields. In particular, radiological technologist are making steady research efforts to reduce patient exposure and improve medical image quality. As a result of this investigation, it is considered that the term "guided by a doctor or dentist" as currently defined in the 'Act on Medical Technicians, etc.' may need to be revised in consideration of the professionalism of the radiological technologist.

Effect of Gene actA on the Invasion Efficiency of Listeria monocytogenes, as Observed in Healthy and Senescent Intestinal Epithelial Cells

  • Ha, Jimyeong;Oh, Hyemin;Kim, Sejeong;Lee, Jeeyeon;Lee, Soomin;Lee, Heeyoung;Choi, Yukyung;Moon, Sung Sil;Choi, Kyoung-Hee;Yoon, Yohan
    • Journal of Microbiology and Biotechnology
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    • v.28 no.1
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    • pp.59-64
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    • 2018
  • Listeria monocytogenes can asymptomatically inhabit the human intestine as a commensal bacterium. However, the mechanism by which L. monocytogenes is able to inhabit the intestine without pathogenic symptoms remains unclear. We compared the invasion efficiency of L. monocytogenes strains with the 268- and 385-bp-long actA gene. Clinical strains SMFM-CI-3 and SMFM-CI-6 with 268-bp actA isolated from patients with listeriosis, and strains SMFM-SI-1 and SMFM-SI-2 with the 385-bp gene isolated from carcasses, were used for inoculum preparation. The invasion efficiency of these strains was evaluated using Caco-2 cells (intestinal epithelial cell line), prepared as normal and healthy cells with tightened tight junctions and senescent cells with loose tight junctions that were loosened by adriamycin treatment. The invasion efficiency of L. monocytogenes strains with the 268-bp-long actA gene was 1.1-2.6-times lower than that of the strains with the 385-bp-long gene in normal and healthy cells. However, the invasion efficiency of both types of strains did not differ in senescent cells. Thus, L. monocytogenes strains with the 268-bp-long actA gene can inhabit the intestine asymptomatically as a commensal bacterium, but they may invade the intestinal epithelial cells and cause listeriosis in senescent cells.