• Journal of KIISE:Computing Practices and Letters
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• v.15 no.8
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• pp.566-575
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• 2009

Clinical Data Interchange Standards Consortium (CDISC) developed global and platform-independent data standards to improve ineffective processes of clinical trial studies. Regardless of its objective toward global cooperation, the current version of the CDISC standard cannot describe clinical trial data in various languages for multi-national investigators or reviewers. This problem applies not only to tabulated datasets in Study Data Tabulation Model (SDTM) but also to extensible markup language representation of the datasets in Operational Data Model (ODM) instances. In order to address this issue, we propose to extend the current version of SDTM and ODM to collect clinical data for multi-national clinical trials. SDTM needs to have new special-purpose domain for multi-language representation purpose. Additionally, ODM is recommended to extend its XML schema using subtyping or type inheritance mechanism respectively. Our extension of SDTM and ODM enable to represent any granule of study data tabulation model or XML data entities to describe in efficient languages. This result will contribute to collect multi-language data easily for multi-national clinical trials.

• The Journal of Korean Obstetrics and Gynecology
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• v.25 no.1
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• pp.79-92
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• 2012

Purpose: Obesity affects dysfunction of Hypothalamus-Pituitary-Ovary(H-P-O) axis. Dysfunction of H-P-O axis could be related to Skin Resistance Variability (SRV). This study investigated the impacts of obesity which related to female age on SRV. Methods: We randomly selected 400 women who had taken CP-6000A test and InBody test on the same day at Oriental Hospital of Sangji University from Jan. 2008 to Jun. 2011. In this study, the Body Mass Index(BMI) range of normal group is 18.5~24.9, obesity group is over 25, the age range of childbearing age group is 24~34 years, post-menopause group is 50~65 years. 139 women that met the criteria of this study were assorted by their BMI and age. After detection of SRV, SPSS 19.0 has conjugated for data analysis and the independent samples t-test and paired samples t-test were used to verify the results. Results: At 1st and 2nd trial, the height of 3 area of childbearing age obesity group was significantly higher than that of childbearing age normal group. At 1st and 2nd trial, the height of 1, 2 area of childbearing age obesity group was higher than that of childbearing age normal group, but there were no significant difference. At 1st and 2nd trial, the height of 1, 2, 3 area of post-menopause obesity group was mostly higher than that of post-menopause normal group, but there were no significant difference. Conclusions: This study showed the SRV of obesity group was higher than that of normal group in most of 1, 2, 3 area. Further study will be needed.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.1
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• pp.63-73
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• 2019

Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.

• International conference on construction engineering and project management
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• 2011.02a
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• pp.350-356
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• 2011

Early neutral evaluation (ENE) is a fairly recent form of alternative dispute resolution procedure used in the construction industry. In the UK, ENE is usually carried out on an entirely without prejudice basis, however the parties may agree that any or part of it may be referred to at trial or any subsequent hearing. The early neutral evaluation consists of a preliminary assessment of the issues in dispute for use as a basis for negotiations which may result in a settlement of the dispute. An independent person is appointed by the parties who reviews the case and provides an opinion, in written form and in some detail, with reasons on the merits of the matters in dispute. The opinion is non-binding but provides the parties with what in the opinion of the independent person a formal tribunal may decide whether a court or an arbitrator, if the dispute is not resolved. However, ENE has yet to take off in the construction industry in the UK. This paper will explain this procedure and explore the use of it in the UK and internationally, considering the benefits and drawbacks of its use. It will consider whether or not it is more effective than other early resolution forms such as mediation and adjudication. It will argue and conclude that it is a very useful cost effective procedure, particularly in the resolution of complex disputes, whether local or international.

• Journal of Preventive Medicine and Public Health
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• v.37 no.4
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• pp.381-389
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• 2004

Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

• Communications for Statistical Applications and Methods
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• v.5 no.2
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• pp.459-475
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• 1998

In many clinical trials, we are interested in comparing the failure time distribution of different treatment groups. Because of ethical and economic reasons, clinical trials need to be monitored for early dramatic benefits or potential harmful effects. Prior knowledge, evolving knowledge, statistical considerations, medical judgment and ethical principles are all involved in the decision to terminate a trial early, and thus the monitoring is usually carried out by an independent scientific committee. This paper reviews the recently proposed group sequential testing procedures for clinical trials with survival data. Design considerations of such clinical trials are also discussed. This paper compares the characteristics of each of these methods and provides the biostatisticians with the guidelines for choosing the appropriate group sequential methods in a given situation.

• 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).

• Journal of Arbitration Studies
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• v.13 no.2
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• pp.403-424
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• 2004

In the solutions of civil disputes, there are decision of a court and alternative dispute resolution. Arbitration is one of alternative dispute resolutions. The decision of a court is the compulsory settlement and the solution by citizenship between two opposing parties, but arbitration is the autonomous and voluntary settlement by a private person, that is arbitrator. Besides these points, arbitration has various features in comparison with a decision of a court. The procedure of arbitration is not open to the public and single trial system guarantees speedy solution of disputes In the procedure of arbitration, arbitrator who pass judgement is selected and appointed by the parties to an affair. And there are questions how the arbitrator to become independent from them. Because Arbitration is not agreed solution which based on the concession between opposing two parties but imposed solution which is alike decision of a court. This study illustrates the system of challenge on arbitrator to guarantee independence of arbitrators.

• Journal of Korean Public Health Nursing
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• v.35 no.1
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• pp.60-71
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• 2021

Purpose: This study examined the socio-demographic and health factors affecting the quit-smoking plan in smoking seniors. Methods: Data were obtained from the Seventh Korean National Health and Nutrition Examination Survey (VII-1, VII-2, VII-3). The sample consisted of 369 smoking seniors. The complex sample was analyzed thought an independent t-test, Chi-square test, and multiple logistic regression. Results: The influential factors on the quit-smoking plan were daily smoking (OR=0.30, CI=0.11-0.78), age of start smoking (OR=1.06, CI=1.01-1.11), daily smoking amount (OR=0.95, CI=0.90-1.00), quit-smoking trial (OR=2.63, CI=1.32-5.23), and cognitive stress (OR=2.13, CI=1.01-4.54). Conclusion: This study revealed the variables that should be considered when setting up a smoking cessation plan for smoking seniors. Based on this, an elderly cessation intervention program can be developed.

• The korean journal of orthodontics
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• v.47 no.1
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• pp.11-20
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• 2017

Objective: This randomized controlled trial aimed to compare the stability of mandibular arch orthodontic treatment outcomes between passive self-ligating and conventional systems during 6 months of retention. Methods: Forty-seven orthodontic patients with mild to moderate crowding malocclusions not requiring extraction were recruited based on inclusion criteria. Patients (mean age $21.58{\pm}2.94years$) were randomized into two groups to receive either passive self-ligating ($Damon^{(R)}$ 3MX, n = 23) or conventional system (Gemini MBT, n = 24) orthodontic treatment. Direct measurements of the final sample comprising 20 study models per group were performed using a digital caliper at the debonding stage, and 1 month, 3 months, and 6 months after debonding. Paired t-test, independent t-test, and non-parametric test were used for statistical analysis. Results: A significant increase (p < 0.01) in incisor irregularity was observed in both self-ligating and conventional system groups. A significant reduction (p < 0.01) in second interpremolar width was observed in both groups. Mandibular arch length decreased significantly (p = 0.001) in the conventional system group but not in the self-ligating system group. A similar pattern of stability was observed for intercanine width, first interpremolar width, intermolar width, and arch depth throughout the 6-month retention period after debonding. Comparison of incisor irregularity and arch dimension changes between self-ligating system and conventional system groups during the 6 months were non-significant. Conclusions: The stability of treatment outcomes for mild to moderate crowding malocclusions was similar between the self-ligating system and conventional system during the first 6 months of retention.