• 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.

Echocardiography Core Laboratory Validation of a Novel Vendor-Independent Web-Based Software for the Assessment of Left Ventricular Global Longitudinal Strain

  • Ernest Spitzer;Benjamin Camacho;Blaz Mrevlje;Hans-Jelle Brandendburg;Claire B. Ren
    • Journal of Cardiovascular Imaging
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    • v.31 no.3
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    • pp.135-141
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    • 2023
  • BACKGROUND: Global longitudinal strain (GLS) is an accurate and reproducible parameter of left ventricular (LV) systolic function which has shown meaningful prognostic value. Fast, user-friendly, and accurate tools are required for its widespread implementation. We aim to compare a novel web-based tool with two established algorithms for strain analysis and test its reproducibility. METHODS: Thirty echocardiographic datasets with focused LV acquisitions were analyzed using three different semi-automated endocardial GLS algorithms by two readers. Analyses were repeated by one reader for the purpose of intra-observer variability. CAAS Qardia (Pie Medical Imaging) was compared with 2DCPA and AutoLV (TomTec). RESULTS: Mean GLS values were -15.0 ± 3.5% from Qardia, -15.3 ± 4.0% from 2DCPA, and -15.2 ± 3.8% from AutoLV. Mean GLS between Qardia and 2DCPA were not statistically different (p = 0.359), with a bias of -0.3%, limits of agreement (LOA) of 3.7%, and an intraclass correlation coefficient (ICC) of 0.88. Mean GLS between Qardia and AutoLV were not statistically different (p = 0.637), with a bias of -0.2%, LOA of 3.4%, and an ICC of 0.89. The coefficient of variation (CV) for intra-observer variability was 4.4% for Qardia, 8.4% 2DCPA, and 7.7% AutoLV. The CV for inter-observer variability was 4.5%, 8.1%, and 8.0%, respectively. CONCLUSIONS: In echocardiographic datasets of good image quality analyzed at an independent core laboratory using a standardized annotation method, a novel web-based tool for GLS analysis showed consistent results when compared with two algorithms of an established platform. Moreover, inter- and intra-observer reproducibility results were excellent.

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.