We fabricated a carbon nanotube (CNT)/ polydimethylsiloxane (PDMS) composite-based dry ECG electrode that can be readily connected to conventional ECG devices, and showed its long-term wearable monitoring capability and robustness to motion and sweat. While the dispersion of CNTs in PDMS is challenging, we optimized the process to disperse untreated CNTs within PDMS by mechanical force only. The electrical and mechanical characteristics of the CNT/PDMS electrode were tested according to the concentration of CNTs and its thickness. The performances of ECG electrodes were evaluated by using 36 types of electrodes which were fabricated with different concentrations of CNTs, and with a differing diameter and thickness. The ECG signals were obtained by using electrodes of diverse sizes to observe the effects of motion and sweat, and the proposed electrode was shown to be robust to both factors. The CNT concentration and diameter of the electrodes were critical parameters in obtaining high-quality ECG signals. The electrode was shown to be biocompatible from the cytotoxicity test. A seven-day continuous wearability test showed that the quality of the ECG signal did not degrade over time, and skin reactions such as itching or erythema were not observed. This electrode could be used for the long-term measurement of other electrical biosignals for ubiquitous health monitoring including EMG, EEG, and ERG.
Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems’ structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based—the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian–the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European–the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK—the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-014-0194-3) contains supplementary material, which is available to authorized users.
In a murine 3LL model, there were no significant differences in tumour growth rate between untreated and simvastatin-treated mice groups. Therefore, while simvastatin had an anti-proliferative effect, it also exhibited immune tolerance-promoting properties during tumour development. Thus, due to these opposing actions, simvastatin had no net effect on tumour growth.
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