• Title/Summary/Keyword: Stage I and II

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Phase II two-stage single-arm clinical trials for testing toxicity levels

  • Kim, Seongho;Wong, Weng Kee
    • Communications for Statistical Applications and Methods
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    • v.26 no.2
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    • pp.163-173
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    • 2019
  • Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

The Post-glacial Vegetation History of the Lowland in Korean Peninsula (한반도 후빙기의 저지대 식생사)

  • 최기룡
    • The Korean Journal of Ecology
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    • v.21 no.2
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    • pp.169-174
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    • 1998
  • This is the review of vegetational history of the post-glacial period in Korea. most of studies for vegetational changes are located in the lowland alluvial plain, especially below the hilly zone of western and eastern coastal regions of Korea. A couple of methods, pollen analysis and radiocarbon dating, have been employed in these studies. These results lead us to establish the pollen zonation in Korea as the followings. Yasuda et al.(1980) classified six period in Yongrang lake of sokcho. These are as follow I. 17,000-15,000yr B.P.: Picea, Abies, Pinus(Haploxylon), Larix stage, II.15,000-10,000yr B.P:Herb, Pteridophyta stage, III.10.000-6,700yr BP.:Quercus stage, IV.6,700-4,500yr B.P.:Pinus, Quercus, Carpinus stage, V.4,500-1,400yr B.P.:Quercus. Pinus stage, VI.1,400yr B.P.-present: Pinus, Herbs stage. Jo(1979) also divided the period into two stages from the outcomes of analysis done in Jumoonjin and other sites I.10,000-6,000yr B.P.:Quercus stage, II.6,000-present: Pinus-Quercus stage, and three substages: IIa.6,000-3,400 yr B.P.:lower Pinus stage, IIb.3,400-2,000yr B.P.:Pinus-Quercus stage, IIc.2,000-present: Pinus stage. Choi(1993, 1996) divided the period into three stages: I.6,000-5,000yr B.P.:Alnus, Quercus stage, II.5,000-4,000yr B.P.: Alnus, Quercus, Pinus stage, III.4,500-2,600yr B.P.: Alnus, Pinus stage. In the period around 6,000yr B.P. distinct dominant species clearly occupied the lowland of the eastern and western coasts. Thus, this strongly supports the fact that even if Korea experienced its warm and wet climate after the lateglacial, it underwent a different environmental change, dry climate, compared to the regions of Japan.

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On the Occurrences of Pyrrhotite from the Yeonhwa 1 Mine, Korea

  • Chung, Jae-Il;Lee, Young-Up
    • Journal of the Korean earth science society
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    • v.24 no.1
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    • pp.36-45
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    • 2003
  • This study is made for examining the characteristics of the lead-zinc deposition from the mineralogy of pyrrhotite at the Yeonhwa 1 Mine, Korea. The pyrrhotite of the Yeonhwa 1 mine is divided two species; the pynhotites I and II. The pyrrhotite I that represents the product in Stage II mineralization is characterized by hexagonal pyrrhotite occurring as the mechanical mixtures of hexagonal and monoclinic phases with various proportion. These mixtures might be formed from 'primary' hexagonal pyrrhotite by the subsequent retrograde reaction and/or by the influence of later mineralization in Stage III. Whereas the pyrrhotite II crystallized out in later Mineralization Stage III (hydrothermal stage) is always monoclinic variant with ferromagnetic properties; no two phase mixtures have been recognized.

Effect of Food and Salinity on Larval Growth and Survival of the River Puffer, Takifugu obscurus (황복, Takifugu obscurus의 초기 발달 동안 성장 및 생존에 있어 먹이와 염분의 효과)

  • 강희웅;강덕영;조기채;이진호;박광재;김종화
    • Journal of Aquaculture
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    • v.17 no.3
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    • pp.221-227
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    • 2004
  • In the present study, we investigated the effects of food and salinity on growth and survival of river puffer, Takifugu obscurus offsprings in indoor land-based tank during the early development. In the food experiment, the river puffer larvae (TL 8.7$\pm$0.1 mm, BW 20.0$\pm$3.2 mg) were fed with tubificid, Limnodrilus gotoi, water flea, Daphnia carinata, mysid, Neomysis awatschensis, Manila clam, Ruditapes philippinarum and artificial food together Artemia nauplii for 30 days, and the growth and the survival of larvae were investigated. In the salinity experiment, the river puffer larvae and juvenile at three stages (Stage I: TL 5.8$\pm$0.4 mm; Stage II: TL 12.0$\pm$0.2 mm, Stage III: TL 44.5$\pm$0.7 mm) were supplied with Artemia nauplii, water flea and/or artificial food and were reared in 0, 10, 20 and 30 psu at respective stages. The results shows that the growth rates of larvae feeding with artificial food and tubificid together Artemia nauplii were higher than those of larvae in other groups, but the survival rates of larvae feeding with water flea and mysid together Artemia nauplii were higher than those of larvae in other groups. In salinity, the results shows that the growth and survival rates of offsprings were significantly higher in 10∼20 psu than those in 0 and 30 psu at Stage I and n. At Stage III, the growth and the survival rates were the highest in 20 psu, but the lowest in 0 psu. However, it should be noted that the rates in 0 and 30 psu were significantly enhanced at Stage III in comparison with those at Stage I and II. Therefore, it is concluded that river puffer, T. obscurus is euryhaline marine species, which can normally grow and live at salinities from 0 to 30 psu, and that a combinative supplement with Artemia nauplii and water flea, D. carinata may confer an advantage on growth and survival of the river puffer offsprings in indoor land-based tank.

Development of Selenium Value-added Rice by Organic Selenium Foliar Spray Application (유기 셀레늄 (Organic Selenium) 엽면처리에 의한 셀레늄 강화 쌀 개발)

  • Won, Dong Wook;Kim, Sun-Ju
    • Korean Journal of Environmental Agriculture
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    • v.38 no.1
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    • pp.47-53
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    • 2019
  • BACKGROUND: This experiment was conducted to examine the effects of organic Se concentration and the number of foliar applications on growth characteristics and Se content in rice. METHODS AND RESULTS: A series of multiple foliar applications were performed at (1) 3 times (maximum tillering stage + booting stage + heading stage), (2) 4 times I (effective tillering stage + maximum tillering stage + booting stage + heading stage), (3) 4 times II (maximum tillering stage + booting stage + heading stage + grain filling stage) according to the development stage. Each set of the foliar application plots was treated with 0, 10, 20, 40, 60, 100 ppm of Se and with mixed pesticide ($P^*$ + Se 40 ppm) in which the treatment time was the same as that of the treatment 4 times II. The total cultivation period of rice was 184 days. Se contents in rice (brown rice, white rice) were analyzed by ICP. CONCLUSION: The number of grains per head tended to decrease with increasing concentrations of organic Se in all treatments. However, number of panicles per hill did not show statically significant differences between the 3 times and 4 times I treatments. The grain yield decreased with the 3 times and 4 times II, but there was no significant difference in 4 times I. Se content in brown rice was the highest at 100 ppm Se (5268.64) treatment and lowest at 10 ppm Se ($1269.19{\mu}g{\cdot}kg^{-1}$) treatment. Se content in the polished rice was the highest at 100 ppm Se (5047.33) treatment and lowest at 10 ppm Se ($885.05{\mu}g{\cdot}kg^{-1}$) treatment. The higher selenium was treated, the higher Se content was found in the rice (brown rice, polished rice).

The Prognostic Effect of Subpleural Lesions in Early Stage Non-small Cell Lung Cancer - Preliminary Report - (초기 비소세포 폐암 환자의 늑막하 병변이 예후에 미치는 영향; 예비 보고)

  • Lee, Ho-Jun;Lee, Hyung-Sik;Hur, Won-Joo;Lee, Ki-Nam;Choi, Pill-Jo
    • Radiation Oncology Journal
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    • v.16 no.4
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    • pp.425-431
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    • 1998
  • Purpose : We retrospectively analyzed the impact of subpleural lesions of early stage non-small cell lung cancer on the patterns of failure to support selection of postoperative adjuvant therapy. Methods and Materials : The study included 91 patients who underwent surgery for early stage non-small cell lung cancer at Dong-A University Hospital from Dec 1990 to Sep 1996. Twenty five patients were excluded due to postoperative mortality (four patients, 4.4$\%$) and stage III (21 patients). Of 66 patients, 22 patients were subpleural lesions (15 patients in stage I, and seven patients in stage II). Postoperative adjuvant radiation therapy was given to seven patients with T2Nl disease. The median follow-up duration was 29.5 months (range; 8-84 months). Results : The overall survival rate was 69.5$\%$ at 3 years. For all patients who presented with (22 patients) and without (44 patients) subpleural lesions, 3-year overall survival rates were 35.5$\%$ and 84.6$\%$, respectively (p=0.0017). For stage I patients who presented with (15 patients) and without (29 patients) subpleural lesions, 3-year overall survival rates were 33.1$\%$ and 92.3$\%$, respectively (p=0.001). For stage II patients who presented with (7 patients) and without (15 patients) subpleural lesions, 3-year overall survival rates were 53.3$\%$ and 45.7$\%$, respectively (p=0.911). For patients with T2N0 disease (34 patients) who presented with (11 patients) and without (23 patients) subpleural lesions, 3-year overall survival rates were 27.3$\%$ and 90.3$\%$, respectively (p=0.009). Conclusion : These observations suggest that the subpleural lesion play an important role as a prognostic factor for early stage non-small cell lung cancer. Especially for T2N0 disease, patients with subpleural lesions showed significantly lower survival rate than those without that.

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Transgressive Geochemical Records in the East China Sea: A Perspective with Holocene Paleoceanography

  • Hyun Sangmin;Lim Dhong-il;Yoo Hai-Soo
    • Economic and Environmental Geology
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    • v.39 no.1 s.176
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    • pp.53-61
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    • 2006
  • Geochemical and sedimentological analyses of sediment piston core were used to trace paleoceanographic environmental changes in the East China Sea. The analytical results revealed three lithostratigraphic units (I, II, and III) corresponding to a highstand stage, a transgressive stage, and a lowstand stage, respectively. Accelerator mass spectrometry (AMS) $^{14}C$ dated the boundaries between the units as 7 ka and II ka. That is, Unit I extended from the present to 7 ka, Unit II occupied a transitional episode from 7 to 11 ka, and Unit III was older than 11 ka. The transitional episode was characterized by sudden fluctuations in various geochemical proxies. Most strikingly, there was a gradual upward increase in both carbonate and total organic carbon (TOe) contents post-7 ka, during which time the ${\delta}^{l3}C$ values of organic material increased to a constant value. The gradual upward increase in the TOC and $CaCO_3$ contents in Unit I were accompanied by slight variations in grain size that probably reflect a stable modern oceanographic environment. Within Unit II (7 to 11 ka), the geochemical signals were characterized by abrupt and steep fluctuations, typical of a transgressive stage. Vertical mixing may have provoked an increase in productivity during this interval, with large amounts of terrigenous organic matter and/or freshwater being supplied by neighboring rivers. The geochemical signals remained stable throughout Unit III but exhibited different patterns than signals in Unit I. The high terrigenous organic matter content of Unit III suggests correspondence to a lowstand stage.

Changes and Distributional Pattern of Microflora in Cotton Waste Media of Oyster Mushroom Cultivation (느타리버섯 균상재배 중 배지내 미생물상의 변화 및 분포양상)

  • Lee, Chan-Jung;Yu, Hyung-Sik;Jhune, Chang-Sung;Cheong, Jong-Chun;Han, Hye-Su
    • The Korean Journal of Mycology
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    • v.37 no.2
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    • pp.150-154
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    • 2009
  • The diversity of microflora according to growth stage of Pleurotus ostreatus and the correlation between microbe and medium fermentation were investigated. In farmhouse I, the aerobic bacteria and fungi as longer of growing period were increased. And, thermophilic bacteria and fluorescent Pseudomonas sp. showed high density at the early stage of spawn inoculation. The thermophilic actinomycetes were distributed evenly during all the growing period, but mesophilic actinomycetes were not observed. In farmhouse II, thermophilic actinomycetes were not observed in fermented medium and density of fungi were suddenly increased at 60 days after spawn inoculation. And also, mushrooms can hardly be harvested due to Penicillium spp. After medium fermentation, density of aerobic bacteria, thermophilic bacteria, and fluorescent Pseudomonas sp. was higher at farmhouse I than those of farmhouse II. In farmhouse I, Bacillus sp. and Pseudomonas sp. dominated at early stage of mushroom growth but as time goes by, density of Bacillus sp. was higher than the others. And also, the kind of microbe showed a few at early stage of mushroom growth but increased as time goes by. In farmhouse II, Bacillus sp. was dominated at early stage of mushroom growth. And the growth of Bacillus sp. and Pseudomonas sp. showed intersect aspect each other in the farmhouse I but Bacillus sp. dominated during all growth periods in the farmhouse II.

Result of Radiation Therapy for Stage I, II Non-Hodgkin's Lymphoma (I, II기 악성 림프종 환자의 방사선 치료 성적)

  • Lee, Kyu-Chan;Kim, Chul-Yong;Choi, Myung-Sun
    • Radiation Oncology Journal
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    • v.11 no.1
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    • pp.159-166
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    • 1993
  • A retrospective analysis was done for 69 patients with Stage I and II non-Hodgkin's lymphoma who were treated from May 1981 to December 1990, in the Department of Radiadtion Oncology, Korea University Hospital. We used Ann Arbor Staging system and Working Formulation for histological classification. Forty-three patients (43/69, $62.3{\%}$) were Stage I and 26 patients (26/69, $37.7{\%}$) were Stage II, and B symptom was found in $10.1{\%}$ (7/69). Nodal lymphoma was $21.7{\%}$ (15/69); 14 patients with supradiaphragmatic disease and 1 patient with infradiaphragmatic disease. Extranodal lymphoma was $78.3{\%}$ (54/69): $64.8{\%}$ (35/54) for head and neck, $25.9{\%}$ (14/54) for gastrointestinal tract. Histologically, low grade consists of $8.7{\%}$ (6/69), intermediate grade $84.2{\%}$ (56/69), high grade $10.1{\%}$ (7/69), and diffuse large cell type was the most frequent form with 36 patients (36/69, $52.2{\%}$). Eighteen patients ($26.1{\%}$) were treated with radiation therapy alone,20 patients ($29.0{\%}$) with radiation therapy combined with chemotherapy, 15 patients ($21.7{\%}$) with radiation therapy combined with surgery and chemotherapy, Median survival duration was 28 months, and the range of survival time was from 1 month to 134 months. Overall five-year survival rate for Stage I and II disease was $54.2{\%}$, with $64.5{\%}$ for Stage I and $37.1{\%}$ for Stage II. For nodal lymphoma,5-year survival rate was $45.9{\%}$, and $56.5{\%}$ for extranodal lymphoma; $60.6{\%}$ for head and neck, $52.9{\%}$ for GI tract primary disease. Local control rate for all patients was $88.4{\%}$ (61/69), with $80{\%}$ (12/15) for nodal lymphoma and $90.7{\%}$ (49/54) for extranodal lymphoma. The total failure rate was $34.8{\%}$ (24/69). Five of 24 ($20.8{\%}$) patients who were failed developed local failure only, $12.5{\%}$ (3/24) local failure with distant failure, and distant failure only were found in $66.7{\%}$ (16/24). Between nodal lymphoma and extranodal lymphoma, there was no significant survival difference, but extranodal lymphoma showed higher incidence.

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Evaluation of Hemodynamic Failure with Acetazolamide Challenged $^{123}I-IMP$ Brain SEPCT and PET (PET과 Acetazolamide 부하 $^{123}I-IMP$ 뇌혈류 SPECT를 이용한 혈역학적 부전의 평가)

  • Chun, Kyung-Ah;Cho, In-Ho;Won, Kyu-Jang;Lee, Hyung-Woo;Hayashida, Kohei
    • The Korean Journal of Nuclear Medicine
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    • v.37 no.2
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    • pp.94-102
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    • 2003
  • Purpose : Cerebral blood flow (CBF) reactivity to acetazolamide (ACZ) is useful to select patients with hemodynamic failure. However, it is still a matter of speculation that varying degrees of regional CBF increases after ACZ administration represent the severity or stage of regional hemodynamic failure as assessed by positron emission tomography (PET). We studied to elucidate whether ACZ challenge $^{123}I-IMP$ brain single photon emission tomography (SPECT) can accurately grade the seventy of regional hemodynamic failure. Materials and Methods: Eighteen patients (M: 16, F: 2, average age: 61 years) with unilateral occlusive disease of the internal carotid artery or the trunk of the middle cerebral artery (MCA). Patients undewent $^{123}I-IMP$ brain SPECT study with acetazolamide challenge and PET study was carried out within 2 weeks before and after SPECT study. Five healthy volunteers with a mean age of 48 years (range: 28-73 yr, M: 3, F: 2) underwent PET studies to determine normal values. In SPECT study, an asymmetry index (Al)-the percentage of radioactivity of region of interest (ROI) in the occlusive cerebrovascular lesion to the contralateral homologous ROI-was used for numerical evaluation of relative $^{123}I-IMP$ distribution. In PET study, regional CBF, oxygen extraction fraction (OEF), cerebral metabolic rate of oxygen ($CMRO_2$) and cerebral blood volume (CBV) values were measured with $^{15}O-labeled$ gas inhalation method and the values were used for comparison with Al (Al during acetazolamide challenge-Al of basal study) on the SPECT study. ROls were classified by severity into three groups (normal, stage I and stage II). Results: Mean values of Al in areas with normal, stage I and stage II hemodynamic failure were $6.25{\pm}7.77%\;(n=107),\;-10.38{\pm}10.41%\:(n=117)\;and\;13.30{\pm}10.51%\;(n=140)$, respectively. Al significantly differed with each groups (p<0.05). Correlation between Al and CBF, OEF and CBV/CBF in hemisphere with occlusive cerebrovascular lesion was 0.20 (p<0.01), -0.28 (p<0.01) and -0.28 (p<0.01), respectively. Conclusion: We concluded that $^{123}I-IMP$ brain SPECT with acetazolamide challenge could determine the severity ad stage of regional hemodynamic failure as assessed by PET.