Fluctuations of Dry and Total Mass of Cells Exposed to Different Molecular Weights of Polyethylene Glycol

Polyethylene glycol (PEG) is used in many applications, and in the clinical field, it is one of the main components of the latest Covid vaccines. Its wide use is justified by a relatively safe profile and few known side effects. However, little is known about the biophysical effects of PEG on cells such as, cell stiffness, dry mass, and total mass. Herein, exploiting a digital holographic microscope, an inertial picobalance, and a nanoindenter, these properties are characterized in rat embryonic fibroblast exposed to different molecular weights of PEG. Immediately after the first minutes of PEG exposure to the cells, a reduction in cell dry mass can be observed as well as a rapid fluctuation in total cell weight. Cell stiffness decreases significantly after 48 h, while no important morphological changes are observed. Here, it is revealed how dry mass and total mass are rapidly and finely regulated, highlighting how the maintenance of cell density is of primary importance in cellular activities.

Ensuring the Continuity of Data Collection in a Focal Epilepsy Clinical Trial During the COVID-19 Pandemic

Objective: To ensure continuity of quality data collection by implementation of novel data capture measures whilst conducting an epilepsy clinical trial in the COVID-19 pandemic. Background: The COVID-19 Pandemic introduced unprecedented complexities in conducting clinical trial assessments at required timepoints via traditional participant visits to clinical sites. Implementation of novel approaches mid-stream to maintain continuity of care for trial participants and satisfy the objectives of the protocol were required. In an ongoing Ph 2 trial in patients with focal epilepsy , mitigations to allow remote collection of data were implemented due to restrictions related to COVID-19. Design/Methods: Based on trial objectives and key data collection timepoints, a protocol assessment determined which visits could be performed remotely. Specific methodology was applied to determine which assessments could be captured remotely via traditional telemedicine. Vendors were evaluated to support remote capture of datapoints not captured via telemedicine, and modifications were subsequently made to the protocol, informed consent form, and trial database. Relevant materials were submitted for IRB, regulatory authority, and ethics committee approval. Results: After IRB, regulatory authority and ethics committee approvals were received, modifications to data collection due to interference related to the COVID-19 pandemic included the introduction of home health care providers to collect lab draws and vital signs at participants' homes, Direct to Patient shipment of study drug, remote ECG collection, and allowance for scales to be conducted via telemedicine. Trial participants are consented to the use of these forms of data collection at their screening visit, and mitigations were successfully implemented across trial sites. Conclusions: To ensure continuity of trial participant care, quality data collection, and the prevention of lost trial data due to COVID-19 complications, modifications to allow remote capture of data were successfully implemented in an ongoing Ph 2 trial in patients with focal epilepsy. 1.