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https://www.readbyqxmd.com/read/28533089/synergistic-anti-tumor-effects-of-bevacizumab-and-tumor-targeted-polymerized-vegf-sirna-nanoparticles
#1
Myung Goo Kim, Sung Duk Jo, Ji Young Yhee, Beom Suk Lee, So Jin Lee, Sung Gurl Park, Sun-Woong Kang, Sun Hwa Kim, Ji Hoon Jeong
A variety of VEGF inhibitors have been reported to treat cancers by suppressing tumor angiogenesis. Bevacizumab, a monoclonal VEGF antibody, was the first FDA approved anti-angiogenic agent for cancer treatments. However, bevacizumab shows modest therapeutic efficiency and often cause resistant problem in significant populations of cancer patients. To solve these problem, we investigated the therapeutic efficacy of siRNA drugs targeting VEGF and combination of the RNAi drug with bevacizumab for cancer treatments...
May 19, 2017: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/28513136/cold-chain-free-storable-hydrogel-for-infant-friendly-oral-delivery-of-amoxicillin-for-the-treatment-of-pneumococcal-pneumonia
#2
Keming Xu, Liang Li, Mingyue Cui, Yiyuan Han, Huseyin Enis Karahan, Vincent Tak Kwong Chow, Chenjie Xu
Pneumonia is the major cause of death in children under five, particularly in developing countries. Antibiotics such as amoxicillin greatly help in mitigating this problem. However, there is lack of an infant/toddler-friendly formulation for countries with limited clean water and electricity. Here we report the development of a shear-thinning hydrogel system for the oral delivery of amoxicillin to the infant/toddler patients, without the need of clean water and refrigeration. The hydrogel formulation consists of metolose (hydroxypropyl methylcellulose) and amoxicillin...
May 17, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28472025/addressing-a-yellow-fever-vaccine-shortage-united-states-2016-2017
#3
Mark D Gershman, Kristina M Angelo, Julian Ritchey, David P Greenberg, Riyadh D Muhammad, Gary Brunette, Martin S Cetron, Mark J Sotir
Recent manufacturing problems resulted in a shortage of the only U.S.-licensed yellow fever vaccine. This shortage is expected to lead to a complete depletion of yellow fever vaccine available for the immunization of U.S. travelers by mid-2017. CDC, the Food and Drug Administration (FDA), and Sanofi Pasteur are collaborating to ensure a continuous yellow fever vaccine supply in the United States. As part of this collaboration, Sanofi Pasteur submitted an expanded access investigational new drug (eIND) application to FDA in September 2016 to allow for the importation and use of an alternative yellow fever vaccine manufactured by Sanofi Pasteur France, with safety and efficacy comparable to the U...
May 5, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28465867/differences-in-antipsychotic-related-adverse-events-in-adult-pediatric-and-geriatric-populations
#4
Hersh Sagreiya, Yi-Ren Chen, Narmadan A Kumarasamy, Karthik Ponnusamy, Doris Chen, Amar K Das
In recent years, antipsychotic medications have increasingly been used in pediatric and geriatric populations, despite the fact that many of these drugs were approved based on clinical trials in adult patients only. Preliminary studies have shown that the "off-label" use of these drugs in pediatric and geriatric populations may result in adverse events not found in adults. In this study, we utilized the large-scale U.S. Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) database to look at differences in adverse events from antipsychotics among adult, pediatric, and geriatric populations...
February 26, 2017: Curēus
https://www.readbyqxmd.com/read/28451497/evaluation-of-adverse-events-in-total-disc-replacement-a-meta-analysis-of-fda-summary-of-safety-and-effectiveness-data
#5
Paul A Anderson, Ahmad Nassr, Bradford L Currier, Arjun S Sebastian, Paul M Arnold, Michael G Fehlings, Thomas E Mroz, K Daniel Riew
STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions. METHODS: A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed...
April 2017: Global Spine Journal
https://www.readbyqxmd.com/read/28449717/a-review-of-patient-reported-outcome-measures-to-assess-female-infertility-related-quality-of-life
#6
REVIEW
Helen Kitchen, Natalie Aldhouse, Andrew Trigg, Roberto Palencia, Stephen Mitchell
BACKGROUND: Infertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. A variety of patient-reported outcome (PRO) measures to assess infertility-related QoL are available; however, there is a concern regarding potential issues with their development methodology, validation and use. This review aimed to i) identify PRO measures used in infertility interventional studies ii) assess validation evidence to identify a reliable, valid PRO measure to assess changes in QoL or treatment satisfaction in clinical studies with female patients following treatment with novel therapies iii) identify potential gaps in evidence for validity...
April 27, 2017: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/28418758/inhaled-heparin-therapeutic-efficacy-and-recent-formulations
#7
Ayca Yildiz-Pekoz, Yildiz Ozsoy
Heparin is well known for its anticoagulant and anti-inflammatory properties. Inhaled heparin regimens are increasingly being used to manage lung disease. It has been used to treat cystic fibrosis, thromboembolism, and pulmonary fibrosis, as well as bronchial asthma and asthma-induced airway hypersensitivity. Several preclinical studies attained some useful effects of heparin-administered, parenterally and through inhalation, treatment of lung disease. Besides, recent clinical trials suggest that inhaled heparin for lung diseases is beneficial and safe, but such data remain to be limited...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28411103/endogenous-regeneration-engineering-growth-factors-for-stroke
#8
REVIEW
Su Jing Chan, Christopher Love, Myron Spector, Simon M Cool, Victor Nurcombe, Eng H Lo
Despite the efforts in developing therapeutics for stroke, recombinant tissue plasminogen activator (rtPA) remains the only FDA approved drug for ischemic stroke. Regenerative medicine targeting endogenous growth factors has drawn much interest in the clinical field as it provides potential restoration for the damaged brain tissue without being limited by a narrow therapeutic window. To date, most of the translational studies using regenerative medicines have encountered problems and failures. In this review, we discuss the effects of some trophic factors which include of erythropoietin (EPO), brain derived neurotrophic factor (BDNF), granulocyte-colony stimulating factor (G-CSF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), epidermal growth factor (EGF) and heparin binding epidermal growth factor (HB-EGF) in experimental ischemic stroke models and elaborate the lost in translation of the candidate growth factors from bench to bedside...
April 12, 2017: Neurochemistry International
https://www.readbyqxmd.com/read/28401382/first-application-of-newly-developed-ft-nir-spectroscopic-methodology-to-predict-authenticity-of-extra-virgin-olive-oil-retail-products-in-the-usa
#9
Magdi M Mossoba, Hormoz Azizian, Ali Reza Fardin-Kia, Sanjeewa R Karunathilaka, John K G Kramer
Economically motivated adulteration (EMA) of extra virgin olive oils (EVOO) has been a worldwide problem and a concern for government regulators for a long time. The US Food and Drug Administration (FDA) is mandated to protect the US public against intentional adulteration of foods and has jurisdiction over deceptive label declarations. To detect EMA of olive oil and address food safety vulnerabilities, we used a previously developed rapid screening methodology to authenticate EVOO. For the first time, a recently developed FT-NIR spectroscopic methodology in conjunction with partial least squares analysis was applied to commercial products labeled EVOO purchased in College Park, MD, USA to rapidly predict whether they are authentic, potentially mixed with refined olive oil (RO) or other vegetable oil(s), or are of lower quality...
April 11, 2017: Lipids
https://www.readbyqxmd.com/read/28392910/drug-shortages-in-israel-regulatory-perspectives-challenges-and-solutions
#10
Eyal Schwartzberg, Denize Ainbinder, Alla Vishkauzan, Ronni Gamzu
BACKGROUND: Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors. The objective of our study was to analyze DSs in Israel during the years 2013-2015, assessing their etiology and exploring the steps taken for their mitigation and prevention...
2017: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/28390806/the-vagal-nerve-stimulation-outcome-and-laryngeal-effect-otolaryngologists-roles-and-perspective
#11
Ahmad I Al Omari, Firas Q Alzoubi, Mohammad M Alsalem, Samah K Aburahma, Diala T Mardini, Paul F Castellanos
INTRODUCTION: Epilepsy is one of the most common neurologic disorders. Vagus nerve stimulation (VNS), first investigated in 1938 and subsequently studied as a potential therapy for epilepsy. The FDA approved the use of VNS in 1997 as an adjunctive non-pharmacologic symptomatic treatment option for refractory epilepsy for adults and adolescents over 12years. VNS can cause laryngeal and voice side effects that can be managed by otolaryngologists safely and effectively. OBJECTIVES: This study is to review the outcomes of vagal nerve stimulator (VNS) implantation in terms of the surgical procedures, complications, seizure frequency, and the clinical effect on larynx and vocal folds motion...
April 4, 2017: American Journal of Otolaryngology
https://www.readbyqxmd.com/read/28361698/a-clustering-based-approach-for-efficient-identification-of-microrna-combinatorial-biomarkers
#12
Yang Yang, Ning Huang, Luning Hao, Wei Kong
BACKGROUND: MicroRNAs (miRNAs) have great potential serving as tumor biomarkers and therapeutic targets. As the rapid development of high-throughput experimental technology, gene expression experiments have become more and more specialized and diversified. The complex data structure has brought great challenge for the identification of biomarkers. In the meantime, current statistical and machine learning methods for detecting biomarkers have the problem of low reliability and biased criteria...
March 14, 2017: BMC Genomics
https://www.readbyqxmd.com/read/28344323/new-knowledge-of-the-mechanisms-of-sorafenib-resistance-in-liver-cancer
#13
REVIEW
Yan-Jing Zhu, Bo Zheng, Hong-Yang Wang, Lei Chen
Sorafenib is an oral multikinase inhibitor that suppresses tumor cell proliferation and angiogenesis and promotes tumor cell apoptosis. It was approved by the FDA for the treatment of advanced renal cell carcinoma in 2006, and as a unique target drug for advanced hepatocellular carcinoma (HCC) in 2007. Sorafenib can significantly extend the median survival time of patients but only by 3-5 months. Moreover, it is associated with serious adverse side effects, and drug resistance often develops. Therefore, it is of great importance to explore the mechanisms underlying sorafenib resistance and to develop individualized therapeutic strategies for coping with these problems...
May 2017: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/28335658/dopamine-antagonists-for-treatment-resistance-in-autism-spectrum-disorders-review-and-focus-on-bdnf-stimulators-loxapine-and-amitriptyline
#14
REVIEW
Jessica A Hellings, L Eugene Arnold, Joan C Han
Drug development and repurposing are urgently needed for individuals with autism spectrum disorders (ASD) and psychiatric comorbidity, which often presents as aggression and self-injury. Areas covered: We review dopamine antagonists, including classical and atypical, as well as unconventional antipsychotics in ASD. The older antipsychotic loxapine is discussed in terms of preliminary albeit limited evidence in ASD. Emerging promise of amitriptyline in ASD is discussed, together with promising BDNF effects of loxapine and amitriptyline...
April 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28329502/challenges-to-smartphone-applications-for-melanoma-detection
#15
Jordan V Wang, Lance W Chapman, Matthew Keller
This commentary addresses the emerging market forhealth-related smartphone applications. Specific todermatology, there has been a significant increasenot only in applications that promote skin cancerawareness and education but also in those meantfor detection. With evidence showing that 365dermatology-related applications were available in2014--up from 230 in 2012--and that 1 in 5 patientsunder the age of 50 have used a smartphone tohelp diagnose a skin problem, there is clearly a largesubset of patients participating in this growing trend...
February 15, 2017: Dermatology Online Journal
https://www.readbyqxmd.com/read/28320310/treetoreads-a-pipeline-for-simulating-raw-reads-from-phylogenies
#16
Emily Jane McTavish, James Pettengill, Steven Davis, Hugh Rand, Errol Strain, Marc Allard, Ruth E Timme
BACKGROUND: Using phylogenomic analysis tools for tracking pathogens has become standard practice in academia, public health agencies, and large industries. Using the same raw read genomic data as input, there are several different approaches being used to infer phylogenetic tree. These include many different SNP pipelines, wgMLST approaches, k-mer algorithms, whole genome alignment and others; each of these has advantages and disadvantages, some have been extensively validated, some are faster, some have higher resolution...
March 20, 2017: BMC Bioinformatics
https://www.readbyqxmd.com/read/28304180/nanomedicine-for-the-treatment-of-acute-respiratory-distress-syndrome-the-2016-ats-bear-cage-award-winning-proposal
#17
Jacob S Brenner
After dozens of clinical trials, there are still no Food and Drug Administration-approved drugs that improve mortality in acute respiratory distress syndrome (ARDS). These poor results may be caused in part by three unique pharmacological challenges presented by ARDS: (1) Patients with ARDS are fragile because of concomitant multiple organ dysfunction, so they do not tolerate off-target side effects of drugs; (2) inhaled drug delivery is impeded by the column of proteinaceous fluid covering the injured alveoli; and (3) ARDS is heterogeneous in its underlying pathophysiology, so targeting one pathway is unlikely to improve most patients...
April 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/28271985/for-ed-the-doctor-is-in-but-the-men-are-staying-away
#18
Joseph Burns
Men's health care changed dramatically after the FDA approved Pfizer's blue, diamond-shaped Viagra. Suddenly men were interested in seeing their doctors if for only one reason. Now, with restrictions on what some call a lifestyle drug, other health problems go uncharted.
February 2017: Managed Care
https://www.readbyqxmd.com/read/28240173/personalized-medicine-of-alcohol-addiction-pharmacogenomics-and-beyond
#19
Vangelis George Manolopoulos, Georgia Ragia
Alcohol addiction or alcoholism is the most severe form of problem drinking. A variety of treatment methods for alcoholism are currently available that combine medications, behavioral treatment and peer support. The drugs that are currently approved by the U.S. Food and Drug Administration (FDA) for treatment of alcohol dependence are disulfiram, naltrexone and acamprosate. For many patients, however, these treatments are not effective. Evidence from a number of different studies suggests that different factors, both psychosocial and economic, as well as genetic variation, are significant contributors to interindividual variation both of clinical presentation of alcohol problems and response to a given treatment...
February 23, 2017: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/28228288/fda-ce-mark-or-something-else-thinking-fast-and-slow
#20
EDITORIAL
Sundeep Mishra
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing...
January 2017: Indian Heart Journal
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