• Title/Summary/Keyword: Phase I study

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Preliminary Results of a Phase I/II Study of Simultaneous Boost Irradiation Radiotherapy for Locally Advanced Nasopharyngeal Carcinoma

  • Xiang, Li;Wang, Yan;Xu, Bing-Qing;Wu, Jing-Bo;Xia, Yun-Fei
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7569-7576
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    • 2013
  • Background: The purpose of this article is to present preliminary results of simultaneous boost irradiation radiotherapy for locally advanced nasopharyngeal carcinoma (NPC). Methods: Fifty-eight patients who underwent simultaneous boost irradiation radiotherapy for NPC in Cancer Center of Sun Yat-sen University between September 2004 and December 2009 were eligible. Acute and late toxicities were scored weekly according to the Radiation Therapy Oncology Group (RTOG) acute and late radiation morbidity scoring schemes. An especial focus was on evidence of post-radiation brain injury. Also quality of life was analysed according to the EORTC (European Organisation for Research and Treatment of Cancer) recommendations. Discrete variables were compared by ${\chi}^2$ test. The Kaplan-Meier method was used to calculate the survival rates and generate survival curves. Results: A total of 58 patients with a mean follow-up time of 36 months completed clinical trials.Fifty-seven patients (98.3) achieved complete remission in the primary sites and cervical lymph nodes, with only one patient (1.7%) showing partial remission.The most frequently observed acute toxicities during the concurrent chemoradiotherapy were mucositis and leucopenia. Four patients (6.9%) had RTOG grade 3 mucositis, whereas four patients (6.9%) had grade 3 leucopenia. No patient had grade 4 acute toxicity. Three (5.17%) of the patients exhibited injury to the brain on routine MRI examination, with a median observation of 32 months (range, 25-42months). All of them were RTOG grade 0. The 3-year overall, regional-free and distant metastasis-free survival rates were 85%, 94% and 91%, respectively. Conclusion: Simultaneous boost irradiation radiotherapy is feasible in patients with locally advanced nasopharyngeal carcinoma. The results showed excellent local control and overall survival, with no significant increase the incidence of radiation brain injury or the extent of damage. A larger population of patients and a longer follow-up period are needed to evaluate ultimate tumor control and late toxicity.

Development and validation of an LC-MS/MS method for determination of compound K in human plasma and clinical application

  • Kim, Jung Soo;Kim, Yunjeong;Han, Song-Hee;Jeon, Ji-Young;Hwang, Minho;Im, Yong-Jin;Kim, Jung Hyun;Lee, Sun Young;Chae, Soo-Wan;Kim, Min-Gul
    • Journal of Ginseng Research
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    • v.37 no.1
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    • pp.135-141
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    • 2013
  • A rapid, sensitive and selective analytical method was developed and validated for the determination of compound K, a major intestinal bacterial metabolite of ginsenosides in human plasma. Liquid-liquid extraction was used for sample preparation and analysis, followed by liquid chromatography tandem spectrometric analysis and an electrospray-ionization interface. Compound K was analyzed on a Phenomenex Luna C18 column ($100{\times}2.00$ mm, 3 ${\mu}m$) with the mobile phase run isocratically with 10 mM ammonium acetate-methanol-acetonitrile (5:47.5:47.5, v/v/v) at a flow rate of 0.5 mL/min. The method was validated for accuracy (relative error <12.63%), precision (coefficient of variation <9.14%), linearity, and recovery. The assay was linear over the entire range of calibration standards i.e., a concentration range of 1 ng/mL to 1,000 ng/mL ($r^2$ >0.9968). The recoveries of compound K after liquid-liquid extraction at 1, 2, 400, and 800 ng/mL were $106.00{\pm}0.08%$, $103.50{\pm}0.19%$, $111.45{\pm}5.21%$, and $89.62{\pm}34.46%$ for intra-day and $85.40{\pm}0.08%$, $94.50{\pm}0.09%$, $112.50{\pm}5.21%$, and $95.87{\pm}34.46%$ for inter-day, respectively. The lower limit of quantification of the analytical method of compound K was 1 ng/mL in human plasma. The developed method was successfully applied to a pharmacokinetic study of compound K after oral administration in ten of healthy human subjects.

Hexachlorobenzene Dechlorination Ability of Microbes from Canal and Estuary Sediments

  • Anotai, Jin;Voranisarakul, J.;Wantichapichat, W.;Chen, I.M.
    • Journal of Wetlands Research
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    • v.9 no.1
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    • pp.107-114
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    • 2007
  • This study aimed to investigate the hexachlorobenzene (HCB) dechlorinating ability of sediment microbes collected from a natural canal receiving secondary effluents from an industrial estate and nearby factories. Nine sites along the stream and one in the estuary in the Gulf of Thailand into which the canal spills were specified and sampling for sediment and water. Preliminary analysis of the sediments showed that the first four sites nearest to the discharging location were contaminated by HCB within the range of 0.18 to 1.25 ppm. Apart from that, 1,3,5-trichlorobenzene which has never been commercially produced or used in any manufacturing processes except for the transformation from higher chlorinated benzene was also identified in the range of 0.16 to 0.24 ppm. This suggested a possibility of sporadically HCB contamination in this stream. Of more important, people in the community along this canal earn their living by coastal fishery; hence, posing a risk of spreading HCB and its less chlorinated congeners via food chain from caught marine creatures to human. As a result, there is an urgent need to understand the behavior of HCB dechlorination in this stream sediment which can lead to a clean-up action in the future. Serum bottles with sediment slurries (sediment to water ratio of 1:1 (v/v) and filtered to remove particles larger than 0.7 mm) from each site were inoculated with 2 mg/l of HCB, kept anaerobically in the dark at room temperature without any nourishment, and analyzed for HCB and its less-chlorinated congeners every 6 days. Total chemical oxygen demand, suspended solids, and volatile suspended solids were in the range of 21,492-73,584, 158,100-518,100 and 6,000-32,700 mg/l, respectively. It was found that all sediment slurries began to dechlorinate HCB in 12 to 30 days and the HCB was completely removed within 42 to 60 days or so. On the other hand, there was no HCB dechlorination occurred in the controlled set which was sterilized by autoclaving prior to the addition of HCB. This implies that the HCB transformation was solely due to microorganisms' activities. HCB was dechlorinated principally via pentachlolobenzene to 1,2,3,5-tetrachlorobenzene and terminated at 1,3,5-trichlorobenzene which is the major pathway as reported by many researchers. Dichlorobenzene has not been detected in any samples within the dechlorination period of 60 days. The results indicate that the microbial matrix in the sediment of this stream has an outstanding capability to dechlorinate HCB. Existing substrates and nutrients which mainly sorbed onto the solid phase and the typical temperature in Thailand were sufficient and suitable to promote the activities of these HCB-dechlorinating microbes.

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Simultaneous Determination of B Group Vitamins in Supplemented Food Products by High Performance Liquid Chromatography-Diode Array Detection

  • Suh, Joon-Hyuk;Yang, Dong-Hyug;Lee, Byung-Kyu;Eom, Han-Young;Kim, Un-Yong;Kim, Jung-Hyun;Lee, Hye-Yeon;Han, Sang-Beom
    • Bulletin of the Korean Chemical Society
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    • v.32 no.8
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    • pp.2648-2656
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    • 2011
  • A simple HPLC-DAD method was developed and validated to determine B group vitamin content (thiamine, riboflavin, nicotinamide, pantothenic acid, pyridoxine and folic acid) in supplemented food samples, i.e., infant formula, cereal, low-calorie food, a multi-vitamin pill and a vitamin drink. In this study, the most significant advantages were simultaneous determination of the six B group vitamins in various food matrices and a small number of sample treatment steps that required only an organic solvent, acetonitrile. Moreover, this method prevents reduction of column durability, because the mobile phase does not contain ion-pairing reagents. Analytes were separated on a Develosil RPAQUEOUS $C_{30}$ (4.6 mm ${\times}$ 250 mm, 5 ${\mu}M$ particle size) column with a gradient elution of acetonitrile and 20 mM phosphate buffer (pH 3.0) at a flow rate between 0.8 and 1.0 mL/min. Detection was performed at 275 nm, except for that of pantothenic acid (205 nm). The calibration curves for all six vitamins showed good linearity with correlation coefficients ($r^2$) higher than 0.995. The developed method was validated with respect to linearity, intra- and inter-day accuracy and precision, limit of quantification (LOQ), recovery and stability. The method showed good precision and accuracy, with intra- and inter-assay coefficients of variation less than 15% at all concentrations. The recovery was carried out according to the standard addition procedure, with yields ranging from 89.8 to 104.4%. This method was successfully applied to the determination of vitamin B groups in supplemented food products.

Green Light-Emitting Phosphor, Ba2xCaMgSi2O8:Eux

  • Kim, Jeong-Seog;Piao, Ji-Zhe;Choi, Jin-Ho;Cheon, Chae-Il;Park, Joo-Suk
    • Journal of the Korean Ceramic Society
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    • v.42 no.3 s.274
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    • pp.145-149
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    • 2005
  • [ $Eu^{2+}$ ]-activated barium magnesium silicate phosphor, $(Ba,Ca)_{3}MgSi_{2}O_{8}:Eu_{x}$, has been known to emit blue-green light. In this study we report the manufacturing processes for producing either pure green or pure blue light-emitting phosphor from the same composition of $Ba_{2-x}Ca_{2}CaMgSi_{2}O_{8}:Eu_{x}$ (0 < x < 1) by controlling heat treatment conditions. Green light emitting phosphor of $Ba_{1.9}CaMgSi_{2}O_{8}:Eu_{0.1}$ can be produced under the sample preparation condition of highly reducing atmosphere of $23\%\;H_2/77\%\;N_2$, while blue or blue-green light emitting phosphor under reducing atmosphere of $5\~20\%\;H_2\;/\;95\~80\%$ N_2. The green light-emitting phosphors are prepared in two steps: firing at $800\~1000^{\circ}C$ for $2\~5$ h in air then at $1100\~1350^{\circ}C$ for 2-5 h under reducing atmo­sphere $23\%$ $H_2/77\%\;N_2$. The excitation spectrum of the green light-emitting phosphor shows a broadband of $300\~410$ nm. The emission spectrum has a maximum intensity at the wavelength of about 501 nm. The CIE value of green light emission is (0.162, 0.528). The pure blue light-emitting phosphors can be produced using the $Ba{2_x}CaMgSi_{2}O_{8}:Eu_{x}$ by introducing additional firing step at $1150\~1300^{\circ}C$ in air before the final reducing treatment. The XRD analysis shows that the green light-emitting phosphor mainly consisted of $Ba_{1.31}Ca_{0.69}SiO_{4}$ (JCPDS $\#$ 36-1449) and other minor phases i.e., $MgSiO_3$ (JCPDS $\#$ 22-0714) and $Ca_{2}BaMgSi_{2}O_{8}$ (JCPDS $\#$ 31-0128). The blue light-emitting phosphor mainly consisted of $Ca_{2}BaMgSi_{2}O_{8}$ phase.

Characteristics of Chaff Echoes Observed by X-band Dual Polarization Radar (X-밴드 이중편파레이더에서 관측된 채프에코의 특성)

  • Seo, Eun-Kyoung;Park, Sora;Nam, Kyung-Yeub;Heo, Sol-Ip
    • Journal of the Korean earth science society
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    • v.34 no.1
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    • pp.1-12
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    • 2013
  • To effectively remove chaff echoes, which are often misidentified as precipitation echoes on weather radars, this study examines the relationship between the radar reflectivity and each of dual polarimetric parameters. The dual polarimetric parameters are collected only for the echo areas identified as chaff echoes on the NIMR X-band dual polarization radar. Overall, the polarimetric parameters (i.e., reflectivity, differential reflectivity, cross correlation coefficient, standard deviation of differential reflectivity and specific differential phase) for chaff echoes have a wider range of values than those for precipitation echoes and the chaff filaments tend to be horizontally oriented to radar beams. There appears to be a considerable overlap in the cross correlation coefficient range of chaff and precipitation echoes since some precipitation echoes have cross correlation coefficient lower than 0.8. Therefore, although the cross correlation coefficient is known to be a good variable in identifying and separating chaff echoes from precipitation echoes, it is suggested that additional care should be taken when using the cross correlation coefficient solely in removing chaff echoes.

The Influence of PDGF-BB Application Time on the Proliferation of HGF Using Decalcifed Dentin (PDGF-BB 적용시간이 decalcified dentin에서의 치은섬유아세포의 증식에 대한 효과)

  • Park, Jin-Woo;Lee, Jae-Mok;Sun, Jo-Young
    • Journal of Periodontal and Implant Science
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    • v.26 no.4
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    • pp.873-887
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    • 1996
  • Platelet-derived growth factor(PDGF) is one of the polypeptide growth fators. PDGF has been reported as a biological mediator which regulates activities of wound healing process including the cell proliferation, migration and metabolism. Recent studies indicated that demineralized root surface as the primary site for growth factor application has advantages over other application method, especially due to binding capacity of growth factor for exposed matrix component of deminera1ized dentin surface. The purpose of this study is to evaluate optimal application time of PDGF-BB on proliferation of human gingival fibroblasts using deminera1ized dentin surface as primary application site. Human gingival fibroblasts and dentin slabs were prepared from the first premolar tooth extracted for the orthodontic treatment, cells were cultured in DMEM/I0% FBS at the $37^{\circ}C$, 5% CO2 incubator. All of the dentin slabs were preconditioned with Tetracycline HCI(100mg/ml) solution and rinsed in PBS. In the cell proliferation experiment, experimental group was immersed in DMEM containing 10% FBS, 50ng/rnl PDGF-BB during different time(30sec, 1, 2, 4, 8 minutes) and dried. Cells at concentration of $1{\times}10^5$cells/ml were seeded in each culture well which contained dentin slabs and incubated for 6 hours. Then, all of the dentin slabs were moved into new 24 well culture dish and incubated for 24, 48, 72 hours. The cell counting was done by hemocytometer with inverted phase contrast microscope after trypsinization. The results were as follows : The application of PDGF-BB for 1, 2 min slightly increased the number of gingival fibroblasts, and the application of PDGF-BB for 4, 8 min prominently increased the number of gingival fibroblasts. The application of PDGF-BB for 4 min showed maximum proliferation rate of gingival fibroblasts at 24, 48, 72 hours, and the application of PDGF-BB for 8 min showed less proliferation rate of gingival fibroblasts compared to the application of PDGF-BB for 4 min at 24, 48, 72 hours. In conclusion, the application of PDGF-BB for 4 min appeared to be optimal to obtain maximum proliferation of gingival fibroblasts using demineralized dentin surface as primary applicaton site of PDGF-BB.

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Evaluation of peri-implant bone density changes in $Br{\aa}nemark$ implants by computer assisted densitometric image analysis (CADIA) (디지털 공제술을 이용한 $Br{\aa}nemark$ 임플란트 주위 골조직 분석)

  • So, Sung-Soo;Noh, Hyuen-Soo;Kim, Chang-Sung;Choi, Seong-Ho;Chae, Jung-Kiu;Kim, Chong-Kwan;Cho, Kyoo-Sung
    • Journal of Periodontal and Implant Science
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    • v.37 no.1
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    • pp.137-150
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    • 2007
  • CADIA(Computer-assisted densitometric image analysis) method is used to analyze bone density changes around the implants. The usefullness and reproducibility of the method was assessed. We tried to find out if there is any possibility to quantitiate and qualitify peri-implant bone density change as time passes. And we concluded that this newly developed linear analysis is efficient for analyzing peri-implant bone density change non-Invasively. In this study, 2152 machined $Br{\aa}nemark$ fixtures installed from 1994 to 2002 in the department of Periodontics, Dental hospital of College of Dentistry, Yonsei University were included. Of these fixtures 22 radiographically analyzable failed fixtures were used as experimental group, and 22 successful implants placed in the same patient were used as control group. 1. 57 out of 1635 machined $Br{\aa}nemark$ standard and Mk II implants system failed, the survival rate was 96.5%. And 11 out of 517 machined $Br{\aa}nemark$ Mk III and Mk IV implants system failed, the survival rate was 97.9%. Total survival rate was 96.8%. 2. 22 failed implants were used for the analysis, 10 of which failed before prosthetic treatment due to infection and overheating. 12 failed due to overload after prosthetic treatment, 63.6% of which failed during the early phase of functional loading, i, e. before 1 year of loading. 3. Bone density change values around coronal region of the failed implants were $-6.54{\pm}6.35$, middle region were $-3.53{\pm}5.78$, apical region were $-0.75{\pm}10.33$, resulting in average of $-3.71{\pm}8.03$. 4. Bone density change values around coronal region of the successful implants were $4.25{\pm}4.66$, middle region were $6.33{\pm}5.02$, apical region were $9.89{\pm}4.67$, resulting in average of $6.27{\pm}5.29$. 5. There was a statistically significant difference between two groups (p<0.01). In conclusion, the linear analysis method using computer-assisted densitometric image analysis could be a useful method for the analysis of implants, and could be used for future implant researchs.

A Simulation Study for Selecting Optimum Position of a Superheater in a Waste Heat Recovery System Integrated with a Large Gasoline Engine (대형 가솔린 엔진의 폐열 회수 장치인 슈퍼히터의 최적 위치선정을 위한 시뮬레이션 연구)

  • Kim, Se Lin;Choi, Kyung Wook;Lee, Ki Hyung;Kim, Ki Bum
    • Transactions of the Korean Society of Mechanical Engineers B
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    • v.40 no.2
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    • pp.69-73
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    • 2016
  • Recently, automotive engineers have paid much attention to waste heat recovery technology as a possible means to improve the thermal efficiency of an automotive engine. A large displacement gasoline engine is generally a V-type engine. It is not cost effective to install two superheaters at each exhaust manifold for the heat recovery purposes. A single superheater could be installed as close to the exhaust manifold as possible for the higher recovery efficiency; however, only half of exhaust gas can be used for heat recovery. On the contrary, the exhaust temperature is decreased for the case where the superheater is installed at a junction of two exhaust tail pipes. With the fact in mind, the optimum position of a single superheater was investigated using simulation models developed from a commercial software package (i.e. AMESim). It was found that installing the superheater near the exhaust manifold could recover 3.8 kW more from the engine exhaust despite utilizing only half of the exhaust mass flow. Based on this result, the optimum layout of an automotive waste heat recovery system was developed and proposed in this paper.

A Study on Anisotropic Compression Behavior of Illite (일라이트의 비등방적 압축특성 연구)

  • Yun, Seohee;Lee, Yongjae
    • Korean Journal of Mineralogy and Petrology
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    • v.33 no.1
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    • pp.11-18
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    • 2020
  • High-pressure synchrotron X-ray powder diffraction experiments were performed on natural illite (K0.65Al2(Al0.65Si3.35)O10(OH)2) using diamond anvil cell (DAC) under two different pressure transmitting media (PTM), i.e., water and ME41 (methanol:ethanol = 4:1 by volume). When using water as PTM, occasional heating was applied up to about 250℃ while reaching pressure up to 2.7 GPa in order to promote both hydrostatic conditions and intercalation of water molecules into the layer. When using ME41, pressure was reached up to 6.9 GPa at room temperature. Under these conditions, illite did not show any expansion of interlayer distance or phase transitions. Pressure-volume data were used to derive bulk moduli (K0) of 45(3) GPa under water and 51(3) GPa under ME41 PTM. indicating no difference in compressibility within the analytical error. Linear compressibilities were then calculated to be βa = 0.0025, βb = 0.0029, βc = 0.0144 under ME41 PTM showing the c-axis is ca. six times more compressible than a- and b-axes. These elastic behaviors of illite were compared to muscovite, one of its structural analogues.