• Title/Summary/Keyword: Trial subject

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An Analysis of Decision Making Factor by Delphi and DEMATEL Model for Decision Support Information System development -Wartime Operational Control Transition approach- (의사결정 지원 정보시스템 개발을 위한 Delphi-DEMATEL모델에 의한 의사결정 요인분석 -전작권 전환 사례를 중심으로-)

  • Park, Sangjung;Koh, Chan
    • Journal of Digital Convergence
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    • v.10 no.11
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    • pp.47-58
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    • 2012
  • This study selects political and military decision factors of Participatory Government's Wartime Operational Control(OPCON) Transition and analyzes, both quantitatively and qualitatively, the effects and relations between those factors. Previous research utilizing the Analytic Hierarchy Process(AHP) selected their decision factors based on academic data and field experience, requiring more objective analysis of the factors. For this study, we conducted a survey among security subject matter experts(SME) both online and offline. The results show that OPCON transition's decision factors were to 'recover military sovereignty', 'set the conditions for peaceful reunification' and 'improve ROK image through enhancing national power' which differs little from the previous AHP method studies. It also showed that 'recover military sovereignty' and 'set the conditions for peaceful reunification' had no relationship to each other and that the key factor that decided the OPCON Transition was actually 'recover military sovereignty' which represents the interest of the liberal party in ROK. This study finds its meaning by analyzing the decision factors of Participartory Government's OPCON Transition thorugh Delphi and DEMATEL method.

Regulations and Guidelines for Planning and Design of Multi-regional Clinical Trials (다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석)

  • Song, Yun-Kyoung;Sohn, Minji;Jeon, Ah Young;Kim, Jae Hyun;Ji, Eunhee;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.146-153
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    • 2018
  • Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

The Influence of Angle Change of the Forefoot's Adhesive Outsole Designs on the Electromyographic Activity of the Erector Spinae and Selected Lower Limb Muscles during Downhill Walking (내리막 보행시 발 전족부 부착형 아웃솔의 각도 변화가 척추기립근과 하지근의 근활성도에 미치는 영향)

  • Lee, Haeng-Seob;Chae, Woen-Sik;Jung, Jea-Hu;Kim, Dong-Soo;Lim, Young-Tae;Jang, Jea-Ik
    • Korean Journal of Applied Biomechanics
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    • v.24 no.2
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    • pp.139-149
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    • 2014
  • The purpose of this study was to evaluate the effect of angle change of forefoot's adhesive outsole on the electromyographic activity (EMG) of the erector spinae and selected lower limbs muscle during downhill walking over $-20^{\circ}$ ramp. Thirteen male university students (age: $25.4{\pm}3.9$ yrs, height: $176.2{\pm}5.1$ cm, weight: $717.4{\pm}105.0$ N) who have no musculoskeletal disorder were recruited as the subjects. To assess the myoelectric activities of selected muscles, six of surface EMG electrodes with on-site pre-amplification circuitry were attached to erector spinae (ES), rectus femoris (RF), biceps femoris (BF), tibialis anterior (TA), lateral gastrocnemius (LG), and medial gastrocnemius (MG). To obtain maximum EMG levels of the selected muscles for normalization, five maximum effort isometric contraction were performed before the experimental trials. Each subject walked over $0^{\circ}$ and $20^{\circ}$ ramp with three different forefeet's EVA outsole (0, 10, $20^{\circ}$) in random order at a speed of $1.2{\pm}0.1$ m/s. For each trial being analyzed, five critical instants and four phases were identified from the recording. The results of this study showed that the average muscle activities of MG and LG decreased in $20^{\circ}$ shoes compared to $0^{\circ}$ and $10^{\circ}$ ones in the initial double limb stance (IDLS). In initial single limb stance (ISLS) phase, the average muscle activities of ES increased with the angle of forefoot's adhesive outsole, indicating that the increment of shoes' angle induce upper body to flex anteriorly in order to maintain balance of trunk. In terminal double limb stance (TDLS) phase, average muscle activities of TA significantly increased in $20^{\circ}$ outsole compared to $0^{\circ}$ and $10^{\circ}$ ones. There was no external forces acting on the right foot other than the gravity during terminal single limb stance (TSLS) phase, all muscles maintained moderate levels of activity.

Evaluation on Motion Features of the World's Second Archer during Back-Tension in Archery (양궁 백 텐션 국면에서 최우수 양궁선수의 동작특성 평가)

  • Yi, Jae-Hun;Hah, Chong-Ku;Ryu, Ji-Seon;Kim, Ki-Chan
    • Korean Journal of Applied Biomechanics
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    • v.17 no.3
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    • pp.197-207
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    • 2007
  • It has been reported that Back-Tension played a significant role in archery (Lee & Bondit, 2005; Kim, 2007) but there are a few researches related Back-Tension in Korea recently. Therefore, the purpose of this study was to investigate archery back tension technique for the second ranked archer in the World and to find ways to improve performance. A subject(height: 185cm, mass: 82kg, years: 21yrs, careers: 12yrs) who is a number of national team and the second ranked archer in the World authorized by FITA (Federation Internationale de Trial Arc) was perticipated in this experiment. When shooting 60 shots($12{\times}5$), shooting motions were recorded with 7 infrared cameras and 2 ultrahigh-speed cameras. A QTM and an Auto Track were used to acquire raw data. The sampling rates of both cameras were 200 Hz. and 1000 Hz. respectively and data were filtered using a fourth order Butterworth low pass filtering with a cutoff-frequency of 30Hz. The parameters were calculated with Matlab6.5 and analyzed with SPSS11.0. After Pearson's correlations between 8 parameters were analyzed, 5 parameters from 13parameters that affected records were analyzed with multiple regression analysis (Enter order: x1, x2, x3, x4, x5). The results were as follows: 1. Comparing between parameters according to scores, the patterns of horizontal and vertical angular velocity(av.) of scapular relative angle was different between 8 score and 9 or 10 scores. 2. The correlations of parameters that affected records were a horizontal av.(x1, p=.032<.05) and a vertical av.(x3, p=.033<.05) of scapular from release to delivery in KB back-tension (anchoring-delivery). 3. The decision coefficients(R2) of above two parameters and three parameters selected by experts that may affect record, that is, an absolute trunk angle(x4) from in KKC back-tension (anchoring-release) and a horizontal relative scapular angle(x2) and an absolute trunk angle(x5) from release to delivery in KB back-tension were 7.7%(x1), 0.1%(x2), 8.5%(x3), 0.7%(x4) and 0.9%(x5) in sequence. 4. The multiple regression equation was a y= -1.16E-2 x1 + 0.109 x2 + 3.437E-2 x3 + 6.139E-2 x4 + 0.117 x5 + 3.420 In conclusion, a total contribution was low, that is, R2(17.9%) suggested that on the one hand, Lim's motion may not depend on a certain factor because his postural factors affected shooting motion are some stable on the other hand, unknown factors may exist(e.g. psychological, physiological factors etc.). Further study of EMG patterns of muscles and anatomic consideration related to shoulder girdle and scapular bones may help to identify mechanism of Back-Tension.

Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study (만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구)

  • Gong, Han Mi;Jun, Seungah;Chung, Yeon-Joong;Kim, Ju-Ran;Lee, Jung Hee;Lee, Hyun-Jong;Park, Chung A;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

An Analysis of Domestic Medicine Study Tendency on Obesity -Focused on The Korean Journal of Obesity- (비만에 대한 국내 의학계의 최근 연구 동향 분석 -대한비만학회지를 중심으로-)

  • Kim, Doo Hee;Shin, Woo Suk;Kim, Dong Hwan;Jeong, Yeon Jae;Im, Han Bit;Park, Won Hyung;Cha, Yun Yeop
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.1
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    • pp.1-9
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    • 2013
  • Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

A Review of Clinical Research Trends in the Treatment of Primary Headache Disorders with Pharmacopuncture (일차성 두통의 약침 치료에 대한 임상연구 동향)

  • Shin, Hee-yeon;Lee, Sang-hwa;Kim, Ha-ri;Kim, Jeong-hwa;Yang, Seung-bo;Cho, Seung-yeon;Park, Jung-mi;Ko, Chang-nam;Park, Seong-uk
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1191-1205
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    • 2018
  • Objectives: This study was performed to review clinical research trends in the treatment of primary headache disorders with pharmacopuncture. Methods: We searched clinical studies on primary headache disorders treated with pharmacopuncture in four electronic databases including OASIS, RISS, CNKI, and Pubmed. The selected studies were analyzed with regard to study design, subject, intervention, evaluation, and result. Results: Five randomized controlled trials, one non-randomized controlled trial, one before-and-after study, and six case series were selected. Most of the studies showed that pharmacopuncture treatment was significantly effective in treating primary headache disorders; however, the quality of the randomized controlled trials was low. Conclusions: According to this study, pharmacopuncture could be a useful treatment option for primary headache disorders. Based on these results, further studies on the effectiveness and safety of pharmacopuncture for primary headache disorders should be performed in the near future.

Exploratory studies of the music analgesic effect in people with glasses through cold-pressor task (안경 착용 여부에 따른 음악 통증완화효과의 탐색적 연구)

  • Choi, Suvin;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
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    • v.33 no.6
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    • pp.823-832
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    • 2020
  • The analgesic effects of music in people with glasses on perceived pain through cold-pressor task (CPT) is assessed based on three-sequence, three-period, crossover trial with three treatment conditions(music-listening, news-listening, and no-sound) to each subject. Fifty subjects are divided into three sequence groups by randomization, and CPTs under the pre-assigned treatment conditions at each period are performed. Pain responses after each CPT, subjects' pain tolerance (PT) in time scale and pain intensity (PI) and pain unpleasantness (PU) in visual analog scale (VAS) are measured. After classifying the group by whether or not to wear glasses, which is the phenotype of the myopia gene, pain responses are compared by F-tests and Tukey's multiple comparisons. CPT pain responses in group with glasses during the music intervention are significantly different from responses during the news intervention and the control conditions, respectively. This study investigates the pain responses of music intervention in the group wearing glasses, which can be seen as a phenotype of the nearsighted gene, and this result would play a role in explaining the biopsychosocial model of the pain mechanism.

The Effect of Low Molecule Collagen Peptide on Skin Anti-glycation and Collagen Synthesis as a Skin Aging Therapy (피부 노화 치료로서 저분자콜라겐펩타이드의 피부 항당화와 콜라겐 합성 효과)

  • Kim, Hong Seok;Hong, Won Kyu;Lee, Mun Hoe;Kim, Hyeong Min;Chung, Hee Chul;Lee, Jin Hee
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.2
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    • pp.147-153
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    • 2021
  • Collagen hydrolysate (CH) is known to prevent skin aging by stimulating skin dermal fibroblasts to promote synthesis of extracellular matrix such as collagen and elastin. Recently, among the various factors that cause skin aging, advanced glycation end products (AGEs) have received particular attention. However, the effect of CH on AGE accumulation has not been studied. Since CH could affect AGE accumulation by promoting production of skin structural proteins, clinical trial was performed using low molecule collagen peptide (LMCP), which were CH containing 25% tripeptide and 4% Gly-Pro-Hyp. Skin autofluorescence (SAF) values were measured using an AGE reader to evaluate accumulation of AGE in skin. As a result of applying 0.5% and 1.0% LMCP solutions to the subject's forearm for 8 weeks, the SAF value at the test site significantly decreased compared to the control site. Additionally, in vitro test was performed using CCD-986sk to evaluate the promotion of collagen synthesis in skin fibroblasts by LMCP. As a result, 800 ㎍/mL of LMCP significantly increased synthesis of human pro-collagen Iα1 (COL1A1) in CCD-986sk. Through this study, we have confirmed that tropical LMCP applications can promote collagen synthesis to help anti-glycation effects, suggesting that LMCP has potential as an anti-aging cosmetic material.

Case Report of the Pityriasis Rosea Patient with Pruritus Treated by Korean Medicine Treatment alone (소양감이 동반된 장미색 비강진 환자의 한방단독치료 보고)

  • Lee, Kyoungeun;Kim, Jungpil;Jeong, Seonhyung;Ahn, Joon;Jeong, Hyein;Kim, Kyounghan;Jang, Insoo;Choi, Yoomin;Oh, Yongtaek
    • Herbal Formula Science
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    • v.30 no.1
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    • pp.27-36
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    • 2022
  • Objective : The purpose of this study is to present a case report with the adult patient who needed active treatment of pityriasis rosea with severe pruritus, and did not respond to steroid treatment in the preceding month. Methods : The subject is an adult patient with pityriasis rosea over the age of 40 without any other diseases. We administered Korean medicine treatment with Bangpungtongseong-san (防⾵通聖散) and acupuncture. The effects of the treatment were evaluated via scales including Pruritus score, Pityriasis Rosea Severity Score (PRSS), and picture. Results : After the treatment Pruritus score/PRSS index of the case changed from 8/20 to 0/0. No other severe adverse reactions were reported. No more recurrence or pruritus was confirmed in follow-up. Conclusions : Korean medicine treatment with Bangpungtongseong-san showed marked improvement in pruritus and skin symptoms of pityriasis rosea in need of active care. With the lack of existing clinical reports of pityriasis rosea, we found that Korean medicine treatment could be an effective way, and it is expected that Bangpungtongseong-san could be administered to pityriasis rosea patients. Randomized-controlled trial for further evaluation will be needed in the future.