• Title/Summary/Keyword: Approved

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Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey (국내 한방병원의 IRB 및 임상시험 실태조사)

  • Jung, Hee-Jung;Park, Ji-Eun;Choi, Snu-Mi
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.122-129
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    • 2010
  • Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

Clinical development of photodynamic agents and therapeutic applications

  • Baskaran, Rengarajan;Lee, Junghan;Yang, Su-Geun
    • Biomaterials Research
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    • v.22 no.4
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    • pp.303-310
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    • 2018
  • Background: Photodynamic therapy (PDT) is photo-treatment of malignant or benign diseases using photosensitizing agents, light, and oxygen which generates cytotoxic reactive oxygens and induces tumour regressions. Several photodynamic treatments have been extensively studied and the photosensitizers (PS) are key to their biological efficacy, while laser and oxygen allow to appropriate and flexible delivery for treatment of diseases. Introduction: In presence of oxygen and the specific light triggering, PS is activated from its ground state into an excited singlet state, generates reactive oxygen species (ROS) and induces apoptosis of cancer tissues. Those PS can be divided by its specific efficiency of ROS generation, absorption wavelength and chemical structure. Main body: Up to dates, several PS were approved for clinical applications or under clinical trials. $Photofrin^{(R)}$ is the first clinically approved photosensitizer for the treatment of cancer. The second generation of PS, Porfimer sodium ($Photofrin^{(R)}$), Temoporfin ($Foscan^{(R)}$), Motexafin lutetium, Palladium bacteriopheophorbide, $Purlytin^{(R)}$, Verteporfin ($Visudyne{(R)}$), Talaporfin ($Laserphyrin^{(R)}$) are clinically approved or under-clinical trials. Now, third generation of PS, which can dramatically improve cancer-targeting efficiency by chemical modification, nano-delivery system or antibody conjugation, are extensively studied for clinical development. Conclusion: Here, we discuss up-to-date information on FDA-approved photodynamic agents, the clinical benefits of these agents. However, PDT is still dearth for the treatment of diseases in specifically deep tissue cancer. Next generation PS will be addressed in the future for PDT. We also provide clinical unmet need for the design of new photosensitizers.

Bambusae Caulis in Taeniam Applicable for Medical Indications Associated with Inflammation

  • Hyo Jae Choi;Yugyeong Gwak;Ji Yeon Lee;Min Jung Kwun;Jun-Yong Choi;Myungsoo Joo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.37 no.1
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    • pp.14-18
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    • 2023
  • Jukyeo (竹茹; Bambusae Caulis in Taeniam: BCT) is an herbal medicine made from the inner part of the bamboo stem of Phyllostachys nigra Munro var. henonis Stapf ex Rendle or Phyllostachys bambusoides Siebold et Zuccarini. Although medical literature published in China and Korea decades ago introduced BCT as a remedy for reducing vomiting, fever, and hematemesis, decoctions containing BCT as a main herb (君藥) in Korea have been approved only for treating neurologic symptoms. Here, we discuss the anti-inflammatory function of BCT. Combined with the clinical usage of a BCT-containing decoction in treating inflammatory diseases in Japan, we raise the possibility of repurposing the BCT-containing decoctions for treating inflammatory diseases. The anti-inflammatory activity of BCT was mainly assessed by using RAW 264.7 cells. The regulation of NF-κB, Nrf2 and A20 activities was determined by western blot and quantitative RT-PCR. The list of decoctions containing BCT currently approved in Korea was obtained from the Korean Ministry of Food and Drug Safety (KFDA). BCT suppressed the activity of pro-inflammatory factor NF-κB elicited by LPS, activated an anti-inflammatory factor Nrf2, and induced A20 that is known to block several inflammatory pathways simultaneously, suggesting that BCT can suppress inflammation via at least 3 different pathways. KFDA approved 11 decoctions containing BCT as a major herb, including Gamiondam-tang (加味溫膽湯; GOT), for treating neurologic disorders. Interestingly, Jukyeoondam-tang (竹茹溫膽湯; JOT), whose composition is almost identical to GOT except for one herb, has been used to treat inflammatory pulmonary disorders including Covid-19 pulmonary infection in Japan Given the anti-inflammatory function of BCT evidenced by medical literature and experimental results and the clinical usage of JOT in treating inflammatory pulmonary disorders, we suggest a repurposing and extension of the BCT-containing decoctions approved in Korea to treating inflammatory diseases.

A Study on the Improvement of On-board Training Program through the Analysis of Satisfaction Level

  • Kim, Hong-Ryeol;Kim, Bu-Gi
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.19 no.3
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    • pp.270-276
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    • 2013
  • The educational process and result of onboard training should be evaluated according to the 1995 Amendments to the International Convention on Standards of Training, Certification and Watch-keeping for seafarers(STCW), 1978. In particular, the revised Convention requires that a trainee's seagoing service must be recorded in each cadet's Training Record Book approved by the maritime administration responsible for the issuance of certificates of competency. Trainees for certification under regulation III/1 of the STCW Convention are required to complete an approved on-board training programme. The purpose of this paper is to understand the compliance of the education for an approved on-board training programme. The questionnaire was distributed among 110 cadets being trained on board the training ship of the maritime college of the Mokpo National Maritime University. In this study, we conducted the questionnaire survey which is related to the on-board training programme such as marine engineering; controlling the operation of the ship and care for persons on board; electrical, electronic and control engineering; etc. The survey revealed that onboard training program was normally satisfactory, however, lack of practical training tools and time have accounted for most of the reasons for dissatisfaction. Therefore, it is our goal to enhance the satisfactory value of onboard training education by analyzing the reason of the dissatisfaction.

Methodology of SMS Manual Enactment for Approved Training Organization(ATO) focusing on C Flight Training Center (항공종사자 전문교육기관의 SMS 매뉴얼 제정을 위한 방법론 - C 비행훈련원의 사례를 중심으로 -)

  • Lee, Doo-Hyeong
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.26 no.3
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    • pp.87-92
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    • 2018
  • This thesis is to provide procedures for documenting implementation performance and methodology of practical SMS enactment for Approved Training Organization(ATO). As an example, C flight training center, according MOLIT "Guidance on SMS Implementation", derived 32 implementation documents after writing the SMS manual to implement it. The 32 implementation documents are divided into 5 fields. In detail, they are (1) 2 documents on SMS Manual, (2) 7 documents on Safety policy and objectives (3) 3 documents on Safety risk management (4) 15 documents on Safety assurance (5) 5 documents on Safety promotion. By describing the documented performances according to these 32 implementation documents that was in use for 1 year in 2017, it is suggested that this procedure can be a methodology for practically enactment and implementing the SMS manual.

Processing, Quality Stability and Utilization of Approved Sardine Surimi for Surimi-based Products (정어리 개량고기풀의 제조와 품질 안정성 및 이용성)

  • 김태진;서상복;이두석;민진기
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.28 no.2
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    • pp.403-408
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    • 1999
  • This study was conducted to investigate chemical properties, quality stability and utilization of approved sardine surimi(ASS) which is developed our laboratory. The product yield of the ASS was about 3 times higher than that of usual sardine surimi(SS). The proper addition concentration of sodium bicarbonate was 0.1% for the neutralization of the ASS. The content of salt soluble protein nitrogen in the ASS was about the half of that in the SS, while the content of water soluble protein nitrogen was 2.4 times higher in ASS. The total amount of free amino acids in the ASS was about 11 times higher than that of the SS. Predominant free amino acids in the ASS were histidine, taurine, glutamic acid and alanine, and those four amino acids occupied 94% of total amount of free amino acids. During cold storage at 21oC for 6 months, the quality of ASS was more stable than that of SS in judging from changes of water soluble and salt soluble protein nitrogen, AV and POV. Quality of fish burger, fish sausage and fried fish paste processed in accordance with commercial processing preparation using the ASS or SS exclusively and mixtures which other white meat fish surimi(alaska pollack, hair tail and sole) were proportionallly added to each of two types of sardine meat were evaluated. In case of fish burger, the product processed from the ASS only were superior.

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A Study on Performance Perceptions of Hospital Coordinators (병원코디네이터의 직무성과 인식)

  • Cho, Kyoung-Won;Kim, Chang-Hwan
    • The Korean Journal of Health Service Management
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    • v.3 no.1
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    • pp.25-32
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    • 2009
  • The goal of this paper is to estimate firm performance of hospital coordinators through a survey on employees of medical institutions placed in Busan and Ulsan. The survey for this paper is constituted by 34 questions of 4 groups related to firm performance, qualification requirement, general fact and a certificate of qualification. The survey was carried out from September 12th, 2008 to September 24th 2008 and 388 question sheets collected finally and used for result analysis. In the result analyses related to hospital coordinator and firm performance, we found some principal outcomes such that 88.6% of respondents approved that hospital image by patients and customers is raised, 87.7% of respondents approved that degree of patient's satisfaction on hospital services is raised, and 81.5% of respondents approved that employees recognized importance of services on customers, by hospital coordinators. In the result analysis on differences in firm performance by presence of a certificate of qualification for hospital coordinator, there were meaningful differences in degree of patient's satisfaction, financial performance and degree of employee's recognition on importance of services. From the all of the above results, we verified that establishment and improvement of educational process for hospital coordinator should be performed through researches on degree of patient's and costumer's satisfaction for hospital coordinator, degree of hospital coordinator's satisfaction for the job and surveys of requirements from related industry.

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Monitoring on the Foods not Approved for Irradiation in Korea by PSL and TL Detection Method (광자극발광법과 열발광법을 이용한 국내 방사선 조사 허용 외 식품에 대한 실태 조사)

  • Cho, Joon-Il;Lee, Ji-Ae;Lee, Soon-Ho;Hwang, In-Gyun
    • Journal of Food Hygiene and Safety
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    • v.25 no.1
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    • pp.73-78
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    • 2010
  • This research was conducted to assess applicability of photostimulated luminescence (PSL) and Thermoluminescence (TL) methods for investigation of infant and young children products, nut, seasoned dried fish, spice, dried fruits, fruit & vegetable, grain and marine products, which are not approved for irradiation in Korea. PSL results show that the photon counts of non-irradiated samples were lower than 700, while those of irradiated samples were higher than 700. In TL measurement, TL ratio of irradiated samples were higher than 0.1 or ones can decrease below 0.1 whereas the temperature range of TL Glow curve was between $150{\sim}250^{\circ}C$. Monitoring result about 8 class of 325 not approved to irradiated foods, photon counts of samples were less than 700, and after re-irradiation TL Ratio ($TL_1/TL_2$) through re-irradiation step at 1 kGy were higher than 0.1 for the all samples. Therefore, these results suggested that PSL and TL measurements were useful detection methods for 8 class food products not approved to irradiation in Korea and all sample (325 cases) were not irradiated when we analysed by PSL and TL methods.

A Survey on Performance Situation of Animal Welfare Approved Farms of Laying Hens (산란계 동물복지 인증농가의 생산실태 조사)

  • Hong, Eui-Chul;Kang, Bo-Seok;Kang, Hwan-Ku;Jeon, Jin-Joo;Kim, Hyun-Soo;Park, Sung-Bok;Kim, Chan-Ho;Suh, Sang-Won;Kim, Sang-Ho
    • Korean Journal of Poultry Science
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    • v.44 no.1
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    • pp.11-18
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    • 2017
  • The purpose of this survey was to collect basic data on breeding systems of animal welfare-approved laying hen farms in Korea. Questionnaires were mailed to 64 animal welfare-approved farms, and 20 questionnaires (31.3%) were returned. The housing systems were fabric coverlet (4 farms, representing 20%), naturally farmed (Yamagisi, 7 farms, 35%), and steel panel-framed housing (9 farms, 45%). The 20 farms had stocking densities of $2{\sim}3birds/m^2$ (2 farms; 10%), $4{\sim}5birds/m^2$ (10 farms; 50%), and $6{\sim}7birds/m^2$ (8 farms; 40%). Breeding methods were floor-housed (14 farms; 70%), free-range (3 farms; 15%), and floor plus free-range (3 farms; 15%). Stocking density was $4{\sim}6birds/m^2$ at most of the farms with fabric coverlet and naturally farmed housing and $6{\sim}7birds/m^2$ at seven farms (of 9 farms) with a steel panel-framed housing. The daily feed intake of 11 farms (55%) was between 120 and 130 g, which included 3 farms (15%) with fabric coverlet, 3 farms (15%) with naturally farmed housing, and 5 farms (25%) with steel panel-framed housing. The age of peak production was 24~28 weeks overall 20 farms. Over 80% of production on fabric coverlet, naturally farmed, and steel panel-framed house farms was on 3, 4 and 6 farms, respectively. Respiratory disease on the 20 farms represented 55% of total disease incidence, and of each housing type represented 75% (fabric coverlet), 70% (naturally farmed) and 33% (steel panel-framed). E. coli disease was only found in the steel panel-framed housing. Most of the animal welfare-approved eggs were sold at large markets or a real sale markets. Egg price was 200~250 won per egg. These results indicate the current situation of animal welfare-approved farms and could be caused that windowless poultry house was applied to animal welfare approved farms.