• 제목/요약/키워드: human clinical trial

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Recent Advances in Anti-inflammatory Synthetic Flavonoids as Potential Drugs

  • Kim, Hyun-Pyo;Park, Hae-Il
    • Natural Product Sciences
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    • 제16권2호
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    • pp.59-67
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    • 2010
  • Flavonoids are well-known anti-inflammatory agents that exert their effects via a variety of mechanisms including antioxidative action, inhibition of eicosanoid metabolizing enzymes and regulation of theexpression of proinflammatory molecules. In this review, synthetic approaches to obtain more useful flavonoid derivatives are summarized. Human clinical trials of flavonoid therapy are discussed. Through continual investigation to identify more potent and comparable flavonoids, new anti-inflammatory flavonoid therapy will be successfully launched, especially for the treatment of chronic inflammatory disorders.

귀비탕증(歸脾湯證)의 병인논적(病因論的) 분석(分析)을 위한 설문문항(說問問項) 개발(開發) (Development of Questionnaires for Pathogenesis Analysis of Guibi-tang Symptom)

  • 이병희;박영재;김민용;;박영배
    • 대한한의진단학회지
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    • 제12권2호
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    • pp.41-48
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    • 2008
  • Background : Guibi-tang is one of the most common herbs in oriental medicine. Principally, this medicine heals illness from overstress. Therefore, it is frequently used in the ancient community. Because of insufficiency in data, objective judgements are difficult in remedial effects by Guibi-tang. In order to make objectivity diagnose data, this research is developed. Purpose : The aim of the research is to make questionnaire for the medicine and the objective is to sell to the public from the local clinic. Methods : The questionnaire which includes symptoms and signs for diagnose of Guibi-tang is studied by the Delphi method and average value. Results : By the Delphi method and average value, 22 Items of questionnaires are choosen for the research. Conclusions : Further research is necessary for modification of questionnaire by statistics and cerification by clinical trial. The statistics and verification by clinical trial is necessary with modification for further research.

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Pentafluorophenylprophyl Ligand-based Liquid Chromatography-Tandem Mass Spectrometric Method for Rapid and Reproducible Determination of Metformin in Human Plasma

  • Yang, Jeong Soo;Oh, Hyeon Ju;Jung, Jin Ah;Kim, Jung-Ryul;Kim, Tae-Eun;Ko, Jae-Wook;Lee, Soo-Youn;Huh, Wooseong
    • Bulletin of the Korean Chemical Society
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    • 제34권11호
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    • pp.3284-3288
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    • 2013
  • This paper describes first development and validation of pentafluorophenylprophyl ligand-based liquid chromatography coupled to tandem mass spectrometry (PFPLC-MS/MS) method to determine metformin, a highly polar compound, in human plasma. Metformin and Phenformin (internal standard) were extracted from human plasma 50 ${\mu}L$ with a single-step protein precipitation. The chromatographic separation was performed using a linear gradient elution of mobile phase involving 5.0 mM ammonium formate solution with 0.1% formic acid (A) and acetonitrile (B) over 3.0 min of run time on a Phenomenex Luna PFP column. The detection was performed using a triple-quadrupole tandem mass spectrometer (Waters Quattro micro) with electrospray ionization in the mode of positive ionization and multiple-reaction monitoring (MRM). The developed method was validated with 5.0 ng/mL of lower limit of quantification (LLOQ). The calibration curve was linear over 5-3000 ng/mL of the concentration range ($R^2$ > 0.99). The specificity, selectivity, carry-over effect, precision, accuracy and stability of the method met the acceptance criteria. The method developed in this study had had rapidness, simplicity and ruggedness. The reliable method was successfully applied to high throughput analysis of real samples for a practical purpose of a pharmacokinetic study.

보중익기탕증(補中益氣湯證)의 병인논(病因論)적 분석을 위한 설문문항(說問問項) 개발(開發) (Development of Questionnaires for Pathogenesis Analysis of Bojungikgitang Symptom)

  • 윤태득;박영재;박영배;이상철;오환섭
    • 대한한의진단학회지
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    • 제11권1호
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    • pp.61-71
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    • 2007
  • Background: Bojungikgitang is one of the most common herbs in oriental medicine. Principally, this medicine heals illness from overwork and stress. Therefore, it is frequently used in the ancient community. Because of insufficiency in data, objective judgements are difficult in remedial effects by Bojungikgitang. In order to make objectivity diagnose data, this research is developed. Purpose: The aim of the research is to make questionnaire for the medicine and the objective is to sell to the public from the local clinic. Methods: The questionnaire which includes symptoms and signs for diagnose of Bojungikgitang is studied by the Delphi method and average value. Results: By the Delphi method and average value, 25 Items of questionnaires are choosen for the research. Conclusions: Further research is necessary for modification of questionnaire by statistics and certification by clinical trial. The statistics and verification by clinical trial is necessary with modification for further research.

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배의 씨방 및 과피의 알콜 발효 추출물이 피부에 미치는 영향 (Effects of Alcoholic Fermentation Extracts from Ovary and Rind of Pear on Human Skin)

  • 김형우;김경윤;김병주;강수우;도윤호;남내이;정현우;최정식;조수인
    • 대한본초학회지
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    • 제24권1호
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    • pp.133-139
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    • 2009
  • Objectives : This study was designed to investigate the effects of alcoholic fermentation extract from ovary and rind of pear on human skin. Methods : We investigated the effects of samples on human skin in terms of clinical trial. 32 of healthy volunteers, who lived in mokpo participated in clinical trial. Effects of sample on hygroscopicity and water-holding capacity were investigated. Sebum, moisture, scabrousness and desquamation were also investigated. Facial massages were conducted 8 times in each volunteers. Results : Single treatment group showed elevated levels of hygroscopicity (Normal : 106.4$\pm$2.1%, vs Pear : 114.1$\pm$6.2) and water-holding capacity (Normal : 87.1$\pm$4.4%, vs Pear : 96.2$\pm$1.3) on forearm of 16 volunteers respectively. In addition, massage group using sample showed elevated moisture (Control : 3.8$\pm$5.8%, vs Sample : 15.2$\pm$4.7%) and lowered scabrousness levels (Control : -12.3$\pm$4.4%, vs Sample : -22.0$\pm$5.2%) significantly. However, the levels of sebum did not affected by sample. Conclusions : These result suggest that alcoholic fermentation extract from ovary and rind of pear has moisturizing effect on human skin.

얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구 (Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy)

  • 공나경;서은성;선지혜;김남권
    • 대한한의학회지
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    • 제38권1호
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

경피적 관동맥혈관성형술 후 Re-188을 이용한 혈관 내 방사선조사요법 (Intracoronary Radiation Therapy Using Re-188 after percutaneous Coronary Angioplasty)

  • 채인호;이명묵;이동수
    • 대한핵의학회:학술대회논문집
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    • 대한핵의학회 1999년도 제38차 춘계학술대회
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    • pp.228-241
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    • 1999
  • Percutaneous coronary angioplasty is well established therapeutic modality in the management of coronary artery disease. However, the high restenosis rate of 30 to 50% limits its usefulness. The principal mechanism of restenosis, intimal hyperplasia, is the proliferative response of vessel wall to injury, which consists largely of smooth muscle cells. A large body of animal investigations and a limited number of clinical studies have established the ability of ionizing radiation to reduce neointimal proliferation and restenosis rate significantly. Human studies have been reported that intravascular radiation after first restenosis inhibits a second restenosis. Encouraged by these reports, we are also conducting a double blind, placebo-controlled, randomized trial to evaluate this new therapeutic modality in patients with coronary artery stenosis. The objective of our trial is to determine the safety and efficacy of catheter-based solutional beta emitting radioisotope system in preventing restenosis after angioplasty. This review describes the vascular brachytherapy systems and isotopes that have been utilized in the initial clinical trials performed in this area of post PTCA coronary restenosis. The results of many worldwide ongoing clinical trials will determine whether this new technology will change the future practice of vascular intervention.

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아토피 피부염의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구 (Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Atopic Dermatitis)

  • 권지예;선지혜;윤화정;김남권
    • 한방안이비인후피부과학회지
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    • 제30권1호
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    • pp.17-28
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    • 2017
  • Objectives : The aim of this study is reviewing the literature to extracting the key parameter and finding the calibration parameter for the clinical study with economical assessment protocol on atopic dermatitis. Methods : Literature search is performed using PUBMED for literature published from Janurary 2000 to December 2016. We included randomized controlled trials(RCTs) with economic assessment in which human participants. Results : Among the articles published from January 2000 to December 2016, The 1464 articles were found. After reviewing the title, abstract and full text, the five articles were selected. Selected articles are classified 3 CEA(cost effective analysis)study, 1 CMA(cost minimizing analysis)study and 1 cost analysis study. Conclusions : We found highly reliable key parameters and calibration parameters, which might be necessary factors for developing research protocol of economic evaluation alongside clinical trial about atopic dermatitis patients.

육미지황탕증(六味地黃湯證)의 병인논(病因論)적 분석을 위한 설문문항(說問問項) 개발(開發) (Development of Questionnaires for Pathogenesis Analysis of Yukmijiwhang-tang Symptom)

  • 조상원;박영재;김민용;오환섭;박영배
    • 대한한의진단학회지
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    • 제12권2호
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    • pp.61-73
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    • 2008
  • Background: Yukmijiwhang-tang is one of the most common herbal formulas in Oriental Medicine. Yukmijiwhang-tang has been widely used as a herbal medicine to replenish Yin and tonify the kidneys for hundred years in Asian countries. Because of insufficiency in data, objective judgements about remedial effects have been difficult. In order to make objectivity diagnostic data, this research is developed. Purpose: The aim of the research is to make a pilot questionnaire for clinical use of Yukmijiwhang-tang. Methods: The questionnaire which includes symptoms and signs for Yukmijiwhang-tang is studied by the Delphi method. Results: By the Delphi method and score evaluation, 30 items of the initial copy of questionnaire are chosen for the research. Conclusions: By the Delphic survey among clinicians, a reference questionnaire for Yukmijiwhang-tang applications was suggested. Further research is necessary for modification of questionnaire by statistics and certification by clinical trial. research.

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Consecutive versus concomitant follicle-stimulating hormone and highly purified human menopausal gonadotropin: A milder response but better quality

  • Maghraby, Hassan Ali;Agameya, Abdel Fattah Mohamed;Swelam, Manal Shafik;El Dabah, Nermeen Ahmed;Ahmed, Ola Youssef
    • Clinical and Experimental Reproductive Medicine
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    • 제49권2호
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    • pp.135-141
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    • 2022
  • Objective: This study investigated the impact of two stimulation protocols using highly purified human menopausal gonadotropin (HP-hMG) on the endocrine profile, follicular fluid soluble Fas levels, and outcomes of intracytoplasmic sperm injection (ICSI) cycles. Methods: This prospective clinical trial included 100 normal-responder women undergoing ovarian stimulation for ICSI; 55 patients received concomitant follicle-stimulating hormone (FSH) plus HP-hMG from the start of stimulation, while 45 patients received FSH followed by HP-hMG during mid/late follicular stimulation. The primary outcome was the number of top-quality embryos. The secondary outcomes were the number and percentage of metaphase II (MII) oocytes and the clinical pregnancy rate. Results: The number of MII oocytes was significantly higher in the concomitant protocol (median, 13.0; interquartile range [IQR], 8.5-18.0 vs. 9.0 [8.0-13.0] in the consecutive protocol; p=0.009); however, the percentage of MII oocytes and the fertilization rate were significantly higher in the consecutive protocol (median, 90.91; IQR, 80.0-100.0 vs. 83.33 [75.0-93.8]; p=0.034 and median, 86.67; IQR, 76.9-100.0 vs. 77.78 [66.7-89.9]; p=0.028, respectively). No significant between-group differences were found in top-quality embryos (p=0.693) or the clinical pregnancy rate (65.9% vs. 61.8% in the consecutive vs. concomitant protocol, respectively). The median follicular fluid soluble Fas antigen level was significantly higher in the concomitant protocol (9,731.0 pg/mL; IQR, 6,004.5-10,807.6 vs. 6,350.2 pg/mL; IQR, 4,382.4-9,418.4; p=0.021). Conclusion: Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI.