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TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.
Trials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
Selective Undercut of Undoped Optical Membranes for Spin-Active Color Centers in 4H- Silicon Carbide.
ACS Nano
January 2025
John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts 02138, United States.
Silicon carbide (SiC) is a semiconductor used in quantum information processing, microelectromechanical systems, photonics, power electronics, and harsh environment sensors. However, its high-temperature stability, high breakdown voltage, wide bandgap, and high mechanical strength are accompanied by a chemical inertness, which makes complex micromachining difficult. Photoelectrochemical (PEC) etching is a simple, rapid means of wet processing SiC, including the use of dopant-selective etch stops that take advantage of the mature SiC homoepitaxy.
View Article and Find Full Text PDFAndexanet alfa: trials just leave us with more questions.
Res Pract Thromb Haemost
January 2025
Department of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanet alfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4).
View Article and Find Full Text PDFCollection of optimizations for untargeted metabolomics analysis of Leishmania promastigotes using gas chromatography-mass spectrometry.
Talanta
January 2025
Center for Multiplatform Metabolomics Studies (CEMM) at the Institute of Chemistry, University of Sao Paulo, Sao Paulo, SP, 05508-000, Brazil. Electronic address:
There is no consensus in the literature regarding the ideal protocol for obtaining and preparing cell samples for untargeted metabolomics. Nevertheless, the procedures must be carefully evaluated for proper and reliable results for each organism under study. This work proposes a novel protocol for determining intracellular metabolites in Leishmania promastigotes and is fully optimized for application in conjunction with gas chromatography-mass spectrometry platforms.
View Article and Find Full Text PDFA 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.
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