• Communications for Statistical Applications and Methods
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• v.15 no.3
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• pp.353-365
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• 2008

The sample size in a clinical trial is determined by the hypothesis, the variance of observations, the effect size, the power and the significance level. Dropouts in clinical trials are inevitable, so we need to consider dropouts on the determination of sample size. It is common that some proportion corresponding to the expected dropout rate would be added to the sample size calculated from a mathematical equation. This paper proposes new equations for calculating sample size dealing with dropouts. Since we observe data longitudinally in most clinical trials, we can use a last observation to impute for missing one in the intention to treat (ITT) trials, and this technique is called last observation carried forward(LOCF). But LOCF might make deviations on the assumed variance and effect size, so that we could not guarantee the power of test with the sample size obtained from the existing equation. This study suggests the formulas for sample size involving information about dropouts and shows the properties of the proposed method in testing equality of means.

• Journal of the Korean Society of Food Science and Nutrition
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• v.39 no.12
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• pp.1800-1806
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• 2010

This study was conducted to evaluate the efficacy and safety of vanadium water (VW) on cancer-related fatigue of non-advanced cancer patients. For the experimental group administration, participants consumed three 500 mL/bottle bottles of Jeju Island's VW, which contained 15~20 ppb of vanadium, three times a day (morning, afternoon, evening) for 4 weeks (28 days) without any additional treatments for fatigue improvement. The control group participants consumed three 500 mL/bottle bottles of ordinary water (0 ppb of vanadium) three times a day for the same period of time without any additional treatments for fatigue improvement. After 4 weeks of VW consumption, total score of Revised Piper Fatigue Scale (RPFS) was reduced 30% compared to the basal score after Fisher's Exact Test which resulted in a statistical borderline significance (p=0.0799) and result of t-test of comparison between two groups' RPFS total score and fatigue cognitive/mood changes resulted in a statistical significance (p=0.0112). In detail, only 36.4% of control group (N=11) showed improvement while 77.8% of treatment group (N=9) showed fatigue improvement. No other lab measures, including thyroid hormone level indicated any significant differences between two groups. In conclusion, daily consumption of 1.5 L of vanadium water for 4 weeks showed improvement of non-advanced cancer patients' fatigue.

• Journal of the Korean Society of Radiology
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• v.16 no.6
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• pp.787-797
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• 2022

The purpose of this study was to confirm the reduction of pain and symptom relief of Parkinson's disease by vertically stimulating the spine through the application of a mechanical bed capable of thermal and massage stimulation. For this purpose, after confirming the segmental motion of the spine due to the use of a medical combination stimulation bed for Parkinson's disease patients, VAS, ODI, gait ability, and spiral drawing tests were performed, and the relationship between the variables was identified. In the 10-day visual analog scale and evaluation of low back pain dysfunction, the average trend of decreasing after bed use was confirmed. For walking ability, a decrease in the moving time and an increase in the moving distance were observed. In the spiral drawing test, the mean test time after using bed was significantly lower than before. As a result, it suggested the possibility of using it as an auxiliary method for recovery and pain relief of Parkinson's disease patients due to spinal segmental movement with mechanical heating and massage. However, this study is a preliminary study, and there is a small number of subjects, so additional research is needed that considers the number and condition of future subjects in detail.

• Communications for Statistical Applications and Methods
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• v.19 no.1
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• pp.47-55
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• 2012

The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

• Science of Emotion and Sensibility
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• v.22 no.2
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• pp.101-108
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• 2019

The aim of this study was to verify differences in autonomic responses that are affected by the configurations of one-room type units using an electrocardiogram (ECG). Accordingly, 43 one-room units that were collected randomly were classified into ten different types of floor plan configurations mainly according to the location of the bathroom and kitchen. An ECG was subsequently measured for each plan type and the average ratio of the LF/HF (Power in low frequency range/Power in high frequency range) was calculated to measure the comfort level of each space. The results revealed a significant statistical difference between the average LF/HF ratio between the plan types (p < 0.05) and provided compelling evidence suggesting that the configuration of the plan may affect the quality of one-room space. This approach appears to be effective in counteracting stress that may exacerbate psychological disorders in single person households.

• Science of Emotion and Sensibility
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• v.2 no.1
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• pp.61-68
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• 1999

본 연구의 목적은 운전 상황과 도로 상황에 따른 자율신경계의 반응을 측정하는 것이다. 지금까지의 생리 신호는 대부분 제한된 실험실에서 측정되었고, 이 결과들은 자연스러운 상황에 측정된 데이터와는 차이가 있을 것이다. 그러므로 보다 동적인 환경에서 인간의 감성을 추출하고자 본 연구를 수행하였다. 건강한 5명의 피험자로부터 심박 변화율, 피부 저항, 피부온도 등의 생리 신호를 측정하였다. 먼저, 정차, 정속 주행, 급출발, 급제동의 운전 상황 변화에 따른 자율신경계의 반응을 측정하였고, 둘째로, 직선 도로와 굴곡이 심한 도로에서 정속 주행을 하면서 생리 신호를 측정하여 도로상황 변화에 따른 자율신경계의 반응을 측정하였다. 정차 및 정속 주행에 비해 급출발, 급제동일 때, 직선도로에 비해 굴곡이 심한 도로에서 주행을 할 때 평균 R-R 간격은 감소하였고, 전력 스펙트럼의 (LF+MF)/HF비는 증가하였고, 피부온도는 감소하였고, 피부저항은 증가하였다. 본 연구로부터, 정차 및 정속 주행에 비해 급출발, 급제동일 때 그리고 직선도로에 비해 굴곡이 심한 도로에서 주행을 할 때 교감신경계의 활성화비가 증가한다는 일치된 경향을 관찰할 수 있었다. 앞으로 피실험자수를 늘려 보다 정확한 통계적 분석을 하고자 한다.

• The Korean Journal of Applied Statistics
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• v.32 no.1
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• pp.1-13
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• 2019

An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

• Science of Emotion and Sensibility
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• v.26 no.3
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• pp.149-160
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• 2023

This study develops a time-varying system-based noncontact fabric sensor that can measure cerebral blood-flow signals to explore the possibility of brain blood-signal detection and emotional evaluation. The textile sensor was implemented as a coil-type sensor by combining 30 silver threads of 40 deniers and then embroidering it with the computer machine. For the cerebral blood-flow measurement experiment, subjects were asked to attach a coil-type sensor to the carotid artery area, wear an electrocardiogram (ECG) electrode and a respiration (RSP) measurement belt. In addition, Doppler ultrasonography was performed using an ultrasonic diagnostic device to measure the speed of blood flow. The subject was asked to wear Meta Quest 2, measure the blood-flow change signal when viewing the manipulated image visual stimulus, and fill out an emotional-evaluation questionnaire. The measurement results show that the textile-sensor-measured signal also changes with a change in the blood-flow rate signal measured using the Doppler ultrasonography. These findings verify that the cerebral blood-flow signal can be measured using a coil-type textile sensor. In addition, the HRV extracted from ECG and PLL signals (textile sensor signals) are calculated and compared for emotional evaluation. The comparison results show that for the change in the ratio because of the activation of the sympathetic and parasympathetic nervous systems due to visual stimulation, the values calculated using the textile sensor and ECG signals tend to be similar. In conclusion, a the proposed time-varying system-based coil-type textile sensor can be used to study changes in the cerebral blood flow and monitor emotions.