Considering future qualification for regulatory science in the early development of microphysiological systems: a case study of microthrombosis in a Vessel-on-Chip.

Microphysiological systems (MPS) and Organs-on-Chips (OoCs) hold significant potential for replicating complex human biological processes . However, their widespread adoption by industry and regulatory bodies depends on effective qualification to demonstrate that these models are fit for purpose. Many models developed in academia are not initially designed with qualification in mind, which limits their future implementation in end-user settings.

Novel strategies to assess cytokine release mediated by chimeric antigen receptor T cells based on the adverse outcome pathway concept.

The success of cellular immunotherapies such as chimeric antigen receptor (CAR) T cell therapy has led to their implementation as a revolutionary treatment option for cancer patients. However, the safe translation of such novel immunotherapies, from non-clinical assessment to first-in-human studies is still hampered by the lack of suitable and models recapitulating the complexity of the human immune system. Additionally, using cells derived from human healthy volunteers in such test systems may not adequately reflect the altered state of the patient's immune system thus potentially underestimating the risk of life-threatening conditions, such as cytokine release syndrome (CRS) following CAR T cell therapy.

Out of Sight, Out of Mind? Neuronal Gamma Oscillations During Occlusion Events in Infants.

Object permanence allows infants to interact successfully with objects in the environment. What happens in the human infant brain when objects move in and out of sight? This study used high-density electroencephalography (hdEEG) to record induced oscillatory brain activities in 29 locomotor infants before, during, and after occlusion of a moving object traveling at different speeds. Temporal spectral evolution (TSE) showed that before and after the occlusion event, event-related synchronized (ERS) brain activity was observed, whereas event-related desynchronized (ERD) activity was detected when the car was hidden behind the occluder.

Determinants of Citizens' Intention to Participate in Self-Led Contact Tracing: Cross-Sectional Online Questionnaire Study.

Background: Contact tracing (CT) is a key intervention to contain outbreaks of communicable diseases. During large-scale outbreaks, public health services may lack the resources required to perform CT effectively. One way of mitigating this issue is to shift some of the tasks in CT normally performed by public health services to cases and their contacts, supported by digital tools.

Rasmussen's Aneurysm in Active Pulmonary Tuberculosis: A Case Report.

Hemoptysis is a common presenting symptom of pulmonary tuberculosis (TB). Rasmussen aneurysm can present with severe hemoptysis, which is usually diagnosed using computed tomography (CT) angiography. A false aneurysmal dilatation of the pulmonary artery is known as a Rasmussen aneurysm.

Standardizing designed and emergent quantitative features in microphysiological systems.

Microphysiological systems (MPSs) are cellular models that replicate aspects of organ and tissue functions in vitro. In contrast with conventional cell cultures, MPSs often provide physiological mechanical cues to cells, include fluid flow and can be interlinked (hence, they are often referred to as microfluidic tissue chips or organs-on-chips). Here, by means of examples of MPSs of the vascular system, intestine, brain and heart, we advocate for the development of standards that allow for comparisons of quantitative physiological features in MPSs and humans.

Graft Steatosis and Donor Diabetes Mellitus Additively Impact on Recipient Outcomes After Liver Transplantation-A European Registry Study.

Background And Aims: Biopsy-proven severe graft steatosis is associated with adverse outcomes after liver transplantation. The concomitant presence of metabolic risk factors might further increase this risk. We studied the association between graft steatosis and metabolic risk factors in the donor, with recipient outcomes after liver transplantation.

Incidence and prevalence of primary biliary cholangitis in the Netherlands - A nationwide cohort study.

Background & Aims: Although primary biliary cholangitis (PBC) is considered a rare disorder, accurate determination of its incidence and prevalence remains challenging due to limited comprehensive population-based registries. We aimed to assess the incidence and prevalence of PBC in the Netherlands over time through the nationwide Dutch PBC Cohort Study (DPCS).

Methods: DPCS retrospectively included every identifiable patient with PBC in the Netherlands from 1990 onwards in all 71 Dutch hospitals.

Type of calcineurin inhibitor and long-term outcomes following liver transplantation in patients with primary biliary cholangitis - an ELTR study.

Background & Aims: Tacrolimus has been associated with recurrence of primary biliary cholangitis (PBC) after liver transplantation (LT), which in turn may reduce survival. This study aimed to assess the association between the type of calcineurin inhibitor used and long-term outcomes following LT in patients with PBC.

Methods: Survival analyses were used to assess the association between immunosuppressive drugs and graft or patient survival among adult patients with PBC in the European Liver Transplant Registry.

Pilot study of implementing Managing and Adapting Practice in a German psychotherapy master's program.

Despite a significant accumulation of research, there has been little systemic implementation of evidence-based practices (EBP) in youth mental health care. The fragmentation of the evidence base complicates implementation efforts. In light of this challenge, we sought to pilot a system that consolidates and coordinates the entire evidence base in a single direct service model (i.

Right Coronary Artery to Left Ventricular Fistula Complicated by Symptomatic Arrhythmia.

Coronary cameral fistulas (CCFs) are rare and are characterized by an abnormal connection between a coronary artery and any of the four chambers of the heart. Most cases of CCFs are asymptomatic. The most common presentation in symptomatic patients includes chest pain or heart failure; however, arrhythmias are rarely associated.

Diagnostic criteria and long-term outcomes in AIH-PBC variant syndrome under combination therapy.

Background & Aims: Autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) can co-exist in AIH-PBC, requiring combined treatment with immunosuppression and ursodeoxycholic acid (UDCA). The Paris criteria are commonly used to identify these patients; however, the optimal diagnostic criteria are unknown. We aimed to evaluate the use and clinical relevance of both Paris and Zhang criteria.

Effects of allopurinol and febuxostat on uric acid transport and transporter expression in human umbilical vein endothelial cells.

Uric acid induces radical oxygen species formation, endothelial inflammation, and endothelial dysfunction which contributes to the progression of atherosclerosis. Febuxostat inhibits BCRP- and allopurinol stimulates MRP4-mediated uric acid efflux in human embryonic kidney cells. We hypothesized that endothelial cells express uric acid transporters that regulate intracellular uric acid concentration and that modulation of these transporters by febuxostat and allopurinol contributes to their different impact on cardiovascular mortality.

Prognostic scores for ursodeoxycholic acid-treated patients predict graft loss and mortality in recurrent primary biliary cholangitis after liver transplantation.

Background & Aims: Recurrent primary biliary cholangitis (rPBC) develops in approximately 30% of patients and negatively impacts graft and overall patient survival after liver transplantation (LT). There is a lack of data regarding the response rate to ursodeoxycholic acid (UDCA) in rPBC. We evaluated a large, international, multi-center cohort to assess the performance of PBC scores in predicting the risk of graft and overall survival after LT in patients with rPBC.

A Symptom-Checker for Adult Patients Visiting an Interdisciplinary Emergency Care Center and the Safety of Patient Self-Triage: Real-Life Prospective Evaluation.

Background: Symptom-checkers have become important tools for self-triage, assisting patients to determine the urgency of medical care. To be safe and effective, these tools must be validated, particularly to avoid potentially hazardous undertriage without leading to inefficient overtriage. Only limited safety data from studies including small sample sizes have been available so far.

Progression of the FIB-4 index among patients with chronic HCV infection and early liver disease.

Background And Aims: Historical paired liver biopsy studies are likely to underestimate current progression of disease in patients with chronic hepatitis C virus (HCV) infection. We aimed to assess liver disease progression according to the non-invasive Fibrosis-4 (FIB-4) index in patients with chronic HCV and early disease.

Methods And Results: Patients diagnosed with chronic HCV and FIB-4 <3.

Summary of the Dutch Multidisciplinary Practice Guideline on Asthma and Pregnancy.

Asthma is the most common chronic respiratory disease in women of childbearing age and during pregnancy. This paper presents a summary of the Dutch multidisciplinary guideline on asthma and pregnancy. The aim of this guideline is to provide structured, where possible, evidence-based recommendations to optimize the management of asthma during pregnancy.

Lifetime prevalence and associated factors of itch with skin conditions: atopic dermatitis, psoriasis and dry skin in individuals aged > 50 years.

Background: Itch, common in dermatological conditions, is often accompanied by psychological distress and reduced quality of life. However, research on the prevalence and associated factors of itch with skin conditions in general populations is limited.

Objectives: This cross-sectional study aimed to determine the lifetime prevalence of itch with skin conditions and to identify its associated factors in individuals aged > 50 years.

House dust mite sublingual allergen immunotherapy tablet is safe and well-tolerated in Dutch clinical practice.

Background: Half (49%) of clinically diagnosed allergic rhinitis (AR) patients are sensitized to house dust mite (HDM). If allergen avoidance and symptomatic medication fail, allergen immunotherapy may be indicated.

Objective: We investigated safety and tolerability of HDM-sublingual immunotherapy by HDM-SLIT tablets in Dutch daily clinical practice.

Systematic Review: Patient and Public Involvement of Children and Young People in Mental Health Research.

Objective: Patient and public involvement (PPI) is an essential ethical component in mental health research, and represents a major opportunity to improve translational mental health research. The goals of this review were to (1) provide a comprehensive overview of empirical research focusing on PPI of children and young people (CYP) in mental health research studies; (2) evaluate the results with CYP and parents of those affected; and (3) derive recommendations for PPI of CYP in future mental health research studies.

Methods: Based on an extensive literature review following the PRISMA guidelines, studies including CYP (age range: 0-21 years) in mental health research were identified and examined along a two-part analysis process considering their usability for mental health research.

Determinants of Dutch public health professionals' intention to use digital contact tracing support tools: A cross-sectional online questionnaire study.

Contact tracing (CT) can be a resource intensive task for public health services. To alleviate their workload and potentially accelerate the CT-process, public health professionals (PHPs) may transfer some tasks in the identification, notification, and monitoring of contacts to cases and their contacts themselves, using 'digital contact tracing support tools' (DCTS-tools). In this study, we aimed to identify determinants of PHPs' intention to use DCTS-tools.