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EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial.
BMJ Open
January 2025
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Introduction: Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial.
View Article and Find Full Text PDFNon-inferiority trials: tyranny or good governance? - Authors' reply.
Lancet Oncol
January 2025
Optimal Cancer Care Alliance, Ann Arbor, MI, USA; Veterans Affairs Center for Clinical Management Research, Charles S Kettles VA Medical Center, Ann Arbor, MI, USA; Division of Oncology and Lung Precision Oncology Program, University of Michigan Division of Hematology/Oncology, Rogel Cancer Center, Institute for Health Policy and Innovation, and Center for Global Health Equity, Ann Arbor, MI, USA.
Non-inferiority trials: tyranny or good governance?
Lancet Oncol
January 2025
Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA.
Understanding Noninferiority Trials: What Stroke Specialists Should Know.
Stroke
January 2025
Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Neuroscience, the Netherlands. (Y.B.W.E.M.R.).
Noninferiority trials aim to prove that the efficacy, defined in terms of a key clinical outcome, of a new treatment is not meaningfully worse than that of an established active control. Noninferiority trials are important when other aspects of care can be improved, such as convenience, toxicity, costs, and safety (nonefficacy benefits). While the motivation for a noninferiority trial is straightforward, the design, execution, and interpretation of these trials is not a trivial task.
View Article and Find Full Text PDFComparison of different puncture needles used for endoscopic ultrasound-guided fine-needle biopsy of Gastrointestinal subepithelial lesions (≤ 2 cm) with respect to the adequacy of specimen collection: study protocol for a multicenter randomized prospective trial.
Trials
December 2024
Second Department of Internal Medicine, Wakayama Medical University, 811-1, Kimiidera, Wakayama City, 641-0012, Japan.
Article Synopsis
- Gastrointestinal subepithelial lesions (SELs) can be benign or malignant, and diagnosing them accurately using endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is challenging, especially for smaller lesions (≤ 2 cm).
- A retrospective study indicated that over 50% of patients with SELs of this size were diagnosed as gastrointestinal stromal tumors (GISTs), highlighting the necessity of using effective EUS-FNB techniques.
- This multicenter study aims to compare the effectiveness of two types of EUS-FNB needles (22G Fork-tip vs. 22G Franseen) in obtaining adequate tissue samples from SELs ≤ 2 cm, with different endpoints focusing on sample quality and procedural outcomes.
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