CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A Phase 3, Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection.

Background: Clostridioides difficile infection (CDI) causes substantial mortality and healthcare burden. We assessed the detoxified toxin-A/B PF-06425090 vaccine for primary CDI prevention.

Methods: This phase 3 observer-blinded study randomized (1:1) ≥50-year-olds at increased CDI risk (N = 17 535) to receive 3 PF-06425090 or placebo doses (0, 1, and 6 months).

The everydayness of falling: consequences and management for adults with cerebral palsy across the life course.

Purpose: To explore the cause, influences and consequences of falling for adults with cerebral palsy (CP) across their life course, and how this is managed.

Materials And Methods: We used interview data from a multimethod UK study exploring the effects of ageing with CP and healthcare across the life course. Twenty-six participants were recruited and interviewed using various digital platforms to maximise inclusive participation in the UK.

Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial.

Introduction: Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months' follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.

Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.

Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.

Background: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity.

Methods: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.

Methods: In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose).

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States.

RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available.

Methods: Healthy adults 18-55 and 65-85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike.

Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.

In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a pandemic. With rapidly accumulating numbers of cases and deaths reported globally, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.

Threats to embodied well-being: An exploration of how disabled people negotiate barriers in hospital settings.

Taking a social model of disability approach, this article explores how disabled people negotiate barriers in the large, modern hospital settings typically found in complex healthcare systems. While there is evidence of intractable barriers in the United Kingdom's National Health Service, little is known about the actions disabled people take in the face of barriers and the immediate effects of doing so. Analysis of data from a qualitative study of disabled people's healthcare encounters is presented.

Implementation of a mandatory checklist of protocols and objectives improves compliance with a wide range of evidence-based intensive care unit practices.

Objective: To determine a) if a checklist covering a diverse group of intensive care unit protocols and objectives would improve clinician consideration of these domains and b) if improved consideration would change practice patterns.

Design: Pre- and post observational study.

Setting: A 24-bed surgical/burn/trauma intensive care unit in a teaching hospital.

Dermal penetration and metabolism of p-aminophenol and p-phenylenediamine: application of the EpiDerm human reconstructed epidermis model.

To address the provision of the 7th Amendment to the EU Cosmetics Directive banning the use of in vivo genotoxicity assays for testing cosmetic ingredients in 2009, the 3D EpiDerm reconstructed human skin micronucleus assay has been developed. To further characterise the EpiDerm tissue for potential use in genotoxicity testing, we have evaluated the dermal penetration and metabolism of two hair dye ingredients, p-aminophenol (PAP) and p-phenylenediamine (PPD) in this reconstructed epidermis model. When EpiDerm tissue was topically exposed to PAP or PPD for 30 min (typical for a hair dye exposure), the majority (80->90%) of PAP or PPD was excluded from skin tissue and removed by rinsing.

Acting the part.

The implementation of two key policies highlighted the need to support nurses and midwives to challenge colleagues effectively. To overcome the difficulties this presented, an innovative training package using drama provided participants with practical tips and a safe environment to practise newly developed skills. The programme was well evaluated but further work needs to be undertaken to evaluate its impact upon practice.

Development of a peptide reactivity assay for screening contact allergens.

Allergic contact dermatitis resulting from skin sensitization is a common occupational and environmental health problem. In recent years, the local lymph node assay (LLNA) has emerged as a practical option for assessing the skin sensitization potential of chemicals. In addition to accurate identification of skin sensitizers, the LLNA can also provide a reliable measure of relative sensitization potency; information that is pivotal in successful management of human health risks.

Description and Microbiology of Home-Canned Tomatoes and Tomato Juice.

Home canners completed questionnaires and submitted 378 jars of tomatoes and 382 jars of tomato juice for analysis. Nearly 50% of the containers were non-canning jars, and 25 jars had held food items such as instant tea or coffee or jelly. A few closures were reused from grocery stock; the remainder were the two-part rim and lid or zinc cap and ring.