1,443 results match your criteria: "Global Clinical[Affiliation]"

Article Synopsis
  • The text discusses the transition from high global warming potential propellants in metered-dose inhalers (MDIs) to those with lower environmental impact, specifically investigating a new formulation of BDP/FF/GB using HFA-152a instead of HFA-134a.
  • Three studies were conducted to compare the pharmacokinetics of the new formulation, focusing on metrics like lung availability and systemic exposure in healthy volunteers, using a crossover design.
  • Results showed that bioequivalence was achieved for systemic exposure of the active ingredients in most cases, but not for one measurement of glycopyrronium bromide, indicating some variability in absorption.
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This article has been removed: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/policies/article-withdrawal).

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This paper seeks to outline the history, market situation, clinical management and product performance related to the correction of presbyopia with both contact lenses and spectacles. The history of the development of various optical forms of presbyopic correction are reviewed, and an overview is presented of the current market status of contact lenses and spectacles. Clinical considerations in the fitting and aftercare of presbyopic contact lens and spectacle lens wearers are presented, with general recommendations for best practice.

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Aims: Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator that lowers serum triglyceride levels and increases high-density lipoprotein cholesterol levels, is approved for treating dyslipidemia as twice-daily immediate-release (IR) tablets. A once-daily extended-release (XR) tablet has also been developed. We aimed to confirm the non-inferiority of XR (0.

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Early identification of high-risk metabolic dysfunction-associated steatohepatitis (MASH) can offer patients access to novel therapeutic options and potentially decrease the risk of progression to cirrhosis. This study aimed to develop an explainable machine learning model for high-risk MASH prediction and compare its performance with well-established biomarkers. Data were derived from the National Health and Nutrition Examination Surveys (NHANES) 2017-March 2020, which included a total of 5281 adults with valid elastography measurements.

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Congenital esophageal stenosis (CES) is an uncommon condition that poses diagnostic and therapeutic challenges due to its rarity and clinical presentation similar to other esophageal disorders. Symptoms typically start with dysphagia around the introduction of solid foods. A broad range of potential differential diagnoses contributes to a delay in obtaining a definitive diagnosis and administering the proper treatment.

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Purpose: To evaluate clinical outcomes after bilateral or contralateral implantation of the Gemetric™ (G) and Gemetric™ Plus (GPlus) diffractive trifocal intraocular lenses (IOLs).

Methods: This was a prospective, randomized, multi-center open-label study comparing clinical results and subjective patient responses around 6 months after implantation of the study lenses (toric and non-toric) in three different groups (bilateral G, bilateral GPlus and contralateral G/GPlus implantation). Results included the manifest refraction, uncorrected and distance corrected monocular and binocular visual acuity (VA) at distance, intermediate and near; the defocus curve; contrast sensitivity; and patient reported outcomes regarding spectacle independence, satisfaction and visual disturbances.

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Ketamine has been repeatedly demonstrated to be an effective treatment in the management of patients with treatment-resistant depression (TRD). An important question is whether it is equally or more effective than the current gold standard of electroconvulsive therapy (ECT), as the adverse effects of ECT can lead to memory loss and neurocognitive deficits. A literature search was conducted for trials that directly compared the efficacy and adverse effects of ketamine and ECT via PubMed and Google Scholar.

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Background: Tepotinib, a MET inhibitor approved for the treatment of MET exon 14 (METex14) skipping NSCLC, demonstrated durable clinical activity in VISION (Cohort A + C; N = 313): objective response rate (ORR) 51.4% (95% CI: 45.8, 57.

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Background: We assessed the relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccine (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD) in preventing respiratory or cardiovascular hospitalizations in older adults.

Methods: FinFluHD was a phase 3b/4 modified double-blind, randomized pragmatic trial. Enrolment of 121,000 adults ≥65 years was planned over three influenza seasons (October to December 2019-2021).

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Background: In REFLEX, subcutaneous interferon beta-1a (sc IFN β-1a) delayed the onset of multiple sclerosis (MS) in patients with a first clinical demyelinating event (FCDE).

Objectives: This analysis aimed to determine whether baseline serum neurofilament light (sNfL) chain can predict conversion to MS and whether correlations exist between baseline sNfL and magnetic resonance imaging (MRI) metrics.

Methods: sNfL was measured for 494 patients who received sc IFN β-1a 44 μg once weekly (qw;  = 168), three times weekly (tiw;  = 161), or placebo ( = 165) over 24 months.

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Background And Aims: This study considers the cost-effectiveness of commonly used cellular, acellular, and matrix‑like products (CAMPs) of human origin also known as human cell and tissue products (HCT/Ps) in the management of diabetic foot ulcers.

Methods: We developed a 1-year economic model assessing six CAMPs [cryopreserved placental membrane with viable cells (vCPM), bioengineered bilayered living cellular construct (BLCC), human fibroblast dermal substitute (hFDS), dehydrated human amnion chorion membrane (dHACM), hypothermically stored amniotic membrane (HSAM) and human amnion membrane allograft (HAMA) which had randomized controlled trial evidence compared with standard of care (SoC). CAMPs were compared indirectly and ranked in order of cost-effectiveness using SoC as the baseline, from a CMS/Medicare's perspective.

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Article Synopsis
  • Decentralized clinical trials (DCTs) emerged during the COVID-19 pandemic, highlighting differing perspectives between clinical trial sites and sponsors in South Korea regarding their implementation and challenges.
  • Both groups reported difficulties during the pandemic, with trial site personnel often relying on their own solutions, while sponsors emphasized the importance of collaboration with sites.
  • Effective communication and cooperation between sponsors and sites are essential for overcoming challenges, and government support is needed to facilitate the successful adoption of DCTs through regulatory changes.*
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There is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs.

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Formulation development of a stable influenza recombinant neuraminidase vaccine candidate.

Hum Vaccin Immunother

December 2024

Sanofi Global Vaccine Drug Product Development, Toronto, ON, Canada.

Current influenza vaccines could be augmented by including recombinant neuraminidase (rNA) protein antigen to broaden protective immunity and improve efficacy. Toward this goal, we investigated formulation conditions to optimize rNA physicochemical stability. When rNA in sodium phosphate saline buffer (NaPBS) was frozen and thawed (F/T), the tetrameric structure transitioned from a "closed" to an "open" conformation, negatively impacting functional activity.

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Background: A next-generation Vero cell rabies vaccine (PVRV-NG2) was developed using the same Pitman-Moore strain as in the licensed purified Vero cell vaccine (PVRV; Verorab) and the human diploid cell vaccine (HDCV; Imovax Rabies®).

Methods: This dual-center, modified, double-blind, phase 3 study evaluated the immunogenic non-inferiority and safety of PVRV-NG2 with and without concomitant intramuscular human rabies immunoglobulin (HRIG) versus PVRV + HRIG and HDCV + HRIG in a simulated post-exposure prophylaxis (PEP) regimen. Healthy adults ≥18 years old (N = 640) were randomized 3:1:1:1 to PVRV-NG2 + HRIG, PVRV + HRIG, HDCV + HRIG, or PVRV-NG2 alone (administered as single vaccine injections on days [D] 0, D3, D7, D14, and 28, with HRIG on D0 in applicable groups).

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Introduction And Significance: Portal vein thrombosis (PVT) is not commonly observed in patients, particularly those who have gone through neonatal intensive care unit (NICU) stays and had umbilical catheters. Although PVT can potentially cause hypertension and gastrointestinal bleeding it is highly unusual for this condition to manifest during childhood.

Case Presentation: The authors present a case of a 10-year-old child who developed portal hypertension, esophageal varices, and multiple thrombophilia associated mutations.

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Two-year treatment persistence with subcutaneous abatacept in rheumatoid arthritis: results from the French cohort of the ASCORE study.

Clin Exp Rheumatol

July 2024

Rheumatology Department, Hôpital Bicêtre, Assistance Publique, Hôpitaux de Paris, Université Paris-Saclay, INSERM UMR1184, Le Kremlin‑Bicêtre, France.

Objectives: While multiple studies have investigated treatment persistence rates with intravenous abatacept, limited information is available about real-world treatment continuation with the subcutaneous form. The international ASCORE study described the characteristics and treatment persistence of real-world patients with rheumatoid arthritis (RA) receiving subcutaneous abatacept. This article presents the findings of the French cohort.

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Exposure to traumatic stress is common among children. Post-traumatic stress disorder (PTSD) is a debilitating chronic mental disorder that can develop following exposure to a traumatic event. Psychopharmacological research in pediatric PTSD is limited.

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Tepotinib is a highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated robust and durable clinical activity in patients with MET exon 14 (METex14) skipping non-small-cell lung cancer (NSCLC). In the Phase II VISION study, patients received oral tepotinib 500 mg once daily. The primary endpoint was an objective response by an independent review committee (IRC) according to RECIST v1.

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Introduction: Receptor-interacting protein kinase 1 (RIPK1), a key mediator of inflammation through necroptosis and proinflammatory cytokine production, may play a role in the pathogenesis of immune-mediated inflammatory diseases such as chronic plaque psoriasis. An experimental medicine study of RIPK1 inhibition with GSK2982772 immediate-release formulation at doses up to 60 mg three times daily in mild to moderate plaque psoriasis indicated that efficacy may be improved with higher trough concentrations of GSK2982772.

Methods: This multicenter, randomized, double-blind, placebo-controlled, repeat-dose study (NCT04316585) assessed the efficacy, safety, pharmacokinetics, and pharmacodynamics of 960 mg GSK2982772 (once-daily modified-release formulation) in patients with moderate to severe plaque psoriasis.

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Article Synopsis
  • - The study compares the ability of MRI and radiographs to detect erosions in the sacroiliac joint (SIJ) for patients with recent-onset axial spondyloarthritis (axSpA) over a 104-week period, with a focus on the effects of the treatment etanercept. - Results showed that MRI detected more erosions than radiographs at baseline and in changes over time, with a significant number of patients demonstrating improved erosion scores on MRI compared to radiographs after treatment. - The research highlights that MRI may be superior in monitoring SIJ erosions in axSpA, suggesting that further investigation into the clinical significance of these findings is needed.
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Article Synopsis
  • This study investigates the effectiveness of tepotinib, a MET inhibitor, in treating hepatocellular carcinoma (HCC) with gene amplification (amp), specifically in patients showing high levels of amp (≥10). * -
  • Preclinical tests on patient-derived tumor models showed tepotinib caused nearly complete tumor regression in cases with high-level amp, while clinical trials indicated that 11 out of 15 patients with amp experienced disease control. * -
  • The findings suggest that high-level amp might drive cancer growth in HCC and that tepotinib could be an effective treatment option for these patients. *
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The Bioavailability of CHF6563, an Ethanol-Free, Sublingual Neonatal Buprenorphine Formulation: A Bridging Study Conducted in Adults.

J Pediatr Pharmacol Ther

February 2024

Global Clinical Development (IB, MB, DS) and at the time of submission MC, Chiesi Farmaceutici, Parma, Italy. MC is currently with NMS, Global Clinical Development, Nerviano Medical Sciences S.r.L., Nerviano, Italy.

Objective: Sublingual buprenorphine has demonstrated efficacy for treatment of the neonatal opioid withdrawal syndrome (NOWS), but the current formulation used in clinical practice contains 30% ethanol. Ethanol as a pharmacologically active excipient ideally should be removed from neonatal formulations. The objective of this study was to determine the relative bioavailability of a novel ethanol-free -formulation (CHF6563) compared with the commonly used ethanolic solution in a phase I, open-label, 2-period, -single-dose, crossover study in healthy adults.

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