• Title/Summary/Keyword: Trial Results

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Survey on the Demand for Clinical Trial Centers for Oriental Medicine (한방임상시험센터의 수요 예측에 대한 조사연구)

  • Seo Jung-Chul;Kim Seung-Ho;Rah Joong-Doug;Jung Sung-Ki;Kwon Young-Kyu
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.85-94
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    • 2005
  • Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

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Study on Mounting Status of Trial Case Lenses (검안렌즈의 장착상태에 대한 연구)

  • Cho, Hyun-Gug;Moon, Byeong-Yeon
    • Journal of Korean Ophthalmic Optics Society
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    • v.18 no.4
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    • pp.405-411
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    • 2013
  • Purpose: In this study, the mounting status of trial case lens was investigated. Methods: We measured distances between geometric center of lens mount and optical center of lens and angle deviations between axis mark on lens and real axis using arbitrary trial case lens sets distributed in Korea, and then, compared those results with international standards. Results: In some of lenses, the prismatic power on geometric center of lens mount and the angle deviations between axis mark and real axis of cylindrical lens were out of tolerance according international standards. Conclusions: The more precise control of the manufacturing process and more thorough quality control for trial case lenses will be required to offer an accurate vision test.

Assessment of therapeutic clinical trials for proximal humeral fractures

  • Jonathan Koa;Mohamad Y. Fares;Mohammad Daher;Joseph A. Abboud
    • Clinics in Shoulder and Elbow
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    • v.27 no.2
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    • pp.237-246
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    • 2024
  • Proximal humeral fractures (PHFs) are a common injury among the older population. An ideal therapeutic protocol has yet to be developed, and numerous clinical trials are being conducted to find the best therapeutic approach. The purpose of this study is to evaluate the current body of knowledge available via interventional clinical trials. In December 2022, interventional clinical trials relating to PHFs on Clinicaltrials.gov were screened. Trial characteristics included duration, status, intervention, phase, outcomes, location, and study design. Publications associated with each trial were searched on PubMed/Medline using the ClinicalTrials.gov registry number. The final dataset comprised 64 trials. The most common trial status was completed (36%). The majority did not have a Food and Drug Administration-defined phase (67%), was randomized (81%), involved a single facility (72%), used a parallel assignment intervention model (80%), and used an open-label approach (45%). Eleven trials were associated with a publication, and the publication rate was 17%. Average enrollment was 86 participants, and mean trial duration was 51.4 months. Europe/UK/Russia/Turkey participated in the most trials (70%). Most of the trials were initiated after 2010 (87.5%). Procedure-related interventions (55%) were most common. Disability/function was the most common primary outcome assessed (61%). The low publication rate and the multitude of trials conducted after 2010 highlight the urgency and need for trial results to be published to establish an ideal therapeutic protocol. Since the majority of the trials involved a single institution and an open-label approach, reinforcing blinding and establishing multi-centered trials can improve the validity of the clinical trial results.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

Effects of Different Fatty Acids and Levels on the Lipogenesis Capacity and Lipolysis Rate of Broilers In Vitro

  • Lien, T.F.;Wu, C.P.;Chen, K.L.;Yang, K.H.
    • Asian-Australasian Journal of Animal Sciences
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    • v.13 no.9
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    • pp.1285-1289
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    • 2000
  • This study investigated the lipogenesis capacity of hepatocytes and lipolysis rate of adipocytes of broilers as affected by different fatty acids (trial one) and different linoleic acid (C18:2) levels (trial two). Twenty 6-wk old broilers were used; their hepatocytes and adipocytes were isolated for the in vitro study. In trial one, four treatments were tested. The control group in which no fatty acid was added, and the test groups to which were added $300{\mu}M$ of C16:0, C18:1 and C18:2, respectively. For trial two, different levels (0, $300{\mu}M$ and 1 mM) of C18:2 combined to fatty acid-free bovine serum albumin (BSA) were added to the medium. According to results of trial one, added fatty acids significantly reduced the incorporation by hepatocytes of [U,$^{14}C$]glucose into total lipid (p<0.05); the lipogenesis capacity in C18:2 group was the lowest. Although a similar pattern was found with [l,$^{14}C$]acetate, the groups only slightly differed in terms of lipogenesis capacity (p=0.11). In addition, the C18:2 group had a significantly (p<0.05) greater lipolysis rate than the C16:0 and control groups. Results of trial two indicated that C18:2 significantly (p<0.05) reduced lipogenesis capacity both for [U,$^{14}C$]glucose and [l,$^{14}C$]acetate, and markedly stimulated the lipolysis rate (p<0.05), displaying a dose response. Results presented herein demonstrate that C18:2 can reduce lipogenesis capacity and stimulate the lipolysis rate in broilers.

Effect Verification of Wearable Assisting Wear for Increasing Golf Carry Distance (골프 비거리 증가를 위한 기능성 보조 웨어의 효과 검증)

  • Park, Yang-Sun;Woo, Byung-Hoon;Lim, Young-Tae
    • Korean Journal of Applied Biomechanics
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    • v.22 no.4
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    • pp.421-428
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    • 2012
  • The purpose of this study was to verify the effects of developed assisting wear which maximize trunk(back) muscle's stretch-shortening effect during backswing and downswing for increasing golf ball carrying distance. Design and fabrication of assistive wear were performed based on the results of analyzed data of trunk EMG activity from the golf drive swings of elite professional male golfers during back swing and downswing phases. After the prototype of wear was produced, surface EMG and Flight scope tests were conducted to verify the effectiveness of the wear for increasing distance to the professional golfers. Results indicated that wearing trial showed significant longer carry distance than the non-wearing trial(p<.001). The carry distance of wearing trial showed an average 229 m compared to the non-wearing trial, the average 225 m. The swing with wearing also produced significantly faster ball speed than the trial without wearing(p<.05). Average 245 Km/h and 244 Km/h were produced for the swing with and without wearing trails, respectively. EMG results also indicated that the muscle activity of left psoas was significantly increased for wearing trial during downswing and near the impact. Thus, this may affect positively to increase club head speed. The activity of the left latissimus dorsi was dramatically increased during the final stage of swing. This generates elongation effect for longer follow-through and increased impulse between club and ball so eventually valid assistance to increase carry distance. Therefore, the developed assisting wear was proved to be effective tool for increasing golf ball carry distance with maximizing trunk(back) muscle's stretch-shortening effect during backswing and downswing.

A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials (성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구)

  • Jung, Hee;Lee, Ji-Hyung;Jang, Bo-Hyoung;Ko, Seong-Gyu
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.363-376
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    • 2007
  • Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

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Age-related Changes in Multi-finger Synergy during Constant Force Production with and without Additional Mechanical Constraint

  • Park, Yang Sun;Kwon, Hyun Joon;Koh, Kyung;Shim, Jae Kun
    • Korean Journal of Applied Biomechanics
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    • v.26 no.2
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    • pp.175-181
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    • 2016
  • Objective: The aim of this study was to investigate age-related changes of multi-finger synergy during a constant force production task with and without an additional mechanical constraint. Method: Fourteen elderly subjects (age: $78.50{\pm}4.63yrs$, height: $157.29{\pm}8.97cm$, weight: $65.13{\pm}6.93kg$) and 14 young subjects (age: $21.13{\pm}1.35yrs$, height: $171.57{\pm}8.43cm$, weight: $70.29{\pm}16.77kg$) participated in this study. The subjects were asked to place their index and middle fingers on two force transducers fixed on a small non-moving teeterboard and produce 10 N by pressing the sensors while watching force feedback on a computer screen under the no additional constraint condition (NAC). The subjects also performed the same task with an additional mechanical constraint (AC) where the subjects were asked to balance a teeterboard that could be rotated by finger forces. An uncontrolled manifold approach was used to calculate within-trial and between-trial multi-finger synergy indices, variance in uncontrolled subspace ($V_{UCM}$), and variance in subspace orthogonal to UCM subspace ($V_{ORT}$). Two-way repeated measured ANOVA was performed with the within-factor of task condition (with and without an additional constraint) and the between factor of groups (elderly and young). Results: The elderly group showed significantly increased within-trial $V_{ORT}$ in AC compared with NAC (p < .05) while the young group showed no significant difference between AC and NAC. There was no significant group difference for within-trial $V_{UCM}$. Between-trial $V_{ORT}$ remained unchanged between groups and conditions. However, between-trial $V_{UCM}$ for the elderly group significantly decreased in AC as compared to NAC, along with no significant difference for the young group. For multi-finger synergy, there was no significant group difference of within-trial synergy. However, between-trial synergy for the elderly group significantly decreased in AC as compared to NAC (p < .05). Conclusion: Our results indicate that aging decreased consistency (i.e., ability to perform the task on a moment-to-moment basis) with an additional mechanical constraint. In addition, aging was associated with decreased multi-finger synergy on a trial-to-trial basis.

The Effect of Lysine to Protein Ratio on Growth Performance and Efficiency of Nitrogen Utilization in Pigs

  • Li, Defa;Xi, Pengbin;Wang, Junxun;Wang, Jitan;Ren, Jiping;Kang, Yufan;Thacker, P.
    • Asian-Australasian Journal of Animal Sciences
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    • v.14 no.9
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    • pp.1282-1289
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    • 2001
  • One feeding trial and two metabolic trials were conducted to investigate the effects of lysine to protein ratio in practical swine diets on growth performance and efficiency of nitrogen retention and utilization in different growing phases. In Trial one (the feeding trial), 90 mixed sex pigs weighing $9.1{\pm}1.4kg$ (Duroc ${\times}$ Landrance ${\times}$ Beijing Black) were used to study the effects of concentrations of 5.2, 5.3, 5.8, 6.4 and 7.2 g lysine/100 g CP in diets containing 1.2% lysine on growth performance and serum urea nitrogen. The results showed that feed conversion efficiency and economic efficiency were best for pigs fed the diet containing the lysine concentration of 5.8 g /100 g crude protein. Serum urea nitrogen concentration decreased linearly (p=0.0009) and serum free lysine content increased linearly (p=0.0017) as the lysine to protein ratio in diets increased from 5.2 to 7.2 g/100 g. In Trials two and three (the metabolic trials), five growing barrows (Duroc ${\times}$ Landrance ${\times}$ Beijing black), with initial body weights of approximately $26{\pm}2.4kg$ and $56.3{\pm}3.5kg$, respectively, were allotted to five dietary treatments according to a $5{\times}5$ Latin square design. Trial two contained 5.2, 5.7, 6.1, 6.7 and 6.8 g lysine/100 g CP treatments. Trial three contained 4.6, 5.0, 5.6, 6.1 and 6.6 g lysine/100 g CP treatments. The results showed that nitrogen retention in growing pigs decreased linearly (p=0.0011 in Trial two; p=0.0099 in Trial three) as the lysine to protein ratio in diets increased. The ratio of lysine to protein in diets resulting in maximum nitrogen retention was 5.2 g/100 g and 5.0 g/100 g in Trial two and Trial three, respectively. In Trial two, apparent biological value and gross nitrogen efficiency increased linearly (p=0.0135 and p=0.0192, respectively) as the lysine to protein ratio increased from 5.2 to 6.8 g lysine/100 g CP. In summary, we concluded that the optimal Lysine to Protein Ratios for 8-20 kg and 20-80 kg pigs were 5.8 g/100 g and 5.0 to 5.2 g/100 g, respectively.

The sea Trial of Deep-sea Crabster CR6000 System (심해용 크랩스터 CR6000 시스템의 실해역 시험 결과)

  • Jun, Bong-Huan;Yoo, Seong-Yeol;Lee, Pan-Mook;Park, Jin-Yeong;Shim, Hyungwon;Baek, Hyuk
    • IEMEK Journal of Embedded Systems and Applications
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    • v.12 no.5
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    • pp.331-341
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    • 2017
  • This paper presents the sea-trial results of Crabster CR6000 which is a deep-sea walking robot developed by KRISO in 2016. Crabster CR6000 is designed to inspect deep-sea environment rejecting the disturbance on the silent and calm abyssal area. The sea-trial was conducted at the East Sea and the Philippine Sea on December 2016. The Crabster CR6000 undocked successfully from the Shuttle after touchdown on the sea-bed and walked out on the soft sediment soil of the 4,743m seafloor at the fourth diving in the Philippine Sea. The advanced technologies and capabilities of CR6000 were verified from the operational and functional test conducted in the sea-trial. The experimental data acquired from the sea-trial were summarized and the first experience of the deep-sea walking robot was presented in this paper.