Re-evaluation of erythritol (E 968) as a food additive.

This opinion addresses the re-evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.

Endovascular approach to a complex thrombus in-transit through a patent foramen ovale.

Large atrial thrombi can be managed percutaneously. We present a case of a 76-year-old female patient who presented to our emergency room with an acute stroke and was managed with mechanical thrombectomy. Further work-up revealed a large complex thrombus in-transit trapped in a patent foramen ovale with a large mobile portion in the left atrium. Due to contraindications for thrombolysis and poor surgical candidacy, an endovascular approach was favored. The procedure was performed successfully, and the patient recovered uneventfully. Learning objective: Endovascular approach with mechanical thrombectomy can be a treatment option for patients that present with large thrombus in-transit when other therapies are contraindicated.

Acute Presentation of a High-Grade Myxofibrosarcoma Originating in the Thoracic Wall: A Case Report.

We report the first case of a patient with myxofibrosarcoma (MFS) who presented acutely with a rib fracture and developed a rapidly expanding loculated hemothorax after chest trauma. The patient was taken to the operating room for evacuation of hemothorax, and samples and biopsy specimens were taken for cytologic and pathologic examination. Final report with immunohistochemical staining showed a high-grade MFS. After the procedure, there was clinical and radiological improvement, and the patient was followed up as an outpatient. Myxofibrosarcoma is a very rare and aggressive connective tissue neoplasm with variable presentations. Surgical resection is the preferred treatment. Prompt diagnosis and adequate management of these tumors are important to reduce their high local recurrence and distant metastasis rates. Therefore, it is important to be aware of its common and uncommon presentations.

Location of Superior Vena Cava Tears in Transvenous Lead Extraction.

BACKGROUND: Superior vena cava (SVC) tears are rare but potentially lethal complications associated with transvenous lead extraction. When lacerations occur, surgeons need to be prepared for an emergent response. Nonetheless, little is known about the precise whereabouts of these lesions. Understanding the location and injury patterns enables a more anticipated and targeted surgical response. METHODS: We collected data via physician interviews after an SVC laceration occurred. These physicians were identified through the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and independent physician reports of adverse events. We identified 116 reports of SVC tears between July 1, 2016, and July 31, 2018. For an SVC tear to be included in our registry, a cardiothoracic surgeon had to be physically present to confirm the injury via emergent sternotomy. In each case, the surgeon recorded the SVC injury's exact location after a repair was attempted. RESULTS: During the study period, 116 SVC tears were confirmed by sternotomy. Tears occurred in any combination of the following locations: SVC-innominate vein, body of the SVC, and SVC-right atrial junction. The majority of tears (n = 72; 62%) were located in the isolated body of the SVC, followed by the SVC-right atrial junction (n = 23;19.8%) and the SVC-innominate junction (n = 17;14.6%). Combined tears were rare, accounting for only 3.6% (n = 4) of the adverse events recorded. CONCLUSIONS: Most SVC tears occurred in the isolated body of the SVC. The second most common location was the SVC-right atrial junction. The SVC-innominate junction was the third most common location for these injuries. Combined tears were uncommon.

Severity of climacteric symptoms among Peruvian women from an urban coastal community and a rural Andean community.

INTRODUCTION: The aim of this study was to evaluate the severity of climacteric symptoms among two Peruvian communities, adjusted for sociodemographic and clinical variables in climacteric women. METHODS: A cross-sectional study was conducted on 90 subjects from two different communities (an urban coastal and a rural Andean district from Peru). The Menopause Rating Scale was used to assess climacteric symptoms. Prevalence ratios with 95% confidence interval (PR 95%CI) were estimated using generalized linear Poisson models with family robust standard errors. RESULTS: A higher probability of severe climacteric symptoms was found in women who were from the Andean community than those who were from the coastal one (PR 2.42, 95%CI 1.47-3.99; p=0.001), which remained in the adjusted model (RP 1.72, 95%CI 1.04-2.86; p=0.035). CONCLUSION: Understanding the variation of climacteric symptoms among geographically distinct communities could contribute to improving women's quality of life.

Carbon nanotube modification of microbial fuel cell electrodes.

The use of carbon nanotubes (CNTs) for energy harvesting devices is preferable due to their unique mechanical, thermal, and electrical properties. On the other hand, microbial fuel cells (MFCs) are promising devices to recover carbon-neutral energy from the organic matters, and have been hindered with major setbacks towards commercialization. Nanoengineered CNT-based materials show remarkable electrochemical properties, and therefore have provided routes towards highly effective modification of MFC compartments to ultimately reach the theoretical limits of biomass energy recovery, low-cost power production, and thus the commercialization of MFCs. Moreover, these CNT-based composites offer significant flexibility in the design of MFCs that enable their use for a broad spectrum of applications ranging from scaled-up power generation to medically related devices. This article reviews the recent advances in the modification of MFCs using CNTs and CNT-based composites, and the extent to which each modification route impacts MFC power and current generation.

Collecting and distributing wearable sensor data: an embedded personal area network to local area network gateway server.

The goal of the concept and of the device presented in this contribution is to be able to collect sensor data from wearable sensors directly, automatically and wirelessly and to make them available over a wired local area network. Several concepts in e-health and telemedicine make use of portable and wearable sensors to collect movement or activity data. Usually these data are either collected via a wireless personal area network or using a connection to the user's smartphone. However, users might not carry smartphones on them while inside a residential building such as a nursing home or a hospital, but also within their home. Also, in such areas the use of other wireless communication technologies might be limited. The presented system is an embedded server which can be deployed in several rooms in order to ensure live data collection in bigger buildings. Also, the collection of data batches recorded out of range, as soon as a connection is established, is also possible. Both, the system concept and the realization are presented.

A novel wearable laser device to regulate stride length in Parkinson's disease.

Decreased stride length is a highly relevant characteristic of the gait in patients with Parkinson's disease (PD). In this paper, a novel wearable laser device for stride length regulation is presented. The device is mounted to one foot and can project a red laser light strip to the floor as a visual cue for the other foot. In the experiment twelve healthy volunteers walked a 20 m straight walkway wearing the system on both feet. As an objective result, the stride length regulation reached an accuracy of 96.1 ± 2.5 (94.0 ± 3.5) % for a pre-defined stride length λdef= 55 (65) cm. The subjective evaluation by the participants using a questionnaire revealed that the visual cue projected from the laser device was considered a stable signal that did not shake during walking. 6 of 12 participants felt that this device was not interfering with their gait, 3 of 12 judged this aspect neutrally, and 3 of 12 considered it somehow bothersome.

A sensor network to iPhone interface separating continuous and sporadic processes in mobile telemedicine.

In this contribution, a new concept for interfacing sensor network nodes (motes) and smartphones is presented for the first time. In the last years, a variety of telemedicine applications on smartphones for data reception, display and transmission have been developed. However, it is not always practical or possible to have a smartphone application running continuously to accomplish these tasks. The presented system allows receiving and storing data continuously using a mote and visualizing or sending it on the go using the smartphone as user interface only when desired. Thus, the processes of data reception and storage run on a safe system consuming less energy and the smartphone's potential along with its battery are not demanded continuously. Both, system concept and realization with an Apple iPhone are presented.

ART - a new concept for an activity recorder and transceiver.

In this contribution, a new concept for an activity recorder and transceiver (ART) is presented. Among the many purposes ART can be used for, this contribution focuses on the development of personal assistant devices for an aging society. Instead of probing a patient's health only when illness occurs, ART offers the possibility to monitor a person ubiquitous in every day life in order e.g. to detect abnormal changes in behavior, mainly based on the recording of discrete events rather than continuous sensor data streams. ARTs are key elements to develop personal assistant devices that are able to support people especially with cognitive impairments to remain living independent and yet secure their home environments. In this document vital demands on such systems will be defined and systematically analyzed. Furthermore the system architecture and possible applications for ARTs will be presented.

A new washable low-cost garment for everyday fall detection.

In this paper, a new garment for automatic fall detection and alert is presented for the first time. It includes a washable pullover with integrated acceleration sensors, evaluation and control electronics. The system measures the accelerations at the torso and on the arms in three directions in space. The fall detection is based on recognizing, by means of the sensors, the posture and abnormal acceleration magnitudes usually associated to a fall. The alarm as well as the movement information is sent via a wireless radio link. A fall will be detected within the pullover's electronics. The fall detection system was tested on ten volunteers. The daily life movements are also stored on a memory card. The latter can be read in on a PC. Thanks to an optimized production process, the system can be affordably reproduced in low volume productions and can be adjusted for any usage. The power supply of the system is realized with rechargeable batteries.

A system for intelligent home care ECG upload and priorisation.

In this contribution, a system for internet based, automated home care ECG upload and priorisation is presented for the first time. It unifies the advantages of existing telemonitoring ECG systems adding functionalities such as automated priorisation and usability for home care. Chronic cardiac diseases are a big group in the geriatric field. Most of them can be easily diagnosed with help of an electrocardiogram. A frequent or long-term ECG analysis allows early diagnosis of e.g. a cardiac infarction. Nevertheless, patients often aren't willing to visit a doctor for prophylactic purposes. Possible solutions of this problem are home care devices, which are used to investigate patients at home without the presence of a doctor on site. As the diffusion of such systems leads to a huge amount of data which has to be managed and evaluated, the presented approach focuses on an easy to use software for ECG upload from home, a web based management application and an algorithm for ECG preanalysis and priorisation.