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Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial
Background
Proton-pump inhibitors (PPI) are liberally prescribed in patients with liver cirrhosis. Observational studies link PPI therapy in cirrhotic patients with an increased risk for infectious complications, hepatic encephalopathy and an increased risk for hospitalization and mortality. However, patients with liver cirrhosis are also considered to be at risk for peptic ulcer bleeding. The STOPPIT trial evaluates if discontinuation of a pre-existing PPI treatment delays a composite endpoint of re-hospitalization and/or death in patients (recently) hospitalized with liver cirrhosis compared to patients on continued PPI medication.
Methods
The STOPPIT-trial is a prospective, multicentre, randomized, double-blinded, placebo-controlled, parallel-group trial. In total, 476 patients with complicated liver cirrhosis who already receive long-term PPI therapy without evidence-based indication are 1:1 randomized to receive either esomeprazole 20 mg (control group) or placebo (intervention group) for 360 days. Patients with an indication for PPI therapy (such as a recent diagnosis of peptic ulcers, severe reflux esophagitis, severe hemorrhagic gastritis, recent endoscopic therapy for oesophageal varices) are excluded. The primary composite endpoint is the time-to re-hospitalization and/or death. Secondary endpoints include rates of re-hospitalization, mortality, occurrence of infections, hepatic decompensation and acute-on-chronic liver failure. The safety endpoint is defined as manifestation of an evidence-based indication for PPI re-therapy. The impact of PPI continuation or discontinuation on the intestinal microbiota will be studied. The recruitment will take place at 18 study sites throughout Germany. Recruitment has started in April 2021.
Discussion
The STOPPIT trial is the first clinical trial to study the effects of PPI withdrawal on relevant outcome variables in patients with complicated liver cirrhosis. If the hypothesis that PPI withdrawal improves clinical outcomes of cirrhosis patients is confirmed, this would argue for a strong restriction of the currently liberal prescription practice of PPIs in this population. If, on the other hand, the trial demonstrates an increased risk of gastrointestinal bleeding events in patients after PPI withdrawal, this could create a rationale for a more liberal, prophylactic PPI treatment in patients with liver cirrhosis.
Trial registration
EU clinical trials register EudraCT 2019-005008-16 (registered December 27, 2019).
ClinicalTrials.gov
NCT04448028 (registered June 25, 2020). German Clinical Trials Register DRKS00021290 (registered March 10, 2021).
Journal Article
Cats : photographs 1942-2018
A career-spanning retrospective of the 20th century's greatest cat photographer, Walter Chandoha.
Book
SAFEE: A Debriefing Tool to Identify Latent Conditions in Simulation-based Hospital Design Testing
In the process of hospital planning and design, the ability to mitigate risk is imperative and practical as design decisions made early can lead to unintended downstream effects that may lead to patient harm. Simulation has been applied as a strategy to identify system gaps and safety threats with the goal to mitigate risk and improve patient outcomes. Early in the pre-construction phase of design development for a new free-standing children’s hospital, Simulation-based Hospital Design Testing (SbHDT) was conducted in a full-scale mock-up. This allowed healthcare teams and architects to actively witness care providing an avenue to study the interaction of humans with their environment, enabling effectively identification of latent conditions that may lay dormant in proposed design features. In order to successfully identify latent conditions in the physical environment and understand the impact of those latent conditions, a specific debriefing framework focused on the built environment was developed and implemented. This article provides a rationale for an approach to debriefing that specifically focuses on the built environment and describes SAFEE, a debriefing guide for simulationists looking to conduct SbHDT.
Journal Article
Uncharted : Lewis and Clark in Arcane America
\"High adventure on the frontier of muskets and magic!\"--Jacket.
Book
Early-stage Alzheimer disease: getting trial-ready
Slowing the progression of Alzheimer disease (AD) might be the greatest unmet medical need of our time. Although one AD therapeutic has received a controversial accelerated approval from the FDA, more effective and accessible therapies are urgently needed. Consensus is growing that for meaningful disease modification in AD, therapeutic intervention must be initiated at very early (preclinical or prodromal) stages of the disease. Although the methods for such early-stage clinical trials have been developed, identification and recruitment of the required asymptomatic or minimally symptomatic study participants takes many years and requires substantial funds. As an example, in the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease Trial (the first phase III trial to be performed in preclinical AD), 3.5 years and more than 5,900 screens were required to recruit and randomize 1,169 participants. A new clinical trials infrastructure is required to increase the efficiency of recruitment and accelerate therapeutic progress. Collaborations in North America, Europe and Asia are now addressing this need by establishing trial-ready cohorts of individuals with preclinical and prodromal AD. These collaborations are employing innovative methods to engage the target population, assess risk of brain amyloid accumulation, select participants for biomarker studies and determine eligibility for trials. In the future, these programmes could provide effective tools for pursuing the primary prevention of AD. Here, we review the lessons learned from the AD trial-ready cohorts that have been established to date, with the aim of informing ongoing and future efforts towards efficient, cost-effective trial recruitment.Consensus is growing that intervention in the very early stages of Alzheimer disease is necessary for disease modification. Here, the authors discuss the challenges of recruiting asymptomatic or mildly symptomatic participants for clinical trials, focusing on ‘trial-ready’ cohorts as a potential solution.
Journal Article
Bullet to the head : revenge never gets old
Jimmy Bobo, a New Orleans hit man and Detective Taylor Kwon, a New York City cop, form an alliance to brings down the killers of their respective partners.
DVD
QuickNAT: A fully convolutional network for quick and accurate segmentation of neuroanatomy
Whole brain segmentation from structural magnetic resonance imaging (MRI) is a prerequisite for most morphological analyses, but is computationally intense and can therefore delay the availability of image markers after scan acquisition. We introduce QuickNAT, a fully convolutional, densely connected neural network that segments a MRI brain scan in 20 s. To enable training of the complex network with millions of learnable parameters using limited annotated data, we propose to first pre-train on auxiliary labels created from existing segmentation software. Subsequently, the pre-trained model is fine-tuned on manual labels to rectify errors in auxiliary labels. With this learning strategy, we are able to use large neuroimaging repositories without manual annotations for training. In an extensive set of evaluations on eight datasets that cover a wide age range, pathology, and different scanners, we demonstrate that QuickNAT achieves superior segmentation accuracy and reliability in comparison to state-of-the-art methods, while being orders of magnitude faster. The speed up facilitates processing of large data repositories and supports translation of imaging biomarkers by making them available within seconds for fast clinical decision making.
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•Introduces a deep learning based whole brain segmentation tool called QuickNAT, processing each 3D MRI T1 brain scans in 20 secs.•The high segmentation accuracy of QuickNAT was evaluated on 5 different benchmark datasets, containing a wide age range, subjects with different pathologies (AD, MCI and CN), and different scanners (1.5T and 3.0T).•QuickNAT can be effectively used for longitudinal studies as it performs well in test-retest and multi-center experiments.
Journal Article