• 제목/요약/키워드: Act of Clinical Research

검색결과 104건 처리시간 0.023초

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

  • 전옥환;박준범;김대진;김대은;문철;구본경
    • 대한임상검사과학회지
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    • 제54권4호
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    • pp.285-292
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    • 2022
  • 국제표준직업분류나 일본·미국의 법률시스템, 양성시스템를 통해서 본 안과검사인력은 안과전문의, 검안사, 시능훈련사, 검안기사, 안과기사가 포함된다. 국가통계포털 자료에 의하면 2022년 안과에 근무하는 안경사의 수는 의료기관 종별에 따라 파악이 가능하지만, 임상병리사의 수는 파악이 불가능하다. 다만, 본 연구를 통해서 상급종합병원의 경우 임상병리사가 안경사보다 많이 근무하는 것으로 조사되었다. 우리나라 안과검사실 인력의 경우 국제표준직업분류, 국제표준교육분류, 의료법, 의료기사 등에 관한 법률 및 고등교육법에 비추어 봤을 때, 미국의 검안사는 비교 대상이 아니며 안과전문의나 검안사의 지도를 받아 업무수행하는 검안기사가 부합되는 직업일 것이다. 민간자격으로 대한안과학회 및 대한검안학회에서 안과검사실에 종사하는 임상병리사 및 안경사에게 '임상검안사'라는 호칭을 부여하여 새로이 자격관리를 정립한다면 국민 안(眼)보건 향상에 더욱 도움이 되리라 생각된다.

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
    • 대한임상검사과학회지
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    • 제53권1호
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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.

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

  • 박종연
    • 보건의료기술평가
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    • 제6권2호
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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.

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

  • 한경훈;김도희;송관영;이계희;강태봉;윤택준
    • 생약학회지
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    • 제43권1호
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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.

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

  • 송영민
    • 의료법학
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    • 제20권2호
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    • pp.173-206
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    • 2019
  • 본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구·치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

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

  • 김미나;이승길;이용식;조삼래;김덕현
    • 한국환경보건학회지
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    • 제44권2호
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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.

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

  • 장태영;김규성;김영효
    • 항공우주의학회지
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    • 제28권1호
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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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    • 제46권2호
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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.

의료기사 등에 관한 법률 중 '의사 또는 치과의사의 지도 아래' 문구의 타당성에 대한 고찰: 방사선사를 중심으로 (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)

  • 주영철;임청환;임우택;홍동희;정홍량;김은혜;윤용수;정영진;최지원;유세종
    • 대한방사선기술학회지:방사선기술과학
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    • 제44권5호
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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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    • 제28권1호
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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.