Articles: patients.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Chronic Lymphocytic Leukemia Therapy Guided by Measurable Residual Disease.
The combination of ibrutinib and venetoclax has been shown to improve outcomes in patients with chronic lymphocytic leukemia (CLL) as compared with chemoimmunotherapy. Whether ibrutinib-venetoclax and personalization of treatment duration according to measurable residual disease (MRD) is more effective than fludarabine-cyclophosphamide-rituximab (FCR) is unclear. ⋯ MRD-directed ibrutinib-venetoclax improved progression-free survival as compared with FCR, and results for overall survival also favored ibrutinib-venetoclax. (Funded by Cancer Research UK and others; FLAIR ISRCTN Registry number, ISRCTN01844152; EudraCT number, 2013-001944-76.).
-
Randomized Controlled Trial
Randomized Controlled Trial of Ketamine and Moderate Sedation for Outpatient Endoscopy in Adults.
Ketamine is an effective sedative agent in a variety of settings due to its desirable properties including preservation of laryngeal reflexes and lack of cardiovascular depression. We hypothesized that ketamine is an effective alternative to standard moderate sedation (SMS) regimens for patients undergoing endoscopy. ⋯ Ketamine is preferred by patients, preserves hemodynamics better than SMS, and can be safely administered by endoscopists. Data suggest that ketamine is a safe and effective sedation option for patients undergoing esophagogastroduodenoscopy or colonoscopy (clinicaltrials.gov NCT03461718).
-
Randomized Controlled Trial
Pressure Injury Mitigation in Prolonged Care: A Randomized Noninferiority and Superiority Trial.
Combat casualties are at increased risk for pressure injuries (PIs) during prolonged casualty care. There is limited research on operational PI risk mitigation strategies. The purpose of this study was to (1) compare a prototype mattress (AirSupport) designed for operational conditions versus the foldable Talon litter and Warrior Evacuation Litter Pad (WELP) on PI risk factors and (2) determine whether the Talon + AirSupport pad was noninferior and superior to the Talon + WELP on skin interface pressure. ⋯ The Talon litter presents a PI risk because of increased skin interface pressure, and hence, immediate action is warranted. The decreased PI risk associated with the lower skin interface pressures on the AirSupport and WELP was offset by the higher skin temperature, which may add the equivalent of 20 to 30 mm Hg pressure to the ischemic burden. Thus, any pressure redistribution intervention must be evaluated with a consideration for skin interface pressure, temperature, and moisture. Data from this study were applied to a predictive model for skin damage. Under operational conditions where resources and the environment may limit patient repositioning, it would be expected that casualties would suffer skin damage within 2 to 5 hours, with the occiput as the highest risk area. The severity of predicted skin damage is lowest on the AirSupport, which is consistent with the noninferiority and superiority of the AirSupport mattress compared to the WELP and Talon. Operational utility: The AirSupport and WELP, which were both superior to the Talon, are operationally feasible solutions to mitigate PI risk. The smaller size of the Talon (2.7 kgs compressible) versus the WELP (5 kgs noncompressible) may make them appropriate for different levels of the operational setting.
-
Randomized Controlled Trial
Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial.
Unmet medical needs remain in patients with red blood cell transfusion-dependent (RBC-TD) lower-risk myelodysplastic syndromes (LR-MDS) who are not responding to or are ineligible for erythropoiesis-stimulating agents (ESAs). Imetelstat, a competitive telomerase inhibitor, showed promising results in a phase 2 trial. We aimed to compare the RBC transfusion independence (RBC-TI) rate with imetelstat versus placebo in patients with RBC-TD LR-MDS. ⋯ Janssen Research & Development before April 18, 2019, and Geron Corporation thereafter.
-
Randomized Controlled Trial Multicenter Study
Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study.
Stepwise intensification of inhaled corticosteroids (ICS) is routine for severe eosinophilic asthma, despite some poor responses to high-dose ICS. Dose reductions are recommended in patients responding to biologics, but little supporting safety evidence exists. ⋯ AstraZeneca.