• Title/Summary/Keyword: Approval standard

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Pilot Study on Characterization of Patients with Low Back Pain: Multi-center, Prospective, Observation Study (요통 환자의 특성 조사 예비 연구: 다기관, 전향적, 관찰연구)

  • Park, Chang-Hyun;Jang, Bo-Hyoung;Ko, You-Me;Park, Dong-Su;Kim, Soon-Joong;Park, Won-Hyung;Cha, Yun-Yeop;Ko, Seong-Gyu;Song, Yun-Kyung
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.2
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    • pp.123-132
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    • 2016
  • Objectives The aim of this study done as pilot study is to analyze the current state of patients who have low back pain through registry. Methods This study is done under approval of Gil Oriental Medical Hospital of Gachon University, Oriental Medical Hospital of Sangji University, Jecheon Oriental Medical Hospital of Se-Myung University IRB. Among subjects who signed the consent form by their own will, we decided whom to register as subjects of this study by the standard of selection and exception. We collected the sociological investigation, character of low pack pain, degree of symptom which they felt before and after the hospitalization from registered subjects. Results 1. The number of the subjects is 16. The average age is 41.0. 9 of them are female, 7 of them are male. Most of the subjects have history illness which has connection with low pack pain. 2. According to the patient's free description of the back pain, 6 of them suffered throbbing pain. And 8 of the patients have chronic pain, 6 of them have intermittent pain of back pain analysing the character of the low back pain. They answered the pain lasted for 47.6 minutes on average. 3. About the change on the average R.O.M. of L-spine, R.O.M. of Lateral bending, Extension, Flexion, Rotation has increased after leaving the hospital compared with before hospitalization. 4. The amount of discomfort or strength of pain, which was checked by VAS on the day of leaving the hospital, has decreased than they were before the hospitalization. And there was the improvement on the dysfunction score and EQ-5D. Conclusions Through this study, we specifically analyzed the symptoms of the low back pain by accumulating the analysis about the symptoms using several indicators and description which is freely spoken by patients about their symptoms. Further research is expected to complete multi-center registry by building registry and by using it, to get various epidemiologic informations about low back pain.

MR Technology to 4T

  • Vaughan, Thomas
    • Proceedings of the KSMRM Conference
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    • 2003.10a
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    • pp.103-105
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    • 2003
  • After fifteen years of development, Magnetic Resonance (MR) technology for human imaging and spectroscopy is reaching a refined state with FDA approved 3T clinical products from Siemens, GE, and Philips. Broker has cleared CE approval with a 4T system. Varian supports a 4T system platform as well. Shielded magnets are standard at 3T from GE, Oxford, Magnex, and IGC. A shielded 4T whole body magnet is available from Oxford. Stronger switched gradients and dynamic shim coils, desired at any field, areespecially useful at higher static magnetic fields B0. In addition to the higher currents required for higher resolution slice or volume selection afforded by higher SNR, whole body gradient coils will be driven at increasing slew rates to meet the needs of new cardiac applications and other requirements. For example 3T and 4T systems are now being equipped with 2kV, 500A gradient coils and amplifiers capable of generating 4G/cm in 200msec, over a 67+/-cm bore diameter. High field EPI applications require oscillation rates at 1 kHz and higher. To achieve a benchmark 0.2 ppm shim over a 30cm sphere in a high field magnet, at least four stages of shimming need to be considered. 1) A good high field magnet will be built to a homogeneity spec. falling in the range of 100 to 150 ppm over this 30cm spherical "sweet spot" 2) Most modern high field magnets will also have superconducting shim coils capable of finding 1.5 ppm by their adjustment during system installation. 3) Passive ferro-magnetic shimming combined with 4) active, high order room temperature shim coils (as many as five orders are now being recommended) will accomplish 0.2 ppm over the 30cm sphere, and 0.1 ppm over a human brain in even the highest field magnets for human studies. Safety concerns for strong, fast gradients at any B0 field include acoustic noise and peripheral nerve stimulation. One or more of the mechanical decoupling methods may lead to quieter gradients. Patient positioning relative to asymmetric or short gradient coils may limit peripheral nerve stimulation at higher slew rates. Gradient designs combining a short coil for local speed and strength with a longer coil for coverage are being developed for 3T systems. Local gradients give another approach to maximizing performance over a limited region while keeping within the physiologically imposed dB0/dt performance limits.

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A Study on Developing Qualification Criteria in the Private Security Industry (민간경비 자격검정 개선방안에 관한 연구)

  • Choe, Jung-Taek
    • Korean Security Journal
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    • no.18
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    • pp.143-167
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    • 2009
  • As of entering the 21st century, a trend in the field of a private security industry among the advanced countries have been increased a qualification system and train session to meet the needs of professionalism. Intensifying the professionalism in Korea, education and train system has been initiated to change but the oligopoly market already formulated due to impractical selection standard and management of education system. Issuing certification and offering basic training through a designated institution for the purpose of improving quality of the private security industry worker, its practical effectiveness were lower than expectation. Rather certification-holder or security agency, institution or truster's rent-seeking behavior have been increased by occupational licensing system. The founded results, which were associated to problems in selecting and educating to the private security guard, in this study were that any verification has been initiated towards dual-system in official approval and structural problems in education system, and non-existence of verification for professionalism and management capability to security agency owner and its upper managerial level. Current a dual system in an officially authorized verification system and completion of security guard credential requested change to an unified official qualification verification system to solve those problems. Ranges of an applicant to the unified official qualification verification system should be extend to the whole population in the private security industry. Moreover, minimization of the dead-weigh loss, which is caused by oligopoly phenomenon while using its market-dominant status, increasement number of designated institution, which allows self-regulating competition, and endowment of autonomy, which is in selecting education and agency, were requested to solve the problems in selecting and educating to the private security guard. In order to minimize stated problems while maintaining objectiveness, a new manage and supervise institution, which is called a 'private security industry committee', should be establish. The private security industry committee is a formation of governance network which are participated from professional group to civil organization.

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Automatic Left Ventricle Segmentation by Edge Classification and Region Growing on Cardiac MRI (심장 자기공명영상의 에지 분류 및 영역 확장 기법을 통한 자동 좌심실 분할 알고리즘)

  • Lee, Hae-Yeoun
    • The KIPS Transactions:PartB
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    • v.15B no.6
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    • pp.507-516
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    • 2008
  • Cardiac disease is the leading cause of death in the world. Quantification of cardiac function is performed by manually calculating blood volume and ejection fraction in routine clinical practice, but it requires high computational costs. In this study, an automatic left ventricle (LV) segmentation algorithm using short-axis cine cardiac MRI is presented. We compensate coil sensitivity of magnitude images depending on coil location, classify edge information after extracting edges, and segment LV by applying region-growing segmentation. We design a weighting function for intensity signal and calculate a blood volume of LV considering partial voxel effects. Using cardiac cine SSFP of 38 subjects with Cornell University IRB approval, we compared our algorithm to manual contour tracing and MASS software. Without partial volume effects, we achieved segmentation accuracy of $3.3mL{\pm}5.8$ (standard deviation) and $3.2mL{\pm}4.3$ in diastolic and systolic phases, respectively. With partial volume effects, the accuracy was $19.1mL{\pm}8.8$ and $10.3mL{\pm}6.1$ in diastolic and systolic phases, respectively. Also in ejection fraction, the accuracy was $-1.3%{\pm}2.6$ and $-2.1%{\pm}2.4$ without and with partial volume effects, respectively. Results support that the proposed algorithm is exact and useful for clinical practice.

Improvement of legal systems of automobile in the era of the 4th industrial revolution (4차 산업혁명 시대의 자동차 관련 법제의 합리적 개선방안)

  • Park, Jong-Su
    • Journal of Legislation Research
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    • no.53
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    • pp.269-310
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    • 2017
  • This article aims at the study on Improvement of legal System which is related to automated vehicles in the era of the 4th industrial revolution. Legal aspects of driving automation have two view points. One is to permit a automated vehicle, the other is to regulate the behavior of driver on the road. Signifying elements of the 4th industrial revolution are IoT, AI, big data, cloud computing etc. Automated vehicles are the imbodiment of those new ICT technologies. The vehicle management act(VMA) rules about vehicle registration and approval of vehicle types. VMA defines a automated vehicle as a vehicle which can be self driven without handling of driver or passenger. Vehicle makers can take temporary driving permission for testing and research the driving automation. Current definition of automated vehicle of VMA is not enough for including all levels of SAE driving automation. In the VMA must be made also a new vehicle safty standard for automated vehicle. In the national assembly is curruntly pending three draft bills about legislation of artificial intelligence. Driving automation and AI technologies must be parallel developed. It is highly expected that more proceeding research of driving automation can be realized as soon as possible.

Studies on Insect Diversity Related to Genetically Engineered Vitamin A Rice under Large Scale Production (비타민 A 강화 벼의 대규모 GMO 포장에서 곤충다양성 분석)

  • Kim, Kyung-Min;Ryu, Tae-Hun;Suh, Sang Jae
    • Korean Journal of Breeding Science
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    • v.42 no.2
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    • pp.157-162
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    • 2010
  • This study was carried out to develop of macro-protocol and the biosafety guide for 'Nakdong', and 'Golden Rice' (genetically modified vitamin A rice) by large scale field trial of GM crops. Typically, when a new GM crop is created, breeders should conduct field test to make sure the GM crop is safe, and provide some information on GM crops for approval. A total of isolated 4,700 $m^2$ field for trial of GM crops were prepared, and 'Nakdong' and 'Golden rice' were cultivated by standard method of RDA (Rural Development Administration, Korea). Field studies indicated that the population densities of insect pests and natural enemies have no difference between two varieties. While insect pest density on 'Nakdong' was slightly higher than on Golden Rice, but natural enemy density on Golden Rice was a little higher. These results provided the insect diversity for risk assessment analysis of Golden Rice and suggested that the macro-protocol could be useful to detect GM plants.

Nursing Students' Attitudes toward Abortion and Perceptions of Euthanasia and Good death (간호대학생의 낙태에 대한 태도와 안락사 및 좋은 죽음에 대한 인식)

  • Kim, Kyung sook
    • Journal of Convergence for Information Technology
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    • v.11 no.3
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    • pp.68-76
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    • 2021
  • This study was attempted to understand the relationship between the attitudes toward abortion, euthanasia, and the level of perception of good death among nursing college students and related factors. The data were collected by using structured questionnaires and the subjects were selected in C and G city. The research method was a descriptive research study, and the mean, standard deviation, frequency analysis, and Pearson's correlation coefficients were analyzed for the variables. The results of this study are as follows. The degree of support for the abortion opposition was 2.51±.56 (score range 1-4), and the opposition to abortion was superior to the approval..The perception of euthanasia was 3.06±.47 points (4 point scale), which was positively recognized at a higher level than the middle, and the good death perception was 2.97±.47 points (4 point scale), which was moderate. 97.1% of the respondents said that they had abortion decisions, and 5.7% of the university students experienced abortion. The attitude toward abortion showed negative correlation with the attitude toward euthanasia (r=-.374, p<.001), showing that the more supportive the anti-abortion, the more positive the attitude toward euthanasia. Therefore, it is necessary to educate the subjects to protect and respect the human rights of patients based on the dignity of life and humanistic thinking while providing nursing services.

Animal Skin Irritation and Skin Sensitization Tests of High Intensity Focused Ultrasound System Cartridges (집속형초음파자극시스템 카트리지의 동물실험을 통한 피부자극시험 및 피부 감작성시험)

  • Jun-tae, Kim;Ju-hee, Kim;Kyu-tai, Joo;Kyung-ah, Kim;Ahnryul, Choi;Jae-hyun, Jo;Jin-houng, Jeong
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.15 no.6
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    • pp.477-484
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    • 2022
  • In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.

Serological responses and protection levels in chickens administered with Newcastle disease vaccines

  • Geumji Seung;Jiye Kim;Hyobi Kim;Ji-Yeon Kim;Yang-Ho Jang;Yeon-Hee Kim;Moon Her;Seong-Joon Yi;Keun-Woo Lee;Il Jang;Young Ju Lee
    • Korean Journal of Veterinary Research
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    • v.62 no.4
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    • pp.29.1-29.7
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    • 2022
  • Vaccination against Newcastle disease (ND) is the most effective means of controlling the disease, and these vaccines are commercialized only after their safety and effectiveness have been verified through tests that comply with Korean Standards of National Lot Release for Veterinary Biologics. This study investigated whether a relatively convenient and safe serological test can be used in place of the challenge test using highly virulent ND virus. Hemagglutination inhibition (HI) assay and enzyme-linked immunosorbent assay (ELISA) were considered positive of log2 2 or more and cutoff value of 200 or more, respectively, in both live and inactivated vaccines. However, when the antibody levels of the live and inactivated vaccines induced using the Ulster 2C, KBNP-C4152R2L, and K148/08 strains were compared, the antibody titers for inactivated vaccines were significantly higher than those for live vaccines in both the HI assay and ELISA. A strong positive correlation was observed between HI and ELISA antibody titers. The live vaccines corresponded to a survival rates of ≥ 80% and the inactivated vaccines corresponded to 100% survival rates. This study confirmed that standard efficacy tests can serve as serological tests, and can replace the challenge test and that the vaccine approval process can be improved.

A Survey on Current Status and Introduction of Single Institutional Review Board (IRB) in Korea (국내 Single IRB 현황 및 도입에 대한 설문조사 연구)

  • Park, Sinyoung;Noh, Yang Hee;Cho, Su jin;Shim, Kyu Young;Park, Eun Young;Kim, Jin Seok
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.6-22
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    • 2020
  • Purpose: Clinical studies require institutional review board (IRB) approval based on the ethical principle and regulations. While the number of clinical studies has been increased and diversified, duplicated IRB review for multi-center studies has become a major issue. Therefore, single IRB system has been suggested in revised Common Rule. This study aimed to identify and assess the current status of single IRB in Korea and the anticipated needs of single IRB from researchers and IRB member or administrators. Methods: We developed 14 questions including perceived advantages and disadvantages of single IRB, and anticipated problems. The online survey collected opinions on single IRB from researchers, IRB members and IRB administrators. We also interviewed five IRB administrators who have an experience of single IRB. Results: A total of 80 responses were analyzed in this study. Although efficiencies were suggested for the advantages of single IRB in terms of reducing burden of duplicated review, respondents also perceived that the different review criteria between single IRB and each IRB would be a major hurdle for adopting single IRB system. Therefore, the standardization of standard of procedures (SOP) and the standardization of IRB submission materials should be preceded. According to the small group experiences of single IRB in Korea, we also observed the similar anticipated problems of single IRB. Conclusion: Single IRB system has many advantages for conducting multi-center trial. However, many specialists still have a lot of concerns about introducing a single IRB system in Korea. Therefore, a gradual, step-by-step process for conducting a single IRB system in Korea will be needed. Many studies for improving currently suggested single IRB system and the improvement of awareness about the essential of single IRB system would be needed.

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