• Title/Summary/Keyword: clinical trial center

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Effect Analysis of Electronic Clinical Trial Systems (효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석)

  • Lee, Hyun-Ju;Choi, In-Young
    • The Journal of the Korea Contents Association
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    • v.11 no.1
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    • pp.350-356
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    • 2011
  • The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

The Problem and Improvement Plan on Acupuncture Treatment in Clinical Trial Based on EBM (근거 중심 의학(EBM)에 바탕을 둔 임상시험(Clinical Trial)에서 침 치료 문제점과 개선 방안에 대하여)

  • Han, Sung-Soo;Koo, Chang-Mo;Hong, Kweon-Eey;Park, Yang-Chun;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.1-8
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    • 2006
  • Introduction : Even though Acupuncture has been know for its effect for a long time, recently it is required to verifiy its effect. To solve this, clinical trial, based on EBM, has been the way to explain acupuncture's treatment effect. Methods: Last year we had a clinical trial based on acupuncture. From this experience we came to a conclusion mentioned below. Results : 1. To find out acupuncture's effect more certainly, it is needed that Korean medical method or treatment should be connected to diagnosis. 2. We had found out that sham and minimal acupuncture are the most appropriate way in single blinding. 3. It is required for the acupuncturist to practice the right real acupuncture point and sham's point in clinical trial. 4. The most important thing to maintain the subjects from dropping out is to always be concerned to the subjects and management them. Conclusion : The best way to advance clinical trial on acupuncture is to use single blinding system with sham acupuncture together in controlled groups and most of all also needs a standardized acupuncture point and depth.

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Validation of LC-MS/MS method for determination of ertapenem in human plasma and urine (인체 혈장 및 소변 중 에르타페넴의 정량을 위한 LC-MS/MS 분석법 검증)

  • Kim, Yun-Jeong;Han, Song-Hee;Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Chae, Soo-Wan;Kim, Min-Gul
    • Analytical Science and Technology
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    • v.25 no.1
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    • pp.19-24
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    • 2012
  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantitative determination of ertapenem in human plasma and urine. After addition of internal standard (ceftazidime), plasma and urine was diluted with methanol and analyzed by LC-MS/MS. Using MS/MS with multiple reaction monitoring (MRM) mode, ertapenem were selectively detected without severeinterference from human plasma and urine. The standard calibration curve for ertapenem was linear ($r^2$= 0.9996)over the concentration range 1~100 ${\mu}g/mL$ in human plasma. The intra- and inter-day precision over the concentration range of ertapenem was lower than 8.9% (correlation of variance, CV), and accuracy was between 97.2~106.2%. On the other hand, it was showed good relationship ($r^2$= 0.9992) and the precision (intra- and inter-day) over the concentration range of ertapenem was lower than CV 7.2%, and accuracy was between 97.9~111.6% for urine. This method has been successfully applied to the pharmacokinetic study of ertapenem in human plasma and urine.

A Test to Compare the Water Resistance Sun Protection Factor of General Water, Artificial Seawater, and Natural Seawater of Sunscreen (자외선 차단제의 일반 물, 인공 해수, 자연 해수의 내수성 차단지수를 비교하기 위한 시험)

  • Hyoung Hoon Hwang;Eun Young Kang;Su Yeong Kim;Hui Jeong Jung;Jun Seong Yang;Won Kyu Hong;Hong Suk Kim
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.49 no.4
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    • pp.349-354
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    • 2023
  • Sunscreen is a product that protects against ultraviolet rays by blocking and scattering ultraviolet rays, and has now become a daily necessity beyond cosmetics. Applying sunscreen is a common and easy way to prevent skin damage caused by ultraviolet rays. Due to its significance, the evaluation of sunscreen has evolved since its regulation by the FDA in 1978, progressing to standardized methods established by ISO. Additionally, to assess the loss of sunscreen due to activities such as water exposure or sweating, the Ministry of Food and Drug Safety in Korea and ISO have established protocols for evaluating the water-resistant sun protection factor (SPF). However, existing evaluations of water resistance have been mainly confined to test methods involving plain water, and methods accounting for the impact of seawater during activities like beach leisure, sports, and recreation are yet to be established. Based on the existing guidelines for testing the water-resistant UV protection index, this study compared the water-resistant UV protection index in water, artificial seawater (salt water) and natural seawater (sea water) to evaluate the UV protection index in real-world situations such as marine leisure, sports, and leisure activities. Through these results, we were able to compare the differences between water resistance sun protection index tests in ordinary water, artificial seawater, and natural seawater, and suggest a method for water resistance sun protection index tests using natural seawater.

Suppression of Inflammatory Macrophage Responese by Glycyrrhiza Uralensis Herbal Acupuncture Extract (감초 약침액이 대식세포주에서 항염증효과에 미치는 영향)

  • Bak, Jong-Phil;Son, Jeong-Hyun;Kim, Yong-Min;Lee, Eun-Yong;Leem, Kang-Hyun;Kim, Ee-Hwa
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.49-58
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    • 2011
  • 목적 : 본 연구는 감초의 염증에 대한 효과를 연구하였다. 감초의 에탄올 그리고 물로 추출한 두 가지의 약침액을 이용하여 쥐의 대식세포에서 유래한 RAW264.7 세포에 대한 염증 억제효과를 확인하였다. 방법 : Inducible nitric oxide synthase(iNOS), cyclooxygenase-2(COX-2)를 포함한 염증성 단백질의 발현과 extracellular signal-regulated kinase 1/2(ERK1/2) 그리고 phosphorylated ERK1/2 의 발현을 Western blot 으로 확인하였고, PGE2의 발현은 ELISA 로 확인하였다. 결과 : RAW264.7 세포에 감초의 물 혹은 에탄올 추출 약침액을 투여한 결과 투여된 농도에 따라 LPS로 유도된 NO의 생성이 억제되었으며 iNOS, COX-2, 그리고 인산화 ERK1/2 의 발현도 감소되었다. 결론 : 본 실험 결과, 적작약의 물 그리고 에탄올 추출 약침액에 대하여 항염증성 효과가 있음을 확인하였다.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.