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https://www.readbyqxmd.com/read/28749100/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28749099/medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-control-material-for-clinical-microbiology-assays-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device...
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28748132/effects-of-intake-of-lactobacillus-casei-subsp-casei-327-on-skin-conditions-a-randomized-double-blind-placebo-controlled-parallel-group-study-in-women
#3
Yuhi Saito, Toshihiro Mihara, Kentaro Maruyama, Jiro Saito, Masumi Ikeda, Akihito Tomonaga, Takehisa Kumagai
Lactic acid bacteria are gut flora that play key roles in intestinal homeostasis, which may affect a variety of physiological functions. Our preliminary double-blind, placebo-controlled, parallel-group trials have suggested that intake of heat-killed Lactobacillus casei subsp. casei 327 (designated L. K-1) is effective for improving skin conditions. The aim of this study was to confirm the effect of L. K-1 intake in a randomized, double-blind, placebo-controlled, parallel-group study in healthy female volunteers...
2017: Bioscience of Microbiota, Food and Health
https://www.readbyqxmd.com/read/28747986/comparison-of-therapeutic-responses-to-an-anticancer-drug-in-three-stocks-of-icr-mice-derived-from-three-different-sources
#4
Ji Eun Sung, Ji Eun Kim, Hyun Ah Lee, Woo Bin Yun, Jun Young Choi, Mi Rim Lee, Jin Ju Park, Hye Ryeong Kim, Bo Ram Song, Young Suk Jung, Kil Soo Kim, Dae Youn Hwang
Korl:ICR mice, established by the Korean National Institute of Food and Drug Safety Evaluation (NIFDS), are characterized based on their genetic variation, response to gastric injury, and response to constipation inducers. To compare the inhibitory responses of ICR stocks obtained from three different sources to the anticancer drug cisplatin (Cis), alterations in tumor volume, histopathological structure, and toxicity were examined in Sarcoma 180 tumor-bearing Korl:ICR, A:ICR (USA source), and B:ICR (Japan source) mice treated with low and high concentrations of Cis (L-Cis and H-Cis, respectively)...
June 2017: Laboratory Animal Research
https://www.readbyqxmd.com/read/28747981/comparison-of-the-response-using-icr-mice-derived-from-three-different-sources-to-multiple-low-dose-streptozotocin-induced-diabetes-mellitus
#5
Do Yeon Lee, Myeong Hwan Kim, Hye Rin Suh, Young Suk Jung, Dae Youn Hwang, Kil Soo Kim
This study was conducted to compare the multiple low-dose streptozotocin (MLDS)-induced diabetic patterns of Korl:ICR, A:ICR, and B:ICR mice obtained from three different sources. Six-week-old male ICR mice were obtained from three difference sources. Korl:ICR mice were kindly provided by the National Institute of Food and Drug Safety Evaluation (NIFDS). The other two groups of ICR mice were purchased from different vendors located in the United States (A:ICR) and Japan (B:ICR). All ICR mice that received MLDS exhibited overt diabetic symptoms throughout the study, and the incidence and development of diabetes mellitus were similar among the three ICR groups...
June 2017: Laboratory Animal Research
https://www.readbyqxmd.com/read/28747946/antiplatelet-treatment-in-the-primary-prophylaxis-of-cardiovascular-disease-in-patients-with-arterial-hypertension
#6
REVIEW
Angelika Osińska, Maciej Osiński, Aleksandra Krasińska, Beata Begier-Krasińska
The benefits of using acetylsalicylic acid (ASA) in the primary prophylaxis of cardiovascular diseases may only slightly exceed the risk of serious bleeding. This warrants the search for alternative, safer preparations with antiaggregatory properties, which could be used in patients burdened with cardiovascular risk factors. Antiaggregatory compounds identified in water-soluble tomato extract include nucleosides, flavonoids, and phenolic acids. The action of standardized tomato extract is multidirectional, reversible, and weaker in comparison to ASA...
June 2017: Kardiochirurgia i Torakochirurgia Polska, Polish Journal of Cardio-Thoracic Surgery
https://www.readbyqxmd.com/read/28745879/plasma-induced-degradation-of-quercetin-associated-with-the-enhancement-of-biological-activities
#7
Tae Hoon Kim, Jaemin Lee, Hyun-Joo Kim, Cheorun Jo
Non-thermal plasma is a promising technology to improve the safety and extension of self-life of various minimally processed foods. However, the plasma-induced systemic degradation research related to changes of chemical structure and biological activity is still very limited. In this study, the enhancement of biological activity and mechanism of degradation of the most common type flavonol, quercetin, induced by a dielectric barrier discharge (DBD) plasma was investigated. Quercetin is dissolved in methanol and exposed to non-thermal DBD plasma for 5, 10, 20, and 30 min...
July 26, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28745729/highlights-of-skin-disease-education-foundation-s-41st-annual-hawaii-dermatology-seminar%C3%A2
#8
Kenneth B Gordon, Craig L Leonardi, Daniel E Furst, Neal Bhatia, Lawrence F Eichenfield, Katie Beleznay
New therapies, recent pathophysiological findings, and updated guidelines combined to create compelling presentations at the Skin Disease Education Foundation's 41st Annual Hawaii Dermatology Seminar™. This educational supplement summarizes the highlights of clinical sessions presented during this CME/CE conference. A growing understanding of the biology of psoriasis has facilitated the development of increasingly efficacious medications. Skin clearance used to be regarded as an impractical goal for psoriasis therapy...
June 2017: Seminars in Cutaneous Medicine and Surgery
https://www.readbyqxmd.com/read/28744099/pharmacokinetics-pharmacodynamics-and-tolerability-of-verinurad-a-selective-uric-acid-reabsorption-inhibitor-in-healthy-adult-male-subjects
#9
Zancong Shen, Michael Gillen, Jeffrey N Miner, Gail Bucci, David M Wilson, Jesse W Hall
PURPOSE: Verinurad (RDEA3170) is a selective uric acid reabsorption inhibitor in clinical development for the treatment of gout and asymptomatic hyperuricemia. The aim of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of verinurad in healthy adult males. SUBJECTS AND METHODS: This was a Phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study. Panels of eight male subjects received a single oral dose of verinurad or placebo in either a fasted or fed state; panels of 10-12 male subjects received ascending doses of once-daily verinurad or placebo in a fasted state for 10 days...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28744073/gadolinium-based-contrast-agents-in-current-practice-risks-of-accumulation-and-toxicity-in-patients-with-normal-renal-function
#10
Anju Ranga, Yatish Agarwal, Kanika J Garg
Despite being decked as the most prized compounds in the nugget box of contrast agents for clinical radiologists, and carrying an indisputable tag of safety of the US Food and Drug Administration for close to three decades, all may not be seemingly well with the family of gadolinium compounds. If the first signs of violations of primum non nocere in relation to gadolinium-based contrast agents (GBCAs) appeared in the millennium year with the first published report of skin fibrosis in patients with compromised renal function, the causal relationship between the development of nephrogenic systemic fibrosis (NSF) and GBCAs, first proposed by two European groups in 2006, further precluded their use in renocompromised patients...
April 2017: Indian Journal of Radiology & Imaging
https://www.readbyqxmd.com/read/28742956/fluorescence-and-sensing-applications-of-graphene-oxide-and-graphene-quantum-dots-a-review
#11
Peng Zheng, Nianqiang Wu
Graphene oxide and graphene quantum dots are attractive fluorophores, which are inexpensive, non-toxic, photo-stable, water-soluble, biocompatible and environmentally friendly. They find extensive applications in fluorescent biosensors and chemi-sensors, in which they either serve as fluorophores or quenchers. As fluorophores, they display the tunable photoluminescence emission and the "Giant Red-Edge Effect". As quenchers, they exhibit a remarkable quenching efficiency via either electron transfer or Förster resonance energy transfer (FRET) process...
July 25, 2017: Chemistry, An Asian Journal
https://www.readbyqxmd.com/read/28742291/evaluating-the-effect-of-the-changes-in-fda-guidelines-for-clozapine-monitoring
#12
Ryan S Sultan, Mark Olfson, Christoph U Correll, Erica J Duncan
BACKGROUND: Concerns exist that clozapine is underutilized in the management of treatment-resistant schizophrenia. Although a 2015 change in the US Food and Drug Administration (FDA) monitoring recommendations lowered the threshold of the absolute neutrophil count for treatment interruption from 1,500/μL to 1,000/μL and removed white blood cell count thresholds from the monitoring algorithm, the implications of this policy change on clozapine interruptions remain unknown. METHODS: We analyzed outpatient prescribing records for antipsychotic medications in the Veterans Integrated Service Network 7 (VISN 7) database between 1999 and 2012 to assess the potential impact of the recent changes in FDA neutropenia monitoring recommendations on clozapine treatment discontinuation...
July 18, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28741967/iglarlixi-a-titratable-once-daily-fixed-ratio-combination-of-basal-insulin-and-lixisenatide-for-intensifying-type-2-diabetes-management-for-patients-inadequately-controlled-on-basal-insulin-with-or-without-oral-agents
#13
Neil Skolnik, Renell S Dupree, Eric L Johnson
BACKGROUND: Achieving and maintaining glycemic control is important for people with type 2 diabetes (T2D) in order to reduce disease-related complications and mortality; however, about half of US patients fail to meet glycemic targets. iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide for once-daily administration, was recently approved by the US Food and Drug Administration for use in adults with T2D inadequately controlled on basal insulin (<60 U daily) or lixisenatide...
July 25, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28741643/self-reference-plasmonic-sensors-based-on-double-fano-resonances
#14
Yujia Wang, Chengwei Sun, Hongyun Li, Qihuang Gong, Jianjun Chen
High-sensitivity plasmonic refractive index sensors show great applications in the areas of biomedical diagnostics, healthcare, food safety, environmental monitoring, homeland security, and chemical reactions. However, the unstable and complicated environments considerably limit their practical applications. By employing the independent double Fano resonances in a simple metallic grating, we experimentally demonstrate a self-reference plasmonic sensor, which significantly reduces the error contributions of the light intensity fluctuations in the long-distance propagation and local temperature variations at the metallic grating, and the detection accuracy is guaranteed...
July 25, 2017: Nanoscale
https://www.readbyqxmd.com/read/28741274/cyclin-dependent-kinase-4-6-inhibitors-in-breast-cancer-palbociclib-ribociclib-and-abemaciclib
#15
REVIEW
Dorota Kwapisz
PURPOSE: The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway plays a crucial role in cell cycle progression and its dysregulation is an important contributor to endocrine therapy resistance. CDK4/6 inhibitors trigger cell cycle arrest in Rb protein (pRb)-competent cells. Recent years have seen the development of selective CDK4/6 inhibitors, which have delivered promising results of efficacy and manageable safety profiles. The main objective of this review is to discuss preclinical and clinical data to date, and ongoing clinical trials with palbociclib, ribociclib, and abemaciclib in breast cancer...
July 24, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28740594/opportunities-for-treatment-of-the-hepatitis-c-virus-infected-patient-with-chronic-kidney-disease
#16
REVIEW
Marco Ladino, Fernando Pedraza, David Roth
The prevalence of hepatitis C virus (HCV) infection amongst patients with chronic kidney disease (CKD) and end-stage renal disease exceeds that of the general population. In addition to predisposing to the development of cirrhosis and hepatocellular carcinoma, infection with HCV has been associated with extra-hepatic complications including CKD, proteinuria, glomerulonephritis, cryoglobulinemia, increased cardiovascular risk, insulin resistance, and lymphoma. With these associated morbidities, infection with HCV is not unexpectedly accompanied by an increase in mortality in the general population as well as in patients with kidney disease...
July 8, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28739655/critical-issues-in-food-allergy-a-national-academies-consensus-report
#17
Scott H Sicherer, Katrina Allen, Gideon Lack, Steve L Taylor, Sharon M Donovan, Maria Oria
The National Academies of Sciences, Engineering, and Medicine convened an expert, ad hoc committee to examine critical issues related to food allergy. The authors of the resulting report, "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy," evaluated the scientific evidence on the prevalence, diagnosis, prevention, and management of food allergy and made recommendations to bring about a safe environment for those affected. The committee recommended approaches to monitor prevalence, explore risk factors, improve diagnosis, and provide evidence-based health care...
July 24, 2017: Pediatrics
https://www.readbyqxmd.com/read/28738754/pralatrexate-a-comprehensive-update-on-pharmacology-clinical-activity-and-strategies-to-optimize-use
#18
Owen A O'Connor, Jennifer Amengual, Donald Colbourn, Changchun Deng, Ahmed Sawas
It has been nearly 8 years since pralatrexate became the first drug approved by the U.S. Food and Drug Administration for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Like most drugs approved for a particular clinical indication, as much or more is learned once it enters mainstream use as in the years leading up to regulatory approval. Over the past several years, many diverse lines of research have shed new insight into both the agent, and the diseases it treats. In this review, we will bring the reader up to date on the many new aspects related to pralatrexate's pharmacology, activity across the panoply of T-cell lymphoproliferative malignancies, as well as some new and emerging guidelines that are likely to improve its safety profile...
November 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28738305/contamination-characteristics-and-source-apportionment-of-methylated-pahs-in-agricultural-soils-from-yangtze-river-delta-china
#19
Weixiao Chen, Xinyi Wu, Haiyun Zhang, Jianteng Sun, Wenxin Liu, Lizhong Zhu, Xiangdong Li, Daniel C W Tsang, Shu Tao, Xilong Wang
Alkylated PAHs (APAHs) have been shown to be more toxic and persistent than their non-alkylated parent compounds. However, little is known about the extent of soil contamination by these pollutants. To help understand agricultural soil pollution by these compounds at a regional scale, a total of 18 methylated PAHs (MPAHs, a major class of APAHs) in 243 soil samples were analyzed. These soil samples were collected from 11 sites in the Yangtze River Delta (YRD) region, a representative fast developing area in China...
July 21, 2017: Environmental Pollution
https://www.readbyqxmd.com/read/28737240/in-gel-and-offgel-based-proteomic-approach-for-authentication-of-meat-species-from-minced-meat-and-meat-products
#20
Basappa M Naveena, Deepak S Jagadeesh, Veeranna Kamuni, Muthukumar M, Vinayak V Kulkarni, Kiran M, Srikanth Rapole
BACKGROUND: Fraudulent mislabelling of processed meat products on global scale which could not be detected using conventional techniques demand for sensitive, robust and accurate methods of meat authentication to ensure food safety and public health. In the present study, we developed in-gel (2-dimensional gel electrophoresis, 2DE) and OFFGEL-based proteomic method for authenticating raw and cooked water buffalo (Bubalus bubalis), sheep (Ovis aries) and goat (Caprus hircus) meat and their mixes...
July 24, 2017: Journal of the Science of Food and Agriculture
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