Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial.

Background: Inclusion of additional influenza A/H3N2 strains in seasonal influenza vaccines could expand coverage against multiple, antigenically distinct, cocirculating A/H3N2 clades and potentially replace the no longer circulating B/Yamagata strain. We aimed to evaluate the safety and immunogenicity of three next-generation seasonal influenza mRNA vaccines with different compositions that encode for haemagglutinins of multiple A/H3N2 strains, with or without the B/Yamagata strain, in adults.

Methods: This randomised, open-label, phase 1/2 trial enrolled healthy adults aged 50-75 years across 22 sites in the USA.

Reduction in the severity and duration of headache following fremanezumab treatment in patients with episodic and chronic migraine.

Objective: To evaluate the impact of fremanezumab on the severity and duration of remaining migraine attacks in patients with chronic migraine (CM) or episodic migraine (EM).

Background: Fremanezumab is a fully humanized monoclonal antibody (IgGΔa) that selectively targets calcitonin gene-related peptide and is efficacious in reducing migraine frequency.

Methods: This exploratory post hoc analysis included data from three randomized, double-blind, 12-week, phase 3 studies (HALO CM, HALO EM, and FOCUS).

Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials.

Background: Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, including the fully humanized monoclonal antibody (IgG2Δa) fremanezumab, have demonstrated safety and efficacy for migraine prevention. Clinical trials include responders and nonresponders; efficacy outcomes describe mean values across both groups and thus provide little insight into the clinical benefit in responders. Clinicians and their patients want to understand the extent of clinical improvement in patients who respond.

Variability in Blood Eosinophil Counts in Patients with Eosinophilic Asthma.

Background: Blood eosinophil (EOS) counts are critical to the accurate identification of asthma phenotypes. However, there are few long-term data on intraindividual EOS count variability among patients with eosinophilic asthma.

Objective: This post hoc analysis of 2 phase III clinical trials from the reslizumab BREATH program explored the variability of blood EOS counts in patients with eosinophilic asthma receiving placebo.

In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV reversibility.

Background: A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials of intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma.

Methods: Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV) reversibility to β-agonists and treatment outcomes were assessed.

Results: Mean baseline FEV reversibility was numerically lower among patients with high (≥ 400 cells/µL) versus low baseline EOS.

Depressed mood and quality of life after subarachnoid hemorrhage.

Background: Cognitive impairment is widely considered the main cause of disability and handicap after subarachnoid hemorrhage (SAH). The impact of depression on recovery after SAH remains poorly defined. We sought to determine the frequency of post-SAH depression, identify risk factors for its development, and evaluate the impact of depression on quality of life (QOL) during the first year of recovery.

Teaching residents to work with torture survivors: experiences from the Bronx Human Rights Clinic.

Introduction: Despite the 1984 United Nations's Convention Against Torture calling to train doctors to work with torture survivors, many physicians are unaware of their obligation and few are taught the requisite clinical skills.

Aim: To describe the development, implementation, and evaluation of a curriculum to teach residents to work with torture survivors.

Participants: Medicine residents in New York City

Program Description: A 2-component curriculum consisting of a series of workshops and clinical experiences, which provide content, skills, and practices regarding the medical, psychological, ethical, and legal aspects of evaluating and caring for torture survivors.

The effect of race on provider decisions to test for illicit drug use in the peripartum setting.

Background: Testing for illicit drugs may expose women who test positive to severe legal and social consequences. It is unknown whether racial disparities in drug testing practices underlie observed disparities in legal and social consequences of positive tests.

Methods: Using administrative hospital and birth certificate data, we analyzed factors associated with both receipt and results of illicit drug testing among women with live births during 2002-2003.

Effects of pegylated interferon alfa-2b on the pharmacokinetic and pharmacodynamic properties of methadone: a prospective, nonrandomized, crossover study in patients coinfected with hepatitis C and HIV receiving methadone maintenance treatment.

Background: Hepatitis C virus (HCV) infection is common among methadone-maintained HIV-positive individuals. Pegylated interferon (pegIFN) used in combination with ribavirin is conventional treatment for HCV. However, pegIFN has been associated with adverse effects (AEs) that may simulate opioid withdrawal and be confused with insufficient methadone dosage.

A randomized, double-blind, placebo-controlled study assessing the anti-inflammatory effects of ketamine in cardiac surgical patients.

Objective: To determine whether ketamine administration affects markers of inflammation in cardiac surgery with cardiopulmonary bypass (CPB) and to investigate differences between 2 low-dose ketamine regimens.

Design: Prospective, randomized, placebo-controlled trial.

Setting: Single-center university hospital.

Clinical trial of a novel surface cooling system for fever control in neurocritical care patients.

Objective: To compare the efficacy of a novel water-circulating surface cooling system with conventional measures for treating fever in neuro-intensive care unit patients.

Design: Prospective, unblinded, randomized controlled trial.

Setting: Neurologic intensive care unit in an urban teaching hospital.

Quantitative continuous EEG for detecting delayed cerebral ischemia in patients with poor-grade subarachnoid hemorrhage.

Objective: Delayed cerebral ischemia (DCI) due to vasospasm is often undetected by clinical exam in patients with poor-grade subarachnoid hemorrhage (SAH). The purpose of this study was to identify quantitative EEG (qEEG) parameters that are most sensitive and specific for the detection of DCI in stuporous or comatose SAH patients.

Methods: Of 78 consecutive Hunt-Hess grade 4 or 5 SAH patients admitted to our Neuro-ICU over a 2-year period, 48 were eligible for participation and 34 were enrolled.

Effect of acute physiologic derangements on outcome after subarachnoid hemorrhage.

Objective: To determine the effect that acute physiologic derangements have on outcome after subarachnoid hemorrhage (SAH) and to design a composite score summarizing these abnormalities.

Design: Prospective observational study.

Setting: Neuroscience intensive care unit in a tertiary care academic center.

Piloting web-based NAMCS data collection for nurse-managed centers.

Research consistently has shown that Nurse Practitioners (NPs) provide health care equivalent to that of physicians, and especially excel in patient education and case management, essential interventions to promote self-care in chronically ill ambulatory patients. Yet large-scale national studies have not been done. Nurse-managed centers are not included in the sampling frame of the National Ambulatory Medical Care Survey (NAMCS) and only 2.

Failure of intraoperative jugular bulb S-100B and neuron-specific enolase sampling to predict cognitive injury after carotid endarterectomy.

Objective: Cognitive decline occurs in 25% of patients after carotid endarterectomy (CEA). Elevated serum concentrations of S-100B and neuron-specific enolase (NSE) occur after stroke, and serum S-100B levels at 24 hours are associated with clinical outcome after both stroke and CEA. We hypothesized that we could detect acute elevations in serum levels of these markers obtained intraoperatively from the jugular bulb (JB) and that these elevations would predict cognitive dysfunction postoperatively as measured by neuropsychometric test performance.

Global cerebral edema after subarachnoid hemorrhage: frequency, predictors, and impact on outcome.

Background And Purpose: Cerebral edema visualized by CT is often seen after subarachnoid hemorrhage (SAH). Inflammatory or circulatory mechanisms have been postulated to explain this radiographic observation after SAH. We sought to determine the frequency, causes, and impact on outcome of early and delayed global cerebral edema after SAH.

Predictors of cognitive dysfunction after subarachnoid hemorrhage.

Background: Cognitive dysfunction is a common and disabling sequela of subarachnoid hemorrhage (SAH). Although several clinical and radiographic findings have been implicated in the pathogenesis of cognitive dysfunction after SAH, few prospective studies have comprehensively and simultaneously evaluated these risk factors.

Methods: Between July 1996 and March 2000, we prospectively evaluated 113 of 248 consecutively admitted nontraumatic SAH patients alive at 3 months with a comprehensive neuropsychological evaluation.