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Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).

Ther Innov Regul Sci 2021 Jul 21. Epub 2021 Jul 21.

Labor Berlin - Charité Vivantes GmbH, Sylter Strasse 2, 13353, Berlin, Germany.

Purpose: This study aimed at the development of a regulatory strategy for compliance of laboratory-developed tests (LDTs) with requirements of the Regulation (EU) 2017/746 ("EU-IVDR") under consideration of international requirements for LDTs as established in major regulatory regions. Furthermore, it was analysed in how far elements of current LDT regulation could qualify for an internationally harmonised concept ensuring quality, safety and performance of LDTs.

Methods: A review of regulatory literature including legislation as well as guidance documents was performed. Read More

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Isolated sarcoid flexor or extensor tenosynovitis of the hand, wrist and distal forearm.

Hand Surg Rehabil 2021 Jul 17. Epub 2021 Jul 17.

Plastic and Reconstructive Surgery Department, Mansoura University Hospitals, El Gomhouria St, Mit Khamis WA Kafr Al Mougi, 36 Albostan street, Talkha, Mansoura, Dakahlia Governorate, Egypt.

Sarcoid tenosynovitis is a rare etiology of chronic tenosynovitis of the hand. Its diagnosis is particularly challenging and must be confirmed by histopathological finding of multiple non-caseating epithelioid granulomatous lesions and giant cells. In this study, we retrospectively investigated cases with isolated sarcoid tenosynovitis of the hand undergoing only tenosynovectomy, and assessed the outcomes. Read More

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Overcoming the challenges of treating haemophilia in resource-limited nations: a focus on medication access and adherence.

Expert Rev Hematol 2021 Jul 18. Epub 2021 Jul 18.

Clinical Biochemistry, Tata Memorial Hospital, Mumbai, India.

Background: Haemophilia is a high cost low volume disease. Resource limited nations (RLN) usually spend very little on health budget and most of it is spent in dealing with common ailments. Clotting products constitute more than 90 percent of the total cost of haemophilia care. Read More

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Hand hygiene education of Greek medical and nursing students: A cross-sectional study.

Nurse Educ Pract 2021 Jun 28;54:103130. Epub 2021 Jun 28.

Department of Hygiene, Epidemiology and Medical Statistics, School of Medicine, National and Kapodistrian University of Athens, 75 Mikras Asias Street, Athens GR-115 27, Greece. Electronic address:

Aim: To investigate medical and nursing students' education on hand hygiene, their attitude on hand hygiene education and how this education influences their hand hygiene knowledge and practices.

Background: Hospital-acquired infections are associated with prolonged hospitalisation and mortality. The most effective measure for their control is healthcare workers' hand hygiene compliance. Read More

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Age and clinical outcomes after hip fracture surgery: do octogenarian, nonagenarian and centenarian classifications matter?

Age Ageing 2021 Jul 3. Epub 2021 Jul 3.

Department of Orthopaedic Surgery, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan.

Background: older patients with hip fractures are arbitrarily classified as octogenarians, nonagenarians and centenarians. We have designed this study to quantify in-hospital mortality and complications among each of these groups. We hypothesised that the associations between age and in-hospital mortality and complications are continuously increasing, and that these risks increase rapidly when patients reach a certain age. Read More

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Application of Combined Prediction Model Based on Core and Coritivity Theory in Continuous Blood Pressure Prediction.

Comb Chem High Throughput Screen 2021 Jul 4. Epub 2021 Jul 4.

School of Mathematics Physics and Statistics, Shanghai University of Engineering Science, Shanghai 201620, China.

Background And Objective: Blood pressure is vital evidence for clinicians to predict diseases and check the curative effect of diagnosis and treatment. To further improve the prediction accuracy of blood pressure, this paper proposes a combined prediction model of blood pressure based on coritivity theory and photoplethysmography.

Method: First of all, we extract eight features of photoplethysmogram, followed by using eight machine learning prediction algorithms such as K-nearest neighbor, classification and regression trees and random forest to predict systolic blood pressure. Read More

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Step-by-step guide to setting up a kidney replacement therapy registry: the challenge of a national kidney replacement therapy registry.

Clin Kidney J 2021 Jul 24;14(7):1731-1737. Epub 2021 Jan 24.

Latin American Dialysis and Renal Transplantation Registry (RLADTR), Montevideo, Uruguay.

Chronic kidney disease (CKD) has become one of the most important public health problems worldwide. Analysis, and understanding, of this global/national/regional reality would benefit from renal registry databases. The implementation of a CKD registry (including all categories) is difficult to achieve, given its high cost. Read More

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Synthesis and comparison of in vitro dual anti-infective activities of novel naphthoquinone hybrids and atovaquone.

Bioorg Chem 2021 Jun 24;114:105118. Epub 2021 Jun 24.

Centre of Excellence for Pharmaceutical Sciences, North-West University, Potchefstroom 2520, South Africa. Electronic address:

A principal factor that contributes towards the failure to eradicate leishmaniasis and tuberculosis infections is the reduced efficacy of existing chemotherapies, owing to a continuous increase in multidrug-resistant strains of the causative pathogens. This accentuates the dire need to develop new and effective drugs against both plights. A series of naphthoquinone-triazole hybrids was synthesized and evaluated in vitro against Leishmania (L. Read More

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Crohn disease-like enterocolitis remission after empagliflozin treatment in a child with glycogen storage disease type Ib: a case report.

Ital J Pediatr 2021 Jul 2;47(1):149. Epub 2021 Jul 2.

Department of Translational Medical Sciences, Section of Pediatrics, University of Naples "Federico II", Naples, Italy.

Background: Besides major clinical/biochemical features, neutropenia and inflammatory bowel disease (IBD) constitute common complications of Glycogen storage disease type Ib (GSD Ib). However, their management is still challenging. Although previous reports have shown benefit of empagliflozin administration on neutropenia, no follow-up data on bowel (macro/microscopic) morphology are available. Read More

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Effects of and on Growth Performance of Broiler Chickens.

Microorganisms 2021 Jun 21;9(6). Epub 2021 Jun 21.

Department of Agricultural and Environmental Sciences, Tennessee State University, Nashville, TN 37209, USA.

There are well documented complications associated with the continuous use of antibiotics in the poultry industry. Over the past few decades, probiotics have emerged as viable alternatives to antibiotics; however, most of these candidate probiotic microorganisms have not been fully evaluated for their effectiveness as potential probiotics for poultry. Recent evaluation of a metagenome of broiler chickens in our laboratory revealed a prevalence of () and Actinobacteria class of bacteria in their gastrointestinal tract. Read More

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A Framework for Continuous Authentication Based on Touch Dynamics Biometrics for Mobile Banking Applications.

Sensors (Basel) 2021 Jun 19;21(12). Epub 2021 Jun 19.

Cybersecurity INCT Unit 6, Decision Technologies Laboratory-LATITUDE, Electrical Engineering Department (ENE), Technology College, University of Brasília (UnB), Brasília 70910-900, Brazil.

As smart devices have become commonly used to access internet banking applications, these devices constitute appealing targets for fraudsters. Impersonation attacks are an essential concern for internet banking providers. Therefore, user authentication countermeasures based on biometrics, whether physiological or behavioral, have been developed, including those based on touch dynamics biometrics. Read More

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Old World Vipers-A Review about Snake Venom Proteomics of Viperinae and Their Variations.

Toxins (Basel) 2021 06 17;13(6). Epub 2021 Jun 17.

Department of Chemistry, Technische Universität Berlin, Straße des 17. Juni 135, 10623 Berlin, Germany.

Fine-tuned by millions of years of evolution, snake venoms have frightened but also fascinated humanity and nowadays they constitute potential resources for drug development, therapeutics and antivenoms. The continuous progress of mass spectrometry techniques and latest advances in proteomics workflows enabled toxinologists to decipher venoms by modern omics technologies, so-called 'venomics'. A tremendous upsurge reporting on snake venom proteomes could be observed. Read More

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Biostimulation and toxicity: The magnitude of the impact of nanomaterials in microorganisms and plants.

J Adv Res 2021 07 5;31:113-126. Epub 2021 Jan 5.

Departamento de Horticultura, Universidad Autónoma Agraria Antonio Narro, 25315 Saltillo, Mexico.

Background: Biostimulation and toxicity constitute the continuous response spectrum of a biological organism against physicochemical or biological factors. Among the environmental agents capable of inducing biostimulation or toxicity are nanomaterials. On the < 100 nm scale, nanomaterials impose both physical effects resulting from the core's and corona's surface properties, and chemical effects related to the core's composition and the corona's functional groups. Read More

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Preliminary prospective study of real-time post-gastrectomy glycemic fluctuations during dumping symptoms using continuous glucose monitoring.

World J Gastroenterol 2021 Jun;27(23):3386-3395

Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.

Background: Although dumping symptoms constitute the most common post-gastrectomy syndromes impairing patient quality of life, the causes, including blood sugar fluctuations, are difficult to elucidate due to limitations in examining dumping symptoms as they occur.

Aim: To investigate relationships between glucose fluctuations and the occurrence of dumping symptoms in patients undergoing gastrectomy for gastric cancer.

Methods: Patients receiving distal gastrectomy with Billroth-I (DG-BI) or Roux-en-Y reconstruction (DG-RY) and total gastrectomy with RY (TG-RY) for gastric cancer (March 2018-January 2020) were prospectively enrolled. Read More

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Public Policies and One Health in Brazil: The Challenge of the Disarticulation.

Front Public Health 2021 4;9:644748. Epub 2021 Jun 4.

Laboratory of Bacterial Diseases, Preventive Veterinary Medicine and Public Health Sector, Veterinary Department, Universidade Federal de Viçosa, Viçosa, Brazil.

Working the One health strategy in developing countries is a challenge, due to structural weaknesses or deprivation of financial, human, and material resources. Brazil has policies and programs that would allow continuous and systematic monitoring of human, animal, and environmental health, recommending strategies for control and prevention. For animals, there are components of the Epidemiological Surveillance of zoonosis and Animal Health Programs. Read More

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A comprehensive review of flow chemistry techniques tailored to the flavours and fragrances industries.

Beilstein J Org Chem 2021 18;17:1181-1312. Epub 2021 May 18.

Department of Chemistry, University of Durham, Stockton Road, Durham, DH1 3LE, United Kingdom.

Due to their intrinsic physical properties, which includes being able to perform as volatile liquids at room and biological temperatures, fragrance ingredients/intermediates make ideal candidates for continuous-flow manufacturing. This review highlights the potential crossover between a multibillion dollar industry and the flourishing sub-field of flow chemistry evolving within the discipline of organic synthesis. This is illustrated through selected examples of industrially important transformations specific to the fragrances and flavours industry and by highlighting the advantages of conducting these transformations by using a flow approach. Read More

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[A growing complex cerebral artery aneurysm treated with cerebral bypass].

Ugeskr Laeger 2021 06;183(23)

Fuciform, partly thrombosed giant middle cerebral artery (MCA) aneurysms constitute a relatively rare entity among intracranial aneurysms. Obliteration of these aneurysm poses a challenge for both neurosurgeons and neurointerventionalists. The present case report on a fuciform MCA aneurysm that continued to grow despite endovascular treatment. Read More

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Spectral collapse in anisotropic two-photon Rabi model.

C F Lo

Sci Rep 2021 Jun 11;11(1):12401. Epub 2021 Jun 11.

Institute of Theoretical Physics and Department of Physics, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.

In this communication, based upon a squeezed-state trial wave function, we have performed a simple variational study of the spectral collapse in the anisotropic two-photon Rabi model. Our analysis indicates that the light-matter interaction and the spin-flipping (together with the anisotropy) effectively constitute two competing impacts upon the radiation mode. Whilst the former tries to decrease the radiation mode frequency, the latter may counteract or reinforce it. Read More

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Dissemination and Acceptance of COVID-19 Misinformation in Iran: A Qualitative Study.

Int Q Community Health Educ 2021 Jun 7:272684X211022155. Epub 2021 Jun 7.

Health Information Technology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Introduction: Misinformation refers to unclear information from unreliable resources, and it is a common phenomenon of society; it can even constitute a part of family and social conversations due to the relative damages. Misinformation dissemination under the circumstances of the COVID-19 pandemic can be considered a cause of health-related anxieties and severe harm to the countries. The present study aims to explain factors related to the dissemination and acceptance of coronavirus misinformation in Iran. Read More

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Translation role of circRNAs in cancers.

J Clin Lab Anal 2021 Jul 7;35(7):e23866. Epub 2021 Jun 7.

Li Huili Hospital Affiliated to Ningbo University School, Ningbo, China.

Circular RNAs (circRNAs) constitute a class of covalently closed RNA molecules. With the continuous advancement of high-throughput sequencing technology and bioinformatics tools, many circRNAs have been identified in various human tissues and cell lines. Notably, recent studies have indicated that some circRNAs have translational functions. Read More

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Clock-controlled arylalkylamine N-acetyltransferase (aaNAT) regulates circadian rhythms of locomotor activity in the American cockroach, Periplaneta americana, via melatonin/MT2-like receptor.

J Pineal Res 2021 Jun 6:e12751. Epub 2021 Jun 6.

Graduate School of Natural Science and Technology, Graduate School of Agricultural Science, Kobe University, Kobe, Japan.

Melatonin (MEL) orchestrates daily and seasonal rhythms (eg, locomotion, sleep/wake cycles, and migration among other rhythms) in diverse organisms. We investigated the effects of pharmacological doses (0.03-1 mM) of exogenous MEL intake in the cockroach, Periplaneta americana, on locomotor activity. Read More

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Monitoring of hospital sewage shows both promise and limitations as an early-warning system for carbapenemase-producing Enterobacterales in a low-prevalence setting.

Water Res 2021 Jul 17;200:117261. Epub 2021 May 17.

Centre for Antibiotic Resistance Research (CARe) at University of Gothenburg, Gothenburg, Sweden; Institute of Biomedicine, Department of Infectious Diseases, University of Gothenburg, Gothenburg, Sweden.

Carbapenemase-producing Enterobacterales (CPE) constitute a significant threat to healthcare systems. Continuous surveillance is important for the management and early warning of these bacteria. Sewage monitoring has been suggested as a possible resource-efficient complement to traditional clinical surveillance. Read More

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Mimicking Complexity of Structured Data Matrix's Information Content: Categorical Exploratory Data Analysis.

Entropy (Basel) 2021 May 11;23(5). Epub 2021 May 11.

Institute of Statistical Science, Academia Sinica, Taipei 115, Taiwan.

We develop Categorical Exploratory Data Analysis (CEDA) with mimicking to explore and exhibit the complexity of information content that is contained within any data matrix: categorical, discrete, or continuous. Such complexity is shown through visible and explainable serial multiscale structural dependency with heterogeneity. CEDA is developed upon all features' categorical nature via histogram and it is guided by all features' associative patterns (order-2 dependence) in a mutual conditional entropy matrix. Read More

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Antibody Therapies for Large B-Cell Lymphoma.

Biologics 2021 18;15:153-174. Epub 2021 May 18.

Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Torino, Italy.

Large B-cell lymphomas (LBCLs) constitute a subgroup of aggressive but highly curable lymphoproliferative diseases. Treatment of relapsed/refractory (R/R) patients still represents an unmet clinical need, and novel drugs and combinations are in continuous development. The pan-B cell panel of surface antigens that characterizes LBCL leads to a large umbrella of druggable targets. Read More

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Heat Tolerance and Occupational Heat Exposure Limits in Older Men with and without Type 2 Diabetes or Hypertension.

Med Sci Sports Exerc 2021 May 12. Epub 2021 May 12.

Human and Environmental Physiology Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, Canada Departments of Medicine, Cardiac Sciences and Community Health Sciences Faculties of Medicine and Kinesiology, University of Calgary, Canada Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada FAME Laboratory, Department of Exercise Science, University of Thessaly, Greece Faculté des sciences de l'activité physique, Université de Sherbrooke, Sherbrooke, Québec, Canada Hypertension Program, Division of Nephrology, University of Ottawa, Ottawa, Canada.

Purpose: To mitigate rises in core temperature >1°C, the American Conference of Governmental Industrial Hygienists (ACGIH) recommends upper limits for heat stress (Action Limit Values; ALV), defined by wet-bulb globe temperature (WBGT) and a worker's metabolic rate. However, these limits are based on data from young men and are assumed to be suitable for all workers, irrespective of age or health status. We therefore explored the impact of aging, type 2 diabetes (T2D), and hypertension (HTN), on tolerance to prolonged, moderate-intensity work above and below these limits. Read More

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Discontinuous epidemic transition due to limited testing.

Nat Commun 2021 05 10;12(1):2586. Epub 2021 May 10.

Institute of Science and Technology Austria, Klosterneuburg, Austria.

High impact epidemics constitute one of the largest threats humanity is facing in the 21 century. In the absence of pharmaceutical interventions, physical distancing together with testing, contact tracing and quarantining are crucial in slowing down epidemic dynamics. Yet, here we show that if testing capacities are limited, containment may fail dramatically because such combined countermeasures drastically change the rules of the epidemic transition: Instead of continuous, the response to countermeasures becomes discontinuous. Read More

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Biological effect of PM on airway epithelium-focus on obstructive lung diseases.

Clin Immunol 2021 06 6;227:108754. Epub 2021 May 6.

Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Poland. Electronic address:

Recently, a continuous increase in environmental pollution has been observed. Despite wide-scale efforts to reduce air pollutant emissions, the problem is still relevant. Exposure to elevated levels of airborne particles increased the incidence of respiratory diseases. Read More

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Role of non-pharmacological interventions for healthy ageing.

Geriatr Psychol Neuropsychiatr Vieil 2021 Apr 26. Epub 2021 Apr 26.

Laboratory EA4556 Epsylon, University of Montpellier, Platform University CEPS, Montpellier, France.

The range of non-pharmacological interventions (NPIs) available for people over 60 years of age is continuously expanding, both in terms of prevention and therapy. They have been empirically selected for centuries and more recently developed through epigenetic studies, clinical trials and technological innovations, and their development has increased and diversified around the world. Residual questions concern: 1) the scope of such treatments which appears to overlap with alternative medicines, 2) their evaluation, which some researchers say is impossible, and 3) their implementation in the elderly, which appears to be overly complicated. Read More

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Overly Strong Priors for Socially Meaningful Visual Signals Are Linked to Psychosis Proneness in Healthy Individuals.

Front Psychol 2021 8;12:583637. Epub 2021 Apr 8.

Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Berlin, Germany.

According to the predictive coding theory of psychosis, hallucinations and delusions are explained by an overweighing of high-level prior expectations relative to sensory information that leads to false perceptions of meaningful signals. However, it is currently unclear whether the hypothesized overweighing of priors (1) represents a pervasive alteration that extends to the visual modality and (2) takes already effect at early automatic processing stages. Here, we addressed these questions by studying visual perception of socially meaningful stimuli in healthy individuals with varying degrees of psychosis proneness ( = 39). Read More

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Unveiling African rainforest composition and vulnerability to global change.

Nature 2021 05 21;593(7857):90-94. Epub 2021 Apr 21.

CIRAD, Forêts et Sociétés, Montpellier, France.

Africa is forecasted to experience large and rapid climate change and population growth during the twenty-first century, which threatens the world's second largest rainforest. Protecting and sustainably managing these African forests requires an increased understanding of their compositional heterogeneity, the environmental drivers of forest composition and their vulnerability to ongoing changes. Here, using a very large dataset of 6 million trees in more than 180,000 field plots, we jointly model the distribution in abundance of the most dominant tree taxa in central Africa, and produce continuous maps of the floristic and functional composition of central African forests. Read More

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