• Title/Summary/Keyword: Cross-over trials

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The Marginal Model for Categorical Data Analysis of $3\times3$ Cross-Trials ($3\times3$ 교차실험을 범주형 자료 분석을 위한 주변확률모형)

  • 안주선
    • The Korean Journal of Applied Statistics
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    • v.14 no.1
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    • pp.25-37
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    • 2001
  • The marginal model is proposed for the analysis of data which have c(2: 3) categories in the 3 x 3 cross-over trials with three periods and three treatments. This model could be used for the counterpart of the Kenward-Jones' joint probability one and should be the generalization of Balagtas et ai's univariate marginal logits one, which analyze the treatment effects in the 3 x 3 cross-over trials with binary response variables[Kenward and Jones(1991), Balagtas et al(1995)]. The model equations for the marginal probability are constructed by the three types of link functions. The methods would be given for making of the link function matrices and model ones, and the estimation of parameters shall be discussed. The proposed model is applied to the analysis of Kenward and Jones' data.

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Comparison of Single Imputation Methods in 2×2 Cross-Over Design with Missing Observations (2×2 교차계획법에서 결측치가 있을 때의 결측치 처리 방법 비교에 관한 연구)

  • Jo, Bobae;Kim, Dongjae
    • The Korean Journal of Applied Statistics
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    • v.28 no.3
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    • pp.529-540
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    • 2015
  • A cross-over design is frequently used in clinical trials (especially in bioequivalence tests with a parametric method) for the comparison of two treatments. Missing values frequently take place in cross-over designs in the second period. Usually, subjects that have missing values are removed and analyzed. However, it can be unsuitable in clinical trials with a small sample size. In this paper, we compare single imputation methods in a $2{\times}2$ cross-over design when missing values exist in the second period. Additionally, parametric and nonparametric methods are compared after applying single imputation methods. A Monte-Carlo simulation study compares type I error and the power of methods.

Nonparametric Tests for 2×2 Cross-Over Design

  • Gee, Kyuhoon;Kim, Dongjae
    • Communications for Statistical Applications and Methods
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    • v.19 no.6
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    • pp.781-791
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    • 2012
  • A $2{\times}2$ Cross-over design is widely used in clinical trials for comparison studies of two kinds of drugs or medical treatments. This design has many statistical methods such as Hills-Armitage's (1979) method or Koch's (1972) method. In this paper, we propose a nonparametric test for $2{\times}2$ Cross-over design based on a two-sample test suggested by Baumgartner et al. (1998). In addition, a Monte Carlo simulation study is adapted to compare the power of the proposed methods with those of previous methods.

Complementary and Alternative Medicine for Oral Health : a Literature Review of Randomized Controlled Clinical Trials (구강건강에 이용되는 보완대체의학 치료: 무작위대조임상연구를 통한 문헌적 고찰)

  • Kim, Da-Hee;Choi, Gwang-Ho;Hwang, Eui-Hyoung;Heo, Kwang-Ho;Kim, Yong-Deok;Shin, Byung-Cheul
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.3
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    • pp.23-39
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    • 2014
  • Objective : This review aims at analyzing Complementary and Alternative Medicine (CAM) therapies, using for oral health to know current use of CAM in dental area by analyzing randomized controlled clinical trials (RCTs). Method : We searched the following 6 electronic databases until 1 July 2014. : Pubmed, Medline, Embase, Allied and Complementary Medicine Database(AMED), Cumulative Index to Nursing and Allied Health Literature(CINAHL), the Cochrane Library. We included parallel RCTs and cross-over RCTs that assessed the efficacy of CAM regardless of blinding and language. Results : A total of 154 RCT articles were included. There were 2-arm parallel study design(69.5%), 3-arm parallel study design(20.8%), 4-arm parallel study design(4.5%) and Cross-over design(5.2%). Complementary and alternative medicine RCTs in oral health tend to increase in the early-2000s and in the mid-2010s. In addition, 154 citations were classified according to diseases and interventions that categorized Natural Products studies(68.2%), Mind and Body Practices studies(31.8%). We classified in detail that vitamin and mineral therapies(29.9%), dietary supplements(24.7%), acupuncture(23.3%), Herbal medicine(13.6%), homeopathy (2.6%), energy therapies(2.6%), Massage(1.9%), biofeedback(0.6%), traditional medicine(0.6%). Conclusion : Increasing publications and diverse interventions regarding CAM for oral health is observed by analyzing RCTs from the literature review. Further studies are needed to be performed as systematic reviews to verify their effectiveness and the research to inquire into side effect.

Evaluations on Salivary Flow Induction and Dissolution Patterns in Saliva of Pilocarpine Chewing Tablet in Healthy Human Volunteers (건강한 성인 지원자를 대상으로 한 필로칼핀 저작정의 타액분비 유도 및 타액중 용출패턴 평가)

  • Park, Kyoung-Ho
    • Journal of Pharmaceutical Investigation
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    • v.27 no.4
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    • pp.331-335
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    • 1997
  • Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

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The amelioration of plasma lipids by Korean traditional confectionery in middle-aged women: A cross-over study with western cookie

  • Hong, Sun Hee;Kim, Mijeong;Woo, Minji;Noh, Jeong Sook;Lee, JaeHwan;Chung, Lana;Song, Yeong Ok
    • Nutrition Research and Practice
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    • v.10 no.6
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    • pp.590-596
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    • 2016
  • BACKGROUND/OBJECTIVES: The purpose of this study was to examine whether plasma lipid profiles are affected differently by snack kinds with equal calorific values. SUBJECTS/METHODS: We compared a Korean traditional confectionery (dasik) with Western confectionery (cookie) in this regard. Controlled cross-over study consisted of two 3-week snack intake phases and for separating, a 2-week washout period (3-2-3) was carried out with 30 healthy women aged between 40-59 years old. Brown rice based Korean traditional confectionery and wheat flour based Western confectionery were used. The participants consumed either dasik or cookie every day for 3 weeks, providing 93 kcal a day. RESULTS: The total cholesterol (TC) in the dasik group had decreased significantly after 3 weeks (P < 0.05). Furthermore, in the dasik group, reduction in TC and low-density lipoprotein-cholesterol were greater than those in the cookie group (P < 0.05). CONCLUSIONS: Prioritizing functional snacks like dasik improves plasma lipid profiles; this may be useful information for individuals who cannot refrain from snacking.

The Role of Milk Products in Metabolic Health and Weight Management

  • Zemel, Michael B.
    • Journal of Dairy Science and Biotechnology
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    • v.28 no.1
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    • pp.17-28
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    • 2010
  • A substantial body of evidence has emerged over the last decade in support of the novel concept that dietary calcium and dairy foods play an important role in regulating energy metabolism and thereby promote healthy weight management and reduce obesity risk. This concept has been demonstrated in experimental animals studies, cross-sectional and prospective population studies and a number of randomized clinical trials. Notably, the effects of dairy foods in weight management are more consistent than the effects of supplemental calcium across clinical trials, and calcium per se is responsible for approximately 40-50% of the effects of dairy. The calcium component is only effective in individuals with chronically low calcium intake, as it serves to prevent the endocrine response to low calcium diets which otherwise favors adipocyte energy storage; calcium also serves to promote energy loss via formation of calcium soaps in the gastrointestinal tract and thereby reduce fat absorption. The calcium-independent anti-obesity bioactivity of dairy resides primarily in whey. The key components identified to date are leucine and bioactive peptides resulting from whey protein digestion. The high concentration of leucine in whey stimulates a repartitioning of dietary energy from adipose tissue to skeletal muscle where it provides the energy required for leucine-stimulated protein synthesis, resulting in increased loss of adipose tissue and preservation of skeletal muscle mass during weight loss. Finally, dairy rich diets suppress the oxidative and inflammatory responses to obesity and thereby attenuate the diabetes and cardiovascular disease risk associated with obesity.

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Cooperative Robot for Table Balancing Using Q-learning (테이블 균형맞춤 작업이 가능한 Q-학습 기반 협력로봇 개발)

  • Kim, Yewon;Kang, Bo-Yeong
    • The Journal of Korea Robotics Society
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    • v.15 no.4
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    • pp.404-412
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    • 2020
  • Typically everyday human life tasks involve at least two people moving objects such as tables and beds, and the balancing of such object changes based on one person's action. However, many studies in previous work performed their tasks solely on robots without factoring human cooperation. Therefore, in this paper, we propose cooperative robot for table balancing using Q-learning that enables cooperative work between human and robot. The human's action is recognized in order to balance the table by the proposed robot whose camera takes the image of the table's state, and it performs the table-balancing action according to the recognized human action without high performance equipment. The classification of human action uses a deep learning technology, specifically AlexNet, and has an accuracy of 96.9% over 10-fold cross-validation. The experiment of Q-learning was carried out over 2,000 episodes with 200 trials. The overall results of the proposed Q-learning show that the Q function stably converged at this number of episodes. This stable convergence determined Q-learning policies for the robot actions. Video of the robotic cooperation with human over the table balancing task using the proposed Q-Learning can be found at http://ibot.knu.ac.kr/videocooperation.html.

Systemic Review : The Study on acupuncture for tension-type headache and migrain in PubMed (PubMed에서 acupuncture와 tension-type headache and migrain로 검색한 최근 연구경향)

  • Kim, Kyung-min;Byun, Im-jeung;Woo, Hyun-su;Lee, Hyun-Jong;Ha, Ji-young;Kim, Jong-deog;Hong, Jang-mu;Lee, Jae-dong;Lee, Yun-ho;Choi, Do-young
    • Journal of Acupuncture Research
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    • v.20 no.1
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    • pp.191-201
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    • 2003
  • Objective : To research the trends of study related to tension-type headache and migrain with acupuncture in PubMed, and to establish the hereafter direction of acupuncture. for tension-type headache and migrain. Methods : We searched in PubMed, with tension-type headache, migrain and acupuncture limitted by abstract and enterz data 10 years. Results : 1. The pattern of the study was as follows: Review article(18), Clinical Trials(23), meta analysis(2) and rondomized controlled trials(16). We further estimated 23 articles. 2. Many of these studies provide equivocal results because of designs, sample size and the others, but in the majority of the trials were concludes that acupuncture offers benefits in the treatment of headache. 3. Acupuncture methods need individualization, a carefully selected placebo and cross-over design must have adequate time between the two treatment periods.

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Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial (생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려)

  • Noh, So-Young;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
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    • v.26 no.4
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    • pp.675-686
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    • 2013
  • The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.