• Title/Summary/Keyword: Pilot trial

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Acupuncture, an Adjunct Therapy for Asthma: a Pilot Study Protocol of Randomized Controlled Trial (본 임상시험을 대비한 천식 침치료 무작위 대조군 예비 임상시험 프로토콜)

  • Choi, Jun-Yong;Oh, Dal-Seok;Roh, Young-Lae;Jung, Hee-Jae;Jung, Sung-Ki;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.25 no.3
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    • pp.43-51
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    • 2008
  • 배경 : 최근까지 이루어진 천식의 침치료 무작위 대조군 연구들에 의한 결과는 뚜렷한 효과를 보여주지 못하고 있다. 이러한 요인의 하나로 적절한 피험자 수를 정하기 위한 예비 임상시험의 부재가 거론되고 있다. 따라서 천식에 대한 침치료의 본 임상시험에 앞서 이의 실행 가능성 및 규모를 예측하는 예비임상시험이 필요한 상황이다. 목적 : 예비임상시험을 통해 서양의학적 치료를 받고 있는 천식환자들에 대한 침치료의 부가적 효과를 검증하기 위한 본 임상시험의 실현 가능성을 예측하기 위함. 방법 : 본 시험은 무작위 단일 맹검 대조군 평행 설계 예비 임상시험이다. 1차 평가변수는 최대 호기량 검사기로 집에서 아침, 저녁으로 매일 측정한 수치로 구해진 최대 호기 유속 일중 변동률의 1주간 평균치 변화이며 2차 평가변수는 의료기관에서 시행하는 폐기능 검사, 기준시점 호흡곤란 지수, 호흡곤란 변화에 대한 지수, 천식환자들의 삶의 질 평가를 위한 설문 등이다. 피험자 수는 총 45명으로 선정 및 제외기준을 통해서 참여하게 되며 1주간의 최대 호기 유속 기저치 평가 기간을 거친 후 진짜침 처치 군, 가짜침 처치 군, 대기군 세 군에 각각 무작위로 15명씩 할당된다. 모든 피험자에게 기존의 천식관련 약물의 사용을 허용하며, 진짜침 처치군 및 가짜침 처치군은 주 3회 4주간 해당 처치를 받고 2주 후에 각 평가 항목에 대하여 추적, 관찰하게 된다. 대기군은 기존의 천식관리를 유지하면서 2주마다 방문하여 총 6주간 평가를 받고 진짜침 처치를 4주간 받게 된다. 고찰 : 본 연구는 국내에서 최초로 이루어지는 천식에 대한 침 무작위 대조군 예비 임상시험으로 향후 적절한 피험자 수와 실행가능성을 예측할 수 있으리라 기대된다.

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The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

The Effectiveness of Acupuncture for Fatigue Severity in Lung Cancer Patients: Pilot Study (침치료가 폐암 환자의 피로도에 미치는 영향: Pilot Study)

  • Hyun, Dae-Sung;Kim, Jong-Dae;Kwon, Hyo-Jung;Jung, Hyun-Jung
    • Korean Journal of Acupuncture
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    • v.29 no.4
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    • pp.623-633
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    • 2012
  • Objectives : Fatigue is a common and distressing symptom that is a concern for cancer patients. It has a decisive effect on quality of life. The purpose of this study was to examine the feasibility of clinical trial to evaluate of efficacy and safety of acupuncture on cancer related fatigue of lung cancer patients. Methods : Total lung cancer 9 patients complained of fatigue were treated by acupuncture twice a week for four weeks(8 times in total). Evaluation of the severity of fatigue was measured by FSS(Fatigue Severity Score). In visit 1, 10, we checked FSS. For check safety of acupuncture treatment, we did blood test. Results : After 4 weeks of acupuncture treatment, the FSS was significantly decreased from $4.92{\pm}1.06$ to $3.74{\pm}1.37$(p=0.008). And the level of hemoglobin was significantly increased from 10.87 g/dl to 12.01 g/dl(p=0.014). No other lab measures indicated any significant differences between before and after acupuncture treatment. Conclusions : This study suggests that acupuncture treatment will be beneficial for lung cancer patients to improve the fatigue severity. And acupuncture treatment is safe method for lung cancer patients. A large-scale study to confirm efficacy and safety of acupuncture is needed.

The pilot study for the effects of Doin-Angyo program in reducing stress among high school students in Gyeongsangbukdo, Korea (경상북도 일부 고교생을 대상으로 한 도인안교의 스트레스 저하 효과에 대한 파일럿 연구)

  • Park, Hye Jung;Lee, Sangjae;Lim, Byungmook
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.2
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    • pp.59-67
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    • 2014
  • Objective : This study was to examine the effects of Doin-Angyo program, evidenced by East Asian Medicine literatures, on stress among smoking adolescents. Method : This study was a prospective community trial using a one-group, pretest-posttest design. As an intervention, Doin-Angyo program was implemented for 10 minutes per session, 3 days a week, for 6 weeks to smoking students who attend a Girl's high school. Psychological stress was measured by self-report questionnaire and physiological stress was measured by salivary cortisol. The final sample for the questionnaire included 18 participants. In addition, pre- and post-salivary cortisol levels of 24 adolescents participating in the last session were compared in order to identify the acute effects of Doin-Angyo program in reducing stress. Results : There were no significant differences in overall stress-test results from the comparisons before and after the intervention. However, we found a significant going-down of the stress level(p = .032) in the question, "About School-work" among six sub-category questions. From the salivary cortisol tests in the last session, we found, in comparison with the standard salivary cortisol density level, $0.3{\mu}g/dL$, the density level tended to go down(p = .062) when higher than the standard, and it went up(p = .001) when lower than the standard, after 10 minute session. Conclusion : The results of this pilot study supported the partial effect of Doin-Angyo program in reducing the stress levels. The study protocol and results can be used to elaborate the community trials design aiming to prove the effect of Korean Medicine based health promotion modalities.

Development of Discretized Combined Unsteady Friction Model for Pipeline Systems (관수로 합성 부정류 차분화 마찰모형의 개발)

  • Choi, Rak-Won;Kim, Sang-Hyun
    • Journal of Korea Water Resources Association
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    • v.45 no.5
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    • pp.455-464
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    • 2012
  • In this study, a combined unsteady friction model has been developed to simulate the waterhammer phenomenon for the pipeline system. The method of characteristics has been employed as the modeling platform for the integration of the acceleration based model and the frequency dependant model for unsteady friction. Both Zielke's model and Ramos model were also compared with pressure measurements of a pilot plant pipeline system. In order to validate the modeling approach, a pipeline system equipped with the high frequency pressure data acquisition system was fabricated. The time series of pressure, introduced by a sudden valve closure, were obtained for two Reynolds numbers. A trial and error method was used to calibrate parameters for unsteady friction model. The comparison between different unsteady friction contributions in pressure variation provided the comprehensive understanding in the pressure damping mechanism of waterhammer. The proper evaluation of unsteady friction impact is a critical factor for accurate simulation of hydraulic transient.

Intracavitary Radiation Therapy for Recurrent Cystic Brain Tumors with Holmium-166-Chico : A Pilot Study

  • Ha, Eun Jin;Gwak, Ho-Shin;Rhee, Chang Hun;Youn, Sang Min;Choi, Chang-Woon;Cheon, Gi Jeong
    • Journal of Korean Neurosurgical Society
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    • v.54 no.3
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    • pp.175-182
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    • 2013
  • Objective : Intracavitary injection of beta-emitting radiation source for control of cystic tumors has been tried with a benefit of localized internal radiation. The authors treated cystic brain tumor patients with Holmium-166-chitosan complex (Ho-166-chico), composed of a beta-emitting radionuclide Holmium-166 and biodegradable chit polymer, and evaluated the safety and effective measurement for response. Methods : Twenty-two patients with recurrent cystic brain tumor and/or located in a deep or eloquent area were enrolled in this pilot study. The cyst volume and wall thickness were determined on CT or MRI to assess radiological response. The activity of Ho-166-chico injected via Ommaya reservoir was prescribed to be 10-25 Gy to the cyst wall in a depth of 4 mm. Results : There was neither complications related to systemic absorption nor leakage of Ho-166-chico in all 22 patients. But, two cases of oculomotor paresis were observed in patients with recurrent craniopharyngioma. Radiological response was seen in 14 of 20 available follow-up images (70%). Seven patients of 'evident' radiological response experienced more than 25% decrease of both cyst volume and wall thickness. Another 7 patients with 'suggestive' response showed decrease of cyst volume without definitive change of the wall thickness or vice versa. All patients with benign tumors or low grade gliomas experienced symptomatic improvement. Conclusion : Ho-166-chico intracavitary radiation therapy for cystic tumor is a safe method of palliation without serious complications. The determination of both minimal effective dosage and time interval of repeated injection through phase 1 trial could improve the results in the future.

A Review of Instrumentation System and Construction of Korea Highway Test Road (시험도로 건설과 계측시스템 구축)

  • 최준성;김도형;김성환
    • Proceedings of the Korean Geotechical Society Conference
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    • 2000.11a
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    • pp.603-606
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    • 2000
  • The cost needed for the construction and management of highways in the whole nation is rapidly growing so the research that can decrease the cost is required. However, most of the highway specs have simply converted from those of other countries, including USA. Therefore, some of our design and construction specs were not the optimum ones based on our own situation, requiring a research under the actual traffic and environment of our nation. The use of test road develops many aspects of highway engineering. Those are evaluation of construction materials, a general overview of korea pavement design and serviceability under the actual traffic and environmental condition of the nation. It is also economical and efficient compared to the trial construction of each item in spreaded form. A test road, 7.7km long with two lanes, is being constructed on the Inner Central Expressway. In this test road, 2.7km is planned for asphalt pavement and 3.4km is planned for concrete pavement. Three test bridges and five earth retaining structures will be included in the test road. Based on the master plan, the major performance was progressing such as detailed research modules of each area, preliminary research for the future research, sensor surveys for the behavior analyses of pavements and structures with installation methods and data acquisition systems, the foundation research of Integrated Instrumentation System and the Management Plan for automated measurement. Some area(structure research division, geotechnical research division) was designed the instrumentation plan because some instrument sensors must be installed during the construction of the test road. And then the instrumentation plan of each area was enforcing because a large majority of the instrument sensors must be installed after the construction of the test road. The field surveys with material property tests and pilot instrumentation test with sensor tests was also performing in accordance with the construction in the field.

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The effects of providing visual feedback and auditory stimulation using a robotic device on balance and gait abilities in persons with stroke: a pilot study

  • Park, Jae Ho;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • v.5 no.3
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    • pp.125-131
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    • 2016
  • Objective: The purpose of this study was to investigate the effects of providing visual feedback and auditory stimulation using a robotic device on balance and gait abilities in stroke patients. Design: Randomized controlled pilot trial. Methods: Fifteen subjects were randomly divided into three groups where five subjects were in the visual feedback robotic device assist gait training (VRGT) group, five subjects in the auditory stimulation robotic device assist gait training (ARGT) group, and five subjects in the control group. Subjects received visual feedback and auditory stimulation while undergoing robotic gait training for 45 minutes, three times a week for 2 weeks, and all subjects had undergone general physical therapy for 30 minutes, five times a week for 2 weeks. All subjects were assessed with the Berg balance scale (BBS), timed up and go (TUG) test, and 10-meter walking test (10MWT) pre- and post-intervention. Results: All subjects showed that BBS, TUG test, and 10MWT scores significantly improved post-intervention (p<0.05), and the control group also had significantly improved post-treatment (p<0.05). The VRGT and the ARGT showed significant improvements in BBS, TUG, and 10MWT scores compared with the control group (p<0.05). The VRGT group showed a significant improvement in BBS, TUG, and 10MWT scores compared with the control group (p<0.05). In addition, it has been confirmed that VRGT had significantly improved in BBS, TUG test, and 10MWT scores compared with the auditory stimulation and control group (p<0.05). Conclusions: The results of this study showed improved balance and gait abilities after VRGT and ARGT groups compared with general physical therapy and was found to be effective in enhancing the functional activity of persons affected with stroke.

A Study of the Effect of Character Perspectives on the Player's Moral Decision in Interactive Story (인터랙티브 스토리 내에서 플레이어의 도덕적 결정에 대한 캐릭터 시점의 영향 연구)

  • Yang, Jung-Woo;Gang, Shin-Jin;Bae, Byung-Chull
    • Journal of Korea Game Society
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    • v.16 no.6
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    • pp.111-120
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    • 2016
  • This paper aims to study whether the perspective of the character controlled by a player can affect the player on her moral decision. To this end we designed and developed Castaway, an interactive story using Unity3D game engine. The main story plot of Castaway is based on the trial 'R v Dudley and Stephens (also known as mignonette 1884) which occurred at 1884 in U.K. In Castaway, the player can choose either the accused or the victim, and then play the interactive story with the perspective of the chosen character. To investigate the relationship between the player's empathy to the player character and player's moral decision, we conducted a small-scale (n=10) pilot study. Results of the pilot study have shown that different perspectives can influence the player on her empathy to player character and her moral decision. In near future we plan to conduct a main study with more participants.

Virtual reality education program including three-dimensional individualized liver model and education videos: A pilot case report in a patient with hepatocellular carcinoma

  • Jinsoo Rhu;Soyoung Lim;Danbee Kang;Juhee Cho;Heesuk Lee;Gyu-Seong Choi;Jong Man Kim;Jae-Won Joh
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.26 no.3
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    • pp.285-288
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    • 2022
  • Three-dimensional (3D) modeling of the liver can be especially useful for both the surgeon and patient to understand the actual location of the tumor and planning the resection plane. Virtual reality (VR) can enhance the understanding of 3D structures and create an environment where the user can focus on contents provided. In the present study, a VR platform was developed using Unreal Engine 4 software (Epic Games, Potomac, MD, USA). Patient's liver based on magnetic resonance image was imported as a 3D model that could distinguish liver parenchyma, vascular structure, and cancer. Preoperative education videos for patients were developed. They could be viewed inside the VR platform. To evaluate the usefulness of VR education program for patients undergoing liver resection for hepatocellular carcinoma, a randomized clinical trial evaluating the knowledge and anxiety of the patient was designed. The case presented in this report was the first experience of performing the VR education program and examining the knowledge and anxiety using questionnaires. When the knowledge score increased, the anxiety score also increased after the education program. Based on findings of this pilot case study, the timing and place where the questionnaire will be answered can be modified for formal initiation of the randomized controlled study to examine the usefulness of VR in patient education.