Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.

Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.

Flexible and modular latent transition analysis-A tutorial using R.

Latent transition analysis (LTA) is a useful statistical modelling approach for describe transitions between latent classes over time. LTA may be characterized in terms of prevalence at each time point and through transition probabilities over time. Investigating predictors of these transitions is often of key interest.

Trends in pulmonary function in patients with Birt-Hogg-Dubé syndrome: a retrospective cohort study.

Background: Birt-Hogg-Dubé syndrome (BHD), a rare genetic disease characterized by multiple pulmonary cysts, can lead to spontaneous pneumothorax, cutaneous hamartomas, renal cysts, and renal cell cancer. The overall aim of this study was to assess clinical characteristics of patients with BHD-emphasizing on trends in pulmonary function patterns.

Methods: By use of data from electronic patient journals, we conducted a retrospective cohort study on clinical characteristics and pulmonary function tests (PFT) from patients with BHD, who were clinically followed-up in a Danish tertiary referral center for rare and interstitial lung diseases.

Multiple, Single Trait GWAS and Supervised Machine Learning Reveal the Genetic Architecture of Fraxinus excelsior Tolerance to Ash Dieback in Europe.

Common ash (Fraxinus excelsior) is under intensive attack from the invasive alien pathogenic fungus Hymenoscyphus fraxineus, causing ash dieback at epidemic levels throughout Europe. Previous studies have found significant genetic variation among genotypes in ash dieback susceptibility and that host phenology, such as autumn yellowing, is correlated with susceptibility of ash trees to H. fraxineus; however, the genomic basis of ash dieback tolerance in F.

No Bacterial Biomass Detected in Tissue From Patients With Ovarian Cancer and Serous Tubal Intraepithelial Carcinomas Using 16S rDNA Sequencing.

The ovarian oncobiome is subject to increasing scientific focus, but a potential link between bacterial dysbiosis and ovarian carcinogenesis remains controversial. Our primary aim was to characterize the bacterial microbiota in epithelial ovarian cancer samples. Secondarily, we aimed to compare results from the bacterial microbiota in formalin-fixed, paraffin-embedded ovarian tissue samples from 194 patients with epithelial ovarian cancer, fallopian tube tissue samples from 16 patients with serous tubal intraepithelial carcinomas and in benign fallopian tube tissue samples from 25 patients.

Optimizing hydrophilic drug incorporation into SEDDS using dry reverse micelles: a comparative study of preparation methods.

Aim: It was the aim of this study to compare two different dry reverse micelle (RM) preparation methods for the incorporation of hydrophilic drugs into oral self-emulsifying drug delivery systems (SEDDS).

Methods: Cationic ethacridine lactate, anionic fluorescein sodium salt and the antibiotic peptide bacitracin were solubilized in RM containing sodium docusate, soy phosphatidylcholine and sorbitan monooleate in highly lipophilic oils such as squalane. In the dry addition (DA) method, drugs were directly added to empty RM in their powder form.

Phosphoproteomics for studying signaling pathways evoked by hormones of the renin-angiotensin system: A source of untapped potential.

The Renin-Angiotensin System (RAS) is a complex neuroendocrine system consisting of a single precursor protein, angiotensinogen (AGT), which is processed into various peptide hormones, including the angiotensins [Ang I, Ang II, Ang III, Ang IV, Ang-(1-9), Ang-(1-7), Ang-(1-5), etc] and Alamandine-related peptides [Ang A, Alamandine, Ala-(1-5)], through intricate enzymatic pathways. Functionally, the RAS is divided into two axes with opposing effects: the classical axis, primarily consisting of Ang II acting through the AT receptor (ATR), and in contrast the protective axis, which includes the receptors Mas, ATR and MrgD and their respective ligands. A key area of RAS research is to gain a better understanding how signaling cascades elicited by these receptors lead to either "classical" or "protective" effects, as imbalances between the two axes can contribute to disease.

Prevalence of thoracic degenerative MRI findings and association with pain and disability: a systematic review.

Objectives: To systematically review the literature on the prevalence of degenerative MRI findings in the thoracic spine and their association with pain and disability.

Materials And Methods: The Medline, EMBASE, CINAHL, and CENTRAL databases were searched. Two independent reviewers screened the articles, extracted the data, and assessed the risk of bias (RoB) using a modified version of the Hoy tool for articles on prevalence and QUADAS-2 for articles on associations.

Childhood vaccinations and the risk of leukemia: A nationwide cohort study.

A protective effect of childhood vaccinations on leukemia risk, particularly acute lymphoblastic leukemia (ALL), has been hypothesized, though findings are inconsistent. We used a nationwide cohort of Danish children born 1997-2018 (n = 1,360,230), to examine associations between childhood vaccinations and leukemia (<20 years) using registry data (follow-up: December 31, 2018). Cox proportional hazard models with age as the underlying time estimated hazard ratios (HRs) for leukemia (any, ALL, acute myeloid [AML], and other), comparing vaccinated with unvaccinated children.

Perceived stress across population segments characterized by differing stressor profiles-A latent class analysis.

Objective: We aimed to 1) identify distinct segments within the general population characterized by various combinations of stressors (stressor profiles) and to 2) examine the socio-demographic composition of these segments and their associations with perceived stress levels.

Methods: Segmentation was carried out by latent class analysis of nine self-reported stressors in a representative sample of Danish adults (N = 32,417) aged 16+ years. Perceived stress level was measured by the Perceived Stress Scale (PSS).

Mapping the landscape and evidence of cross-sectoral collaboration models targeting individuals referred for assessment of attention-deficit hyperactivity disorder or autism spectrum disorder: protocol for a scoping review.

Introduction: Neurodevelopmental disorders, notably attention-deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), present substantial challenges in mental health. Individuals referred for assessment in a psychiatric unit experience complex needs. This implies that their needs necessitate coordination across multiple sectors.

What is the current scope of research assessing patients' and clinicians' perspectives on clozapine treatment? A comprehensive scoping review.

Objectives: Clozapine is continuously underused. The existing systematic reviews addressing barriers to clozapine prescribing primarily focus on clinical staff's attitudes and perceived barriers to prescribing. However, a preliminary literature search revealed additional literature on the subject not previously included in systematic reviews, including literature on patient perspectives.

Tattoo ink exposure is associated with lymphoma and skin cancers - a Danish study of twins.

Background: We aim to study the potential association between tattoo ink exposure and development of certain types of cancers in the recently established Danish Twin Tattoo Cohort. Tattoo ink is known to transfer from skin to blood and accumulate in regional lymph nodes. We are concerned that tattoo ink induces inflammation at the deposit site, leading to chronic inflammation and increasing risk of abnormal cell proliferation, especially skin cancer and lymphoma.

Health-related quality of life at diagnosis and follow-up in Faroese and Danish patients with inflammatory bowel disease - a Faroese IBD cohort study.

Background And Aims: Patients with inflammatory bowel disease (IBD) have lower health-related quality of life (HRQoL) than the general population. The highest incidence and prevalence rates of IBD in the world are found in the Faroe Islands, however, the HRQoL of Faroese patients is unknown. This study aimed to determine their HRQoL at diagnosis and two years of follow-up in comparison with Danish patients.

Types of dietary sugars and carbohydrates, cardiometabolic risk factors, and risk of diabetes: a cohort study from the general Danish population.

Background: The role of carbohydrates in diabetes risk is of particular interest due to conflicting results. This study aims to examine the prospective association between types of dietary carbohydrates (fiber, starch, total sugar, glucose, fructose, lactose, maltose, and added sugar) and the risk of diabetes. Further, this study examines the cross-sectional associations between these nutrients and cardiometabolic risk factors.

Association between exposure to pyrethroids and chlorpyrifos at age 5 years and IQ at age 7 years among children from the Odense Child Cohort, a prospective birth cohort study.

Background: Over the past decade, the use of organophosphate insecticides including chlorpyrifos has faced increasing restrictions due to health concerns, leading to a rise in use of pyrethroids. Concerns about neurodevelopmental insults following pyrethroids exposure exist, but few studies have examined the long-term effects of childhood exposure to chlorpyrifos and pyrethroids on IQ.

Objective: To investigate the prospective associations between pyrethroids and chlorpyrifos exposure at age 5 years and IQ scores assessed at age 7.

Chronic pain and comorbid posttraumatic stress disorder: Potential mechanisms, conceptualizations, and interventions.

Posttraumatic stress disorder (PTSD) is a common comorbidity to chronic pain, among others due to potentially shared posttraumatic origin. There has been growing interest in this field in the past decades, also providing some important studies to support our understanding of this comorbidity and how to address it in clinical practice. However, there are still important questions, particularly regarding the potentially shared vulnerabilities, mutually maintaining mechanisms, and how to best treat this comorbidity.

Effectiveness of the handgrip test for assessing readiness in national level basketball players: a cohort study.

Background: Assessing player readiness is crucial in elite basketball. This study aims to provide a practical method for monitoring player readiness through the handgrip test and identify associations with wellness scales.

Methods: Fifteen players (age: 25.

Community health nurses' concerns about infant regulatory problems are predictive of mental disorders diagnosed at hospital: a prospective cohort study.

Introduction: Regulatory problems of eating, sleeping, and crying in infancy may index mental health vulnerability in older ages, and knowledge is needed to inform strategies to break the developmental trajectories of dysregulation in early childhood. In this study, we examined the prospective associations between infant regulatory problems at the age of 8-10 months identified by community health nurses (CHN) and mental disorders diagnosed in hospital settings in children aged 1-8 years.

Methods: From a cohort of all newborn children in 15 municipalities in the Capital Region of Copenhagen ( = 43,922) we included all children who were examined by CHNs at the scheduled home visit at the age of 8-10 months ( = 36,338).

Lower Bone Mineral Density in Female Elite Athletes With Menstrual Dysfunction From Mixed Sports.

Menstrual dysfunction (MD) in female athletes might be indicative of the syndrome of relative energy deficiency in sports (REDs), associated with, e.g., impaired bone health, an increased risk of injury, and decreased performance.

Cost-utility and cost-benefit analysis of a multi-component intervention (NEXpro) for neck-related symptoms in Swiss office workers.

Background: Neck pain is a significant public health issue, especially among office workers, with a prevalence ranging from 42 to 68%. This study aimed to evaluate the cost-utility and cost-benefit of a multi-component intervention targeting neck pain in the general population of office workers in Switzerland. The 12-week multi-component intervention consisted of neck exercises, health promotion information workshops, and workplace ergonomics sessions.

Deep Radiogenomics Sequencing for Breast Tumor Gene-Phenotype Decoding Using Dynamic Contrast Magnetic Resonance Imaging.

Purpose: We aim to perform radiogenomic profiling of breast cancer tumors using dynamic contrast magnetic resonance imaging (MRI) for the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) genes.

Methods: The dataset used in the current study consists of imaging data of 922 biopsy-confirmed invasive breast cancer patients with ER, PR, and HER2 gene mutation status. Breast MR images, including a T1-weighted pre-contrast sequence and three post-contrast sequences, were enrolled for analysis.

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.