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18: How has the U.S. Food and Drug Administration morcellation warning affected rates of minimally invasive hysterectomy in a large multi-center managed care setting?
Hysterectomy is the most common major gynecologic procedure in the world. Minimally invasive surgery is preferred to laparotomy due to its well-known benefits including lower blood loss, fewer perioperative complications, shorter hospital stay, quicker recovery time, and better cosmetic results. In 2014, the FDA issued a warning against the use of laparoscopic power morcellation in the majority of women undergoing myomectomy and hysterectomy for the treatment of fibroids, citing the risk of dissemination of an occult malignancy. (Source: American Journal of Obstetrics and Gynecology)
Source: American Journal of Obstetrics and Gynecology - February 27, 2017 Category: OBGYN Authors: S. Saadat, D. Arden Tags: Oral Presentation Source Type: research

[Evaluating the efficacy of long acting injectable antipsychotics through clinical trials].
Authors: Fakra E, Azorin JM, Belzeaux R, Adida M, Blin O, Kaladjian A Abstract After reminding the various phases of the development of molecules, this article will state the stages of commercialisation of treatments, underlining the FDA (Food and Drug Administration) and the EMA (European Medicine Agency) requirements. Like all the other treatments available in Europe and in the United States, the long acting injectable antipsychotics (LAI) have to prove their efficacy compared to placebo and their non-inferiority compared to a treatment of reference, usually the same molecule in the oral form. These criteria of e...
Source: L Encephale - February 27, 2017 Category: Psychiatry Tags: Encephale Source Type: research

Patient Experience of Sentinel Lymph Node Biopsy for Melanoma
Sentinel lymph node biopsy (SLNB) has become an established investigation for assessing microscopic nodal metastasis in melanoma. In a 10-year review of SLNB for melanoma at a single institution, our unit reported a complication rate of 6%1. Despite the widespread use of SLNB for melanoma there are no studies that evaluate patient experience. A method of identifying this information is the study of patient reported outcome measures (PROMs), defined by the Food and Drug Administration as a “measurement of any aspect of a patient's health status that comes directly from the patient”. (Source: Journal of Plastic, Reconstr...
Source: Journal of Plastic, Reconstructive and Aesthetic Surgery - February 26, 2017 Category: Cosmetic Surgery Authors: Hazim Sadideen, Shobhit Saxena, Thomas D. Dobbs, Titus Adams Tags: Correspondence and Communications Source Type: research

FDA Benchmark Medical Device Flow Models for CFD Validation
Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent grou...
Source: ASAIO Journal - February 25, 2017 Category: Medical Equipment Tags: Biomedical Engineering Source Type: research

Comparison of Luminex NxTAG Respiratory Pathogen Panel and xTAG Respiratory Viral Panel FAST Version 2 for the Detection of Respiratory Viruses.
Authors: Lee CK, Lee HK, Ng CW, Chiu L, Tang JW, Loh TP, Koay ES Abstract Owing to advancements in molecular diagnostics, recent years have seen an increasing number of laboratories adopting respiratory viral panels to detect respiratory pathogens. In December 2015, the NxTAG respiratory pathogen panel (NxTAG RPP) was approved by the United States Food and Drug Administration. We compared the clinical performance of this new assay with that of the xTAG respiratory viral panel (xTAG RVP) FAST v2 using 142 clinical samples and 12 external quality assessment samples. Discordant results were resolved by using a laborat...
Source: Annals of Laboratory Medicine - February 24, 2017 Category: Laboratory Medicine Tags: Ann Lab Med Source Type: research

Belladonna found in certain homeopathic teething tablets
The U.S. Food and Drug Administration announced Jan. 29 that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - February 24, 2017 Category: Psychiatry Tags: From the FDA Source Type: research

FDA Promotes Safe Use of OTC Medications
* The Food and Drug Administration (FDA) has updated the labeling of all over-the-counter (OTC) medications to promote clarity and understanding. * Nurses can use several free resources from the FDA to help educate the public on reading and interpreting OTC labels. (Source: AJN)
Source: AJN - February 23, 2017 Category: Nursing Tags: Drug Watch Source Type: research

FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis.
Abstract On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Company) for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The approval was based on efficacy and safety data demonstrated in an open-label, randomized study of 821 patients with advanced RCC who progressed after at least one anti-angiogenic therapy. Patients were randomized to nivolumab or everolimus and followed for disease progression. The primary end point was overall survival. Subsequent therapies, including everolimus for patients who devel...
Source: The Oncologist - February 23, 2017 Category: Cancer & Oncology Authors: Xu JX, Maher VE, Zhang L, Tang S, Sridhara R, Ibrahim A, Kim G, Pazdur R Tags: Oncologist Source Type: research

Hyaluronic Acid Fillers in Soft Tissue Regeneration
Facial plast Surg 2017; 33: 087-096 DOI: 10.1055/s-0036-1597685Over the last years, hyaluronic acid (HA) injectable dermal fillers (DFs) have become the most popular agents for soft tissue contouring and volumizing. HA fillers are characterized by most of the properties that an ideal DF should have, due to HA unique chemical-physical properties, biocompatibility, biodegradability, and versatility. Therefore, HA DFs have revolutionized the filler market with a high number of products, which differ in terms of HA source, cross-linkage (agent and degree), HA concentration, hardness, cohesivity, consistency, inclusion or lack ...
Source: Facial Plastic Surgery - February 22, 2017 Category: Cosmetic Surgery Authors: Fallacara, Arianna Manfredini, Stefano Durini, Elisa Vertuani, Silvia Tags: Rapid Communication Source Type: research

Useful vs Misleading Evidence in Observational Research
Few issues can be more important to physicians or patients than that treatment decisions are based on reliable information about benefits and harms. While randomized clinical trials (RCTs) are generally regarded as the most valid source of evidence about benefits and some harms, concerns about their generalizability, costs, and heterogeneity of treatment effects have led to the search for other sources of information to augment or possibly replace trials. This is embodied in the recently passed 21st Century Cures Act, which mandates that the US Food and Drug Administration develop rules for the use of “real world evidenc...
Source: JAMA - February 21, 2017 Category: Journals (General) Source Type: research

When is proton pump inhibitor use appropriate?
Proton pump inhibitor (PPI) therapy is commonly used outside of Food and Drug Administration indication for a broad range of conditions such as extra-esophageal reflux and PPI-responsive esophageal eosinophili... (Source: BMC Medicine)
Source: BMC Medicine - February 21, 2017 Category: Internal Medicine Authors: Rena Yadlapati and Peter J. Kahrilas Source Type: research

Green Laser induced foveal cyst sustained in a recreational laser light show
We report the case of a 9-year-old boy complained of visual loss in his right eye after watching green laser light show being hit by a ray of a laser at shopping center before five days ago. The laser had a maximum power rating of 30 mW (US Food and Drug Administration class IIIB). Best-corrected visual acuity in his right eye was 0.2 with Snellen at 5 days after the injury. Dilated fundoscopic examination demonstrated a macular hole apperiance in the right eye. Spectral domain optical coherence tomography (OCT, Spectralis, Heidelberg Engineering, Heidelberg, Germany) demonstrate a steep fovea contour, a thickening of the ...
Source: Saudi Journal of Ophthalmology - February 21, 2017 Category: Opthalmology Source Type: research

Error in Text
This article was corrected online. (Source: JAMA - Journal of the American Medical Association)
Source: JAMA - Journal of the American Medical Association - February 20, 2017 Category: Journals (General) Source Type: research

The European Medicines Agency and Clinical Study Reports
This Viewpoint argues that publication by the European Medicines Agency of clinical study reports as part of its approval process for commercial drugs sets a standard of transparency that could challenge the reputation of the US Food and Drug Administration as the international standard-bearer in drug and device approval. (Source: JAMA - Journal of the American Medical Association)
Source: JAMA - Journal of the American Medical Association - February 20, 2017 Category: Journals (General) Source Type: research

Multiple Sclerosis and Autologous Hematopoietic Stem Cell Transplantation
There have been treatments approved by the US Food and Drug Administration for relapsing-remitting multiple sclerosis (RRMS) for more than 20 years. During this time, the efficacy of newly approved therapies has steadily improved, and we are now seeing that many patients do well with these treatments. Some patients have fared so well with treatments that neurologists have begun to use the term NEDA (no evidence of disease activity) to describe patients with multiple sclerosis (MS) who do not experience relapses, disability progression, or new lesions on magnetic resonance imaging, which is becoming the new goal of MS thera...
Source: JAMA Neurology - February 20, 2017 Category: Neurology Source Type: research

First UHPLC –MS/MS method coupled with automated online SPE for quantification both of tacrolimus and everolimus in peripheral blood mononuclear cells and its application on samples from co‐treated pediatric patients.
Tacrolimus (TAC, FK‐506) and everolimus (EVE, RAD001) are immunosuppressors used to treat pediatric patients undergoing liver transplantation. Their hematic TDM by liquid chromatography became standard practice. However, it does not always reflect concentrations at their active site. Our aim was to develop and validate a new method for the simultaneous TAC and EVE quantification into target cells: peripheral blood mononuclear cells (PBMCs). Peripheral blood mononuclear cells were collected using cell preparation tubes; cells number and mean cell volume were evaluated by an automatic cell counter. TAC and EVE were quantif...
Source: Journal of Mass Spectrometry - February 20, 2017 Category: Chemistry Authors: Debora Pensi, Amedeo De Nicol ò, Michele Pinon, Clarissa Pisciotta, Pier Luigi Calvo, Antonello Nonnato, Renato Romagnoli, Francesco Tandoi, Giovanni Di Perri, Antonio D'Avolio Tags: Featured article Source Type: research

Breaking ground for psychological science: The U.S. Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) regulates products accounting for 20% of U.S. consumer spending. Many of its actions depend on assumptions about behavior. Will people heed food recall notices? Will they follow medication schedules? Will they have realistic expectations regarding the benefits and risks of new products? Over time, FDA has increasingly made psychology integral to its processes for answering such questions. That progress has come when windows of opportunity have found psychologists with science relevant to FDA ’s needs, FDA with staff who can translate that research into agency terms, and a regul...
Source: American Psychologist - February 20, 2017 Category: Psychiatry & Psychology Authors: Fischhoff, Baruch Source Type: research

Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States
Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. (Source: Journal...
Source: Journal of Vascular Surgery - February 19, 2017 Category: Surgery Authors: Jessica P. Simons, Bing Shue, Julie M. Flahive, Francesco A. Aiello, Robert C. Steppacher, Elizabeth A. Eaton, Louis M. Messina, Andres Schanzer Tags: Clinical paper Source Type: research

Targeting phosphodiesterase 5 as a therapeutic option against myocardial ischemia/reperfusion injury and in treating heart failure
Abstract Phosphodiesterase type 5 (PDE5) selectively hydrolyses the second messenger cyclic 3´‐5´guanosine monophosphate (cGMP) into 5’‐GMP, thereby regulating its intracellular concentrations. Dysregulation of the cGMP‐dependent pathway plays a significant role in various cardiovascular diseases. Therefore, its modulation by drugs, such as PDE5 inhibitors, may represent an effective therapeutic approach. There are currently four PDE5 inhibitors available for the treatment of erectile dysfunction: sildenafil, vardenafil, tadalafil, and avanafil. Sildenafil and tadalafil also received Food and Drug Administration ...
Source: British Journal of Pharmacology - February 18, 2017 Category: Drugs & Pharmacology Authors: Sevil Korkmaz ‐Icöz, Tamás Radovits, Gábor Szabó Tags: REVIEW ARTICLE THEMED ISSUE Source Type: research

We thank Dr Galvis and colleagues for their correspondence. The European Society of Cataract and Refractive Surgeons reported in 2007 the only randomized clinical trial (RCT) evaluating the use of intracameral antibiotics for endophthalmitis prophylaxis during cataract surgery.1 However, this study was limited by the relatively high rates of endophthalmitis in eyes not randomized to receive intracameral cefuroxime, the use of topical levofloxacin, and the use of multiple surgical techniques. The US Food and Drug Administration requires ≥2 consistent trials for good reason. (Source: Ophthalmology)
Source: Ophthalmology - February 17, 2017 Category: Opthalmology Authors: Stephen G. Schwartz, Harry W. Flynn, Andrzej Grzybowski, Nidhi Relhan, Frederick L. Ferris Tags: Correspondence Source Type: research

Antagonist Treatment for Opioid Use Disorder
In the editorial “Using science to battle stigma in addressing the opioid epidemic: opioid agonist therapy saves lives,”1 Sarah Wakeman astutely emphasizes the current underutilization of medication-assisted treatments for opioid use disorders, despite the striking evidence behind their effectiveness. The editor ial, however, focuses solely on agonist therapy, without mention of US Food and Drug Administration (FDA)-approved antagonist therapy (ie, extended-release injection naltrexone [XR-NTX]), available in the United States as VIVITROL. (Source: The American Journal of Medicine)
Source: The American Journal of Medicine - February 17, 2017 Category: Journals (General) Authors: Bernard L. Silverman, Sarah C. Akerman Tags: AJM online Source Type: research

An international vascular registry infrastructure for medical device evaluation and surveillance †
The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - February 17, 2017 Category: Surgery Authors: Art Sedrakyan, Jack L. Cronenwett, Maarit Venermo, Larry Kraiss, Danica Marinac-Dabic, Martin Bj örck Tags: Special communication Source Type: research

Inactivation of Salmonella Enteritidis PT30 on the surface of unpeeled almonds by cold plasma
In this study the inactivation of Salmonella Enteritidis PT 30 (ATCC BAA-1045) on the surface of unpeeled almonds by cold atmospheric pressure plasma was investigated. Air, O2, N2, CO2 and 90% CO2 +10% Ar were used as process gas. Inoculum preparation and inoculation of almonds was done according to the guidelines recommended by the Almond Board of California. Furthermore, impact of plasma treatment on product color was measured. All plasma treatments inactivated Salmonella. Maximum achieved inactivation depends on the used process gas. Air plasma inactivated >5.0 log10, O2 plasma 4.8 and N2 plasma 2.0 log10 after 1...
Source: Innovative Food Science and Emerging Technologies - February 17, 2017 Category: Food Science Source Type: research

Modern multiple myeloma therapy: deep, sustained treatment response and good clinical outcomes
Abstract In the USA at the beginning of this century, the average overall survival in patients with multiple myeloma was about 3 years. Around that time, three drugs (bortezomib, lenalidomide and thalidomide) were introduced for the treatment of multiple myeloma and, in 2012, carfilzomib received accelerated approval by the US Food and Drug Administration (FDA). Driven by access to better drugs, median overall survival in younger patients (aged <50 years) was >10 years by 2014. The FDA approved 14 new drugs for the treatment of cancer in 2015; four of these were approved for the treatment of myeloma (panobinostat, da...
Source: Journal of Internal Medicine - February 16, 2017 Category: Internal Medicine Authors: O. Landgren, K. Iskander Tags: Review Source Type: research

Design and rationale of the EBBINGHAUS trial: A phase 3, double ‐blind, placebo‐controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid‐lowering therapy—A cognitive study of patients enrolled in the FOURIER trial
Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin‐type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long‐term PCSK9i use and cognition changes. Patients with prior cardiovascular disease treated with maximally tolerated statin enrolled in FOURIER (the randomized, double‐blind, placebo‐controlled cardiovascular outcome study of the PCSK9i evolocumab) could participate in this ...
Source: Clinical Cardiology - February 16, 2017 Category: Cardiology Authors: Robert P. Giugliano, Francois Mach, Kenton Zavitz, Christopher Kurtz, Jingjing Schneider, Huei Wang, Anthony Keech, Terje R. Pedersen, Marc S. Sabatine, Peter S. Sever, Narimon Honarpour, Scott M. Wasserman, Brian R. Ott, Tags: TRIAL DESIGNS Source Type: research

Women in Clinical Trials —Sex Matters
In 2016, the United States Food and Drug Administration (FDA) Office of Women ’s Health and the National Institutes of Health (NIH) Office of Research on Women’s Health launched an initiative, “Diverse Women in Clinical Trials,” an outreach effort to increase the number of women and minorities as participants and investigators in clinical research.1 The NIH is mandate d to ensure that women and minority groups are sufficiently represented in clinical research based on the question under study. The Office of Research on Women’s Health and a national data system were established for collection and dissemination of ...
Source: The Journal for Nurse Practitioners - February 16, 2017 Category: Nursing Authors: Denise G. Link Tags: Quality Care for Women ’s Health Source Type: research

A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One Year Follow-up Results – Letter to the Editor
(Source: The Journal of Minimally Invasive Gynecology)
Source: The Journal of Minimally Invasive Gynecology - February 16, 2017 Category: OBGYN Authors: Vance McCausland, Arthur McCausland Tags: LETTER TO THE EDITOR Source Type: research

Simultaneous determination of the bioactive components in rat plasma by UPLC-MS/MS and application in pharmacokinetic studies after oral administration of Radix scutellariae extract.
Abstract A highly sensitive and rapid ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) has been developed and validated for simultaneous quantification of the four main bioactive compounds, i.e., baicalin, baicalein, wogonoside and wogonin in rat plasma after oral administration of Radix scutellariae extract. Clarithromycin was used as an internal standard (IS). Plasma samples were processed by protein precipitation with methanol. The separation was performed on an Acquity BEH C18 column (100 mm × 2.1 mm, 1.7 µm) at a flow rate of 0.4 mL/min, using 0.1% formic acid-acetoni...
Source: Biomedical Chromatography : BMC - February 16, 2017 Category: Biomedical Science Authors: Tao JH, Xu J, Jiang S, Ling Y, Wang DG Tags: Biomed Chromatogr Source Type: research

A Review of the Antiviral Properties of Black Elder (Sambucus nigra L.) Products
Black elder (Sambucus nigra L.) has a long ethnobotanical history across many disparate cultures as a treatment for viral infection and is currently one of the most‐used medicinal plants worldwide. Until recently, however, substantial scientific research concerning its antiviral properties has been lacking. Here, we evaluate the state of current scientific research concerning the use of elderberry extract and related products as antivirals, particularly in the treatment of influenza, as well as their safety and health impacts as dietary supplements. While the extent of black elder's antiviral effects are not well known, ...
Source: Phytotherapy Research - February 15, 2017 Category: Biochemistry Authors: Randall S. Porter, Robert F. Bode Tags: Review Source Type: research

Gemfibrozil, Food and Drug Administration ‐approved lipid‐lowering drug, increases longevity in mouse model of Late Infantile Neuronal Ceroid Lipofuscinosis
This article is protected by copyright. All rights reserved. (Source: Journal of Neurochemistry)
Source: Journal of Neurochemistry - February 15, 2017 Category: Neuroscience Authors: Arunava Ghosh, Suresh Babu Rangasamy, Khushbu K. Modi, Kalipada Pahan Tags: Original Article Source Type: research

Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial
Publication date: Available online 15 February 2017 Source:The Lancet HIV Author(s): Paul E Sax, Edwin DeJesus, Gordon Crofoot, Douglas Ward, Paul Benson, Robin Dretler, Anthony Mills, Cynthia Brinson, Julie Peloquin, Xuelian Wei, Kirsten White, Andrew Cheng, Hal Martin, Erin Quirk Background All recent treatment guidelines recommend integrase strand transfer inhibitors (INSTIs) as components of initial HIV therapy. Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity in a 10 day monotherapy study and has a high in-vitro resistance barrier. On the basis of these results, we did a phase 2 trial compari...
Source: The Lancet HIV - February 15, 2017 Category: Infectious Diseases Source Type: research

[Research Articles] High-throughput screening of tyrosine kinase inhibitor cardiotoxicity with human induced pluripotent stem cells
Tyrosine kinase inhibitors (TKIs), despite their efficacy as anticancer therapeutics, are associated with cardiovascular side effects ranging from induced arrhythmias to heart failure. We used human induced pluripotent stem cell–derived cardiomyocytes (hiPSC-CMs), generated from 11 healthy individuals and 2 patients receiving cancer treatment, to screen U.S. Food and Drug Administration–approved TKIs for cardiotoxicities by measuring alterations in cardiomyocyte viability, contractility, electrophysiology, calcium handling, and signaling. With these data, we generated a "cardiac safety index" to reflect the car...
Source: Science Translational Medicine - February 15, 2017 Category: Biomedical Science Authors: Sharma, A., Burridge, P. W., McKeithan, W. L., Serrano, R., Shukla, P., Sayed, N., Churko, J. M., Kitani, T., Wu, H., Holmström, A., Matsa, E., Zhang, Y., Kumar, A., Fan, A. C., del Alamo, J. C., Wu, S. M., Moslehi, J. J., Mercola, M., Wu, J. C. Tags: Research Articles Source Type: research

Novel and Expanded Oncology Drug Approvals of 2016-PART 2: New Options in the Management of Hematologic Malignancies.
This article reviews each of these drugs and their indications, mechanisms of action, accompanying pivotal trial data, pertinent toxicities, use in special populations, and appropriate clinical context. PMID: 28205194 [PubMed - in process] (Source: Oncology (Williston Park, N.Y.))
Source: Oncology (Williston Park, N.Y.) - February 15, 2017 Category: Cancer & Oncology Authors: Knepper TC, Saller J, Walko CM Tags: Oncology (Williston Park) Source Type: research

Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management.
This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning. PMID: 28205191 [PubMed - in process] (Source: Oncology (Williston Park, N.Y.))
Source: Oncology (Williston Park, N.Y.) - February 15, 2017 Category: Cancer & Oncology Authors: Knepper TC, Saller J, Walko CM Tags: Oncology (Williston Park) Source Type: research

An Updated Protocol for Evaluating Chest Pain and Managing Acute Coronary Syndromes
Clinical pathways can optimize care both across and within institutions, but regular updates to these pathways based on new clinical trials, professional guidelines, and Food and Drug Administration approvals are essential. Herein we describe the most recent revisions to the New York-Presbyterian Hospital (Columbia University Medical Center and Weill Cornell Medical Center) clinical pathway for acute coronary syndromes and chest pain, which incorporates novel data regarding the timing and administration of P2Y12 inhibition (including the intravenous P2Y12 inhibitor cangrelor) and the appropriateness of prolonged (>1 year) ...
Source: Critical Pathways in Cardiology - February 14, 2017 Category: Cardiology Tags: Pathway Source Type: research

Preclinical Efficacy Failure of Human CNS-Derived Stem Cells for Use in the Pathway Study of  Cervical Spinal Cord Injury
Publication date: 14 February 2017 Source:Stem Cell Reports, Volume 8, Issue 2 Author(s): Aileen J. Anderson, Katja M. Piltti, Mitra J. Hooshmand, Rebecca A. Nishi, Brian J. Cummings We previously showed the efficacy of multiple research cell lines (RCLs) of human CNS neural stem cells (HuCNS-SCs) in mouse and rat models of thoracic spinal cord injury (SCI), supporting a thoracic SCI clinical trial. Experts recommend in vivo preclinical testing of the intended clinical cell lot/line (CCL) in models with validity for the planned clinical target. We therefore tested the efficacy of two HuCNS-SC lines in cervical SCI: one R...
Source: Stem Cell Reports - February 14, 2017 Category: Stem Cells Source Type: research

Interpreting Cardiovascular Endpoints in Trials of Antihyperglycemic Drugs
AbstractIn view of the significant cardiovascular (CV) morbidity and mortality in patients with type 2 diabetes mellitus, and concerns raised about the CV safety of some glucose-lowering drugs, the US Food and Drug Administration (FDA) issued guidance for the industry in 2008 to demonstrate CV safety for the approval of all new antihyperglycemic drugs. Seven randomized controlled trials involving around 60,000 participants have been completed so far and have demonstrated the CV safety of dipeptidyl peptidase 4 inhibitors (saxagliptin, alogliptin and sitagliptin), glucagon-like peptide-1 receptor agonists (lixisenatide, lir...
Source: American Journal of Cardiovascular Drugs - February 14, 2017 Category: Cardiology Source Type: research

Therapies of Early, Advanced, and Late Onset Forms of Axial Spondyloarthritis, and the Need for Treat to Target Strategies
This study aims to provide an update on current status of pharmacological therapies in early and advanced stages of axial spondyloarthritis (axSpA), as well as its late onset forms, and to discuss the need for treat to target strategies in this entity.Recent FindingsEfficacy of TNF inhibitors has been assessed in randomized controlled trials in axSpA, which included patients who had non-radiographic axSpA according to the ASAS classification criteria. The role of IL17/23 pathway as a therapeutic target in ankylosing spondylitis (AS) has been the focus of phase III studies of secukinumab (named MEASURE 1 and MEASURE 2) and ...
Source: Current Rheumatology Reports - February 14, 2017 Category: Rheumatology Source Type: research

Diagnosing acute HIV infection: The performance of quantitative HIV-1 RNA testing (viral load) in the 2014 laboratory testing algorithm
In June 2014, the Centers for Disease Control and Prevention and Association of Public Health Laboratories updated the recommended algorithm for HIV testing by laboratories in the United States [1]; discordant results from fourth-generation HIV antigen/antibody screening immunoassays (reactive) and antibody confirmation assays (nonreative) should be resolved by an HIV-1 nucleic acid test to distinguish acute HIV infection (AHI) from false-positive fourth-generation immunoassay result1. Currently, the only HIV-1 nucleic acid test approved by the Food and Drug Administration (FDA) for the indication of HIV diagnosis is a qua...
Source: Journal of Clinical Virology - February 14, 2017 Category: Virology Authors: Hsiu Wu, Stephanie E. Cohen, Emily Westheimer, Cynthia L. Gay, Laura Hall, Charles Rose, Lisa B. Hightow-Weidman, Severin Gose, Jie Fu, Philip J. Peters Tags: Letter to the Editor Source Type: research

Microdrilling Surgery Augmented With Intra-articular Bone Marrow Aspirate Concentrate, Platelet-Rich Plasma, and Hyaluronic Acid: A Technique for Cartilage Repair in the Knee
We describe a Food and Drug Administration–compliant modification of this technique using microdrilling augmented with intra-articular bone marrow aspirate concentrate, platelet-rich plasma, and hyaluronic acid. (Source: Arthroscopy Techniques)
Source: Arthroscopy Techniques - February 13, 2017 Category: Surgery Source Type: research

An International Vascular Registry Infrastructure for Medical Device Evaluation and Surveillance
The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement. (Source: European Journal of Vascular and Endovascular Surgery)
Source: European Journal of Vascular and Endovascular Surgery - February 13, 2017 Category: Surgery Authors: A. Sedrakyan, J.L. Cronenwett, M. Venermo, L. Kraiss, D. Marinac-Dabic, M. Bj örck Tags: Special Communication Source Type: research

Medical Device Recalls in Radiation Oncology: Analysis of U.S. Food and Drug Administration Data, 2002-2015
Summary: FDA recalls among radiation oncology devices peaked in 2011 and mostly reflected software issues. These recalls differ significantly from other devices in cause of recall, recall class (severity), quantity in commerce, and time from 510(k) market clearance to recall. The field should demand better design of these systems as well as improved regulatory requirements, software quality efforts, and enhanced post-market surveillance. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - February 12, 2017 Category: Radiology Authors: Michael J. Connor, Kathryn Tringale, Vitali Moiseenko, Deborah C. Marshall, Kevin Moore, Laura Cervino, Todd Atwood, Derek Brown, Arno J. Mundt, Todd Pawlicki, Abram Recht, Jona A. Hattangadi-Gluth Tags: Physics Contribution Source Type: research

Regulatory strategies to facilitate surgical innovation
Phoebe Mounts, PhD, Esq, is a partner in the Food and Drug Administration Practice Group in the Washington, DC, office of Morgan Lewis& Bockius LLP. She counsels clients on regulatory issues for medical devices, drugs, and biologics. Prior to joining Morgan Lewis, she was on the faculty of the Johns Hopkins University School of Public Health in the Department of Molecular Microbiology, Immunology, and Infectious Diseases. Although she is a partner in the FDA Practice Group at Morgan Lewis, the  views expressed in this article are hers and should not be attributed to the Firm. (Source: Surgery)
Source: Surgery - February 10, 2017 Category: Surgery Authors: Phoebe Mounts Tags: Innovation Source Type: research

Immune checkpoint inhibitors in first-line therapy of advanced non-small cell lung cancer
Purpose of review: Evading immune destruction is a hallmark of cancer. The first therapeutic wave in immunotherapies comprised a series of monoclonal antibodies directed against the immune checkpoint molecules cytotoxic T-lymphocyte-associated protein 4, programmed death 1 (PD-1), and programmed death ligand-1 (PD-L1) revolutionizing the therapeutic landscape of advanced non-small cell lung cancer. They were validated initially as second-line treatment, becoming the new standard of care. Recent findings: Based on immunotherapies efficacy, different strategies are being successfully investigated in first-line treatment, in...
Source: Current Opinion in Oncology - February 10, 2017 Category: Cancer & Oncology Tags: LUNG AND MEDIASTINUM: Edited by Robert Pirker Source Type: research

Concurrent driver mutations/rearrangements in non-small-cell lung cancer
Purpose of review: The concept of mutually exclusive oncogenic driver alterations has prevailed over the past decade, but recent reports have stressed the possible occurrence of dual-positive non-small-cell lung cancer (NSCLC) and even triple-positive disease for these oncogenes. This entity presents novel prognostic and therapeutic challenges. The present review highlights the available data in an effort to clarify the clinical and pathological significance of coexisting mutations as well as the subsequent therapeutic consequences. Recent findings: Patients with a known driver oncogene can be successfully treated with th...
Source: Current Opinion in Oncology - February 10, 2017 Category: Cancer & Oncology Tags: LUNG AND MEDIASTINUM: Edited by Robert Pirker Source Type: research

Treatment and surveillance of advanced, metastatic iodine-resistant differentiated thyroid cancer
Purpose of review: This review will focus on the management and treatment of metastatic thyroid cancer that is radioactive iodine refractory and review the new drugs and their mechanism of actions as well as their adverse events. Recent findings: Until recently, there were no efficacious therapeutic modalities for these patients. With advancement in knowledge and research of the molecular aberrations and oncogenic mutations in thyroid cancer as well as further understanding the role of angiogenesis in tumor growth molecular pathogenesis, novel targeted therapies are available for these patients. Some of these drugs have s...
Source: Current Opinion in Oncology - February 10, 2017 Category: Cancer & Oncology Tags: Special Commentary Source Type: research

Lombard Aorfix high angulation device, sac behavior following implantation
Short neck length, and angulated infrarenal aortic necks, are historically associated with sac expansion following endovascular abdominal aortic aneurysm repair. Aorfix (Lombard Medical, Inc, Irvine, Calif), a conformable stent graft US Food and Drug Administration approved for highly angulated necks, was investigated in the US Pythagoras Trial. We investigated the incidence of, and factors related to, sac regression and expansion following implantation of the Aorfix device. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - February 10, 2017 Category: Surgery Authors: Edward A. McGillicuddy, Mark Fillinger, William P. Robinson, Kim Hodgson, William D. Jordan, Adam W. Beck, Mahmoud Malas, Michael Belkin Tags: Clinical paper Source Type: research

Measurement of agitation and aggression in adult and aged neuropsychiatric patients: review of definitions and frequently used measurement scales.
Abstract Agitation and aggression in adult psychiatric patients with psychoses and in persons with dementia increase the burden of disease and frequently cause hospitalization. The implementation of currently available management strategies and the development of new ones is hindered by inconsistent terminology that confuses agitation with aggression. This confusion is maintained by many rating scales that fail to distinguish between these two syndromes. We review the frequently used rating scales with a particular focus on their ability to separate agitation from aggression. Agitation and aggression are two diffe...
Source: CNS Spectrums - February 9, 2017 Category: Neurology Authors: Volicer L, Citrome L, Volavka J Tags: CNS Spectr Source Type: research

A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid Technologies(TM) (ALT(®)) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza(®).
This study compared the bioavailability of SC401 (1530 mg EPA-ethyl esters [EEs] and DHA-EEs plus Advanced Lipid Technologies(⁎) [ALT(†)], a proprietary lipid-delivery platform to improve absorption), with. Lovaza(‡) (3600 mg ω-3, primarily EPA-EEs and DHA-EEs) under low-fat feeding conditions. METHODS: This was a Phase I, randomized, open-label, single-dose, 2-way crossover study in healthy participants housed from day -3 to day 2 in each treatment period. Blood samples for pharmacokinetic measurements were collected before and after dosing, and safety profile and tolerability were assessed. FINDINGS: In ...
Source: Clinical Therapeutics - February 9, 2017 Category: Drugs & Pharmacology Authors: Lopez-Toledano MA, Thorsteinsson T, Daak A, Maki KC, Johns C, Rabinowicz AL, Sancilio FD Tags: Clin Ther Source Type: research

In vitro screening of an FDA-Approved Library against ESKAPE pathogens.
Abstract Bacterial resistance to conventional antibiotics is an increasingly serious threat to public health worldwide that requires immediate exploration and the development of novel antimicrobial compounds. Drug repurposing is an inexpensive and untapped source of new antimicrobial leads, and it holds many attractive features warranting further attention for antimicrobial drug discovery. In an effort to repurpose drugs and explore new leads in the field of antimicrobial drug discovery, we performed a whole-cell screening assay of 1,600 Food and Drug Administration (FDA) approved drugs against Enterococcus faeciu...
Source: Current Pharmaceutical Design - February 9, 2017 Category: Drugs & Pharmacology Authors: Younis W, AbdelKhalek A, Mayhoub AS, Seleem MN Tags: Curr Pharm Des Source Type: research