• 제목/요약/키워드: Trial Subject

검색결과 236건 처리시간 0.03초

실험적 성대마비 개에서 자가이개연골의 성대근육내 주입 후 조직학적 변화 : 2년 후 결과 (Histology of Injected Autologous Auricular Cartilage in the Paralyzed Canine Vocal Fold at Two Year)

  • 이병주;이진춘;전경명;고의경;노환중;이창훈;왕수건
    • 대한후두음성언어의학회지
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    • 제16권2호
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    • pp.113-117
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    • 2005
  • Background and Objective : Vocal fold augmentation by injectable material under direct visual control is an easy and simple operation. However, when autologous fat or bovine collagen is used, the resoiption creates a problem. And autologous fascia is debating about absorption now days. We previously reported on the one year results of injected autologous auricular cartilage for volumetric augmentation in paralyzed canine vocal cord. This study evaluates the long-term histomorphologic results of injected autologous auricular cartilage for the augmentation of the paralyzed canine vocal fold at two year. Material and Methods . A prospective trial of autologous cartilage augmentation of vocal cord in animal model. Three dogs were operated upon. A piece of auricular cartilage was harvested from the ear and minced into tiny chips with a scalpel. Fat was harvested from inguinal area and minced with a scalpel. The minced cartilage and fat-paste (0.2ml) was injected using a pressure syringe into the paralyzed thyroarytenoid muscle using direct laryngoscopy. Three animals were sacrificed at 2 years. Each subject underwent laryngectomy and serial coronal sections of paraffin blocks from the posterior vocal fold were made. Results There was no significant complication perioperatively and during follow-up. The injected cartilage which appeared to have lost viability existed in the vocalis muscles until 24 months. Fibrotic change was exhibited in the surrounding injected cartilage. Conclusion : The autologous auricular cartilage graft is well tolerated and may be very effective material for volumetric augmentation on paralyzed vocal cord.

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

  • 박상중;고찬
    • 디지털융복합연구
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    • 제10권11호
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    • pp.47-58
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    • 2012
  • 본 연구는 Delphi 및 DEMATEL 기법을 활용하여 참여정부의 전시작전통제권(이후 전작권) 전환에 관한 정치 군사적 결정요인을 선정하고, 이들 결정요인간의 영향정도 및 관계를 정량적 정성적으로 분석하는데 있다. AHP를 활용한 기존 연구에서는 전작권 전환 결정요인을 학술자료와 현장실무경험을 바탕으로 선정하여, 요인선정에 대한 보다 객관적인 분석이 요구되었다. 본 연구를 위해 온라인 및 오프라인 환경에서 안보 관련 전문가 집단을 대상으로 일련의 설문을 실시하였다. 분석결과로 참여정부의 전작권 전환 결정요인은 크게 '군사주권의 회복', '평화통일을 위한 여건조성', '우리나라의 국력신장에 따른 국격 제고'로 AHP기법에 의한 기존연구와 대동소이하였으며, 전작권 전환 결정요인간의 영향 및 관계는 '군사주권 회복'과 '평화통일을 위한 여건조성'은 별개 사안으로 상호 연관성이 없고 '군사주권 회복'이라는 진보세력의 정치적 이익이 주된 결정요인이었던 것으로 나타났다. 본 연구는 Delphi 및 DEMATEL 기법을 적용하여 참여정부의 전작권 전환 결정요인에 대해 정략적 정성적 분석을 실시하였는데 의의가 있다.

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

  • 송윤경;손민지;전아영;김재현;지은희;오정미;김인화
    • 한국임상약학회지
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    • 제28권2호
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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.

내리막 보행시 발 전족부 부착형 아웃솔의 각도 변화가 척추기립근과 하지근의 근활성도에 미치는 영향 (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)

  • 이행섭;채원식;정재후;김동수;임영태;장재익
    • 한국운동역학회지
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    • 제24권2호
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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.

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

  • 이재훈;하종규;류지선;김기찬
    • 한국운동역학회지
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    • 제17권3호
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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.

만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구 (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)

  • 공한미;전승아;정연중;김주란;이정희;이현종;박정아;김재수
    • Korean Journal of Acupuncture
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    • 제37권1호
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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.

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

  • 김두희;신우석;김동환;정연재;임한빛;박원형;차윤엽
    • 한방비만학회지
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    • 제13권1호
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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.

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

  • 신희연;이상화;김하리;김정화;양승보;조승연;박정미;고창남;박성욱
    • 대한한방내과학회지
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    • 제39권6호
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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.

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

  • 최수빈;박상규
    • 응용통계연구
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    • 제33권6호
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    • pp.823-832
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    • 2020
  • 음악청취가 통증완화효과에 어떤 영향을 미치는지를 확인하기 위해 음악청취조건, 뉴스청취조건 그리고 대조조건을 활용한 3×3 교차시험과 통증유발시험을 수행하였다. 총 50명의 피험자를 세 순서집단으로 랜덤하게 나눈 후 세 가지 청취조건 하에서 각각 통증유발시험을 수행한 후 통증한계, 통증강도, 통증불쾌감 등을 측정하고 분석하였다. 최근 시력과 지적능력간의 상관관계가 존재한다는 연구가 발표되면서 안경착용 여부에 따른 음악중재효과를 분석해보는 것도 의미가 있다고 생각하여, 안경착용여부에 따른 집단을 분류한 후 음악청취의 통증완화효과를 F-검정과 Tukey의 다중비교방법으로 분석하였다. 통증유발시험 분석 결과 안경착용집단의 통증완화효과가 음악청취조건에서 뉴스청취조건이나 대조조건보다 통계적으로 유의하게 나타남을 확인할 수 있었다. 이 연구가 탐색적 연구로서의 한계를 가지고 있지만 통증관리에서 음악중재를 활용할 수 있는 기준을 제시하는 한편 통증반응을 설명하는 생물심리사회모형의 타당성을 검증할 수 있는 연구로 의미를 가지고 있다.

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

  • 김홍석;홍원규;이문회;김형민;정희철;이진희
    • 대한화장품학회지
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    • 제47권2호
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    • pp.147-153
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    • 2021
  • 콜라겐 가수 분해물(collagen hydrolysate, CH)은 피부 진피 섬유아세포를 자극하여 콜라겐과 엘라스틴 같은 세포 외 기질 합성을 촉진함으로써 피부 노화 방지에 도움을 주는 것으로 알려져 있다. 최근 피부 노화를 일으키는 다양한 요인 중 최종당화산물(advanced glycation end products, AGEs)이 주목을 받고 있음에도 불구하고, 아직까지 CH가 AGE축적에 미치는 영향은 연구된 바 없다. CH는 피부 구조단백질의 생성을 촉진하여 AGE 축적에 영향을 줄 수 있으므로, 이를 확인하기 위해 트리펩타이드25%, Gly-Pro-Hyp 4%를 함유한 CH인 저분자콜라겐펩타이드(low molecule weight collagen peptide, LMCP)를 이용하여 임상시험을 수행하였다. 피부 조직 내 AGE 축적량을 평가하기 위해 AGE reader를 사용하여 피부자가형광(skin autofluorescence, SAF) 값을 측정하였다. 0.5%와 1.0% LMCP 용액을 8 주 동안 피험자의 전박에 도포한 결과, 시험부위의 SAF값이 대조부위에 비해 유의하게 감소하였다. 추가적으로, LMCP에 의한 피부섬유아세포의 콜라겐 합성 촉진을 평가하기 위해 CCD-986sk를 이용하여 in vitro test를 수행하였다. 그 결과, 800 ㎍/mL의 LMCP는 CCD-986sk의 human pro-collagen Iα1(COL1A1) 합성을 증가시켰다. 본 연구를 통해 LMCP도포가 콜라겐 합성을 촉진하여 항당화 효과에 도움을 줄 수 있다는 것을 확인하였으며, 이는 LMCP가 노화 방지 화장품 원료로써 잠재력이 있음을 시사한다.