Articles: function.
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Randomized Controlled Trial Multicenter Study Comparative Study
Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.
Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). ⋯ Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).
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Multicenter Study
Gene Editing for CEP290-Associated Retinal Degeneration.
CEP290-associated inherited retinal degeneration causes severe early-onset vision loss due to pathogenic variants in CEP290. EDIT-101 is a clustered regularly interspaced short palindromic repeats (CRISPR)-CRISPR-associated protein 9 (Cas9) gene-editing complex designed to treat inherited retinal degeneration caused by a specific damaging variant in intron 26 of CEP290 (IVS26 variant). ⋯ The safety profile and improvements in photoreceptor function after EDIT-101 treatment in this small phase 1-2 study support further research of in vivo CRISPR-Cas9 gene editing to treat inherited retinal degenerations due to the IVS26 variant of CEP290 and other genetic causes. (Funded by Editas Medicine and others; BRILLIANCE ClinicalTrials.gov number, NCT03872479.).
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Little is known about the contribution of placebo effects and changes observed with no treatment in interventions for nonspecific low back pain (NSLBP). This systematic review assessed the proportions of the overall treatment effect that may be attributable to specific treatment effects, placebo effects, and changes observed with no treatment in randomized controlled trials (RCTs) in patients with NSLBP. Trials published before 2019 were identified from a published systematic review, and the search was updated in MEDLINE, Embase, and Cochrane Central for trials published between January 2019 and March 2023. ⋯ For physical function (11 studies) and HRQoL (6 studies), these proportions were 34%, 13%, and 53%, and 11%, 41%, and 48%, respectively. These results show that approximately half of the overall treatment effect of conservative and mainly passive interventions for patients with chronic NSLBP is attributable to changes observed with no treatment, rather than specific or placebo effects of treatments. However, the certainty of evidence was very low to low, suggesting that the true effects might be markedly different from the effect sizes underlying these estimates.
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Pain is a major socio-psychological problem worldwide. Chronic pain has a negative effect on areas of psychological functioning such as depression, anxiety, and perceived stress. ⋯ In general, the results revealed that experiential avoidance can mediate the relationship among pain, pain anxiety, and pain disability as a maladaptive regulation strategy. The results obtained from this study seem to introduce experiential avoidance as a vulnerability factor effectively.