• Journal of Society of Preventive Korean Medicine
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• v.16 no.2
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• pp.17-30
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• 2012

Objectives : This study was to analyse the reasons for the early termination of our clinical trials that were to know the influences of Tai-chi on non-motor symptoms of Parkinson's disease. Methods : We stopped the primary study of Tai-chi to observe the changes of non-motor symptoms of Parkinson's disease. So we carried out the survey to our participants of clinical trials. We conducted the survey about the patient's characteristics of usual exercise, experience of Tai-chi, appropriate time allocation, difficulties of proceeding the program and patient's opinion for the improvement of education. And the 4 questions about the contributiveness of Tai-chi for the Parkinson's disease, usability of supplied references, difficulties and time allocation of education were using the questionaries form of 5-point scale(Likert scale). Results : The results of survey showed that the benefits of Tai-chi program for the improvement of symptoms was $3.15{\pm}0.89$ and difficulty of lecture was $3.76{\pm}1.09$. 41% of participants answered that the motions of the Tai-chi is difficult to follow and 17% of participants felt the imbalance during the motion of Tai-chi. Conclusions : Participants replied that the Tai-chi is hard for the patients of Parkinson's disease and the time for the education was too short to keep doing exercise. Thus we have plan to educate the patients of Parkinson's disease with Tai-chi program consists of easier motion by developing ourselves or searching previous studies.

• Journal of Acupuncture Research
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• v.23 no.2
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• pp.159-164
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• 2006

Objectives : This study was conducted for objective verification of effects of spiral taping therapy for the patients with motor disturbance. Methods : To verify whether spiral taping therapy is effective for treating motor disturbance from cervical sprain, 28 patients were randomly allocated into the control and experiment groups. Then 23 subjects who fulfilled the experiment requirements were measured for lateral rotation angle using the goniometer. Changes in rotation were observed and compared. Control group received acupuncture and herbal acupuncture treatment, whileas the experiment group received spiral taping therapy in addition. Results : Differences in age and the degree of motor disturbance were disregarded in comparison of the groups prior to rendering treatments. For the control group, significant changes were observed after the second treatment until the termination of treatment. For the experiment group, significant changes were observed after the first treatment until the termination of treatment. Difference between the groups was insignificant but experiment group with spiral taping therapy showed better results. Conclusion : Spiral taping therapy can be an effective complementary treatment method for treating neck motor disturbance. Further studies in the subject should be conducted to yield more concrete verification.

• Journal of the Korean Statistical Society
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• v.29 no.4
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• pp.435-441
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• 2000

Ko(1998, 1999) proposed certain flexible two-stage plans that could be served as one-step interim analysis in on-going clinical trials. The proposed Plans are optimal simultaneously in both a Bayes and a Neyman-Pearson sense. The Neyman-Pearson interpretation is that average expected sample size is being minimized, subject just to the two overall error rates $\alpha$ and $\beta$, respectively of first and second kind. The Bayes interpretation is that Bayes risk, involving both sampling cost and wrong decision losses, is being minimized. An example of this correspondence are given by using a binomial setting.

• Communications for Statistical Applications and Methods
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• v.18 no.5
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• pp.581-594
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• 2011

The traditional method of 3+3 standard design and model-based Bayesian continual reassessment method (CRM) are commonly used in Phase I clinical trials to identify the maximal tolerated dose(MTD) of a new drug. In this paper we review clinical examples of Phase I trials that were carried out in patients with refractory or relapsed leukemia and myelodysplastic syndrome. The recently proposed 3+1+1 design and rolling-6 design can shorten the trial duration, when a very slow accrual of patients with a simple 3+3 standard design may result in the untimely termination of trials. Too conservative approaches in determining the dose levels in Phase I clinical trials can leave clinical investigators unable to accurately determine the MTD. When determining future patient doses, the designs that use a time-to-event CRM can cooperate late toxicities by accounting for the proportion of the observation period of each enrolled patient. With the CRM design, simulations under different scenarios during the trial are important in detecting the under- or over-estimation of the initial estimate of the dose-limiting toxicity rate for each dose level. We present the advantages and drawbacks of the designs used in Phase I clinical trials for leukemia patients.

• The Korean Journal of Applied Statistics
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• v.17 no.2
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• pp.253-267
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• 2004

In some clinical trials, one may see that a significant fraction of patients are cured and their original disease does not recur even after termination of treatment and pro-longed follow-up. This situation occurs frequently in pediatric cancer trials where there are excellent therapeutic results. In such cases, interest concentrated on the difference of cure rates rather than other types of differences in failure distributions. Various authors have investigated the parametric and nonparametric methods for testing the difference of cure rates. In this study, we compare by simulation the power and size of a parametric test and five nonparametric tests in a various range of the alternatives, censoring rates and cure rates. Our objectives are to determine if any test was preferable on the basis of size and power in various situation, and to investigate the effect of the model misspecification.

• Communications for Statistical Applications and Methods
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• v.23 no.1
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• pp.57-70
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• 2016

Type-II progressive censoring is one of the censoring methods frequently used in clinical studies, reliability trials, quality control of products and industrial experiments. Sometimes in Type-II progressive censoring experiments, the failure rate is low so the waiting time to observe the $m^{th}$ failure will be very long; however, the experimenter may have to terminate the experiment before a predetermined time. In this article, if two generalized types of Type-II progressive censoring are reminded, we then make some changes in the removal method of Type-II progressive censoring such that without reducing the deduction quality, the termination time of the experiment decreases. This can be done with decreasing withdraws throughout the steps of the experiment with a special reasonable method. A simulation study is done and the results are tabulated at the end of this article for a comparison between introduced method and Type-II progressive censoring.

• Journal of Pharmacopuncture
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• v.7 no.1 s.12
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• pp.15-26
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• 2004

Background : This study was conducted to evaluate the effects of wild ginseng herbal acupuncture developed for the intravenous use. Healthy male and female volunteers(n=57) went through Randomized Control Trials(RCT). Methods : For those who are under a medication due to common cold or other illnesses were excluded in the primary stage and the subjects with possible abnormalities in the pre-screening process were also excluded in the secondary stage. Then the examination groups were determined by random sampling. Experiment groups were divided into Normal saline injection group(control group), cultivated wild ginseng herbal acupuncture group(experiment group 1) and natural wild ginseng herbal acupuncture group(experiment group 2) Blood tension, body temperature, pulse, and other criteria were measured and analyzed. Results : 1. Intravenous injection of cultivated wild ginseng herbal acupuncture and natural wild ginseng herbal acupuncture didn't cause significant changes in the blood tension, pulse, body temperature, and etc. 2. No significant differences were witnessed in CBC, ESR, biochemistry of blood test and UA between the experiment groups. 3. No significant changes were noted in the thermography before and after the test in the experiment groups. 4. Some of the common physical changes occurring during and after the administration were fatigue, chest distension, and headache in all of the experiment groups. 5. Comparing general condition after one week from the termination of administration, the control group showed worst condition while as the natural wild ginseng herbal acupuncture group displayed best condition. Conclusion : From the above results, we can carefully deduce that the intravenous injection of the wild ginseng herbal acupuncture didn't show significant differences compared to injection of the normal saline. We can infer it is safe on the human body and further studies and reports must be followed.

• Biomolecules & Therapeutics
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• v.26 no.6
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• pp.599-607
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• 2018

Fasiglifam (TAK-875) a G-protein coupled receptor 40 (GPR40) agonist, significantly improves hyperglycemia without hypoglycemia and weight gain, the major side effects of conventional anti-diabetics. Unfortunately, during multi-center Phase 3 clinical trials, unexpected liver toxicity resulted in premature termination of its development. Here, we investigated whether TAK-875 directly inflicts toxicity on hepatocytes and explored its underlying mechanism of toxicity. TAK-875 decreased viability of 2D and 3D cultures of HepG2, a human hepatocarcinoma cell line, in concentration-(>$50{\mu}M$) and time-dependent manners, both of which corresponded with ROS generation. An antioxidant, N-acetylcysteine, attenuated TAK-875-mediated hepatotoxicity, which confirmed the role of ROS generation. Of note, knockdown of GPR40 using siRNA abolished the hepatotoxicity of TAK-875 and attenuated ROS generation. In contrast, TAK-875 induced no cytotoxicity in fibroblasts up to $500{\mu}M$. Supporting the hepatotoxic potential of TAK-875, exposure to TAK-875 resulted in increased mortality of zebrafish larvae at$25{\mu}M$. Histopathological examination of zebrafish exposed to TAK-875 revealed severe hepatotoxicity as manifested by degenerated hypertrophic hepatocytes with cytoplasmic vacuolation and acentric nuclei, confirming that TAK-875 may induce direct hepatotoxicity and that ROS generation may be involved in a GPR40-dependent manner.