• The Journal of Korean Obstetrics and Gynecology
• /
• v.21 no.3
• /
• pp.75-89
• /
• 2008

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• Korean Institute of Interior Design Journal
• /
• no.30
• /
• pp.28-34
• /
• 2002

We need to think that space is not static but dynamic because it becomes wide and narrow, newly appears and disappears by human's behavior. Generally such movement in a space is a thing of feeling and dynamic about movement. But it is extending the experience of the subject by scientific technique's development and anticipation about the feature. The practical movement is actively introduced into architecture and interior design scope and occurs a trial about this movement. By using four elements -a form, hue, movement, light- kineticism becomes visual arts united with art and science. It recovers the art's sociality and arises participation of spectators. In the environment and art field kineticism is not simple ostentation but a current trial for human's mind and sensitivility. Kineticism is four-dimensional space considered by human's experience and is related to an observer, or experiential subject of space. Now the space except human's mind feature re-illuminates kineticism, that is, the field of the formative arts in the early part of the 20th century and gets to be 'the consensus space'.

• Korean Journal of Biological Psychiatry
• /
• v.19 no.4
• /
• pp.153-158
• /
• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• Korean Journal of Applied Biomechanics
• /
• v.32 no.1
• /
• pp.24-30
• /
• 2022

Objective: The purpose of this study was to determine the factors of successful and unsuccessful movements through the analysis of kinematics and muscle activity of the Free Aerial Cartwheel on the balance beam. Method: Subjects (Age: 22.8 ± 2.4 yrs., Height: 158.7 ± 5.0 cm, Body mass: 54.1 ± 6.4 kg, Career: 13 ± 2.4 yrs.) who were currently active as female gymnasts participated in the study. They had no history of surgical treatment within 3 months. Subject criteria included more than 10 years of professional experience in college and professional level of gymnastics and the ability to conduct the Free Aerial Cartwheel on the Balance Beam. Each subject performed 10 times of Free Aerial Cartwheel on the balance beam. One successful trial and one unsuccessful trial (failure) among 10 trials were selected for the comparison. Results: It was found that longer time required in case of unsuccessful trial when performing the Free Aerial Cartwheel on the balance beam compared with successful trial. It is expected to be the result of movement in the last landing section (i.e. phase 5). In addition, it was found that the center of gravity of the body descends at a high speed to perform the jump (i.e. phase 2) in order to obtain a sufficient jumping height when the movement is successful while the knee joint is rapidly extended to perform a jump when movement fails. In the single landing section after the jump (i.e. phase 4), if the ankle joint rapidly dorsiflexed after take-off and the hip joint rapidly flexed, so landing was not successful. Conversely, in a successful landing movement, muscle activity of the biceps femoris was greatly activated resulting no shaking in the last landing section (i.e. phase 5). Conclusion: In order to succeed in this movement, it is necessary to perform a strong jump after rapidly descending the center of gravity of the body using the force of the biceps femoris muscle. Further improvement of the skills on the balance beam requires the analysis of the game-like situation with continuous research on kinematic and kinematic analysis of various techniques, jumps, turns, etc.

• Korean Journal of Clinical Pharmacy
• /
• v.32 no.3
• /
• pp.166-177
• /
• 2022

Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.

• Journal of East-West Nursing Research
• /
• v.17 no.1
• /
• pp.9-15
• /
• 2011

Purpose: The purpose of this study was to investigate recognition and knowledge regarding clinical trials, in particular, after a clinical trial education program (CTEP) among student nurses. Methods: A cross-sectional survey design of 215 student nurses at a university in Seoul was used with structured questionnaires. Results: Respondents had a high level of need for clinical trial and moderate levels in favorable image, safety, and need for education regarding clinical trial. The respondents who had participated in the CTEP felt the clinical trial more favorable and safer than those who did not. However, there were no significant differences in necessity of clinical trials and need for education regarding clinical trial between the CTEP participation and no participation groups. Respondents had a high level of knowledge about clinical trial, even though half of the respondents misunderstood that the physician can convince the subject to participate in clinical trial. There was no significant difference in knowledge level between groups. One third of the respondents had an intention to work in the area related to clinical trial because of aptitude or future prospect. Conclusion: The results of this study demonstrated that the CTEP might have an effect on student nurses' recognition rather than knowledge. The CTEP should be therefore developed targeting specific areas of misconceptions and recognition changes.

• Korean Journal of Clinical Pharmacy
• /
• v.26 no.2
• /
• pp.181-186
• /
• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• Journal of Korean Library and Information Science Society
• /
• v.45 no.3
• /
• pp.63-92
• /
• 2014

This study developed the subject guide by policy areas for advancement of policy information service, designed the system for constructing the policy-related resources, and tried to construct policy information resources on a trial basis. For the development and construction of policy areas subject guide, first, we divided the aggregated materials into top 9 types, and subdivided into 19 types. Second, we constructed the policy contents for subject guide service, based on BRM classification system which is functional classification of government. Third, a total of 6,305 were build in accordance with 133 BRM subject guide. As a result, it is said that the effectiveness of the policy subject guide developed by this study, were verified by constructing the experimental data.

• The Journal of Advanced Prosthodontics
• /
• v.5 no.2
• /
• pp.204-208
• /
• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

• Journal of Acupuncture Research
• /
• v.24 no.1
• /
• pp.127-135
• /
• 2007

Objectives: To evaluate the methodological quality of Korean Acupuncture Clinical trials Methods : Two independent researchers reviewed 12 protocols of Acupuncture clinical trials which were conducted in Korea 2006. Also, Survey Principal Investigator of those was conducted. We compare the results of protocol review with investigator reponses of actual practice. Quality assessment consisted of 5 items including random sequence generation, randomization method, allocation concealment, subject blinding, assessor blinding. Results : Randomization was performed using the proper procedure to insure that treatment assignment is unbiased and concealed from subjects in all clinical trials, According to protocols, 6(50%) of 12 clinical trials used computer-generated random numbers, 6(50%) remaining trials didn't describe the randomization method. Also all trials used appropriate randomization methods on the basis of the survey results: 8 trials used computer-generated random number, 2 used random table. Of 7 protocols in which allocation concealment was stated, 5(71%) reported appropriate method (Calling a central office or statisticians, Sealed opaque envelopes). However according to survey, 5(42%) of 12 trials used inappropriate allocation concealment (Keeping a master randomization list and referring to when subject entered the trial). In addition, the result of protocol review and survey response was not coincident in 5(42%) trials. Subject blinding was conducted in all except 1 clinical trials. Although 11(92%) of 12 trials were conducted using assessor blinding in actual practice, only 7(58%) reported that in protocol. Conclusion : Although randomization and blinding were conducted adequately, allocation concealment was used inadequately, Not only appropriate allocation concealment, but also every quality assessment item including randomization, blinding should be stated in more detail in protocol.