• 제목/요약/키워드: Multi-center Trial

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Inference for heterogeneity of treatment eect in multi-center clinical trial

  • Ha, Il-Do
    • Journal of the Korean Data and Information Science Society
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    • 제22권3호
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    • pp.605-612
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    • 2011
  • In multi-center randomized clinical trial the treatment eect may be changed over centers. It is thus important to investigate the heterogeneity in treatment eect between centers. For this, uncorrelated random-eect models assuming independence between random-eect terms have been often used, which may be a strong assumption. In this paper we propose a correlated frailty modelling approach of investigating such heterogeneity using the hierarchical-likelihood method when the outcome is time-to-event. In particular, we show how to construct a proper prediction interval for frailty, which explores graphically the potential heterogeneity for a treatment-by-center interaction term. The proposed method is illustrated via numerical studies based on data from the design of a multi-center clinical trial.

갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜 (The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial)

  • 박지은;오달석;강경원;김동일;최선미
    • Korean Journal of Acupuncture
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    • 제24권3호
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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Balance Training Program for Community-Dwelling Elders with Risk of Falls: A Multi-center Randomized Controlled Trial

  • Yang Rae Kim
    • Physical Therapy Rehabilitation Science
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    • 제12권2호
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    • pp.192-200
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    • 2023
  • Objective: This study aimed to assess the effectiveness of a balance training program in improving balance and functional independence to reduce fall risks among community-dwelling elders. Design: A multi-center randomized controlled trial Methods: A total of 66participants were randomly assigned to a balance training group or a control group. The balance training program, conducted three times a week for 32 weeks, included warm-up exercises, main balance training exercises, and cooldown stretch exercises. Outcome measures included the Berg Balance Scale (BBS), Timed Up and Go Test (TUGT), and Modified Barthel Index (MBI). Results: The balance training group demonstrated significant improvements in all outcome measures, indicating enhanced balance, improved functional mobility, and increased independence in activities of daily living. In contrast, the control group showed only slight improvements in BBS, TUGT and MBI scores. Conclusions: These findings provide evidence supporting the effectiveness of balance training programs in reducing fall risk and promoting health and wellbeing among community-dwelling elders. Future research should aim to refine the design of these programs and assess the sustainability of the observed improvements.

효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석 (Effect Analysis of Electronic Clinical Trial Systems)

  • 이현주;최인영
    • 한국콘텐츠학회논문지
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    • 제11권1호
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    • pp.350-356
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    • 2011
  • 본 연구의 목적은 전자적 임상시험 데이터 관리를 위한 설계 시 시간적 요인에 주목하여 시스템의 효율성을 검증해 보고자 함이다. 임상시험 데이터 관리에 대한 관심이 커지고 있고 시스템 도입이 활발한 데 반해, 실제 효율성 측정에 관한 실증연구는 많지 않다. 특히 국내의 경우 임상시험 데이터 관리를 위한 전산화 도입률 조차 낮은 실정이다. 본 연구는 전자적 임상시험 데이터 관리에 대한 중요성 인식 확산을 위하여 전자적 시스템의 효과에 대한 실증연구를 시도하였으며, 시간효율성 측정지표를 활용하여 다기관 임상시험 사례의 자료를 분석하였다. 연구결과로서 전자적 시스템으로의 전환이 임상시험 전체 프로세스에 제공할 수 있는 시간 측면에서의 효율성을 검증하였으며 전자적 임상시험 데이터 관리 시스템의 활용 효과를 분석하기 위한 국내 첫 실증연구의 시도라는 의미가 있다. 나아가 전략적 데이터 관리 수립 및 임상단계 별 비교연구 등 향후 다양한 비교 연구들의 초석이 될 것이다.

Age-related Changes in Multi-finger Synergy during Constant Force Production with and without Additional Mechanical Constraint

  • Park, Yang Sun;Kwon, Hyun Joon;Koh, Kyung;Shim, Jae Kun
    • 한국운동역학회지
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    • 제26권2호
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    • pp.175-181
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    • 2016
  • Objective: The aim of this study was to investigate age-related changes of multi-finger synergy during a constant force production task with and without an additional mechanical constraint. Method: Fourteen elderly subjects (age: $78.50{\pm}4.63yrs$, height: $157.29{\pm}8.97cm$, weight: $65.13{\pm}6.93kg$) and 14 young subjects (age: $21.13{\pm}1.35yrs$, height: $171.57{\pm}8.43cm$, weight: $70.29{\pm}16.77kg$) participated in this study. The subjects were asked to place their index and middle fingers on two force transducers fixed on a small non-moving teeterboard and produce 10 N by pressing the sensors while watching force feedback on a computer screen under the no additional constraint condition (NAC). The subjects also performed the same task with an additional mechanical constraint (AC) where the subjects were asked to balance a teeterboard that could be rotated by finger forces. An uncontrolled manifold approach was used to calculate within-trial and between-trial multi-finger synergy indices, variance in uncontrolled subspace ($V_{UCM}$), and variance in subspace orthogonal to UCM subspace ($V_{ORT}$). Two-way repeated measured ANOVA was performed with the within-factor of task condition (with and without an additional constraint) and the between factor of groups (elderly and young). Results: The elderly group showed significantly increased within-trial $V_{ORT}$ in AC compared with NAC (p < .05) while the young group showed no significant difference between AC and NAC. There was no significant group difference for within-trial $V_{UCM}$. Between-trial $V_{ORT}$ remained unchanged between groups and conditions. However, between-trial $V_{UCM}$ for the elderly group significantly decreased in AC as compared to NAC, along with no significant difference for the young group. For multi-finger synergy, there was no significant group difference of within-trial synergy. However, between-trial synergy for the elderly group significantly decreased in AC as compared to NAC (p < .05). Conclusion: Our results indicate that aging decreased consistency (i.e., ability to perform the task on a moment-to-moment basis) with an additional mechanical constraint. In addition, aging was associated with decreased multi-finger synergy on a trial-to-trial basis.

가감자운액(加減紫雲液) 도포가 자외선으로 유발된 피부 홍반에 미치는 영향 (Effects of Gagam-Jawoonaek about Erythema by UV Exposure)

  • 김태연;김용민
    • 동의생리병리학회지
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    • 제28권1호
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    • pp.94-101
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    • 2014
  • We studied to investigate the erythema reduction effects generated by Gagam-Jawoonaek(GJ) application(appl.) after UV exposure. Twenty women in their twenties to fifties with no skin diseases were recruited. We exposed UV as a 6 subsites on the left upper arm of subjects using multi-port solar simulator. After setting Gagam-Jawoonaek(GJ) application(appl.) subsites and non-appl. subsites, we measured erythema degrees($a^*$ values) of the subsites using spectrophotometer. We measured $a^*$ values four times(before UV exposure, before application of GJ, twenty-four and forty-eight hours after first application of GJ). We analyzed data using student's t-test. After UV exposure, $a^*$ values on the left upper arm increased. Twenty-four hours after first GJ treat., the changes of $a^*$ value on GJ treat. subsites($1.22{\pm}0.13AU$) were bigger than GJ non-treat. subsites($1.04{\pm}0.12AU$), but there was no statistically significance. Forty-eight hours after first GJ treat., the changes of $a^*$ value on GJ treat. subsites($1.95{\pm}0.11AU$) were bigger than GJ non-treat. subsites($1.58{\pm}0.13AU$), a statistically significance. Gagam-Jawoonaek could decrease erythema by UV exposure.

주생활양식별 부엌 공간 계획을 위한 사용자 요구 (User Needs for the Planning of Kitchen considering Housing lifestyle)

  • 이윤재;이세나;이현수
    • 한국주거학회:학술대회논문집
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    • 한국주거학회 2005년도 추계학술대회 논문집
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    • pp.185-188
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    • 2005
  • With the development of digital technology and the advent of the concept of well-being, kitchen will be worked as the center of housing and turn into multi-functional space. So a research is requested to consider the users' needs for kitchen based on their life characteristics. The purpose of this study is to find out housing lifestyles, and to search and analyze users' needs for kitchen planning according to their lifestyles. And then plans for kitchen design are suggested. The findings are as follows. (1) Housing lifestyles of users living in apartment are categorized into the type of network and trial & development, pursing the new environment and technology, the type of high quality and convenience, seeking the way to make housework easy and comfortable, the type of housework oriented and the type of unspecification. (2) The type of network and trial & development requests home automation, confrontation layout of counter-top, the type of high quality and convenience requests enlargement of kitchen space, the newest appliance and kitchen island, the type of housework oriented requests the efficiency of space utilization with a counter-top style table, and the type of unspecification asks space for study and office work. All of the types have needs for water use space, larger storing space and a Kimchi refrigerator.

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온경탕이 족부냉증에 미치는 영향에 대한 다기관 이중맹검 무작위 대조군 연구 (Effect of Onkyung-tang on Cold Hypersensitivity on Feet: A Multi-center Double-blind Randomized Controlled Trial)

  • 권나연;유준상;김형준;이동녕
    • 대한한방부인과학회지
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    • 제33권3호
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    • pp.149-174
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    • 2020
  • Objectives: This study was aimed to figure out the effect of Onkyung-tang (OKT) on cold hypersensitivity on feet in female patients. Methods: This study was designed to implement multi-center randomized clinical trial in three korean medical hospitals. The female patients who were enrolled in this study were 112 women who suffered from cold hypersensitivity on feet. They were randomly allocated into OKT group or control group in 1:1 ratio. The primary outcome was change in score of visual analogue scale of hypersensitivity on feet, and the secondary outcomes were thermometer of LU4, PC8, ST32, LR3, visual analogue scale of hypersensitivity on hands, result of cold stress test, and score of World Health Organization Quality of Life-BREF. Results: In both group, the VAS of hypersensitivity on feet and hands was decreased while taking the medicine, and the effect of decreasing the VAS continues for the 4 weeks after the end of medication (p<0.001, 0.003, 0.001). In OKT group, the body temperature difference in lower extremity (ST32-LR3) was steadily decreased at every visit and it was statistically significant(p=0.003, <0.001). On the other hand, in control group, the body temperature difference in lower extremity was decreased only while taking the medicine (p<0.001). Conclusions: OKT significantly reduced discomfort coldness on feet in patients, and the effect of treatment was maintained at least for four weeks after medication.