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Jashvant Poeran, Mathias Opperer, Rehana Rasul, Madhu Mazumdar, Federico P Girardi, Alexander P Hughes, Stavros G Memtsoudis, Vassilios Vougioukas
Study Design Retrospective cohort study. Objective The U.S. Food and Drug Administration issued a warning in 2008 against off-label bone morphogenetic protein (BMP-2) use. We aimed to determine (off-label) BMP-2 use in two periods and associations with complications. Methods We included 340,393 patients undergoing spinal fusions from the Premier Perspective database (2006 to 2012). BMP-2 use was determined from billing in 2006 to 2008 versus 2009 to 2012. Outcomes included revisions, length of hospital stay (LOHS), and cost of hospital stay (COH)...
November 2016: Global Spine Journal
Meredith K Chuk, Yeruk Mulugeta, Michelle Roth-Cline, Nitin Mehrotra, Gregory H Reaman
The enrollment of adolescents with cancer in clinical trials is much lower than younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment on adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data is lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies...
October 25, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Pasqualino Sirignano, Francesco Speziale, Nunzio Montelione, Chiara Pranteda, Giuseppe Galzerano, Wassim Mansour, Enrico Sbarigia, Carlo Setacci
Objectives. To compare durability and survival after endovascular aneurysm repair (EVAR) and open repair (OR) of abdominal aortic aneurysms (AAAs) in young patients. Material and Methods. A retrospective study was conducted between 2005 and 2014 on all consecutive patients of 60 years of age or younger. Measures considered for analysis were reintervention related to AAA, laparotomy and access vessel injury during EVAR, and all-cause mortality during hospitalization and follow-up. Results. Seventy out of 119 patients were treated by OR (58...
2016: BioMed Research International
Jung Taek Kim, Hyung Jun Jeong, Soong Joon Lee, Hee Joong Kim, Jeong Joon Yoo
PURPOSE: Atypical femoral fracture (AFF), periprosthetic femoral fracture (PPFF) and femoral nonunion (FNU) are recalcitrant challenges for orthopedic surgeons. Teriparatide (TPTD) had been demonstrated to have anabolic effects on bone in various studies. We postulated that adjuvant TPTD after operation would enhance biologic stimulation for bone formation. We investigated (1) whether the adjuvant TPTD could achieve satisfactory union rate of surgically challenging cases such as displaced AFF, PPFF and FNU; (2) whether the adjuvant TPTD could promote development of abundant callus after surgical fixation; (3) whether the adjuvant TPTD had medically serious adverse effects...
September 2016: Hip Pelvis
Li Zhao, Marta Vidorreta, Salil Soman, John A Detre, David C Alsop
PURPOSE: To improve pseudo-continuous arterial spin labeling (PCASL) robustness to off-resonance and pulsatile blood flow velocity. METHODS: Bloch equations were solved to evaluate the effect of labeling parameters in a pulsatile flow model for a range of off-resonance. Experimental confirmation was achieved in volunteers using linear phase increase between labeling pulses to approximate off-resonance errors. We first assessed the location of the labeling plane in four volunteers...
October 23, 2016: Magnetic Resonance in Medicine: Official Journal of the Society of Magnetic Resonance in Medicine
Joan H Krause
Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the FDA against the excesses of a profit-driven marketplace. Far from ameliorating concerns over manufacturer influence, the New Model proposed by Bennett et al...
November 2015: Journal of Law and the Biosciences
Jill K Logan, Hardin Pantle
PURPOSE: The role of topical tranexamic acid in the management of anterior epistaxis in adult patients in the emergency department (ED) is examined. SUMMARY: The use of alternative agents for the treatment of epistaxis before the use of nasal packing may be reasonable due to patient discomfort, potential complications, and the need for follow-up with a healthcare provider for packing removal. One such agent is tranexamic acid. Two published studies evaluated the off-label use of topical tranexamic acid for the treatment of epistaxis...
November 1, 2016: American Journal of Health-system Pharmacy: AJHP
Emilie Hein Zobel, Bernt Johan von Scholten, Morten Lindhardt, Frederik Persson, Tine Willum Hansen, Peter Rossing
AIMS/HYPOTHESIS: Management of diabetic nephropathy includes reduction of albuminuria, blood pressure and weight. The GLP-1 receptor agonist liraglutide may possess these pleiotropic effects in addition to the glucose lowering effect. We aimed to elucidate the individual liraglutide treatment response by determining if high responders (highest reduction) in each risk factor also had high response in other renal risk factors (cross-dependency). METHODS: Open-label study: 31 type 2 diabetics treated with liraglutide for 7weeks...
September 30, 2016: Journal of Diabetes and its Complications
Kenneth M McCullough, Dennis Choi, Jidong Guo, Kelsey Zimmerman, Jordan Walton, Donald G Rainnie, Kerry J Ressler
Molecular characterization of neuron populations, particularly those controlling threat responses, is essential for understanding the cellular basis of behaviour and identifying pharmacological agents acting selectively on fear-controlling circuitry. Here we demonstrate a comprehensive workflow for identification of pharmacologically tractable markers of behaviourally characterized cell populations. Thy1-eNpHR-, Thy1-Cre- and Thy1-eYFP-labelled neurons of the BLA consistently act as fear inhibiting or 'Fear-Off' neurons during behaviour...
October 21, 2016: Nature Communications
Sofian Berrouiguet, Maria Luisa Barrigón, Sara A Brandt, Santiago Ovejero-García, Raquel Álvarez-García, Juan Jose Carballo, Philippe Lenca, Philippe Courtet, Enrique Baca-García
PURPOSE: The emergence of electronic prescribing devices with clinical decision support systems (CDSS) is able to significantly improve management pharmacological treatments. We developed a web application available on smartphones in order to help clinicians monitor prescription and further propose CDSS. METHOD: A web application ( was developed to assess patients and collect data regarding gender, age, diagnosis and treatment. We analyzed antipsychotic prescriptions in 4345 patients attended in five Psychiatric Community Mental Health Centers from June 2014 to October 2014...
2016: PloS One
Clemens Glombitza, Rishi R Adhikari, Natascha Riedinger, William P Gilhooly, Kai-Uwe Hinrichs, Fumio Inagaki
Sulfate reduction is the predominant anaerobic microbial process of organic matter mineralization in marine sediments, with recent studies revealing that sulfate reduction not only occurs in sulfate-rich sediments, but even extends to deeper, methanogenic sediments at very low background concentrations of sulfate. Using samples retrieved off the Shimokita Peninsula, Japan, during the Integrated Ocean Drilling Program (IODP) Expedition 337, we measured potential sulfate reduction rates by slurry incubations with (35)S-labeled sulfate in deep methanogenic sediments between 1276...
2016: Frontiers in Microbiology
Dennis Bourdette
No abstract text is available yet for this article.
October 19, 2016: Neurology
Jonatan Salzer, Rasmus Svenningsson, Peter Alping, Lenka Novakova, Anna Björck, Katharina Fink, Protik Islam-Jakobsson, Clas Malmeström, Markus Axelsson, Mattias Vågberg, Peter Sundström, Jan Lycke, Fredrik Piehl, Anders Svenningsson
OBJECTIVE: To investigate the safety and efficacy of rituximab in multiple sclerosis (MS). METHODS: In this retrospective uncontrolled observational multicenter study, off-label rituximab-treated patients with MS were identified through the Swedish MS register. Outcome data were collected from the MS register and medical charts. Adverse events (AEs) grades 2-5 according to the Common Terminology Criteria for Adverse Events were recorded. RESULTS: A total of 822 rituximab-treated patients with MS were identified: 557 relapsing-remitting MS (RRMS), 198 secondary progressive MS (SPMS), and 67 primary progressive MS (PPMS)...
October 19, 2016: Neurology
Aline Iannone, Antonio Pedro de Mello Cruz, Joaquim Pereira Brasil-Neto, Raphael Boechat-Barros
Transcranial magnetic stimulation (TMS) has recently been investigated as a possible adjuvant treatment for many neuropsychiatric disorders, and has already been approved for the treatment of drug-resistant depression in the United States and in Brazil, among other countries. Although its use in other neuropsychiatric disorders is still largely experimental, many physicians have been using it as an off-label add-on therapy for various disorders. More recently, another technique, transcranial direct current stimulation (tDCS), has also become available as a much cheaper and portable alternative to TMS, although its mechanisms of action are different from those of TMS...
October 2016: Arquivos de Neuro-psiquiatria
Takayuki Warisawa, Toru Naganuma, Sunao Nakamura
We report a case of percutaneous coronary intervention in a bifurcation lesion involving left circumflex (LCx) artery and 2 major posterolateral (PL) arteries. The target LCx had diffuse long and severely calcified lesion with the acute takeoff angle from the left main. Despite adequate lesion preparation with rotational atherectomy and balloon angioplasty, the stent was not deliverable, even with deep intubation of 7Fr-guiding catheter. Conventional use of guiding extension catheter (GEC) would have required removal of a wire from at least one PL because of the device interference in the GEC...
October 18, 2016: Cardiovascular Intervention and Therapeutics
S K Plontke, G Götze, T Rahne, A Liebau
Local drug application to the inner ear offers a number of advantages over systemic delivery. Local drug therapy currently encompasses extracochlear administration (intratympanic injection); intracochlear administration, particularly for gene and stem cell therapy; as well as various combinations with auditory neurosensory prostheses, either evaluated in preclinical or clinical studies, or off-label. To improve rehabilitation with cochlear implants (CI), one focus is the development of drug-releasing electrode carriers, e...
October 18, 2016: HNO
Huan Mark Nguyen, Doreen Pon
OBJECTIVE: Evaluate recent clinical studies involving the use of dexmedetomidine (DEX) infusion for the treatment of delirium in the intensive care unit (ICU). METHODS: A literature search was conducted to identify peer-reviewed articles in MEDLINE (1966-June 2016) using the terms sedation, analgesic, dexmedetomidine, delirium, and critically ill adult patients. RESULTS: Two studies in the ICU setting reported the potential benefits of DEX for managing agitation during weaning from mechanical ventilation...
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
Miriam Jauset-Rubio, Markéta Svobodová, Teresa Mairal, Calum McNeil, Neil Keegan, Mohammad S El-Shahawi, Abdulaziz S Bashammakh, Abdulrahman O Alyoubi, Ciara K O'Sullivan
In this work, different methodologies were evaluated in search of robust, simple, rapid, ultrasensitive, and user-friendly lateral flow aptamer assays. In one approach, we developed a competitive based lateral flow aptamer assay, in which β-conglutin immobilized on the test line of a nitrocellulose membrane and β-conglutin in the test sample compete for binding to AuNP labeled aptamer. The control line exploits an immobilized DNA probe complementary to the labeled aptamer, forcing displacement of the aptamer from the β-conglutin-aptamer complex...
October 18, 2016: Analytical Chemistry
Jennifer L Schroeck, James Ford, Erin L Conway, Kari E Kurtzhalts, Megan E Gee, Krista A Vollmer, Kari A Mergenhagen
PURPOSE: Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. METHODS: A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population...
October 14, 2016: Clinical Therapeutics
Giulio Illuminati, Francesco G Calio', Giulia Pizzardi, Chiara Amatucci, Federica Masci, Piergaspare Palumbo
INTRODUCTION: Intra and perioperative anticoagulation in patients with heparin induced thrombocytopenia (HIT), candidates for peripheral vascular surgery remains a challenge, as the best alternative to heparin has not yet been established. We evaluated the off-label use of fondaparinux in four patients with HIT, undergoing peripheral vascular surgery procedures. PRESENTATION OF CASES: Four patients of whom 3 men of a mean age of 66 years, with proven heparin induced thrombocytopenia (HIT) underwent two axillo-femoral bypasses, one femoro-popliteal bypass and one resection of a splenic artery aneurysm under fondaparinux...
October 8, 2016: International Journal of Surgery Case Reports
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