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Effect of Lemborexant on Daytime Functioning in Adults With Insomnia: Patient-Reported Outcomes From a Phase 3 Clinical Trial.
Prim Care Companion CNS Disord
January 2025
Eisai Inc, Nutley, New Jersey.
Insomnia and some insomnia treatments can impact an individual's daytime functioning. Here, we performed post hoc analyses of patient-reported outcomes from a phase 3 clinical trial to assess the impact of lemborexant (LEM), a dual orexin receptor antagonist, on daytime functioning. Adults with insomnia were randomized 1:1:1 to receive placebo, LEM 5 mg (LEM5) or LEM 10 mg (LEM10) for 6 months.
View Article and Find Full Text PDFGlutathione, Vitamin C, and Cysteine Use in Autistic Children With Disruptive Behavior: A Double-Blind, Placebo-Controlled Crossover Pilot Study.
J Dev Behav Pediatr
January 2025
Department of Pediatrics and Norton Children's Research Institute, School of Medicine, University of Louisville, Louisville, KY.
Objective: Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by social communication differences and restricted interests. One proposed biologic mechanism underlying ASD is oxidative stress, leading to the clinical use of glutathione based on anecdotal reports of improved behavior in autistic children. In this pilot study, we tested this observation using a randomized clinical trial format to collect preliminary data on glutathione safety and efficacy.
View Article and Find Full Text PDFEfficacy and safety of finerenone in patients with chronic kidney disease and type 2 diabetes by diuretic use: A FIDELITY analysis.
Eur J Heart Fail
January 2025
Department of Medicine, University of Chicago Medicine, Chicago, IL, USA.
Aims: This post hoc analysis aimed to assess the efficacy and safety of the non-steroidal mineralocorticoid receptor antagonist finerenone by baseline diuretic use in FIDELITY, a pre-specified pooled analysis of the phase III trials FIDELIO-DKD and FIGARO-DKD.
Methods And Results: Eligible patients with type 2 diabetes (T2D) and chronic kidney disease (CKD; urine albumin-to-creatinine ratio [UACR] ≥30-<300 mg/g and estimated glomerular filtration rate [eGFR] ≥25-≤90 ml/min/1.73 m, or UACR ≥300-≤5000 mg/g and eGFR ≥25 ml/min/1.
Treatment of rheumatoid arthritis-associated interstitial lung disease: An appraisal of the 2023 ACR/CHEST guideline.
Curr Treatm Opt Rheumatol
December 2024
Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA USA.
Purpose Of Review: To summarize the current treatment landscape of rheumatoid arthritis-associated interstitial lung disease (RA-ILD) in the context of the recent 2023 American College of Rheumatology/American College of Chest Physicians guideline for ILD treatment in systemic autoimmune rheumatic diseases.
Recent Findings: The guideline conditionally recommends mycophenolate, azathioprine, and rituximab for first-line RA-ILD therapy, with cyclophosphamide and short-term glucocorticoids as additional options. For RA-ILD progression after first line, mycophenolate, rituximab, nintedanib, tocilizumab, cyclophosphamide, and pirfenidone are conditionally recommended, while long-term glucocorticoids are conditionally recommended against.
Efficacy and safety of a proprietary extract in skin health - a randomized, placebo-controlled clinical study in healthy volunteers.
Am J Transl Res
December 2024
Trial Guna Private Limited 476, JP Nagar, Bangalore 560083, India.
Objectives: The concept of beauty from within is a growing trend in the market and people now look for oral supplements that can enhance the well-being of skin from within. Within this principle, a proprietary pomegranate extract (Grantria), standardized to ellagic acid, punicic acid and punicalagin, was developed using ADOP (Advanced Oil-Powder) technology and was clinically evaluated for its efficacy and safety in healthy adults.
Methods: This evaluation was carried out as a randomized, placebo-controlled clinical study for 60 days at a daily dose of 300 mg.
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