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https://www.readbyqxmd.com/read/28445381/regulatory-advocacy-update-american-society-of-plastic-surgeons-comments-in-response-to-the-u-s-food-and-drug-administration-draft-guidance-documents-on-human-cell-and-tissue-products
#1
J Peter Rubin, Richard A D'Amico, Ricardo Rodriguez, Sydney R Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H Song, Charles Butler, Keith M Hume
The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.
May 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28445237/effects-of-polymyxin-b-hemoperfusion-on-mortality-in-patients-with-severe-sepsis-and-septic-shock-a-systemic-review-meta-analysis-update-and-disease-severity-subgroup-meta-analysis
#2
Tzu Chang, Yu-Kang Tu, Chen-Tse Lee, Anne Chao, Chi-Hsiang Huang, Ming-Jiuh Wang, Yu-Chang Yeh
OBJECTIVE: Several studies have reported a survival benefit for polymyxin B hemoperfusion treatment in patients with severe sepsis and septic shock. However, recently, a propensity-matched analysis and a randomized controlled trial reported no survival benefit for polymyxin B hemoperfusion treatment. We performed an up-to-date meta-analysis to determine the effect of polymyxin B hemoperfusion treatment on mortality in patients with severe sepsis and septic shock. DATA SOURCES: PubMed, Embase, and Cochrane Library were searched from inception to May 2016...
April 25, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28445203/considerations-for-refractive-surgery-in-the-glaucoma-patient
#3
Meleha Ahmad, Isaac Chocron, Anurag Shrivastava
PURPOSE OF REVIEW: Given the popularity of keratorefractive surgery, and an aging populous of patients who have undergone these procedures, there is an increasing need for updated management protocols. This is particularly relevant for patients with chronic progressive diseases such as glaucoma, due to the variety of related diagnostic and management challenges inherent to these diseases. Here, we will review the current literature to provide an update on the management of patients with glaucoma who are undergoing, or have had laser ablative refractive surgery...
April 25, 2017: Current Opinion in Ophthalmology
https://www.readbyqxmd.com/read/28445189/proton-pump-inhibitor-responsive-esophageal-eosinophilia-still-a-valid-diagnosis
#4
Javier Molina-Infante, Pedro L Gonzalez-Cordero, Alfredo J Lucendo
PURPOSE OF REVIEW: To update rapidly evolving concepts regarding the controversial entity of 'proton pump inhibitor (PPI)-responsive esophageal eosinophilia,' referring to patients with clinical, endoscopic and histologic features of eosinophilic esophagitis (EoE) who achieve remission on PPI therapy. RECENT FINDINGS: Up to half of pediatric and adult patients with typical EoE symptoms and histology achieve clinico-pathologic remission on PPI therapy, irrespective of whether esophageal pH monitoring demonstrates abnormal acid reflux...
April 25, 2017: Current Opinion in Gastroenterology
https://www.readbyqxmd.com/read/28445176/novel-lipid-modifying-drugs-to-lower-ldl-cholesterol
#5
Arjen J Cupido, Laurens F Reeskamp, John J P Kastelein
PURPOSE OF REVIEW: Statins have long been the cornerstone for the prevention of cardiovascular disease (CVD). However, because of perceived adverse effects and insufficient efficacy in certain groups of patients, considerable interest exists in the search for alternatives to lower LDL-cholesterol (LDL-C), and the recent approvals of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors underlines the success of this quest. Here, we give an updated overview on the most recent developments in the area of LDL-C lowering agents...
April 25, 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28445108/manganese-provision-in-parenteral-nutrition-an-update
#6
Callum Livingstone
Manganese (Mn) is an essential micronutrient required for the activity of metalloenzymes. It is an essential component of parenteral nutrition (PN), but requirements are low. Mn status is difficult to assess, with the commonest method being measurement of its concentration in whole blood. This method has limitations, including artifactually high concentrations resulting from contamination of specimen tubes. Mn toxicity is a well-recognized complication of PN, the risk of which increases if there is cholestasis or if the patient has received high doses...
April 1, 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28445098/comparative-analysis-of-human-epidermal-growth-factor-receptor-2-testing-in-breast-cancer-according-to-2007-and-2013-american-society-of-clinical-oncology-college-of-american-pathologists-guideline-recommendations
#7
Wedad M Hanna, Elzbieta Slodkowska, Fang-I Lu, Houman Nafisi, Sharon Nofech-Mozes
Purpose To study the effect of the 2013 updates to the 2007 American Society of Clinical Oncology/College of American Pathologists recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer on testing patterns and interpretation in a large regional reference laboratory. Patients and Methods Patient cases with HER2 testing scores for breast biomarker evaluation were selected from our laboratory information system during two 12-month periods (2012 and 2014). The number of tests performed, type of specimens, proportion of HER2-positive and equivocal patient cases, and number of repeat tests on subsequent excisional specimens were examined and compared...
April 26, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28444814/chronic-antibody-mediated-rejection-in-nonhuman-primate-renal-allografts-validation-of-human-histological-and-molecular-phenotypes
#8
B A Adam, R N Smith, I A Rosales, M Matsunami, B Afzali, T Oura, A B Cosimi, T Kawai, R B Colvin, M Mengel
Molecular testing represents a promising adjunct for the diagnosis of antibody-mediated rejection (AMR). Here we apply a novel gene expression platform in sequential formalin-fixed paraffin-embedded (FFPE) samples from nonhuman primate (NHP) renal transplants. We analyzed 34 previously-described gene transcripts related to AMR in humans in 197 archival NHP samples, including 102 from recipients that developed chronic AMR, 80 from recipients without AMR, and 15 normal native nephrectomies. Three endothelial genes (VWF, DARC, CAV1), derived from 10-fold cross-validation ROC curve analysis, demonstrated excellent discrimination between AMR and non-AMR samples (AUC=0...
April 26, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28444765/interinstrumental-transfer-of-a-fast-short-end-injection-capillary-electrophoretic-method-application-to-the-separation-of-niobium-tantalum-and-their-substituted-ions
#9
Bart De Cock, James D Oliver, Nathalie Delaunay, Gauthier Deblonde, Debby Mangelings, Yvan Vander Heyden
The interinstrumental transfer of a short-end capillary electrophoretic method was studied. A model separation of the hexameric forms of Niobium, Tantalum and their substituted ions (Nb6-x Tax with 0≤x≤6) was selected as test case. The method was first optimised on a Beckman instrument and in a second step transferred to an Agilent instrument. The transfer needed updated guidelines that tackled differences in effective capillary length, 8.5 (Agilent) versus 10 cm (Beckman), because of instrumental different capillary cartridges...
April 26, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28444684/-evaluation-and-treatment-of-sleep-problems-in-children-diagnosed-with-attention-deficit-hyperactivity-disorder-an-update-of-the-evidence
#10
REVIEW
M Chamorro, J P Lara, I Insa, M Espadas, J A Alda-Diez
INTRODUCTION: Attention deficit hyperactivity disorder (ADHD) affects approximately 5% of all children and adolescents, and these patients frequently suffer from sleep problems. The association between sleep disorders and ADHD, however, is multifaceted and complex. AIMS: To explore the relationship between sleep disorders and ADHD. DEVELOPMENT: Sleep problems in children with ADHD include altered sleep and specific disorders per se or that may be due to comorbid psychiatric disorders or to the stimulants they receive as treatment for their ADHD...
May 1, 2017: Revista de Neurologia
https://www.readbyqxmd.com/read/28444664/endocrine-complications-of-surgical-treatment-of-thyroid-cancer-an-update
#11
Pedro Iglesias, Juan José Díez
Postoperative hypoparathyroidism (HypoPT) and hypothyroidism (HypoT) are the main endocrine complications after the surgical treatment for thyroid cancer. Postsurgical HypoPT can be transient, protracted or permanent. Its frequency varies according to the underlying cervical pathology, surgical technique, and mainly the experience of the surgeon. Risk factors for HypoPT include aggressiveness of the tumor, extent of surgery, the presence of parathyroid gland in the pathologic specimen, and surgeon experience...
April 25, 2017: Experimental and Clinical Endocrinology & Diabetes
https://www.readbyqxmd.com/read/28444451/new-tumor-entities-in-the-4th-edition-of-the-world-health-organization-classification-of-head-and-neck-tumors-nasal-cavity-paranasal-sinuses-and-skull-base
#12
REVIEW
Lester D R Thompson, Alessandro Franchi
The World Health Organization recently published the 4th edition of the Classification of Head and Neck Tumors, including several new entities, emerging entities, and significant updates to the classification and characterization of tumor and tumor-like lesions, specifically as it relates to nasal cavity, paranasal sinuses, and skull base in this overview. Of note, three new entities (NUT carcinoma, seromucinous hamartoma, biphenotypic sinonasal sarcoma,) were added to this section, while emerging entities (SMARCB1-deficient carcinoma and HPV-related carcinoma with adenoid cystic-like features) and several tumor-like entities (respiratory epithelial adenomatoid hamartoma, chondromesenchymal hamartoma) were included as provisional diagnoses or discussed in the setting of the differential diagnosis...
April 25, 2017: Virchows Archiv: An International Journal of Pathology
https://www.readbyqxmd.com/read/28444309/frequency-of-youth-e-cigarette-tobacco-and-poly-use-in-the-united-states-2015-update-to-villanti-et-al-frequency-of-youth-e-cigarette-and-tobacco-use-patterns-in-the-united-states-measurement-precision-is-critical-to-inform-public-health
#13
Lauren K Collins, Andrea C Villanti, Jennifer L Pearson, Allison M Glasser, Amanda L Johnson, Raymond S Niaura, David B Abrams
No abstract text is available yet for this article.
April 22, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/28444286/screening-for-preeclampsia-us-preventive-services-task-force-recommendation-statement
#14
Kirsten Bibbins-Domingo, David C Grossman, Susan J Curry, Michael J Barry, Karina W Davidson, Chyke A Doubeni, John W Epling, Alex R Kemper, Alex H Krist, Ann E Kurth, C Seth Landefeld, Carol M Mangione, William R Phillips, Maureen G Phipps, Michael Silverstein, Melissa A Simon, Chien-Wen Tseng
Importance: Preeclampsia affects approximately 4% of pregnancies in the United States. It is the second leading cause of maternal mortality worldwide and may lead to serious maternal complications, including stroke, eclampsia, and organ failure. Adverse perinatal outcomes for the fetus and newborn include intrauterine growth restriction, low birth weight, and stillbirth. Many of the complications associated with preeclampsia lead to early induction of labor or cesarean delivery and subsequent preterm birth...
April 25, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28444114/efficacy-of-everolimus-plus-octreotide-lar-in-patients-with-advanced-neuroendocrine-tumor-and-carcinoid-syndrome-final-overall-survival-from-the-randomized-placebo-controlled-phase-3-radiant-2-study
#15
M E Pavel, E Baudin, K E Öberg, J D Hainsworth, M Voi, N Rouyrre, M Peeters, D J Gross, J C Yao
Background: In the phase 3 RADIANT-2 study, everolimus plus octreotide long-acting repeatable (LAR) showed improvement of 5.1 months in median progression-free survival vs placebo plus octreotide LAR among patients with advanced neuroendocrine tumors associated with carcinoid syndrome. The progression-free survival P-value was marginally above the prespecified threshold for statistical significance. Here, we report final overall survival (OS) and key safety update from RADIANT-2. Patients and methods: The RADIANT-2 trial compared everolimus (10 mg/day, orally; n= 216) vs placebo ( n= 213), both in conjunction with octreotide LAR (30 mg, intramuscularly, every 28 days)...
April 24, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28444082/ii-brazilian-consensus-on-the-use-of-human-immunoglobulin-in-patients-with-primary-immunodeficiencies
#16
Ekaterini Simões Goudouris, Almerinda Maria do Rego Silva, Aluce Loureiro Ouricuri, Anete Sevciovic Grumach, Antonio Condino-Neto, Beatriz Tavares Costa-Carvalho, Carolina Cardoso de Mello Prando, Cristina Maria Kokron, Dewton de Moraes Vasconcelos, Fabíola Scancetti Tavares, Gesmar Rodrigues Silva Segundo, Irma Cecília Douglas Paes Barreto, Mayra de Barros Dorna, Myrthes Anna Maragna Toledo Barros, Wilma Carvalho Neves Forte
In the last few years, new primary immunodeficiencies and genetic defects have been described. Recently, immunoglobulin products with improved compositions and for subcutaneous use have become available in Brazil. In order to guide physicians on the use of human immunoglobulin to treat primary immunodeficiencies, based on a narrative literature review and their professional experience, the members of the Primary Immunodeficiency Group of the Brazilian Society of Allergy and Immunology prepared an updated document of the 1st Brazilian Consensus, published in 2010...
2017: Einstein
https://www.readbyqxmd.com/read/28443893/trail-np-hybrids-for-cancer-therapy-a-review
#17
REVIEW
H Belkahla, G Herlem, F Picaud, T Gharbi, M Hémadi, S Ammar, O Micheau
Cancer is a worldwide health problem. It is now considered as a leading cause of morbidity and mortality in developed countries. In the last few decades, considerable progress has been made in anti-cancer therapies, allowing the cure of patients suffering from this disease, or at least helping to prolong their lives. Several cancers, such as those of the lung and pancreas, are still devastating in the absence of therapeutic options. In the early 90s, TRAIL (Tumor Necrosis Factor-related apoptosis-inducing ligand), a cytokine belonging to the TNF superfamily, attracted major interest in oncology owing to its selective anti-tumor properties...
April 26, 2017: Nanoscale
https://www.readbyqxmd.com/read/28443384/biological-and-targeted-therapies-of-systemic-lupus-erythematosus-evidence-and-the-state-of-the-art
#18
Chi Chiu Mok
Systemic lupus erythematosus (SLE) is a multi-systemic disease characterized by an unpredictable disease course and periods of remission and flare, leading to organ damage and mortality. Novel biological agents are being developed (targeting the lymphocytes, accessory molecules and cytokines) that aim to enhance the therapeutic efficacy when combined with standard therapies. Areas covered: This article updates recent data on the use of biological and targeted therapies in SLE. Expert opinion: B cells remain the main target of development of novel therapeutics in SLE...
April 26, 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28443377/association-of-microrna-146a-and-microrna-149-polymorphisms-with-strokes-in-asian-populations-an-updated-meta-analysis
#19
Jiaxiu Du, Chuanju Cui, Shuling Zhang, Xiaopeng Yang, Jiyu Lou
Strokes are a major cause of disability and death worldwide. An association between microRNA-146a (miR-146a) and miR-149 polymorphisms and strokes was inconclusive. This meta-analysis aimed to reevaluate the strength of the association by searching online databases and retrieving relevant case-control studies published between 2000 and 2016. Nine articles including 8 on miR-146a rs2910164 G/C and 3 on miR-149 rs2292832 C/T in 3372 patients with stroke and 4394 controls were included. The miR-149 rs2292832 was significantly associated with the risk of a stroke under allelic (C vs T: odds ratio [OR] = 1...
January 1, 2017: Angiology
https://www.readbyqxmd.com/read/28443359/targeting-lrrk2-in-parkinson-s-disease-an-update-on-recent-developments
#20
Sharon L Chan, Eng-King Tan
LRRK2 research has progressed significantly in recent years with more reports of LRRK2 interactors and the development of more specific and sophisticated LRRK2 kinase inhibitors. Identification of bone fide LRRK2 substrates will provide new therapeutic targets in LRRK2-linked Parkinson's disease (PD). Areas covered: This review aims to put current LRRK2 research into perspective. Beginning with recent LRRK2 mammalian models employed for in vivo validation of LRRK2 substrates, followed by updates on reported LRRK2 interactors and their inferred mechanisms...
April 26, 2017: Expert Opinion on Therapeutic Targets
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