• Title/Summary/Keyword: Pilot protocol study

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Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

Analysis of Differences in Attention Allocation Patterns between Expert and Novice Pilots (숙련급 조종사와 초급 조종사와의 주의 배분 차이 분석)

  • Park, Sang-Su;Kim, Gi-U;Myeong, No-Hae
    • Journal of the Ergonomics Society of Korea
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    • v.23 no.1
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    • pp.49-63
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    • 2004
  • In this study. differences in attention allocation patterns between expert and novIce pilots were investigated by a verbal protocol when pilots were engaged in a task during the instrument flight. Ten pilots including experts and novices were participated to conduct a pre-determined task(a fix-to-fix) on F-5E Cockpit Procedure Trainer Simulator. Experts show better performance as expected with more stable variations in speed. altitude. and attitude. In attention allocation patterns. novices allocated about 83% of attentional resources on the primary instruments (airspeed indicator. altitude indicator. and attitude) relating to the task of the basic flight while experts spent 57%. This difference in the availability of attentional resources allowed expert pilots to accomplish the task better than novices. In other words. training a pilot should consider a program for building up wider instrument scanning patterns to become an expert in a shorter time.

Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong;Seo, Jung-Chul;Park, Sung-Hoon;Kwak, Min-Ah;Shin, Im Hee;Min, Bo-Mi;Cho, Min-Su;Roh, Woon-Seok;Jung, Jin-Yong
    • Journal of Pharmacopuncture
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    • v.18 no.1
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    • pp.79-85
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    • 2015
  • Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women with Overactive Bladder; a Pilot Study of Randomized Clinical Controlled Trial (폐경 여성의 과민성 방광에 대한 전침 치료와 침 치료의 유효성과 안전성 평가 ; 무작위 대조군 예비 임상시험)

  • Nam, Eun-Young;Jung, Seung-Hyun;Bae, In-Suk;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.1
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    • pp.84-98
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    • 2018
  • Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.

A pilot study of half-value layer measurements using a semiconductor dosimeter for intraoral radiography

  • Shun Nouchi;Hidenori Yoshida;Yusaku Miki;Yasuhito Tezuka;Ruri Ogawa;Ichiro Ogura
    • Imaging Science in Dentistry
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    • v.53 no.3
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    • pp.217-220
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    • 2023
  • Purpose: This pilot study was conducted to evaluate half-value layer (HVL) measurements obtained using a semiconductor dosimeter for intraoral radiography. Materials and Methods: This study included 8 aluminum plates, 4 of which were low-purity (less than 99.9%) and 4 high-purity (greater than 99.9%). Intraoral radiography was performed using an intraoral X-ray unit in accordance with the dental protocol at the authors' affiliated hospital: tube voltage, 60 kVp and 70 kVp; tube current, 7 mA; and exposure time, 0.10 s. The accuracy of HVL measurements for intraoral radiography was assessed using a semiconductor dosimeter. A simple regression analysis was performed to compare the aluminum plate thickness and HVL in relation to the tube voltage (60 kVp and 70 kVp) and aluminum purity (low and high). Results: For the low-purity aluminum plates, the HVL at 60 kVp (Y) and 70 kVp (Y) was significantly correlated with the thickness of the aluminum plate (X), with Y=1.708+0.415X (r=0.999, P<0.05) and Y=1.980+0.484X (r=0.999, P<0.05), respectively. Similarly, for the high-purity aluminum plates, the HVL at 60 kVp (Y) and 70 kVp (Y) was significantly correlated with the plate thickness(X), with Y=1.696+0.454X (r=0.999, P<0.05) and Y=1.968+0.515X (r=0.998, P<0.05), respectively. Conclusion: This pilot study examined the relationship between aluminum plate thickness and HVL measurements using a semiconductor dosimeter for intraoral radiography. Semiconductor dosimeters may prove useful in HVL measurement for purposes such as quality assurance in dental X-ray imaging.

Development of the Model for Community-based Health Care Program for Premature Infants and Family (미숙아를 위한 지역중심 건강관리사업의 모델개발)

  • Ahn Young-Mee
    • Child Health Nursing Research
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    • v.8 no.2
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    • pp.129-140
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    • 2002
  • The article reports the process, contents and strategies in the development of community based-heath care management program for high-risk infants and family, which was based on literature review, empirical needs assessment from pilot study. The program was divided into two emphasis areas: (1) identification and home visiting nursing care program, and (2) the construction of self-supporting group. The contents of home visiting nursing care were developed from the pilot study of the direct home visiting to premature infants after discharge. The documentation form for home care was standardized, including the demographic data, birth history, home care services, education and counsels, and visiting schedules. The integrated education protocol was elaborated to enhance the body of knowledge as well as clinical competency in caring high-risk infants and family by the supports of neonatologists, nursing scholar, and clinical specialists. In addition, the process and strategies in developing self-supporting group, consisting the high-risk infants and family, and any significant others were addressed. Emphases were given to the role of public health center and the recycling health care referral system to maximize the growth and development of high-risk infants on the community-base, which in turn, contributing to decrease the postneonatal mortality rate.

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Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial (슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜)

  • Lee, Seung-Hoon;Kim, Kun-Hyung;Kim, Tae-Hun;Kim, Jung-Eun;Kim, Joo-Hee;Kang, Kyung-Won;Jung, So-Young;Kim, Ae-Ran;Park, Hyo-Ju;Shin, Mi-Suk;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.1-15
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    • 2011
  • Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue : a Protocol for a Pilot Randomized Controlled Trial (만성피로증후군과 특발성 만성피로에 대한 침 치료의 유효성 및 안전성 평가 : 무작위 대조 예비 임상연구 프로토콜)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Jung, So-Yong;Kim, Ae-Ran;Shin, Mi-Suk;Park, Hyo-Ju;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.3
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    • pp.151-163
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    • 2011
  • Objectives : Our aim is to evaluate feasibility for massive clinical research and to make basic analysis of efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : This study is a protocol for a pilot randomized controlled trial. It was developed through literature searches and discussions among researchers. Results : Forty participants allocated to acupuncture group and wait-list group. Participants allocated to acupuncture group will be treated three times per week for a total of 12 sessions over four weeks. Eight points (GV20; bilatral GB20, BL11, BL13, BL15, BL18, BL20, BL23) have been selected for the acupuncture group. Participants in the wait-list group will not receive acupuncture treatment during study period and follow-up will be made in the 5th and 9th weeks after random allocation. Then the same acupuncture treatment as that performed to the acupuncture group will be made to the wait-list group. Fatigue Severity Scale, a short form of Stress Response Inventory, Beck Depression Inventory, and Insomnia Severity Index will be used as outcome variables to evaluate the efficacy of acupuncture. Safety will be assessed at every visit. Conclusions : The trial based on this study will be performed. The results of the trial will provide basis for the efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

Exploring Visualization Process of Expert Teachers: a Case of the Simple Visual Task

  • HEO, Gyun
    • Educational Technology International
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    • v.7 no.1
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    • pp.21-37
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    • 2006
  • This paper focuses on finding out visualization process by means of VTA(Visual Task Analysis) of expert teachers' simple task. Findings indicate teachers have coding schema of performing visual task as such; (a) the analyzing by reading and some activities in the task text, (b) conceptualizing or understanding in his/her own way, (c) the explaining of the action or product, (d) the searching by thinking or finding, (e) the decision of visualizing of the task. Expert teachers tried to visualize in the form of abstract graph, and to omit the object which was not directly related to the topic at the pilot study. VAT based on ground theory and protocol analysis was developed and performed. This case study suggests that an additional study for searching a guide and method might be beneficial for conducting a visual task analysis.

A Study on the Design of Hardware Switching Mechanism using TCP/IP Communication (TCP/IP를 이용한 하드웨어 전환장치 설계에 관한 연구)

  • Kim, Chong-Sup;Cho, In-Je;Lim, Sang-Soo;Ahn, Jong-Min;Kang, Im-Ju
    • Journal of Institute of Control, Robotics and Systems
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    • v.13 no.7
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    • pp.694-702
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    • 2007
  • The SSWM(Software Switching Mechanism) of I-processor concept using non-real time in-house software simulation program is an effective method in order to develop the flight control law in desktop or HQS environment. And, this system has some advantages compare to HSWM(Hardware Switching Mechanism) such as remove the time delay effectiveness and reduce the costs of development. But, if this system loading to the OFP(Operational Flight Program), the OFP guarantee the enough throughput in order to calculate the two control law at once. Therefore, the HSWM(Hardware Switching Mechanism) of 2-processor concept is necessary. This paper addresses the concept of HSWM of the HQS-PC interface using TCP/IP(Transmission Control Protocol/Internet Protocol) communication based on flight control law of advanced supersonic trainer. And, the fader logic of TFS(Transient Free Switch) and stand-by mode of reset '0' type are designed in order to reduce the abrupt transient response and minimize the integrator effect in pitch axis. The result of the analysis based on HQS pilot simulation using HSWM reveals that the flight control systems are switching between two computers without any problem.