39 results match your criteria: "Global Clinical Affairs[Affiliation]"
J Pathol Inform
December 2024
Global Clinical Affairs, Leica Biosystems Imaging, Inc., Buffalo Grove, IL, USA.
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.
View Article and Find Full Text PDFMicrobiol Spectr
October 2024
University Hospital Münster, Institute of Medical Microbiology, Münster, Germany.
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).
View Article and Find Full Text PDFHealth Sci Rep
March 2024
Medical Science Liaisons and Clinical Strategy Global Clinical Affairs, R&D 5600 Clearfork Main St Fort Worth 76107 TX USA.
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.
J Rheumatol
May 2024
M. Dougados, MD, Department of Rheumatology, CHU Cochin, Paris, France.
BMC Pulm Med
January 2024
Global Clinical Affairs, Clinical Application, Ambu A/S, Baltorpbakken 13, Ballerup, 2750, Denmark.
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.
View Article and Find Full Text PDFDiagn Microbiol Infect Dis
July 2023
Laboratoire de Bactériologie, Centre Hospitalier de Valenciennes, Valenciennes, France. Electronic address:
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.
J Clin Apher
August 2023
Innovation Department, CSL Plasma, Boca Raton, Florida, USA.
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.
View Article and Find Full Text PDFJ 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.
Can J Dent Hyg
October 2022
Manager of clinical research, Global Clinical Affairs, Dentsply Sirona, Mölndal, Sweden.
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).
Eur J Heart Fail
February 2023
Heart and Vascular Center, Center for Advanced Heart Disease, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
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.
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.
View Article and Find Full Text PDFJ Clin Microbiol
July 2022
bioMérieux, La Balme les Grottes, France.
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.
View Article and Find Full Text PDFWound Manag Prev
February 2022
Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois.
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).
J Diabetes Sci Technol
May 2023
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
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.
View Article and Find Full Text PDFInt 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.
View Article and Find Full Text PDFJ Orthop Surg Res
November 2021
Global Scientific Affairs and Clinical Engagement, LifeNet Health®, 1864 Concert Drive, Virginia Beach, VA, 23453, USA.
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.
Circ Heart Fail
October 2021
Center for Advanced Heart Disease, Brigham and Women's Hospital, Boston, MA (M.R.M.).
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).
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.
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:
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.
View Article and Find Full Text PDFBJS Open
January 2021
Health Economics and Market Access, Smith+Nephew, Hull, UK.
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.
Arthritis Res Ther
January 2021
René Descartes University, Université de Paris, Department of Rheumatology - Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France.
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.
View Article and Find Full Text PDFAm 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).
View Article and Find Full Text PDFJ Orthop Surg Res
November 2020
Global Clinical Affairs, LifeNet Health®, Virginia Beach, VA, USA.
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.
Br J Nurs
September 2020
Vice-president, Global Clinical Affairs, Avanos Medical.