• Title/Summary/Keyword: exposure test

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Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method (퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석)

  • Lim, Hoi-Jeong;Kim, Yoon-I;Jung, Young-Bok;Seong, Sang-Cheol;Ahn, Jin-Hwan;Roh, Kwon-Jae;Kim, Jung-Man;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.37 no.4
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    • pp.381-389
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    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

Study on Image Quality and Radiation Dose due to the Arm Position in the Abdomen/Pelvis CT (복부/골반 CT 검사 시 팔의 위치에 따른 방사선 선량과 영상화질 비교 연구)

  • Lee, Jongwoong;Won, Doyeon;Jung, Jaeeun;Kim, Hyeongyun
    • Journal of the Korean Society of Radiology
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    • v.9 no.6
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    • pp.337-342
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    • 2015
  • The one-year-follow-up test of abdomen/pelvis from 10 patients who were scanned more than twice a years were analyzed the radiation dose and image quality depend on the position of the arm retrospectively from January to December in 2013. There were classified two groups, group A was examined with raising an arm on standard position and group B was performed with lowering an arm, respectively. Group A of an average mAs from the first dose amount was shown 11.4% less compared to Group B. And the value of CTDI from Group B also was investigated 11.3% less. To compare the quality comparison of the second image as histogram value, the value of max from both of two groups was measured similarly. However, a big difference was shown from the value of min and SD, the short dose was appeared depends on the position of arm even though Group A was radiated more than Group B. Less exposure to the medical image quality only by working CT scan when the examiner actively raise the arm before the development and testing of high-end equipment introduction of complex algorithms for obtaining an optimized image will be provided to the patient.

Development of liquid target for beam-target neutron source & two-channel prototype ITER vacuum ultraviolet spectrometer

  • Ahn, B.N.;Lee, Y.M.;Dang, J.J.;Hwang, Y.S.;Seon, C.R.;Lee, H.G.;Biel, W.;Barnsley, R.;Kim, D.E.;Kim, J.G.
    • Proceedings of the Korean Vacuum Society Conference
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    • 2011.02a
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    • pp.421-422
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    • 2011
  • The first part is about development of a liquid target for a neutron source, which is designed to overcome many of the limitations of traditional beam-target neutron generators by utilizing a liquid target neutron source. One of the most critical aspects of the beam-target neutron generator is the target integrity under the beam exposure. A liquid target can be a good solution to overcome damage to the target such as target erosion and depletion of hydrogen isotopes in the active layer, especially for the one operating at high neutron fluxes with no need for water cooling. There is no inherent target lifetime for the liquid target neutron generator when used with continuous refreshment of the target surface exposed to the energetic beam. In this work, liquid target containing hydrogen has been developed and tested in vacuum environment. Potentially, liquid targets could allow a point neutron source whose spatial extension is on the order of 1 to $10{\mu}m$. And the second is about the vacuum ultraviolet (VUV) spectrometer which is designed as a five-channel spectral system for ITER main plasma measurement. To develop and verify the design, a two-channel prototype system was fabricated with No. 3 (14.4 nm~31.8 nm) and No. 4 (29.0 nm~60.0 nm) among the five channels. For test of the prototype system, a hollow cathode lamp is used as a light source. The system is composed of a collimating mirror to collect the light from source to slit, and two holographic diffraction gratings with toroidal geometry to diffract and also to collimate the light from the common slit to detectors. The two gratings are positioned at different optical distances and heights as designed. To study the appropriate detector for ITER VUV system, two different electronic detectors of the back-illuminated charge coupled device and the micro-channel plate electron multiplier were installed and the performance has been investigated and compared in the same experimental conditions. The overall system performance was verified by measuring the spectrums.

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Knowledge and attitude change towards radiation protection after radiation safety management education in dental hygiene students (치위생과 학생들의 학업관련 특성에 따른 방사선안전관리 교육 후 방사선 방어에 대한 지식과 태도의 변화)

  • Kim, Sung-Ae;Lee, Ji-Young;Hwang, Se-Hyun;Cho, Mi-Suk;Park, Jung-Hyun;Jung, Nam-Yeong;Yu, Byeng-Chul
    • Journal of Korean society of Dental Hygiene
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    • v.15 no.1
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    • pp.101-109
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    • 2015
  • Objectives: The purpose of the study is to investigate the knowledge and attitude towards radiation protection after radiation safety management education in dental hygiene students. Methods: After receiving informed consents, a self-reported questionnaire was carried out for 135 dental hygiene students in Busan on June 17 for preliminary survey and September 3 for post-education survey, 2011. The questionnaire was modified from Han and consisted of 5 questions of general characteristics, 6 questions of radiation use, 7 questions of scholastic characteristics, 15 questions of knowledge towards radiation safety management, and 15 questions of attitude towards radiation safety management. Cronbach's alpha was 0.808 in the knowledge towards radiation safety management. Attitude towards radiation safety management included 15 questions of general attitude towards radiation safety management, individual and patient, and attitude toward radiation exposure reduction measured by Likert 5 scale. Cronbach's alpha was 0.970 in the attitude towards radiation safety management. Data were analyzed using SAS version 9.2 for educational analysis, technical analysis and multivariate analysis, paired t-test, and GLM. Results: Significant differences were shown in the knowledge and attitudes towards radiation safety management; the level of knowledge was respectively $9.8{\pm}3.0$ and $12.9{\pm}1.9$ points before and after education, and the level of attitude was $4.28{\pm}0.51$ and $4.53{\pm}0.47$ before and after the education. The levels of knowledge and attitude according to general characteristics showed a significant differences in grade and academic results. Post-education survey suggested that the education is very important and necessary and can change the knowledge and attitude towards radiation safety management in the dental hygiene students. Conclusions: Through the radiation safety management education, the levels of knowledge and attitude towards radiation safety management have changed significantly, which showed that the radiation safety management education proved to be very effective. Therefore, an effective radiation safety management education program is necessary to improve the levels of knowledge and attitude towards radiation safety management in the dental hygiene students.

Effects of Exogenous Insulin-like Growth Factor 2 on Neural Differentiation of Parthenogenetic Murine Embryonic Stem Cells

  • Choi, Young-Ju;Park, Sang-Kyu;Kang, Ho-In;Roh, Sang-Ho
    • Reproductive and Developmental Biology
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    • v.36 no.1
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    • pp.33-37
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    • 2012
  • Differential capacity of the parthenogenetic embryonic stem cells (PESCs) is still under controversy and the mechanisms of its neural induction are yet poorly understood. Here we demonstrated neural lineage induction of PESCs by addition of insulin-like growth factor-2 (Igf2), which is an important factor for embryo organ development and a paternally expressed imprinting gene. Murine PESCs were aggregated to embryoid bodies (EBs) by suspension culture under the leukemia inhibitory factor-free condition for 4 days. To test the effect of exogenous Igf2, 30 ng/ml of Igf2 was supplemented to EBs induction medium. Then neural induction was carried out with serum-free medium containing insulin, transferrin, selenium, and fibronectin complex (ITSFn) for 12 days. Normal murine embryonic stem cells derived from fertilized embryos (ESCs) were used as the control group. Neural potential of differentiated PESCs and ESCs were analyzed by immunofluorescent labeling and real-time PCR assay (Nestin, neural progenitor marker; Tuj1, neuronal cell marker; GFAP, glial cell marker). The differentiated cells from both ESC and PESC showed heterogeneous population of Nestin, Tuj1, and GFAP positive cells. In terms of the level of gene expression, PESC showed 4 times higher level of GFAP expression than ESCs. After exposure to Igf2, the expression level of GFAP decreased both in derivatives of PESCs and ESCs. Interestingly, the expression level of $Tuj1$ increased only in ESCs, not in PESCs. The results show that IGF2 is a positive effector for suppressing over-expressed glial differentiation during neural induction of PESCs and for promoting neuronal differentiation of ESCs, while exogenous Igf2 could not accelerate the neuronal differentiation of PESCs. Although exogenous Igf2 promotes neuronal differentiation of normal ESCs, expression of endogenous $Igf2$ may be critical for initiating neuronal differentiation of pluripotent stem cells. The findings may contribute to understanding of the relationship between imprinting mechanism and neural differentiation and its application to neural tissue repair in the future.

Bioanalytical method validation for determination of arsenic speciation in dog plasma using HPLC-ICP/MS (Dog 혈장 중 HPLC-ICP/MS를 이용한 비소 화학종 분석법 검증)

  • Kim, Jong-Hwan;Kwon, Young Sang;Shin, Min-Chul;Kim, Su Jong;Seo, Jong-Su
    • Analytical Science and Technology
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    • v.29 no.5
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    • pp.234-241
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    • 2016
  • The approach presented in this article refers to the bioanalytical method validation for the detection and quantitative determination of arsenic species including arsenite (As(III)), arsenate (As(V)), dimethylarsinic acid (DMA) and monomethylarsonic acid (MMA) in dog plasma by high-performance liquid chromatography inductively coupled plasma mass spectrometry (HPLC-ICP/MS). The arsenic species were separated using an agilent As speciation column by a mobile phase of 2 mM sodium phosphate monobasic, 0.2 mM ethylenediaminetetraacetic acid disodium salt dehydrate, 10 mM sodium acetate, 3 mM sodium nitrate and 1 % ethyl alcohol at pH 11 (adjusted with 1M NaOH). The method validation experiment was obtained selectivity, linearity, accuracy, precision, matrix effect, recovery, system suitability, dilution integrity and various stabilities. All calibration curves showed good linearity (R2>0.999) within test ranges. The lower limit of quantitation (LLOQ) was 5 ng/mL for As(III), As(V) and DMA, and 20 ng/mL for MMA. The system suitability and dilution values were within 6.5 % and 7.7 %. Subsequently, the developed and validated HPLC-ICP/MS method was also successfully applied to determine the arsenic speciation in dog plasma samples, and the recoveries for the spiked samples were in the range of 91.5–102.2 %. Therefore, this method could be applied to the evaluation of arsenic exposure, health effect assessment and other bio-monitoring studies in biological samples.

Development and Verification of Eco-hybrid Rolling Mat for Preventing Bank Erosion Based on Large-scale Experiments (실규모 하천 실험을 통한 하안침식 방지 Eco-hybrid 롤링매트 공법 개발 및 검증)

  • Ji, Un;Jang, Eun-Kyung;Ahn, Myeonghui;Kim, Won
    • Ecology and Resilient Infrastructure
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    • v.6 no.4
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    • pp.217-226
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    • 2019
  • Optimum engineering methods for bank protection were classified based on steepness of bank slope and an existence of waterfront facility in the floodplain, and a new concept of eco-hybrid rolling mat method which could be applicable for the unfitted cases with previously developed countermeasures was suggested in this study. The eco-hybrid rolling mat method can be constructed while maintaining the river environment and ecosystem that does not interfere with the ground and slopes, when bank erosion occurs, it is an economical and efficient construction method that can protect the revetment and the bank slope immediately. The developed eco-hybrid rolling mat method was verified for the designed structure, system, function and effect based on large-scale river experiments including field exposure and decomposition test. As a result, the normal operation and effect of the rolling mat ted under low and high velocity conditions were confirmed with respect to bank protection. The effect of bank erosion prevention was quantitatively validated by sediment concentration monitoring and analysis, and the product specification of the eco-hybrid rolling mat was presented based on the standardized mat applied in real-scale tests.

Oxidation Characteristic Changes in Insulation Oil Depending upon Storage Environments and Oil Resources (저장 환경 및 원료에 따른 전기절연유 산화특성 연구)

  • Lee, Don-Min;Park, Cheon-Kyu;Ha, Jong-Han;Lee, Bong-Hee
    • Applied Chemistry for Engineering
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    • v.27 no.5
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    • pp.495-501
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    • 2016
  • Mineral oil has been widely used as an insulating oil for electrical transformers for a long time, but the necessity of employing new insulation oil such as vegetable oil has been increased due to urgent needs for the biodegradability when it leaks and also for the thermal stability at a higher operation temperature. Although specific periods are required between the production and consumption, there are still short of the data to prove the insulation oils' storage stability depending upon various circumstances and their resources. Thus, this paper demonstrates the insulation oils' oxidation characteristics of both mineral and vegetable oils when each was exposed to different environments for 12 weeks. From this test, some properties including total acid number, water content and dielectric breakdown were changed under specific conditions and resources. Vegetable oils showed higher hydrophilicity and water saturation than those of mineral oils due to their molecular compositions. Under sunlight exposure condition, all insulation oils oxidized and changed their properties when exposing to the direct light, regardless of the resource used.

An Experimental Study on the Application of LIBS for the Diagnosis of Concrete Deterioration (콘크리트 열화 진단의 LIBS 적용을 위한 실험적 연구)

  • Woo, Sang-Kyun;Chu, In-Yeop;Youn, Byong-Don
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.21 no.6
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    • pp.140-146
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    • 2017
  • It is laser induced breakdown spectroscopy(LIBS) that enables qualitative and quantitative analysis of the elements contained in unknown specimen by comparing the wavelength characteristics of each element obtained from the spectral analysis of the standard specimen with the wavelength analysis results from unknown specimens. In this study, the applicability of LIBS to the analysis of major deterioration factors affecting concrete durability was experimentally analyzed. That is, the possibility of applying LIBS to the diagnosis of concrete deterioration by studying the quantitative detection of harmful deteriorating factors on chloride, sulfate and carbonated mortar specimens using LIBS was studied. As a result of LIBS test for each chloride and sulfate specimen, the LIBS spectral wavelength intensity of chlorine and sulfur ions increased linearly with increasing concentration. Carbon ion LIBS spectral wave intensities of carbonated specimens increased nonlinearly over the duration of carbonation exposure. From the above results, it can be partially confirmed that LIBS can be applied to the diagnosis of concrete deterioration. In case of concrete carbonation, it is presumed that carbon content is contained in the cement itself and is different from the detection of chloride and sulfate specimen. Therefore, it is considered that more various parameter studies should be performed to apply LIBS to concrete carbonation.

Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • Genomics & Informatics
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    • v.16 no.3
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    • pp.52-58
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    • 2018
  • In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.