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Unlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.
View Article and Find Full Text PDFUnlabelled: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete.
View Article and Find Full Text PDFParsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy?
Open Heart
January 2025
Cardiology, Radboudumc, Nijmegen, The Netherlands
Background And Aims: Due to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).
View Article and Find Full Text PDFRole of Absorbable Polysaccharide Hemostatic Powder in the Prevention of Complications After Axillary Lymph Node Dissection in Breast Cancer Patients: A Multicenter Retrospective Analysis.
Medicina (Kaunas)
January 2025
Department of Advanced Since and Surgery, General, Mini-Invasive, Oncological and Obesity Surgery, Luigi Vanvitelli University of Campania, 80138 Naples, Italy.
: Although breast surgery has undergone a drastic de-escalation in recent decades, axillary dissection is still indicated in some selected cases. Unfortunately, in 3-85% of cases, complications such as seroma formation occur, highlighting the need for more accurate hemostasis systems. The aim of this study is to evaluate the effectiveness of absorbable polysaccharide hemostatic such as Haemocer in preventing postoperative seroma.
View Article and Find Full Text PDFNeoadjuvant Immunotherapy and De-escalation of Surgery in Locally Advanced Breast Implant-associated Anaplastic Large Cell Lymphoma.
Arch Plast Surg
January 2025
Department of Plastic, Reconstructive, and Esthetic surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of non-Hodgkin T-cell lymphoma diagnosed in patients with a history of breast implants. Most patients develop a periprosthetic effusion at early stages of disease while less common presentations include a palpable mass, severe capsular contracture, lymphadenopathy, or cutaneous erythema. Due to the complex nature of this disease, a multidisciplinary approach is necessary for optimal management, particularly in locally advanced disease or inoperable patients.
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