• Title/Summary/Keyword: e-clinical data

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Bioequivalence of Famcivir Tablet to FamvirTM Tablet 250 mg (Famciclovir 250 mg) (팜비어 정 250밀리그람(팜시클로버 250 mg)에 대한 팜시버 정의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Oh, In-Joon;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.4
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    • pp.295-301
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    • 2005
  • Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.

Periimplant bone change after alveolar ridge preservation: radiographic retrospective study (발치와 치조제 보존술 후 식립한 임플란트 주위 골 변화: 후향적 방사선학적 분석)

  • Shim, Da-Eun;Pang, Eun-Kyoung
    • The Journal of Korean Academy of Prosthodontics
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    • v.59 no.3
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    • pp.281-290
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    • 2021
  • Purpose. The aim of this study is to evaluate bone change around the implant in patients who underwent alveolar ridge preservation for implantation in the posterior teeth using radiographic data measuring changes of mesial, distal crestal bone level according to post-implantation, post-final prosthesis delivery and follow-up periods. Materials and methods. In total, 36 implants were placed in 32 patients. The mesial and distal crestal bone level of all the areas where alveolar ridge preservation was performed uses panoramic images taken post-implantation, post-final prosthesis delivery, and follow-up period each was measured and evaluated as a vertical value. The following factors were analyzed: associations between changes of crestal bone level and factors (e.g., age, sex, systemic diseases, dentist, implant location, tooth, bone type, membrane). The statistical analysis was performed using the mean, standard deviation and independent t-test, paired t-test (P < .05). Results. Analysis of crestal bone level differences between periods shows statistically significant differences (P < .05). There was no statistically significant difference when the changes of crestal bone level between post-implantation, post-final prosthesis delivery and follow-up periods were correlated with each factors. Conclusion. After alveolar ridge preservation, bone around the implant remained stable during the maintenance period without being affected by the patient and surgical factors, and alveolar ridge preservation is considered a clinically usable procedure.

The E-mail Survey on the Neck Pain for Acupuncture and Moxibustion Clinical Guideline (경항통에 관한 침구임상 진료지침 개발을 위한 전자우편 설문조사)

  • Kim, Hyun-Wook;Kim, Sung-Soo;Nam, Dong-Woo;Kim, Eun-Jung;Hong, Kwon-Eui;Kim, Sung-Chul;Kim, Sun-Woong;Lee, Jae-Dong;Kim, Kap-Sung;Lee, Geon-Mok
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.67-80
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    • 2009
  • Objectives : The purpose of this survey is the development on the neck pain for acupuncture and moxibustion clinical guideline. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results and Conclusions : 1. The first selected pattern identification on the neck pain This study shows that the meridian pattern identification was selected 35 times(61.4%), the pattern identification based on cause of disease was selected 8 times(14.0%), the visceral pattern identification was selected 7 times(12.3%), the other pattern identification was selected 4 times(7.0%), Qi blood yin yang pattern identification was selected 2 times(3.5%), according to symptoms was selected 1 time(2.4%). 2. Meridian pattern identification Small intestine meridian of hand Taeyang was used 39 times(18.1%), Large intestine meridian of hand Yangmyeong and Bladder meridian of foot Taeyang was used 34 times(15.7%), Gall-bladder meridian of foot Soyang was 32 times(14.8%), Tripple energizer meridian of hand Soyang was used 31 times(14.4%), Governor meridian was used 30 times(13.9%), Lung meridian of hand Taeeum was used 8 times(3.7%), Heart meridian of hand Soeum and Pericarduim meridian of hand Gworeum was used 4 times(1.9%). 3. Pattern identification based on cause of disease Wind-Cold-Dampness was used 31 times(17.5%), Accumulation of the collateral by Phelgm-Dampness was used 16 times(14.0%), affection by exopathogen Wind-Cold(stiff neck, sprain of cervical) was used 13 times (11.4%), Defecient-Cold was used 10 times(8.8%), affection by exopathogen Wind-Dampness was used 9 times(7.9%), Deep Invasion by Wind-Cold was used 8 times(7.0%), Wind-Cold was used 7 times (6.1%), Wind-Cold was used 6 times(5.3%), Accumulation in the Center by Phelgm-Dampness, Imparement of bou fluid by Pathogenic Heat, Wind-Heat with Dampness was used 5 times(4.4%), affection by exopathogen Wind-Dampness and Accumulation of the collateral by Wind-Cold was used 4 times(3.5%), Invasion of Dampness-Heat was used 2 times(1.8%). 4. Visceral pattern identification Rising of the Liver yang was used 16 times(41%), Yin deficiency of Liver and Kidney+pathogens was used 15 times(38.5%), Yin deficiency of Liver and Kidney was used 8 times(20.5%) on this survey.

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Effect of Safflower and Safflower Seed Extract on Osteogenic Differentiation of MC3T3E1 Cells (홍화, 홍화씨 추출물이 MC3T3E1 세포의 골분화 과정에 미치는 영향)

  • Yu, Sung-ryul;Shin, Seon-mi
    • The Journal of Internal Korean Medicine
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    • v.36 no.4
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    • pp.518-526
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    • 2015
  • Objectives This study investigated the effect of purified safflower (Carthamus tinctorius Linne) and safflower seed (Carthamus tinctorius L. seed; CS) extract, using hot water and ethanol extract methods , on the osteogenic differentiation of MC3T3E1 cells.Methods The safflower and safflower seed were extracted with hot water and ethanol. The samples were concentrated by a rotary evaporator and then freeze-dried using a freeze-dryer. The MC3T3E1 cells were propagated and maintained in DMEM (Gibco) containing 10% FBS and a 1% antibiotic antimycotic solution. To induce osteogenic differentiation, the cells were treated for 14 days with DMEM with 10 mM β-glycerophosphate and 50 μM ascorbic acid. Extract doses were confirmed by the results of an MTT assay, and treatment of the extracts was performed in a differentiation medium every two days. The ALP staining and activity were tested after osteogenic differentiation for five days, and after 14 days, osteogenic differentiation was determined by alizarin red S staining. The mRNA expressions of osteogenic-related genes were quantified using quantitative real-time PCR.Results In the results of the MTT assay, all concentrations of safflower extracts had no toxicity in the MC3T3El cells. But in the groups of 100 ng/ml and 200 ng/ml concentrations of safflower seed extracts, the cell viability was significantly reduced by up to 40-50%. So we fixed the treatment concentration of the extract at 50 ng/ml. In the ALP and alizarin red S staining, all extract groups increased osteogenic differentiation compared with the control group. The water-safflower extract group showed the highest mRNA level of Alp, Runx2, and Dlx5 genes. The mRNA level of Ocn, an osteogenic gene related to late-stage differentiation, in the ethanol-safflower extract group increased the mineralization more significantly than in other groups.Conclusions These data suggest that the extract of safflower increases the osteoblastic differentiation activates of MC3T3E1 cells like the extract of safflower seed. The water-extract and ethanol-extract of safflower have effects on different stages of osteogenesis in MC3T3El. Not only safflower seed but also safflower will be useful therapeutic reagents for age-associated chronic diseases such as osteoporosis.

Role of FAK Phosphorylation in Cobalt Chloride-Induced Epithelial-to-Mesenchymal-Like Transition (Cobalt chloride에 의해 유도되는 상피-중간엽 이행에서의 국소부착 단백질의 인산화의 역할 규명)

  • Nam, Ju-Ock
    • Journal of Life Science
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    • v.21 no.2
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    • pp.286-291
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    • 2011
  • Hypoxia is a common condition found in a wide range of solid tumors and is often associated with metastasis and poor clinical outcomes. In the present study, we found that HIF-$1{\alpha}$ was induced by cobalt chloride (500 ${\mu}M$) treatment on human lung cancer cells, A549 and H460, for 24 hr. However, cobalt chloride (500 ${\mu}M$) did not affect cell proliferation of A549 and H460 in 48 hr. Cobalt chloride (500 ${\mu}M$) additionally induced epithelial-to-mesenchymal-like transition (EMT) such as reduced E-cadherin expression and increased ${\alpha}$-SMA expression. These results were confirmed by immunofluorecence experiment in H460 cells. E-cadherin was localized on the outer cell membrane. However, when the cells were treated with 500 ${\mu}M$ cobalt chloride for 24 hr, diffuse E-cadherin staining was observed, characteristic of a migratory mesenchymal phenotype. We also found that cobalt chloride induced integrin ${\beta}3$ expression and FAK phosphorylation in human lung cancer cells using western blotting and FACS anlaysis. Our data suggest that integrin ${\beta}3$-induced FAK phosphorylation may be developed into target molecules for blocking tumor metastasis.

Influences of luting cement shade on the color of various translucent monolithic zirconia and lithium disilicate ceramics for veneer restorations

  • Ghada Alrabeah;Nawaf Alamro;Atif Alghamdi;Ahmed Almslam;Meshari Azaaqi
    • The Journal of Advanced Prosthodontics
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    • v.15 no.5
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    • pp.238-247
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    • 2023
  • PURPOSE. The purpose of this study was to assess the effect of resin cement shade on the color of different novel ultratranslucent monolithic zirconia and lithium disilicate veneer materials. MATERIALS AND METHODS. For a total of 40 specimens, flat cylindrical discs with a 9-mm diameter and 0.5-mm thickness were created using CAD/CAM technology. The specimens were divided into five groups according to their material (n = 8) (e.max, Prettau, Aidite, Shofu and Dima) using A1 shade. Resin discs with the same diameter and shade as the specimens served as tooth-colored substructures. Three shades (neutral, light and warm) of resin cement try-in pastes (Variolink Esthetic LC) were used as the luting cement material. The color of each material group was measured before and after cementation using the three cement shades, and the CIE L*a*b* coordinates were obtained with a spectrophotometer. Values for the translucency parameter (TP) and color change delta E (E) before (baseline) and after cementation of each specimen were determined. To compare differences among the material groups within each shade of cement and among various shades of cement within each material, the data were analyzed using one-way ANOVA and post hoc testing. RESULTS. Color coordinates L*, a* and b* significantly changed after the application of try-in pastes relative to baseline values, with a noticeable decrease in lightness (L*) (P < .05). A significant color change (ΔE) was observed in all tested materials after cementation, with ΔE values exceeding 3.3 (P < .05). Although TP changed after cementation for most materials tested, these changes were not statistically significant (P > .05). Shofu and Dima ceramics showed the lowest TP values, while Aidite and Prettau showed the highest TP values. For e.max, translucency decreased after cementation with neutral and warm shades, and it significantly increased after cementation with a light shade. CONCLUSION. The shade of cement significantly altered the final color of the ceramic veneer material to a level above the threshold at which the clinical perception of color change occurred (> 3.3). The TP was not influenced by the cement shade. The translucency levels of the novel ultratranslucent multilayer monolithic zirconia ceramics Aidite and Prettau were higher than that of the lithium disilicate e.max material.

Physical Activities and Health Belief of Elementary School Students for Obesity Prevention and Management among Elementary School Students (비만 예방 및 관리를 위한 초등학생의 신체활동과 건강신념)

  • Yang, Sook-Ja;Jang, Se-Hee;Kim, Shin-Jeong
    • Journal of Korean Public Health Nursing
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    • v.26 no.2
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    • pp.227-238
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    • 2012
  • Purpose: The purpose of this study was to examine physical activities and health belief in order to provide basic data on obesity prevention and management among elementary school students based on the health belief model. Methods: Participants included 194 fifth grade students in an elementary school located in Seoul. Data were collected by questionnaires and physical measurement, including weight and height. The SPSS Win 17.0 program using descriptive statistics, ANOVA with Scheff$\acute{e}$ post hoc tests, and Cronbach's alpha coefficients was used in data analysis. Results: Significant differences were observed in physical activity according to perceived severity (F=3.444, p=.034), perceived benefit (F=7.674, p=.001), perceived barrier (F=21.014, p<.001), and self-efficacy (F=22.098, p<.001). A significant difference in physical activity (t=4.502, p<.001) and perceived severity (t=-2.278, p=.024) was observed according to gender. Significant differences in physical activity (t=7.633, p=.006), perceived barrier (t=10.826, p=.001), and self-efficacy (t=5.928, p=.016) were observed according to obesity status. Significant differences were observed in physical activity (F=7.503, p=.001), perceived susceptibility (F=37.904, p<.001), and perceived barrier (F=3.425, p=.035) depending on level of satisfaction with body image. Conclusions: In order to promote physical activity among children with low physical activity, development of program with an emphasis on the benefits of physical activity and physical activity self-efficacy, and to decrease the barriers to physical activity is needed.

Xeroderma pigmentosum group A with mutational hot spot (c.390-1G>C in XPA ) in South Korea

  • Choi, Jung Yoon;Yun, Hyung Ho;Lee, Cha Gon
    • Journal of Genetic Medicine
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    • v.13 no.1
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    • pp.20-25
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    • 2016
  • Purpose: Xeroderma pigmentosum (XP) is rare autosomal recessive genetic disorder of DNA repair in which the ability to repair damage caused by ultraviolet light is deficient. We reported the first molecularly confirmed Korean patient of XP by targeted exome sequencing. The prevalence of XP included all subtype and carrier frequency of XP-A the using public data were estimated for the first time in South Korea. Materials and Methods: We described a 4-year-old Korean girl with clinical diagnosis of XP. We performed targeted exome sequencing in the patient for genetic confirmation considering disease genetic heterogeneity and for differential diagnosis. We verified a carrier frequency of c.390-1G>C in XPA gene known as mutational hot spot using Korean Reference Genome Data Base. We estimated the period prevalence of all subtypes of XP based on claims data of the Health Insurance Review and Assessment Service in South Korea. Results: We identified homozygous splicing mutation of XPA (c.390-1G>C) in the patient. The carrier frequency of risk for XPA (c.390-1G>C) was relatively high 1.608 e-03 (allele count 2/1244). The prevalence of XP in South Korea was 0.3 per million people. Conclusion: We expect that c.390-1G>C is hot spot for the mutation of XPA and possible founder variant in South Korea. However, the prevalence in South Korea was extremely low compared with Western countries and Japan.

Dentists' opinions on return to work of career interrupted dental hygienists (경력이 단절된 치과위생사의 직무 복귀에 대한 치과의사의 의견)

  • Park, Kui-Ok;Jang, Young-Eun;Kim, Sun-Il;Park, Ji-Eun;Lee, Sun-Mi;Kim, Nam-Hee
    • Journal of Korean society of Dental Hygiene
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    • v.16 no.5
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    • pp.741-750
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    • 2016
  • Objectives: This study aims to identify dentists' opinions about the return to work of the dental hygienists with career interrupted. Convenience sampling was made of 22 dentists with the clinical experience (about 0.25%) of the 4,944 members of Gyeonggi-do Dental Association. Data were collected through an electronic survey using e-mails and telephone interviews and analyzed using the constant comparison method. Methods: Open coding was assigned to the initial data from the survey in an explicit language, and focusing on the types of their employment, working conditions, etc. Summarization and conceptualization were made of the second data in an implicit language. Results: Most of the dentists were found to have positive attitudes toward the return to work of career interrupted dental hygienists and hope to adjust their wages based on their job performance or after their probational period expires. Most of the dentists were found to have positive attitudes towards the hygienists' flexible working although their concerns about work efficiency and hospital atmosphere. This study is a qualitative study that describes dentists' opinions and presents the need for the career interrupted dental hygienists to return to work. Conclusions: The study proposed that the educational institutions should take into account the hygienists' opinions when implementing the programs for promoting their return to work and their evaluative studies.

FusionScan: accurate prediction of fusion genes from RNA-Seq data

  • Kim, Pora;Jang, Ye Eun;Lee, Sanghyuk
    • Genomics & Informatics
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    • v.17 no.3
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    • pp.26.1-26.12
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    • 2019
  • Identification of fusion gene is of prominent importance in cancer research field because of their potential as carcinogenic drivers. RNA sequencing (RNA-Seq) data have been the most useful source for identification of fusion transcripts. Although a number of algorithms have been developed thus far, most programs produce too many false-positives, thus making experimental confirmation almost impossible. We still lack a reliable program that achieves high precision with reasonable recall rate. Here, we present FusionScan, a highly optimized tool for predicting fusion transcripts from RNA-Seq data. We specifically search for split reads composed of intact exons at the fusion boundaries. Using 269 known fusion cases as the reference, we have implemented various mapping and filtering strategies to remove false-positives without discarding genuine fusions. In the performance test using three cell line datasets with validated fusion cases (NCI-H660, K562, and MCF-7), FusionScan outperformed other existing programs by a considerable margin, achieving the precision and recall rates of 60% and 79%, respectively. Simulation test also demonstrated that FusionScan recovered most of true positives without producing an overwhelming number of false-positives regardless of sequencing depth and read length. The computation time was comparable to other leading tools. We also provide several curative means to help users investigate the details of fusion candidates easily. We believe that FusionScan would be a reliable, efficient and convenient program for detecting fusion transcripts that meet the requirements in the clinical and experimental community. FusionScan is freely available at http://fusionscan.ewha.ac.kr/.