Leveraging Model Master Files for Long-Acting Injectables.

The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on May 2-3, 2024, titled "Considerations and Potential Regulatory Applications for a Model Master File (Lachaine et al Can J Psychiatry.

Coeliac disease: complications and comorbidities.

Coeliac disease is an autoimmune disease characterized by small intestinal villus atrophy and inflammation upon exposure to gluten. It has a global prevalence of approximately 1%. Although the gluten-free diet can be an effective treatment, this diet is burdensome with practical difficulties and frequent inadvertent gluten exposure.

Management factors affecting milk yield, composition, and quality on smallholder dairy farms.

A cross-sectional study on 156 smallholder dairy farms in Rwanda was carried out to assess the association between farm management practices and milk yield and quality. A pre-tested questionnaire was used to collect data on cow characteristics and farm management practices. Milk yield was recorded at household level, milk composition was monitored using a Lactoscan device (Milk Analyzer).

Associations between common genetic variants and income provide insights about the socio-economic health gradient.

We conducted a genome-wide association study on income among individuals of European descent (N = 668,288) to investigate the relationship between socio-economic status and health disparities. We identified 162 genomic loci associated with a common genetic factor underlying various income measures, all with small effect sizes (the Income Factor). Our polygenic index captures 1-5% of income variance, with only one fourth due to direct genetic effects.

Can response to ADHD medication be predicted?

Predictors for the pharmacological effect of ADHD medication in children and adolescents are lacking. This study examined clinically relevant factors in a large (N = 638) prospective cohort reflecting real-world evidence. Children and adolescents aged 6-17 diagnosed with ADHD were evaluated at baseline and three months following ADHD medication initiation.

Working capacity level defines the specific impairment profile of the comprehensive ICF core set for multiple sclerosis.

Multiple sclerosis (MS) unfavorably affects working capacity. The Comprehensive International Classification of Functioning, Disability and Health Core Set for MS (cICF-MS), issued by the World Health Organization, has not yet been extended to evaluate working capacity level (WCL). To evaluate the relative importance of cICF-MS categories in relation to WCL.

A catalogue of land-based adaptation and mitigation solutions to tackle climate change.

Informing and engaging all actors in the land sector, including land-owners and managers, researchers, policy-makers and citizens, on the most effective sustainable land-based solutions and behavioural changes is a key strategy for achieving climate change adaptation and mitigation targets at the global as well as at EU and local level. One requisite to support actors in the land sector is to provide them publicly available, reliable and ready-to-use information related to the implementation of Land-based Adaptation and Mitigation Solutions (LAMS). Here we introduce a LAMS catalogue, a collection of meaningful quantitative and qualitative information on 60 solutions characterised according to a set of specifications (e.

Overcoming the technical challenge of venous resection with pancreatectomy: Which factors determine survival?

Background: Pancreatectomy with venous resection (PVR) is nowadays considered standard. However, there is still concern about increased postoperative morbidity and impaired long-term outcome depending on the type of venous resection and reconstruction. The aim was to investigate the predictors of morbidity and long-term survival in patients undergoing PVR in a high-volume center.

Treatment effect of head extension by cervical collar on moderate obstructive sleep apnea-A randomized controlled trial.

As available treatments in obstructive sleep apnea are all associated with side-effects or adherence problems, there is a need for alternative treatment options. In this randomized, open, parallel-group intervention study, the effect of head extension by cervical collar was evaluated in patients with moderate obstructive sleep apnea. One-hundred patients with moderate obstructive sleep apnea (apneas and hypopneas per estimated hours asleep = respiratory events index: 15-30) were randomized to either lifestyle intervention, or cervical collar in combination with lifestyle intervention.

Surveillance of primary sclerosing cholangitis - a comparison of scheduled or on-demand ERCP with annual MRI surveillance: a multicenter study.

Primary sclerosing cholangitis (PSC) is associated with a high risk of hepatobiliary malignancy, especially cholangiocarcinoma (CCA). There are no good tumor markers to screen for CCA, and current recommendations for PSC monitoring are mainly based on expert opinions. The optimal strategy to assess disease progression and screen for CCA - the main cause of death of PSC patients - remains unclear.

Docking Structures Induced by Substitution Motifs of Softwood Xylan at Various Cellulose Surfaces.

To understand xylan-cellulose interactions in softwood, the adsorption behavior of hexameric softwood xylan proxies with various substitutions was analyzed on the three surfaces of a hexagonal cellulose microfibril. The study found that all surfaces could bind xylan motifs, showing equally high affinity for the hydrophilic (110) and hydrophobic (100) surfaces and significantly lower affinity for the hydrophilic (11̅0) surface. Unsubstituted xylose hexamers had the highest affinity and most ordered adsorption structures, while substitutions generally reduced the affinity and regularity.

Capacity and limitations of microfluidic flow to increase solute transport in three-dimensional cell cultures.

Culturing living cells in three-dimensional environments increases the biological relevance of laboratory experiments, but requires solutes to overcome a diffusion barrier to reach the centre of cellular constructs. We present a theoretical and numerical investigation that brings a mechanistic understanding of how microfluidic culture conditions, including chamber size, inlet fluid velocity and spatial confinement, affect solute distribution within three-dimensional cellular constructs. Contact with the chamber substrate reduces the maximally achievable construct radius by 15%.

Cotadutide reversible self-assembly based long-acting injectable depot for sustained delivery of GLP-1 glucagon receptor agonists with controlled burst release.

Cota is a lipidated dual GLP-1 and Glucagon receptor agonist that was investigated for the treatment of various metabolic diseases, it is designed for once daily subcutaneous administration. Invasive daily injections often result in poor patient compliance with chronic disease, and here, we demonstrate an innovative strategy of encapsulating reversible cota self-assembled fibers within an in-situ forming depot of low molecular weight poly(lactic-co-glycolic) acid (LWPLGA) for sustained delivery GLP-1 and Glucagon receptor agonist with controlled burst release. This could be a suitable alternative to other sustained delivery strategies for fibrillating peptides.

Chromosome-scale genome assembly reveals how repeat elements shape non-coding RNA landscapes active during newt limb regeneration.

Newts have large genomes harboring many repeat elements. How these elements shape the genome and relate to newts' unique regeneration ability remains unknown. We present here the chromosome-scale assembly of the 20.

Review: A systematic review of dairy cow health, welfare, and behaviour in year-round loose range housing.

This systematic review compares the health, welfare, and behaviour of dairy cows in year-round loose housing systems against those kept in other housing systems in temperate regions. Year-round loose housing systems comprised housing where dairy cows had no access to the outdoors or only had access to a yard, pen or run. The comparator housing systems also comprised housing with and without outdoor access (including grazing).

Healthcare professionals' attitudes to animal assisted activity with dogs in paediatric care.

Background: Hospitalization for children often involves stress induced by fear and pain. Complementary therapies, such as Animal Assisted Activities (AAA) with dogs, can alleviate the hospital experience.

Purpose: The first aim of this study was to initiate the development of an instrument that measures healthcare professionals' attitudes toward complementary therapy, specifically dogs in AAA.

Towards circularity for agro-waste: Minimal soil hazards of olive pomace bioconverted frass by insect larvae as an organic fertilizer.

As global populations escalate and the demand for food and feed intensifies, the generation of agri-food waste is becoming an increasingly critical issue. Addressing this challenge is crucial for optimizing food production and advancing sustainable waste management practices. In this context, insects, including the Black Soldier Fly (BSF, Hermetia illucens), present opportunities for circularity through the bioconversion of organic waste.

2D Surface Optical Reflectance for use in Harsh Reactive Environments.

In recent years, studies of surfaces at more realistic conditions has advanced significantly, leading to an increased understanding of surface dynamics under reaction conditions. The development has mainly been due to the development of new experimental techniques or new experimental approaches. Techniques such as High Pressure Scanning Tunneling/Force Microscopy (HPSTM/HPAFM), Ambient Pressure X-ray Photo emission Spectroscopy (APXPS), Surface X-Ray Diffraction (SXRD), Polarization-Modulation InfraRed Reflection Absorption Spectroscopy (PMIRRAS) and Planar Laser Induced Fluorescence (PLIF) at semi-realistic conditions has been used to study planar model catalysts or industrial materials under operating conditions.

Engagement With an Internet-Administered, Guided, Low-Intensity Cognitive Behavioral Therapy Intervention for Parents of Children Treated for Cancer: Analysis of Log-Data From the ENGAGE Feasibility Trial.

Background: Parents of children treated for cancer may experience psychological difficulties including depression, anxiety, and posttraumatic stress. Digital interventions, such as internet-administered cognitive behavioral therapy, offer an accessible and flexible means to support parents. However, engagement with and adherence to digital interventions remain a significant challenge, potentially limiting efficacy.

Role of Tailored Timing and Frequency Prompts on the Efficacy of an Internet-Delivered Stress Recovery Intervention for Health Care Workers: Randomized Controlled Trial.

Background: Prompts offer a promising strategy to promote client engagement in internet-delivered cognitive behavioral therapy (ICBT). However, if the prompts do not meet the needs of clients, they can potentially be more obtrusive rather than helpful.

Objective: The aim of this study was to test if prompts tailored based on timing and frequency, aligned with preintervention goal setting, can increase usage and the efficacy of a therapist-supported ICBT stress recovery intervention for health care workers.

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery Fourth report: Focus on standardized outcome ratios.

Objectives: This fourth report aimed to provide insights into patient characteristics, outcomes, and standardized outcome ratios of patients implanted with durable Mechanical Circulatory Support across participating centers in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) registry.

Methods: All registered patients receiving durable mechanical circulatory support up to August 2024 were included. Expected number of events were predicted using penalized logistic regression.

Enhancing Reflexivity in Research and Practice in Healthcare Through Oral-Based Autoethnography.

Autoethnography is an increasingly used method to promote individual and group reflexivity in research, not the least in healthcare. However, autoethnography's uptake among practitioners is impeded by the fact that it has not been adequately adapted to practitioner settings from its academic origins. This article analyzes the experience of a research team comprised of practitioners/surgeons and social scientists using primarily oral-based autoethnographic practices to promote reflexive collaboration in a longitudinal research and innovation project on selection and training of surgical residents.

The role of extra-familial factors in adolescence for the association between out-of-home care and adult psychiatric disorders-A birth cohort study.

Background: Psychiatric disorders are a substantial public health concern, and childhood adversity a well-known risk factor for it. Investigating gender differences in vulnerability and resilience processes following out-of-home care (OHC) as proxy for childhood adversity can help map opportunities for the prevention of psychiatric disorders.

Methods: We followed a large birth cohort for psychiatric disorders (anxiety, depression, and self-harm, and substance misuse) between age 25-62 years, comparing individuals with and without OHC experience.