• 제목/요약/키워드: crossover design

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로그변환 모델에 따른 생물학적 동등성 판정 연구 (Analysis of Bioequivalence Study using a Log-transformed Model)

  • 이영주;김윤균;이명걸;정석재;이민화;심창구
    • 약학회지
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    • 제44권4호
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    • pp.308-314
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    • 2000
  • Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).

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The Combined Effect of Caffeine and Ornithine on the Mood of Healthy Office Workers

  • Misaizu, Akane;Kokubo, Takeshi;Tazumi, Kyoko;Kanayama, Masaya;Miura, Yutaka
    • Preventive Nutrition and Food Science
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    • 제19권4호
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    • pp.367-372
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    • 2014
  • Caffeine is widely consumed and well known for stimulating the central nervous system. When developing new foods and beverages that contain caffeine, it is important to explore the potential synergistic effects of consuming amino acids and other food ingredients with caffeine on humans. Given the physiological pathways affected by the amino acid ornithine, consumption of ornithine with caffeine may have synergistic effects. The purpose of the present study was to examine the effect of consuming caffeine with ornithine in humans. The study used a randomized, placebo-controlled, double-blinded crossover design. The subjects were all healthy office workers who ingested the placebo, 100 mg caffeine, or 100 mg caffeine plus 200 mg ornithine in the morning and completed questionnaires about their mood. Office workers who consumed the combination of caffeine and ornithine had higher mood ratings 8 h after consumption than office workers who consumed caffeine alone. The results of the present study suggest that there is a unique synergistic effect between caffeine and ornithine on the mood of healthy office workers and that ornithine may potentiate the effects of caffeine.

Immediate Effects of Release Ball Massage and Self-stretching Exercise on Hamstring's Temperature, Range of Motion and Strength in 20's Women

  • Jeong, Younghun;Park, Jihwan;Yu, Jin;Lee, Sunyeong;Ha, Jihee;Choo, Yeonki;Oh, Taeyoung
    • 국제물리치료학회지
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    • 제10권1호
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    • pp.1739-1745
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    • 2019
  • Background: There have been many studies on self-myofascial release (SMR) stretching, but there are few comparative studies on the effects of massages using a release ball, which is a type of the SMR method. Objective: To investigate the immediate effects of release ball massage and self-stretching on proprioceptive sensory, hamstring's temperature, range of motion (ROM) muscle strength,. Design: Crossover study. Methods: Thirty women in 20's at S University in Busan voluntarily participated in the study. Participants were random to release ball group (n=15) or self-stretching group (n=15). Both groups performed 3 sets of exercises, stretching for 30 seconds and resting for 15 seconds in each position. The proprioceptive sensory, temperature of the hamstring muscle, ROM, and strength were measured before exercise, 5 minutes after exercise, and 30 minutes after exercise. Results: Release ball group showed significant differences in muscle length and temperature over time (p<.05). The comparison between two group over time showed significant differences in muscle length, temperature, and muscle strength (p<.05). Conclusions: These results demonstrate that release ball massage and self-stretching are beneficial for improving hamstring's temperature, ROM and muscle strength.

Effect of Rehabilitation Exercise for Golfers on the X-factor and Ground Reaction Force according to Phase of the Golf Swing

  • yoon, Junggyu;Cho, Byungyun
    • 국제물리치료학회지
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    • 제10권1호
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    • pp.1706-1710
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    • 2019
  • Background: Despite frequent shoulder injuries of rotator cuff muscle of golfers by the result of overuse and poor swing mechanics, there is little research on shoulder specific rehabilitation exercises for injured rotator cuff muscle and golf swing Objective: To examined the effect of rehabilitation exercise for golfers on the X factor and ground reaction force (GRF) according to phase of the golf swing. Design: Crossover study Methods: The participants were 13 amateur golfers selected for a 4 week rehabilitation exercise for golfers. A rehabilitation exercise for golfers consisting of 5 steps and 4 items (sleeper stretch, full side plank, push up to plank, high plank knee unders) were applied to all participants. A three dimensional motion analyzer and force platform (SMART-E, BTS, Italy) were used to measure the X factor (angle between shoulder and pelvis at top of back swing) and GRF according to phase of the golf swing. All dependent variables were measured before and after exercise. The collected data was analyzed using the paired t test and SPSS 21.0. Results: The GRF had a statistically significant increase in the impact phase and ratio impact/weight after rehabilitation exercise for golfers (p<.05). The X-factor, GRF in top of back swing and finish were no significant differences between before and after exercise (p>.05). Conclusions: These results suggested that rehabilitation exercise for golfers was effective for increasing GRF in the impact phase and ratio impact/weight for amateur golfer.

Effects of Backward Walking Training with Task Orientation on the Functional Gait of Children with Spastic Hemiplegia

  • Choi, Ji Young;Son, Sung Min;Kim, Chang Ju
    • The Journal of Korean Physical Therapy
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    • 제31권5호
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    • pp.292-297
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    • 2019
  • Purpose: This study examined the effects of backward walking training with task orientation on the functional walking ability of children with cerebral palsy. Methods: This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation facility with cross-over to the other intervention arm following a two-week break. For a total of 12 children with spastic hemiplegia cerebral palsy, the forward walking training group (n=6) underwent training three times a week for three weeks, 40 minutes a day, and the backward walking training group (n=6) was also trained under the same conditions. To identify the functional walking ability, variables, such as the walking speed, stride length, and step length, were measured using a walk analyzer (OptoGait, Microgate S.r.l, Italy). Results: Both groups showed significant increases in walking speed, stride length, and step length (p<0.01). The backward walking group showed more significant improvement in the walking speed from pre- to post-test (p<0.05). The gait characteristics were similar in the two groups (stride length and step length) but the walking speed in the backward walking group showed a mean difference between the positive effects higher than the forward walking group. Conclusion: Task-oriented backward walking training, which was conducted on the ground, may be a more effective treatment approach for improving the walking functions of spastic hemiplegia children than forward walk training.

인공신경망을 이용한 플라이애시 및 실리카 흄 복합 콘크리트의 압축강도 예측 (Prediction of strength development of fly ash and silica fume ternary composite concrete using artificial neural network)

  • 번위결;최영지;왕소용
    • 산업기술연구
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    • 제41권1호
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    • pp.1-6
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    • 2021
  • Fly ash and silica fume belong to industry by-products that can be used to produce concrete. This study shows the model of a neural network to evaluate the strength development of blended concrete containing fly ash and silica fume. The neural network model has four input parameters, such as fly ash replacement content, silica fume replacement content, water/binder ratio, and ages. Strength is the output variable of neural network. Based on the backpropagation algorithm, the values of elements in the hidden layer of neural network are determined. The number of neurons in the hidden layer is confirmed based on trial calculations. We find (1) neural network can give a reasonable evaluation of the strength development of composite concrete. Neural network can reflect the improvement of strength due to silica fume additions and can consider the reductions of strength as water/binder increases. (2) When the number of neurons in the hidden layer is five, the prediction results show more accuracy than four neurons in the hidden layer. Moreover, five neurons in the hidden layer can reproduce the strength crossover between fly ash concrete and plain concrete. Summarily, the neural network-based model is valuable for design sustainable composite concrete containing silica fume and fly ash.

혈액투석 환자의 동정맥루 천자 시 피부자극법과 국소마취크림 도포에 따른 통증과 심박변이도 비교 (Comparison of Skin Stimulation Method and Topical Anesthetic Cream on Pain and Heart Rate Variability during Arteriovenous Fistula Puncture in Hemodialysis Patients)

  • 강효영;채영란
    • Journal of Korean Biological Nursing Science
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    • 제21권3호
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    • pp.207-216
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    • 2019
  • Purpose: The purpose of this was to compare effects of application of the skin stimulation method and topical anesthetic cream on pain, heart rate variability and satisfaction according to nursing intervention methods during arteriovenous fistula puncture in chronic renal failure hemodialysis patients. Methods: This study was a crossover design. Participants were 36 patients with chronic renal failure receiving hemodialysis treatment. Two forms of intervention were applied to participants, and then pain and heart rate variability were measured during the puncture. Results: There were no statistically significant differences according to each treatment in vein pain and artery pain. Also, there were no statistically significant differences according to each treatment in stress index, sympathetic activity (LF), parasympathetic activity (HF) and sympathetic activity/parasympathetic activity (LF/HF ratio). Satisfaction with application of skin stimulation method was statistically higher than that of topical anesthetic cream application. Conclusion: This suggests that application of the skin stimulation method complements disadvantages of topical anesthetic cream application and demonstrates possibility of application as a nursing intervention method which can be conveniently used by nurses in clinical practice.

펫푸드(반려동물 식품) 선택속성에 대한 소비자 특성 분석 (Consumer Characteristics in Terms of Pet Food Selection Attributes)

  • 박명은;엄지범
    • 농촌지도와개발
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    • 제28권2호
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    • pp.85-98
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    • 2021
  • This study aims to examine consumer types based on pet food selection attributes and to analyze the differences in consumer characteristics by those types. In this study, the researcher uses k-means cluster analysis and crossover analysis to determine market segmention, and then analyzes the resultant characteristics by categorizing consumers. A total of 202 cases are used for this study. First, the selection attributes are classified into the six factors of credibility, quality, design, convenience, information, and price. Second, the clusters are categorized into the four clusters, which are designated pet food lower-involvement type, pet food information- and price-seeking type, pet food convenience-seeking type, and pet food higher-involvement type. Third, these four groups exhibit statistically significant differences in terms of occupational variables, number of pets, and purchase frequency. The results of this study may provide helpful information in establishing customized, market-based marketing strategies based on the characteristics of pet food consumers.

Change in Pelvic Motion Caused by Visual Biofeedback Influences Trunk and Hip Muscle Activities During Side-Lying Hip Abduction in Asymptomatic Individuals

  • Yu, Ilyoung;Kang, Minhyeok
    • 국제물리치료학회지
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    • 제10권3호
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    • pp.1818-1822
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    • 2019
  • Background: Ipsilateral pelvic elevation has been reported as a common compensatory movement during side-lying hip abduction. It has been reported that pelvic elevation inhibits sufficient contraction of gluteus medius. However, few studies have identified the effects of controlled pelvic elevation on the trunk and hip muscles. Objective: To examine the effects of controlled pelvic elevation using visual biofeedback on the muscle activity of the trunk and hip muscles. Design: Crossover study. Methods: Twelve healthy males performed side-lying hip abduction exercises with and without visual biofeedback for pelvic elevation. Electromyography (EMG) activities of the gluteus medius, quadratus lumborum, and multifidus were analyzed using a wireless EMG system while the ipsilateral pelvic elevation angle was measured using a motion sensor during side-lying hip abduction exercises. Results: EMG activities of the gluteus medius (p = .002), quadratus lumborum (p = .022), and multifidus (p = .020) were significantly increased and ipsilateral pelvic elevation was significantly decreased (p = .001) during side-lying hip abduction with visual biofeedback compared to without visual biofeedback. Conclusions: The results of this study suggest that the application of biofeedback for pelvic motion could improve the trunk and hip muscle activation pattern and decrease compensatory pelvic motion during side-lying hip abduction exercise.

실시간 비침습적 뇌전기 자극이 양손 힘 조절능력에 미치는 영향 (Online-Effects of Transcranial Direct Current Stimulation on Bimanual Force Control Performances in Healthy Young Adults)

  • Tae Lee, Lee;Joon Ho, Lee;Nyeonju, Kang
    • 한국운동역학회지
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    • 제32권4호
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    • pp.121-127
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    • 2022
  • Objective: The purpose of this study was to investigate potential effects of transcranial direct current stimulation (tDCS) on bimanual force control capabilities in healthy young adults. Method: Eighteen right-handed healthy young adults (10 females and 8 males; age: 23.55 ± 3.56 yrs) participated in this crossover design study. All participants were randomly allocated to both active-tDCS and sham-tDCS conditions, respectively. While receiving 20 min of active- or sham-tDCS interventions, all participants performed bimanual isometric force control tasks at four submaximal targeted force levels (i.e., 5%, 10%, 15, and 20% of maximal voluntary contraction: MVC). To compare bimanual force control capabilities including force accuracy, variability, and regularity between active-tDCS and sham-tDCS conditions, we conducted two-way repeated measures ANOVAs (2 × 4; tDCS condition × Force levels). Results: We found no significant difference in baseline MVC between active-tDCS and sham-tDCS conditions. Moreover, our findings revealed that providing bilateral tDCS including anodal tDCS on left primary motor cortex (M1) and cathodal on right M1 while conducting bimanual force control trials significantly decreased force variability and regularity at 5%MVC. Conclusion: These findings suggest that providing bilateral tDCS on M1 areas may improve bimanual force control capabilities at a relatively low targeted force level.