How can external data sources be used to provide context for the results of an open-label trial?

The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure ... NCI's Dictionary of Cancer Terms provides easy-to-understand definitions for words and phrases related to cancer and medicine. Jul 9, 2021 ... Phase 1b open-label trial of afatinib plus Xentuzumab (BI 836845) in patients with EGFR mutation-positive NSCLC after progression on EGFR tyrosine kinase ... Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI. A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease that causes inflammation of the membranes that ... Methods: This Phase 4, multicenter, open label study included patients with uncontrolled gout (SU ≥6 mg/dL, oral urate-lowering therapy intolerance/inefficacy, ... This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects ... Triheptanoin dramatically reduced by 90% the number of non-epileptic paroxysmal manifestations over 2 months in GLUT1-DS and improved patient's brain energy ... (143) - Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement ... Abstract. Many oncology clinical trials are randomized open-label trials. In order to minimize operational bias while not hindering critical activities in ...