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A co-registration method to validate optical coherence tomography in the breast surgical cavity.
Heliyon
January 2025
BRITElab, Harry Perkins Institute of Medical Research, QEII Medical Centre Nedlands and Centre for Medical Research, The University of Western Australia, Perth, Australia.
Breast-conserving surgery accompanied by adjuvant radiotherapy is the standard of care for patients with early-stage breast cancer. However, re-excision is reported in 20-30 % of cases, largely because of close or involved tumor margins in the specimen. Several intraoperative tumor margin assessment techniques have been proposed to overcome this issue, however, none have been widely adopted.
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February 2025
Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Background: Recently it has been suggested that coronary microvascular dysfunction (CMD) may explain the high false-positive rate of exercise electrocardiographic stress testing (EST). However, patients with angina but non-obstructive coronary artery disease (ANOCA) present with a broader spectrum of coronary vasomotor dysfunction (CVDys), namely coronary artery spasm (CAS), CMD or a combination of both. We aim to investigate the diagnostic value of EST for the entire CVDys spectrum.
View Article and Find Full Text PDFPeak Procedural ACT Is Associated With All-Cause Mortality After Femoral Access PCI.
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View Article and Find Full Text PDFWhich clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study.
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European Medicines Agency, Amsterdam, The Netherlands
Objectives: In the European Union, a new orphan medicinal product must demonstrate 'significant benefit' over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products-either directly by a head-to-head comparison within a clinical trial or indirectly as a cross-trial comparison-are necessary. In this study, we investigate the types of trial designs and statistical approaches used for demonstrating a significant benefit of a new orphan medicinal product against approved comparators used between 2012 and 2022.
View Article and Find Full Text PDFAssessment of a novel unidirectional mid-term absorbable barbed suture versus a competitor barbed suture for vaginal cuff closure after gynaecology surgery, study protocol of a randomized controlled trial - BARHYSTER.
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Background: Total laparoscopic hysterectomy (TLH) is nowadays the standard to treat benign and malignant disease occurring in the uterus, but the number of robotic-assisted surgeries is increasing worldwide. To facilitate the handling of sutures in a bi- and tri-dimensional plane, a new type of suture material has been developed, named barbed sutures, which are in use in different indications. In comparison to conventional suture materials, the barbs anchor the suture in the tissue, provide tissue approximation and prevent slippage without the need for knot tying.
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