• Title/Summary/Keyword: e-clinical data

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HER-2/neu Status: A Neglected Marker of Prognostication and Management of Breast Cancer Patients in India

  • Zubeda, Syeda;Kaipa, Prabhakar Rao;Shaik, Noor Ahmad;Mohiuddin, Mohammed Khaliq;Vaidya, Sireesha;Pavani, Boddana;Srinivasulu, Mukta;Latha, Manolla Madhavi;Hasan, Qurratulain
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.4
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    • pp.2231-2235
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    • 2013
  • Background: Categorizing breast tumors based on the ER, PR and HER/Neu 2 receptor status is necessary in order to predict outcome and assist in management of breast cancer. Herfe we assessed this question in South Indian patients. Materials and Methods: A total of 619 formalin fixed paraffin embedded breast tumor tissues were collected from pathology archives after receipt of ethical clearance. With the help of primary and secondary conjugated antibodies, expression status of ER, PR and HER2/neu was determined. All the experimental data were assessed for correlations with histopathological features of tumors and clinical presentation of the subjects. Results: In the present study, the ages ranged from 20-87 years with a mean of $50.0{\pm}12.q$ years, and majority of the tumors (84%) were of infiltrating duct cell carcinoma type. Assessment of ER, PR and Her-2/neu expression showed that 46% were triple negative. Interestingly, an inverse relation between ER, PR and HER-2/neu was apparent in 41.2% (p<0.0001) of the tumors, of which 24.5% (p<0.0001) were ER and PR co-negative but HER-2 positive. Conclusions: ER and PR positive tumors are less common (i.e<30%) compared to HER-2/neu positive tumors (i.e>50%) in Indian breast cancer patients, underlining the need for effective diagnostic screening and specific therapeutic managements in order to improve the survival rate of patients in low resource countries such as India.

The Antibiotic Resistance Pattern of Gram-Negative Bacteria in Children Younger Than 24 Months with a Urinary Tract Infection: A Retrospective Single-Center Study over 15 Consecutive Years

  • Lee, Yoon Kyoung;Lee, Haejeong;Kim, Jong Min;Kang, Ji-Man;Lee, Sang Taek;Lee, Nam Yong;Kim, Yae-Jean;Cho, Heeyeon
    • Childhood Kidney Diseases
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    • v.19 no.2
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    • pp.148-153
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    • 2015
  • Purpose: We investigated trends in antibiotic resistance for gram-negative bacteria in infants with a urinary tract infection (UTI) over 15 years at a single institution. Methods: A retrospective chart review was conducted for children younger than 24 months who visited the emergency room and were diagnosed with a UTI between January 2000 and December 2014. We selected urine culture data that grew Escherichia coli and Klebsiella pneumoniae. Baseline clinical information and results of antimicrobial susceptibility tests were analyzed by dividing the 15-year study time frame into three periods (A: 2000-2004, B: 2005-2009, and C: 2010-2014). Results: During the study period, 478 applicable children were identified (E. coli, 89.7% and K. pneumoniae, 10.3%). Antibiotic resistance to third-generation cephalosporins was increased from period A to period C (A, 2.1%; B, 8.3%; C, 8.8%; P=0.025). Resistance to quinolones also showed a steady pattern during periods A to C, although it was not statistically significant (A, 7.9%; B, 9.7%; C, 12.4%; P=0.221). The incidence of Extended-spectrum ${\beta}$-lactamase (ESBL)-producing gram-negative bacteria increased from period A to period C (A, 1.4%; B, 7.6%; C, 8.2%; P=0.012). Conclusion: This study revealed that the common uropathogens E. coli and K. pneumoniae experienced increasing resistance rates against third-generation cephalosporins and a constant antibiotic resistance to quinolones in children younger than 24 months. We also showed a recent increased incidence of ESBL-producing gram-negative bacteria in patients with community-acquired UTIs. Therefore, it is necessary to actively surveil resistance in order to properly select empirical antibiotics.

EU FP6 Welfare Quality® Poultry Assessment Systems

  • Butterworth, A.
    • Korean Journal of Poultry Science
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    • v.36 no.3
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    • pp.239-246
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    • 2009
  • Animal welfare is of considerable importance to European consumers and citizens, this being most recently confirmed in EU barometer studies. Researchers and others have long proposed that animal-based measures (measures taken on animals, e.g. their health and behaviour) can provide a valid indicator of animal welfare; since welfare is a characteristic of the individual animal. Therefore, a welfare assessment can be essentially based on animal-based measures, but with use of resource measures to provide the capacity to assess 'risk factors'. The first goal of this project was to develop a welfare monitoring system that enables assessment of welfare status through standardised conversion of welfare measures into accessible and understandable information. The acquired information on one hand provides feedback to animal unit managers about the welfare status of their animals, and on the other, information on the welfare status of animal-related products for consumers and retailers. The second goal of Welfare $Quality^{(R)}$ was to improve animal welfare by minimising the occurrence of harmful behavioural and physiological states, improving human-animal relationships, and providing animals with safe and stimulating environments. The different measurable aspects of welfare to be covered are turned into welfare criteria. The criteria reflect what is meaningful to animals as understood by animal welfare science. Once all the measures have been performed on an animal unit, a bottom-up approach is followed to produce an overall assessment of animal welfare on that particular unit: first the data collected (i.e. values obtained for the different measures on the animal unit) are combined to calculate criterion-scores; then criterion-scores are combined to calculate principle-scores; and finally the animal unit is assigned to a welfare category according to the principle-scores it obtained.

Biological Activity of Recombinant Human Erythropoietin (EPO) In Vivo and In Vitro

  • Park Jong-Ju;Lee Hyen-Gi;Nam In-Suk;Park Hee-Ja;Kim Min-Su;Chung Yun-Hi;Naidansuren Purevjargal;Kang Hye-Young;Lee Poong-Yun;Park Jin-Gi;Seong Hwan-Hoo;Chang Won-Kyong;Kang Myung-Hwa
    • Reproductive and Developmental Biology
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    • v.29 no.2
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    • pp.69-73
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    • 2005
  • The hematopoietic growth factor erythropoietin (EPO) is required for the maintenance, proliferation, and differentiation of the stem cells that produce erythrocytes. To analyse the biological activity of the recombinant human EPO (rec-hEPO), we have cloned the EPO cDNA and genomic DNA and produced rec-hEPO in the CHO cell lines. The growth and differentiation of EPO-dependent human leukemic cell line (F36E) were used to measure cytokine dependency and in vitro bioactivity of rec-hEPO. MIT assay values were increased by survival of F36E cells at 24h or 72h. The hematocrit and RBC values were increased by subcutaneous injection of 20 IU (in mice) and 100IU(in rats) rec-hEPO. Hematocrit values remarkably increased at $13.2\%$ (in mice) and $12.2\%$ (in rats). The pharmacokinetic behavior with injection of 6 IU of rec-hEPO remained detectable after 24 h in all mice tested. The highest peat appeared at 2h after injection. The long half-life of rec-hEPO is likely to confer clinical advantages by allowing less frequent dosing in patients treated for anemia. These data demonstratethat ree-hEPO produced in this study has a potent activity in vivo and in vitro. The results also suggest that biological activity of ree-hEPO could be remarkably enhanced by genetic engineering that affects the potential activity, including mutants with added oligosaccharide chain and designed to produce EPO-EPO fusion protein.

G894T and 4a/b Polymorphisms of NOS3 Gene are Not Associated with Cancer Risk: a Meta-analysis

  • Haque, Shafiul;Mandal, Raju K;Akhter, Naseem;Panda, Aditya K;Hussain, Arif;Khan, Saif;Lohani, Mohtashim
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.7
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    • pp.2929-2937
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    • 2015
  • Endothelial nitric oxide synthase (eNOS or NOS3) produces nitric oxide and genetic polymorphisms of NOS3 gene play significant roles in various processes of carcinogenesis. The results from published studies on the association between NOS3 G894T and NOS3 intron 4 (4a/b) polymorphisms and cancer risk are conflicting and inconclusive. However, i n order to assess this relationship more precisely, a meta-analysis was performed with PubMed (Medline), EMBASE and Google web searches until February 2014 to select all published case-control and cohort studies. Genotype distribution data were collected to calculate the pooled odd ratios (ORs) and 95% confidence intervals (CIs) to evaluate the strength of association. A total of 10,546 cancer cases and 10,550 controls were included from twenty four case-control studies for the NOS3 G894T polymorphism. The results indicated no significant association with cancer risk as observed in allelic (T vs G: OR=1.024, 95%CI=0.954 to 1.099, p=0.508), homozygous (TT vs GG: OR=1.137, 95%CI=0.944 to 1.370, p=0.176), heterozygous (GT vs GG: OR=0.993, 95%CI=0.932 to 1.059, p=0.835), recessive (TT vs GG+GT: OR=1.100, 95%CI=0.936 to 1.293, p=0.249) and dominant (TT+GT vs GG: OR=1.012, 95%CI=0.927 to 1.105, p=0.789) genetic models. Similarly, a total of 3,449 cancer cases and 3,691 controls were recruited from fourteen case-control studies for NOS3 4a/b polymorphism. Pooled results indicated no significant association under allelic (A vs B: OR=0.981, 95%CI=0.725 to 1.329, p=0.902), homozygous (AA vs BB: OR=1.166, 95%CI=0.524 to 2.593, p=0.707), heterozygous (BA vs BB: OR=1.129, 95%CI=0.896 to 1.422, p=0.305), dominant (AA+BA vs BB: OR=1.046, 95%CI=0.779 to 1.405, p=0.763) and recessive (AA vs BB+BA: OR=1.196, 95%CI=0.587 to 2.439, p=0.622) genetic contrast models. This meta-analysis suggests that G894T and 4a/b polymorphisms of NOS3 gene are not associated with increased or decreased risk of overall cancer.

Circulating Antibodies directed toward Ovarian Proteins in Women with Premature Ovarian Failure (조기난소부전증 여성에서 난소단백질에 대한 순환항체에 관한 연구)

  • Lee, Jin-Yong;Kim, Jung-Gu;Park, Chang-Soo;Choi, Young-Min;Shin, Chang-Jae;Moon, Shin-Yong;Chang, Yoon-Seok
    • Clinical and Experimental Reproductive Medicine
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    • v.20 no.2
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    • pp.137-147
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    • 1993
  • The purpose of this study is to identify the presence of the circulating antibodies directed toward ovarian proteins{antiovarian antibodies, AOA) and the nature of antigenic ovarian structure by comparing the binding activities to 4 types of ovarian proteins, particulated and solubilized forms of pig ovarian and granulosa cell membranes in sera of patients with premature ovarian failure(POF) and to evaluate the usefulness of circulating AOA as a follow up tool after treatment. Measurements of AOA were performed by enzyme linked immunosorbent assay(ELISA) in sera of 58 patients with POF, 51 had normal chromosomes and 7 had X chromosome abnormalities. Sera of 21 natural menopausal women and 17 castrated women were also tested and sera of 32 healthy premenopausal women were served as controls. ELISA reactivities against particulated porcine granulosa cell membrane proteins was the greatest among 4 different ovarian proteins. Fifteen(29%) of 51 POF patients with normal chromosome and 1(14.3%) of 7 POF patients with X chromosome abnormalities had AOA while none of 32 controls and 21 natural menopausal women and 17 castrated women had AOA. One POF patient with 47, XXX was identified AOA positive. The ELISA reactivities were followed up monthly up to 5 months in 4 AOA positive POF patients after estrogen-progestin{E-P) therapy. There was a decreasing tendency of the ELISA reactivities in all these patients after E-P therapy and two of them converted to AOA negative. These data suggest that antigenic structure may be components of granulosa cell membrane and the determination of circulating AOA may be useful in the follow up after treatment in patients with autoimmune POF.

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Determination of Beam Quality Correction Factors for the PTW-Markus Chamber for Electron Beam Qualities R50=1.0 and 1.4 g/cm2 (전자선 선질 R50=1.0과 1.4 g/cm2에 대한 PTW-Markus 전리함의 선질보정인자 결정에 관한 연구)

  • Kim, Me Young;Rhee, Dong Joo;Moon, Young Min;Jeong, Dong Hyeok
    • Progress in Medical Physics
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    • v.26 no.3
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    • pp.178-184
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    • 2015
  • The Markus ionization chamber(R) is a small plane parallel ionization chamber widely used in clinical electron beam dosimetry. Plane parallel chambers were recommended for low energy electron dosimetry with the beam quality at $R_{50}<4.0g/cm^2$ (${\bar{E}}{\approx}10MeV$) according to TRS-398 protocol. However, the quality correction factors ($k_{Q,Q_0}$) of the Markus chamber was not presented in TRS-398 protocol for electron beam quality at $R_{50}<2.0g/cm^2$ (${\bar{E}}{\approx}4MeV$). In this study, the $k_{Q,Q_0}$ factors of the Markus chambers (PTW-34045) for beam qualities at $R_{50}=1.0$, 1.4, 2.0, 2.5, 3.0, and $5.0g/cm^2$ were determined by Monte Carlo calculations (DOSRZnrc/EGSnrc) and the dosimetric formalism of quality correction factor. The derived $k_{Q,Q_0}$ values were evaluated using the produced data based on TRS-398 and TG-51 protocols and known values for the Markus chamber.

Total Intracranial Volume Measurement for Children by Using an Automatized Program (자동화 프로그램을 이용한 아동의 전체두개강내용적 평가)

  • Lee, Jeonghwan;Kim, Ji-Eun;Im, Sungjin;Ju, Gawon;Kim, Siekyeong;Son, Jung-Woo;Shin, Chul-Jin;Lee, Sang-Ick;Ghim, Hei-Rhee
    • Korean Journal of Biological Psychiatry
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    • v.21 no.3
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    • pp.81-86
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    • 2014
  • Objectives Total intracranial volume (TIV) is a major nuisance of neuroimaging research for interindividual differences of brain structure and function. Authors intended to prove the reliability of the atlas scaling factor (ASF) method for TIV estimation in FreeSurfer by comparing it with the results of manual tracing as reference method. Methods The TIVs of 26 normal children and 26 children with attention-deficit hyperactivity disorder (ADHD) were obtained by using FreeSurfer reconstruction and manual tracing with T1-weighted images. Manual tracing performed in every 10th slice of MRI dataset from midline of sagittal plane by one researcher who was blinded from clinical data. Another reseacher performed manual tracing independently for randomly selected 20 dataset to verify interrater reliability. Results The interrater reliability was excellent (intraclass coefficient = 0.91, p < 7.1e-07). There were no significant differences of age and gender distribution between normal and ADHD groups. No significant differences were found between TIVs from ASF method and manual tracing. Strong correlation between TIVs from 2 different methods were shown (r = 0.90, p < 2.2e-16). Conclusions The ASF method for TIV estimation by using FreeSurfer showed good agreement with the reference method. We can use the TIV from ASF method for correction in analysis of structural and functional neuroimaging studies with not only elderly subjects but also children, even with ADHD.

Inhibitory effects of Paridis Rhizoma in the activation and proliferation of eosinophils: implications on its regulatory roles for asthma (rmIL-5로 유도된 호산구의 활성화 및 성장에서 중루의 천식반응 억제효과)

  • Sin, Mi-Kyung;Kil, Ki-Jeong;Lee, Young-Chul;Kim, Jin-Suk;Seo, Young-Bae;Roh, Seong-Soo
    • The Korea Journal of Herbology
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    • v.20 no.2
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    • pp.159-169
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    • 2005
  • Objectives : This study was carried out for the purpose of knowing the effect from anti-arthma action of the abstraction from a extract of Paridis Rhizoma(EPR). In order to know what the effect of controlling an abstraction from Paridis Rhizoma. and about the expression of B cells and Ig E cells, mast cells it was necessary for it to be activated by ovalbumin. Methods : In order to know what the effect was on the organization of cytokine gene expression from The increase and divorce of the B cells and allergic acting by EPR, we found it necessary to examine the BALF. At the same time, as we examined the histamine release by ELISA method, we also examined the effect of EPR. Results : EPR at $100\;{\mu}g/ml$, the highest concentration examined did not have any cytotoxic effects on mLFCs. In FACS analysis, number of granulocyte/lymphocyte, $CD3e^+/CCR3^+,\;CD4^+\;and\;CD23^+/B220^+$ in asthma-induced lung cells were significantly decreased by EPR treatment compared to the control group. In RT-PCR analysis, mRNA expression for CCR3, eotaxin and histamine in asthma-induced lung cells, which was induced by rIL-3 plus rmIL-5 treatments, was significantly decreased by EPR treatment. In ELISA analysis, production levels of IL-4, IL-13 and histamine in asthma-induced lung cells, which were induced by rIL-3 plus rmIL-5 co-treatment, were significantly decreased by EPR treatment. EPR treatments significantly inhibited the proliferation of eosinohils prepared from asthma-induced mouse lung tissues compared to the non-EPR treated control cells. Immunohistochemical analysis revealed that EPR treatment significantly decreased the levels of eosipnphil activation compared to non-treated cells. Conclusion : The present data suggested that Paridis Rhizoma may have an effects on the inhibition of parameters associated with asthma responses in eosinpophils, and thus implicate the possibility for the clinical application of Paridis Rhizoma.

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Bioequivalence of Pinatos Capsule 10 mg to Ketas Capsule 10 mg (Ibudilast 10 mg) (케타스 캡슐 10밀리그램(이부딜라스트 10 밀리그램)에 대한 피나토스 캡슐 10밀리그램의 생물학적동등성)

  • Kang, Hyun-Ah;Kim, Se-Mi;Kang, Min-Sun;Yoo, Dong-Jin;Lee, Sang-No;Kwon, In-Ho;Yoo, Hee-Doo;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.40 no.2
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    • pp.117-123
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    • 2010
  • Ibudilast, 3-isobutyryl-2-isopropyrazolo[1,5-a]pyridine, is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). It preferentially inhibits PDE 3A, PDE4, PDE10 and PDE11 as well as a number of the other PDE families, albeit to a lesser extent. Ibudilast is used clinically to treat bronchial asthma and cerebrovascular disorders. Thes e clinical uses are based on the ability of ibudilast to inhibit platelet aggregation, improve cerebral blood flow and attenuate allergic reactions. The purpose of the present study was to evaluate the bioequivalence of two ibudilast capsules, Ketas capsule (Handok Pharmaceuticals Co., Ltd.) and Pinatos capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of ibudilast from the two ibudilast formulations was tested using KP Apparatus method with various dissolution media. Twenty six healthy male subjects, 23.31${\pm}$1.09 years in age and 70.45${\pm}$8.51 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 10 mg as ibudilast was orally administered, blood samples were taken at predetermined time intervals and the concentrations of ibudilast in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were 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, Ketas, were 6.99%, -2.48% and 9.93% 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 log 0.8 to log 1.25 (e.g., log 0.8791~log 1.1861 and log 0.8347~log 1.1199 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Pinatos capsule was bioequivalent to Ketas capsule.