• Title/Summary/Keyword: Trial subject

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ANALYSIS OF M/M/c RETRIAL QUEUE WITH THRESHOLDS, PH DISTRIBUTION OF RETRIAL TIMES AND UNRELIABLE SERVERS

  • CHAKRAVARTHY, SRINIVAS R.;OZKAR, SERIFE;SHRUTI, SHRUTI
    • Journal of applied mathematics & informatics
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    • v.39 no.1_2
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    • pp.173-196
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    • 2021
  • This paper treats a retrial queue with phase type retrial times and a threshold type-policy, where each server is subject to breakdowns and repairs. Upon a server failure, the customer whose service gets interrupted will be handed over to another available server, if any; otherwise, the customer may opt to join the retrial orbit or depart from the system according to a Bernoulli trial. We analyze such a multi-server retrial queue using the recently introduced threshold-based retrial times for orbiting customers. Applying the matrix-analytic method, we carry out the steady-state analysis and report a few illustrative numerical examples.

The effect of listening to music on cardiovascular and autonomic reactivity to sympathoexcitation in young adults (음악 청취가 교감신경 활성화에 대한 심혈관 및 자율신경 반응 완화에 미치는 영향)

  • Jeong In Kwon;Hyun Jeong Kim;Min Jeong Cho;Yoo Sung Oh;Sae Young Jae
    • Journal of the Korean Applied Science and Technology
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    • v.40 no.4
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    • pp.674-684
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    • 2023
  • The purpose of this study was to investigate the effect of acute listening to music on the cardiovascular reactivity to sympathoexcitation. In this crossover design study, 15 healthy adults(23.1±1.94(yrs) were randomized to either (1)acute listen to the subject's preferred music for 30 minutes and (2)sat as a time control by an experiment coordinator. After completing each trial, the cold pressor test(CPT) was conducted. Heart rate(HR) and blood pressure(BP) were measured for 4 times at baseline, during and after the CPT. Heart rate variability(HRV) were measured for 3 times at baseline, prior and after the CPT. HR and BP increased during the CPT in both trial and returned to baseline after CPT(time effect, p < .001). After CPT, brachial systolic BP reactivity to the CPT was attenuated in listening to music trial compared to control trial(p = . 008). As a result of heart rate variability(HRV), the difference values between the baseline and prior to the CPT showed a significant increase in standard deviation of the NN intervals(SDNN), total power(TP) and high frequency(HF) only in the music trial (p = .001, p = .002, p = .011). The difference value between prior to and after the CPT did not show significance. But compared with the control trial, the music trial was confirmed that SDNN, TP and HF were more activated. Therefore, listening to music alleviated anxiety and tension before the CPT, and it is estimated that it had a favorable effect on stability after the CPT. This findings showed that listening to music may have a positive effect on brachial systolic BP and HRV to sympathoexcitation.

An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea (우리나라 의료기관 Institutional Review Board의 취약한 연구 대상자 관련 표준운영지침서 운영 현황과 윤리적 고찰)

  • Eun Hwa Byun;Byung In Choe
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.21-32
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    • 2023
  • Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

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A Clinical Study to Evaluate the Efficacy and Safety of Hair Ampoules Containing Malva Verticillata Seed Extract in Subject with Alopecia (탈모 환자에서 동규자(冬葵子) 추출물을 함유하는 두피 앰플의 탈모 증상 완화 기능성 및 안전성을 평가하기 위한 임상적 연구)

  • Young-Chae Song;Bich-Euro Park;Kim Tae-Jun;Yong-Min Kim;Sang-Jun Lee;Su-Hyun Ahn;Chun-Mong Lee;Kwang-Sik Lee;Jung-No Lee;Hee-Taek Kim
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.37 no.2
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    • pp.37-57
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    • 2024
  • Objectives : The purpose of this study is to evaluate the efficacy and safety of hair Ampoules with Malva Verticillata Seed Extract in alopecia patients. Methods : This 24-week clinical study enrolled 70 patients with Alopecia. A series of clinical examinations, subjects were evaluated at 0, 8, 16 and 24-week, counting of the number of hairs on the crown, and subject survey after using the Ampoules. Results : The clinical evaluation showed a significantly difference (p<0.05) after 24 weeks of product use compared to the baseline in the change in hair count in the treatment group compared to the control group within and between groups. It showed greater improvement in the treatment group than in the control group in hair count, hair thickness, and hair loss symptoms in the top of the head and forehead. No severe adverse events were observed during the clinical trial. Counclusions : This suggests that this hair ampoules containing Malva Verticillata Seed Extract could help prevent hair loss in alopecia patients without inducing side effects.

Effective Recruitment Strategies in Clinical Trials : An analysis of methods used in functional dyspepsia clinical trial (임상연구의 효과적인 대상자 모집 전략 - 기능성 소화불량증 임상시험 자료에 대한 분석 -)

  • Jerng, Ui-Min;Ko, Seok-Jae;Han, Ga-Jin;Oh, Seung-Hwan;Kim, Jin-Sung;Ryu, Bong-Ha;Park, Jae-Woo
    • The Journal of Internal Korean Medicine
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    • v.31 no.4
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    • pp.722-730
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    • 2010
  • Objectives : While the proportion of clinical trials is increasing in oriental medical research, no studies in recruitment strategies exist. This study was conducted to investigate which recruitment strategy was efficient to increase the number of potential subject and to reduce cost. Methods : Data from 179 callers in a single-center between June 22 and August 12, 2010 were analyzed. Results : We found that daily newspaper and free newspaper advertisement collected maximal participants. Advertisements in the hospital and on the Internet were considered as the most cost-effective methods. Conclusions : Intensive multiple overlapping recruitment strategies might be effective in success of participant registration in a clinical trial.

Investigation of Logisitic Regression Equation of Vacuous Pulse and Replete Pulse for Efficacy Evaluation of Clip-type Pulsimeter by using Magnetic Hall Device (자성홀소자를 이용한 집게형 맥진기의 유효성 평가를 위한 허맥과 실맥 로지스틱 회귀식 탐색)

  • Yu, Jun-Sang;Chang, Sei-Jin;Sun, Seung-Ho;Hong, Yu-Sik;Lee, Sang-Suk
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.17 no.1
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    • pp.63-76
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    • 2013
  • The aims of this study are to investigate a logisitic regression equation of the vacuous pulse and the replete pulse for efficacy evaluation of clip-type pulsimeter by using magnetic Hall device. To evaluate the efficacy of clip-type pulsimeter by using magnetic Hall device as sensing the minute movement of a radial artery, one research clinical trial have been performed. The number of subject was 120, the clinical data of patients did treated with a normal statistical method. The systolic peak amplitude, the reflective peak amplitude and time, and the notch peak amplitude and time are analyzed major efficacy parameters to discern the vacuous pulse and the replete pulse. The equations included of five parameters such as systolic peak amplitude, the reflective peak amplitude and time, and the notch peak amplitude and notch amplitude time for determination of the vacuous pulse and the replete pulse were deducted by statistical logistic regression method. It suggests that the logistic regression equations are possible to develop the oriental algorithm for pulse diagnosis.

Kinetic Feedback Frequency Effects on Learning Weight Shifting Skills in Nondisabled Subjects (체중이동 과제 학습시 효과적인 운동학적 되먹임 유형과 상대적 빈도)

  • Cha, Seung-Kyu;Park, So-Yeon;Chung, Jin-Ho;Kim, Young-Ho
    • Physical Therapy Korea
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    • v.7 no.1
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    • pp.55-63
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    • 2000
  • Physical therapists have been using balance and weight shifting training to induce improvements in standing and walking. This study compared the effects of kinetic feedback frequency and concurrent kinetic feedback on the performance and learning of a weight shifting skill in young, nondisabled adults. Sixteen young adults without known impairment of the neuromusculoskeletal system volunteered for the study. Subjects in each of three kinetic feedback groups performed a weight shifting task in an attempt to minimize error between their effort and a center of pressure (COP) template for a 12 second period. Feedback was provided: 1) concurrently (concurrent feedback), 2) after each trial (100% feedback), 3) after every other trial (50% feedback). Immediate and delayed (24 hour) retention tests were performed without feedback. During acquisition phase, the concurrent feedback group exhibited less error than either of the post response feedback group. For the immediate retention test, the 50% feedback group exhibited less error than did the 100% feedback and concurrent feedback. During the delayed retention, 50% feedback group displayed less error than did the other groups. But no significant differences were found between groups. These results suggest that practice with concurrent feedback is beneficial for the immediate performance, but not for the learning of this weight shifting skill. Lower frequency of feedback resulted in more permanent changes in the subject's ability to complete the task.

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The Study on theses of Chuna (推拿) (추나(推拿) 관련 논문에 대한 연구)

  • Kim, Min-Kyun;Heo, Dong-Seok;Oh, Min-Seok;Yoon, Il-Ji
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.2 no.1
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    • pp.127-152
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    • 2007
  • Objectives : To research the trend of the study related to Chuna(推拿) and to establish the direction of further studies into the Chuna(推拿). Methods : We reviewed and analyzed all theses published by Korean research institution. And these theses were classified by research institutions, published year, field of study, subject, research methods, thesis types, illness and symptoms. Results : The following results were obtained in this study. 1. Classified by the major field of study, oriental medicine accounted for 59 papers, followed by 18 in physical education and 2 in the science of nursing and medicine. 2. Upon classifying theses according to research method and thesis types, research related to clinical trial accounted for nearly half of all theses. It was followed by consideration of documents. 3. After 1998 deals with the effects of the Chuna on variable illnesses such as: ossified posterior longitudinal ligament, chronic coccyalgia, entrapment neuropathy, low birth weight infant, Bell's palsy, stress incontinence, paramenia, Parkinson disease, Bertolloti syndrom, TMJ (because of scoliosis) etc. 4. Two most widely cured illnesses using the Chuna therapy are scoliosis and HNP of L-spine. However, when considering the fact that several clinical tests and casuistics did not include research into Lumbago (including HNP of L-spine), it can be concluded that most of the Chuna therapies have been concentrated on Lumbago. Conclusion : As it can be seen in the above results, the possibility of curing illness through Chuna and the usefulness of Chuna have been shown factually and clinically through various consideration of documents, clinical trial & casuistics. Based upon such facts, it is regarded that further scientific research along with additional clinical approaches involving the Chuna should be performed.

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A Study on Development of Libraries' Information Literacy Program based on Integrated Tasks to Support the Free Semester System (자유학기제 지원을 위한 통합 주제 중심의 도서관 정보활용교육 프로그램 개발에 대한 연구)

  • Lee, Kyeong-Hwa;Song, Gi-Ho
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.27 no.4
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    • pp.85-104
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    • 2016
  • The purpose of this study is to suggest the developmental strategies of information literacy program based on the integrated topics to promote inquiry abilities of middle school students who take part in the free semester system. To that end, the content of the 2015 revised curriculum on a national level was analyzed to develop 6 inquiry themes that incorporate Korean, Social Studies, Music and Art. The instruction and learning guide were consisted of three stages of forming a background knowledge, researching and creating and evaluating the conclusion of the research. The detailed activities for research step were consisted of the four steps of recognition of the problem, information analysis and interpretation, compilation of information and evaluation for each activity. Among the themes "environment" and "appreciation" were applied to a public library and a middle school library as a trial. The trial application saw that students took an interest in programs that subject themes are link with various topics. They were also very satisfied with such programs.

Readability of Patient Information Leaflets in Clinical Trials (임상시험 시험대상자설명서의 가독성 평가)

  • Choi, Im-Soon;Yong, Chul-Soon;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.1
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    • pp.33-39
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    • 2016
  • Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision-making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae's vocabulary grading framework, which was compared to the difficulty level of words found in the $6^{th}$ grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients' understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient's autonomy and therefore guaranteeing participant's rights.