Efficacy, immunogenicity, and safety of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine.

Background: In this phase 3 trial of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine (RSVPreF3-Mat), a higher rate of preterm birth was observed in the vaccine (6.8%) versus the placebo group (4.9%).

Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.

Background: For decades, poor treatment options and low-quality evidence plagued care for patients with rifampin-resistant tuberculosis. The advent of new drugs to treat tuberculosis and enhanced funding now permit randomized, controlled trials of shortened-duration, all-oral treatments for rifampin-resistant tuberculosis.

Methods: We conducted a phase 3, multinational, open-label, randomized, controlled noninferiority trial to compare standard therapy for treatment of fluoroquinolone-susceptible, rifampin-resistant tuberculosis with five 9-month oral regimens that included various combinations of bedaquiline (B), delamanid (D), linezolid (L), levofloxacin (Lfx) or moxifloxacin (M), clofazimine (C), and pyrazinamide (Z).

The TOXIN knowledge graph: supporting animal-free risk assessment of cosmetics.

The European Union's ban on animal testing for cosmetic products and their ingredients, combined with the lack of validated animal-free methods, poses challenges in evaluating their potential repeated-dose organ toxicity. To address this, innovative strategies like Next-Generation Risk Assessment (NGRA) are being explored, integrating historical animal data with new mechanistic insights from non-animal New Approach Methodologies (NAMs). This paper introduces the TOXIN knowledge graph (TOXIN KG), a tool designed to retrieve toxicological information on cosmetic ingredients, with a focus on liver-related data.

Frequency, financial impact, and factors associated with cost outliers in intensive care units: a cohort study in Belgium.

Objective: This study aimed to explore the association between high outliers and intensive care unit admissions and to identify the factors contributing to high intensive care unit costs.

Methods: This retrospective cohort study used data from 17 Belgian hospitals from 2018 and 2019. The study focused on the 10 most frequently admitted diagnosis-related groups in the intensive care unit.

Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.

Background: ANDROMEDA-SHOCK 2 is an international, multicenter, randomized controlled trial comparing hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock to standard care resuscitation to test the hypothesis that the former is associated with lower morbidity and mortality in terms of hierarchal analysis of outcomes.

Objective: To report the statistical plan for the ANDROMEDA--SHOCK 2 randomized clinical trial.

Methods: We briefly describe the trial design, patients, methods of randomization, interventions, outcomes, and sample size.

Early-onset sleep alterations found in patients with amyotrophic lateral sclerosis are ameliorated by orexin antagonist in mouse models.

Sleep alterations have been described in several neurodegenerative diseases yet are currently poorly characterized in amyotrophic lateral sclerosis (ALS). This study investigates sleep macroarchitecture and related hypothalamic signaling disruptions in ALS. Using polysomnography, we found that both patients with ALS as well as asymptomatic and mutation carriers exhibited increased wakefulness and reduced non-rapid eye movement sleep.

REACH assessment of humans exposed to chemicals indirectly via the environment: screening modeling in EUSES versus state of the science.

The assessment of humans indirectly exposed to chemicals via the environment (HvE) is an assessment element of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation. The European Union System for the Evaluation of Substances (EUSES) is the default screening tool, aimed at prioritizing chemicals for further refinement/higher tier assessment. This review summarizes the approach used in EUSES, evaluates the state of the science in human exposure modeling via the environment, and identifies areas for further research to strengthen the confidence and applicability of EUSES for assessing HvE.

Replication-Poison Treatment in BRCA1-Deficient Breast Cancer Causes MRE11 Over-Resection that Induces Single-Stranded DNA Accumulation and Mitotic Catastrophe.

BRCA1 deficiency is observed in approximately 25% of triple-negative breast cancer (TNBC). BRCA1, a key player of homologous recombination (HR) repair, is also involved in stalled DNA replication fork protection and repair. Here, we investigated the sensitivity of BRCA1-deficient TNBC models to the frequently used replication chain terminator gemcitabine, which does not directly induce DNA breaks.

Nurses and allied professionals' engagement in clinical research-in-practice: a statement of the Association of Cardiovascular Nursing & Allied Professions of the European Society of Cardiology.

Many nurses and allied professionals (NAPs) lack the skills, knowledge and confidence to engage in conducting and implementing research. This statement describes the importance of NAPs' involvement in clinical research within the context of cardiovascular care. The existing gaps, barriers and enablers to NAPs involvement in research as a potential response to workforce issues in these professions as well as to contribute to excellence in patient care delivery and associated outcomes are identified.

Algebraic Depletion Interactions in Two-Temperature Mixtures.

The phase separation that occurs in two-temperature mixtures, which are driven out of equilibrium at the local scale, has been thoroughly characterized, but much less is known about the depletion interactions that drive it. Using numerical simulations in dimension 2, we show that the depletion interactions extend beyond two particle diameters in dilute systems, as expected at equilibrium, and decay algebraically with an exponent -4. Solving for the N-particle distribution function in the stationary state, perturbatively in the interaction potential, we show that algebraic correlations with an exponent -2d arise from triplets of particles at different temperatures in spatial dimension d.

Impact of tissue-independent positron range correction on [Ga]Ga-DOTATOC and [Ga]Ga-PSMA PET image reconstructions: a patient data study.

Purpose: The positron range effect can impair PET image quality of Gallium-68 (Ga). A positron range correction (PRC) can be applied to reduce this effect. In this study, the effect of a tissue-independent PRC for Ga was investigated on patient data.

Fibroblast transcriptomics uncovers pathogenic genomic variants in individuals with exome-negative childhood onset epilepsy.

Objective: This study aims to improve genetic diagnosis in childhood onset epilepsy with neurodevelopmental problems by utilizing RNA sequencing of fibroblasts to identify pathogenic variants that may be missed by exome sequencing and copy number variation analysis.

Methods: We enrolled 41 individuals with childhood onset epilepsy and neurodevelopmental problems who previously had inconclusive genetic testing. Fibroblast samples were cultured and analyzed using RNA sequencing to detect aberrant expression, aberrant splicing, and monoallelic expression using the Detection of RNA Outlier Pipeline (DROP) pipeline.

The Effectiveness of Budesonide Once Daily as Maintenance Treatment of Eosinophilic Esophagitis.

Background: Swallowed topical corticosteroids (STC) are an effective first-line therapy for patients with eosinophilic esophagitis (EoE), both for induction and maintenance of remission. All interventional trials with STC used twice-daily dosing regimens. However, in other inflammatory gastrointestinal disorders, corticosteroids are given once daily (OD) with equal outcomes and improved compliance.

Worth your sweat: wearable microfluidic flow rate sensors for meaningful sweat analytics.

Wearable microfluidic sweat sensors could play a major role in the future of monitoring health and wellbeing. Sweat contains biomarkers to monitor health and hydration status, and it can provide information on drug intake, making it an interesting non-invasive alternative to blood. However, sweat is not created in excess, and this requires smart sweat collection strategies to handle small volumes.

EZH2 inhibition enhances the activity of Carboplatin in aggressive-variant prostate cancer cell lines.

Background: Aggressive Variant Prostate Cancers (AVPCs) are incurable malignancies. Platinum-based chemotherapies are used for the palliative treatment of AVPC. The Polycomb Repressive Complex 2 (PRC2) promotes prostate cancer progression histone H3 Lysine 27 tri-methylation (H3K27me3).

Telomere Length and Symptoms of Attention Deficit and Hyperactivity Disorder in Children at 6-12 Years.

Objective: To explore the association between telomere length (TL) and attention deficit hyperactivity disorder (ADHD) symptoms in children at 6-12 years.

Method: Data from 1,759 children belonging to the HELIX project cohorts and the Asturias, Gipuzkoa and Valencia cohorts of INMA project were included. TL was determined by blood sample using a PCR protocol.

Minimally invasive compared to open surgery in patients with low-risk cervical cancer following simple hysterectomy: An exploratory analysis from the Gynegologic Cancer Intergroup/Canadian Cancer Trials Group CX.5/SHAPE trial.

Objective: The Laparoscopic Approach to Cervical Cancer trial demonstrated that minimally invasive radical hysterectomy was associated with worse disease-free survival and overall survival among women with early-stage cervical cancer. It is unknown whether this applies to patients with low-risk disease following simple hysterectomy.

Methods: Among patients who underwent simple hysterectomy in the Simple Hysterectomy And PElvic node assessment trial, univariate and multivariate Cox models were used to assess the association of minimally invasive versus open surgery with clinical outcomes, including pelvic and extra-pelvic recurrence-free survival, overall recurrence-free survival, and overall survival.

Quality-of-Life Measurement in Epidermolysis Bullosa. Position Statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient-Oriented Outcomes and External Experts.

In this paper, the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life (QoL) and Patient-Oriented Outcomes presents its position statements on health-related (HR) QoL assessment in epidermolysis bullosa (EB). The EADV TF on QoL and Patient-Oriented Outcomes recommends the use of the EB-specific instrument QOLEB in patients over the age of 10 years and, in addition to the QOLEB, the use of iscorEB-p in moderate-to-severe EB; the IntoDermQoL proxy instrument with its EB-specific module should be used in children aged under 5 years. The EB-specific instrument iscorEB-p, and the dermatology-specific instrument CDLQI may measure HRQoL in children with EB aged from 5 to 10 years.

A Belgian physician-initiated trial investigating the LifeStream peripheral stent graft system for the treatment of complex TASC C and D iliac lesions.

Background: Due to the heterogeneity of literature findings, stent type selection for the endovascular treatment of complex aorto-iliac occlusive disease remains challenging. The BELSTREAM study, a physician-initiated, prospective, multicenter, single-arm study, aims to report the safety and efficacy of the balloon expandable LifeStream Peripheral Stent Graft System (BD, Tempe, Arizona, USA) for the treatment of complex TASC C and D aorto-iliac artery lesions.

Methods: Seventy patients and 133 lesions were included at six Belgian institutions.