scholarly journals P34 Reliable results in continuous bioanalysis of paediatric renin samples – comprehensive quality assessment within clinical studies in children

2019 ◽  
Vol 104 (6) ◽  
pp. e31.1-e31
Author(s):  
M Feickert ◽  
I Burdman ◽  
N Makowski ◽  
M Ali ◽  
S Farahani ◽  
...  
Keyword(s):  
Heart Failure ◽  
European Medicines Agency ◽  
List Type ◽  
High Quality ◽  
Reliable Determination ◽  
Assay Validation ◽  
Paediatric Study ◽  
Quality Approach

BackgroundAs the initiator of the Renin-Angiotensin-Aldosterone-system, renin plays an essential role in the vicious circle of heart failure. Therefore, renin was determined in the investigators driven ‘Labelling of Enalapril from neonates up to adolescents’ (LENA) study to evaluate its role in paediatric heart failure. Due to the often long-lasting periods of recruitment of paediatric subjects, the assay performance has to be guaranteed over the whole recruiting time. Therefore, to ensure the high quality of the determined renin study samples after successful assay validation,1 a multi-step quality approach was used to get reliable results over a period of 30 months.MethodsBased on a multi-step quality approach consisting of calibration standards (CSs), quality controls (QCs) and incurred sample reanalysis (ISR), study samples of unknown renin concentrations were determined. Results within predefined limits of CSs (6 levels) and QCs according to European Medicine Agency (EMA) guidelines were required for evaluating the study samples.2 ISR was performed for randomly selected paediatric samples to evaluate the long-term accuracy of the validated assay.Results133 analytical runs were conducted for renin from February 2016 to August 2018. In 119 (88.8%) valid runs, a total number of 1414 of CCs and 952 of QCs were determined. Thereof 99.9% of CCs and 98.3% of QCs were in the predefined limits according to EMA. 143 incurred sample pairs were reanalysed resulting in 95.8% of samples within EMA guidelines. Using this multi-step quality approach, the reliable determination of 965 LENA paediatric study samples was guaranteed.ConclusionIn addition to the assay validation, the multi-step quality approach ensured the reliability of the determined renin concentrations in the continuous bioanalysis of the paediatric study samples and guaranteed the high quality of the collected data in the LENA study.ReferencesSchaefer J, Burckhardt BB, Tins J, et al. Validated low-volume immunoassay for the reliable determination of direct renin especially valuable for pediatric investigations. J Immunoass Immunochem 2017;38:579–94. doi:10.1080/15321819.2017.1350707Guideline on bioanalytical method validation. European Medicines Agency, London, UK (2011).Disclosure(s)Martin Feickert, Ilja Burdman, Nina Makowski, Moshin Ali, Anke Bartel, and Bjoern B. Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA)

scholarly journals Does the manual insertion torque of smartpegs affect the outcome of implant stability quotients (ISQ) during resonance frequency analysis (RFA)?

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ingrid Kästel ◽  
Giles de Quincey ◽  
Jörg Neugebauer ◽  
Robert Sader ◽  
Peter Gehrke
Keyword(s):  
Resonance Frequency ◽  
Frequency Analysis ◽  
Insertion Torque ◽  
Resonance Frequency Analysis ◽  
Implant Stability ◽  
Reliable Determination ◽  
Torque Values ◽  
Finger Pressure

Abstract Background There is disagreement about the optimal torque for tightening smartpegs for resonance frequency analysis (RFA). Subjective finger pressure during hand tightening could affect the reliability of the resulting values. The aim of the current study was therefore to assess whether or not the insertion torque of a smartpeg magnetic device influences the implant stability quotient (ISQ) value during RFA. Methods Thirty self-tapping screw implants (XiVE S, Dentsply Sirona Implants, Bensheim, Germany) with a diameter of 3.8 mm and a length of 11 mm were inserted in three cow ribs with a bone quality of D1. The RFA value of each implant was measured (Ostell, FA W&H Dentalwerk, Bürmoos, Austria) in two orthogonal directions (mesial and buccal) after tightening the corresponding smartpeg type 45 with a mechanically defined value of 5 Ncm (Meg Torq device, Megagen, Daegu, South Korea) (test). Additionally, 4 different examiners measured the RFA after hand tightening the smartpegs, and the results were compared (control). Insertion torque values were determined by measuring the unscrew torque of hand seated smartpegs (Tohnichi Manufacturing Co. Ltd, Tokyo, Japan). Results The ISQ values varied from 2 to 11 Ncm by hand tightening and from 2 to 6 Ncm by machine tightening. The comparison of hand and machine tightening of smartpegs displayed only minor differences in the mean ISQ values with low standard deviations (mesial 79.76 ± 2,11, buccal 77.98 ± 2,) and no statistical difference (mesial p = 0,343 and buccal p = 0,890). Conclusions Manual tightening of smartpeg transducers allows for an objective and reliable determination of ISQ values during RFA.

scholarly journals Development of new total RNA isolation method for tissues with rich phenolic compounds

2020 ◽  
Vol 45 (4) ◽  
pp. 343-350
Author(s):  
Zafer Seçgin ◽  
Gökhan Gökdemir ◽  
Elif Seda Atabay ◽  
Aslıhan Kurt Kızıldoğan ◽  
Musa Kavas
Keyword(s):  
Phenolic Compounds ◽  
Rna Sequencing ◽  
Rna Isolation ◽  
Wall Structure ◽  
Isolation Method ◽  
High Quality ◽  
Ctab Method ◽  
Total Rna Isolation

AbstractBackgroundRNAs to be used in transcriptome analysis must be of high quality and pure in order to ensure maximum representation of the expressed genes. RNA isolation is difficult in hazelnut tissues containing large amounts of secondary metabolite, phenolic compounds and the cell wall structure. Commonly used protocols for RNA isolation are those that require a lot of labor and time and also do not allow sufficient RNA isolation when applied to tissues rich in phenolic compounds. This study was aimed to develop an efficient method for isolation of total RNAs from bud of hazelnut to be used in RNA sequencing.Materials and methodsAn optimized new method was successfully applied on three different hazelnuts genotypes (Çakıldak, Palaz, Tombul) and about 25 times higher amount of total RNAs per mg fresh tissues were obtained compared to classical CTAB method. Different methods have been tried for the isolation of RNA from hazelnut tissues and the determination of the quality of the obtained RNAs.ResultsThe quality and quantity of isolalated total RNAs were determined by spectrophotometer, electrophoresis and PCR. This success has been caught without any compromise of purity since A260/A280 ratios ranged from 1.90 to 2.04 and A260/A230 ratios were >2.0 in all purified RNAs.ConclusionThe total RNAs isolated with new protocol was found to be suitable for RNA sequencing and other molecular applications.

Electric and thermoelectric properties of CdTe/PbTe epitaxial nanocomposite

2014 ◽  
Vol 07 (06) ◽  
pp. 1440007
Author(s):  
Michal Szot ◽  
Krzysztof Dybko ◽  
Piotr Dziawa ◽  
Leszek Kowalczyk ◽  
Viktor Domukhovski ◽  
...  
Keyword(s):  
Thermoelectric Properties ◽  
Carrier Mobility ◽  
Room Temperature ◽  
Molecular Beam ◽  
High Quality ◽  
Polycrystalline Solid ◽  
Hall Effect Measurements ◽  
Shubnikov De Haas Oscillations

The electric and thermoelectric properties of novel, CdTe / PbTe layered nanocomposite material are investigated. The molecular beam epitaxy (MBE) method was used for preparation of samples with well controlled distances (from 20 to 70 nm) between the layers of CdTe nanograins embedded in PbTe thermoelectric matrix as well as with number of these layers from 2 to 10. The Hall effect measurements performed in temperature range from 4–300 K revealed that carrier mobility is strongly affected by scattering on CdTe grain boundaries. The observation of Shubnikov-de Haas oscillations confirms high quality of the samples and allows determination of effective mass of conducting electrons m* = 0.04m0. The measurements of the room temperature Seebeck coefficient together with electrical conductivity lead to the power factors which are comparable to those reported in PbTe / CdTe polycrystalline solid solutions.

scholarly journals P05 Establishing the integrity of the continually paediatric pharmacokinetic bioanalysis for clinical trial within an academia environment using quality assessment process

2019 ◽  
Vol 104 (6) ◽  
pp. e19.2-e19
Author(s):  
M Ali ◽  
J Tins ◽  
BB Burckhardt
Keyword(s):  
Method Validation ◽  
Assessment Process ◽  
Study Patient ◽  
European Medicines Agency ◽  
Pharmacokinetic Data ◽  
List Type ◽  
Bioanalytical Method Validation ◽  
Reliable Determination ◽  
Bioanalytical Method ◽  
Enalapril And Enalaprilat

BackgroundEuropean Medicines Agency (EMA) outlines criterion for validation of bioanalytical assay applied under Good Clinical Laboratory Practice (GCLP) within clinical studies. The validation is performed once and does not inevitably ensures comparable reliability over long duration of assay’s applicability. To address this hurdle, the investigator-driven ‘Labelling of Enalapril from Neonates up to Adolescents’ project (LENA) adapted quality system comparable to industry. A comprehensive set of quality measures was applied to ensure reliability of monthly quantified paediatric samples over duration of 31 months.MethodsA 3-step quality approach analysing the calibration standards (CS), quality controls (QCs) and incurred sample reanalysis (ISR) was used to established reliability of unknown samples. Unknown concentrations were reported only if results of known CS (11 levels) and QCs were within the predefined limits. A maximum deviation of ±15% was acceptable at all five QCs level. ISR was conducted for randomly selected paediatric samples to monitor the assay’s performance over time. The acceptable%difference was ±20% for at least 67% of the ISR according to international guidelines. 1,2Results38 analytical runs were conducted for two drugs (enalapril/enalaprilat) from February 2016 to August 2018. Calibration curve evaluation accounted for exclusion of four enalapril and five enalaprilat runs. Additional investigation of QCs resulted in further exclusion of two enalapril and one enalaprilat runs. Within 32 valid runs 820, QCs were measured for enalapril and enalaprilat. 94% enalapril and 89% enalaprilat QCs were within limits (±15%). This set ensured reliable determination of 1262 LENA paediatric study samples. 93 and 104 incurred samples for enalapril and enalaprilat were reanalysed. ISR for enalapril (70%) and enalaprilat (67%) was also within guidelines.1,2ConclusionThe analysis of bioanalytical data ensured the reliability of reported unknown concentrations. It ensured consistent and reliable pharmacokinetic data from first to the last LENA study patient.ReferencesGuideline on bioanalytical method validation. European Medicines Agency, London, UK ( 2011).Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Rockville, MD, USA ( 2018).Disclosure(s)Mohsin Ali, Jutta Tins, Bjoern B Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA)

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

Simultaneous Prediction of Muscle and Contact Forces in the Knee During Gait

2009 ◽  
Author(s):  
Benjamin J. Fregly ◽  
Yi-Chung Lin ◽  
Jonathan P. Walter ◽  
Justin W. Fernandez ◽  
Scott A. Banks ◽  
...  
Keyword(s):  
Contact Forces ◽  
Muscle Coordination ◽  
Reliable Determination ◽  
Joint Forces ◽  
Simultaneous Prediction ◽  
Joint Contact ◽  
Internal Forces ◽  
Independent Ambulation

Walking is important for human health, and independent ambulation predicts quality of life [1]. The study and treatment of neurological and joint disorders that inhibit walking would be more effective if muscle and joint forces could be determined reliably for individual patients. Knowledge of muscle forces is needed to characterize muscle coordination, which is a factor in neurological disorders such as cerebral palsy and stroke, while knowledge of joint contact forces is needed to characterize articular loading, which is a factor in bone and joint disorders such as osteoporosis and osteoarthritis. Reliable determination of these internal forces for individual patients would facilitate the design of customized surgical and rehabilitation treatments that maximize functional outcome.

scholarly journals Evaluation of the influence of the therapy with fosinopril and zofenopril on the regulatory-adaptive status of patients with diastolic chronic heart failure

2019 ◽  
Vol 10 (4) ◽  
pp. 23-28
Author(s):  
Svetlana N. Nedvetskaya ◽  
Vitalii G. Tregubov ◽  
Iosif Z. Shubitidze ◽  
Vladimir M. Pokrovskiy
Keyword(s):  
Heart Failure ◽  
New York ◽  
Chronic Heart Failure ◽  
Subjective Evaluation ◽  
Heart Association ◽  
Functional Class ◽  
New York Heart Association

Aim. Еvaluate the influence of combination therapy with fosinopril or zofenopril on the regulatory-adaptive status (RAS) of patients with diastolic chronic heart failure (CHF). Material and methods. The study includes 80 patients with CHF I-II functional class according to the classification of the New York heart Association with left ventricle ejection fraction ≥50% because of hypertensive disease (HD) of III stage, who were randomized into two groups for treatment with fosinopril (14.7±4.2 mg/day, n=40) or zofenopril (22.5±7.5 mg/day, n=40). As part of combination pharmacotherapy, patients were included nebivolol (7.1±2.0 mg/day and 6.8±1.9 mg/day), in the presence of indications, atorvastatin and acetylsalicylic acid in the intestinal shell were prescribed. Initially and after six months, the following was done: a quantitative evaluation of the RAS (by cardio-respiratory synchronism test), echocardiography, tredmil-test, six-minute walking test, determination of the N-terminal precursor of the natriuretic brain peptide level in blood plasma and subjective evaluation of quality of life. Results. Therapy, using fosinopril, in comparison with zofenopril, more improved RAS (by 66.5%, p

scholarly journals DETERMINATION OF SOCIALIZATION FEATURES IN PHYSICAL EDUCATION STAFF TRAINING AS A SOCIAL AND EDUCATIONAL ISSUE

2017 ◽  
Vol 2017 (3) ◽  
pp. 43-49
Author(s):  
Любовь Стройкина ◽  
Liubov' Stroikina ◽  
Илья Ельцов ◽  
Il'ia El'tsov ◽  
Владимир Свинаренко ◽  
...  
Keyword(s):  
Physical Education ◽  
Professional Education ◽  
Personality Development ◽  
Theory And Practice ◽  
High Quality ◽  
Sport Sociology ◽  
Developmental Issues ◽  
Pedagogical Research

The article describes the theory and practice of inclusion of future physical education teacher in the process of refinement of the socialization concept. A productive study and clarification of the socialization concept is carried out in the courses of Theoretical Pedagogy and Practical pedagogy. The specificity of identifying and solving the problems of socialization depends on the involvement of future PE teachers in scientific and pedagogical research of optimal possibilities for personality development in the constructs of self-realization and self-affirmation. The determination of the socialization category is a complex pedagogically corrected process. The quality of the detailed definitions in the professional education model is a unique tool that guarantees a high quality of solution for developmental issues. The specifics of the choice of the direction for the specification of socialization category depend on the sport chosen by future PE teachers. The quality of socialization as a product of anthropo-sphere and education evolution can be learned from the portfolio kept by the student. The features of high-quality solutions are defined in the pedagogical constructs and pedagogical conditions of modern education, and socialization is no exception as a multidimensional phenomenon and the product of social and educational relations. The specificity of the clarification of the socialization category can be found in the structure of the module "Social pedagogy", "Pedagogy of physical culture and sport", "Sociology of Sport." The Kemerovo State University (Novokuznetsk branch) pays special attention at the technology of system-pedagogical modeling that makes it possible to include future PE teachers into modeling and specification of "socialization" category.

scholarly journals Evaluation of competitiveness of retail enterprises in Nalchik

2020 ◽  
Vol 82 (1) ◽  
pp. 404-408
Author(s):  
I. S. Dzakhmisheva
Keyword(s):  
Retail Trade ◽  
Economic Indicators ◽  
High Quality ◽  
Weighting Factors ◽  
Regional Characteristics ◽  
Trading Company ◽  
Goods And Services ◽  
Sequence Selection

The article defines the ability of retailers, the ability of retailers to meet the requirements of consumers in high-quality products and trade services, taking into account local or regional characteristics. A generalization of the existing terminology allows us to understand the competitiveness of retailers as the ability of a retailer to meet the requirements of consumers in high-quality products and trading services taking into account local or regional characteristics. Assessment of the competitiveness level of a retail trade enterprise is carried out in the following sequence: selection of criteria and their assessment; determination of criteria weighting factors; calculation of a generalized criterion. To calculate the generalized competitiveness level of a retail trade enterprise, criteria and their scores are proposed, and their weighting factors are determined. An essential criterion for the competitiveness of retail enterprises is the degree to which they meet their real needs, which determines the different attractiveness of competitors to consumers. A direct comparison of retail enterprises in a series of similar ones (selling similar products or providing the same services) was carried out according to the main parameters (indicators): the atmosphere of the store, the internal environment of the store, the quality of goods and services, the image of the enterprise; financial and economic indicators. A comparative assessment of the competitiveness of retail trade enterprises has made it possible to establish that the Deya hypermarket is the most competitive trading enterprise. Along with this, it is necessary to direct the activities of the hypermarket to improve the financial and economic component and increase the image of the enterprise. One of the ways to increase the financial and economic indicators of a trading company is merchandising.

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