Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies.

Insights into the time needed for evaluation of risk minimization measures' (RMMs) effectiveness might identify areas for improvement. We assessed the duration of time intervals between regulatory milestones for RMM effectiveness studies assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). We included completed RMM effectiveness post-authorization safety studies (PASSs) assessed by PRAC between 2016 and 2022.

Participatory Action Research to Enhance Patient-Centred Goal Setting in Geriatric Rehabilitation: A Nursing Team's Quest.

Aim: The aim of this study was to provide insights into how, through exploring goal-setting interventions, a nursing team in geriatric rehabilitation might refine their patient-centred strategies.

Design: The study design was participatory action research (PAR).

Method: Team members and nursing students, under the guidance of a facilitator, performed two PAR cycles.

Postoperative accuracy quantification of corrective osteotomies: standardisation of Q3D-CT methodology.

Purpose: Currently, no gold standard exists for 3D analysis of virtually planned surgery accuracy postoperatively. The aim of this study was to present a new, validated and standardised methodology for 3D postoperative assessment of surgical accuracy in patients undergoing 3D virtually planned and guided corrective osteotomies.

Methods: All patients who underwent 3D planned corrective osteotomy in 2021-2022 at our center with a postoperative CT were included.

Implant irritation and removal rates in operatively treated multiple rib fractures: a 49-month follow-up study.

Purpose: Little is known about the prevalence, impact and change of the symptoms after implant removal due to irritation in multiple rib fractures. This study aims to explore these aspects to improve treatment decision-making.

Methods: Data was collected from two hospitals in the Netherlands and Switzerland.

Genome-wide association analysis of composite sleep health scores in 413,904 individuals.

Recent genome-wide association studies (GWASs) of several individual sleep traits have identified hundreds of genetic loci, suggesting diverse mechanisms. Moreover, sleep traits are moderately correlated, so together may provide a more complete picture of sleep health, while illuminating distinct domains. Here we construct novel sleep health scores (SHSs) incorporating five core self-report measures: sleep duration, insomnia symptoms, chronotype, snoring, and daytime sleepiness, using additive (SHS-ADD) and five principal components-based (SHS-PCs) approaches.

Defining Hyperphagia for Improved Diagnosis and Management of MC4R Pathway-Associated Disease: A Roundtable Summary.

Purpose Of Review: Hyperphagia is a condition associated with rare obesity-related diseases, presenting as a pathologic, insatiable hunger accompanied by abnormal food-seeking behaviors. In October 2023, a group of researchers and clinicians with expert knowledge on hyperphagia convened at the annual ObesityWeek meeting to discuss the need for a unified definition of hyperphagia and key items necessary to improve the identification, assessment, and treatment of hyperphagia in patients with melanocortin 4 receptor (MC4R) pathway-associated diseases.

Recent Findings: The definition of hyperphagia proposed by this group is a pathologic, insatiable hunger accompanied by abnormal food-seeking behaviors.

Patient-specific implants combined with 3D-printed drilling guides for corrective osteotomies of multiplanar tibial and femoral shaft malunions leads to more accurate corrections.

Purpose: The aim of this study was to evaluate the feasibility of using patient-specific implants (PSI) for complex shaft corrective osteotomies in multiplanar deformities of long bones in the lower extremities. Additionally, it aimed to investigate the added value of these implants by quantifying surgical accuracy on postoperative CT, comparing their outcomes to two commonly used techniques: 3D virtual visualizations and 3D-printed surgical guides.

Methods: Six tibial and femoral shaft corrective osteotomies were planned and performed on three Thiel embalmed human specimen.

A network of interacting ciliary tip proteins with opposing activities imparts slow and processive microtubule growth.

Cilia are motile or sensory organelles present on many eukaryotic cells. Their formation and function rely on axonemal microtubules, which exhibit very slow dynamics, but the underlying mechanisms are largely unexplored. Here we reconstituted in vitro the individual and collective activities of the ciliary tip module proteins CEP104, CSPP1, TOGARAM1, ARMC9 and CCDC66, which interact with each other and with microtubules and, when mutated in humans, cause ciliopathies such as Joubert syndrome.

Type B ankle fractures with additional medium-sized posterior fragment: mid-term functional and radiological outcome after fixation versus no fixation of the posterior fragment.

Purpose: Guidelines for treatment of medium-sized posterior fragments in trimalleolar fractures are scarce and show varying advice. Recent trials comparing fixation and no fixation of posterior fragments, show no difference in outcomes one year postoperatively. This study compares functional outcome and development of osteoarthritis in patients with fixation of a posterior malleolar fracture to patients without fixation of the posterior malleolus fracture.

Prevalence, incidence, and complications of malnutrition in severely injured patients.

Background: Severely injured patients may suffer from acute disease-related or injury-related malnutrition involving a marked inflammatory response. This study investigated the prevalence and incidence of malnutrition and its relation with complications in severely injured patients admitted to the intensive care unit (ICU).

Methods: This observational prospective cohort study included severely injured patients (Injury Severity Score ≥ 16), admitted to the ICU of five level-1 trauma centers in the Netherlands and United States.

The severely injured older patient: identifying patients at high risk for mortality using the Dutch National Trauma Registry.

Purpose: The incidence of severely injured older trauma patients is increasing globally, portraying high mortality rates. Exploring the demographics and clinical outcomes of this subgroup is essential to further improve specialised care at the right place. This study was performed to identify severely injured older patients at high risk for mortality by examining their characteristics and identifying prognostic factors contributing to mortality.

The interface of depression and diabetes: treatment considerations.

This state-of-the-art review explores the relationship between depression and diabetes, highlighting the two-way influences that make treatment challenging and worsen the outcomes of both conditions. Depression and diabetes often co-occur and share genetic, lifestyle, and psychosocial risk factors. Lifestyle elements such as diet, physical activity, and sleep patterns play a role on the development and management of both conditions, highlighting the need for integrated treatment strategies.

Zinc absorption from maize-based meals enriched with edible house crickets: a randomized crossover stable-isotope study in Kenyan pre-school children.

Edible insects have been proposed as a novel and sustainable source of protein and other essential nutrients for human consumption but nutrient absorption efficiency is still uncertain. We investigated zinc absorption from house crickets (Acheta domesticus) in a single-center and single-blinded cross-over study with children aged 24-36 months old in Kenya from September-November 2021. For this, children were randomized to consume two different experimental meals labeled with stable isotopes of zinc (Zn) at two different days, separated by a wash-out period of one month.

Palbociclib Is Safe for Breast Cancer Patients With Mild Hepatic Impairment: A Multicenter Retrospective Study Using Real-World Data.

The liver is crucial for metabolizing the anticancer drug palbociclib, but limited information is available on the impact of hepatic impairment on its toxicity and efficacy, with no real-world data available. This study aims to evaluate how hepatic impairment affects hematological toxicity and progression-free survival (PFS) of palbociclib in advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer, using the National Cancer Institute scoring system, in a large real-world dataset. This multicenter retrospective observational study included female patients treated with palbociclib between August 2017 and February 2024.

Advances in digital camera-based phenotyping of Botrytis disease development.

Botrytis cinerea is an important generalist fungal plant pathogen that causes great economic losses. Conventional detection methods to identify B. cinerea infections rely on visual assessments, which are error prone, subjective, labor intensive, hard to quantify, and unsuitable for artificial intelligence (AI) and machine learning (ML) applications.

Distillation for in situ recovery of volatile fermentation products.

Many fermentation products inhibit their own microbial production, which complicates industrial-scale fermentation development for these products. When a product is volatile, this inhibition can be circumvented by removing product during fermentation through evaporation in a loop around the bioreactor. Microbes can survive this loop if its temperature is reduced using vacuum.

Effect of Cariprazine on Outcomes in Older-aged and Younger-aged Patients with Bipolar I Disorder: A Post-hoc Analysis.

Objectives: To evaluate cariprazine in adults with older- and younger-age bipolar I disorder (OABD-I and YABD-I) and compare treatment effects between them.

Design And Setting: Pooled post-hoc analysis of studies in depressive or acute manic/mixed episodes associated with bipolar I disorder.

Participants: 475/1383 patients (34.

A Call for a Neoadjuvant Kidney Cancer Consortium: Lessons Learned from Other Cancer Types.

Neoadjuvant systemic treatment strategies have improved outcomes in several solid tumour types. This success has not yet been replicated in renal cell carcinoma (RCC). A consensus and international collaboration are urgently needed for the development of adaptive perioperative immunotherapy strategies for patients with RCC at high risk of recurrence.

Cracking the Code of Calcification: How Presence and Burden among Intracranial Arteries Influence Stroke Incidence and Recurrence.

Background: Intracranial atherosclerosis accounts for about 8% of all strokes in Western societies but the influence of arterial calcification on plaque instability is a topic on ongoing debate.

Purpose: Explore the association between the presence and burden of calcium in atherosclerotic plaques among intracranial arteries with the risk of clinical or silent stroke events through a systematic review and meta-analysis.

Data Sources: Adhering to PRISMA guidelines, studies from PubMed and Embase were analyzed up to May 2024.

Child exposure to N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD) and its derived quinone (6PPDQ) in e-waste areas: Urinary concentrations, sources, and health effect assessment.

N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine quinone (6PPDQ) and its parent 6PPD are ubiquitous in the environment and may induce multi-endpoint toxicity. Electronic waste (e-waste) dismantling is an under-recognized source of 6PPD and 6PPDQ emissions, and there is a lack of epidemiological investigations into their presence and health effects in local populations. This study aimed to determine the urinary concentrations of 6PPD and 6PPDQ in children aged 2-7 years from e-waste dismantling areas and evaluate their potential risk to physical growth.

Establishing a Pan-European, multi-disciplinary taphonomic research Infrastructure: The 'UK-Netherlands decomposition experimental research (UNDER) Group'.

This study unveils the establishment of the United Kingdom-Netherlands Decomposition Experimental Research (UNDER) working group, marking a pioneering initiative in practical Forensic Taphonomy within the UK. Our primary objective was to craft a cohesive multidisciplinary framework, designed to ethically orchestrate, execute, and assess human decomposition. Concurrently, we aimed to amass data through human burials, fostering collaboration among diverse forensic experts across Europe.

International benchmarking of stage at diagnosis for six childhood solid tumours (the BENCHISTA project): a population-based, retrospective cohort study.

Background: International variation in childhood cancer survival might be explained by differences in stage at diagnosis, among other factors. As part of the BENCHISTA project, we aimed to assess geographical variation in tumour stage at diagnosis through the application, by population-based cancer registries working with clinicians, of the international consensus Toronto Childhood Cancer Stage Guidelines.

Methods: This population-based, retrospective cohort study involved 67 cancer registries from 23 European countries, Australia, Brazil, Japan, and Canada.

Characteristics of children and adolescents with multidrug-resistant and rifampicin-resistant tuberculosis and their association with treatment outcomes: a systematic review and individual participant data meta-analysis.

Background: There are few data on the treatment of children and adolescents with multidrug-resistant (MDR) or rifampicin-resistant (RR) tuberculosis, especially with more recently available drugs and regimens. We aimed to describe the clinical and treatment characteristics and their associations with treatment outcomes in this susceptible population.

Methods: We conducted a systematic review and individual participant data meta-analysis.

Analysis of trends and allergenicity risk assessments in novel food approvals within the European Union between 2018 and 2023.

Novel food (NF) approvals in the European Union between 2018 and 2023 (n = 117) were retrieved and analysed. They consist of new NF (52.1%), modification (38.

A proposed screening strategy for evaluating the genotoxicity potential of botanicals and botanical extracts.

Botanicals have long been used to promote health and treat diseases, but the safety of many currently marketed botanicals has not been adequately evaluated. Given the chemical complexity of botanicals, which often contain numerous unknown constituents, and their widespread use, comprehensive toxicity assessments are needed. The Botanical Safety Consortium was established to address this challenge.