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A randomized, placebo-controlled, cross-over trial of ketamine in Rett syndrome.
J Neurodev Disord
January 2025
Rett Syndrome Research Trust, Trumbull, CT, USA.
Background: Preclinical studies and anecdotal case reports support the potential therapeutic benefit of low-dose oral ketamine as a treatment of clinical symptoms in Rett syndrome (RTT); however, no controlled studies have been conducted in RTT to evaluate safety, tolerability and efficacy.
Design: This was a sequentially initiated, dose-escalating cohort, placebo-controlled, double blind, randomized sequence, cross-over study of oral ketamine in 6-12-year-old girls with RTT to evaluate short-term safety and tolerability and explore efficacy.
Methods: Participants were randomized to either five days treatment with oral ketamine or matched placebo, followed by a nine-day wash-out period and then crossed-over to the opposite treatment.
Targeting Kv7 Potassium Channels for Epilepsy.
CNS Drugs
January 2025
Division of Pharmacology, Department of Neuroscience, University of Naples "Federico II", Naples, Italy.
Voltage-gated Kv7 potassium channels, particularly Kv7.2 and Kv.7.
View Article and Find Full Text PDFA Prospective, Open-Label, Randomized, Comparative, Investigator-Initiated Study to Evaluate the Safety and Effectiveness of Autologous Growth Factor Concentrate Using the Healrex Therapy Kit With Standard Wound Care in Lower-Extremity Diabetic Ulcer.
Cureus
December 2024
Business Development Hospitals, Wockhardt Hospitals Ltd., Mumbai, IND.
Background and objectives The persistent nature of diabetic foot ulcers (DFUs) is mainly attributable to compromised wound healing mechanisms, which are aggravated due to poor blood flow, neuropathy, and infection. Growth factors have become essential agents in the treatment of DFUs, serving as primary mediators that enhance wound healing through the stimulation of cell proliferation, migration, and angiogenesis. This prospective open-label, randomised, comparative, multi-centre, investigator-initiated study compared the safety and effectiveness of adjuvant therapy with topical application of autologous growth factor concentrate (AGFC) using the Healrex therapy kit (Wockhardt, India) versus standard of care (SoC) in DFUs.
View Article and Find Full Text PDFAlterations in the uterine echotexture, hemodynamics, and histological findings in relation to metabolomic profiles in goats with different ovarian activities (active versus inactive ovaries).
Vet Res Commun
January 2025
Laboratory of Veterinary Physiology, Department of Veterinary Medicine, Faculty of Agriculture, Tokyo University of Agriculture and Technology, 3-5-8 Saiwai-Cho, 183-8509, Fuchu, Tokyo, Japan.
This study investigated, for the first time, the alterations in the uterine echotexture and blood flow in cyclic and acyclic (inactive ovary) goats using ultrasonography. The study aimed also to evaluate the metabolomic changes in the plasma of cyclic and acyclic goats. Furthermore, the histopathological approach was applied to the specimens of the uterus to validate the findings of this study.
View Article and Find Full Text PDFTAK-994 Mechanistic Investigation into Drug-Induced Liver Injury.
Toxicol Sci
January 2025
Takeda Development Center Americas, Inc, Cambridge, MA, USA.
The frequency of drug-induced liver injury (DILI) in clinical trials remains a challenge for drug developers despite advances in human hepatotoxicity models and improvements in reducing liver-related attrition in preclinical species. TAK-994, an oral orexin receptor 2 agonist, was withdrawn from phase II clinical trials due to the appearance of severe DILI. Here, we investigate the likely mechanism of TAK-994 DILI in hepatic cell culture systems examined cytotoxicity, mitochondrial toxicity, impact on drug transporter proteins, and covalent binding.
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