Publications by authors named "Gault N"

Bell's palsy (BP) is reported as the most common cause of facial paralysis, yet literature lacks a standardized definition of BP. To identify and categorize how the term "Bell's palsy" is defined and applied in published medical literature. Randomized controlled trials, clinical trials, systematic reviews, meta-analyses, and reviews containing "Bell's palsy" were identified in MEDLINE, Embase, and CENTRAL databases from inception until April 2, 2024.

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In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres.

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Background: There is a lack of studies exploring factors influencing synkinesis severity. This study aims to identify factors that may contribute to variations in severity of facial synkinesis.

Methods: Patients with a diagnosis of facial synkinesis presenting between 2009 and 2024 were reviewed.

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Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023.

Methods: We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making.

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Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology.

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Article Synopsis
  • The study analyzes the use of the French National Health Data System (SNDS), which provides healthcare data for nearly the entire population of France, focusing on the trends in pharmacoepidemiological research based on this data.
  • A systematic review of articles from 2012 to 2018 revealed an upward trend in published studies, with the majority focusing on drug utilization, safety, and effectiveness, and a notable concentration on medications for the nervous and cardiovascular systems.
  • The findings suggest that while the SNDS is increasingly valuable for drug safety research, there is a need for more studies involving specific populations such as children, pregnant women, and the elderly, who are usually not represented in clinical trials.
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Background: Alongside the recent worldwide expansion of hypervirulent Klebsiella pneumoniae (KP) infections, the available literature regarding cases of community acquired pneumonias (KP-CAP) remains scarce but reports a strikingly high and early mortality. We performed a retrospective multicenter study (7 ICU in France) between 2015 and 2019, comparing prognosis and severity of KP-CAP versus Streptococcus pneumoniae - CAP (SP-CAP).

Methods: For each KP-CAP, three SP-CAP admitted in ICUs within the same center and within the same 6-month window were selected.

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Background: The treatment of postparetic facial synkinesis is based on a combination of nonsurgical and surgical strategies. Improvements toward the restoration of a natural smile have been obtained with selective neurectomies and depressor anguli oris myectomy, but the lower lip frequently remains asymmetric and cranially displaced. The aim of this study was to evaluate the effect of the mentalis muscle on the position and symmetry of the lower lip in patients with synkinesis and to assess the added benefit of neurectomies of nerves innervating the mentalis muscle in improving the lower lip configuration and mandibular teeth show.

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Background: In postparetic synkinesis, muscle tone imbalance between upper and lower lip depressors and elevators results in the inability to produce an effective smile. Surgical treatments to improve smile focus on restoring tonicity balance between perioral muscles by weakening hypertoned muscles through selective myectomies or selective neurectomies. The goal of this study was to compare objective outcomes between selective myectomies alone with those of selective myectomies combined with selective neurectomies.

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Background: Human multilineage-differentiating stress enduring (Muse) cells are nontumorigenic endogenous pluripotent-like stem cells that can be easily obtained from various adult or fetal tissues. Regenerative effects of Muse cells have been shown in some disease models. Muse cells specifically home in damaged tissues where they exert pleiotropic effects.

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  • Researchers studied 1,227 COVID-19 survivors to see if taking corticosteroids affected their health after leaving the hospital.
  • They found that people who took corticosteroids had more health issues later compared to those who didn't, especially those on lower doses.
  • The study suggests that using corticosteroids while in the hospital might lead to more problems later on for some patients.
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  • A study aimed to identify undiagnosed patients with type 2 diabetes who also have nonalcoholic steatohepatitis (NASH) or advanced fibrosis (AF), highlighting the importance of early intervention.* -
  • The research involved screening 713 diabetic outpatients for liver disease, leading to 360 liver biopsies, which revealed high prevalence rates of NASH (58%) and AF (38%).* -
  • The study concluded that using readily available data effectively predicts liver complications in type 2 diabetes patients, emphasizing the need for further liver assessments.*
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BACKGROUND: In patients with noncirrhotic chronic portal vein thrombosis (PVT), the benefit of long-term anticoagulation is unknown. We assessed the effects of rivaroxaban on the risk of venous thromboembolism and portal hypertension-related bleeding in such patients. METHODS: In this multicenter, controlled trial, we randomly assigned patients with noncirrhotic chronic PVT without major risk factors for thrombosis to receive either rivaroxaban 15 mg/day or no anticoagulation.

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Background: Patient-important outcomes (PIOs) have emerged in respiratory medicine, in order to place the patient at the center of research. Mortality is a debated PIO in lung transplantation (LTx). The use of PIO in this specific setting has never been studied.

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  • Crohn's disease (CD) affects around 20% of patients with complications such as perianal fistulas, where achieving permanent closure remains difficult for doctors.
  • This study aimed to explore how serum adalimumab (ADA) levels relate to the clinical remission of fistulas associated with CD.
  • Results showed that higher serum ADA concentrations were linked to successful clinical remission, with 44% of patients achieving it, but no significant difference was found in ADA levels between those with and without healed fistulas.
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A total of 2%-10% of patients with vascular liver disease (VLD) have paroxysmal nocturnal hemoglobinuria (PNH). Eculizumab reduces complement-mediated haemolytic activity in PNH. This study was aimed at assessing the impact of eculizumab on VLD outcome.

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Unlabelled: Analysis of off-label prescriptions of medicines in hospital in adult patients and study of feasibility of their detection by use of international disease classification, 10th version (IDC-10 codes).

Context: In order to improve the appropriate use of medicines, a method of detection of off label prescriptions, especially in hospitalised patients, should be available.

Study Objectives: Evaluate the performance of the detection of off-label prescriptions in hospitalised patients by use of IDC-10 codes.

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Postnatal and adult neurogenesis in the subventricular zone and subgranular zone of animals such as rodents and non-human primates has been observed with many different technical approaches. Since most techniques used in animals cannot be used in humans, the majority of human neurogenesis studies rely on postmortem immunohistochemistry. This technique is difficult in human tissue, due to poor and variable preservation of antigens and samples.

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Early diagnosis of acute mesenteric ischemia (AMI) remains a clinical challenge, and no biomarker has been consistently validated. We aimed to assess the accuracy of three promising circulating biomarkers for diagnosing AMI-citrulline, intestinal fatty acid-binding protein (I-FABP), and D-lactate. A cross-sectional diagnostic study enrolled AMI patients admitted to the intestinal stroke center and controls with acute abdominal pain of another origin.

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Objective: To describe the frequency of clinical signs and the accuracy of video diagnosis of sport-related concussion.

Design: An observational cross-sectional study.

Setting And Participants: Videos from a database of all suspected sport-related concussion in TOP14 matches (French professional male rugby Championship) were used, from 2012 to 2015 seasons.

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Iron deficiency with or without anemia, needing continuous iron supplementation, is very common in obese patients, particularly those requiring bariatric surgery. The aim of this study was to address the impact of weight loss on the rescue of iron balance in patients who underwent sleeve gastrectomy (SG), a procedure that preserves the duodenum, the main site of iron absorption. The cohort included 88 obese women; sampling of blood and duodenal biopsies of 35 patients were performed before and one year after SG.

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Article Synopsis
  • The study aimed to identify the incidence and risk factors for relapse of methicillin sensitive Staphylococcus aureus (MSSA) ventilator-associated pneumonia (VAP) in patients with trauma and non-traumatic brain injuries.
  • A total of 165 ICU patients developed MSSA-VAP, with 33% experiencing a relapse, which included treatment failure and other pathogen VAP.
  • Key predictors of relapse include the presence of Streptococcus species and oropharyngeal flora, Glasgow coma scale scores, need for emergency surgery, and acute respiratory distress syndrome.
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  • A recent study focused on predicting non-alcoholic liver disease in patients with type 2 diabetes using non-invasive blood tests for fibrosis, NASH, and steatosis.
  • The investigation involved 272 patients and assessed the performance of a new testing panel called Nash-FibroTest, which uses an Obuchowski measure for accuracy rather than traditional methods.
  • Results showed that the panel effectively diagnosed stages of fibrosis and grades of NASH and steatosis from a single blood sample, outperforming traditional assessment methods in some aspects.
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  • This study investigates the impact of chronic use of RAAS blockers on mortality rates in COVID-19 patients, focusing on a group of hypertensive individuals treated in a nationwide cohort.* -
  • Data from 1,160 hypertensive patients showed no significant difference in 30-day mortality between chronic RAAS blocker users and non-users, suggesting these medications do not worsen COVID-19 outcomes.* -
  • The findings challenge earlier claims about the risks associated with RAAS blockers during the pandemic, suggesting these medications can safely continue without fear of increased mortality.*
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