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Serum Biomarkers in Transthyretin Amyloidosis: An Overview of Neurofilaments, Cardiac, Renal, and Gastrointestinal Involvement.
Neurol Ther
January 2025
Department of Neuroscience, Università Cattolica del Sacro Cuore, Rome, Italy.
Hereditary transthyretin amyloidosis (ATTRv, v for variant) is a genetic disorder characterized by the deposition of misfolded transthyretin (TTR) protein in tissues, resulting in progressive dysfunction of multiple organs, including the nervous system, heart, kidneys, and gastrointestinal (GI) tract. Noninvasive serum biomarkers have become key tools for diagnosing and monitoring ATTRv. This review examines the role of available biomarkers for neurological, cardiac, renal, gastrointestinal, and multisystemic involvement in ATTRv.
View Article and Find Full Text PDFUse of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFEvolving concepts in intracranial pressure monitoring - from traditional monitoring to precision medicine.
Neurotherapeutics
January 2025
Division of Neurosciences Critical Care, Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:
A wide range of acute brain injuries, including both traumatic and non-traumatic causes, can result in elevated intracranial pressure (ICP), which in turn can cause further secondary injury to the brain, initiating a vicious cascade of propagating injury. Elevated ICP is therefore a neurological injury that requires intensive monitoring and time-sensitive interventions. Patients at high risk for developing elevated ICP undergo placement of invasive ICP monitors including external ventricular drains, intraparenchymal ICP monitors, and lumbar drains.
View Article and Find Full Text PDFHistorical and political context for Philip Morris International's continuing medical education courses on harm reduction.
Tob Control
January 2025
Retired, University of California San Francisco, San Francisco, California, USA.
In 2024, Philip Morris International's (PMI) website stated they support 'independent' continuing medical education courses on harm reduction for medical and other healthcare professionals. These courses mirrored industry marketing and political strategies by presenting smokeless tobacco products and e-cigarettes as alternatives to smoking, sometimes without mentioning tobacco cessation. The enactment of the US Family Smoking and Tobacco Control Act gave the US Food and Drug Agency jurisdiction over tobacco products and included the industry's 'continuum of risk' frame, and emboldened tobacco companies to make harm reduction claims about these products, which they had previously avoided for fear of triggering restrictive regulation of cigarettes.
View Article and Find Full Text PDFPatellar Instability After Total Knee Arthroplasty.
J Knee Surg
January 2025
Lenox Hill Hospital Department of Orthopedic Surgery, Northwell Health, New York, United States.
Patellar instability following total knee arthroplasty (TKA) is a rare, yet serious complication, potentially requiring revision surgery or resulting in chronic dysfunction. When encountered, it is paramount to understand the etiologies, diagnostic approaches, treatment options, and outcomes of the selected treatment. The most common cause of patella instability is improper positioning of components, leading to lateral maltracking of the patella.
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