• Title/Summary/Keyword: Multi-center Trial

Search Result 75, Processing Time 0.032 seconds

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

  • Ha, Il-Do
    • Journal of the Korean Data and Information Science Society
    • /
    • v.22 no.3
    • /
    • pp.605-612
    • /
    • 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.

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

  • Park, Ji-Eun;Oh, Dal-Seok;Kang, Kyung-Won;Kim, Dong-Il;Choi, Sun-Mi
    • Korean Journal of Acupuncture
    • /
    • v.24 no.3
    • /
    • pp.33-45
    • /
    • 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.

  • PDF

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

  • Yang Rae Kim
    • Physical Therapy Rehabilitation Science
    • /
    • v.12 no.2
    • /
    • pp.192-200
    • /
    • 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.

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

  • Lee, Hyun-Ju;Choi, In-Young
    • The Journal of the Korea Contents Association
    • /
    • v.11 no.1
    • /
    • pp.350-356
    • /
    • 2011
  • The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

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
    • Korean Journal of Applied Biomechanics
    • /
    • v.26 no.2
    • /
    • pp.175-181
    • /
    • 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.

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

  • Kim, Tae Yeon;Kim, Yong Min
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.28 no.1
    • /
    • pp.94-101
    • /
    • 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.

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

  • Lee, Youn-Jae;Lee, Se-Na;Lee, Hyun-Soo
    • Proceeding of Spring/Autumn Annual Conference of KHA
    • /
    • 2005.11a
    • /
    • pp.185-188
    • /
    • 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.

  • PDF

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

  • Kwon, Na-Yoen;Yoo, Joon-Sang;Kim, Hyeong-Jun;Lee, Dong Nyung
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.33 no.3
    • /
    • pp.149-174
    • /
    • 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.