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Tight Control and Radiological Progression: The Radiographic Outcomes of the TICOPA Study.
J Rheumatol
March 2025
L.C. Coates, MBChB, PhD, University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, UK.
J Rheumatol 2025; doi: 10.3899/jrheum.2024-1035In the Abstract, Results, regarding the definition of radiographic progression, the text should be "an increase in total erosion score of ≥ 2 at week 48.
View Article and Find Full Text PDFFrom Paper to Digital: Evaluating Electronic Medical Records and their Compliance with EMA Guidelines in European Clinical Trials.
Rev Recent Clin Trials
January 2025
Dipartimento Patologia e Cura del Bambino, Regina Margherita AOU Città della Salute e della Scienza di Torino, Presidio Infantile Regina Margherita, Turin, Italy.
Background: Over the past decade, there has been a significant shift from paper-based to digital medical record management, driven largely by advances in digital technology. This transition has led to widespread adoption of Electronic Medical Records (EMRs), with the expectation that paper documentation will soon be fully replaced. In response, the European Medicines Agency's "Guideline on Computerised Systems in Clinical Trials" outlines essential criteria for validated EMR systems to ensure data integrity and security, and sets standards for electronic source documents in clinical trials.
View Article and Find Full Text PDFPartial AUCs in Long-Acting Injectables: Rationale, Challenges, Variability, Usefulness, and Clinical Relevance.
Pharmaceutics
December 2024
Pharmathen SA, 31 Spartis Str., 14452 Metamorfosi Attica, Greece.
Regulatory authorities typically require bioequivalence to be demonstrated by comparing pharmacokinetic parameters like area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C). Because in certain cases, AUC and C alone may not be adequate to identify formulation differences in early and/or late segments of the dosing interval, partial AUCs (pAUCs) have been proposed as additional metrics to evaluate bioequivalence. Even though cut-off points for pAUCs are usually decided based on clinical relevance, the identification of the correct cut-off range remains elusive in many other cases and tends to contribute to increased pAUC estimate variabilities.
View Article and Find Full Text PDFEstimating Earphone Level and Dose Using Real-Ear Measures and Ecological Momentary Assessment.
Am J Audiol
March 2025
Department of Communication Sciences and Disorders, University of Wisconsin-Madison.
Purpose: Prior work estimating sound exposure dose from earphone use has typically measured earphone use time with retrospective questionnaires or device-based tracking, both of which have limitations. This research note presents an exploratory analysis of sound exposure dose from earphone use among college-aged adults using real-ear measures to estimate exposure level and ecological momentary assessment (EMA) to estimate use time.
Method: Earphone levels were measured at the ear drum of 53 college students using their own devices, earphones, and preferred music and speech stimuli at their normal listening volume.
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