39 results match your criteria: "Global Clinical Affairs[Affiliation]"

Background: Digital pathology systems (DPS) are emerging as capable technologies for clinical practice. Studies have analyzed pathologists' diagnostic concordance by comparing reviews of whole slide images (WSIs) to glass slides (e.g.

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The performance of a novel selective agar was evaluated against the performance of conventional mycobacterial cultures, i.e., a combination of the mycobacterial growth indicator tube (MGIT) with Löwenstein-Jensen (LJ), for the detection of nontuberculous mycobacteria (NTM) in sputum samples from people with cystic fibrosis (pwCF).

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Background And Aims: This study considers the cost-effectiveness of commonly used cellular, acellular, and matrix‑like products (CAMPs) of human origin also known as human cell and tissue products (HCT/Ps) in the management of diabetic foot ulcers.

Methods: We developed a 1-year economic model assessing six CAMPs [cryopreserved placental membrane with viable cells (vCPM), bioengineered bilayered living cellular construct (BLCC), human fibroblast dermal substitute (hFDS), dehydrated human amnion chorion membrane (dHACM), hypothermically stored amniotic membrane (HSAM) and human amnion membrane allograft (HAMA) which had randomized controlled trial evidence compared with standard of care (SoC). CAMPs were compared indirectly and ranked in order of cost-effectiveness using SoC as the baseline, from a CMS/Medicare's perspective.

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Article Synopsis
  • - The study compares the ability of MRI and radiographs to detect erosions in the sacroiliac joint (SIJ) for patients with recent-onset axial spondyloarthritis (axSpA) over a 104-week period, with a focus on the effects of the treatment etanercept. - Results showed that MRI detected more erosions than radiographs at baseline and in changes over time, with a significant number of patients demonstrating improved erosion scores on MRI compared to radiographs after treatment. - The research highlights that MRI may be superior in monitoring SIJ erosions in axSpA, suggesting that further investigation into the clinical significance of these findings is needed.
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Background: Flexible bronchoscopy procedures require detailed anatomical knowledge and advanced technical skills. Simulation-based training offers a patient-safe training environment that can be more efficient than patient-based training. Physical models are cheaper than virtual reality simulators and allow trainees to be acquainted with the equipment used in the clinic.

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Study Objective: To compare the antimicrobial susceptibility testing (AST) performance of positive blood cultures (PBC) VITEK®2 off-label use (D0) and traditional VITEK®2 workflow using isolated colonies after overnight (D1).

Methods: Patient samples with monomicrobial Gram-negative rod or Gram-positive cocci in clusters bacteremia were tested on D0 and compared to D1 AST results in 7 laboratories in France.

Results: Overall, categorical and essential agreement rates were 98.

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Background: Safe, efficient, and reliable innovations among donation systems are needed to meet the growing global demand for source plasma. This study assessed the ability of a new donation system to collect appropriate product weights based on the US Food and Drug Administration nomogram for source plasma collections. Procedure duration and safety endpoints were also collected.

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Longitudinal changes in subgingival biofilm composition following periodontal treatment.

J Periodontol

September 2023

Oral Sciences, Dental School, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.

Background: Current periodontal treatment involves instrumentation using hand and/or ultrasonic instruments, which are used either alone or in combination based on patient and clinician preference, with comparable clinical outcomes. This study sought to investigate early and later changes in the subgingival biofilm following periodontal treatment, to identify whether these changes were associated with treatment outcomes, and to investigate whether the biofilm responded differently to hand compared with ultrasonic instruments.

Methods: This was a secondary-outcome analysis of a randomized-controlled trial.

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Background: Ultrasonic instrumentation (USI) has evolved, but it is unclear if dental hygiene curricula have kept pace. This study compares 2 dental hygiene cohorts with differing USI curricula to investigate if a contemporary USI curriculum enhanced students' USI preparation, use, and confidence.

Methods: A 2-group observational study compared a "traditional" USI curriculum (TC) cohort to a later "contemporary" USI curriculum cohort (CC).

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Aims: We assessed the incidence, predictors and clinical correlates of de-novo aortic regurgitation (AR), which physiologically reduces left ventricular assist device (LVAD) effectiveness due to recirculation syndrome, in the MOMENTUM 3 trial portfolio of the fully magnetically levitated HeartMate 3 (HM3) pump using the randomized pivotal trial (PT) and post-trial continued access protocol (CAP).

Methods And Results: De-novo aortic regurgitation incidence at 2 years was analysed in the randomized PT and validated in the first 1000 implanted patients of the CAP. Patients with concomitant/prior aortic valve surgery or without baseline or post-implant echocardiograms were excluded from this analysis.

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Aerosol reduction efficacy of different intra-oral suction devices during ultrasonic scaling and high-speed handpiece use.

BMC Oral Health

September 2022

Oral Sciences, Glasgow Dental Hospital and School, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G2 3JZ, UK.

Background: The COVID-19 pandemic led to significant changes in the provision of dental services, aimed at reducing the spread of respiratory pathogens through restrictions on aerosol generating procedures (AGPs). Evaluating the risk that AGPs pose in terms of SARS-CoV-2 transmission is complex, and measuring dental aerosols is challenging. To date, few studies focus on intra-oral suction.

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Fosfomycin is a phosphonic acid derivative active against a wide spectrum of Gram-positive and Gram-negative pathogens. It is used for the treatment of uncomplicated urinary tract infections (uUTI) or severe infections by oral or intravenous (i.v.

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Background: Longitudinal patient-reported data are limited for people living with an ostomy.

Purpose: The Observational Study of Ostomy Consumers (OSO) registry collects data from individuals living with an ostomy.

Methods: Self-reported data were collected via repeated electronic surveys completed by adults living with an ostomy in the United States (US) and United Kingdom (UK).

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Background: The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making.

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Development and Validation of a Machine Learning Model Predicting Arteriovenous Fistula Failure in a Large Network of Dialysis Clinics.

Int J Environ Res Public Health

November 2021

Clinical & Data Intelligence Systems-Advanced Analytics, Fresenius Medical Care, 26020 Vaiano Cremasco, Italy.

Vascular access surveillance of dialysis patients is a challenging task for clinicians. We derived and validated an arteriovenous fistula failure model (AVF-FM) based on machine learning. The AVF-FM is an XG-Boost algorithm aimed at predicting AVF failure within three months among in-centre dialysis patients.

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Background: The objectives of this study were to build upon previously-reported 12-month findings by retrospectively comparing 24-month follow-up hospitalization charges and potentially-relevant readmissions in US lumbar fusion surgeries that employed either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a nationwide healthcare system database.

Methods: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2 in the original study, of whom 3,792 patients (23.4%) were identified in the current study with all-cause readmissions during the 24-month follow-up period.

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Background: Heart failure disproportionately affects Black patients. Whether differences among race influence outcomes in advanced heart failure with use of a fully magnetically levitated continuous-flow left ventricular assist device remains uncertain.

Methods: We included 515 IDE (Investigational Device Exemption) clinical trial patients and 500 Continued Access Protocol patients implanted with the HeartMate 3 left ventricular assist device in the MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).

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Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial.

J Antimicrob Chemother

November 2021

Cardiff University, Division of Infection and Immunity, Department of Medical Microbiology, University Hospital of Wales, Cardiff, UK.

Objectives: To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections.

Methods: MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab®), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains.

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Spirituality in Cancer Care: Introduction.

Semin Oncol Nurs

October 2021

School of Nursing and Midwifery, University College Cork, Cork, Ireland; Global Clinical Affairs Department, Terumo Blood and Cell Technologies, Lakewood, Colo, USA. Electronic address:

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Pharmacokinetic and Pharmacological Aspects of a Papain-Based Enzyme Solution for Rescuing Clogged Enteral Feeding Tubes.

Gastroenterol Nurs

November 2021

Mark C. Lavigne, PhD, is Clinical Science Fellow, Global Clinical Affairs, Avanos Medical, Inc., Alpharetta, Georgia.

Successful enteral feeding depends on patent enteral feeding tubes to permit trouble-free entry of nutritional formula into the alimentary tract. However, tube clogs can be a challenging complication of enteral feeding. This report addresses questions about using a papain-based enzyme solution to unclog enteral feeding tubes, including any effects that papain may have on patients and if solution use should be contraindicated in patients on ketogenic diets.

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Background: Surgical-site complications (SSCs) remain a significant cause of morbidity and mortality, particularly in high-risk patients. The aim of this study was to determine whether prophylactic use of a specific single-use negative-pressure wound therapy (sNPWT) device reduced the incidence of SSCs after closed surgical incisions compared with conventional dressings.

Methods: A systematic literature review was performed using MEDLINE, Embase and the Cochrane Library to identify articles published from January 2011 to August 2018.

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Background: Limited information is available on the impact of treatment with a tumor necrosis factor inhibitor (TNFi) on structural lesions in patients with recent-onset axial spondyloarthritis (axSpA). We compared 2-year structural lesion changes on magnetic resonance imaging (MRI) in the sacroiliac joints (SIJ) of patients with recent-onset axSpA receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). We also evaluated the relationship between the Ankylosing Spondylitis Disease Activity Score (ASDAS) and change in MRI structural parameters.

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Hand hygiene feedback impacts compliance.

Am J Infect Control

July 2021

Proventix Systems Inc., Birmingham, AL.

Background: Health care-acquired infections are one of the top causes of mortality in the United States (Stone, 2009; Scott, 2009). Hand hygiene (HH) can reduce the incidence of such infections. Adherence to HH practices remains challenging for health care workers (World Health Organization, 2014).

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Background: The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed.

Methods: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.

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