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Freedom trial

Jose A Morfin, Richard J Fluck, Eric D Weinhandl, Sheru Kansal, Peter A McCullough, Paul Komenda
Hemodialysis (HD) treatment can be difficult to tolerate. Common complications are intradialytic hypotension (IDH) and long time to recovery after an HD session. IDH, as defined by nadir systolic blood pressure < 90mmHg and intradialytic decline > 30mmHg, occurs in almost 8% of HD sessions. IDH may be caused by aggressive ultrafiltration in response to interdialytic weight gain, can lead to myocardial stunning and cardiac arrhythmias, and is associated with increased risk for death. Long recovery time after a treatment session is also common...
November 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
George L Bakris, John M Burkart, Eric D Weinhandl, Peter A McCullough, Michael A Kraus
Hypertension is a cardinal feature of end-stage renal disease (ESRD). Hypertensive nephropathy is the primary cause of ESRD for nearly 30% of patients, and the prevalence of hypertension is >85% in new patients with ESRD. In contemporary hemodialysis (HD) patients, mean predialysis systolic blood pressure (SBP) is nearly 150mmHg, and about 70%, 50%, and 40% use β-blockers, calcium channel blockers, and renin-angiotensin system inhibitors, respectively. Predialysis SBP generally exhibits a U-shaped association with mortality risk...
November 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Gijsbert D Musters, Charlotte E L Klaver, Robbert J I Bosker, Jacobus W A Burger, Peter van Duijvendijk, Boudewijn van Etten, Anna A W van Geloven, Eelco J R de Graaf, Christiaan Hoff, Jeroen W A Leijtens, Harm J T Rutten, Baljit Singh, Ronald J C L M Vuylsteke, Johannes H W de Wilt, Marcel G W Dijkgraaf, Willem A Bemelman, Pieter J Tanis
OBJECTIVE: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). BACKGROUND: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. METHODS: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm)...
September 20, 2016: Annals of Surgery
Mu Qin, Xu Liu, Shao-Hui Wu, Xiao-Dong Zhang
Several clinically relevant outcomes post atrial substrate modification in patients with atrial fibrillation (AF) have not been systematically analyzed among published studies on adjunctive cardiac ganglionated plexi (GP) or complex fractionated atrial electograms (CFAE) ablation vs. pulmonary vein isolation (PVI) alone. Out of 176 reports identified, the present meta-analysis included 14 randomized and non-randomized controlled trials (1613 patients) meeting inclusion criteria. Addition of GP ablation to PVI significantly increased freedom from atrial tachyarrhythmia in short- (OR: 1...
2016: PloS One
Katherine J Hahn, Shannon J Morales, James H Lewis
Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the patient was asymptomatic but he developed liver aminotransferase elevations: AST 340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a Roussel Uclaf Causality Assessment Method score of 10, giving a high probable likelihood that enoxaparin was the cause of hepatic injury...
December 2015: Drug Saf Case Rep
Ali Talasaz, Ana Luisa Trejos, Rajni Patel
The lack of haptic feedback in roboticsassisted surgery can result in tissue damage or accidental tool-tissue hits. This paper focuses on exploring the effect of haptic feedback via direct force reflection and visual presentation of force magnitude on performance during robotics-assisted minimally invasive surgery (RAMIS) suturing. For this purpose, a haptics-enabled dual-arm master-slave teleoperation system capable of measuring tool-tissue interaction forces in all 7 Degrees-of-Freedom (DOFs) was used. Two suturing tasks, tissue puncturing and knottightening, were chosen to assess user skills when suturing on phantom tissue...
October 12, 2016: IEEE Transactions on Haptics
Robert J Fox, Andrew Chan, Annie Zhang, James Xiao, Dane Levison, James B Lewin, Michael R Edwards, Jing L Marantz
Objective Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) and fingolimod are approved oral disease-modifying treatments for relapsing-remitting multiple sclerosis. In phase 3 trials, DMF (DEFINE/CONFIRM) and fingolimod (FREEDOMS/FREEDOMS II) resulted in significant reductions in clinical and magnetic resonance imaging activity, with acceptable safety profiles. Direct comparisons of these treatments are not possible due to a lack of head-to-head trials. We compared 2-year efficacy of DMF versus fingolimod at the approved dosage using a matching-adjusted indirect approach...
October 13, 2016: Current Medical Research and Opinion
Richard B Lipton, Sagar Munjal, Dawn C Buse, Kristina M Fanning, Alix Bennett, Michael L Reed
BACKGROUND: Pain freedom at 2 hours and sustained pain response at 24 hours are important outcomes of acute migraine therapy. Some studies have examined rates and predictors of successful treatment outcomes for single attacks in clinical trials. However, little is known about predictors of typical response to acute treatment over multiple attacks in the population. OBJECTIVES: To identify sociodemographic features, headache characteristics, comorbidities and treatment-related factors that predict acute treatment success or failure at 2 hours and 24 hours post dose in a US population sample of persons with episodic migraine...
October 12, 2016: Headache
Shaun A Hussain, Gary W Mathern, Raman Sankar, Joyce Y Wu
OBJECTIVE: Fast ripples (FR, 250-500Hz) are proposed biomarkers of the epileptogenic zone on the basis of several retrospective reports linking postoperative seizure freedom to their complete resection. There are no clinical trials or prospective reports validating the use of FR as characterized by electrocorticography (ECoG), to guide the scope of epilepsy surgery, and to inform prognosis thereafter. We set out to prospectively evaluate the utility of FR resection to predict postoperative epilepsy outcomes, and examine the feasibility of "live" intraoperative FR ascertainment...
September 23, 2016: Epilepsy Research
M Baulac, W Byrnes, P Williams, S Borghs, E Webster, M De Backer, P Dedeken
OBJECTIVE: To assess prospectively the effectiveness of lacosamide (LCM) added to levetiracetam (LEV) after down-titration of a concomitant sodium channel blocker (SCB) among patients with focal epilepsy not adequately controlled on LEV and SCB. METHODS: In this open-label trial, LCM was initiated at 100 mg/day and up-titrated to 200-600 mg/day over 9 weeks; SCB down-titration started when LCM dose reached 200 mg/day. Patients remained on stable LCM/LEV doses for 12 weeks' maintenance (21-week treatment period)...
October 6, 2016: Acta Neurologica Scandinavica
Francesco Brigo, Nicola Luigi Bragazzi, Raffaele Nardone, Eugen Trinka
BACKGROUND: Brivaracetam (BRV), eslicarbazepine acetate (ESL), lacosamide (LCM), and perampanel (PER) have been recently marketed as adjunctive treatments for focal onset seizures. To date, no randomized controlled trial (RCT) has directly compared BRV with ESL, LCM, or PER. PURPOSE: To compare BRV with the other add-on AEDs in patients with uncontrolled focal epilepsy, estimating their efficacy and tolerability through an adjusted, common-reference based indirect comparison meta-analysis...
September 24, 2016: Seizure: the Journal of the British Epilepsy Association
Sheldon M Singh, Andre d'Avila, Young-Hoon Kim, Arash Aryana, J Michael Mangrum, Gregory F Michaud, Srinivas R Dukkipati, Conor D Barrett, E Kevin Heist, Michael K Parides, Kevin E Thorpe, Vivek Y Reddy
AIMS: Controversy on the optimal ablation strategy for persistent atrial fibrillation (AF) exists with limited work evaluating a strategy of pulmonary vein isolation (PVI) alone when AF terminates during PVI. Thirty-five patients had AF termination during PVI in the Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF; number: NCT01014741) study. The objective of the current study is to report the 1-year outcome after PVI alone in this unique patient group...
October 4, 2016: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
Benjamin W Starnes, Rachel E Heneghan, Billi Tatum
OBJECTIVE: The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair. METHODS: Data from a nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on May 31, 2015, with outcomes analysis through December 31, 2015...
September 26, 2016: Journal of Vascular Surgery
Thomas K Jones, Jonathan J Rome, Aimee K Armstrong, Felix Berger, William E Hellenbrand, Allison K Cabalka, Lee N Benson, David T Balzer, John P Cheatham, Andreas Eicken, Doff B McElhinney
BACKGROUND: Tricuspid regurgitation (TR) is a common and important comorbidity in patients with postoperative right ventricular outflow tract (RVOT) obstruction or pulmonary regurgitation (PR). Transcatheter pulmonary valve replacement (TPVR) has become a useful tool in the management of postoperative RVOT obstruction and PR, but it is unknown whether relief of the right ventricular volume and/or pressure overload by TPVR will have a beneficial effect on TR, as is often seen with surgical pulmonary valve replacement...
October 4, 2016: Journal of the American College of Cardiology
Zaina T Al-Salama, Lesley J Scott
Sumatriptan nasal powder delivered by a breath powered delivery device (ONZETRA(®) Xsail(®)) is indicated for the acute treatment of migraine with or without aura in adults. This narrative review discusses the clinical use of sumatriptan nasal powder in this population and summarizes its pharmacological properties. In migraineurs, sumatriptan nasal powder treatment was associated with significantly greater rates of pain relief than placebo from 0.5-2 h postdose after a single treatment in the phase 3 TARGET trial, with these benefits sustained at 24 and 48 h postdose...
October 2016: Drugs
Ian L Valerio, Jennifer M Sabino, Christopher L Dearth
Background: A large volume of service members have sustained complex injuries during Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF). These injuries are complicated by contamination with particulate and foreign materials, have high rates of bacterial and/or fungal infections, are often composite-type defects with massive soft tissue wounds, and usually have multisystem involvement. While traditional treatment modalities remain a mainstay for optimal wound care, traditional reconstruction approaches alone may be inadequate to fully address the scope and magnitude of such massive complex wounds...
September 1, 2016: Advances in Wound Care
Zhen Hong, Yushi Inoue, Weiping Liao, Hongmei Meng, Xuefeng Wang, Wenmin Wang, Liemin Zhou, Liming Zhang, Xinlu Du, Frank Tennigkeit
OBJECTIVE: To evaluate the efficacy and safety of adjunctive lacosamide treatment in Chinese and Japanese adults with uncontrolled focal (partial-onset) seizures (POS), with or without secondary generalization. METHODS: A 24-week, randomized, double-blind, placebo-controlled study (EP0008; NCT01710657) was conducted in patients (aged 16-70 years) with uncontrolled POS and taking 1-3 concomitant antiepileptic drugs from 72 sites across China and Japan. Following an 8-week Baseline period, randomized patients received lacosamide 200mg/day (100mg twice daily), 400mg/day (200mg twice daily), or placebo for 4-week Titration and 12-week Maintenance periods...
September 1, 2016: Epilepsy Research
Nicolas Noiseux, Samer Mansour, Richard Weisel, Louis-Mathieu Stevens, Shant Der Sarkissian, Katherine Tsang, Andrew M Crean, Eric Larose, Shu-Hong Li, Bernd Wintersperger, Minh Quan Vu, Ignacio Prieto, Ren-Ke Li, Denis Claude Roy, Terrence M Yau
OBJECTIVES: The IMPACT-CABG trial is the first North American multicenter phase II randomized study of intramyocardial delivery of autologous CD133(+) stem cells in patients with chronic ischemic cardiomyopathy undergoing coronary artery bypass grafting. The primary objective was to demonstrate safety, including freedom from major adverse cardiac events. The secondary objective was to evaluate feasibility of same-day autologous cell preparation. Although the trial was not powered to evaluate LV function, exploratory data were collected...
August 13, 2016: Journal of Thoracic and Cardiovascular Surgery
Alexander Pott, Marvin Messemer, Kerstin Petscher, Mario Iturbe-Orbe, Carlo Bothner, Wolfgang Rottbauer, Tillman Dahme
BACKGROUND: Pulmonary vein isolation is an established therapy for symptomatic atrial fibrillation. Despite the fact that incidence and prevalence of atrial fibrillation increases with age, patients over 75 years of age have been excluded in all major atrial fibrillation ablation trials. Pulmonary vein isolation with the cryoballoon has been shown to be equally effective compared to irrigated radiofrequency catheter ablation, but patients over 75 years have also been excluded. The 2nd generation cryoballoon has shown superior efficacy compared to the 1st generation cryoballoon...
September 17, 2016: Journal of Cardiology
Joshua L Chan, Jon A Kobashigawa, Heidi J Reich, Danny Ramzy, Maria M Thottam, Zhe Yu, Tamar L Aintablian, Frank Liou, Jignesh K Patel, Michelle M Kittleson, Lawrence S Czer, Alfredo Trento, Fardad Esmailian
BACKGROUND: The Organ Care System, an ex-vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. It is unknown whether using the Organ Care System influences 2-year outcomes after heart transplantation. We reviewed our institutional experience to compare 2-year outcomes for patients randomized to the Organ Care System or standard cold storage. METHODS: Between 2011 and 2013, heart transplant candidates from a single tertiary-care medical center enrolled within the PROCEED II trial were randomized to either standard cold storage or the Organ Care System...
August 20, 2016: Journal of Heart and Lung Transplantation
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