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https://www.readbyqxmd.com/read/28634727/safety-and-efficacy-of-chemosaturation-in-patients-with-primary-and-secondary-liver-tumors
#1
Martha M Kirstein, Steffen Marquardt, Nils Jedicke, Silke Marhenke, Wolfgang Koppert, Michael P Manns, Frank Wacker, Arndt Vogel
BACKGROUND: Chemosaturation with percutaneous hepatic perfusion (CS-PHP; hepatic CHEMOSAT(®) delivery system; Delcath Systems Inc, USA) is a novel medical device, which delivers high doses of melphalan directly to the liver in patients with primary and secondary liver tumors while limiting systemic toxicity through hemofiltration of the hepatic venous blood. The aim of this study was to analyze the safety and efficacy of the second-generation CS-PHP after 54 treatments at Hannover Medical School, Germany...
June 20, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28634495/choking-hazards-are-current-product-testing-methods-for-small-parts-adequate
#2
Athena Neofotistos, Nancy Cowles, Ragini Sharma
Choking on small parts remains one of the leading causes of death and injury in infants and toddlers. The current method of testing for small parts, created by the Consumer Product Safety Commission (CPSC), has become outdated and has yet to be changed despite the many deaths and injuries of children. The method uses a device called the small parts test fixture (SPTF) that is supposed to mimic the size of a fully expanded throat of a toddler. If a product does not fit inside the cavity of the SPTF, then it is deemed safe to play with because it "will not fit" in the esophagus of a child...
2017: International Journal of Pediatrics
https://www.readbyqxmd.com/read/28632188/smartphone-based-food-diagnostic-technologies-a-review
#3
REVIEW
Giovanni Rateni, Paolo Dario, Filippo Cavallo
A new generation of mobile sensing approaches offers significant advantages over traditional platforms in terms of test speed, control, low cost, ease-of-operation, and data management, and requires minimal equipment and user involvement. The marriage of novel sensing technologies with cellphones enables the development of powerful lab-on-smartphone platforms for many important applications including medical diagnosis, environmental monitoring, and food safety analysis. This paper reviews the recent advancements and developments in the field of smartphone-based food diagnostic technologies, with an emphasis on custom modules to enhance smartphone sensing capabilities...
June 20, 2017: Sensors
https://www.readbyqxmd.com/read/28630897/flexible-and-stretchable-power-sources-for-wearable-electronics
#4
Alla M Zamarayeva, Aminy E Ostfeld, Michael Wang, Jerica K Duey, Igal Deckman, Balthazar P Lechêne, Greg Davies, Daniel A Steingart, Ana Claudia Arias
Flexible and stretchable power sources represent a key technology for the realization of wearable electronics. Developing flexible and stretchable batteries with mechanical endurance that is on par with commercial standards and offer compliance while retaining safety remains a significant challenge. We present a unique approach that demonstrates mechanically robust, intrinsically safe silver-zinc batteries. This approach uses current collectors with enhanced mechanical design, such as helical springs and serpentines, as a structural support and backbone for all battery components...
June 2017: Science Advances
https://www.readbyqxmd.com/read/28629390/results-of-the-first-interim-analysis-of-the-rapper-ii-trial-in-patients-with-spinal-cord-injury-ambulation-and-functional-exercise-programs-in-the-rex-powered-walking-aid
#5
Nick Birch, Jon Graham, Tom Priestley, Chris Heywood, Mohamed Sakel, Angela Gall, Andrew Nunn, Nada Signal
BACKGROUND: The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire...
June 19, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/28626966/anode-improvement-in-rechargeable-lithium-sulfur-batteries
#6
REVIEW
Tao Tao, Shengguo Lu, Ye Fan, Weiwei Lei, Shaoming Huang, Ying Chen
Owing to their theoretical energy density of 2600 Wh kg(-1) , lithium-sulfur batteries represent a promising future energy storage device to power electric vehicles. However, the practical applications of lithium-sulfur batteries suffer from poor cycle life and low Coulombic efficiency, which is attributed, in part, to the polysulfide shuttle and Li dendrite formation. Suppressing Li dendrite growth, blocking the unfavorable reaction between soluble polysulfides and Li, and improving the safety of Li-S batteries have become very important for the development of high-performance lithium sulfur batteries...
June 19, 2017: Advanced Materials
https://www.readbyqxmd.com/read/28626796/determining-underground-mining-work-postures-using-motion-capture-and-digital-human-modeling
#7
Timothy J Lutz, Joseph P DuCarme, Adam K Smith, Dean Ambrose
According to Mine Safety and Health Administration (MSHA) data, during 2008-2012 in the U.S., there were, on average, 65 lost-time accidents per year during routine mining and maintenance activities involving remote-controlled continuous mining machines (CMMs). To address this problem, the National Institute for Occupational Safety and Health (NIOSH) is currently investigating the implementation and integration of existing and emerging technologies in underground mines to provide automated, intelligent proximity detection (iPD) devices on CMMs...
December 27, 2016: Journal of Environment and Health Sciences
https://www.readbyqxmd.com/read/28626370/donor-safety-in-haemapheresis-development-of-an-internet-based-registry-for-comprehensive-assessment-of-adverse-events-from-healthy-donors
#8
Hans-Gert Heuft, Eike Fischer, Tina Weingand, Thomas Burkhardt, Gerda Leitner, Hagen Baume, Jörg-Peter Schmidt, Andreas Buser, Gabriele Fauchald, Ute Reinicke Voigt, Behrouz Mansouri-Taleghani
BACKGROUND: Currently, there is an extensive but highly inconsistent body of literature regarding donor adverse events (AEs) in haemapheresis. As the reports diverge with respect to types and grading of AEs, apheresis procedures and machines, the range of haemapheresis-related AEs varies widely from about 0.03% to 6.6%. METHODS: The German Society for Transfusion Medicine and Immunohaematology (DGTI) formed a 'Haemapheresis Vigilance Working Party' (Arbeitsgemeinschaft Hämapheresevigilanz; AGHV) to create an on-line registry for comprehensive and comparable AE assessment with all available apheresis devices in all types of preparative haemapheresis: plasmapheresis (PLS), plateletpheresis (PLT), red blood cell apheresis, all kind of leukaphereses (autologous/allogeneic blood stem cell apheresis, granulocyte apheresis, lymphocyte/monocyte apheresis) and all possible types of multi-component apheresis...
June 2017: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/28625964/antegrade-dissection-and-reentry-as-part-of-the-hybrid-chronic-total-occlusion-revascularization-strategy-a-subanalysis-of-the-recharge-registry-registry-of-crossboss-and-hybrid-procedures-in-france-the-netherlands-belgium-and-united-kingdom
#9
Joren Maeremans, Jo Dens, James C Spratt, Alan J Bagnall, Wynand Stuijfzand, Alexander Nap, Pierfrancesco Agostoni, William Wilson, Colm G Hanratty, Simon Wilson, Benjamin Faurie, Alexandre Avran, Erwan Bressollette, Mohaned Egred, Paul Knaapen, Simon Walsh
BACKGROUND: Development of the CrossBoss and Stingray devices for antegrade dissection and reentry (ADR) of chronic total occlusions has improved historically suboptimal outcomes. However, the outcomes, safety, and failure modes of the technique have to be studied in a larger patient cohort. This preplanned substudy of the RECHARGE registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom) aims to evaluate the value and use of ADR and determine its future position in contemporary chronic total occlusion intervention...
June 2017: Circulation. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28625931/overview-of-the-risk-areas-associated-with-care-in-nursing-homes
#10
Delphine Teigné, Marion Lucas, Brice Leclère, Leila Moret, Noémie Terrien
As the number of dependant elderly people rises, the place occupied by nursing homes in the French health care system becomes more and more important, and the question of resident safety is more significant than ever. A transfer of the notions developed for hospitals is useful but insufficient, as they mainly focus on the technical facet of care. In order to propose a wider view of risk management in nursing homes, we reviewed the French medical literature published between 2005 and 2016 in search of articles about adverse events related to health care in French nursing homes...
June 1, 2017: Gériatrie et Psychologie Neuropsychiatrie du Vieillissement
https://www.readbyqxmd.com/read/28625909/multilevel-acdf-with-zero-profile-devices-analysis-of-safety-and-feasibility-with-a-focus-on-sagittal-alignment-and-its-impact-on-clinical-outcome-a-single-institution-experience-and-review-of-the-literature
#11
Vincenzo Albanese, Francesco Certo, Massimiliano Visocchi, Giuseppe Mv Barbagallo
BACKGROUND: In multilevel degenerative conditions posterior approaches are often preferred, but anterior approaches provide comparable clinical results and better alignment. Anterior plating entails higher rates of soft tissue injuries and dysphagia, particularly in multilevel cases. This study evaluates efficacy and safety of zero-profile devices in three and four-level ACDF, analyzing patients' clinical and radiological long-term outcome. METHODS: We prospectively enrolled 24 patients with cervical spondylotic myeloradiculopathy (CSM), who underwent three and four-level ACDF with Zero-P device...
June 15, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/28625777/safety-and-tolerability-of-subcutaneous-trastuzumab-for-the-adjuvant-treatment-of-human-epidermal-growth-factor-receptor-2-positive-early-breast-cancer-safeher-phase-iii-study-s-primary-analysis-of-2573-patients
#12
J Gligorov, B Ataseven, M Verrill, M De Laurentiis, K H Jung, H A Azim, N Al-Sakaff, S Lauer, M Shing, X Pivot
AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin(®) SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles...
June 15, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28625383/the-assessment-of-the-watchman-device-in-patients-unsuitable-for-oral-anticoagulation-asap-too-trial
#13
David R Holmes, Vivek Y Reddy, Maurice Buchbinder, Kenneth Stein, Myriah Elletson, Martin W Bergmann, Boris Schmidt, Jacqueline Saw
BACKGROUND: Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial. STUDY OBJECTIVES: The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28625366/feasibility-of-transcatheter-aortic-valve-replacement-in-low-risk-patients-with-symptomatic-severe-aortic-stenosis-rationale-and-design-of-the-low-risk-tavr-lrt-study
#14
Toby Rogers, Rebecca Torguson, Roshni Bastian, Paul Corso, Ron Waksman
BACKGROUND: Safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis have not yet been established. HYPOTHESIS: Transcatheter aortic valve replacement is feasible in patients with symptomatic severe aortic stenosis and low risk for surgical aortic valve replacement. DESIGN: The LRT study is the first US Food and Drug Administration-approved Investigational Device Exemption prospective multicenter feasibility trial of TAVR in low-risk patients...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28624970/cardiovascular-implantable-electronic-devices-a-review-of-the-dangers-and-difficulties-in-mr-scanning-and-attempts-to-improve-safety
#15
REVIEW
Pei Ghim Poh, Charlene Liew, Colin Yeo, Le Roy Chong, Andrew Tan, Angeline Poh
An increasing number of patients are being treated with cardiovascular implantable electronic devices (CIEDs), many of which are MR conditional. There is a lack of literature on the safe scanning of MR conditional CIEDs. This review article discusses MR imaging safety in patients with implanted CIEDs. Guidelines on safe use and indications of imaging patients with MR conditional CIEDs are described, followed by a pictorial essay of the radiographic features of these devices. We also discuss the challenges of monitoring the patient in the MR environment, advances in MRI conditional imaging of devices, availability, limitations and workflow including vendor-specific and other collaborative efforts to simplify the scanning process...
June 17, 2017: Insights Into Imaging
https://www.readbyqxmd.com/read/28624705/controlled-release-of-basic-fibroblast-growth-factor-for-angiogenesis-using-acoustically-responsive-scaffolds
#16
Alexander Moncion, Melissa Lin, Eric G O'Neill, Renny T Franceschi, Oliver D Kripfgans, Andrew J Putnam, Mario L Fabiilli
The clinical translation of pro-angiogenic growth factors for treatment of vascular disease has remained a challenge due to safety and efficacy concerns. Various approaches have been used to design spatiotemporally-controlled delivery systems for growth factors in order to recapitulate aspects of endogenous signaling and thus assist in translation. We have developed acoustically-responsive scaffolds (ARSs), which are fibrin scaffolds doped with a payload-containing, sonosensitive emulsion. Payload release can be controlled non-invasively and in an on-demand manner using focused, megahertz-range ultrasound (US)...
June 9, 2017: Biomaterials
https://www.readbyqxmd.com/read/28624422/endovascular-proximal-forearm-arteriovenous-fistula-for-hemodialysis-access-results-of-the-prospective-multicenter-novel-endovascular-access-trial-neat
#17
Charmaine E Lok, Dheeraj K Rajan, Jason Clement, Mercedeh Kiaii, Ravi Sidhu, Ken Thomson, George Buldo, Christine Dipchand, Louise Moist, Joanna Sasal
BACKGROUND: Hemodialysis arteriovenous fistulas (AVFs) are suboptimally used primarily due to problems with maturation, early thrombosis, and patient nonacceptance. An endovascular approach to fistula creation without open surgery offers another hemodialysis vascular access option. STUDY DESIGN: Prospective, single-arm, multicenter study (Novel Endovascular Access Trial [NEAT]). SETTINGS & PARTICIPANTS: Consecutive adult non-dialysis-dependent and dialysis-dependent patients referred for vascular access creation at 9 centers in Canada, Australia, and New Zealand...
June 9, 2017: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/28622836/safety-assessment-of-the-use-of-ultrasonic-energy-in-the-proximity-of-the-recurrent-laryngeal-nerve-in-a-porcine-model
#18
Karla V Chávez, Elpidio M Barajas, Francisco Soroa, Armando Gamboa-Dominguez, Samuel Ordóñez, Juan P Pantoja, Mauricio Sierra, David Velázquez-Fernández, Miguel F Herrera
BACKGROUND: Advanced bipolar and ultrasonic energy have demonstrated reduction of operating time and blood loss in thyroidectomy. However, these devices generate heat and thermal dispersion that may damage adjacent structures such as the recurrent laryngeal nerve (RLN). This study was designed to evaluate the safety profile of the Harmonic Focus+(®) (HF+) device through the evaluation of thermal injury to the RLN using different algorithms of distance and time with state of the art technology...
June 7, 2017: American Journal of Surgery
https://www.readbyqxmd.com/read/28622144/a-technological-advance-for-21st-century-obstetricians-the-electronically-controlled-vacuum-extractor
#19
Nicola Perone
OBJECTIVE: To describe an innovative electronically-controlled vacuum extractor (VE) in detail and to illustrate its performance characteristics, as observed in a laboratory study. DESIGN: Thirty simulated, vacuum-assisted deliveries. MAIN OUTCOME MEASURE(S): (1) The ability to measure in real-time of the pull applied and to sound an alert, when the traction approaches the negative pressure under the cup, to prevent its detachment. (2) The recording and printing of a graphic representation of the pull applied (vacuum delivery graph)...
June 5, 2017: Journal of Perinatal Medicine
https://www.readbyqxmd.com/read/28622078/a-feasibility-study-and-technical-tips-for-the-use-of-an-articulating-bipolar-vessel-sealer-in-da-vinci-robot-assisted-gastrectomy
#20
Seong-Ho Kong, Tae Han Kim, Yeon Ju Huh, Seung-Young Oh, Hye Seong Ahn, So Yong Park, Yun Suk Choi, Yun-Suhk Suh, Hyuk-Joon Lee, Han-Kwang Yang
BACKGROUND: The aim of this study was to evaluate the efficacy and safety of a new articulating bipolar energy device, the EndoWrist(®) One™ Vessel Sealer (VS), in da Vinci(®) robot-assisted gastrectomy. MATERIALS AND METHODS: Patients (n = 17) with cT1/2 gastric cancer who underwent robotic gastrectomy using the VS were prospectively enrolled in the study group (VS group). The clinicopathological outcomes, including operative time, intraoperative blood loss, amount of postoperative drainage, postoperative biochemical analysis results, and complication rates, were prospectively collected and compared with those of patients who underwent robotic gastrectomy using conventional ultrasonic shear force ([US] group, n = 52) during the same time period...
June 16, 2017: Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A
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