Publications by authors named "HERMAN G"

Article Synopsis
  • The study investigates how antiviral monoclonal antibodies (mAbs), particularly casirivimab and imdevimab (CAS+IMD), affect immune responses when individuals are vaccinated against SARS-CoV-2 after receiving mAb treatment.
  • It was found that the presence of CAS+IMD during vaccination reduced the effectiveness of the vaccine in generating neutralizing antibodies, though other immune responses remained intact.
  • This reduction in antibody production is linked to "epitope masking," but can be reversed with booster shots, and influences the immune response differently in those who had not yet begun their natural immunity when treated with mAbs.
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  • Fibrodysplasia ossificans progressiva (FOP) is a rare condition where bones form in soft tissue, referred to as heterotopic ossification (HO), and this study examined imaging methods to identify and measure new HO lesions.
  • The research analyzed data from a phase 2 clinical trial comparing the effectiveness of garetosmab (a therapy) with a placebo in adults with FOP, utilizing both PET/CT and CT scans to detect lesions over 28 weeks.
  • Results showed that both PET/CT and CT-only methods detected a similar number and volume of new lesions, indicating that CT-only imaging is an effective alternative for monitoring HO changes in FOP patients.
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  • Pregnant women with COVID-19 are at higher risk for severe outcomes, and this study evaluated the safety and effectiveness of the monoclonal antibody treatment CAS+IMD in this population.* -
  • The study, which involved 82 pregnant participants, found that CAS+IMD was well tolerated with minimal adverse reactions, and it effectively reduced viral loads without significantly affecting fetal development.* -
  • Overall, the treatment showed promising safety and efficacy, suggesting it could be a viable option for managing COVID-19 in pregnant women, although conclusions about its effects are limited due to a small number of placebo recipients.*
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  • A clinical trial assessed the safety of the combination of casirivimab and imdevimab (CAS + IMD) in children with COVID-19.
  • The results showed that the treatment was well tolerated, similar to findings in adults, with minimal immune response side effects.
  • The study supports further development of advanced monoclonal antibodies for children at higher risk for COVID-19.
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Background: In 2021, the EAU Guidelines implemented a novel, expert opinion-based follow-up scheme, with a three-risk-category system for clear cell (cc) and non-cc renal cell carcinoma (non-ccRCC) after surgery with curative intent. We aimed to validate the novel follow-up scheme and provide data-driven recurrence estimates according to risk groups, to confirm or implement the oncologic surveillance strategy.

Methods: We identified 5,320 patients from a prospectively maintained database involving 28 French referral centers.

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Heart failure is a leading cause of morbidity and mortality. Elevated intracardiac pressures and myocyte stretch in heart failure trigger the release of counter-regulatory natriuretic peptides, which act through their receptor (NPR1) to affect vasodilation, diuresis and natriuresis, lowering venous pressures and relieving venous congestion. Recombinant natriuretic peptide infusions were developed to treat heart failure but have been limited by a short duration of effect.

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Background: Deeper insight is needed on how monoclonal antibodies (mAbs) affect vaccine-mediated immune responses when targeting the same protein. We describe the first prospective randomised trial designed to understand mAb-mediated alterations in vaccine-induced immune responses to SARS-CoV-2 spike protein epitopes.

Methods: This randomised, open-label, parallel-group study assessed the potential interaction of a mAb combination, casirivimab and imdevimab, with a vaccine, Moderna's mRNA-1273, in healthy SARS-CoV-2 immunologically naive, seronegative adults at six centres in the USA.

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Indoor air quality (IAQ) and indoor air pollution are critical issues impacting urban environments, significantly affecting the quality of life. Nowadays, poor IAQ is linked to respiratory and cardiovascular diseases, allergic reactions, and cognitive impairments, particularly in settings like classrooms. Thus, this study investigates the impact of indoor environmental quality on student health in a university classroom over a year, using various sensors to measure 19 environmental parameters, including temperature, relative humidity, CO, CO, volatile organic compounds (VOCs), particulate matter (PM), and other pollutants.

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Background: Nasal epithelial cells are important regulators of barrier function and immune signaling; however, in allergic rhinitis (AR) these functions can be disrupted by inflammatory mediators. We aimed to better discern AR disease mechanisms using transcriptome data from nasal brushing samples from individuals with and without AR.

Methods: Data were drawn from a feasibility study of individuals with and without AR to Timothy grass and from a clinical trial evaluating 16 weeks of treatment with the following: dupilumab, a monoclonal antibody that binds interleukin (IL)-4Rα and inhibits type 2 inflammation by blocking signaling of both IL-4/IL-13; subcutaneous immunotherapy with Timothy grass (SCIT), which inhibits allergic responses through pleiotropic effects; SCIT + dupilumab; or placebo.

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Background: Virologic determinants of seroconversion to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were defined in a post hoc analysis of prospectively studied vaccine- and infection-naïve individuals at high risk for coronavirus disease 2019 (COVID-19).

Methods: This phase 3 COVID-19 prevention trial (NCT04452318) with casirivimab and imdevimab was conducted in July 2020-February 2021, before widespread vaccine availability. Placebo-treated participants who were uninfected (SARS-CoV-2 quantitative reverse transcription polymerase chain reaction [RT-qPCR] negative) and seronegative were assessed weekly for 28 days (efficacy assessment period [EAP]) for COVID-19 symptoms and SARS-CoV-2 infection by RT-qPCR of nasopharyngeal swab samples and for serostatus by antinucleocapsid immunoglobulin (Ig) G.

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Deficiency in the adipose-derived hormone leptin or leptin receptor signaling causes class 3 obesity in individuals with genetic loss-of-function mutations in leptin or its receptor LEPR and metabolic and liver disease in individuals with hypoleptinemia secondary to lipoatrophy such as in individuals with generalized lipodystrophy. Therapies that restore leptin-LEPR signaling may resolve these metabolic sequelae. We developed a fully human monoclonal antibody (mAb), REGN4461 (mibavademab), that activates the human LEPR in the absence or presence of leptin.

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Background: Clinical methods for assessing quality of movement and functional tests are important to clinicians. Typical deviations from normal kinematics during the clinical test of Forward Step Down Test (FSDT) are pelvic tilt and hip adduction which are associated with the risk of knee pain.

Objectives: (1) to examine the correlation between clinical assessment of the FSDT and joint angle measurements of pelvis, hip, knee and ankle joints in males and females; (2) to examine the differences in joint angles between individuals rated as good, fair or poor in a FSDT performance test.

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Article Synopsis
  • - Fibrodysplasia ossificans progressiva (FOP) is a rare condition that causes painful heterotopic ossification in connective tissues, leading to disability.
  • - In the LUMINA-1 phase 2 trial, adults with FOP were given either garetosmab (an activin A-blocking antibody) or a placebo over two 28-week periods, focusing on safety and effects on HO lesions.
  • - Although the primary efficacy endpoint was not met in the first period, garetosmab significantly reduced the development of new HO lesions in the second period compared to placebo, with ongoing investigations into its effectiveness.
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The US fee-for-service payment system under-reimburses clinics offering access to comprehensive treatments for opioid use disorder (OUD). The funding shortfall limits a clinic's ability to expand and improve access, especially for socially marginalized patients with OUD. New payment models, however, should reflect the high variation in cost for using a clinic's clinical and voluntary psychosocial and recovery support services.

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Background: Spatial patterns of brain functional connectivity can vary substantially at the individual level. Applying cortical surface-based approaches with individualized rather than group templates may accelerate the discovery of biological markers related to psychiatric disorders. We investigated cortico-subcortical networks from multi-cohort data in people with schizophrenia spectrum disorders (SSDs) and healthy controls (HC) using individualized connectivity profiles.

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Background: Non-standardized assessment tools are preferred when assessing communication of individuals with developmental disabilities. Currently, there are limited tools available for assessing this population. Informant report tools such as the Pragmatics Profile (PP) of Everyday Communication Skills are beneficial in gathering a representative view of an individual's communication.

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To investigate the role of glial cells in the regulation of glucoprivic responses in rats, a chemogenetic approach was used to activate astrocytes neighboring catecholamine (CA) neurons in the ventromedial medulla (VLM) where A1 and C1 CA cell groups overlap (A1/C1). Previous results indicate that activation of CA neurons in this region is necessary and sufficient for feeding and corticosterone release in response to glucoprivation. However, it is not known whether astrocyte neighbors of CA neurons contribute to glucoregulatory responses.

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Background: Randomized controlled trials evaluated monoclonal antibodies for the treatment (Study 2067) and prevention (Study 2069) of coronavirus disease 2019 (COVID-19). Household contacts of the infected index case in Study 2067 were enrolled in Study 2069 and prospectively followed; these cohorts provided a unique opportunity to evaluate correlates of transmission, specifically viral load.

Methods: This post hoc analysis was designed to identify and evaluate correlates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission, adjusting for potential confounding factors related to source SARS-CoV-2 viral load and risk of SARS-CoV-2 acquisition in this population.

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While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.

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Background: Individuals who are immunocompromised (IC) are at high risk for severe coronavirus disease 2019 (COVID-19).

Methods: Post hoc analyses of a double-blind trial conducted prior to Omicron (June 2020-April 2021), in hospitalized patients with COVID-19 assessed viral load, clinical outcomes, and safety of casirivimab plus imdevimab (CAS + IMD) versus placebo in IC versus overall study patients.

Results: Ninety-nine of 1940 (5.

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Background: The COVID-19 pandemic has highlighted the need for reliable information, especially around vaccines. Vaccine hesitancy is a growing concern and a great threat to broader public health. The prevalence of social media within our daily lives emphasizes the importance of accurately analyzing how health information is being disseminated to the public.

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We conducted a analysis in seropositive patients who were negative or borderline for functional neutralizing antibodies (NAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline from a phase 1, 2, and 3 trial of casirivimab and imdevimab (CAS+IMD) treatment in hospitalized coronavirus disease 2019 (COVID-19) patients on low-flow or no supplemental oxygen prior to the emergence of Omicron-lineage variants. Patients were randomized to a single dose of 2.4 g CAS+IMD, 8.

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Cardiac autonomic neuropathy (CAN) is a complication of diabetes mellitus, which imposes significant functional limitations and at times, sudden death. In an evolving healthcare landscape, physical therapists are assuming greater clinical responsibility and thus must be aware of this potential complication and tailor the plan of care appropriately. The purpose of this case report is to highlight the need for increased awareness of CAN among physical therapists in order to improve screening, diagnosis, and treatment.

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Article Synopsis
  • - A study examined genetic mutations in individuals with autism spectrum disorder (ASD) by analyzing data from 63,237 people, identifying 72 genes linked to ASD at a very low false discovery rate.
  • - The research found that genetic mutations contributing to ASD included de novo protein-truncating variants (PTVs), damaging missense variants, and copy number variants (CNVs), with CNVs posing the highest risk.
  • - When including data from a larger group with developmental delay, 373 genes were connected to both ASD and developmental delay, revealing different mutation frequencies in the two groups and suggesting shared genetic pathways between ASD and other neuropsychiatric disorders like schizophrenia.
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Importance: The monoclonal antibody combination of casirivimab and imdevimab reduced viral load, hospitalization, or death when administered as a 1200-mg or greater intravenous (IV) dose in a phase 3 COVID-19 outpatient study. Subcutaneous (SC) and/or lower IV doses should increase accessibility and/or drug supplies for patients.

Objective: To assess the virologic efficacy of casirivimab and imdevimab across different IV and SC doses compared with placebo.

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