• Title/Summary/Keyword: Multi-center Trial

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Development of Standardized Predictive Models for Traditional Korean Medical Diagnostic Pattern Identification in Stroke Subjects: A Hospital-based Multi-center Trial

  • Jung, Woo-Sang;Cho, Seung-Yeon;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Kwon, Seungwon
    • The Journal of Korean Medicine
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    • v.40 no.4
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    • pp.49-60
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    • 2019
  • Objectives: To develop a standardized diagnostic pattern identification equation for stroke patients, our group conducted a study to derive the predictive logistic equations. However, the sample size was relatively small. In the current study, we aimed to derive new predictive logistic equations for each diagnostic pattern using an expanded number of subjects. Methods: This study was a hospital-based multi-center trial recruited stroke patients within 30 days of symptom onset. Patients' general information, and the variables related to diagnostic pattern identification were measured. The diagnostic pattern of each patient was identified independently by two Korean Medicine Doctors. To derive a predictive model for pattern identification, binary logistic regression analysis was applied. Results: Among the 1,251 patients, 385 patients (30.8%) had the Fire Heat Pattern, 460 patients (36.8%) the Phlegm Dampness Pattern, 212 patients (16.9%) the Qi Deficiency Pattern, and 194 patients (15.5%) the Yin Deficiency Pattern. After the regression analysis, the predictive logistic equations for each pattern were determined. Conclusion: The predictive equations for Fire Heat, Phlegm Dampness, Qi Deficiency, and Yin Deficiency would be useful to determine individual stroke patients' pattern identification in the clinical setting. However, further studies using objective measurements are necessary to validate these data.

An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease (파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜)

  • HuiYan Zhao;Ojin Kwon;Bok-Nam Seo;Seong-Uk Park;Horyong Yoo;Jung-Hee Jang
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.1-10
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    • 2024
  • Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • Genomics & Informatics
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    • v.16 no.3
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    • pp.52-58
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    • 2018
  • In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

Low-Tube-Voltage CT Urography Using Low-Concentration-Iodine Contrast Media and Iterative Reconstruction: A Multi-Institutional Randomized Controlled Trial for Comparison with Conventional CT Urography

  • Kim, Sang Youn;Cho, Jeong Yeon;Lee, Joongyub;Hwang, Sung Il;Moon, Min Hoan;Lee, Eun Ju;Hong, Seong Sook;Kim, Chan Kyo;Kim, Kyeong Ah;Park, Sung Bin;Sung, Deuk Jae;Kim, Yongsoo;Kim, You Me;Jung, Sung Il;Rha, Sung Eun;Kim, Dong Won;Lee, Hyun;Shim, Youngsup;Hwang, Inpyeong;Woo, Sungmin;Choi, Hyuck Jae
    • Korean Journal of Radiology
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    • v.19 no.6
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    • pp.1119-1129
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    • 2018
  • Objective: To compare the image quality of low-tube-voltage and low-iodine-concentration-contrast-medium (LVLC) computed tomography urography (CTU) with iterative reconstruction (IR) with that of conventional CTU. Materials and Methods: This prospective, multi-institutional, randomized controlled trial was performed at 16 hospitals using CT scanners from various vendors. Patients were randomly assigned to the following groups: 1) the LVLC-CTU (80 kVp and 240 mgI/mL) with IR group and 2) the conventional CTU (120 kVp and 350 mgI/mL) with filtered-back projection group. The overall diagnostic acceptability, sharpness, and noise were assessed. Additionally, the mean attenuation, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and figure of merit (FOM) in the urinary tract were evaluated. Results: The study included 299 patients (LVLC-CTU group: 150 patients; conventional CTU group: 149 patients). The LVLC-CTU group had a significantly lower effective radiation dose ($5.73{\pm}4.04$ vs. $8.43{\pm}4.38mSv$) compared to the conventional CTU group. LVLC-CTU showed at least standard diagnostic acceptability (score ${\geq}3$), but it was non-inferior when compared to conventional CTU. The mean attenuation value, mean SNR, CNR, and FOM in all pre-defined segments of the urinary tract were significantly higher in the LVLC-CTU group than in the conventional CTU group. Conclusion: The diagnostic acceptability and quantitative image quality of LVLC-CTU with IR are not inferior to those of conventional CTU. Additionally, LVLC-CTU with IR is beneficial because both radiation exposure and total iodine load are reduced.

A parameter calibration method for PFC simulation: Development and a case study of limestone

  • Xu, Z.H.;Wang, W.Y.;Lin, P.;Xiong, Y.;Liu, Z.Y.;He, S.J.
    • Geomechanics and Engineering
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    • v.22 no.1
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    • pp.97-108
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    • 2020
  • The time-consuming and less objectivity are the main problems of conventional micromechanical parameters calibration method of Particle Flow Code simulations. Thus this study aims to address these two limitation of the conventional "trial-and-error" method. A new calibration method for the linear parallel bond model (CM-LPBM) is proposed. First, numerical simulations are conducted based on the results of the uniaxial compression tests on limestone. The macroscopic response of the numerical model agrees well with the results of the uniaxial compression tests. To reduce the number of the independent micromechanical parameters, numerical simulations are then carried out. Based on the results of the orthogonal experiments and the multi-factor variance analysis, main micromechanical parameters affecting the macro parameters of rocks are proposed. The macro-micro parameter functions are ultimately established using multiple linear regression, and the iteration correction formulas of the micromechanical parameters are obtained. To further verify the validity of the proposed method, a case study is carried out. The error between the macro mechanical response and the numerical results is less than 5%. Hence the calibration method, i.e., the CM-LPBM, is reliable for obtaining the micromechanical parameters quickly and accurately, providing reference for the calibration of micromechanical parameters.

Computational Methods for On-Node Performance Optimization and Inter-Node Scalability of HPC Applications

  • Kim, Byoung-Do;Rosales-Fernandez, Carlos;Kim, Sungho
    • Journal of Computing Science and Engineering
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    • v.6 no.4
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    • pp.294-309
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    • 2012
  • In the age of multi-core and specialized accelerators in high performance computing (HPC) systems, it is critical to understand application characteristics and apply suitable optimizations in order to fully utilize advanced computing system. Often time, the process involves multiple stages of application performance diagnosis and a trial-and-error type of approach for optimization. In this study, a general guideline of performance optimization has been demonstrated with two class-representing applications. The main focuses are on node-level optimization and inter-node scalability improvement. While the number of optimization case studies is somewhat limited in this paper, the result provides insights into the systematic approach in HPC applications performance engineering.

Development of a Design System for Multi-Stage Gear Driver (1st Report : Proposal Formal Processes for Dimensional Design)

  • Chong, Tae-Hyoun
    • International Journal of Precision Engineering and Manufacturing
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    • v.2 no.2
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    • pp.57-64
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    • 2001
  • In recent years, the concern of designing multi-stage gear drives ha increased with more application of them in high-speed and high-load. Until now, however, the researches on the design of gear drives have been focused on single gear pairs. Thus the design practice for multi-stage gear drives has been depended on experiences and expertise of designers and carried out commonly by trial and error. We propose an automation algorithm for the design of two-and three-strage cylindrical gear drives. The two types of dimensional design processes have been proposed to determine gear dimensions in a formal way. The first design process(Process I) uses to total volume of gears to determine gear ration , and uses K factor , unit load and aspect ration to determine gear dimensions, The second one(Process II) makes use of Niemann's formula and center distance to calculate gear ratio and gear dimensions. Process I and Process II employ material date from AGMA and ISO standards, respectively. The configuration design determines the positions of gears with minimizing the volume of gearbox by using a simulated annealing algorithm. The availability of the design algorithm is validated by the design examples to two-and three=stage gear drives.

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Development of a Design System for Multi-Stage Gear Drives (1st Report : Procposal of Formal Processes for Dimensional Design of Gears) (다단 치차장치 설계 시스템 개발에 관한 연구(제 1보: 정식화된 제원 설계 프로세스의 제안))

  • Jeong, Tae-Hyeong
    • Journal of the Korean Society for Precision Engineering
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    • v.17 no.9
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    • pp.202-209
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    • 2000
  • In recent years the concern of designing multi-stage gear drives increases with the more application of gear drives in high-speed and high-load. until now however research on the gear drive design has been focused on single gear pairs and the design has been depended on experiences and know-how of designers and carried out commonly by trial and error. We propose the automation of the dimensional design of gears and the configuration design for gear arrangement of two-and three-stage cylindrical gear drives. The dimensional design is divided into two types of design processes to determine the dimensions of gears. The first design process(Process I) uses the total volume of gears to determine gear ratio and uses K factor unit load and aspect ratio to determine gear dimensions. The second one(Process II) makes use of Niemann's formula and center distance to calculate gear ratio and dimensions. Process I and II employ material data from AGMA and ISO standards respectively. The configuration design determines the positions of gears to minimize the volume of gearbox by simulated annealing algorithm. Finally the availability of the design algorithm is validated by the design examples of two-and three-stage gear drives.

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Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial (폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구)

  • Kim, Jung-Eun;Choi, Sun-Mi;Choi, Jin-Bong;Kim, Hyeong-Jun;Kwon, Ojin;Kim, Jae-Hong;Park, Ji-Eun
    • Korean Journal of Acupuncture
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    • v.34 no.3
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

Sequential patient recruitment monitoring in multi-center clinical trials

  • Kim, Dong-Yun;Han, Sung-Min;Youngblood, Marston Jr.
    • Communications for Statistical Applications and Methods
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    • v.25 no.5
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    • pp.501-512
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    • 2018
  • We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.