Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

Mitochondrial protective potential of fucoxanthin in brain disorders.

Mitochondrial dysfunction is a common feature of brain disorders. Mitochondria play a central role in oxidative phosphorylation; thus changes in energy metabolism in the brain have been reported in conditions such as Alzheimer's disease, Parkinson's disease, and stroke. In addition, mitochondria regulate cellular responses associated with neuronal damage such as the production of reactive oxygen species (ROS), opening of the mitochondrial permeability transition pore (mPTP), and apoptosis.

Objective outcome prediction in depression through functional MRI brain network dynamics.

Research Purpose: Subjective clinical decision-making in major depressive disorder (MDD) may result in low treatment effectiveness. This study aims to identify objective predictors of MDD outcome using resting-state functional MRI scans, acquired from 25 MDD patients at baseline. Over a year, patients were assessed every 3 months, labeled as positive or negative outcome (change in depression severity).