keyword
MENU ▼
Read by QxMD icon Read
search

Device AND safety

keyword
https://www.readbyqxmd.com/read/29156183/medical-devices-for-obesity-treatment-endoscopic-bariatric-therapies
#1
REVIEW
Eric J Vargas, Monika Rizk, Fateh Bazerbachi, Barham K Abu Dayyeh
Endoscopic bariatric therapies (EBTs) are effective tools for the management of obesity. By mimicking restrictive and bypass surgery physiology, they provide a safe and effective treatment option with the added capabilities of reaching a broader population. Multiple efficacious medical devices, such as intragastric balloons, endoscopic suturing/plication devices, and bypass liners, at various stages of development are available in the United States. EBTs represent the newest addition to a multidisciplinary approach in obesity management...
January 2018: Medical Clinics of North America
https://www.readbyqxmd.com/read/29156020/doubly-committed-ventricular-septal-defect-closure-using-eccentric-occluder-via-ultraminimal-incision
#2
Jin Yu, Lianglong Ma, Jingjing Ye, Zewei Zhang, Jianhua Li, Jiangen Yu, Guoping Jiang
OBJECTIVES: This study aimed to investigate the safety, feasibility and availability of doubly committed ventricular septal defect (DCVSD) closure via an ultraminimal intercostal incision under the guidance of transoesophageal echocardiography in children. METHODS: From August 2014 to August 2016, 35 children with DCVSDs (≤5 mm in diameter) were enrolled in this study. A left parasternal ultraminimal intercostal incision (≤1 cm) and a pericardium hanging technique were employed without sternal incision...
October 1, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/29154750/global-perspectives-on-ensuring-the-safety-of%C3%A2-pharmaceutical-products-in-the-distribution-process%C3%A2
#3
Sohyun Jeong, Eunhee Ji
OBJECTIVE: The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world...
November 20, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29154522/distribution-and-evaluation-of-a-carbon-monoxide-detector-intervention-in-two-settings-emergency-department-and-urban-community
#4
Lara B McKenzie, Kristin J Roberts, Wendy C Shields, Eileen McDonald, Elise Omaki, Mahmoud Abdel-Rasoul, Andrea C Gielen
The objective of this study was to describe changes in carbon monoxide (CO) safety knowledge and observed CO detector use following distribution of a CO detector use intervention in two environments, a pediatric emergency department (Ohio) and an urban community (Maryland). A total of 301 participants completed the 6-month follow up (Ohio: n = 125; Maryland: n = 176). The majority of participants was female, 25–34 years of age, and employed (full or part time). We found that CO safety knowledge did not differ between settings at enrollment, but significantly improved at the follow-up visits...
May 2017: Journal of Environmental Health
https://www.readbyqxmd.com/read/29152821/skin-care-products-can-aggravate-epidermal-function-studies-in-a-murine-model-suggest-a-pathogenic-role-in-sensitive-skin
#5
Zhengxiao Li, Lizhi Hu, Peter M Elias, Mao-Qiang Man
BACKGROUND: Sensitive skin is defined as a spectrum of unpleasant sensations in response to a variety of stimuli. However, only some skin care products provoke cutaneous symptoms in individuals with sensitive skin. Hence, it would be useful to identify products that could provoke cutaneous symptoms in individuals with sensitive skin. OBJECTIVE: To assess whether vehicles, as well as certain branded skin care products, can alter epidermal function following topical applications to normal mouse skin...
November 20, 2017: Contact Dermatitis
https://www.readbyqxmd.com/read/29152718/an-extension-of-a-multicenter-randomized-split-face-clinical-trial-evaluating-the-efficacy-and-safety-of-chromophore-gel-assisted-blue-light-phototherapy-for-the-treatment-of-acne
#6
Andreas Nikolis, Stéphane Fauverghe, Giovanni Scapagnini, Dimitrios Sotiriadis, George Kontochristopoulos, Athanasios Petridis, Dimitrios Rigopoulos, Clio Dessinioti, Konstantinos Kalokasidis, Christina Antoniou
A variety of laser/light-based devices have been reported to be effective for the treatment of acne, yet no long-term data on efficacy and safety have been published. A first 12-week clinical trial ("Main trial") recently demonstrated that the KLOX BioPhotonic System, an LED blue light device using photo-converter chromophores, can significantly improve moderate and severe facial acne vulgaris with an excellent safety profile. This Extension trial followed the Main trial, using the same BioPhotonic System, with the same dose and instructions for use, on patients having already completed treatment in the Main trial...
November 20, 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/29151791/modern-lymphatic-dissection-techniques-for-preventing-post-renal-transplant-lymphocele
#7
Ciprian Valerian Lucan, Ionut Jurchis, Mihai Suciu, Sonia Emilia Selicean, Salvatore Buttice
Background and aims: Development of a lymphocele is a well-known complication following kidney transplant. Among causative factors, recipient iliac lymphatics dissection plays an important role. Electrothermal bipolar sealing devices (LigaSure(TM)) have been shown to decrease lymphatic leakage in a number of instances. The aim of this study was to investigate whether the use of this device decreases post-operative lymphatic complications in kidney transplant. Methods: 48 patients admitted for renal transplant were included in the study...
2017: Clujul Medical (1957)
https://www.readbyqxmd.com/read/29151491/early-safety-and-efficacy-of-transcatheter-aortic-valve-implantation-for-asian-nonagenarians-from-kmh-registry
#8
Mizuki Miura, Shinichi Shirai, Yukari Uemura, Hiroyuki Jinnouchi, Takashi Morinaga, Akihiro Isotani, Shun Watanabe, Masaomi Hayashi, Norihiko Kamioka, Atsushi Nagasawa, Shinichi Kakumoto, Katsuhiro Seo, Yoshio Arai, Michiya Hanyu, Kenji Ando
As Japan has one of the most rapidly aging populations in the world, transcatheter aortic valve implantation (TAVI) is likely to be performed in increasing numbers of older people. There is little information on either the efficacy or the safety of TAVI in nonagenarians in Asia.From October 2013 to June 2015, 112 consecutive patients underwent TAVI with Edwards SAPIEN XT valves in our institution. We compared 25 patients aged at least 90 years (mean 91.6 ± 1.7 years) with 87 patients aged under 90 years (mean 82...
November 17, 2017: International Heart Journal
https://www.readbyqxmd.com/read/29151132/safety-of-intrathecal-route-focus-to-methylprednisolone-acetate-depo-medrol-use
#9
REVIEW
Joël Schlatter, David Nguyen, Michèle Zamy, Sofiane Kabiche, Jean-Eudes Fontan, Salvatore Cisternino
PURPOSE: Complications of the intrathecal route may cause potential toxicity related to the medical device and properties of the administered drug and/or excipient. A description of clinical and histological effects of polyethylene glycol and miripirium after Depo-Medrol injection, and the adverse reactions of particulate methylprednisolone acetate was conducted. The safety of the intrathecal route with excipients, label and off-label drugs is discussed. METHODS: A bibliographic search in Medline, Google, and Cochrane database from 1940 to June 2016 was performed...
November 18, 2017: European Spine Journal
https://www.readbyqxmd.com/read/29150698/surgical-techniques-for-left-atrial-appendage-exclusion
#10
REVIEW
Sacha P Salzberg, Maximilian Y Emmert, Etem Caliskan
The increasing prevalence of atrial fibrillation with the aging population and its associated major morbidity and mortality due to thromboembolic stroke have resulted in intensive research on stroke prevention or stroke risk reduction strategies. Several surgical techniques for left atrial appendage (LAA) occlusion have evolved over the past decades. Surgeons have been using different techniques leading to highly variable and, in particular, poor data on outcomes. LAA closure is performed either as a concomitant procedure during open-heart surgery or as a stand-alone surgical procedure as part of minimally invasive (mini-thoracotomy or thoracoscopy) arrhythmia surgery...
November 17, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/29148092/an-inductively-coupled-ultra-thin-flexible-and-passive-rf-resonator-for-mri-marking-and-guiding-purposes-clinical-feasibility
#11
Akbar Alipour, Sayim Gokyar, Oktay Algin, Ergin Atalar, Hilmi Volkan Demir
PURPOSE: The purpose of this study is to develop a wireless, flexible, ultra-thin, and passive radiofrequency-based MRI resonant fiducial marker, and to validate its feasibility in a phantom model and several body regions. METHODS: Standard microfabrication processing was used to fabricate the resonant marker. The proposed marker consists of two metal traces in the shape of a square with an edge length of 8 mm, with upper and lower traces connected to each other by a metalized via...
November 16, 2017: Magnetic Resonance in Medicine: Official Journal of the Society of Magnetic Resonance in Medicine
https://www.readbyqxmd.com/read/29146270/retrospective-cohort-study-on-angio-seal-closure-device-safety-and-effectiveness-in-antegrade-superficial-femoral-artery-punctures-a-comparison-with-antegrade-common-femoral-artery-punctures
#12
Tarig Adlan, Yousef Shahin, Peter Kember, John Isaacs, Richard Seymour
PURPOSE: This retrospective study evaluates the effectiveness and safety of the Angio-Seal closure device in superficial femoral artery (SFA) antegrade punctures compared to common femoral artery (CFA) antegrade punctures. METHODS: Over a period of 46 months from January 2012, consecutive patients who underwent antegrade CFA or SFA punctures using Angio-Seal as a closure device in a single centre were studied. Patients were identified by reading all the individual reports on our radiology system for all patients who underwent any angiographic examination during the study period, and their individual case notes were subsequently reviewed...
November 13, 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/29145233/prospective-evaluation-of-the-feasibility-safety-and-efficacy-of-cocoon-duct-occluder-for-transcatheter-closure-of-large-patent-ductus-arteriosus-a-single-center-study-with-short-and-medium-term-follow-up-results
#13
Santosh Kumar Sinha, Mahmadula Razi, Rama Niwas Pandey, Prakash Kumar, Vinay Krishna, Mukesh Jitendra Jha, Vikas Mishra, Mohammad Asif, Nasar Abdali, Pradyot Tewari, Ramesh Thakur, Umeshwar Pandey, Chandra Mohan Varma
OBJECTIVE: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). METHODS: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined...
November 2017: Anatolian Journal of Cardiology
https://www.readbyqxmd.com/read/29144717/review-of-non-invasive-vagus-nerve-stimulation-gammacore-efficacy-safety-potential-impact-on-comorbidities-and-economic-burden-for-episodic-and-chronic-cluster-headache
#14
Mkaya Mwamburi, Eric J Liebler, Andrew T Tenaglia
The FDA has cleared gammaCore (non-invasive vagus nerve stimulator [nVNS]) for the treatment of episodic cluster headache (eCH). With the exception of subcutaneous sumatriptan, all other treatments are used off label and have many limitations. The FDA approval process for devices differs from that of drugs. We performed a review of the literature to evaluate new evidence on various aspects of gammaCore treatment and impact. The ACute Treatment of Cluster Headache Studies (ACT1 and ACT2), both double-blind sham-controlled randomized trials, did not meet the primary endpoints of the trials but each demonstrated significant superiority of gammaCore among patients with eCH...
November 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/29143795/deep-see-joint-object-detection-tracking-and-recognition-with-application-to-visually-impaired-navigational-assistance
#15
Ruxandra Tapu, Bogdan Mocanu, Titus Zaharia
In this paper, we introduce the so-called DEEP-SEE framework that jointly exploits computer vision algorithms and deep convolutional neural networks (CNNs) to detect, track and recognize in real time objects encountered during navigation in the outdoor environment. A first feature concerns an object detection technique designed to localize both static and dynamic objects without any a priori knowledge about their position, type or shape. The methodological core of the proposed approach relies on a novel object tracking method based on two convolutional neural networks trained offline...
October 28, 2017: Sensors
https://www.readbyqxmd.com/read/29143099/-left-atrial-appendage-clusure-in-nonvalvular-atrial-fibrillation-clinical-evidence-2017
#16
REVIEW
Steffen Gloekler, Bajram Hajredini, Simon Rycerz, Sebastian Jäckle, Werner Jung
Nonvalvular atrial fibrillation (AF) is the most common arrhythmia with a prevalence of 1-2% and affects approximately 15-20% of all octogenarians. Patients are at increased risk of thromboembolic stroke, with an overall risk of 5% per year. Thrombi form almost exclusively in the left atrial appendage (LAA), a blind sac-like heterogeneous structure trabeculated by pectinate muscles. In the past five decades, life-long oral anticoagulation (OAC) with vitamin K antagonists (VKA) has been the state-of-the art treatment to prevent stroke and systemic embolism from thrombi in AF...
November 15, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/29142627/a-comparison-of-anterior-cervical-discectomy-and-fusion-versus-fusion-combined-with-artificial-disc-replacement-for-treating-3-level-cervical-spondylotic-disease
#17
Seo-Ryang Jang, Sang-Bok Lee, Kyoung-Suok Cho
Objective: The purpose of this study is to evaluate the efficacy and safety of 3-level hybrid surgery (HS), which combines fusion and cervical disc replacement (CDR), compared to 3-level fusionin patient with cervical spondylosis involving 3 levels. Methods: Patients in the anterior cervical discectomy and fusion (ACDF) group (n=30) underwent 3-level fusion and the HS group (n=19) underwent combined surgery with fusion and CDR. Clinical outcomes were evaluated using the visual analogue scale for the arm, the neck disability index (NDI), Odom criteria and postoperative complications...
November 2017: Journal of Korean Neurosurgical Society
https://www.readbyqxmd.com/read/29142012/a-transcatheter-interatrial-shunt-device-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-reduce-lap-hf-i-a-phase-2-randomized-sham-controlled-trial
#18
Ted Feldman, Laura Mauri, Rami Kahwash, Sheldon Litwin, Mark J Ricciardi, Pim van der Harst, Martin Penicka, Peter S Fail, David M Kaye, Mark C Petrie, Anupam Basuray, Scott L Hummel, Rhondalyn Forde-McLean, Christopher D Nielsen, Scott Lilly, Joseph M Massaro, Daniel Burkhoff, Sanjiv J Shah
Background -In non-randomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), less symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and mid-range or preserved ejection fraction (EF ≥ 40%). We conducted the first randomized, sham-controlled trial to evaluate the IASD in HF with EF ≥ 40%. Methods -REDUCE LAP-HF I was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, EF ≥ 40%, exercise PCWP ≥ 25 mmHg, and PCWP-right atrial pressure gradient ≥ 5 mmHg...
November 15, 2017: Circulation
https://www.readbyqxmd.com/read/29141057/lasers-light-and-the-treatment-of-acne-a-comprehensive-review-of-the-literature
#19
Lana X Tong, Jeremy A Brauer
INTRODUCTION: Acne vulgaris is common dermatologic condition with an estimated prevalence of 70 to 87%. Acne has been shown to have a significant impact on patient quality of life and mental health, especially as inflammatory lesions typically occur on cosmetically sensitive areas with the potential for permanent scarring. There have been numerous advances in the treatment of inflammatory acne with light-based and laser devices. OBJECTIVE: To review the current evidence for light-based and laser treatments in the management of inflammatory acne...
November 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29137498/core-needle-biopsy-of-thyroid-nodules-outcomes-and-safety-from-a-large-single-center-single-operator-study
#20
Jooae Choe, Jung Hwan Baek, Hye Sun Park, Young Jun Choi, Jeong Hyun Lee
Background There currently remains a debate over the use of core needle biopsy (CNB) or fine needle aspiration (FNA) for diagnosis of thyroid nodules. The major drawbacks of previous CNB studies include heterogeneity of the study population, variable techniques, devices, and operator experience affecting the outcome of the procedure. Purpose To assess the diagnostic performance and safety of CNB of thyroid nodules performed by a single experienced operator in consecutive patients. Material and Methods From January 2012 to December 2012, 538 thyroid nodules that underwent CNB were retrospectively evaluated...
January 1, 2017: Acta Radiologica
keyword
keyword
62593
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"