• Title/Summary/Keyword: Multi-center Trial

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The Improvement of Mixed Extracts of Fructus Aurantii and Mulberry Leaves on Lipid Metabolism (지각과 상엽 혼합추출물이 지질 개선에 미치는 영향)

  • Park, Seong-Woo;Shin, Yong-Cheol;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.12 no.1
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    • pp.135-147
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    • 2008
  • Background : Diabetes is a chronic disease characterized by deficiency of insulin. It has been reported that Fructus aurantii and mulberry leaves have the effect of anti-diabetes. Methods : To investigate the improvement of mixed extracts of Fructus aurantii and mulberry leaves on lipid metabolism, we performed double-blinded, randomized and placebo-controlled multi-center clinical trial. Results : Mixed extracts of Fructus aurantii and mulberry leaves significantly reduced total cholesterol. Conclusion : These results suggest that mixed extracts of Fructus aurantii and mulberry leaves improve lipid metabolism.

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Tolerance analysis of Multi-Configurative Microscopic System for Inspecting the Wire-Bonding Status of Semiconductor Chips (반도체 와이어 본딩 검사용 다중배치 현미경 광학계에 대한 공차분석)

  • Ryu, Jae-Myung;Kim, Jae-Bum;Kang, Geon-Mo;Jung, Jin-Ho;Baek, Seung-Sun;Jo, Jae-Heung
    • Korean Journal of Optics and Photonics
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    • v.17 no.2
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    • pp.149-158
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    • 2006
  • We have analyzed various tolerances of the multi-configurative microscopic system for inspecting the wire-bonding of a reed frame by using the Gaussian bracket method and the equivalent lens method. The tolerances for the curvature and the thickness, which are axial symmetric tolerances, are given by varying the back focal length within a fecal depth under diffraction-limited conditions. Moreover, by using the trial and error method, the axial non-symmetric tolerances for decenter and tilt are established by assigning the 5% variation of MTF(modulation transfer function) at the spatial frequency of 50 lp/mm and at the field angle of 0.7 field. As the tolerances with the most probable distribution are distributed within the range of the decay rate of less than 5% independent of the probability distribution of tolerances, we can achieve completely the desired design performances of the multi-configurative microscopic system by using the various ranges of these tolerances.

Weekly Variation in Ischemic Stroke Incidence According to the Age and Sex (성별과 연령에 따른 허혈성 뇌졸중 발생의 요일 변화)

  • Kim, So-Yeon;Lee, Sang-Kwan
    • The Journal of Internal Korean Medicine
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    • v.31 no.2
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    • pp.308-313
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    • 2010
  • Objectives : The weekly variation of ischemic stroke incidence according to the age and sex. Methods : 977 consecutively admitted patients (521 males and 456 females) in a single stroke center from 2006 to 2008. All cases were confirmed with standardized criteria. We used the independent t-test and $x^2$ test in statistical methods. Results : The results demonstrated significant weekly variations of ischemic stroke incidence showing higher incidence on Saturday, Monday and Tuesday and lower incidence on the other days. Difference of ischemic stroke incidence was also shown between transit days, which included the transit days from the weekend to the week and vice versa, and non-transit days. Those aged older than 60 years and females showed more significant differences of weekly variation on transit days than on non-transit days. Conclusions : Ischemic stroke incidence has significant weekly variation, and transit days have higher incidence than non-transit days. Further study is required to identify the general weekly variation by multi-center trial.

The Relationship between Pulse Pattern and NIHSS Score in Early Stroke Patient;Multi Center Trials (초기 중풍 환자에 있어서 맥상(脈象)과 NIHSS과의 상관성 연구;다기관 임상연구)

  • Ma, Mi-Jin;Gang, A-Mi;Choi, Dong-Jun;Han, Chang-Ho;Lee, Won-Chul;Jun, Chan-Yong;Cho, Ki-Ho;Choi, Sun-Mi
    • The Journal of Internal Korean Medicine
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    • v.28 no.4
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    • pp.727-732
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    • 2007
  • Objectives : This study investigated using National Institutes of Health Strokes Scale in acute and subacute stroke patients and evaluated relativity of pulse pattern to NIHSS. Methods : 104 acute and subacute stroke patients were selected from 4 oriental medical hospitals from April 2007 to May 2007. The patients were admitted to hospital within 1 month after stroke. Pulse feeling diagnosis was done by oriental medical doctor and classified into 7 subtypes. Results : There were significant results statistically between slow/rapid pulse and NIHSS score in the male group; in the female group, there were no significant results statistically but the results showed that slow pulse has lower NIHSS score than rapid pulse. Patients with surging pulse had lower NIHSS score than the other patients. Another pulse pattern had no relativity to NIHSS score.

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MULTI-PHYSICAL SIMULATION FOR THE DESIGN OF AN ELECTRIC RESISTOJET GAS THRUSTER IN THE NEXTSAT-1 (차세대 인공위성 전기저항제트 가스추력기의 다물리 수치모사)

  • Chang, S.M.;Choi, J.C.;Han, C.Y.;Shin, G.H.
    • Journal of computational fluids engineering
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    • v.21 no.2
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    • pp.112-119
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    • 2016
  • NEXTSat-1 is the next-generation small-size artificial satellite system planed by the Satellite Technology Research Center(SatTReC) in Korea Advanced Institute of Science and Technology(KAIST). For the control of attitude and transition of the orbit, the system has adopted a RHM(Resisto-jet Head Module), which has a very simple geometry with a reasonable efficiency. An axisymmetric model is devised with two coil-resistance heaters using xenon(Xe) gas, and the minimum required specific impulse is 60 seconds under the thrust more than 30 milli-Newton. To design the module, seven basic parameters should be decided: the nozzle shape, the power distribution of heater, the pressure drop of filter, the diameter of nozzle throat, the slant length and the angle of nozzle, and the size of reservoir, etc. After quasi one-dimensional analysis, a theoretical value of specific impulse is calculated, and the optima of parameters are found out from the baseline with a series of multi-physical numerical simulations based on the compressible Navier-Stokes equations for gas and the heat conduction energy equation for solid. A commercial code, COMSOL Multiphysics is used for the computation with a FEM (finite element method) based numerical scheme. The final values of design parameters indicate 5.8% better performance than those of baseline design after the verification with all the tuned parameters. The present method should be effective to reduce the time cost of trial and error in the development of RHM, the thruster of NEXTSat-1.

School-based nutrition education improves breakfast-related personal influences and behavior of Indonesian adolescents: a cluster randomized controlled study

  • Indriasari, Rahayu;Nadjamuddin, Ulfah;Arsyad, Dian Sidik;Iswarawanti, Dwi Nastiti
    • Nutrition Research and Practice
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    • v.15 no.5
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    • pp.639-654
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    • 2021
  • BACKGROUND/OBJECTIVES: Many adolescents in developing countries skip breakfast. Innovative nutrition education (NE) strategies are needed to enhance knowledge and skills related to the breakfasts of adolescents in a low socioeconomic setting. The objective was to evaluate short- and long-term effects of a multi-strategy, school-based NE intervention on adolescents' breakfast-related personal influences and behaviors. SUBJECTS/METHODS: An intervention study with a cluster randomized controlled trial design was conducted in 4 senior high schools in Makassar, Indonesia. The multi-strategy NE intervention was delivered for 3 months. Data were collected using a self-administered questionnaire and a 3-day breakfast recall (face-to-face interview). Wilcoxon, McNemar, and Mann-Whitney tests were used to determine intra- and intergroup differences. RESULTS: Unlike knowledge, improvement was observed in attitude and self-efficacy scores in the intervention groups (IGs) (P < 0.01); however, no significant changes were observed in the control group (CG). More students showed improved motivation in the IG than in the CG (P > 0.05). Changes in breakfast frequency and macronutrient intake from breakfast were greater in the IG than in the CG (P < 0.05). CONCLUSIONS: A multi-strategy NE intervention is effective in producing positive changes in breakfast-related attitude, self-efficacy, and motivation of adolescents from a low-middle socioeconomic setting. The intervention improved breakfast frequency and nutrient intake. This intervention has promise for sustaining the observed changes over the long-term.

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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Clinical Evaluation of $Doxycycline(Vibramycin^{\circledR})$ in Respiratory Tract Infection ($Doxycycline(Vibramycin^{\circledR})$의 호흡기감염증(呼吸器感染症)에 대(對)한 임상적(臨床的) 효과(效果))

  • Lim, J.K.;Kim, M.S.;Shin, S.G.;Yoon, H.I.;Hong, S.A.
    • The Korean Journal of Pharmacology
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    • v.11 no.2
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    • pp.47-53
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    • 1975
  • Pan-Korean multi-center trial of doxycycline in the treatment of upper and lower respiratory infection was carried out in the summer(from May to October) of 1975. A total of 204 patients between the ages of 3 and 75 was treated by 37 physicians including the internal medicine, pediatrics and ENT specialist in 17 general hospitals and 2 private clinics all-over the country. The dosage recommended was 200 mg on the first day of therapy followed by 100 mg daily thereafter. The pediatric dosage was 4 mg/kg on the first day and then 2mg/kg on each successive day. The subjective and objective signs of respiratory infection such as temperature, cough, sputum, pain and associated inflammatory symptoms were assessed using the carefully designed protocols and it showed rapid improvement by the fifth day (80%) of therapy. Only minor side-effects were reported and these were mild and mainly limited to gastrointestinal tract. The overall evaluation of the trial showed that 170 patients(83.3%) had a very good or good result, 13 patients (6.4%) a moderate and another 13 patients (6.4%) a negative result.

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A Study on the Methodology of Acupuncture Clinical Trial on the Postmenopausal and Perimenopausal Hot Flashes (갱년기 안면홍조에 대한 침 임상시험 방법론 연구)

  • Roh, Jin-Ju;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.21 no.4
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    • pp.193-206
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    • 2008
  • Purpose: In spite of many arguments on the result of WHI (Women's Health Initiative) study, no one can deny the necessity for researches on the alternative treatment to HRT (hormone replacement therapy). In this study, the author wanted to investigate the method of precedent acupuncture RCTs (randomized controlled trials) to make out the appropriate acupuncture study design on postmenopausal and perimenopausal hot flashes in Korea. Methods: Precedent studies were investigated using Pubmed search and key-words "acupuncture and hot flash", "acupuncture and menopause", "acupuncture and vasomotor", limited to RCT, from 2000 to 2008 April. Results: As a result. 10 studies were searched. In the hereafter studies, multi-center clinical trials which consist of population group of postmenopausal and perimenopausal women that would be pre-stratified and more than 50 patients per treatment arm seem adequate. Sham control study can make out the proper consequence because many people are get used to acupuncture in Korea. Flexible choice of acupoints addressed an individual's symptoms using standardized algorithm is recommended. Treatment consist of 4 weeks' observation, 11 acupuncture sessions during 7 weeks, follow-up of 3 months or more after treatment and hot flash score as a primary outcome measure seem appropriate. After all, higher level of description according to global standard must be obtained in the study report and publishing. Conclusion: The researchers should develope the methodology of acupuncture clinical trial on the postmenopausal and perimenopausal hot flashes.

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Effects and Safety of Electroacupuncture on Cold Hypersensitivity on Hands and Feet by Sasang Constitution: A Multi-center, Randomized Controlled Trial (수족냉증에 대한 전침치료의 사상체질별 효과 및 안전성: 다기관 무작위 대조군 연구)

  • Kwon, Na-Yoen;Yu, Jun-Sang;Kim, Dong-Il;Kim, Hyeong-Jun;Lee, Dong-Nyung
    • Journal of Sasang Constitutional Medicine
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    • v.33 no.2
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    • pp.47-64
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    • 2021
  • Objectives The purpose of this study was to figure out the effect and safety of electro-acupuncture and acupuncture on cold hypersensitivity on hands and feet(CHHF) by Sasang constitution. Methods 72 subjects were recruited from three Korean medical hospitals from October 2019 to October 2020. Subjects were randomly allocated in 1:1:1 ratio to electro-acupuncture group(EA group), acupuncture group(AC group), and control group. The EA and AC group received treatment twice a week for 5 weeks. We tried to confirm the effectiveness of electro-acupuncture and acupuncture treatment by checking changes in Visual analogue score(VAS), body temperature of LU4, PC8, ST32, LR3, and WHOQOL-BREF score. Results The VAS score of CHHF was reduced after treatment, and the effect continued for 4 weeks after the end of treatment in all Sasang constitution, all treatment groups. In all Sasang constitution, the body temperature of the electro-acupuncture group or acupuncture grouop was higher than that of the control group except LU4 in visit 11. And no clinically significant adverse events have been identified. Conclusions Electro-acupuncture and acupuncture treatment are effective on hypersensitivity on hands on feet, and the effect was shown regardless of Sasang constitution.