• Title/Summary/Keyword: Phase I study

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Maximum Tolerated Dose Estimation Applied Biased Coin Design in a Phase I Clinical Trial

  • Kim, Yu Rim;Kim, Dongjae
    • Communications for Statistical Applications and Methods
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    • v.19 no.6
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    • pp.877-884
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    • 2012
  • Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

A Study on Quantitative Performance Index for Phase-Change Cooling Systems (상변화 냉각시스템의 정량적 성능지수 연구)

  • Jang, Myeong-Eon;Song, Hye-Eun
    • Journal of the Korea Institute of Military Science and Technology
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    • v.23 no.3
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    • pp.237-245
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    • 2020
  • In this paper, I introduce Phase-Change Cooling for thermal management of high power devices that can be applied to High Power Laser and Electric Propulsion Systems which are composed of multiple distributed superheat sources. Phase-Change Cooling can be good used to efficient cooling of their heat sources. Phase-Change Cooling has extremely high efficiency of two-phase heat transport by utilizing heat of vaporization, relatively low flow rates and reduced pumps power. And I suggest TPI(Thermal Performance Index) which is a quantitative performance index of Phase-Change Cooling for thermal management. I quantify the performance of Phase-Change Cooling by introducing TPI. I present the test results of TPI's changing refrigerant, heat sink and flow rate of the Phase-Change Cooling system through the experiments and analyze these results.

A Review of Dose Finding Methods and Theory

  • Cheung, Ying Kuen
    • Communications for Statistical Applications and Methods
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    • v.22 no.5
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    • pp.401-413
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    • 2015
  • In this article, we review the statistical methods and theory for dose finding in early phase clinical trials, where the primary objective is to identify an acceptable dose for further clinical investigation. The dose finding literature is initially motivated by applications in phase I clinical trials, in which dose finding is often formulated as a percentile estimation problem. We will present some important phase I methods and give an update on new theoretical developments since a recent review by Cheung (2010), with an aim to cover a broader class of dose finding problems and to illustrate how the general dose finding theory may be applied to evaluate and improve a method. Specifically, we will illustrate theoretical techniques with some numerical results in the context of a phase I/II study that uses trinary toxicity/efficacy outcomes as basis of dose finding.

A Study on the PR shaped SQAM error rate with carrier phase error (PR Shape된 SQAM의 오율에 반송파위상오차가 미치는 영향에 대한 연구)

  • 박용우;이형재
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.9 no.1
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    • pp.11-17
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    • 1984
  • A study is presented showing the effect of carrier phase error on the error-rate of a (Class I, II, IV)PR shaped SQAM digital communication system. A simple upper bound on the probabilty of error as a function of phase error is derived and compared to one another. The results show that the three system can be used appropriately if carrier phase error is less than 3$^{\circ}$. However, if phase error is larger than 3, the PR class I is the best choice.

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A Study on Performance Requirement of I/Q Impairments for RF Implementation in W-CDMA User Equipment (W-CDMA 사용자장치 RF 구현을 위한 I/Q 열화성능요구규격 연구)

  • Lee, Il-Kyoo
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.19 no.1
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    • pp.148-154
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    • 2005
  • This paper deals with performance degradations caused by RF I/Q impairments such as amplitude mismatch and phase mismatch in W-CDMA user equipment which uses QPSK(Quadrature Phase Shift Keying) modulation. The impacts of I/Q impairments on the BER(Bit Error Rate) are analyzed by using the variations of adjacent symbol distance. The BER versus amplitude mismatch and phase mismatch with QPSK constellation is reviewed through Matlab simulation. Performance degradation produced by RF I/Q impairments is measured with the implemented RF transceiver and modulation/demodulation test equipments through EVM(Error Vector Magnitude). The minimum performance requirements of amplitude mismatch and phase mismatch in W-CDMA user equipment are presented from the point of hardware implementation and the test method of the impairments is also included.

Analysis of Lower Extremity Muscle Activities in Parkinson's Patients for Improving to Stop Task (파킨슨 환자의 멈춤 보행 시 하지 근전도 분석)

  • Yang, Chang-Soo;Lim, Bee-Oh
    • Korean Journal of Applied Biomechanics
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    • v.22 no.3
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    • pp.333-339
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    • 2012
  • Freezing of gait is a severely problem in people with Parkinson's disease. The purpose of this study was to investigate the muscle activities of adductor longus, gluteus medius, gluteus maximus, biceps femoris, rectus femoris, gastrocnemius, and tibialis anterior using Noraxon 8 channels EMG system during stop task in patients with Parkinson's disease. Seven parkinson's patients and age matched normal participants were recruited in the study. Filtered EMG signals were rectified, smoothed and integrated. To control for the altered timing and magnitude of activity, iEMG was normalized for time and peak value. The results indicated that the patients with Parkinson showed decreased gait cycle, stance phase, swing phase time, swing phase time ratio and increased stance phase time ratio than normal participants. The patients with Parkinson showed decreased gastrocnemius muscle activity time ratio, while increased tibialis anterior muscle activity time ratio than normal participants. During stance phase before stop, the patients with Parkinson showed relatively lower average and peak iEMG in anterior tibialis and gastrocnemius muscle than normal participants. During swing phase before stop, the patients with Parkinson showed relatively higher average iEMG in gastrocnemius muscle than normal participants. During stop phase, the patients with Parkinson showed relatively lower average and peak iEMG in anterior tibialis and gastrocnemius muscle than normal participants.

Lectine-binding patterns of spermatogenic cells in the Jindo dog (진도견 정자형성계 세포들의 Lectin-binding patterns)

  • Park, Young-seok;Lee, Seong-ho
    • Korean Journal of Veterinary Research
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    • v.36 no.3
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    • pp.531-539
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    • 1996
  • The lectin-binding patterns in the testis of the sexually matured Jindo dog were investigated to study the distribution of glycoconjugates in the seminiferous tubule under light and transmission electron microscopy. Positive reactions to Wheat germ agglutinin(WGA) and Dolichos biflorus agglutinin (DBA) were observed in the Sertoli cell and in the residual body of spermatid with a stronger reaction in the Sertoli cell to the lectins than in the residual body. Strong reactions to Soybean agglutinin(SBA) and Peanut agglutinin(PNA) were observed in the acrosome vesicles of the Golgi- and cap-phase spermatid, while a moderate reaction was observed in the acrosome-phase, maturation-phase spermatid and the residual body. The acrosome area of the spermatid reacted intensively to Griffonia simplicifolia agglutinin( GS-I) when the cell was in the acrosome-phase and maturation-phase, and the same reaction to the GS-I was observed in the residual body. However, the seminiferous tubule did not react to Ulex europeus agglutinin I(UEA-I). The gold-labelling of the Sertoli cells with DBA resulted in positive reactions of the Sertoli cell column and processes when observed under the electron microscopy, while the Golgi-, cap- and acrosome-phase spermatids reacted positively to SBA in the peripheral low-dense area of the acrosome vesicle of spermatid. Based on these results, we concluded that differences in the lectin-binding pattern of the seminiferous tubules were recognized in the Jindo dog compared to other animals.

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Recovery of IGF-I Using Liquid Emulsion Membranes (액막법을 이용한 IGF-I 회수)

  • 최광수;문용일
    • Korean Journal of Animal Reproduction
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    • v.22 no.1
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    • pp.89-94
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    • 1998
  • A study was made to investigate the effects of concerning factors with IGF-I recovery on the final IGF-I concentration in the effluent and to establish recovery conditions of IGF-I using liquid emulsion membranes(LEM). D2EHPA was best carrier among Amberlite LA2, Aliquit 336 and D2EHPA for recovery rate of IGF-I. Recovery rate of IGF-I by D2EHPA volume in the oil phase was increased as increasing D2EHPA volume, and optimal volume of D2EHPA was 5% in this experiment. The recovery rate of IGF-I by D2EHPA was increased by the decreasing from pH 7 to pH 4 of external phase. Therefore, optimal pH value was 4.0. Optimal concentrations of sulfuric acid in internal phase, paraffin oil in oil phase and Span 80 for recovery rate of IGF-I were 0.1M, 2.0% and 5%, respectively, and optimal W/O rate was 2. These results suggested that optimal conditions for recovery of IGF-I were D2EHPA(5%) as carrier, pH 4.0, 0.1M sulfuric acid, 2% paraffin oil, 2.0 W/O rate and 5.0% Span 80.

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Early-Phase SPECT/CT for Diagnosing Osteomyelitis: A Retrospective Pilot Study

  • Soo Jin Lee;Kyoung Sook Won;Hyung Jin Choi;Yun Young Choi
    • Korean Journal of Radiology
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    • v.22 no.4
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    • pp.604-611
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    • 2021
  • Objective: The aim of this pilot study was to investigate the potential of early-phase single-photon emission computed tomography (SPECT)/computed tomography (CT) using technetium-99m methyl diphosphonate (99mTc-MDP) for diagnosing osteomyelitis (OM). Materials and Methods: Twenty-one patients with suspected OM were enrolled retrospectively. Three-phase bone scan (TPBS), early-phase SPECT/CT (immediately after blood pool planar imaging), and delayed-phase SPECT/CT (immediately after delayed planar imaging) were performed. The final diagnoses were established through surgery or clinical follow-up for over 6 months. We compared three diagnostic criteria based on (I) TPBS alone, (II) combined TPBS and delayed-phase SPECT/CT, and (III) early-phase SPECT/CT alone. Results: OM was diagnosed in 11 of 21 patients (nine surgically and two clinically). Of the 11 OM patients, criterion-I, criterion-II, and criterion-III were positive in six, seven, and 10 patients, respectively. Of the 10 non-OM patients, criterion-I, criterion-II, and criterion-III were negative in five, five, and seven patients, respectively. The sensitivity/specificity/accuracy of criterion-I, criterion-II, and criterion-III for diagnosing OM were 54.5%/50.0%/55.0%, 63.6%/50.0%/57.1%, and 90.9%/70.0%/87.5%, respectively. Conclusion: This pilot study demonstrated the potential of using the early-phase SPECT/CT to diagnose OM. Based on the results, prospective studies with a larger sample size should be conducted to confirm the efficacy of early-phase SPECT/CT.

Uncertainty and Nursing Need According to Illness Phases in Cancer Patients (질병단계별 암 환자의 불확실성과 간호 요구도)

  • Lee, Mi-Sun;Kim, Hee-Ju;Suh, Soon-Rim
    • Korean Journal of Adult Nursing
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    • v.20 no.1
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    • pp.1-9
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    • 2008
  • Purposes: This study examined uncertainty and nursing need according to illness phases(phase I, II, III) in cancer patients, and investigated relationships between uncertainty and nursing need. Methods: A cross-sectional descriptive study was conducted with a sample of 121 adult cancer patients treated in two hospitals. Results: As for the total score, the uncertainty was not significantly different across the subgroups by illness phase. As for the subscale score, however, two sub-scales of the uncertainty were different across the subgroups. 'The unpredictability' was highest in illness phase I and II groups, while 'the lack of information' was highest in the illness phase III group. Nursing need as the total score was not significantly different across the subgroups by illness phase. However, all subscale scores of the nursing need were significantly different across the subgroups. Educational need was highest in the illness phase I group; physical and emotional needs were highest in the illness phase III group. Uncertainty and nursing need were not related to each other at any illness phase. Conclusion: The results suggest that nursing need and uncertainty may change across illness phases. Clinicians need to consider this pattern in caring for cancer patients.

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