• 제목/요약/키워드: trial plan

검색결과 158건 처리시간 0.03초

모나코 치료계획 시스템에서 단계적 최적화 조건 실현의 유용성 (The Availability of the step optimization in Monaco Planning system)

  • 김대섭
    • 대한방사선치료학회지
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    • 제26권2호
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    • pp.207-216
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    • 2014
  • 목 적 : 모나코 치료계획 시스템은 몬테카를로 알고리즘을 기반으로 선량을 구현하는 대표적인 시스템이다. 모나코 치료계획 시스템에서 치료계획 완성 후, 같은 조건으로 최적화를 재 실시하여 처음과는 다른 치료계획이 만들어질 때 본 연구는 이러한 차이를 줄이는 방법을 제시하고자 한다. 대상 및 방법 : 모나코 치료계획 시스템은 세기변조방사선치료나 용적변조방사선치료를 위한 역 선량계산을 실시할 때, 두 단계를 거쳐 최적화를 실시한다. 본 연구는 우선 최적화 두 단계를 모두 실시하여 선량으로 완성된 치료계획을, 최적화 조건을 바꾸지 않고 일반적인 1단계부터 2단계까지 순차적 최적화를 실시하였다. 이때 2단계에선 펜슬 빔과 몬테카를로 알고리즘을 각각 적용하여 실험을 실시하였다. 두 가지 알고리즘의 치료계획 모두 처음 완성된 치료계획과 최적화를 재 실시한 치료계획을 비교하고 선량 측정기를 이용하여 치료선량을 평가하였다. 두 번째는 초기 완성된 치료계획에 대하여 최적화를 재 실시할 때 단계적으로 실시하여 치료계획을 완성하고 선량을 측정하였다. 결 과 : 초기 완성된 치료계획에서 동일한 조건으로 일반적인 최적화를 다시 실시한 결과는 동일하지 않았다. 치료계획시스템의 비교에서 보면 유사한 선량-용적 히스토그람은 유사한 경향을 나타내지만 최고선량, 선량 균질도 및 제한 선량 등은 최적화 조건을 만족 시키지 못하는 다른 값을 보였다. 또한 선량측정비교에서도 20%이상 다르게 나타냈다. 또한 선량 알고리즘이 달라져도 다른 측정 값이 나왔다. 반면, 단계적 최적화를 실시 할 경우에는, 초기 치료계획과 비교하였을 때 종양 및 정상 장기의 선량 분포가 5% 이하의 차이를 보였다. 결 론 : 치료계획의 최적화 과정은 수 많은 시행 착오를 수행하며 궁극적인 해를 찾아가는 과정이다. 이때 초기 치료계획의 완성만을 신뢰하며 최적화를 실시하면 또 다른 치료계획이 만들어 질 수 있다. 유사한 경향을 보이긴 하지만, 반드시 최적화 조건을 만족한다고 볼 수 없기 때문에, 최적화 과정을 재 실시할 경우에는 반드시 단계적인 최적화 과정을 통하여 선량분포를 확인하면서 순차적으로 최적화 조건을 적용해야 할 것이다.

고혈압-뜸 임상시험 참여자들의 혈압 관리행동에 대한 질적연구 (A Qualitative Study on Management Behaviors about Blood Pressure of Participants in Moxibustion Clinical Trial for Hypertension)

  • 문아지;김태정;이성근;김남권;이기상
    • 대한한방내과학회지
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    • 제33권4호
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    • pp.543-557
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    • 2012
  • Objectives : The purpose of this study which adopted a qualitative method was to evaluate blood pressure management behaviors of pre- and stage 1 hypertension patients and to provide fundamental data for developing a strategy about proper oriental medical treatment through analyzing factors related to a moxibustion clinical trial. Methods : Semi-structured interviews that focused on personal experiences with hypertension and its management were conducted with 10 hypertensive patients. The interviews lasted for approximately 50 minutes. Results : Most participants recognized that the direct cause of high blood pressure was unhealthy behavior rather than inheritance. Thus, the hypertensive patient believed they could recover their blood pressure to a normal level through removing the direct cause of hypertension instead of taking drugs. The reasons for these statements were that the drugs for controlling hypertension are not natural and they may have side effects. On future management plan of patients, most of them will continue to keep moxibustion and healthy behavior in the well-controlled blood pressure group. However in the uncontrolled blood pressure group, there was an increasing tendency to begin medication. Conclusions : For developing a strategy for an individual approach to hypertension management, we need to develop a client-centered attitude and strategy. That is, we need to tailor our approach to individual cases to avoid generalizations and stereotyping when developing an adherence increasing strategy.

토크전단형 고력볼트의 토크계수 변동에 따른 체결축력 확보방안에 관한 연구 (A Study on the Secure Plan of Clamping Force according to the Variation of Torque-Coefficient in Torque-Shear High Strength Bolts)

  • 이현주;나환선;최성모
    • 복합신소재구조학회 논문집
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    • 제5권3호
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    • pp.8-16
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    • 2014
  • Torque control method and turn of nut method are specified as clamping method of high strength bolts in the steel construction specifications. Quality control of torque coefficient is essential activity because torque control method, which is presently adopted as clamping method in domestic construction sites, is affected by variation of torque coefficient. The clamping of torque shear bolt is based on KS B 2819. It was misunderstood that the tension force of the TS bolt was induced generally at the break of pin-tail specified. However, the clamping forces on slip critical connections do not often meet the intended tension, as it considerably varies due to torque coefficient dependent on the environmental factors and temperature variables despite the break of the pin tail.This study was focused to evaluate the effect of environmental factors and errors of installing bolts during tightening high strength bolts. The environmental parameters were composed of 'wet' condition, 'rust' condition, 'only exposure to air' condition. And the manufacture of trial product was planned to identify the induced force into the bolts. The algorithm for a trial product was composed of the relation between electricity energy taken from torque shear wrench and tension force from hydraulic tension meter.

부분적으로 관측가능하고 비결정적인 계획문제를 풀기 위한 휴리스틱 탐색 알고리즘 (A Heuristic Search Algorithm for Solving Partially-Observable, Non-Deterministic Planning Problems)

  • 김현식;박찬영;김인철
    • 한국정보과학회논문지:컴퓨팅의 실제 및 레터
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    • 제15권10호
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    • pp.786-790
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    • 2009
  • 본 논문에서는 불완전한 인식과 비결정적 동작을 함께 포함한 조건부 계획문제를 풀기 위한 새로운 휴리스틱 탐색 알고리즘 HSCP를 소개한다. HSCP 탐색 알고리즘은 하나의 완전한 해 그래프가 구해질 때까지 AND-OR 탐색시도를 반복한다. HSCP 알고리즘의 AND-OR 탐색시도는, 기존의 휴리스틱 AND-OR 탐색 알고리즘들인 $AO^*$$LAO^*$와는 달리, 오직 하나의 후보 해 그래프를 확장하는데 집중한다. 또한, 실시간 동적 프로그래밍 알고리즘들인 RTDP와 LRTDP와는 달리, 모든 상태들의 가치 평가치가 수렴할 때까지 미루지 않고 바로 해를 구한다. 따라서 HSCP 탐색 알고리즘은 양질의 조건부 계획을 매우 효율적으로 구해줄 수 있다는 장점이 있다.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • 제35권3호
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

수산자원전용조사선 탐구 21호에 탑재된 최첨단 음향장비 소개와 첫 시험조사 (First Trial of the State of the Art Acoustic Systems Mounted on the R/V Tamgu 21)

  • 황강석;이정훈;박정호;차형기;최정화;이형빈;박준성;강명희
    • 한국수산과학회지
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    • 제49권4호
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    • pp.509-515
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    • 2016
  • At the first time in South Korea, the state of the art acoustic systems were mounted on the R/V Tamgu 21. The acoustic systems are an EK80 broadband echosounder (18, 38, 70, 120, 200 and 333 kHz) which has two beam modes such as continuous wave (narrowband) and frequency modulation (broadband), an ME70 multibeam echosounder (70-120 kHz), and a SH90 sonar (111.5-115.5 kHz). Acoustic data from broadband mode have a very short range resolution, a large detection range, a high signal to noise ratio, and a wide and consecutive frequency response. In ME70, each individual beam consisted in a multibeam plays a role as a spilt beam. The first trial of the cutting edge acoustic system installed on the R/V Tamgu 21 was conducted from 15 Feb to 29 Feb 2016 in East Sea, South Sea and East China Sea. The properties of the acoustic systems were elucidated and exploratory results from three systems were exhibited. Lastly, issues which should be considered and future research plan are mentioned.

다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구 (A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System)

  • 김유림;유우진;박호준;장원석
    • 대한의용생체공학회:의공학회지
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    • 제40권6호
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    • pp.250-259
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    • 2019
  • Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

임상시험용 의약품의 안전성 정보보고를 위한 평가 등 관리방안 설문조사 연구 (A survey for Management of Drug Safety Evaluation System for Investigational Product)

  • 이보미;박상준;심다영;이하은;이정은;김상희;조혜경;신주영
    • 한국임상약학회지
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    • 제31권1호
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    • pp.53-60
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    • 2021
  • Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Effects of Inspiratory Training on Respiratory Function and Balance in Stroke Patients: A Randomized Controlled Trial

  • Ku Man;Park Dae-Sung
    • Physical Therapy Rehabilitation Science
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    • 제13권1호
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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.

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study

  • Yujin Choi;Yunna Kim;Do-Hyung Kwon;Sunyoung Choi;Young-Eun Choi;Eun Kyoung Ahn;Seung-Hun Cho;Hyungjun Kim
    • 대한약침학회지
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    • 제27권1호
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    • pp.27-37
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    • 2024
  • Objectives: Posttraumatic stress disorder (PTSD) is a prevalent mental health condition, and techniques using sensory stimulation in processing traumatic memories have gained attention. The Emotional Freedom Techniques (EFT) is a psychotherapy that combines tapping on acupoints with exposure to cognitive reframing. This pilot study aimed to assess the feasibility of EFT as a treatment for PTSD by answering the following research questions: 1) What is the compliance and completion rate of patients with PTSD with regard to EFT protocol? Is the dropout rate reasonable? 2) Is the effect size of EFT protocol for PTSD sufficient to justify a future trial? Methods: Thirty participants diagnosed with PTSD were recruited. They received weekly EFT sessions for five weeks, in which they repeated a statement acknowledging the problem and accepting themselves while tapping the SI3 acupoint on the side of their hand. PTSD symptoms were evaluated using the PTSD Checklist for DSM-5 (PCL-5) before and after the intervention. Results: Of the 30 PTSD patients (mean age: 34.1 ± 9.1, 80% female), 96.7% showed over 80% compliance to the EFT sessions, and 86.7% completed the entire study process. The mean PCL-5 total score decreased significantly after the intervention, with a large effect size (change from baseline: -14.33 [95% CI: -19.79, -8.86], p < 0.0001, d = 1.06). Conclusion: The study suggests that EFT is a feasible treatment for PTSD, with high session compliance and low dropout rates. The effect size observed in this study supports the need for a larger trial in the future to further investigate EFT as a treatment for PTSD. However, the lack of a control group and the use of a self-rated questionnaire for PTSD symptoms are limitations of this study. The findings of this pilot study can be used to plan a future trial.