Establishing quality assurance for COVID-19 antigen tests in the Indo Pacific Region: A multi-site implementation study.

Background: Quality assurance programs (QAPs) are used to evaluate the analytical quality of a diagnostic test and provide feedback to improve quality processes in testing. Rapid diagnostic tests were used in both laboratory and non-laboratory settings to diagnose COVID-19, although varied in reported performance. We aimed to design and implement a QAP for antigen rapid diagnostic tests (Ag-RDTs) for COVID-19 in Cambodia, Lao PDR, and Papua New Guinea.

Inter-assay variability in the measurement of urinary C-terminal cross-linked telopeptide of type II collagen following anterior cruciate ligament reconstruction.

Objective: To compare urinary C-terminal cross-linked telopeptide of type II collagen (u-CTX-II) concentrations and trends as measured by two different commercially available enzyme-linked immunosorbent assays (ELISA) in a cohort of patients in the first year following anterior cruciate ligament (ACL) reconstruction.

Design: 22 ACL-injured patients undergoing reconstructive surgery (mean age 25.2 (SD 8.

Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: analysis of key subgroups of the MAIA study.

In the MAIA study (median follow-up, 56.2 months), daratumumab plus lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival (PFS) and overall survival versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible newly diagnosed multiple myeloma (NDMM). In this post hoc analysis of clinically important subgroups in MAIA (median follow-up, 64.

The role of multi-modality imaging for the assessment of left atrium and left atrial appendage. A clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC).

Structural, architectural, contractile or electrophysiological alterations may occur in the left atrium (LA). The concept of LA cardiopathy is supported by accumulating scientific evidence demonstrating that LA remodeling has become a cornerstone diagnostic and prognostic marker. The structure and the function of LA and left atrial appendage (LAA) which is an integral part of the LA, are key elements for a better understanding of multiple clinical conditions, most notably atrial fibrillation (AF), cardioembolism, heart failure and mitral valve diseases.

Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials.

Purpose: Over the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner.

Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study.

Introduction: Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNS) is a new treatment for managing OSA, and this study is intended to determine whether an HNS system is a safe and effective treatment option for adults with OSA.

Finding the right dose: a scoping review examining facilitation as an implementation strategy for evidence-based stroke care.

Background: Despite evidence supporting interventions that improve outcomes for patients with stroke, their implementation remains suboptimal. Facilitation can support implementation of research into clinical practice by helping people develop the strategies to implement change. However, variability in the amount (dose) and type of facilitation activities/facilitator roles that make up the facilitation strategies (content), may affect the effectiveness of facilitation.

Cardiac-targeted delivery of a novel Drp1 inhibitor for acute cardioprotection.

Dynamin-related protein 1 (Drp1) is a mitochondrial fission protein and a viable target for cardioprotection against myocardial ischaemia-reperfusion injury. Here, we reported a novel Drp1 inhibitor (DRP1i1), delivered using a cardiac-targeted nanoparticle drug delivery system, as a more effective approach for achieving acute cardioprotection. DRP1i1 was encapsulated in cubosome nanoparticles with conjugated cardiac-homing peptides (NanoDRP1i1) and the encapsulation efficiency was 99.

Chronic Rhinosinusitis with Nasal Polyps and Biologics: A Call for Better Data Standardisation and Presentation in Clinical Studies.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is often severe, debilitating and difficult to treat. Recent randomised control trials (RCTs) of biologics that target key inflammatory pathways have demonstrated clinical efficacy in treating CRSwNP. Such RCTs must facilitate meta-analysis.

Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial.

Background: There are no approved oral disease-modifying treatments for Alzheimer's disease (AD).

Objectives: The objective of this study was to assess efficacy and safety of blarcamesine (ANAVEX®2-73), an orally available small-molecule activator of the sigma-1 receptor (SIGMAR1) in early AD through restoration of cellular homeostasis including autophagy enhancement.

Design: ANAVEX2-73-AD-004 was a randomized, double-blind, placebo-controlled, 48-week Phase IIb/III trial.

Progression from outpatient referral to spinal surgery in an Australian cohort with degenerative spinal disease.

Background: Degenerative spine disease (DSD) encompasses a range of conditions with increasing prevalence and a significant burden of disease. Patients with DSD are often referred to a neurosurgery clinic with lengthy waiting times from referral to consultation. The reported proportion of referred patients who undergo spinal surgery varies from 20.

Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized controlled trial.

Introduction: This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.

Research Design And Methods: In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 670G) or standard therapy (insulin pump or multiple daily injections without real-time continuous glucose monitoring). Psychological outcomes (awareness and fear of hypoglycemia; and diabetes-specific positive well-being, diabetes distress, diabetes treatment satisfaction, and diabetes-specific quality of life (QoL)) were measured at enrollment, mid-trial and end-trial.

First-year burden of disease for babies admitted to special care nurseries: Systematic review and meta-analysis.

Aim: This systematic review aimed to report on health outcomes of newborn babies admitted to special care nurseries up to age 1 year, and where possible, compare their outcomes with those of healthy term babies.

Methods: Systematic searches through Ovid MEDLINE, PubMed and Embase databases. We included studies reporting outcomes up to age 1 year for special care nursery babies and moderate-late preterm babies, restricting to studies published after 2000.

Adenomas from individuals with pathogenic biallelic variants in the MUTYH and NTHL1 genes demonstrate base excision repair tumour mutational signature profiles similar to colorectal cancers, expanding potential diagnostic and variant classification applications.

Background: Colorectal cancers (CRCs) from people with biallelic germline likely pathogenic/pathogenic variants in MUTYH or NTHL1 exhibit specific single base substitution (SBS) mutational signatures, namely combined SBS18 and SBS36 (SBS18+SBS36), and SBS30, respectively. The aim was to determine if adenomas from biallelic cases demonstrated these mutational signatures at diagnostic levels.

Methods: Whole-exome sequencing of FFPE tissue and matched blood-derived DNA was performed on 9 adenomas and 15 CRCs from 13 biallelic MUTYH cases, on 7 adenomas and 2 CRCs from 5 biallelic NTHL1 cases and on 27 adenomas and 26 CRCs from 46 non-hereditary (sporadic) participants.

Synthesising enablers and barriers to hepatocellular carcinoma surveillance-A systematic review of qualitative findings.

Background & Aims: This systematic literature review of qualitative findings aims to identify the perceived barriers and enablers for hepatocellular carcinoma (HCC) surveillance from patient and clinician perspectives.

Methods: A systematic search of databases using key term combinations with the following inclusion criteria: 1) qualitative and quantitative (survey) studies exploring barriers and enablers of HCC surveillance, and 2) qualitative and quantitative (survey) studies exploring barriers and enablers of enagagement in clinical care for patients with cirrhosis and/or viral hepatitis.

Results: The search returned 445 citations: 371 did not meet the study criteria and were excluded.

Coronary atherosclerosis in athletes: emerging concepts and preventive strategies.

There should be no assumption that an athlete is immune to coronary artery disease (CAD), even when traditional cardiovascular (CV) risk factors appear well-managed. Excelling in certain aspects of health does not equate to total CV protection. Recent data from cardiac imaging studies have raised the possibility that long-term, high-volume, high-intensity endurance exercise is associated with coronary atherosclerosis.

A Comparison of Glucose and Additional Signals for Three Different Exercise Types in Adolescents with Type 1 Diabetes Using a Hybrid Closed-Loop System.

To compare glycemic outcomes during and following moderate-intensity exercise (MIE), high-intensity interval exercise (HIE), and resistance exercise (RE) in adolescents with type 1 diabetes (T1D) using a hybrid closed-loop (HCL) insulin pump while measuring additional physiological signals associated with activity. Twenty-eight adolescents (average age 16.3 ± 2.

Trajectory of Depressive Symptoms in a Longitudinal Stroke Cohort.

Objectives: Knowledge of the trajectory of post-stroke depression is important to identify high-risk patients, develop precise management programs and enhance prognosis. We aimed to characterise the course of depressive symptoms within the first year post-stroke and to evaluate associations with time.

Materials And Methods: Depressive symptoms were measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) within the first week, and at 3- and 12-months post-stroke.

Hospital-level volume in extracorporeal membrane oxygenation cases and death or disability at 6 months.

Objective: Extracorporeal membrane oxygenation (ECMO) is a high-risk procedure with significant morbidity and mortality and there is an uncertain volume-outcome relationship, especially regarding long-term functional outcomes. The aim of this study was to examine the association between ECMO centre volume and long-term death and disability outcomes.

Design Setting And Participants: This is a registry-embedded observational cohort study.

Intensified and Accelerated Rescue Infliximab Therapy for Acute Severe Ulcerative Colitis in Pregnancy: A Case Report.

Acute severe ulcerative colitis (ASUC) in pregnancy poses a clinical challenge with significant risk to both mother and fetus. Anti-TNF alpha therapy is known to be safe in pregnancy, however, data surrounding outcomes in ASUC is limited. In this report, we present the case of a pregnant patient of 10 weeks' gestation with ASUC successfully managed with intensified and accelerated infliximab therapy for a total dose of 35 mg/kg during a single admission.