• Title/Summary/Keyword: Phase I study

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Prediction of Distribution for Five Organic Contaminants in Biopiles by Level I Fugacity Model (Level I Fugacity Model을 이용한 Biopile 내 유기화합물 5종의 분포 예측)

  • Kim, Kye-Hoon;Kim, Ho-Jin;Pollard, Simon J.T.
    • Korean Journal of Soil Science and Fertilizer
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    • v.41 no.3
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    • pp.228-234
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    • 2008
  • The purpose of this study was to predict environmental distribution of anthracene, benzene, benzo[a]pyrene, 1-methylphenanthrene and phenanthrene in a four phase biopile system - air, water, soil and non aqueous phase liquid (NAPL) phase using level I fugacity model. Soil samples used for this study were collected from three sites in the United Kingdom which were historically contaminated with petroleum hydrocarbons. The level I fugacities (f) for the five contaminants were markedly different, however, the fugacities of each contaminant in three soil samples did not show significant difference. NAPL and soil were the dominant phases for all five contaminants. Results of this study indicated that difference in percentage of organic carbon strongly influenced the partitioning behavior of the cntaminants. The presence of benzene calls for an urgent need for risk-based management of air and water phase. Whereas insignificant amount of chemicals leached in the water phase for other organic contaminants showing greatly reduced potential of groundwater contamination. Furthermore, this study helped us to confirm the association of risk critical contaminants with the residual saturation in treated soils. They also can be used to emphasize the importance of accounting for the partitioning behavior of both NAPL and soil phases in the process of the risk assessment of the sites contaminated with petroleum hydrocarbons.

Determination of Grayanotoxin I and Grayanotoxin III in mad honey from Nepal using liquid chromatography-tandem mass spectrometry

  • Ahn, Su Youn;Kim, Suncheun;Cho, Hwangeui
    • Analytical Science and Technology
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    • v.35 no.2
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    • pp.82-91
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    • 2022
  • Grayanotoxin-contaminated honey exhibits toxicity. In this study, a reliable and sensitive liquid-chromatography-tandem-mass-spectrometric method (LC-MS/MS) was developed and validated for the quantitation of grayanotoxin I and grayanotoxin III in honey. The grayanotoxins were extracted from honey via solid phase extraction and separated on a biphenyl column with a mobile phase consisting of 0.5 % acetic acid in water and methanol. Mass spectrometric detection was performed in the multiple-reaction monitoring mode with positive electrospray ionization. The calibration curve covered the range 0.25 to 100 ㎍/g. The intra- and inter-day deviations were less than 10.6 %, and the accuracy was between 94.3 and 114.0 %. The validated method was successfully applied to the determination of grayanotoxins in mad honey from Nepal. The concentrations of grayanotoxin I and grayanotoxin III in 33 out of 60 mad honey samples were 0.75 - 64.86 ㎍/g and 0.25 - 63.99 ㎍/g, respectively. The method established herein would help in preventing and confirming grayanotoxin poisoning.

Biomechanical Analysis on Change of Toe-out Angle in Squat (스쿼트 시 Toe-out 각도 변화에 따른 운동역학적 변인 분석)

  • Song, Hyeong Kyeong;So, Jae Moo
    • Korean Journal of Applied Biomechanics
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    • v.29 no.3
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    • pp.185-196
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    • 2019
  • Objective: The aim of this study was to suggest correct and effective way of squat through biomechanical analysis variables on the change of the toe-out angle. Method: 7 high school male weightlifter (age: $17.57{\pm}0.53yrs$, height: $174.0{\pm}3.93cm$, weight: $81.0{\pm}9.17kg$, 1RM: $164.29{\pm}20.7kg$) participated in this study. Results: Angle of the hip joint at E2 was smaller than toe-out angle was in $20^{\circ}$ than in $0^{\circ}$ (p<.05). Angular velocity of the foot joint at E1 and E3 was quicker that in $10^{\circ}$ than in $30^{\circ}$ (p<.05). Anterior-posterior stability index was greater that toe-out angle was in $30^{\circ}$ than in $0^{\circ}$ (p<.05). In average iEMG of flexion phase, VM of right, left leg showed high activity at toe-out angle $30^{\circ}$. In average iEMG of flexion phase, extension phase and in peak iEMG, RF of right leg, VM and VL of left leg showed high activity at all of the toe-out angles. In average iEMG of flexion phase, extension phase and in peak iEMG, all of the muscles activity of right leg showed high in $10^{\circ}$ and low in $0^{\circ}$, $30^{\circ}$. Conclusion: It is judged that setting the toe-out angle $10^{\circ}$ in squat help to efficiently use muscles and ensure stability.

The Comparison of Bunsen Reaction With Phase Separation in Sulfur-lodine Thermochemical Hydrogen Production Process (황-요오드 열화학 수소 제조 공정에서 분젠 반응과 상 분리 비고)

  • Lee, Kwang-Jin;Ahn, Sueng-Hyuk;Kim, Young-Ho;Park, Chu-Sik;Bae, Ki-Kwang
    • Transactions of the Korean hydrogen and new energy society
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    • v.19 no.2
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    • pp.111-117
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    • 2008
  • A Bunsen reaction section is a primary stage of Sulfur-iodine thermochemical hydrogen production cycle. This section is important, because it decides the efficiency of next stages. In order to produce hydrogen very efficiently, the characteristics of Bunsen reaction were investigated via two experimental methods. The one is a phase separation of $H_2SO_4-HI-H_2O-I_2$ mixture system, and the other is a direct Bunsen reaction. The characteristics of each method were investigated and compared. As the result of this study, the amount of HI and $I_2$ in $H_2SO_4$ phase via Bunsen reaction was more decreased than that via $H_2SO_4-HI-H_2O-I_2$ mixture system with increasing $I_2$ concentration. However, the amount of $H_2SO_4$ in $HI_x$ phase via Bunsen reaction was remarkably increased with increasing $I_2$ concentration, while that via $H_2SO_4-HI-H_2O-I_2$ mixture system was decreased. On the other hand, the range of initial composition which is able to separate into two liquid phases without $I_2$ solidification was almost alike.

Spinal Noradrenergic Modulation and the Role of the Alpha-2 Receptor in the Antinociceptive Effect of Intrathecal Nefopam in the Formalin Test

  • Jeong, Shin Ho;Heo, Bong Ha;Park, Sun Hong;Kim, Woong Mo;Lee, Hyung Gon;Yoon, Myung Ha;Choi, Jeong Il
    • The Korean Journal of Pain
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    • v.27 no.1
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    • pp.23-29
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    • 2014
  • Background: Nefopam has shown an analgesic effect on acute pain including postoperative pain. The reuptake of monoamines including serotonin and noradrenaline has been proposed as the mechanism of the analgesic action of nefopam, but it remains unclear. Although alpha-adrenergic agents are being widely used in the perioperative period, the role of noradrenergic modulation in the analgesic effect of nefopam has not been fully addressed. Methods: Changes in the antinociceptive effect of intrathecal (i.t.) nefopam against formalin-elicited flinching responses were explored in Sprague-Dawley rats pretreated with i.t. 6-hydroxydopamine (6-OHDA), which depletes spinal noradrenaline. In addition, antagonism to the effect of nefopam by prazosin and yohimbine was evaluated to further elucidate the antinociceptive mechanism of i.t. nefopam. Results: Pretreatment with i.t. 6-OHDA alone did not alter the flinching responses in either phase of the formalin test, while it attenuated the antinociceptive effect of i.t. nefopam significantly during phase 1, but not phase 2. The antagonist of the alpha-2 receptor, but not the alpha-1 receptor, reduced partially, but significantly, the antinociceptive effect of i.t. nefopam during phase 1, but not during phase 2. Conclusions: This study demonstrates that spinal noradrenergic modulation plays an important role in the antinociceptive effect of i.t. nefopam against formalin-elicited acute initial pain, but not facilitated pain, and this action involves the spinal alpha-2 but not the alpha-1 receptor.

Nutrient Utilization and Compensatory Growth in Crossbred (Bos indicus×Bos taurus) Calves

  • Santra, A.;Pathak, N.N.
    • Asian-Australasian Journal of Animal Sciences
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    • v.12 no.8
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    • pp.1285-1291
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    • 1999
  • A feeding trial was carried out over 238 days to determine the effect of compensatory growth in crossbred calves having 166 kg body weight. Fifteen crossbred calves were divided into two groups of five calves (G1 group) and ten calves (G2 group) as per randomized block design. Growth study was conducted on the feeding of wheat straw based diet containing 60 and 30 percent concentrate supplying equal amount of protein in group G1 and G2 respectively for 119 days (phase - I). At the end of phase-I, calves of G2 group were subdivided in to two groups (G3 and G4). One sub group (G4) received 60% concentrate in their diet (during 120 to 238 days of experiment) while other subgroup G3 received 30% concentrate in their diet (phase-II). The calves of G1 group continued to receive the same diet as during phase-I experiment. Mean DM intake was significantly higher in calves fed high level of concentrate (in G1 and G4 groups), which resulted in significantly higher digestibility of all nutrients except NDF. Nitrogen balance was positive in all the groups and showed significant differences in phase-II (higher nitrogen retention in G4 group than G1 group). ME intake was significantly affected by the level of dietary concentrate, being higher in high concentrate fed group (G1 and G4 than G2 and G3 group). Higher daily body weight gain in the calves of G4 group during phase-II than in G1 and G3 groups was due to compensatory growth on shifting animals from low concentrate to high concentrate based ration. Average daily body weight gain was higher in phase-I than in the phase-II. Protein and energy intake per unit body weight gain were significantly lower in calves fed high concentrate diet.

The Correlation of Voice Characteristics and Depression Index Analysis in Accordance with Menstrual Cycle (월경주기에 따른 우울지수 정도와 음성특성과의 상관관계 분석)

  • Kim, YuMi;Jang, Seoung-Jin;Kim, Eunyeon;Choi, Yaelin
    • Phonetics and Speech Sciences
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    • v.6 no.3
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    • pp.41-48
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    • 2014
  • This study investigated the differences between emotional parameters BDI, VHI, STAI-X-I and STAI-X-II according to the menstrual cycles of the female and the relation between changes of the depression index and voice characteristics (jitter, shimmer, CPP, HNR, $pF0{\cdot}F1{\cdot}F2{\cdot}F3$, sF0, sF4, sB1, $H1_{c/u}$, $A1_u$, $A3_c$, $H1A3_{c/u}$, $H1A1_u$). Twenty three females ($30{\pm}4.4$ years old) living in Seoul and Gyeonggi Province were participated in this study to answer the questionnaires and record their voice. The participants prolonged /a/ vowel for 5 seconds in a natural condition for their voice recording. Voice data were analyzed using the Matlab and Praat program. A t-test and a correlation analysis were conducted by using SPSS for the statistical analysis. The results are as follows. First, the BDI is significantly higher in group I (lurear phase contrast the menstrual period) and group II (follicular phase against the menstrual period) than group III (luteal phase for follicular phase) (p<.05). Second, shimmer, CPP, pF0 showed a statistically high correlation regarding the BDI in group I (lurear phase contrast the menstrual period). Voice parameters may be useful as supplement in evaluating the emotional change in the phase of menstrual cycle.

An R package UnifiedDoseFinding for continuous and ordinal outcomes in Phase I dose-finding trials

  • Pan, Haitao;Mu, Rongji;Hsu, Chia-Wei;Zhou, Shouhao
    • Communications for Statistical Applications and Methods
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    • v.29 no.4
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    • pp.421-439
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    • 2022
  • Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

Maximum tolerated dose estimation by Biased coin design and stopping rule in Phase I clinical trial (제 1상 임상시험에서 Biased Coin Design과 멈춤규칙을 이용한 MTD 추정법)

  • Jeon, Soyoung;Kim, Dongjae
    • The Korean Journal of Applied Statistics
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    • v.33 no.2
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    • pp.137-145
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    • 2020
  • Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

A Comparison Study of Cervical Flexion-Relaxation Ratio in the Normal and Forward Head Postures

  • Yeo, Sang-Seok;Kwon, Jung-Won
    • The Journal of Korean Physical Therapy
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    • v.32 no.6
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    • pp.378-382
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    • 2020
  • Purpose: This study aimed to examine the effects of forward head posture on the flexion-relaxation ratio (FRR) and muscle activity during sustained neck flexion and to investigate the correlation between craniovertebral angle and FRR. Methods: Nineteen subjects participated in this study and were allocated to a forward head posture (FHP) group or a non-forward head posture (NFHP) group. Craniovertebral angle (CVA) and FRR were measured in all subjects, and all participants performed a standardized cervical flexion-extension movement in two phases: Phase I, sustained cervical full flexion for 5s; and Phase II, cervical extension with the return to the starting position for 5s. The value of CVA has calculated three times, and the value of FRR was measured three times in order to obtain the mean value. Results: FRR values in the FHP and NFHP group were significantly different (p<0.05). Phase I was significantly different, but the Phase II was not significantly different between the FHP and NFHP group (p>0.05). There was a significant correlation between the muscle activity of Phase I and CVA (p<0.05). However, FRR and the muscle activity of the Phase II were not a significant correlation with the CVA (p>0.05). Conclusion: FHP increases the muscle activity of the cervical erector spinae during sustained neck flexion and reduces FRR, which can cause fatigue in the cervical erector spinae. In addition, for those with a smaller CVA, muscle activity of the cervical erector spinae is increased during sustained neck flexion, which can increase neck muscle tension.