• Title/Summary/Keyword: Phase III design

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A comparison of multiple hypothesis testing methods and combination methods in seamless Phase II/III clinical trials (심리스 제2상/제3상 임상시험에서 다중가설검정방법과 결합검정방법의 비교연구)

  • Han, Song;Yoo, Hanna;Lee, Jae Won
    • The Korean Journal of Applied Statistics
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    • v.32 no.1
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    • pp.1-13
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    • 2019
  • An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

Effects of Cardiac Rehabilitation Programs(Phase III) on Cardiovascular and Cardiorespiratory Function of the Elderly with Myocardial Infarction (심장재활 프로그램(Phase III)이 심근경색증 노인의 심혈관과 심폐기능에 미치는 효과)

  • Kim, Jeong-Sun;Kim, Young-Joo;Jeong, Myung-Ho
    • Korean Journal of Adult Nursing
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    • v.21 no.2
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    • pp.212-224
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    • 2009
  • Purpose: The purpose of this study was to examine the effects of the cardiac rehabilitation program(Phase III) on cardiovascular and cardiorespiratory function in the elderly (age, ${\geq}$ 60) who experienced acute myocardial infarction. Methods: The design of research was nonequivalent control group pretest-posttest design. Subjects were 10 people in the experimental group and 10 in the control group. The intervention program was the cardiac rehabilitation program(Phase III), and was performed for 50 ~ 60 minutes, twice a week for 8 weeks. The dependent variables were the cardiovascular and cardiorespiratory function. Results: Significant differences were shown in RHR, RSBP, SRPP, SBS, BMI, PT of the experimental group after the intervention. As for the differences in the amount of changes, there were differences among groups in RHR, RSBP, SRPP, SBS, PMET, and PT of the experimental group. Conclusion: The cardiac rehabilitation program(Phase III) may be effective in improving cardiovascular function and enhancing cardiorespiratory function in elderly patients with acute myocardial infarction.

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Environment Design Process Based on Systems Approach (체계적 접근방법에 의한 환경설계과정에 대한 고찰)

  • 이재익
    • Archives of design research
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    • v.2 no.1
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    • pp.99-106
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    • 1989
  • Environmental designers face a wide range of problems to be solved in their day-to-day works. The scale and number of problems and so enormous that designers should be a way out to meet these complex situation. Lately, environmental design process based on systems a.pproach is chosen for design methodology. It is a very complicated procedure with many alternatives. It is a evolutionary process that establishes the solution of a series of problems. This study attempt to tell the designer how to find design solution to problems and how to organize form as solution problems. The model of this design process is largely composed of three phases; Phase I : Problem definition and existing system analysis. Phase II : design goals and objectives, design criteria Phase III : creative process of design form.

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A Form Based Distribution Design Methodology for Distributed Databases (분산 테이타베이스를 위한 양식을 이용한 분산 설계 방법론)

  • Lee, Hui-Seok;Kim, Hui-Jin;Kim, Yeong-Sam
    • Asia pacific journal of information systems
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    • v.5 no.2
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    • pp.101-129
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    • 1995
  • This paper proposes a form-based distributed database design methodology ($FD^3$). The methodology consists of five design phases such as (i) form requirement analysis (ii) schema integration (iii) distribution analysis (iv) distribution design, and (v) local logical/physical design. In the $FD^3$, all the important design information for each phase is obtained by using an organizations forms, Users requirements are analyzed by using forms that contain logical and quantitative information for distribution design. $FD^3$ resolves naming conflicts by employing SQLs based on the form field data in the schema integration phase. Furthermore, $FD^3$ enhances the quality of distributed database design by incorporating communication costs into the design model. A real-life case is illustrated to demonstrate the usefulness of the $FD^3$.

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Maxillary protraction using customized mini-plates for anchorage in an adolescent girl with skeletal Class III malocclusion

  • Liang, Shuran;Xie, Xianju;Wang, Fan;Chang, Qiao;Wang, Hongmei;Bai, Yuxing
    • The korean journal of orthodontics
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    • v.50 no.5
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    • pp.346-355
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    • 2020
  • The treatment of skeletal Class III malocclusion in adolescents is challenging. Maxillary protraction, particularly that using bone anchorage, has been proven to be an effective method for the stimulation of maxillary growth. However, the conventional procedure, which involves the surgical implantation of mini-plates, is traumatic and associated with a high risk. Three-dimensional (3D) digital technology offers the possibility of individualized treatment. Customized mini-plates can be designed according to the shape of the maxillary surface and the positions of the roots on cone-beam computed tomography scans; this reduces both the surgical risk and patient trauma. Here we report a case involving a 12-year-old adolescent girl with skeletal Class III malocclusion and midface deficiency that was treated in two phases. In phase 1, rapid maxillary expansion and protraction were performed using 3D-printed mini-plates for anchorage. The mini-plates exhibited better adaptation to the bone contour, and titanium screw implantation was safer because of the customized design. The orthopedic force applied to each mini-plate was approximately 400-500 g, and the plates remained stable during the maxillary protraction process, which exhibited efficacious orthopedic effects and significantly improved the facial profile and esthetics. In phase 2, fixed appliances were used for alignment and leveling of the maxillary and mandibular dentitions. The complete two-phase treatment lasted for 24 months. After 48 months of retention, the treatment outcomes remained stable.

Development of Site Characterization Technologies for Crystalline Rocks at Mizunami Underground Research Laboratory (MIU) - Surface-based Investigation Phase - (미즈나미 지하처분연구시설 결정질암에 대한 부지 특성규명 기술 개발 -지표기반 조사단계-)

  • Hama, Katsuhiro
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.11 no.2
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    • pp.115-131
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    • 2013
  • The Mizunami Underground Laboratory (MIU) Project is a comprehensive research project investigating the deep underground environment within crystalline rock being conducted by Japan Atomic Energy Agency. The MIU Project has three overlapping phases: Surface-based Investigation phase (Phase I), Construction phase (Phase II), and Operation phase (Phase III), with a total duration of 20 years. The overall project goals of the MIU Project from Phase I through to Phase III are: 1) to establish techniques for investigation, analysis and assessment of the deep geological environment, and 2) to develop a range of engineering for deep underground application. For the overall project goals 1), the Phase I goals were set to construct models of the geological environment from all surface-based investigation results that describe the geological environment prior to excavation and predict excavation response. For the overall project goals 2), the Phase I goals were set to formulate detailed design concepts and a construction plan for the underground facilities. This paper introduces geosynthesis procedures for the investigation and assessment of the hydrochemistry of groundwater in crystalline rock.

Developing a Design Support System for Database Distribution : Relational Schema as an Input (데이터베이스 분산 설계 지원 시스템 개발: 관계형 스키마를 입력으로)

  • Lee, Hui-Seok;Ji, Jeong-Kang;Kim, Tae-Hun;Yeo, Ji-Yeong
    • Asia pacific journal of information systems
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    • v.6 no.1
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    • pp.165-194
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    • 1996
  • Data distribution is one of the most important steps in distributed database design. This paper proposes a methodology for distributing database by using a relational schema as an input. A design support system called DBDD (Database Distribution Design) is implemented within the framework of this methodology. The methodology consists of three phases such as (i) schema analysis, (ii) fragmentation, and (iii) allocation. In the schema analysis phase, all the table names are acquired from a global relational schema. In the fragmentation phase, fragments are generated according to transaction retrieval patterns. Furthermore, DBDD enhances the design quality by allocating fragments in a progressive manner. A real-life case is illustrated to demonstrate the practical usefulness of the DBDD.

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Attitude Controller Design and Flight Test of KSR-III Sounding Rocket (KSR-III 과학로켓의 자세제어기 설계와 비행시험)

  • Roh, Woong-Rae;Cho, Hyun-Chul;Ahn, Jae-Myung;Choi, Hyung-Don
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.32 no.3
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    • pp.88-94
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    • 2004
  • The KSR-III rocket is a liquid propellant sounding rocket and thrust vector control actuators and cold gas thrusters are used to control pitch and yaw, roll attitude respectively during thrusting phase. In this paper, the structure of designed attitude controller and gain scheduling, results of stability analysis for KSR-III rocket are presented. The attitude controller is implemented with flight software in the domestically developed INS and successfully performed its function in the flight test. The flight data are coincident with simulation results.

The Development of an ADDIE Based Instructional Model for ELT in Early Childhood Education

  • MARIAM, Nuzhat;NAM, Chang-woo
    • Educational Technology International
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    • v.20 no.1
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    • pp.25-55
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    • 2019
  • The core purpose of the study is to develop and validate an ADDIE model based instructional model for English Language Teaching (ELT) in early childhood classroom in Bangladesh as an aid to teachers to reconstruct their knowledge and experience more strategically, and for them to design and implement their instruction more structurally. This study is developmental in nature which has been divided in five phases as follows. Phase I: Existing methods and instructional strategy review, Phase II: Instructional model development, Phase III: Delphi 1st round, Phase IV: Delphi 2nd round and Phase V: Model validation. After reviewing relevant literature and existing strategy in phase I, the 1st version of instructional model is made phase II. Next in phase III and phase IV, two rounds of Delphi have been conducted where experts related to different concerning areas of this study reviewed the 1st version and gradually the final version of the instructional model is made. Finally, the instructional model for English teachers of early childhood classroom in Bangladesh got validated by the same Delphi panelists in Phase V. In respect with each phases of ADDIE, the instructional model elaborates the 1) representative key points, 2) instructors' activities prescribed for the instructors, 3) supporting strategies. Both the conceptual and procedural models are included in this study for clearer identification of the whole process. Lastly the study provides some recommendations for instructors and practitioners on choosing the instructional model like doing prior need analysis, incorporating teacher training programs, training students, keeping on researching for finding effective teaching technique and tools and being open to changes etc. In addition, the study also acknowledges its limitations like not being able to consider the psychological factors due to time limitation. Finally, at the end the study points out the areas that welcome further research.

Heteroscedasticity of Random Effects in Crossover Design

  • Ahn, Chul-H.
    • Proceedings of the Korean Statistical Society Conference
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    • 2002.11a
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    • pp.79-83
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    • 2002
  • A phase III clinical trial of a new drug for neutropenia induced by chemotherapy is presented and consider adding random effects in crossover design which was used in the clinical study. The diagnostics for its heteroscedasticity based on score statistic is derived for detecting homoscedasticity of errors in crossover design. A small simulation study is peformed to investigate the finite sample behaviour of the test statistic which is known to have an asymptotic chi-square distribution under the null hypothesis.

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