Real-world evidence of the safety and survival with CD19 CAR-T cell therapy for relapsed/refractory solid organ transplant-related PTLD.

The use of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for relapsed/refractory solid organ transplantation (SOT)-related post-transplant lymphoproliferative disorder (PTLD) is not well studied. We conducted a multicentre, retrospective analysis of adults with relapsed/refractory SOT-associated PTLD. Among 22 relapsed/refractory SOT-PTLD patients, the pathology was monomorphic B cell.

Humoral immune response to SARS-CoV-2 in pregnant and nonpregnant women following infection.

Background: Immune changes that occur during pregnancy may place pregnant women at an increased risk for severe disease following viral infections like SARS-CoV-2. Whether these immunologic changes modify the immune response to SARS-CoV-2 infection during pregnancy is not well understood.

Objective: This study aimed to compare the humoral immune response to SARS-CoV-2 infection in pregnant and nonpregnant women.

Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial.

Purpose: The goal of this study was to assess the acceptability of a single-dose bioadhesive 2% clindamycin vaginal gel for bacterial vaginosis (BV).

Methods: This double-blind, placebo-controlled, randomized study compared a new clindamycin gel with placebo gel (2:1 ratio). The primary objective was efficacy; secondary objectives were safety and acceptability.

Healthcare cost and race: analysis of young women with stroke.

Background: Over the last decade, the prevalence of young stroke has increased 40% particularly among vulnerable populations. These strokes are often more severe with worse outcomes. However, few studies have examined the impact on annual healthcare costs.

Development of a Biosimilar of Agalsidase Beta for the Treatment of Fabry Disease: Preclinical Evaluation.

Background And Objective: Fabry disease (FD) is a rare lysosomal storage disorder caused by a deficiency of the enzyme α-galactosidase A (aGal A). Since 2001, two different enzyme replacement therapies have been authorized, with agalsidase beta being used in most parts of the Western world. Currently, biosimilars of several expensive enzyme therapies are under development to improve their accessibility for patients.

Long-Term Health Care Utilization After Cardiac Surgery in Children Covered Under Medicaid.

Background: Understanding the longitudinal burden of health care expenditures and utilization after pediatric cardiac surgery is needed to counsel families, improve care, and reduce outcome inequities.

Objectives: The purpose of this study was to describe and identify predictors of health care expenditures and utilization for Medicaid-insured pediatric cardiac surgical patients.

Methods: All Medicaid enrolled children age <18 years undergoing cardiac surgery in the New York State CHS-COLOUR database, from 2006 to 2019, were followed in Medicaid claims data through 2019.

Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks.

Purpose: The aim of this study was to assess the initial experience, technical success, and clinical benefit of AneuFix (TripleMed, Geleen, the Netherlands), a novel biocompatible and non-inflammatory elastomer that is directly injected into the aneurysm sac by a translumbar puncture in patients with a type II endoleak and a growing aneurysm.

Materials And Methods: A multicenter, prospective, pivotal study was conducted (ClinicalTrials.gov:NCT02487290).

A Cervical Cancer Screening Toolkit for Somali Women: A Pilot Randomized Controlled Trial.

This study aims to determine whether a novel cervical cancer screening toolkit will increase rates of pap test completion and HPV vaccination among Somali women living in the United States. We conducted a randomized controlled, pilot trial from June 2021 to February 2022. Somali women aged 21 to 70 were randomized to either receive a toolkit (infographic, video and an in-person health seminar) or not.

The Scratch Collapse Test in patients diagnosed with Anterior Cutaneous Nerve Entrapment Syndrome (ACNES): A report of three cases.

Introduction And Importance: The Scratch Collapse Test (SCT) is currently used as a supportive tool diagnosing peripheral nerve neuropathies including carpal tunnel syndrome or peroneal nerve entrapment. Some patients with chronic abdominal pain suffer from entrapment of terminal branches of intercostal nerves (anterior cutaneous nerve entrapment syndrome, ACNES). ACNES is characterized by a severe disabling pain at a predictable area of the anterior abdomen.

The Epilepsy Ontology: a community-based ontology tailored for semantic interoperability and text mining.

Motivation: Epilepsy is a multifaceted complex disorder that requires a precise understanding of the classification, diagnosis, treatment and disease mechanism governing it. Although scattered resources are available on epilepsy, comprehensive and structured knowledge is missing. In contemplation to promote multidisciplinary knowledge exchange and facilitate advancement in clinical management, especially in pre-clinical research, a disease-specific ontology is necessary.

Real-Life Experience of Tralokinumab for the Treatment of Adult Patients with Severe Atopic Dermatitis: A Multicentric Prospective Study.

Background: Tralokinumab, the first fully human monoclonal antibody that binds specifically to interleukin-13, was safe and effective for treating atopic dermatitis (AD) in clinical trials, but real-life experience is still limited.

Objectives: The objective of this study was to evaluate the effectiveness and safety of tralokinumab in severe AD in a real-life multicenter prospective cohort.

Methods: Adult patients with severe AD were enrolled between January 2022 and July 2022 and received tralokinumab subcutaneously for 16 weeks.

The Cell Transformation Assay: A Historical Assessment of Current Knowledge of Applications in an Integrated Approach to Testing and Assessment for Non-Genotoxic Carcinogens.

The history of the development of the cell transformation assays (CTAs) is described, providing an overview of in vitro cell transformation from its origin to the new transcriptomic-based CTAs. Application of this knowledge is utilized to address how the different types of CTAs, variously addressing initiation and promotion, can be included on a mechanistic basis within the integrated approach to testing and assessment (IATA) for non-genotoxic carcinogens. Building upon assay assessments targeting the key events in the IATA, we identify how the different CTA models can appropriately fit, following preceding steps in the IATA.

Disparities in Perceived Physical and Mental Wellness: Relationships Between Social Vulnerability, Cardiovascular Risk Factor Prevalence, and Health Behaviors Among Elderly US Residents.

Introduction: Cardiovascular disease (CVD) is the leading cause of death for males, females, and people of most racial and ethnic groups in the United States. In addition to known epidemiological and behavioral risk factors, recent evidence suggests that circumstantial or behavioral factors may also be associated with CVD. This study evaluates the contribution of cardiovascular disease (CVD) risk factors, community vulnerabilities, and individual health behaviors to individual physical and mental wellness among Black and White, male, and female Medicare beneficiaries.

Scalable RT-LAMP-based SARS-CoV-2 testing for infection surveillance with applications in pandemic preparedness.

Throughout the SARS-CoV-2 pandemic, limited diagnostic capacities prevented sentinel testing, demonstrating the need for novel testing infrastructures. Here, we describe the setup of a cost-effective platform that can be employed in a high-throughput manner, which allows surveillance testing as an acute pandemic control and preparedness tool, exemplified by SARS-CoV-2 diagnostics in an academic environment. The strategy involves self-sampling based on gargling saline, pseudonymized sample handling, automated RNA extraction, and viral RNA detection using a semiquantitative multiplexed colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay with an analytical sensitivity comparable with RT-qPCR.

Biomarker Response to Mindfulness Intervention in Veterans Diagnosed with Post-traumatic Stress Disorder.

Objectives: This study evaluates the effects of treatment with mindfulness-based stress reduction (MBSR) compared to the active control, present-centered group therapy (PCGT), on morning plasma cortisol, interleukin-6 (IL-6), and C-reactive protein (CRP) in veterans diagnosed with post-traumatic stress disorder (PTSD).

Methods: In a post hoc exploratory analysis, we pooled biomarkers and clinical outcomes of mindfulness, PTSD, and depression from two randomized controlled trials comparing MBSR ( = 104) to PCGT ( = 106) in U.S.

OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines.

The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries.

Histopathologic and Transcriptomic Profiling Identifies Novel Trophoblast Defects in Patients With Preeclampsia and Maternal Vascular Malperfusion.

Preeclampsia (PE) is a heterogeneous disease for which the current clinical classification system is based on the presence or absence of specific clinical features. PE-associated placentas also show heterogeneous findings on pathologic examination, suggesting that further subclassification is possible. We combined clinical, pathologic, immunohistochemical, and transcriptomic profiling of placentas to develop integrated signatures for multiple subclasses of PE.

Sociodemographic risk factors, parental stress and social support in the neonatal intensive care unit.

Objective: Investigate relationships among neonatal intensive care unit (NICU) parent demographics, reported stress and social support.

Design: Cross-sectional observation.

Setting: Tertiary referral NICU in Mid-Atlantic USA.

Racial, ethnic, and sex disparities in the incidence and cognitive symptomology of long COVID-19.

Background: The pandemic has highlighted and exacerbated health inequities in both acute coronavirus disease 2019 (COVID-19) and its longer-term sequelae. Given the heterogeneity in definitions of long COVID and the lack of centralized registries of patients with the disease, little is known about the differential prevalence among racial, ethnic, and sex subgroups. This study examines long COVID among Black, White, Asian, and Hispanic Americans and evaluates differences in the associated cognitive symptomology.

Acute Effects of Combined Lower-Body High-Intensity Interval Training and Upper-Body Strength Exercise on Explosive Strength Performance in Naturally Menstruating Women.

Purpose: We aimed at investigating the acute effects of lower-body high-intensity interval training (HIIT) on upper- and lower-body explosive strength assessed by mean propulsive velocity (MPV) in naturally menstruating women. In addition, we assessed the combination of lower-body HIIT and squat, as well as lower-body HIIT and bench press, on bench press and squat MPV.

Methods: Thirteen women (age: 23 [2] y, menstrual cycle length: 28.

Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma in Standard-of-Care Practice: Results From the US Lymphoma CAR T Consortium.

Purpose: Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). This therapy was approved on the basis of the single-arm phase II ZUMA-2 trial, which showed best overall and complete response rates of 91% and 68%, respectively. We report clinical outcomes with brexu-cel in the standard-of-care setting for the approved indication.

SARS-CoV-2 Infection in Winter 2021/2022: The Association of Varying Clinical Manifestations With and Without Prior Vaccination.

Importance SARS-CoV-2 is a rapidly evolving virus with many strains. Although vaccines have proven to be effective against earlier strains of the virus, the efficacy of vaccination status against later strains is still an area of active research. Objective To determine if vaccination status was associated with symptomatology due to infection by later strains of SARS-CoV-2.

ANATOMICAL AND FUNCTIONAL OUTCOMES OF BEVACIZUMAB TREATMENT IN PEDIATRIC AUTOSOMAL RECESSIVE BESTROPHINOPATHY.

Purpose: The purpose of this study was to report functional and anatomical outcomes of anti-VEGF treatment in eyes with autosomal recessive bestrophinopathy (ARB) presenting in the first decade of life.

Methods: The study included case series of four eyes from two siblings with compound heterozygous mutations in the BEST1 gene who were treated with eight monthly intravitreal bevacizumab injections. Response to treatment was analyzed using color fundus photography, fundus autofluorescence, optical coherence tomography, OCT angiography, and microperimetry.