• Title/Summary/Keyword: independent trial

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Independent Data Monitoring Committees: Review of Current Guidelines (국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황)

  • Lee, Bo Ram;Lee, Kyung Eun
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.181-186
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    • 2016
  • Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

Speed Control of tne Induction Motor Using SCR (Trial Manufacturing of Solid-state Frequency Converter) (SCR를 이용한 유도전동기의 속도제어에 관한 연구)

  • Jong Swoo Won
    • 전기의세계
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    • v.19 no.4
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    • pp.1-11
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    • 1970
  • It is well known that solid-state devices like inverter and converter made by transistor and other semi-conductors are widely used for the purpose of motor speed control in industrial fields. This paper is devoted primarily to a study of Trial Manufacturing of Solid-state Frequency Converter by means of single-phase bridge-type SCR inverter. The principle of the trial product belongs to AC-DC-AC conversion system. The voltage to be impressed to the motor in case of speed control by frequency conversion method is necessary to be proportional to frequency. It also requires the frequency and voltage are independent to hte load variation. In order to meet above requests required to motor speed control., the trial product introduced the open loop system in the frequency setting and closed loop system in the voltage setting. The trial product showed the favorable performance characteristics in speed control of singlephase fractional horsepower motor from 45HZ through 80HZ.

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Independent Component Analysis of the Event-Related Potential during Visual Oddball Tasks with Multiple Difficulty Levels (다중 난이도를 갖는 시각적 Oddball 작업 수행 시 사상관련전위의 독립요소분석)

  • Kim, Ja-Hyun;Yoon, Jin;Kim, Kyung-Hwan
    • Journal of Biomedical Engineering Research
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    • v.29 no.1
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    • pp.73-81
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    • 2008
  • The purpose of this study is to observe the brain activity patterns during visual oddball tasks with two difficulty levels by the analysis of high-density event-related potential (ERP). Along with conventional statistical analysis of averaged ERP waveforms, we applied independent component analysis (ICA) for the individual, single-trial analysis and verified its effectiveness. We could identify multiple ERP components such as early visual components (P1, N1), and two components which seem to be important task-related components and showed difficulty-dependent variability (P2, P300). The P2 was found around central region at $180{\sim}220ms$, and the P300 was found globally at $300{\sim}500ms$ poststimulus. As the task became difficult, the P2 amplitude increased, and the P300 amplitude decreased. After single-trial ERPs were decomposed into multiple independent components (ICs), several ICs resulting from P2 and P300 sources were identified. These ICs were projected onto scalp electrodes and the projected ICs were statistically compared according to two task difficulties. For most subjects, the results obtained from single-trial/individual analysis using ICA gave the tendencies of amplitude change that are similar to the averaged ERP analysis for most subjects. The temporal pattern and number of ICs corresponding to ${\mu}$ rhythm was not dependent on the task difficulty. It seems that the motor response was not affected by the task difficulty.

Comparative Analysis of Two Independent Proportions in Non-Inferiority Trials (비열등성 임상시험에서 독립인 두 비율 차 검정에 대한 비교 연구)

  • Yoon, Min;Kwak, Min-Jung
    • The Korean Journal of Applied Statistics
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    • v.23 no.6
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    • pp.1115-1124
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    • 2010
  • Normal approximation methods under the null hypothesis of no difference are frequently used to test the two independent proportions in non-inferiority trials. However, these tests are not appropriate under the null hypothesis of non-zero difference. We review the likelihood score methods proposed by Miettinen and Nurminen, Farrington and Manning, and Gart and Nam and compare the performance of these tests. The simulation study shows that the likelihood score tests under the null hypothesis of non-zero difference have better performance at a Type I error and power than usual normal approximation methods.

The perception in regard to the clinical trial of dental hygienists (치과위생사의 임상시험에 대한 인식도)

  • Chang, Na-Hee;Jung, Ui-Jung;Jang, Gye-Won
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.6
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    • pp.839-847
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    • 2014
  • Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.

The Effect of Broadcasting Sow Suckling Grunts in the Lactation Shed on Piglet Growth

  • Cronin, G.M.;Leeson, E.;Cronin, J.G.;Barnett, J.L.
    • Asian-Australasian Journal of Animal Sciences
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    • v.14 no.7
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    • pp.1019-1023
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    • 2001
  • An on-farm trial was conducted in temperature-controlled lactation rooms at a commercial pig farm to investigate the efficacy of broadcasting sow suckling grunts from day 4 of lactation, on increasing piglet growth to weaning. In the Broadcast treatment, sows and litters were exposed to a 3-min broadcast from loud-speakers every 42 min. The Control treatment was not exposed to the broadcast. All sows and litters had similar husbandry and piglets were provided with creep feed on the floor twice daily. In each of the three replicates in time, the Broadcast and Control treatments were allocated to different lactation rooms at random and there were 12 sows and litters per treatment per replicate. A total of four identical lactation rooms were available for the trial, each containing 28 conventional sow and litter crates with piglet heater in the creep area. A non-trial room separated the two treatment rooms in each replicate to minimise the chance that the broadcast grunt stimulation was audible to the Control treatment litters. Five "normal and average-looking" piglets from the trial litters were weighed twice, 7 d apart. The cohort of five piglets was identified by ear-tags and formed the experimental unit for the statistical analysis. The average (${\pm}SD$) age of piglets at initial weighing was 7.7(${\pm}2.22$) days. For each litter, mean piglet live weight at day 14 of lactation was estimated by linear regression of the two weights recorded seven days apart, when on average, the Broadcast treatment had been exposed to the stimulation for 10 days. Piglets in the Broadcast treatment were heavier (p<0.01) at day 14 of lactation compared to Control treatment (4.24 and 3.92 kg, respectively) and tended to have a greater average daily weight gain over the 7-d period (245 and 228 g/day, respectively; p<0.08). The results suggest piglet growth was improved by about 8% in response to the regular, timed broadcast of sow suckling grunts in the lactation shed. The independent contributions of milk and creep feed to the improved growth remain to be determined.

Influence of Kaolinite Clay Supplementation on Growth Performance and Digestive Function in Finishing Calf-fed Holstein Steers

  • Ortiz, Jose;Montano, Martin;Plascencia, Alejandro;Salinas, Jaime;Torrentera, Noemi;Zinn, Richard A.
    • Asian-Australasian Journal of Animal Sciences
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    • v.29 no.11
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    • pp.1569-1575
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    • 2016
  • Two experiments were conducted to examine the influence of kaolinite clay supplementation (0%, 1%, or 2% diet dry matter [DM] basis) on characteristics of digestion (Trial 1) and growth performance (Trial 2) in calf-fed Holstein steers fed a finishing diet. In Trial 1, 6 Holstein steers ($539{\pm}15kg$) with ruminal and duodenal cannulas were used to evaluate treatment effects on characteristics of digestion. Kaolinite clay supplementation decreased total tract DM digestion (linear effect, p<0.01) without effects ($p{\geq}0.10$) on site and extent of digestion of organic matter, neutral detergent fiber, starch and N, or ruminal microbial efficiency. There were no treatment effects on ruminal pH, volatile fatty acids molar proportions or estimated methane production. In Trial 2, 108 Holstein steers ($132.4{\pm}5.6kg$) were used in a 308-d study to evaluate growth performance and carcass characteristics. There were no treatment effects (p>0.10) on average daily gain (ADG) and gain efficiency (ADG/dry matter intake). Kaolinite supplementation tended (linear effect, p = 0.08) to increase dietary net energy (NE) during the initial 112-d period. However, the overall (308-d) effect of supplementation dietary NE was not appreciable (p>0.20). However, due to the inertness of kaolinite, itself, the ratio of observed-to-expected dietary NE increased with kaolinite supplementation. This effect was more pronounced (linear effect, $p{\leq}0.03$) during the initial 224 d of the study. Overall (308 d), kaolinite supplementation tended to increase (linear effect, p = 0.07) dietary NE by 3% over expected. Kaolinite supplementation did not affect carcass weight, yield grade, longissimus area, kidney, pelvic and heart fat, and quality grade, but decreased (linear effect, p = 0.01) dressing percentage. It is concluded that kaolinite supplementation up to 2% of diet DM may enhance energetic efficiency of calf-fed Holstein steers in a manner independent of changes in characteristics of ruminal and total tract digestion.

Investigation of the Effects of Resting Time and Trial on the Maximal Grip Strength

  • Kwak, Doo-Hwan;Lee, Kyung-Sun;Kwag, Jong-Seon;Jung, Myung-Chul;Kong, Yong-Ku
    • Journal of the Ergonomics Society of Korea
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    • v.30 no.3
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    • pp.381-387
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    • 2011
  • Objective: The aim of this study was to investigate the maximal grip strength for the combinations of resting time and trial and to provide guideline of resting time for the maximum gripping task associated with the number of trials. Background: Despite many previous researches for the maximal grip strength, few studies have considered the effect of both trials and rest time on the maximum grip strength. Methods: A total of thirty subjects participated in the study. The average of maximum grip strength was measured using JAMAR hydraulic hand dynamometer. The testing position was same as the position recommended by the American Society of Hand Therapists. The between-subject experimental design has been conducted in this study. Trials(1~20 trials) and rest time(2, 3, and 4min) were considered as independent variables, and the maximum grip strength was considered as dependent variable, respectively, in this study. Results: According to the result of the number of trials, the maximal grip strength decreased gradually as the number of trials increased. The ANOVA result showed that the main effect was significant for both resting time(p<.0001) and trial(p<.0001), and the interaction was significant(p<0.0086). Conclusions: The maximal grip strength decreased gradually as the number of trials increased. Thus, basic guideline of resting time was suggested for the number of trials of maximal grip strength tests in this study.

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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