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Virtualized Clinical Studies to Assess the Natural History and Impact of Gut Microbiome Modulation in Non-Hospitalized Patients with Mild to Moderate COVID-19 a Randomized, Open-Label, Prospective Study with a Parallel Group Study Evaluating the Physiologic Effects of KB109 on Gut Microbiota Structure and Function: A Structured Summary of a Study Protocol for a Randomized Controlled Study

Abstract Objectives These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COVID-19). KB109 is a novel synthetic glycan that was formulated to modulate the gut microbiome composition and metabolic output in order to increase beneficial short-chain fatty acid (SCFA) production in the gut. The K031 study is designed to evaluate the safety of KB109 and characterize its impact on the natural progression of COVID-19 in patients with mild to moderate disease. The K032 study is evaluating the effect of KB109 on the gut microbiota structure and function in this same patient population. Additionally, both studies are evaluating measures of health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity in patients who received SSC alone or with KB109. Noteworthy aspects of these outpatient studies include study design measures aimed at limiting in-person interactions to minimize the risk of infection spread, such as use of online diaries, telemedicine, and at-home sample collection.

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Thermal modelling of the multi-stage heating system with variable boundary conditions in the wafer based precision glass moulding process

In the precision glass moulding process, the heat transfer and the resulting transient temperature distributions of the molten glass are of great importance because they significantly affect the productivity as well as the thermally induced residual stresses in the final product. Thermal modelling of the heating system in the glass moulding process considering detailed heating mechanisms therefore plays an important part in optimizing the heating system and the subsequent pressing stage in the lens manufacturing process.The current paper deals with three-dimensional transient thermal modelling of the multi-stage heating system in a wafer based glass moulding process. In order to investigate the importance of the radiation from the interior and surface of the glass, a simple finite volume code is developed to model one dimensional radiation–conduction heat transfer in the glass wafer for an extreme case with very high temperature difference considering temperature dependant thermal conductivity and heat capacity. Afterwards, by using three-dimensional FEM modelling along with a predefined experimental test, the equivalent glass–mould interface contact resistance is determined for two different pressures. Finally, the three-dimensional modelling of the multi-stage heating system in the wafer based glass moulding process is simulated with the FEM software ABAQUS for a particular industrial application for mobile phone camera lenses to obtain the temperature distribution in the glass wafer. In the numerical modelling, the interface boundary conditions for each heating stage are changed according to the determining heat transfer mechanism(s). Numerical results are compared with experimental data to show the validity of the numerical modelling. The obtained results show that the right thermal modelling is highly dependent on the proper choice of thermal boundary conditions in different stages according to the real physical phenomena behind the process.

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