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https://www.readbyqxmd.com/read/27935738/the-coronary-sinus-reducer-clinical-evidence-and-technical-aspects
#1
Francesco Giannini, Andrea Aurelio, Richard J Jabbour, Luca Ferri, Antonio Colombo, Azeem Latib
Chronic refractory angina is often a disabling condition, predominantly due to severe obstructive coronary artery disease, that is inadequately controlled by optimal medical therapy and not amenable to further percutaneous or surgical revascularization. Mortality rates associated with this condition are relatively low in clinically stable patients. However, it is associated with a high hospitalization rate and a reduction in both exercise capacity and quality of life. Due to the paucity of available treatment options, there is an unmet need for new therapies for these patients and for a reduction in the associated economic healthcare burden...
December 9, 2016: Expert Review of Cardiovascular Therapy
https://www.readbyqxmd.com/read/27933720/autogenous-bone-grafting-for-treatment-of-osseous-defect-after-impacted-mandibular-third-molar-extraction-a-randomized-controlled-trial
#2
Jing Ge, Chi Yang, Jiawei Zheng, Yingkai Hu
BACKGROUND: Extraction of impacted mandibular third molar (M3) has been cited as causing osseous defect at the distal aspect of the adjacent second molar (M2). PURPOSE: This randomized controlled trial was aimed to evaluate the effect of autogenous bone grafting in situ for regeneration of periodontal osseous defect distal to the M2 compared with non-grafting after impacted M3 removal. MATERIALS AND METHODS: A total of 60 sites in 51 adult patients were enrolled and randomly assigned to the control group or the test group...
December 8, 2016: Clinical Implant Dentistry and related Research
https://www.readbyqxmd.com/read/27933290/validation-of-a-cochlear-implant-patient-specific-model-of-the-voltage-distribution-in-a-clinical-setting
#3
Waldo Nogueira, Daniel Schurzig, Andreas Büchner, Richard T Penninger, Waldemar Würfel
Cochlear Implants (CIs) are medical implantable devices that can restore the sense of hearing in people with profound hearing loss. Clinical trials assessing speech intelligibility in CI users have found large intersubject variability. One possibility to explain the variability is the individual differences in the interface created between electrodes of the CI and the auditory nerve. In order to understand the variability, models of the voltage distribution of the electrically stimulated cochlea may be useful...
2016: Frontiers in Bioengineering and Biotechnology
https://www.readbyqxmd.com/read/27933150/implementing-mobile-devices-to-reduce-non-rostered-workload-for-junior-doctors
#4
Allan Plant, Suzanne Round, Joe Bourne
There is a large body of evidence demonstrating the detrimental effect of long work hours on the performance, mood, and job satisfaction of junior doctors. By extension these effects carry over into the realm of patient safety, compromising the quality of care provision. House officers in the general surgery department of Tauranga Hospital, New Zealand are often required to arrive at work well before their rostered start time of 7.30am to hand write the results of clinical investigations on their patient lists...
2016: BMJ Quality Improvement Reports
https://www.readbyqxmd.com/read/27931259/abdominal-septic-shock-endotoxin-adsorption-treatment-asset-endotoxin-removal-in-abdominal-and-urogenital-septic-shock-with-the-alteco%C3%A2-lps-adsorber-study-protocol-for-a-double-blinded-randomized-placebo-controlled-trial
#5
Miklos Lipcsey, Jyrki Tenhunen, Jan Sjölin, Robert Frithiof, Stepani Bendel, Hans Flaatten, Rafael Kawati, Anne Kuitunen, Tor Inge Tønnessen, Sten Rubertsson
BACKGROUND: Severe sepsis and septic shock are common in intensive care and carry high mortality rates. In patients with Gram-negative infections, early and extensive removal of endotoxin may limit the inflammatory response that characterizes septic shock. The Alteco® LPS Adsorber (hereafter referred to cited as the lipopolysaccharide (LPS) Adsorber) can be used for endotoxin removal and attenuate the deleterious inflammatory and clinical responses seen in septic shock. METHODS/DESIGN: The Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) trial is a pilot study investigating the feasibility and safety of LPS Adsorber therapy...
December 8, 2016: Trials
https://www.readbyqxmd.com/read/27929503/real-time-in-vivo-dosimetry-for-sbrt-prostate-treatment-using-plastic-scintillating-dosimetry-embedded-in-a-rectal-balloon-a-case-study
#6
Justin L Cantley, Chee-Wai Cheng, Fredrick B Jesseph, Tarun K Podder, Valdir C Colussi, Bryan J Traughber, Lee E Ponsky
A novel FDA approved in vivo dosimetry device system using plastic scintillating detectors placed in an endorectal balloon to provide real-time in vivo dosimetry for prostatic rectal interface was tested for use with stereotactic body radiotherapy (SBRT). The system was used for the first time ever to measure dose during linear accelerator based SBRT. A single patient was treated with a total dose of 36.25 Gy given in 5 fractions. Delivered dose was measured for each treatment with the detectors placed against the anterior rectal wall near the prostate rectal interface...
November 8, 2016: Journal of Applied Clinical Medical Physics
https://www.readbyqxmd.com/read/27922026/percutaneous-gastrostomy-device-for-the-treatment-of-class-ii-and-class-iii-obesity-results-of-a-randomized-controlled-trial
#7
Christopher C Thompson, Barham K Abu Dayyeh, Robert Kushner, Shelby Sullivan, Alan B Schorr, Anastassia Amaro, Caroline M Apovian, Terrence Fullum, Amir Zarrinpar, Michael D Jensen, Adam C Stein, Steven Edmundowicz, Michel Kahaleh, Marvin Ryou, J Matthew Bohning, Gregory Ginsberg, Christopher Huang, Daniel D Tran, Joseph P Glaser, John A Martin, David L Jaffe, Francis A Farraye, Samuel B Ho, Nitin Kumar, Donna Harakal, Meredith Young, Catherine E Thomas, Alpana P Shukla, Michele B Ryan, Miki Haas, Heidi Goldsmith, Jennifer McCrea, Louis J Aronne
OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m(2) were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27921374/efficacy-of-a-novel-granulocyte-monocyte-apheresis-adsorber-device-in-the-treatment-of-inflammatory-bowel-diseases-a-pilot-study
#8
Maria Di Girolamo, Alessandro Sartini, Rosina Critelli, Angela Bertani, Alberto Merighi, Erica Villa
Granulocyte monocyte apheresis (GMA) is a non-pharmacological treatment for inflammatory bowel disease. In our study, we tested a novel GMA adsorber device in terms of clinical efficacy and safety in patients' non-response to pharmacological therapy. Secondary outcomes were the evaluation of adsorber's technical performance, the reduction of inflammatory markers and the improvement of patients' life quality. The prospective study included 18 patients enrolled from 2011 to 2012 with a monitoring of 48 weeks...
December 5, 2016: Therapeutic Apheresis and Dialysis
https://www.readbyqxmd.com/read/27920513/bronchodilator-efficacy-of-18-%C3%AE-g-once-daily-tiotropium-inhalation-via-discair-%C3%A2-versus-handihaler-%C3%A2-in-adults-with-chronic-obstructive-pulmonary-disease-randomized-active-controlled-parallel-group-open-label-phase-iv-trial
#9
Pinar Yildiz, Mesut Bayraktaroglu, Didem Gorgun, Funda Secik
PURPOSE: To compare the bronchodilator efficacy of 18 μg once-daily tiotropium inhalation administered via Discair(®) versus HandiHaler(®) in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler)...
2016: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/27919609/randomised-controlled-trial-potential-benefit-of-a-footplate-neuromuscular-electrical-stimulation-device-in-patients-with-chronic-venous-disease
#10
R Ravikumar, K J Williams, A Babber, T R A Lane, H M Moore, A H Davies
OBJECTIVES: Chronic venous disease (CVD) is common, affecting a quarter of the population. Current conservative methods of treatment aim to prevent progression of disease by reducing ambulatory venous pressure. Neuromuscular electrical stimulation (NMES) refers to the use of electrical impulses to elicit muscle contraction. This pilot randomised controlled trial investigates the effect of a footplate NMES device (REVITIVE) on venous flow parameters, limb oedema, and quality of life outcome measures in patients with CVD...
December 2, 2016: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/27918772/energy-based-facial-rejuvenation-advances-in-diagnosis-and-treatment
#11
Christopher J Britt, Benjamin Marcus
Importance: The market for nonsurgical, energy-based facial rejuvenation techniques has increased exponentially since lasers were first used for skin rejuvenation in 1983. Advances in this area have led to a wide range of products that require the modern facial plastic surgeon to have a large repertoire of knowledge. Objective: To serve as a guide for current trends in the development of technology, applications, and outcomes of laser and laser-related technology over the past 5 years...
December 1, 2016: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/27916744/does-acute-coronary-syndrome-impact-on-the-incidence-of-thrombosis-after-the-implantation-of-absorb-bioresorbable-vascular-scaffold
#12
Yohei Sotomi, Yosuke Miyazaki, Carlos Colet, Taku Asano, Pannipa Suwannasom, Jan Tijssen, Robbert J de Winter, Ron Waksman, Michael J Lipinski, Yoshinobu Onuma, Patrick W Serruys
AIMS: In the drug eluting stent (DES) era, patients with acute coronary syndrome (ACS) had a higher risk of early stent thrombosis compared with stable patients. The present study evaluated whether the same is true for the bioresorbable vascular scaffold (BVS: Abbott Vascular, Santa Clara CA). METHODS AND RESULTS: We assessed the relationship between the incidence of definite/probable scaffold thrombosis (ScT) (overall ScT and early ScT) and ACS percentage with the latest publications including the most recent large randomized controlled trials...
December 6, 2016: EuroIntervention
https://www.readbyqxmd.com/read/27916592/new-developments-in-cardiac-regeneration
#13
REVIEW
Thi Yen Loan Le, Sujitha Thavapalachandran, Eddy Kizana, James Jh Chong
Numerous pharmacological and device therapies have improved adverse cardiac remodelling and mortality in heart failure. However, none are able to regenerate damaged cardiac tissue. Stem cell based therapies using multipotent (adult) stem cells and pluripotent stem cells are new approaches that could potentially achieve the elusive goal of true cardiac regeneration. Over the past two decades, various stem cell based approaches have been shown to improve left ventricular function in pre-clinical animal models...
November 19, 2016: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/27914501/levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-on-cardiopulmonary-bypass-rationale-and-study-design-of-the-levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-requiring
#14
Rajendra H Mehta, Sean Van Diepen, James Meza, Paula Bokesch, Jeffrey D Leimberger, Sandra Tourt-Uhlig, Merri Swartz, Jodi Parrotta, Rachael Jankowich, Douglas Hay, Robert W Harrison, Stephen Fremes, Shaun G Goodman, John Luber, Wolfgang Toller, Matthias Heringlake, Kevin J Anstrom, Jerrold H Levy, Robert A Harrington, John H Alexander
BACKGROUND: Low cardiac output syndrome is associated with increased mortality and occurs in 3% to 14% of patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). Levosimendan, a novel calcium sensitizer and KATP channel activator with inotropic, vasodilatory, and cardioprotective properties, has shown significant promise in reducing the incidence of low cardiac output syndrome and related adverse outcomes in patients undergoing cardiac surgery on CPB. METHODS: LEVO-CTS is a phase 3 randomized, controlled, multicenter study evaluating the efficacy, safety, and cost-effectiveness of levosimendan in reducing morbidity and mortality in high-risk patients with reduced left ventricular ejection fraction (≤35%) undergoing cardiac surgery on CPB...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914489/rationale-and-design-of-the-east-west-late-lumen-loss-study-comparison-of-late-lumen-loss-between-eastern-and-western-drug-eluting-stent-study-cohorts
#15
Robert W Harrison, Vaishnavi Radhakrishnan, Peter S Lam, Dominic J Allocco, Sandeep Brar, Martin Fahy, Rebecca Fisher, Fumiaki Ikeno, Philippe Généreux, Takeshi Kimura, Minglei Liu, Weng Kit Lye, Gary S Mintz, Hirofumi Nagai, Yuka Suzuki, Roseann White, John C Allen, Mitchell W Krucoff
BACKGROUND: The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914488/safety-of-6-month-duration-of-dual-antiplatelet-therapy-after-percutaneous-coronary-intervention-in-patients-with-acute-coronary-syndromes-rationale-and-design-of-the-smart-angioplasty-research-team-safety-of-6-month-duration-of-dual-antiplatelet-therapy-after
#16
Joo Myung Lee, Deok-Kyu Cho, Joo-Yong Hahn, Young Bin Song, Taek Kyu Park, Ju-Hyeon Oh, Jin Bae Lee, Joon-Hyung Doh, Sang-Hyun Kim, Jeong Hoon Yang, Jin-Ho Choi, Seung-Hyuck Choi, Sang Hoon Lee, Hyeon-Cheol Gwon
BACKGROUND AND RATIONALE: Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. STUDY DESIGN: The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914309/unique-approach-to-sensorimotor-training-with-a-new-device-combining-air-cushion-with-stochastic-translations-a-prospective-randomized-controlled-clinical-trial
#17
Christian Mittermaier, Maximilian Schindler, Benjamin Loader, Thomas Waldhoer, Clemens Ambrozy, Richard Crevenna, Karin Pieber
Sensorimotor training with a wide variety of available devices represents an important component in rehabilitation and prevention of different sports injuries and chronic diseases. The purpose of this study was to evaluate the effects of a sensorimotor training with a newly developed device, which consists of an instable platform moving on an air cushion, providing dynamic balance training by tilting and unanticipated stochastic translations on postural control. Seventy-two healthy young subjects were included in this prospective, randomized, controlled, and observer-blinded study...
November 25, 2016: Gait & Posture
https://www.readbyqxmd.com/read/27911868/design-and-implementation-of-a-mobile-system-for-lung-cancer-patient-follow-up-in-china-and-initial-report-of-the-ongoing-patient-registry
#18
Xiangyun Ye, Jia Wei, Ziming Li, Xiaomin Niu, Jiemin Wang, Yunqin Chen, Zongming Guo, Shun Lu
INTRODUCTION: Management of lung cancer remains a challenge. Although clinical and biological patient data are crucial for cancer research, these data may be missing from registries and clinical trials. Biobanks provide a source of high-quality biological material for clinical research; however, linking these samples to the corresponding patient and clinical data is technically challenging. We describe the mobile Lung Cancer Care system (mLCCare), a novel tool which integrates biological and clinical patient data into a single resource...
November 30, 2016: Oncotarget
https://www.readbyqxmd.com/read/27910725/an-over-the-counter-central-sensitization-therapy-a-chronic-back-pain-registry-study-of-pain-relief-medication-use-and-their-adverse-effects
#19
Richard Staelin, Sree N Koneru, Ian M Rawe
AIM: Back pain, the most prevalent musculoskeletal chronic pain condition, is usually treated with analgesic medications of questionable efficacy and frequent occurrence of adverse side effects. OBJECTIVE: The objective was to determine the effectiveness of the ActiPatch medical devices in reducing chronic back pain, document medication related adverse side effects and establish their impact on quality of life. METHODS: Upon completing a 7-day trial, subjects were contacted via email with an assessment form using the Constant Contact email program...
December 2, 2016: Pain Management
https://www.readbyqxmd.com/read/27910052/a-needleless-liquid-jet-injection-delivery-approach-for-cardiac-gene-therapy
#20
Anthony S Fargnoli, Michael G Katz, Charles R Bridges
Fundamentally, cardiac gene therapy clinical trials have demonstrated that route efficiency is paramount in achieving maximum myocardial expression within safety limits. Gene transfer phenomena are largely influenced by physical transport principles (i.e., pressure, residence time, dispersion trafficking, mechanical resistance) that are independent of therapeutic characteristics. An alternative to intracoronary infusion methods, in an effort to improve efficiency in terms of cardiac specificity, is direct myocardial delivery via surgical injection...
2017: Methods in Molecular Biology
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