Doctors as Device Manufacturers? Regulation of Clinician-Generated Innovation in the ICU.

Critical care physicians are rich sources of innovation, developing new diagnostic, prognostic, and treatment tools they deploy in clinical practice, including novel software-based tools. Many of these tools are validated and promise to actively help patients, but physicians may be unlikely to distribute, implement, or share them with other centers noncommercially because of unsettled ethical, regulatory, or medicolegal concerns. This Viewpoint explores the potential barriers and risks critical care physicians face in disseminating device-related innovations for noncommercial purposes and proposes a framework for risk-based evaluation to foster clear pathways to safeguard equitable patient access and responsible implementation of clinician-generated technological innovations in critical care.

The Influence of Project ECHO and Integrated Behavioral Health in Primary Care on Emergency Department Visits Among Youth Diagnosed with Depression.

Rates of depression among youth and emergency department (ED) visits for un- or under-treated symptoms are on the rise. Early identification and treatment of depression is imperative at the patient, program, system, and population levels. This paper examines the individual and cumulative impact of Project ECHO and the inclusion of IBH services in pediatric primary care practices on mental health-related ED rates among youth diagnosed with depression for those practices.

Aneurysm dome and vessel pressure measurements with coiling, stent assisted coiling and flow diversion.

Background: Variability in long-term endovascular treatment outcomes for intracranial aneurysms has prompted questions regarding the effects of these treatments on aneurysm hemodynamics. Endovascular techniques disrupt aneurysmal blood flow and shear, but their influence on intra-aneurysmal pressure remains unclear. A better understanding of aneurysm pressure effects may aid in predicting outcomes and guiding treatment decisions.

Olanzapine versus quetiapine in critically ill patients with hyperactive delirium: Protocol for a multicentre, cluster-randomised, double-crossover, pragmatic clinical trial (CALM-ICU).

Background: Patients in the intensive care unit (ICU) frequently develop hyperactive delirium, which may be accompanied by behaviour that increases clinical risks to themselves as well as other patients and staff. There is a paucity of evidence to inform the urgent enteral administration of antipsychotic drugs to treat such hyperactive delirium and behavioural disturbances.

Objective: The aim of this study is to test the efficacy and safety of administering enteral olanzapine when compared to quetiapine in critically ill patients with hyperactive delirium.

Intracranial hemorrhagic events associated with flow diversion treatment: a retrospective analysis from a single academic institution.

Intracranial hemorrhages are highly concerning but underreported complications related to flow diversion (FD) treatment of intracranial aneurysms. Herein, we aimed to characterize these complications and the factors influencing their occurrence. We retrospectively reviewed patients treated with FD from 2013 to 2023 at a single U.

Ready-to-load MHC-I Nanoparticles for High-throughput T cell Screening Studies.

MHC-I proteins present epitopic peptides to CD8+ T cells to elicit multifaceted adaptive immune responses. The affinity and avidity of interactions between peptide-MHC molecules and T-cell receptors (TCR) are fundamental parameters that contribute to the induction of activated or anergic T cell states. Here, we present a loadable system, VLP-Open HLA, featuring a virus-like particle (VLP) that can accommodate up to 60 loadable HLA (HLA - human leukocyte antigen) molecules.

Occult metastases and survival of lung cancer by clinical diagnosis and CT screening: A simulation study.

Objectives: It is significant to know how much early detection and screening could reduce the proportion of occult metastases and benefit NSCLC patients.

Methods: We used previously designed and validated mathematical models to obtain the characteristics of LC in the population including undetectable metastases at the time of diagnosis. The survival was simulated using the survival functions from Surveillance, Epidemiology and End Results (SEER) data stratified by stage.

Utility of Fluorescein Angiography for Early Detection of Familial Exudative Vitreoretinopathy in Neurodevelopmental Disorder With Spastic Diplegia and Visual Defects due to Variants.

Purpose: To investigate whether wide-angle fluorescein angiography (FA) was useful for detecting familial exudative retinopathy (FEVR) in patients with neurodevelopmental disorder with spastic diplegia and visual defects (NEDSDV).

Methods: This was a retrospective chart review from 2013 to 2023 of all consecutive patients with NEDSDV and pathogenic or likely pathogenic variants.

Results: Seven patients (four females, three males) were seen in the ophthalmology clinic (median age: 14 months).

Managing Posttraumatic Limb Deformity in Pediatric and Adolescent Patients.

Musculoskeletal injuries in children offer unique challenges compared with those in adults. Even low-energy injuries that involve the physis have the potential to cause a growth disturbance that could require treatment. Higher-energy injuries can be complicated by the same soft-tissue disruption, fracture contamination, and bone loss that are seen in adults.

Association of SARS-CoV-2 Infection during pregnancy with placental weight and histopathologic lesions.

Introduction: The reported gross and histopathologic changes in the placenta associated with SARS-CoV-2 infection are heterogeneous. We sought to summarize placental histopathologic findings from pregnancies affected by SARS-CoV-2 infection according to timing of infection and symptom severity.

Methods: We conducted a retrospective cohort study of patients with SARS-CoV-2 infection during pregnancy who had deliveries at Mayo Clinic, Rochester, Minnesota, from April 2020 through June 2021.

Reducing Intubations and Related Risks in Neonates with Retinopathy of Prematurity Undergoing Laser Photocoagulation.

Introduction: Although associated with respiratory morbidity, elective endotracheal intubation (ETI) for laser photocoagulation for retinopathy of prematurity (ROP) is the standard practice at our institution, with 100% of patients undergoing preoperation ETI. To mitigate this risk, we strove to reduce the percentage of infants intubated for laser photocoagulation by 30% by June 2022.

Methods: We assembled a multidisciplinary team and implemented a deep sedation guideline utilizing dexmedetomidine, fentanyl, and midazolam with noninvasive ventilation support for laser photocoagulation in January 2020.

Nicotine increases hepatocyte transthyretin turnover: A possible mechanism for the protective effect of smoking on preeclampsia?

Transthyretin is a thyroid hormone binding protein with a major role in the distribution of thyroid hormones to peripheral tissues. In preeclampsia, the failing placenta releases soluble endoglin into the maternal circulation causing systemic vascular dysfunction. Our group has previously shown that transthyretin binds to soluble endoglin and is taken up as a complex into hepatocytes.

Early adolescent second-generation antipsychotic exposure produces long-term, post-treatment increases in body weight and metabolism-associated gene expression.

The use of second-generation antipsychotic (SGA) medications in pediatric patients raises concerns about potential long-term adverse outcomes. The current study evaluated the long-term effects of treatment with risperidone or olanzapine on body weight, caloric intake, serum insulin, blood glucose, and metabolism-associated gene expression in C57Bl/6J female mice. Compared to mice treated with vehicle, female mice treated with risperidone or olanzapine gained weight at higher rates during treatment and maintained higher body weights for months following treatment cessation.

Lymphogranuloma Venereum Surveillance in Chlamydia trachomatis Positive Male Rectal Swabs Collected from I Want The Kit in Maryland, United States.

Background: Infection with Chlamydia trachomatis (CT) can have distinct clinical presentations, such as trachoma, or lymphogranuloma venereum (LGV). Certain populations are at greater risk for LGV acquisition and transmission, which requires a longer duration of therapy than other urogenital CT sexually transmitted infections (STIs). Commercial assays are not available in the United States to distinguish LGV from non-LGV serovars.

Scenario and Shooting Performance in Incumbent Deputy Sheriffs/Police Officers, Cadets, and Cadets Who Worked in Custody/Corrections Facilities.

Lockie, RG, Young, MA, Lanham, SN, Orr, RM, Dawes, JJ, and Nagel, TR. Scenario and shooting performance in incumbent deputy sheriffs/police officers, cadets, and cadets who worked in custody/corrections facilities. J Strength Cond Res XX(X): 000-000, 2024-Job-specific fitness of law enforcement personnel can decline during their careers.

Transcriptional regulation in the absence of inositol trisphosphate receptor calcium signaling.

The activation of IP receptor (IPR) Ca channels generates agonist-mediated Ca signals that are critical for the regulation of a wide range of biological processes. It is therefore surprising that CRISPR induced loss of all three IPR isoforms (TKO) in HEK293 and HeLa cell lines yields cells that can survive, grow and divide, albeit more slowly than wild-type cells. In an effort to understand the adaptive mechanisms involved, we have examined the activity of key Ca dependent transcription factors (NFAT, CREB and AP-1) and signaling pathways using luciferase-reporter assays, phosphoprotein immunoblots and whole genome transcriptomic studies.

Circadian disruption and its impact on the cardiovascular system.

Circadian rhythms are highly conserved biorhythms of ~24 h that govern many fundamental biological processes, including cardiovascular (CV) homeostasis. Disrupting the timing of cellular oscillators promotes cellular stress, and induction of pathogenic pathways underpins the pathogenesis of many CV diseases (CVDs). Thus, shift work, late eating, sleep disturbances, and other disruptors can result in an elevated risk of heart disease and increased incidence of adverse CV events.

The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression.

Objective: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression.

Methods: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support.

Intra-abdominal Hypertension Is a Strong Predictor of Mortality and Poor Clinical Outcome in Severe Acute Pancreatitis.

Background: Acute pancreatitis is one of the leading causes of mortality and morbidity. Most acute pancreatitis scoring systems have no pathophysiologic basis when evaluating severity. Such a limitation led to an interest in measuring intra-abdominal pressure (IAP) as a method to predict outcomes in patients with acute pancreatitis.

Evaluation of the Queensland JEV vaccine program response to the 2022 Australian outbreak.

In 2022, the largest ever virgin soil outbreak of Japanese encephalitis (JE) occurred in Australia resulting in 45 reported human cases of JE, with seven fatalities. Japanese encephalitis virus (JEV) was detected in 84 piggeries across Australia. In response, states implemented targeted vaccination programs for those individuals at the highest risk of JEV exposure.

Evaluation of inflammation adjustment methods to assess iron deficiency using longitudinal data from norovirus human challenge trials.

Accounting for inflammation is necessary to assess iron deficiency using ferritin. A limitation of existing inflammation-adjustment methods is reliance on cross-sectional data to evaluate method performance. The study objective was to evaluate three inflammation-adjustment methods using longitudinal data from two controlled trials where apparently healthy adults (n = 52) were exposed to norovirus.

Species diversity in the new lamprey genus Occidentis, formerly classified as western North American 'Lampetra'.

Accurate taxonomy is fundamental to the study and conservation of biodiversity. Because of their morphological similarities, most brook and river lampreys in western North America have been placed in the genus Lampetra along with lampreys from Eurasia and eastern North America. However, molecular-based phylogenetic studies dating back several decades indicate that lampreys from Pacific drainages are genetically distinct from Atlantic Lampetra.