• Title/Summary/Keyword: clinical trial center

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Pk/PD Study Using PET Biomarker

  • Yu, Kyung-Sang;Jang, In-Jin;Lim, Kyoung-Soo;Kwon, Jun-Soo;Jeong, Jae-Min;Lee, Jae-Sung;Kim, Jung-Ryul;Cho, Joo-Youn;Shin, Sang-Goo
    • 대한임상약리학회:학술대회논문집
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    • 2006.11a
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    • pp.141-142
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    • 2006
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An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial (실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석)

  • Yun, Young-Ju;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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Safety and Effectiveness of Fluoroscopy-Guided Acupotomy for Carpal Tunnel Syndrome: Protocol for a Pilot Randomized, Patient-Assessor Blind, Parallel Clinical Trial

  • Yang, Muhack;Kim, Jae Kyoun;Park, Gun Woo;Cha, Eunhye;Jang, Jongwon;Seo, Jihye;Lee, Sangkwan;Kim, Sungchul
    • Journal of Acupuncture Research
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    • v.36 no.2
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    • pp.100-106
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    • 2019
  • Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

Pharmacokinetic Propertiese of Entecavir 1 mg in Korean Healthy Volunteers (건강한 한국인 피험자에서 Entecavir 1 mg 제제의 약동학적 특성 평가)

  • Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Kim, Yun-Jeong;Han, Su-Mi;Im, Sung-Hyuk;Chae, Soo-Wan;Kim, Min-Gul
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.3
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    • pp.224-227
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    • 2011
  • Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to evaluate the safety and pharmacokinetic profile after a single dose of entecavir 1 mg administration in Korean healthy male subjects. Eight volunteers were enrolled. After a single dose of 1 mg entecavir was orally administered, blood samples were collected at specific time intervals from 0-168 hours. The plasma concentrations of entecavir were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles. The mean values for $AUC_{last}$ and $AUC_{inf}$ were $14.84{\pm}7.81ng{\cdot}hr/mL$ and $20.71{\pm}8.80ng{\cdot}hr/mL$, respectively. The mean value for $C_{max}$ was $9.19{\pm}4.91ng/ml$ and median value for $t_{max}$ was 0.58 hr. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. The results are suggested to be useful in clinical trials of entecavir in Korean subject including bioequivalence study.

A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials (성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구)

  • Jung, Hee;Lee, Ji-Hyung;Jang, Bo-Hyoung;Ko, Seong-Gyu
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.363-376
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    • 2007
  • Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

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An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.38 no.4
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline (침구임상시험 가이드라인 개발과정에서 IRB의 윤리적·과학적 지적사항 사례 조사 연구)

  • Leem, Jung Tae;Lee, Seung Hoon;Han, Ga Jin;Kim, Eun Jung;Seo, Byung Kwan;Kim, Tae Hun;Lee, Seung Deok;Kim, Jong Uk;Yu, A Mi;Nam, Dong Woo;Lee, Jun Hee
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.11-21
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    • 2015
  • Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

A Phase II, double-blinded, randomized, multicenter clinical trial for evaluation of efficacy and safety of rhEGF in patients with diabetic foot ulcer (제 2 상, 이중맹검, 무작위배정, 다기관 공동임상시험의 결과 : 당뇨병성 족부궤양에 대한 표피 성장인자(Epidermal Growth Factor, EGF)의 치료 효과를 평가)

  • Choi Ji-Hyeon;Jung Kui-Oak;Sohn Ho-Young;Kim Young-Sul;Lee Hong-Gyu;Lee Kui-Up;Lee Hyun-Chul;Lee Byung-Doo;Park Byung-Joo
    • 대한예방의학회:학술대회논문집
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    • 2001.10a
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    • pp.305-307
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    • 2001
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Survey on the Demand for Clinical Trial Centers for Oriental Medicine (한방임상시험센터의 수요 예측에 대한 조사연구)

  • Seo Jung-Chul;Kim Seung-Ho;Rah Joong-Doug;Jung Sung-Ki;Kwon Young-Kyu
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.85-94
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    • 2005
  • Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

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