• Title/Summary/Keyword: independent trial

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Type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy in adults: A randomized clinical trial

  • Sadek, Mais M.;Sabet, Noha E.;Hassan, Islam T.
    • The korean journal of orthodontics
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    • v.49 no.6
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    • pp.381-392
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    • 2019
  • Objective: The objective of this two-arm parallel trial was to compare the type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy. Methods: Twenty-eight subjects were randomized in a 1 : 1 ratio to either the labial or lingual group. En masse anterior retraction was performed using labial biocreative therapy in group A and lingual biocreative therapy in group B. Cone beam computed tomography scans were taken before and after retraction and the primary outcome was the type of tooth movement during anterior retraction. Data were analyzed using paired t-tests for comparisons within each group and independent-sample t-test for comparison of the mean treatment changes between the two groups. Results: Significant differences were found between the two groups in relation to the type of tooth movement (labiolingual inclination of the central incisor; mean difference, $5.85{\pm}1.85^{\circ}$). The canine showed significant distal tipping in the lingual group (mean difference, $6.98{\pm}1.25^{\circ}$). The canine was significantly more intruded in the lingual group (mean difference, $1.67{\pm}0.49mm$). Good anchorage control and significant soft tissue changes occurred in both groups. No serious adverse effects were detected. Conclusions: With a 10-mm retraction hook, the labial biocreative technique with the reverse curve overlay provided anterior retraction with good torque control, while in the lingual group, anterior retraction occurred with controlled tipping movement with significant distal tipping and intrusion of the canine (trial registration: The trial was registered at ClinicalTrials.gov [NCT03239275]).

Comparison of Efficiency between Individual Randomization and Cluster Randomization in the Field Trial (지역사회 임상시험시 개인별 무작위배정과 군집 무작위배정의 효율성 비교)

  • Koo, Hye-Won;Kwak, Min-Jeong;Lee, Young-Jo;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.33 no.1
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    • pp.51-55
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    • 2000
  • Objectives . In large-scale field trials, randomization by cluster is frequently used because of the administrative convenience, a desire to reduce the effect of treatment contamination, and the need to avoid ethical issues that might of otherwise arise. Cluster randomization trials are experiments in which intact social unit, e.g., families, schools, cities, rather than independent individuals are randomly allocated to intervention groups. The positive correlation among responses of subjects from the same cluster is in matter in cluster randomization. This thesis is to compare the results of three randomization methods by standard error of estimator of treatment effect. Methods : We simulated cholesterol data varing the size of the cluster and the level of the correlation in clusters and analyzed the effect of cholesterol-lowering agent. Results : In intra-cluster randomization the standard error of the estimator of treatment effect is smallest relative to that in inter-cluster randomization and that in individual randomization. Conclusions : Infra-cluster randomization is the most efficient in its standard error of estimator of treatment effect but other factor should be considered when selecting a specific randomization method.

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Sex differences in repeatability of measurement for hamstring strength during maximal voluntary contractions (최대 수의적 수축 동안 뒤넙다리근 근력 반복성의 남녀 차이)

  • Lim, Woo Taek
    • Journal of Korean Physical Therapy Science
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    • v.27 no.1
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    • pp.9-17
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    • 2020
  • Background: This study aimed to examine the repeatability of hamstring strength during maximal voluntary contractions (MVCs) and to examine the sex difference. Design: Quasi-experiment design. Methods: The study recruited 23 healthy young individuals as participants. Hamstring flexibility was measured before and after MVCs by active knee extension test. Five trials of MVCs were performed, and hip extension forces were measured using a strain gauge during MVCs. Repeatability was confirmed by intraclass correlation coefficient (ICC) and coefficient of variation, and the difference between male and female participants was confirmed by independent samples t-test. Results: The forces measured during MVCs were significantly different between men and women over five trials. We observed the minimum and maximum force production at the first and fifth trial of MVCs in both men and women. Excellent to moderate reliability of the hamstring strength during MVCs was found in men (ICC range, 0.70-0.98) and women (ICC range, 0.66-0.90). There was no significant difference in hamstring flexibility between men and women. Conclusion: In clinical settings, we recommend excluding the first trial of MVCs in both men and women. Additionally, performing at least three trials of MVCs would be useful to improve the reliability of the baseline measures in women.

Effects of Active Vibration Exercise Using a Flexi-Bar on the Activity of Scapular Stabilizing Muscles: A Randomized Controlled Trial

  • Park, Chibok;Kim, Byeonggeun
    • Journal of International Academy of Physical Therapy Research
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    • v.11 no.1
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    • pp.1975-1980
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    • 2020
  • Background: It has been argued that changes in muscle activity in the upper trapezius and serratus anterior may or may not cause shoulder joint pain and dysfunction. Objective: To investigate the effects of active vibration exercise on muscle activity regarding scapular stabilization using a flexi-bar. Design: A randomized controlled trial. Methods: A total of 24 subjects were randomly assigned to a flexi-bar group with active vibration and general stick group with non-active vibration. Both groups performed the same four action programs for 6 weeks, three times a week for 30 minutes at a time. The upper trapezius muscle, middle trapezius muscle, lower trapezius muscle and serratus anterior muscle of the dominant side was measured by electromyography before and after the 6 weeks of exercise. The independent t-test and paired t-test were used to analyze data. Results: There was a significant difference between groups in upper trapezius muscle and serratus anterior muscle activity after exercise (P<.05). Also, there was a significant difference in upper trapezius muscle and serratus anterior muscle activity before and after exercise in the flexi-bar group (P<.05). Conclusion: This study demonstrates that active vibration exercise using a flexi-Bar contribute to reduce the activity of the upper trapezius muscle and promote the activity of the serratus anterior muscle.

Handling dependencies among performance shaping factors in SPARH through DEMATEL method

  • Zhihui Xu;Shuwen Shang;Xiaoyan Su;Hong Qian;Xiaolei Pan
    • Nuclear Engineering and Technology
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    • v.55 no.8
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    • pp.2897-2904
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    • 2023
  • The Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method is a widely used method in human reliability analysis (HRA). Performance shaping factors (PSFs) refer to the factors that may influence human performance and are used to adjust nominal human error probabilities (HEPs) in SPAR-H. However, the PSFs are assumed to be independent, which is unrealistic and can lead to unreasonable estimation of HEPs. In this paper, a new method is proposed to handle the dependencies among PSFs in SPAR-H to obtain more reasonable results. Firstly, the dependencies among PSFs are analyzed by using decision-making trial and evaluation laboratory (DEMATEL) method. Then, PSFs are assigned different weights according to their dependent relationships. Finally, multipliers of PSFs are modified based on the relative weights of PSFs. A case study is illustrated that the proposed method is effective in handling the dependent PSFs in SPAR-H, where the duplicate calculations of the dependent part can be reduced. The proposed method can deal with a more general situation that PSFs are dependent, and can provide more reasonable results.

An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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The Influence of Metastatic Lymph Node Ratio on the Treatment Outcomes in the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) Trial: A Phase III Trial

  • Kim, Youjin;Park, Se Hoon;Kim, Kyoung-Mee;Choi, Min Gew;Lee, Jun Ho;Sohn, Tae Sung;Bae, Jae Moon;Kim, Sung;Lee, Su Jin;Kim, Seung Tae;Lee, Jeeyun;Park, Joon Oh;Park, Young Suk;Lim, Ho Yeong;Kang, Won Ki
    • Journal of Gastric Cancer
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    • v.16 no.2
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    • pp.105-110
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    • 2016
  • Purpose: In the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial, we investigated whether chemoradiotherapy after D2 gastrectomy reduces the rate of recurrence. Recently, the ratio of metastatic lymph nodes to examined lymph nodes (N ratio) has been proposed as an independent prognostic factor in gastric cancer (GC). The aim of this study was to investigate the relationship between the metastatic N ratio and prognosis of GC after curative D2 surgery. Materials and Methods: We retrospectively reviewed the data of 458 ARTIST patients who underwent D2 gastrectomy followed by adjuvant chemotherapy (XP, n=228) or chemoradiotherapy (XPRT, n=230). The disease-free survival (DFS) rates of patients were used to evaluate the influence of N ratio on the treatment outcome. To achieve this, 4 different N ratio categories (0%, 1%~9%, 10%~25%, and >25%) were compared on the basis of their influence on the treatment outcome. Results: On multivariate analysis, the N ratio remained an independent prognostic factor for DFS. The hazard ratios (HRs) for the N ratio categories of 0%, 1%~9%, 10%~25%, and >25% were 1, 1.061, 1.202, and 3.571, respectively. In patients having N ratio >25%, the 5-year DFS rates were 55% and 28% for the XPRT and XP arms, respectively (HR, 0.527; 95% confidence interval, 0.307~0.904; P=0.020). Conclusions: In patients with curatively resected GC, the N ratio was independently associated with DFS. Although this finding warrants further investigation in future prospective studies, the benefit of chemoradiotherapy for D2 resected GC appears to be more beneficial in cancers having N ratios >25%.

Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study (마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구)

  • Yang, Chang-Sop;Hsing, Li-Chang;Jeong, Hyun-Suk;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature - (치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 -)

  • Kwon, Yong-Ju;Cho, Hye-Young;Whang, Wei-Wan;Cho, Seung-Run
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

A study on a sequences of games with draw (비김이 있는 연속적인 게임에 관한 연구)

  • Cho, Daehyeon
    • Journal of the Korean Data and Information Science Society
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    • v.28 no.4
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    • pp.783-796
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    • 2017
  • In the theory of probability, a Bernoulli trial is a random experiment with exactly two possible outcomes, "success" and "failure", in which the probability of success is the same every time the experiment is conducted. In the successive games of scissors paper stone there exists the case of draw in each game. In this paper we are interested in the ultimate success probability of each participant and the expected number of the game till any one of the two has the ultimate victory. Using our results, we can calculate the ultimate winning probability of each player of the two players and the expected number of the game till any one of the two has the ultimate victory in any case whether there is draw or not in each game.