• The Korean Society of Law and Medicine
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• v.13 no.2
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• Physical Therapy Rehabilitation Science
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• v.13 no.1
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• pp.26-35
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• 2024

Objective: The aim of this study is to explore how using inspiratory training affects the respiratory function and balance of stroke patients. We also plan to compare the results with a control group that does not receive the intervention. Design: A Randomized Controlled Trial Methods: In this study, 27 chronic stroke patients were randomly assigned to either a control group (n=14) or an experimental group (n=13). Both groups underwent six weeks of common interventions involving standard physiotherapy and treadmill training. Additionally, the experimental group received inspiratory training. Respiratory function and balance were evaluated using Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP), Peak Expiratory Flow (PEF), Five times Sit-to-Stand (FTSTS), Seated Center of Pressure (S-COP), and Timed Up and Go (TUG) tests. Results: Respiratory function and balance were compared within each group before and after intervention. The experimental group, which received inspiratory training, showed significant improvements in FVC (0.26±0.18), FEV1 (0.35±0.32), MIP (11.54±12.39), PEF (1.12±1.52), and TUG (-3.39±2.45) compared to pre-intervention values (p<0.05). When comparing changes between groups post-intervention, the experimental group demonstrated significant increases in FVC, FEV1, MIP, PEF, and TUG compared to the control group (p<0.05). However, there were no significant differences in MEP, FTSTS, and S-COP. Conclusions: The results of this study indicate a positive effect of inspiratory training on chronic stroke patients. These findings suggest that with further research involving a larger sample size and enhanced intervention methods, inspiratory training could be employed positively in the rehabilitation of stroke patients.

• Journal of applied mathematics & informatics
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• v.22 no.1_2
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• pp.317-329
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• 2006

In this paper, a singularly perturbed ordinary differential equation with non-smooth data is considered. The numerical method is generated by means of a Petrov-Galerkin finite element method with the piecewise-exponential test function and the piecewise-linear trial function. At the discontinuous point of the coefficient, a special technique is used. The method is shown to be first-order accurate and singular perturbation parameter uniform convergence. Finally, numerical results are presented, which are in agreement with theoretical results.

• Proceedings of the Korean Institute of Intelligent Systems Conference
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• 1993.06a
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• pp.861-864
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• 1993

This research provides the results of a trial to generate the chaos by using nonlinear function constructed by fuzzy inference rules. The chaos generation function or chaotic behavior can be obtained by using Takagi-Sugeno fuzzy model with some constraint of the relationship of its parameters. Two examples are shown in this research. The first is simple example that construct of logistic image by fuzzy model. The second is more complicated one that provide the chaotic time series by non-linear autoregression based on fuzzy model. Simulated results are shown in these examples.

• Journal of Korean Foot and Ankle Society
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• v.21 no.1
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• pp.33-38
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• 2017

Purpose: The patient-reported outcome measure (PROM) is used to quantify the subjective state of patients before and after the treatment. The electronic method was recently developed and used for the completion of PROM, in addition to the conventional paper and pencil method. This study identified whether the results of Foot Function Index (FFI) and Foot and Ankle Outcome Score (FAOS) using the paper and pencil method was different from those using the electronic method. Materials and Methods: Between May 2016 and August 2016, 42 patients who were admitted to the Seoul Foot and Ankle Center two days before surgery were included for evaluation. The mean age was 46 years (range, 21~72 years). There were 29 males and 13 females. To use the electronic method, the PADAS software (PADAS, Seoul, Korea) was implemented using a touch pad. The primary trial of FFI and FAOS was performed using either the paper-and-pencil method or the electronic method. At 24 hours after the primary test, a secondary trial of FFI and FAOS was performed using the other method. Then, we identified the reliability of FFI and FAOS between the two methods by calculating the intraclass coefficient. Results: Twenty-two patients underwent the first trial using the paper-and-pencil method, and 20 patients underwent the first trial using the electronic method. Of the 42 patients, 8 patients were excluded from this study and only 34 patients were included in this study. The reliability of FFI was excellent with an intraclass coefficient of 0.957, and the reliability of FAOS was also excellent with an intraclass coefficient of 0.840. Conclusion: The paper-and-pencil method and the electronic method have the same result for the completion of FFI and FAOS in this study. Therefore, it is commonly considered that the completion of FFI and FAOS using the electronic method can be applied in practice.

• Journal of Mechanical Science and Technology
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• v.20 no.1
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• pp.94-109
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• 2006

An improved meshfree method called the Petrov-Galerkin natural element (PG-NE) method is introduced in order to secure the numerical integration accuracy. As in the Bubnov-Galerkin natural element (BG-NE) method, we use Laplace interpolation function for the trial basis function and Delaunay triangles to define a regular integration background mesh. But, unlike the BG-NE method, the test basis function is differently chosen, based on the Petrov-Galerkin concept, such that its support coincides exactly with a regular integration region in background mesh. Illustrative numerical experiments verify that the present method successfully prevents the numerical accuracy deterioration stemming from the numerical integration error.

• Journal of Pharmacopuncture
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• v.11 no.2
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• pp.21-31
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• 2008

Objective This study was performed to investigate whether Bee Venom Pharmacopuncture(BVP) could be a more effective modality than Warm Needling(WN) in relieving pain and symptoms of knee osteoarthritis(OA). Design Prospective, randomized and controlled clinical trial. Setting Single center trial in Korea Patients 49 volunteers with knee OA participated in the study. All the participants were screened through an inclusion and exclusion criteria. 33 participants were completed the clinical trial. Intervention The subjects were randomly assigned to one of two groups. One group received BVP(n=18), while the other group received WN(n=15). Sixteen sessions of BVP or WN were given at the pain region of the problematic knee for 8 weeks. Primary outcome measure is the Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index scores(Korean WOMAC, KWOMAC). Secondary outcome measure is the physical health scores based on the 36-Item Short-Form Health Survey(SF-36) and Patient Global Assessment(PGA). KWOMAC and SF-36 were measured third (baseline, 4 and 8 weeks). PGA was measured twice(4 and 8 weeks). Results BVP group showed significant decrease compared to WN group in pain, function and total scores of KWOMAC according to the Mann-Whitney U-test. In the PGA, BVP group, compared to WN group, showed a significant increase. Conclusions BVP was more effective in relieving pain of knee OA than WN. These findings suggest that BVP is a promising alternative for treating knee OA.

• Korean Journal of Acupuncture
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• v.26 no.4
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• pp.53-66
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• 2009

Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.

• Journal of Cardiovascular Imaging
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• v.31 no.3
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• pp.135-141
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• 2023

BACKGROUND: Global longitudinal strain (GLS) is an accurate and reproducible parameter of left ventricular (LV) systolic function which has shown meaningful prognostic value. Fast, user-friendly, and accurate tools are required for its widespread implementation. We aim to compare a novel web-based tool with two established algorithms for strain analysis and test its reproducibility. METHODS: Thirty echocardiographic datasets with focused LV acquisitions were analyzed using three different semi-automated endocardial GLS algorithms by two readers. Analyses were repeated by one reader for the purpose of intra-observer variability. CAAS Qardia (Pie Medical Imaging) was compared with 2DCPA and AutoLV (TomTec). RESULTS: Mean GLS values were -15.0 ± 3.5% from Qardia, -15.3 ± 4.0% from 2DCPA, and -15.2 ± 3.8% from AutoLV. Mean GLS between Qardia and 2DCPA were not statistically different (p = 0.359), with a bias of -0.3%, limits of agreement (LOA) of 3.7%, and an intraclass correlation coefficient (ICC) of 0.88. Mean GLS between Qardia and AutoLV were not statistically different (p = 0.637), with a bias of -0.2%, LOA of 3.4%, and an ICC of 0.89. The coefficient of variation (CV) for intra-observer variability was 4.4% for Qardia, 8.4% 2DCPA, and 7.7% AutoLV. The CV for inter-observer variability was 4.5%, 8.1%, and 8.0%, respectively. CONCLUSIONS: In echocardiographic datasets of good image quality analyzed at an independent core laboratory using a standardized annotation method, a novel web-based tool for GLS analysis showed consistent results when compared with two algorithms of an established platform. Moreover, inter- and intra-observer reproducibility results were excellent.

• Journal of Acupuncture Research
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• v.27 no.4
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• pp.115-125
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• 2010

Objectives : The purpose of this study is to determine the effect of Bee-venom Acupuncture on upper limb spasticity control in stroke patients. Methods : Ten stroke patients with upper limb spasticity were randomly divided into two groups, a Bee-Venom Acupuncture group(group I) and a normal saline group(group II). After 1 week resting phase, this trial was used a cross-over trial. The numbers of Pharmacopuncture treatment were 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), WMFT(Wolf Motor Function Test), The 10-second Test were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p<.05) in MAS, WMFT, The 10-second Test. But Group II showed no significant improvement(p<.05) in MAS, WMFT, The 10-second Test. The results showed significant difference in WMFT, The 10-second Test, but no significant difference in MAS between two groups. Conclusions : These results showed that Bee-venom Acupuncture might decrease upper limb spasticity and increase arm motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on upper limb in spasticity by Bee-Venom Acupuncture.