• Title/Summary/Keyword: Trial function

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Effect of Aspartate and Asparagine on Metabolism and Central Nervous System Effect of Alcohol in Healthy Male Volunteers (Aspartate 및 Asparagine 투여가 알코올 대사 및 중추신경계 효과에 미치는 영향)

  • Yim, Dong-Seok;Lee, Kyung-Hun;Jang, In-Jin;Shin, Sang-Goo;Lee, Yoon-Sung;Park, Sang-Chul
    • The Korean Journal of Pharmacology
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    • v.31 no.2
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    • pp.261-269
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    • 1995
  • Background; To explore the efficacy of aspartate as NAD regenerating agent for ethanol and acetaldehyde oxidation, we performed crossover challenge in two groups of volunteers by coadministration of various doses of aspartate, asparagine and ethanol. Methods; 18 healthy male volunteers were randomly divided into two groups. 6 volunteers of the first group were administered 5 gm monosodium aspartate(MSA), 5 gm asparagine or placebo with 100 ml of $40^{\circ}$ whiskey by the 3 way-crossover design, while 12 volunteers of the other group were administered placebo, 1, 2 or 5 bottles of $Aspar^(circledR)$ containing 1 gm of MSA per bottle with 100 ml of $40^{\circ}$ whiskey by the 4 way-crossover design. Ethanol(and acetaldehyde) concentrations in venous blood drawn at 0, 0.25, 0.5, 1, 2, 4, 8th hour after ethanol ingestion were analysed by gas chromatogaphy. Subjective symptoms, liver function tests and psychomotor function tests were also performed during the study periods. Result; Plasma concentration and AUC of acetaldehyde in asparagine and MSA trials on ethanol ingestion were significantly lower than those of placebo trial in the 1st group. Plasma ethanol concentration of 5 bottle $Aspar^(circledR)$ trial was significantly lower than that of placebo trial in the 2nd group. Improvement of subjective symptoms or psychomotor performance by the treatment was not statistically significant. Conclusion; Aspartate and asparagine may be prospective candidates for acceleration of ethanol metabolism and prevention of ethanol toxicity.

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The Effect of Glasthma Syrup in Asthma: a study protocol for a triple-blind randomized controlled trial

  • Derakhshan, Ali Reza;Saeidinejat, Shahin;Khadem-Rezaiyan, Majid;Asnaashari, Amir-Mohammad-Hashem;Mirsadraee, Majid;Salari, Roshanak;Jabbari-Azad, Farahzad;Jalali, Shima;Jalali, Shabnam
    • Journal of Pharmacopuncture
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    • v.25 no.3
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    • pp.233-241
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    • 2022
  • Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

A Clinical Study of Ventilator Weaning Following Open Heart Surgery (개심술후의 Ventilator Weaning 에 관한 임상적 고찰)

  • Kim, Kyou-Tae;Han, Sung-Sae;Lee, Chong-Tae
    • Journal of Chest Surgery
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    • v.14 no.3
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    • pp.187-194
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    • 1981
  • Cardiac surgery is generally followed by a period of routine ventilator support. When the patient seems hemodynamically stable and relatively alert following surgery, respiratory adequacy is tested by the weaning trial. In this study, physiological and clinical prediction of postoperative respiratory adequacy, including values of pulmonary function tests, were examined in an attempt to identity those few variables which predicted the outcome of the ventilator weaning trial following surgery. Our series comprised 27 patients who underwent elective open intracardiac operations at the Department of Thoracic and Cardiovascular Surgery, School of Medicine, Kyungpook National University, from October 1979 to July, 1980. The pulmonary function tests performed on all patients included the following; forced vital capacity [FVC], forced expiratory volume [FEV1.0], forced expiratory flow [FEF 25--75~], residual volume [RV], and functional residual capacity [FRC], measured with a helium dilution technique. Of our 27 patients, 8 were successfully weaned within 20 hours of operation. All patients with cyanotic heart diseases or acquired heart diseases were unsuccessfully weaned. The bypass time in the successful weaning group was shorter in the mean value [82.8 minutes]than in the unsuccessful weaning group [120.5 minutes]. There was a relatively significant difference in the mean values for the two groups in arterial pressure, bleeding amounts and FiO2 among the postoperative monitoring variables, and in forced vital capacity [FVC]. The postoperative clinical assessments appeared vague but corresponded reasonably well to appraisal of success in weaning, especially in variables of cough and self-respiration efforts.

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Study on the current collection & vibration characteristics of the KHST's pantograph through trial running test up to 350km/h (한국형 고속열차의 350km/h 본선 주행시험을 통해 본 고속열차용 팬터그래프의 이선 특성과 동적 특성 고찰)

  • Mok, Jin-Yong;Park, Chan-Kyoung;Park, Choon-Soo;Kim, Ki-Hwan
    • Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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    • 2005.05a
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    • pp.459-462
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    • 2005
  • The KHST(Korean High Speed Train) which had been developed by through 'G7-R&D project' has succeeded trial running test up to 350km/h on the Kyoung-Bu High Speed Track in December 16th, 2004. In order to evaluate the function and characteristics of KHST, various experimental conditions have been considered and conducted. In this paper, measured current collection characteristics and dynamic behaviors of KHST's pantograph are analysed over 300 to 350km/h in running speed of KHST. A measuring system developed and installed on the KHST for measuring the performance and mechanical characteristics of the KHST's pantograph was used for this trial running test and eventually, we proofed that KHST has a remarkable and stable current collection characteristics as it had been designed.

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A single blind randomised placebo controlled clinical trial of a classical Ayurvedic formulation Ashokarista in the treatment of menorrhagia and dysmenorrhoea

  • Akhtar, Yasmeen;Alamgir, Mahiuddin;Khan, Mahmud Tareq Hassan;Hannan, JMA.;Choudhuri, M Shahabuddin Kabir
    • Advances in Traditional Medicine
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    • v.7 no.4
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    • pp.372-378
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    • 2007
  • A well known Ayurvedic formulation Ashokarista, used for menstrual disorders has been studied in a single blind randomised placebo controlled clinical trial for the treatment of menorrhagia and dysmenorrhoea. Dysmenorrhoea and menorrhagia patients who were taking Ashokarista (20 ml twice daily) for 10 menstrual cycles had an increase in haemoglobin level. Menorrhagia treated group has shown to reduce the erythrocyte sedimentation rate level that has been increased in the menorrhagia control group. The platelet count, total count and differential count were observed unchanged in the study. The Ashokarista did not affect the SGPT and SGOT level, which signify its lack of toxicity in hepatic function. The treated menorrhagic patients showed an increase in serum albumin content and decrease in blood clotting time, whereas the serum protein content was observed unchanged. There was a significant increase in both serum cholesterol and triglyceride level, which usually associated with the use of oral contraceptives. No major side effects were observed by the clinicians during the study.

Bootstrap Confidence Intervals for an Adjusted Survivor Function under the Dependent Censoring Model

  • Lee, Seung-Yeoun;Sok, Yong-U
    • Communications for Statistical Applications and Methods
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    • v.8 no.1
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    • pp.127-135
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    • 2001
  • In this paper, we consider a simple method for testing the assumption of independent censoring on the basis of a Cox proportional hazards regression model with a time-dependent covariate. This method involves a two-stage sampling in which a random subset of censored observations is selected and followed-up until their true survival times are observed. Lee and Wolfe(1998) proposed an adjusted estimate of the survivor function for the dependent censoring under a proportional hazards alternative. This paper extends their result to obtain a bootstrap confidence interval for the adjusted survivor function under the dependent censoring. The proposed procedure is illustrated with an example of a clinical trial for lung cancer analysed in Lee and Wolfe(1998).

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The Effect of Transcranial Direct-Current Stimulation on Cognitive Function and Depression in Stroke Patient's through a Computerized Cognitive Rehabilitation Program (경두개 직류전류자극과 전산화 인지재활 프로그램이 뇌졸중 환자의 인지기능 및 우울감에 미치는 영향)

  • An, Taegyu;Kwon, Hyukchul
    • Journal of The Korean Society of Integrative Medicine
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    • v.7 no.3
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    • pp.33-40
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    • 2019
  • Purpose : The purpose of this randomized controlled trial study was to examine the effect of transcranial direct current stimulation (tDCS) on cognitive function and depression in stroke patients. Methods : Thirty stroke patients were randomly divided into an experimental group (n = 15) and a control group (n = 15). The experimental group received tDCS while performing computerized cognitive rehabilitation programs, and the control group was provided with sham tDCS while operating the same programs. The 30-minute intervention was implemented five times per week for six weeks. To assess cognitive function before and after the intervention, the Neurobehavioral Cognitive Status Examination was conducted; the Beck Depression Inventory BDI was employed to assess depression. Results : The experimental group showed statistically significant increases in cognitive function and decreases in depression (p < .05 ). Comparing the amount of variation between the groups after arbitration also showed significant differences in cognitive function and depression between the two groups (p > .05). Conclusion : The application of tDCS and computerized cognitive rehabilitation programs for stroke patients may positively affect their cognitive function and depression. Therefore, tDCS used with computerized cognitive rehabilitation programs is positively applicable to the enhancement of cognitive function in stroke patients and reduction of depression.

A Study on the Effect which the Method of Deep Breathing with the Use of Incentive Spirometer has on the function of pulmonary Ventilation - In Upper Abdominal Operation Patients - (Incentive Spirometer를 사용한 심호흡 방법이 폐환기 기능에 미치는 효과에 관한 연구 -상복부 수술 환자를 대상으로-)

  • 김종혜;변영순
    • Journal of Korean Academy of Nursing
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    • v.21 no.3
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    • pp.268-280
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    • 1991
  • The nursing intervention for the prevention of the pulmonary complication and of the function lowering of pulmonary ventilation which emerge with high generation frequency during the nursing of operation patient is necessary for performing the qualitative nursing for operation patient. So, this researcher tried this study so as to obtain the data which can be utilized for the trial of nursing intervention, by grasping the effect that the deep breathing with Incentive Spirometer has on the function of pulmonary ventilation, analysing the factor to have influence on the function of pulmonary ventilation, and applying the effective method of deep breathing to the clinic. By making 42 patients who underwent the operation of upper abdomen after admitting G Hospital in Seoul from Mar. 7, 1991 to Apr.30, 1991 as the object, they were classified into the experiment group that the deep breathing was made with the use of Incentive Spiromenter and the comparison group that the deep breathing exercise was made without the use of Incentive Spirometer. And then, by measuring Tidal Volume and Forced Vital Capacity with Respirometer and $O_2$ Saturation with Pulse Oximeter at preoperation postoperation 24 hours, 72 hours, and 120 hours data were collected. The collected data were analyzed with of, average, standard deviation, x$^2$-test, t-test and ANOVA by SPSS. The result of this study is as follows : 1. As for the hypothesis that the function of pulmonary ventilation at postoperation 24 hours, 72 hours and 120 hours will be better in the experiment group that the deep breathing was made with the use of Incentive Spirometer, in comparison with the comparison group that deep breathing was made without the use of Incentive Spirometer, experiment group and comparison group didn't show the significant difference in Tidal Volume, Foreced Vital Capacity and $O_2$ Saturation at postoperation 24 hours and 72 hours. But experiment group and comparison group showed the significant difference in Tidal Volume at postoperation 120 hours (p<0.01). So, this hypothesis was supported partially. 2. The variables that there were the significant differences about the function of pulmonary ventilation in experiment group at postoperation 24 hours stastically were smoking existence (p<0.05), and the variables that there were not significant differences about the function of pulmonary ventilation were distinction of sex, age, anesthetic duration, smoking extent, body weight, surface area of body, existence of narcotic use, regular exercise existence, and past experience existence of respiratory disease. As above result, it appeared that the method of deep breathing with the use of the Incentive Spirometer is more effective for the function recovery of pulmonary ventilation, in comparison with the deep breathing without use of Incentive Spirometer and that smoking existence was the factor to have influence on the function of pulmonary ventilation. In the aspect of clinic, the trial of nursing intervention of deep breathing with use of Incentive Spirometer is expected. And, in the aspect of study, the study through various operative site patients about the effect of Incentive Spirometer use at the clinic will have to be confirmed.

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A Systematic Review and Meta-Analysis of the Effects of Simultaneous Dual-Task Training on Executive Function in Older Adults (동시적 이중과제 훈련이 노인의 실행기능에 미치는 효과: 체계적 고찰 및 메타분석)

  • Jeun, Yu-Jin;Park, Jin-Hyuck
    • Therapeutic Science for Rehabilitation
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    • v.10 no.3
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    • pp.23-41
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    • 2021
  • Objective : The purpose of this study was to analyze the effects of simultaneous dual-task training to assess executive function in older adults. Methods : We searched the PubMed, EMBASE, Cochrane, Web of Science, and RISS databases of publicated studies in the past decade. Seven studies were selected based on the inclusion and exclusion criteria. Qualitative assessment and meta-analysis were performed for the seven studies. Results : A randomized controlled trial design was used in the selected studies, and PEDro Scores above seven were obtained. The Trial Making Test (TMT) evaluated the effects of dual-task training on executive function in four studies. The Color Trail Test (CTT) was used in two studies, and Stroop test was used in three studies. The effect size for total executive function was 0.38, which was small. The effect sizes for TMT and CTT were 0.37. Stroop Test was 0.34, demonstrating that their effect sizes were also small. Only significant effects in total executive function, TMT, and CTT showed significant effects (all p<0.05). Conclusion : This study confirmed that dual-task training was effective in improving executive function in older adults. To improve the effectiveness of dual-task training, the difficulty of the dual-task training should be considered. It is also necessary to implement assessments that can evaluate performance under dual-task conditions as well as conventional test tools for executive function. In the future, dual-task training could be used as an appropriate intervention for executive function in older adults to delay the onset of dementia.

Group sequential testing methods for comparing cure rates (임상시험에서 치료율 비교를 위한 집단축차검정법에 관한 고찰)

  • 박경미;이재원
    • The Korean Journal of Applied Statistics
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    • v.9 no.2
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    • pp.95-108
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    • 1996
  • There are many clinical trials where a large portion of the patients are cured of disease. In such a case, one might be more interested in testing the differences in cure rates rather than other types of differences in failure distribution. For ethical and economic reasons, clinical trials must be repeatedly monitored for evidence of treatment benefit or harm. In this article, we examined by simulation the properties of nonparametric group sequential methods for comparing the cure rates between two treatment groups during the trial in a wide range of alternatives, censoring rates and cure rates.

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