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https://www.readbyqxmd.com/read/28625557/-more-than-3-hours-and-less-than-3-years-safety-of-anaesthetic-procedures-in-infants-less-than-3-years-old-subected-to-surgery-for-more-the-3-hours
#1
Julián Álvarez Escudero, Rosa María Paredes Esteban, Francisco José Cambra Lasaosa, Máximo Vento, Maite López Gil, Juan Carlos de Agustín Asencio, María Teresa Moral Pumarega
An FDA alert in December 2016 on the safety of general anesthesia and sedations in patients less than 3 years of age and pregnant women has raised doubts in relation to the attitude that professionals implicated in these procedures should adopt in relation to these specific group of patients. Confronted with this situation, the following medical scientific societies: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), have established a working group to analyze and clarify the safety of these techniques...
June 15, 2017: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría (A.E.P.)
https://www.readbyqxmd.com/read/28618340/fast-and-efficient-zirconia-based-reversed-phase-chromatography-for-selective-determination-of-triptans-in-rat-plasma
#2
Sameh Ahmed, Noha N Atia
Selective and fast chromatographic method was essential for the determination of triptans, selective serotonin receptor (5-HT1) agonists, in biological specimens. However, selective chromatographic separation of these highly basic drugs is a challenging problem on silica-based stationary phases. Zirconia-based stationary phases have been introduced as an efficient alternative for silica-based columns offering unique stability, selectivity, and retention ability for various classes of drugs. Herein, a new selective, fast and reproducible high performance liquid chromatographic method (HPLC) was developed and validated for the determination of four triptans in plasma samples namely; Sumatriptan (SMT), Zolmitriptan (ZLT), Eletriptan (ELT) and Rizatriptan (RZT)...
June 7, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28616097/updated-report-on-tools-to-measure-outcomes-of-clinical-trials-in-fragile-x-syndrome
#3
REVIEW
Dejan B Budimirovic, Elizabeth Berry-Kravis, Craig A Erickson, Scott S Hall, David Hessl, Allan L Reiss, Margaret K King, Leonard Abbeduto, Walter E Kaufmann
OBJECTIVE: Fragile X syndrome (FXS) has been the neurodevelopmental disorder with the most active translation of preclinical breakthroughs into clinical trials. This process has led to a critical assessment of outcome measures, which resulted in a comprehensive review published in 2013. Nevertheless, the disappointing outcome of several recent phase III drug trials in FXS, and parallel efforts at evaluating behavioral endpoints for trials in autism spectrum disorder (ASD), has emphasized the need for re-assessing outcome measures and revising recommendations for FXS...
2017: Journal of Neurodevelopmental Disorders
https://www.readbyqxmd.com/read/28593780/-complications-tension-free-vaginal-tape-surgery
#4
P Piškytlová
OBJECTIVE: A comprehensive overview of the potential complications associated with vaginal tape operations, which are commonly used in the treatment of stress urinary incontinence in women. DESIGN: Review article. SETTING: Department of Obstetrics and Gynecology, Oblastní nemocnice Kolín, a.s. METHODS: Using medical databases were searched articles dealing with complications tension-free vaginal tape procedures. In individual cases, complications were observed their causes and solutions...
2017: Ceská Gynekologie
https://www.readbyqxmd.com/read/28583106/prescription-drug-use-during-pregnancy-in-southern-tigray-region-north-ethiopia
#5
Fantahun Molla, Admassu Assen, Solomon Abrha, Birhanetensay Masresha, Arega Gashaw, Abrham Wondimu, Yared Belete, Wondim Melkam
BACKGROUND: Judicious utilization of drugs rescues the fetus from the harmful effects while treating the health problems of the pregnant women. This study aimed at evaluating drug utilization pattern and its associated factors among pregnant women in Southern Tigray, Ethiopia. METHOD: Institution based cross-sectional study was conducted among 647 pregnant women who had been attending obstetrics-gynecology and antenatal care units in different health facilities of Southern Tigray region...
June 5, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28571554/methotrexate-in-the-treatment-of-psoriasis-and-rheumatoid-arthritis-mechanistic-insights-current-issues-and-novel-delivery-approaches
#6
P Rajitha, Raja Biswas, M Sabitha, R Jayakumar
Our review is focused on the use of methotrexate in drug therapy of two autoimmune diseases, psoriasis and rheumatoid arthritis (RA). The article describes the pathogenesis of psoriasis and RA, the role of methotrexate in the treatment of these diseases with more focused review on the mechanism behind the clinical benefits of methotrexate therapy. Methotrexate due to its cytotoxic, anti-inflammatory and immune modulatory activities provides clinical benefits in the therapy of the selected diseases. This review also gives a panorama of the problems associated with the use of methotrexate in the selected diseases and the guidelines provided by FDA for its safe use...
May 31, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28566572/importance-of-reverse-translational-research-rtr
#7
Yuichi Sugiyama
 When events lead to clinical problems, the mechanisms involved often remain unclear. This is true for medications and therapies, in addition to problems inherent in an underlying disease. However, the recent development of modeling and metric methods makes it possible to estimate the relationship between side effects and various factors to explain inter-individual differences, such as genetic polymorphisms, co-administered drugs, age, gender, dysfunction of the liver/kidney based upon the database for side effects [such as Food and Drug Administration-Adverse Event Reporting System (FDA-AERS)] and the database in a patient's medical records...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28541222/drug-target-prediction-by-multi-view-low-rank-embedding
#8
Limin Li, Menglan Cai
Drug repositioning has been a key problem in drug development, and heterogeneous data sources are used to predict drug-target interactions by different approaches. However, most of studies focus on a single representation of drugs or proteins. It has been shown that integrating multi-view representations of drugs and proteins can strengthen the prediction ability. For example, a drug can be represented by its chemical structure, or by its chemical response in different cells. A protein can be represented by its sequence, or by its gene expression values in different cells...
May 18, 2017: IEEE/ACM Transactions on Computational Biology and Bioinformatics
https://www.readbyqxmd.com/read/28538203/uhplc-ms-ms-method-with-sample-dilution-to-test-therapeutic-adherence-through-quantification-of-ten-antihypertensive-drugs-in-urine-samples
#9
Amedeo De Nicolò, Valeria Avataneo, Franco Rabbia, Mauro Sciandra, Francesco Tosello, Jessica Cusato, Elisa Perlo, Paolo Mulatero, Franco Veglio, Giovanni Di Perri, Antonio D'Avolio
Nowadays, hypertension represents an important health problem, particularly in developed countries. In some cases the standard therapeutic approaches are not able to reestablish the normal blood pressure values: this condition is called "resistant hypertension". However, a fraction of cases of resistant hypertension are actually due to poor adherence to the prescribed therapy. Therapeutic Drug Monitoring could represent a direct and useful tool to correctly identify non-compliant patients. Nevertheless, high throughput methods for the simultaneous monitoring of a wide panel of drugs in the same analysis are lacking and, furthermore, there is not a generally acknowledged "standard" matrix for this test (plasma or urine)...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28533089/synergistic-anti-tumor-effects-of-bevacizumab-and-tumor-targeted-polymerized-vegf-sirna-nanoparticles
#10
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...
July 15, 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
#11
Keming Xu, Liang Li, Mingyue Cui, Yiyuan Han, H Enis Karahan, Vincent T K 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 a lack of an infant/toddler-friendly formulation for countries with limited clean water orr electricity. Here, we report the development of a shear-thinning hydrogel system for the oral delivery of amoxicillin to infant/toddler patients, without the need of clean water and refrigeration. The hydrogel formulation consists of metolose (hydroxypropyl methylcellulose) and amoxicillin...
June 7, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28472025/addressing-a-yellow-fever-vaccine-shortage-united-states-2016-2017
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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...
July 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
#18
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
#19
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
#20
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
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