• Title/Summary/Keyword: Trial

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Basic Research to Identify Application Criterion for Korean Version of FSFI as an Assessment Tool for Clinical Trial of Sexual Dysfunction in Female (여성의 성기능장애 평가 척도인 한글판 FSFI 척도의 임상시험 적용 기준에 관한 기초 연구)

  • Kim, dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.21 no.3
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    • pp.121-131
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    • 2008
  • Purpose: To confirm reference value for Korean version of FSFI in selecting subjects for clinical trial of sexual dysfunction in female. Methods: Purpose of the research was explained and anonymity was guaranteed to 41 women enlisted in 6 oriental medical clinics in Seoul and Incheon province and the scores for Korean version of FSFI which participants made out themselves were analyzed so that mean value and the distribution could be investigated. Results: Mean value for Korean version of FSFI of 40 participants scored 26.32 and from this score, the participants of clinical trial were enlisted to confirm whether or not the mean value could be applied. Conclusion: The mean value for Korean version of FSFI, which scored 26 might be acceptable as a criterion for selecting participants in clinical trial of sexual dysfunction.

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Tidal current simulation around the Straits of Korea and its application to a speed trial

  • Lee, Hee-Su;Lee, Byung-Hyuk;Kim, Kyung sung;Kim, Sung Yong;Park, Jong-Chun
    • International Journal of Naval Architecture and Ocean Engineering
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    • v.11 no.1
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    • pp.474-481
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    • 2019
  • The speed trial of a ship is one of the important elements guaranteeing its performance under the contract between the ship owner and shipbuilding company. A speed trial at sea, where the tidal current and waves are suppressed to the maximum, can prevent measurement errors due to external force conditions. On the other hand, it is difficult to maintain a calm sea state in most sea areas determined by the influence of the tidal current, wave, wind, etc. Therefore, this study evaluated a method of simulating a tidal current, which is one of the external force conditions, at the speed test operation of a ship, and applied the simulation result to the plan of a speed trial.

Model-Ship Correlation Study on the Powering Performance for a Large Container Carrier

  • Hwangbo, S.M.;Go, S.C.
    • Journal of Ship and Ocean Technology
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    • v.5 no.4
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    • pp.44-50
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    • 2001
  • Large container carriers are suffering from lack of knowledge on reliable correlation allowances between model tests and full-scale trials, especially at fully loaded condition, Careful full-scale sea trial with a full loading of containers both in holds and on decks was carried out to clarify it. Model test results were analyzed by different methods but with the same measuring data to figure out appropriated correlations factors for each analysis methods, Even if it is no doubt that model test technique is one of the most reliable tool to predict full scale powering performance, its assumptions and simplifications which have been applied on the course of data manipulation and analysis need a feedback from sea trial data for a fine tuning, so called correlation factor. It can be stated that the best correlation allowances at fully loaded condition for both 2-dimensional and 3-dimensional analysis methods are fecund through the careful sea trial results and relevant study on the large size container carriers.

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Rapid and Sensitive Analysis of Valproic Acid in Human Red Blood Cell by LC-MS/MS

  • Han, Song-Hee;Kim, Yun-Jeong;Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Jeong, Jin-A;Lee, Chang-Seop;Chae, Soo-Wan;Kim, Min-Gul
    • Bulletin of the Korean Chemical Society
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    • v.33 no.5
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    • pp.1681-1685
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    • 2012
  • A sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed to determine valproic acid in human red blood cell (RBC). It is important to measure the drug concentration of the RBC as well as that of the plasma because of drug partitioning for pharmacokinetic and pharmacodynamic study. The method was linear over the dynamic range of 1-100 ${\mu}g$/mL with a correlation coefficient $r$ = 0.9997. The linearity of this method was established from 1 to 100 ${\mu}g$/mL for valproic acid in red blood cell with accuracy and precision within 15% at all concentrations. The intra-run and inter-run assay accuracy and coefficient of variations are all within 15% for all QC samples prepared in plasma and red blood human samples. Then, valproic acid amount by protein precipitation in plasma was quantified by LC-MS/MS mass spectrometry. The distribution ratio of VPA in RBC and plasma was analyzed by clinical samples. Based on measurement of the valproic acid in human red blood cell, this method has been applied to clinical research for study of distribution ratio of valproic acid in blood.

Acupuncture Experience in Patients with Chronic Low Back Pain(2): A Qualitative Study - Focused on Participants in Randomized Controlled Trial (만성 요통 환자의 침 치료 경험(2): 질적 연구 - 무작위 대조군 연구 피험자를 대상으로)

  • Kim, Song-Yi;Lee, Kee-Byoung;Lee, Hyangsook;Son, Haeng-Mi;Song, Mi-Yeon;Lee, Hyejung;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.29 no.4
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    • pp.581-597
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    • 2012
  • Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

Turmeric (Curcuma longa) Root Powder and Mannanoligosaccharides as Alternatives to Antibiotics in Broiler Chicken Diets

  • Samarasinghe, K.;Wenk, C.;Silva, K.F.S.T.;Gunasekera, J.M.D.M.
    • Asian-Australasian Journal of Animal Sciences
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    • v.16 no.10
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    • pp.1495-1500
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    • 2003
  • Two bio-assays were conducted to evaluate turmeric root powder and mannan-oligosaccharides (MOS) as alternatives to feed antibiotics for broilers. In one trial, one hundred and eighty 19-days old broilers assigned to 18 groups of 10 were fed on one of six experimental diets with three replicates during four weeks. The diets included a basal feed without additives and with either virginiamycin, MOS, or turmeric at 1, 2 and 3 g/kg, respectively. In the second trial, one hundred and forty four 21-days old broilers arranged in 16 groups of nine were fed on the first four diets with four replicates for a similar period. Virginiamycin, MOS and turmeric (1 g/kg) in the first trial generally improved the weight gain of broilers by 3.4, 6.2 and 5.3%, respectively. In the second trial they increased the weight gain significantly (p<0.05) by 8.8, 8.0 and 15.1%, respectively. Additives improved the feed efficiency up to 15.1% and carcass recovery up to 3.1% (p<0.05). Virginiamycin, MOS and turmeric (1 g/kg) markedly reduced the abdominal fat content from 1.91% BW in the control to 1.44, 0.97 and 1.2% BW, respectively, in the first trial. The corresponding values obtained in the second trial were 1.01, 0.55 and 0.6%, respectively as compared to 1.22% in the control group. All additives showed a remarkable inhibition of duodenal coliform bacteria, yeast and mould in the caecum, and all viable microbes in the ileum. A significant (p<0.05) improvement in energy and protein utilization could be recorded with supplemented diets except for high turmeric diets. Dietary 2 and 3 g/kg addition of turmeric reduced energy and protein utilization as well as fat deposition. Present results reveal that turmeric and MOS are satisfactory alternatives to antibiotics in broiler feeds. Both MOS and turmeric possess an antimicrobial effect in vivo. Turmeric may also depress fat deposition in broilers.

A Study of the Court-Annexed ADR and Its Implications in the United States (미국의 사법형 ADR제도와 그 함의에 대한 연구)

  • Kim, Chin-Hyon;Chung, Yong-Kyun
    • Journal of Arbitration Studies
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    • v.21 no.3
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    • pp.55-87
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    • 2011
  • This paper is to illustrate a variety of court-annexed ADR programs and vindicate its implications of court-annexed ADR in United States. It has been almost three decades since Frank Sender articulated his vision of the multi-door courthouse. The court-annexed ADR originated from the concept of multi-door court house. Professor Sander argued that the court must transform from the court that provides litigation, only one type of dispute resolution, to the multi-door courthouse which provides a variety of dispute resolution methods including a number of ADR programs. The types of court-annexed ADR on which this paper focus are court-annexed mediation, court-annexed arbitration, mini trial, early neutral evaluation(ENE), summary jury trial, rent-a-judge, and med-arb in United States. The findings of this paper is as follows. First, the ADR movement is the irreversible and dominant phenomenon in the US court. The motivation of incorporating ADR into court is to reduce the cost of court to handle the civil disputes and to eliminate the delay of litigation process in the court. At the same time, a couple of studies of ADR revealed that the ADR program satisfied users of ADR. Second, the landscape of ADR has not been fixed. In 1970's, the court-annexed arbitration has been popular. In 1980's, the diverse kinds of ADR programs were introduced into the federal court as well as state courts, such as mini trial, early neutral evaluation(ENE), summary jury trial, and court-annexed mediation. But in 2000s, the court-annexed mediation has been the dominant type of ADR in United States. Third, the each type of ADR program has its own place for the dispute resolution. Since Korean society enters into the stage in which diverse kind of disputes occur in the areas of environment, construction, medicare, etc, it is desirable to take into consideration of the introduction of ADR to dispute resolution in Korea.

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Pilot Clinical Trial to Evaluate the Efficacy of Needle-Embedding Acupuncture Therapy at Gokji(LI11) on TEWL (곡지혈 매선침 시술이 경피수분 손실량에 미치는 영향)

  • Lee, Ho Chan;Jung, Mi Young;Choi, Jung Hwa;Jeong, Min Yeong;Park, Soo Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.32 no.4
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    • pp.291-297
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    • 2018
  • The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

Development of Guidance on the Pharmacokinetic Studies of Therapeutic Biologics (생명공학의약품의 약동학 시험 지침 개발 연구)

  • Lee, Hae-Won;Lim, Mi-Sun;Seong, Sook-Jin;Lee, Joo-Mi;Park, Sung-Min;Noh, Keum-Han;Park, Sung-Ho;Kim, Eun-Jung;Kang, Won-Ku;Yoon, Young-Ran
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.21-29
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    • 2012
  • Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.

The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial (화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험)

  • Choi, Woo-Jin;Lee, Seung-Gi;Son, In-Bong;Sun, Seung-Ho
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.2
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.