157 research outputs found
Алгоритм оценки климато-экологических параметров окружающей среды Евразии
В работе представлен алгоритм климатической кластеризации. Алгоритм позволяет проводить выделения климатических кластеров в различных пространственно-временных масштабах, используя описание температурных сигналов. Характеристики фазы и амплитуды температурных сигналов впервые применены в качестве критериев выделения климатических кластеров. В результате применения алгоритма климатической кластеризации удалось исходное пространство температурных сигналов структурировать в определенное количество климатических кластеров.The paper presents an algorithm for climate clustering. The algorithm allows to allocate clusters of clusters at various space-time scales, using the description of temperature signals. The characteristics of the phase and amplitude of the temperature signals were first applied as criteria for the isolation of climatic clusters. As a result of the application of the climate clustering algorithm, the initial space of temperature signals was structured into a certain number of climatic clusters
Relaxin: Review of Biology and Potential Role in Treating Heart Failure
Relaxin is a naturally occurring human peptide initially identified as a reproductive hormone. More recently, relaxin has been shown to play a key role in the maternal hemodynamic and renal adjustments that accommodate pregnancy. An understanding of these physiologic effects has led to the evaluation of relaxin as a pharmacologic agent for the treatment of patients with acute heart failure. Preliminary results have been encouraging. In addition, the other known biologic properties of relaxin, including anti-inflammatory effects, extracellular matrix remodeling effects, and angiogenic and anti-ischemic effects, all may play a role in potential benefits of relaxin therapy. Ongoing, large-scale clinical testing will provide additional insights into the potential role of relaxin in the treatment of heart failure
INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes
Background
The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials.
Methods
In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow.
Discussion
The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers
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