New regulation of medical devices in the EU: impact in dermatology.

Medical device (MD) is a broad term that encompasses products ranging from, for example, examination gloves to digital dermoscopy systems; all of which are regulated by a new regulatory framework in the EU from May 2021. The new Medical Device Regulation (MDR) (Regulation EU 2017/745) will have a significant effect on suppliers of MD and will have subsequent effects also for dermatologists and other clinicians. Medical device software and apps are reclassified leading to more stringent requirements on documentation within, e.

Prevalence and correlates of body image dissatisfaction in postmenopausal women.

Dissatisfaction with one's body image is widespread and can have serious health consequences; however, research about its prevalence and correlates in older women is limited. We analyzed data from 75,256 women participating in the Women's Health Initiative Observational Study, a longitudinal study of postmenopausal women's health. Measures used in the study were collected at baseline and/or the third year of follow-up between 1993 and 2002.

Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer.

Background: Longitudinal quality of life (QoL) was compared for patients with esophageal cancer receiving definitive chemoradiotherapy (CRT) with conventional-dose (CD) vs. high-dose (HD) radiotherapy as used in the RTOG phase III 94-05 trial (Intergroup 0123).

Methods: Between June 12, 1995, and July 1, 1999, 236 patients with cT1-4NxM0 esophageal cancer were randomized to CD CRT (50.

The relationship between the acute cerebral metabolic response to citalopram and chronic citalopram treatment outcome.

Objectives: Given the challenges in the clinical management of geriatric depression, research over the past decade has focused on developing early neurobiological markers of antidepressant treatment response. This study tested the hypothesis that lower baseline glucose metabolism and greater acute cerebral metabolic responses to a single, intravenous (IV) dose of the selective serotonin reuptake inhibitor (SSRI) citalopram would be associated with greater improvement of depressive symptoms after 12 weeks of citalopram treatment in geriatric depression.

Methods: sixteen geriatric depressed patients underwent two scans to measure cerebral glucose metabolism after administration of either a saline placebo or citalopram infusion (40 mg, IV).

Immunization with cocktail of HIV-derived peptides in montanide ISA-51 is immunogenic, but causes sterile abscesses and unacceptable reactogenicity.

Background: A peptide vaccine was produced containing B and T cell epitopes from the V3 and C4 Envelope domains of 4 subtype B HIV-1 isolates (MN, RF, CanO, & Ev91). The peptide mixture was formulated as an emulsion in incomplete Freund's adjuvant (IFA).

Methods: Low-risk, healthy adult subjects were enrolled in a randomized, placebo-controlled dose-escalation study, and selected using criteria specifying that 50% in each study group would be HLA-B7+.