Tag: safety

Safety and clinical activity of autologous RNA chimeric antigen receptor T-cell therapy in myasthenia gravis (MG-001): a prospective, multicentre, open-label, non-randomised phase 1b/2a study

This phase 1b/2a multicenter, open-label trial evaluated Descartes-08, an autologous RNA-engineered anti-BCMA CAR T-cell therapy, in 14 adults with generalized myasthenia gravis (MG). Unlike conventional DNA-based CAR T therapies, Descartes-08 utilizes transient mRNA expression, eliminating the need for lymphodepletion. Participants received up to six weekly infusions. The therapy was well

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Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial

This randomized, multicenter, double-blind clinical trial assessed the safety and efficacy of intravenous ferumoxytol compared to ferric carboxymaltose (FCM) in patients with iron deficiency anemia (IDA) unresponsive or intolerant to oral iron. A total of 1,997 patients received either ferumoxytol (n=997) or FCM (n=1000) over ≥15 minutes on days 1

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Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension

This study evaluated the safety and pharmacokinetics of intravenous citrulline in infants and children undergoing congenital heart surgery. In Phase 1, a dose-escalation protocol (50, 100, 150 mg/kg) was used, with a target plasma citrulline trough of 80–100 µmol/L. The 150 mg/kg dose achieved this target. Due to citrulline’s short

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Testosterone Replacement Therapy and Cardiovascular Disease

This review examines the evolving evidence on the cardiovascular safety of testosterone replacement therapy (TRT) in men with hypogonadism. While earlier observational studies raised alarms over increased cardiovascular risks—including myocardial infarction and stroke—recent randomized trials, particularly the TRAVERSE study, provide reassurance that TRT does not significantly increase the risk of

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Efficacy and Safety of Silymarin-Containing Antioxidant Serum as an Adjuvant Treatment of Mild-to-Moderate Acne Vulgaris: A Prospective, Open-Label Pilot Study

This 2023 prospective, open-label pilot study assessed the efficacy and safety of a 0.5% silymarin-loaded antioxidant serum (SAS) as an adjunct treatment in 22 Korean patients with mild-to-moderate acne vulgaris. Over four weeks, patients applied the serum twice daily in addition to their regular acne treatments. The study reported reductions

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