An Integrated Mobile Platform for Automated Data Collection and Real-Time Patient Monitoring in Diabetes Clinical Trials

We present a new mobile platform to be used in clinical trials aimed at both collecting data and assessing new technologies and treatments for diabetes care. The main components of the platform are a mobile app, that automatically collects data from continuous glucose monitoring sensors and activity trackers, and also allows users to manually log daily events; a cloud database for safe data storage; a web interface, which allows clinicians to monitor patients’ status in real-time. The platform is modular and highly customizable for a multitude of purposes in clinical research. Preliminary tests performed for daily-life data gathering by both clinicians and users are extremely encouraging.     

Cost-effectiveness analysis of two vacuum-assisted breast biopsy systems: Mammotome and Vacora

Purpose

This study was undertaken to compare the cost effectiveness of two vacuum-assisted breast biopsy devices, the Mammotome and Vacora systems.

Materials and methods

Between January and June 2006, 238 vacuum-assisted breast biopsies were performed at our radiology department. Five out of 238 lesions were excluded because of inadequate sampling. The Mammotome system was used in 108/233 lesions and the Vacora system in 125/233. Fifty-eight lesions underwent ultrasound-guided breast biopsy, and 50 lesions underwent mammography-guided biopsy with both Mammotome and Vacora devices. Magnetic-resonance-guided biopsy was possible with the Vacora system only (17/125 lesions).

Results

All procedures were successfully completed. No significant differences were found between the results of the Mammotome and Vacora biopsies in terms of effectiveness: sensitivity was 84.4% and 86.2%, respectively, and specificity 100%. In terms of cost, the Mammotome system has higher costs per procedure compared with the Vacora.

Conclusions

Our clinical results confirm the diagnostic accuracy of both the Mammotome and Vacora systems, whereas our cost analysis shows that there is a considerable difference, mostly related to the initial investment.     

Seizure duration and latency of hypermotor manifestations distinguish frontal from extrafrontal onset in sleep‐related hypermotor epilepsy

Sleep‐related hypermotor epilepsy (SHE) is an epilepsy syndrome that is characterized by the occurrence of sleep‐related hypermotor seizures of variable complexity and duration. Seizures usually arise in the frontal lobe, but extrafrontal seizure onset zones are well described. To identify clinically relevant ictal features of SHE that could distinguish a frontal from an extrafrontal onset zone, we conducted a retrospective analysis of seizure characteristics in 58 patients with drug‐resistant SHE (43 frontal and 15 extrafrontal) who underwent video‐stereo‐electroencephalographic recordings and became seizure‐free after epilepsy surgery. We found that the mean duration of electrographic seizures and clinically observable ictal manifestations were significantly shorter in frontal SHE compared to extrafrontal SHE. The mean latency between electrographic seizure onset and the onset of hypermotor manifestations was also shorter in frontal SHE. Accordingly, a latency > 5 seconds between the first video‐detectable movement (eg, eye opening or a minor motor event) and the onset of hypermotor manifestations yielded a sensitivity of 75% and a specificity of 90% for an extrafrontal onset, thereby indicating that specific ictal features in SHE can provide clinically useful clues to increase diagnostic accuracy in this syndrome.     

Spray-dried microspheres based on methylpyrrolidinone chitosan as new carrier for nasal administration of metoclopramide.

The work purpose was to study the application of 5-methylpyrrolidinone chitosan (MPC) for preparing mucoadhesive microparticles for the nasal administration of drugs. Microspheres were produced by the spray-drying technique using MPC; metoclopramide hydrochloride (MC) was chosen as model drug. Chitosan microparticles were prepared as a comparison. The microparticles obtained were characterised (encapsulation efficiency, morphology, size and drug release behaviour). In-vitro mucoadhesive tests, swelling tests and ex-vivo studies using sheep nasal mucosa were performed. The hydrogel formation from microspheres was studied in different media and at different pHs. Microspheres are able to control the in-vitro MC release. MPC microparticles show good in-vitro mucoadhesive properties and ex-vivo controlled permeation profiles. The hydrogel formation is dependent mainly on the medium used: ionically crosslinked hydrogel was hypothesized. These in-vitro and ex-vivo preliminary results show that spray-dried microspheres based on MPC could be a suitable nasal delivery system for the administration of metoclopramide.     

POEMS syndrome: a case report

A case of POEMS syndrome in a 43-year-old male with polyneuropathy, osteolytic lesion of the basin due to solitary IgA-lambda plasmacytoma, cutaneous scleroderma-like changes, diffuse lymphadenopathy and hepatosplenomegaly is described. Liver biopsy showed a regenerative process of the parenchyma without laboratory and histologic evidence of necrosis. A peculiar finding was the onset of a right hemiparesis in the absence of signs of vascular disease or other predisposing factors. The possible links between the peculiar elements of the POEMS syndrome are briefly analyzed and discussed.