1,222 results match your criteria: "and ‡Late Clinical Research and Development[Affiliation]"

Introduction: The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid, single-vial formulation has been developed to simplify administration and prevent reconstitution errors. We present pooled safety data from two randomized, controlled, observer-blind phase 2b clinical trials, in which the fully liquid presentation was compared with the licensed presentation.

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A fully automated deep learning pipeline for micro-CT-imaging-based densitometry of lung fibrosis murine models.

Respir Res

November 2022

Chiesi Farmaceutici S.P.A, Corporate Pre-Clinical Research and Development, Largo Belloli, 11/A, 43122, Parma, Italy.

Idiopathic pulmonary fibrosis, the archetype of pulmonary fibrosis (PF), is a chronic lung disease of a poor prognosis, characterized by progressively worsening of lung function. Although histology is still the gold standard for PF assessment in preclinical practice, histological data typically involve less than 1% of total lung volume and are not amenable to longitudinal studies. A miniaturized version of computed tomography (µCT) has been introduced to radiologically examine lung in preclinical murine models of PF.

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SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy.

Oncologist

January 2023

Gastrointestinal and Lymphoma Unit, Royal Marsden NHS Foundation Trust, London and Surrey, UK.

Introduction: Patients with gastrointestinal (GI) cancers have an increased risk of serious complications and death from SARS-CoV-2 infection. The immunogenicity of vaccines in patients with GI cancers receiving anti-cancer therapies is unclear. We conducted a prospective study to evaluate the prevalence of neutralizing antibodies in a cohort of GI cancer patients receiving chemotherapy following SARS-CoV-2 vaccination.

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The antitumor effect of antibody-drug conjugates (ADC) is the main factor in achieving cures. Although the mechanism of tumor resistance to treatment is multifaceted, tumor-derived extracellular vesicles (T-EVs) have been implicated as contributing to the attenuation of ADC therapeutic efficacy. Thus, strategies to eliminate T-EVs are highly promising for overcoming drug resistance.

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Background: The meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®; Pfizer Ltd, Sandwich, Kent, UK) is licensed in more than 80 countries worldwide for the prevention of meningococcal disease caused by serogroups A, C, W, and Y in individuals throughout their lifespans. This report summarizes safety data from the MenACWY-TT clinical development program and postmarketing experience.

Methods: Within the clinical study program, reactogenicity data were based on 3 primary studies, including a large pooled analysis across multiple age groups, and long-term safety data were derived from 3 studies evaluating long-term antibody persistence.

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Background And Aims: We focused on determining the risk factors, thromboembolic events, and clinical course of New-Onset Atrial Fibrillation (NOAF) among hospitalized coronavirus disease (COVID-19) patients.

Methods: This retrospective study was conducted in the major referral centers in Tehran, Iran. Of 1764 patients enrolled in the study from January 2020 until July 2021, 147 had NOAF, and 1617 had normal sinus rhythm.

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Evidence demonstrated that metabolic-associated T cell abnormalities could be detected in the early stage of RA development. In this context, molecular evaluations have revealed changes in metabolic pathways, leading to the aggressive phenotype of RA T cells. A growing list of genes is downregulated or upregulated in RA T cells, and most of these genes with abnormal expression fall into the category of metabolic pathways.

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Article Synopsis
  • Status epilepticus (SE) is a critical condition needing quick treatment, and this study compares the effectiveness and safety of levetiracetam (LEV) versus fosphenytoin (FPHT) as second-line treatments after initial diazepam administration.
  • The trial involved 176 adult patients with SE, showing similar seizure cessation rates: 83.8% for FPHT and 89.2% for LEV, with LEV demonstrating non-inferiority in efficacy.
  • LEV had a better safety profile, with no serious adverse events reported, suggesting it could be a viable alternative for treating SE alongside FPHT.
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Human Monkeypox (HMPX) outbreak in the year 2022 occurs in many countries outside of the African regions, a common location of such outbreaks, with a considerable rate of human-to-human transmission, which was an uncommon route of infection before. The epidemiological reports also represent a sharping pace of infection spreading between communities rather than in previous outbreaks as the following pace of afflictions is unpredictable. Also, the cautions regarding the sexually transmitted infection of the such virus have been raised in this outbreak.

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Background/aim: This study describes a rare cell sorter (RCS) method to detect circulating tumor cells (CTCs) and CTC clusters in whole blood without pretreatment.

Patients And Methods: We collected samples from breast cancer patients at the University of Tsukuba Hospital. A total of 15 whole-blood specimens from patients with breast cancer were collected and analyzed via a microfluidics chip, fluorescence-conjugated antibody staining, and fluorescence microscopy.

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Δ-Tetrahydrocannabinol Vapor Exposure Produces Conditioned Place Preference in Male and Female Rats.

Cannabis Cannabinoid Res

February 2024

Division of Behavioral Biology, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

The use of place conditioning procedures and drug vapor exposure models can increase our understanding of the rewarding and aversive effects of vaped cannabis products. Currently there are limited data on the conditioned rewarding effects of vaporized Δ-tetrahydrocannabinol (THC), the primary psychoactive constituent of cannabis in rats, and no studies to date examining sex differences. Male and female Sprague-Dawley rats (=96; 12 per sex/group) underwent place conditioning sessions immediately after exposure to THC or vehicle (propylene glycol [PG]) vapor.

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Incidence of Lyme neuroborreliosis in Denmark: Exploring observed trends using public surveillance data, 2015-2019.

Ticks Tick Borne Dis

November 2022

Vaccines Medical Development & Scientific/Clinical Affairs, Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address:

Lyme neuroborreliosis (LNB) can be a serious manifestation of Lyme borreliosis. We describe the incidence, time trends and geographic distribution of LNB in Denmark. We obtained LNB cases reported by laboratories and physicians (2015-2019) from the online platform maintained by the Statens Serum Institut (SSI) (2021b).

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Article Synopsis
  • Development of new vaccines for SARS-CoV-2 aims to improve availability in low-income areas, despite existing effective vaccines.
  • A study tracked immune responses in young and old volunteers after receiving the GRAd-COV2 vaccine, showing strong antibody and T-cell responses that were maintained for 3 months but declined by 6 months.
  • GRAd-COV2 demonstrated good safety and immune response, making it a promising candidate for further clinical development as part of the COVID-19 vaccination strategy.
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Background: Infliximab (IFX) biosimilar was the first biosimilar approved in Jordan in 2014, with limited evidence of its safety and effectiveness from the Middle East and North Africa (MENA) region. Thus, this study aimed to evaluate the safety and effectiveness of IFX biosimilar in active rheumatoid arthritis (RA) patients over 34 weeks by investigating (1) the adverse events (AEs), serious adverse events (SAEs), and therapy discontinuation and (2) the score changes of the 28-Joint Disease Activity Score (DAS28) and the Health Assessment Questionnaire Disability Index (HAQ-DI).

Methods: This multicenter prospective cohort study collected clinical parameters within hospital settings every four weeks.

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Background: The meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.

Methods: We conducted two phase 2 randomised, controlled, observer-blinded studies including healthy toddlers (age 12-23 months) across 26 Australian, Czech, Finnish, and Polish centres, and older children (age 2-9 years) across 14 Finnish and Polish centres.

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Article Synopsis
  • Diabetic foot ulcers (DFUs) often resist standard treatments, leading to severe health risks; ABCB5 mesenchymal stem cells (MSCs) could serve as a promising new option due to their healing and anti-inflammatory properties.* -
  • The study investigated the angiogenic capabilities of ABCB5 MSCs, showing that they can express factors necessary for blood vessel formation and enhance healing in animal models with ischemia.* -
  • A clinical trial demonstrated the safety and effectiveness of applying ABCB5 MSCs to hard-to-treat DFUs, potentially offering a new treatment avenue for those suffering from chronic wounds.*
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Background: Since heart failure (HF) and ischemic stroke have common risk factors, their concurrent occurrence is likely. Strokes in HF patients could be life-threatening and lead to severe disabilities, longer hospitalization time, and mortality. The present study aims to investigate the prevalence of HF and its severity based on ejection fraction (EF) in patients with acute ischemic stroke.

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Background: Polycystic ovary syndrome (PCOS) is the most common endocrine, metabolic, and multi-causal disorder in the reproductive period with a possible genetic origin. Women with PCOS are characterized by oligo-ovulation, clinical or biochemical hyperandrogenism, and polycystic ovaries. Women with PCOS have an increased number of antral follicles.

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Colostrum is the first food for newborns and it contains various crucial immune factors. The concentrations of immune factors in breast milk may change depending on maternal characteristics such as body mass index, collection day, and age at first pregnancy. In this exploratory study, we investigated the association between TGF-β1, TGF-β2, and IgA in colostrum and rarely studied factors that affect breast milk components, including the use of labor-inducing medication, colostrum secretion, sex of newborns, breast or nipple problems, and nipple care.

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Objective: To evaluate the clinical and radiographic findings of long head biceps tendon (LHBT) transfer in traumatic proximal humeral fractures with the biceps groove breakage or comminution.

Methods: In this interventional study, subjects surveyed in terms of shoulder function, clinical signs of LHBT tendinitis, radiographic signs of transferred biceps as a possible depressor of the shoulder, and mechanical changes of the scapula. Data were analyzed in SPSS version 21.

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Purpose: Anatomical variations of the pancreas are relatively frequent and often understudied. The ductal system of the pancreas has multiple variations, which are not frequently reported in the literature.

Materials And Methods: The anatomy of the pancreas was studied through macroscopic anatomical dissection on 50 organ complexes (the pancreas, spleen, and duodenum) donated to the department of human anatomy, from patients, who died of causes not related to pancreatic diseases.

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Background: Behcet's disease (BD) is a chronic fatal illness with a relapsing remitting nature and significant organ-threatening morbidity and mortality. The aim of this research was to examine studies which were conducted on investigation of prevalence of quality of life among patients with Behcet's disease.

Methods: A total of 13 articles were extracted from four main databases including PubMed, EMBASE, Scopus, and Web of Science from the onset of 2000 to January 2021.

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Rodent Thermoregulation: Considerations for Tail-Cuff Blood Pressure Measurements.

J Am Assoc Lab Anim Sci

September 2022

Pre-Clinical Research and Development, Kent Scientific Corporation, Torrington, Connecticut.

Noninvasive blood pressure measurement devices have gained popularity in recent years as an alternative to radiotelemetry and other invasive blood pressure measurement techniques. While many factors must be considered when choosing a measurement method, specific variables should be evaluated when using a tail-cuff blood pressure technique. Rodents have complex and dynamic thermal biology processes that involve fluctuating vasomotor tone of the tail.

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Antithrombin resistance (ATR) is a newly identified strong genetic predisposition to venous thromboembolism (VTE) caused by genetic variations in prothrombin with substitutions of Arg at position 596 with either Leu, Gln, or Trp. In the present report, we identified a missense variant p.Arg596Gln in 3 patients from 2 families with unprovoked VTE who each experienced their first VTE event at 19, 67, and 19 years old.

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Background: Coronal alignment after total knee arthroplasty (TKA) would influence the implant survival. Coronal alignment could be measured on short and full-length X-rays. The goal of the current study was to assess the correlation of short and full-length X-rays to accurate prediction of the true Hip-Knee-Ankle alignment after TKA in the Iranian population.

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