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https://www.readbyqxmd.com/read/29168673/the-role-of-dalbavancin-in-the-multi-disciplinary-management-of-wound-infections-in-orthopaedic-surgery
#1
Fabio Arena, Emilio Romanini, Elia Rosi, Carlo Salomone, Gabriele Tucci, Ciro Pempinello, Massimo Fantoni
Antimicrobial resistance is continuously increasing among bacterial clinical isolates (especially methicillin resistance in Staphylococcus aureus, MRSA), negatively impacting on outcomes of patients with Surgical Site Infections (SSIs). A multi-disciplinary team work is essential for SSIs prevention and for the choice of antibiotic therapy of orthopaedic SSIs. In particular, an Antibiotic Stewardship (AS) approach is recommended for preserving the activity of old and new antimicrobials. Dalbavancin is a novel antimicrobial agent, belonging to the lipoglycopeptides family, recently approved by FDA for the treatment of ABSSSIs (Acute Bacterial Skin and Skin Structure Infections) and can be considered as a candidate for the treatment of orthopaedic superficial SSIs...
November 23, 2017: Journal of Chemotherapy
https://www.readbyqxmd.com/read/29168193/the-effects-of-long-term-varenicline-administration-on-ethanol-and-sucrose-seeking-and-self-administration-in-male-p-rats
#2
Cristine L Czachowski, Janice C Froehlich, Michael DeLory
BACKGROUND: Varenicline, a partial agonist at α4β2 and full agonist at α7 nicotinic cholinergic receptors, is FDA approved for treatment of smoking cessation and has been found to reduce alcohol craving in clinical populations. In rodents, varenicline decreases free-choice ethanol intake with somewhat mixed findings in operant paradigms that utilize a combined appetitive/consummatory response. METHODS: The present experiment utilized an operant paradigm that procedurally separates appetitive from consummatory responding and a "reward blocking" approach (i...
November 23, 2017: Alcoholism, Clinical and Experimental Research
https://www.readbyqxmd.com/read/29167924/persistent-cytarabine-and-daunorubicin-exposure-after-administration-of-novel-liposomal-formulation-cpx-351-population-pharmacokinetic-assessment
#3
Mina Nikanjam, Edmund V Capparelli, Jeffrey E Lancet, Arthur Louie, Gary Schiller
PURPOSE: CPX-351 is a novel liposomal formulation of cytarabine and daunorubicin which has recently been FDA approved for treatment of acute myeloid leukemia (AML). The current study investigated the pharmacokinetics (PK) of this liposomal formulation. METHODS: CPX-351 PK data (cytarabine, daunorubicin, and metabolites) from a phase I study of relapsed and refractory AML were used for the analysis. Therapy was given days 1, 3, and 5 of induction (3-134 units/m(2))...
November 22, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29167693/approving-cancer-treatments-based-on-endpoints-other-than-overall-survival-an-analysis-of-historical-data-using-the-pace-continuous-innovation-indicators%C3%A2-cii
#4
Neon Brooks, Mario Campone, Silvia Paddock, Scott Shortenhaus, David Grainger, Jacqueline Zummo, Samuel Thomas, Rose Li
Background: There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available...
2017: Drugs in Context
https://www.readbyqxmd.com/read/29167292/clinical-evaluation-of-the-cepheid-xpert%C3%A2-tv-assay-for-detection-of-trichomonas-vaginalis-with-prospectively-collected-female-and-male-specimens
#5
Jane R Schwebke, C A Gaydos, T Davis, J Marrazzo, D Furgerson, S N Taylor, B Smith, L H Bachmann, R Ackerman, T Spurrell, D Ferris, C A Burnham, H Reno, J Lebed, D Eisenberg, P Kerndt, S Philip, J Jordan, N Quigley
Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and acquisition/transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA-cleared in the United States for detection of Trichomonas vaginalis (TV) in specimens from both women and men. This current study reports the results of a multicenter study recently conducted using the Xpert TV Assay to test specimens from both men and women. On-demand results were available in as little as 40 minutes for positive specimens...
November 22, 2017: Journal of Clinical Microbiology
https://www.readbyqxmd.com/read/29167143/summaries-of-safety-labeling-changes-approved-by-fda-boxed-warnings-highlights-july-september-2017
#6
(no author information available yet)
No abstract text is available yet for this article.
December 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29167132/summaries-of-safety-labeling-changes-approved-by-fda-boxed-warnings-highlights-july-september-2017
#7
(no author information available yet)
No abstract text is available yet for this article.
December 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29165815/development-and-validation-of-a-liquid-chromatography-tandem-mass-spectrometry-analytical-method-for-the-therapeutic-drug-monitoring-of-eight-novel-anticancer-drugs
#8
M Herbrink, N de Vries, H Rosing, A D R Huitema, B Nuijen, J H M Schellens, J H Beijnen
To support therapeutic drug monitoring (TDM) of patients with cancer, a fast and accurate method for simultaneous quantification of the registered anticancer drugs afatinib, axitinib, ceritinib, crizotinib, dabrafenib, enzalutamide, regorafenib and trametinib in human plasma using liquid chromatography tandem mass spectrometry was developed and validated. Human plasma samples were collected from treated patients and stored at -20 (o) C. Analytes and internal standards (stable isotopically labeled analytes) were extracted with acetonitrile...
November 22, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29165314/towards-natural-mimetics-of-metformin-and-rapamycin
#9
Alexander Aliper, Leslie Jellen, Franco Cortese, Artem Artemov, Darla Karpinsky-Semper, Alexey Moskalev, Andrew G Swick, Alex Zhavoronkov
Aging is now at the forefront of major challenges faced globally, creating an immediate need for safe, widescale interventions to reduce the burden of chronic disease and extend human healthspan. Metformin and rapamycin are two FDA-approved mTOR inhibitors proposed for this purpose, exhibiting significant anti-cancer and anti-aging properties beyond their current clinical applications. However, each faces issues with approval for off-label, prophylactic use due to adverse effects. Here, we initiate an effort to identify nutraceuticals-safer, naturally-occurring compounds-that mimic the anti-aging effects of metformin and rapamycin without adverse effects...
November 15, 2017: Aging
https://www.readbyqxmd.com/read/29165087/nucleotide-reverse-transcriptase-inhibitors-a-thorough-review-present-status-and-future-perspective-as-hiv-therapeutics
#10
Ashley D Holec, Subhra Mandal, Pavan Kumar Prathipati, Christopher J Destache
Human immunodeficiency virus type-1 (HIV-1) infection leads to acquired immunodeficiency syndrome (AIDS), a severe fatal viral infection that has claimed approximately 658,507 lives in the US within the year 2010-2014. Antiretroviral (ARV) therapy has proven to inhibit HIV-1, but unlike other viral illness, not cure the infection. Among various Food and Drug Administration (FDA)-approved ARVs, nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) are most effective in limiting HIV-1 infection. This review focuses on NRTIs mechanism of action and metabolism...
November 19, 2017: Current HIV Research
https://www.readbyqxmd.com/read/29165075/preferential-formulation-of-second-generation-antipsychotic-asenapine-as-inclusion-complex-with-sulphobutylether-%C3%AE-cd-captisol-in-vitro-and-in-vivo-evaluation
#11
Amelia Makarand Avachat, Juilee A Kulkarni, Charul M Avachat, Rohan Pradhan, Tushar S Suryawanshi, E M Khan, Elvis A F Martis, Evans C Coutinho, Subhash Padhye
Asenapine is an anti-psychotic agent approved by the US-FDA for treatment of acute schizophrenia and manic or bipolar I disorder in adults. It is poorly absorbed when administered orally, hence exhibits poor oral bioavailability, which limits its use in clinical practice. Consequently, enhancement in its solubility through complexation with three different cyclodextrins, viz. βCD (β cyclodextrin), HPβCD (Hydroxypropyl β cyclodextrin) and sulphobutylether-βCD (Captisol®) was attempted and compared. Kneading method was used for preparation of inclusion complexes which were characterized by FTIR, DSC, and XRD methods...
November 20, 2017: Current Drug Delivery
https://www.readbyqxmd.com/read/29164603/18f-pet-with-florbetapir-for-the-early-diagnosis-of-alzheimer-s-disease-dementia-and-other-dementias-in-people-with-mild-cognitive-impairment-mci
#12
REVIEW
Gabriel Martínez, Robin Wm Vernooij, Paulina Fuentes Padilla, Javier Zamora, Xavier Bonfill Cosp, Leon Flicker
BACKGROUND: (18)F-florbetapir uptake by brain tissue measured by positron emission tomography (PET) is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using amyloid biomarkers tests like (18)F-florbetapir...
November 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29164602/18f-pet-with-flutemetamol-for-the-early-diagnosis-of-alzheimer-s-disease-dementia-and-other-dementias-in-people-with-mild-cognitive-impairment-mci
#13
REVIEW
Gabriel Martínez, Robin Wm Vernooij, Paulina Fuentes Padilla, Javier Zamora, Leon Flicker, Xavier Bonfill Cosp
BACKGROUND: (18)F-flutemetamol uptake by brain tissue, measured by positron emission tomography (PET), is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and the confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using some amyloid biomarkers tests like (18)F-flutemetamol...
November 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29164600/18f-pet-with-florbetaben-for-the-early-diagnosis-of-alzheimer-s-disease-dementia-and-other-dementias-in-people-with-mild-cognitive-impairment-mci
#14
REVIEW
Gabriel Martínez, Robin Wm Vernooij, Paulina Fuentes Padilla, Javier Zamora, Leon Flicker, Xavier Bonfill Cosp
BACKGROUND: (18)F-florbetaben uptake by brain tissue, measured by positron emission tomography (PET), is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using some amyloid biomarkers tests like (18)F-florbetaben...
November 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29164374/fixed-dose-4-factor-prothrombin-complex-concentrate-for-the-emergent-reversal-of-warfarin-a-retrospective-analysis
#15
Greta Astrup, Preeyaporn Sarangarm, Allison Burnett
Published literature suggests that a fixed-dose 4-factor prothrombin complex concentrate (4FPCC) may be efficacious in managing warfarin-associated hemorrhage, however the ideal dose is still unclear. The purpose of this evaluation was to determine the efficacy of fixed-dose 4FPCC in reducing the International Normalized Ratio (INR) to ≤ 1.5 among warfarin patients with need for urgent or emergent anticoagulation reversal. Starting October 2016, our institution changed from standard 4FPCC FDA-labeled dosing based on the patient's presenting INR and weight, to a fixed-dose of 1500 units for all patients requiring urgent or emergent warfarin reversal...
November 21, 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/29163822/structural-basis-of-the-therapeutic-anti-pd-l1-antibody-atezolizumab
#16
Fei Zhang, Xiaoqiang Qi, Xiaoxiao Wang, Diyang Wei, Jiawei Wu, Lingling Feng, Haiyan Cai, Yugang Wang, Naiyan Zeng, Ting Xu, Aiwu Zhou, Ying Zheng
Monoclonal antibodies targeting PD-1/PD-L1 signaling pathway have achieved unprecedented success in cancer treatment over the last few years. Atezolizumab is the first PD-L1 monoclonal antibody approved by US FDA for cancer therapy; however the molecular basis of atezolizumab in blocking PD-1/PD-L1 interaction is not fully understood. Here we have solved the crystal structure of PD-L1/atezolizumab complex at 2.9 angstrom resolution. The structure shows that atezolizumab binds the front beta-sheet of PD-L1 through three CDR loops from the heavy chain and one CDR loop from the light chain...
October 27, 2017: Oncotarget
https://www.readbyqxmd.com/read/29163815/pd-l1-expression-heterogeneity-in-non-small-cell-lung-cancer-evaluation-of-small-biopsies-reliability
#17
Enrico Munari, Giuseppe Zamboni, Marcella Marconi, Marco Sommaggio, Matteo Brunelli, Guido Martignoni, George J Netto, Francesca Moretta, Maria Cristina Mingari, Matteo Salgarello, Alberto Terzi, Vincenzo Picece, Carlo Pomari, Gianluigi Lunardi, Alberto Cavazza, Giulio Rossi, Lorenzo Moretta, Giuseppe Bogina
Immunotherapy with checkpoint inhibitors, allowing recovery of effector cells function, has demonstrated to be highly effective in many tumor types and represents a true revolution in oncology. Recently, the anti-PD1 agent pembrolizumab was granted FDA approval for the first line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors show PD-L1 expression in ≥ 50% of neoplastic cells and as a second line treatment for patients with NSCLC expressing PD-L1 in ≥1% of neoplastic cells, evaluated with a validated assay...
October 27, 2017: Oncotarget
https://www.readbyqxmd.com/read/29163675/effects-of-different-concentrations-of-type-i-collagen-hydrogel-on-the-growth-and-differentiation-of-chondrocytes
#18
Deshan Hu, Xiuli Shan
The objective of this study was to analyze the effects of type-I collagen hydrogel of different concentrations on the growth and differentiation of rabbit chondrocytes. Articular cartilage from New Zealand white rabbits was harvested and cultured. Second-generation chondrocytes were collected for in vitro culture with 10, 7, and 5 mg/ml type-I collagen hydrogel, respectively (denoted as groups A, B, and C). After in vitro culture for 1 day, chondrocytes were stained with fluorescein diacetate (FDA)/propidium iodide (PI), and cell viability was observed by laser confocal microscopy...
December 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/29162825/outcomes-of-patients-with-sarcoma-enrolled-in-clinical-trials-of-pazopanib-combined-with-histone-deacetylase-mtor-her2-or-mek-inhibitors
#19
Vikas Dembla, Roman Groisberg, Ken Hess, Siqing Fu, Jennifer Wheler, David S Hong, Filip Janku, Ralph Zinner, Sarina Anne Piha-Paul, Vinod Ravi, Robert S Benjamin, Shreyaskumar Patel, Neeta Somaiah, Cynthia E Herzog, Daniel D Karp, Jason Roszik, Funda Meric-Bernstam, Vivek Subbiah
Pazopanib is US FDA approved for the treatment of advanced soft tissue sarcomas. All patients with this disease ultimately develop resistance to therapy. Mechanisms of resistance include activation of the mTOR, histone deacetylase (HDAC), MAPK, and ERBB4 pathways. We hypothesized that combining pazopanib with other targeted agents inhibiting these pathways would increase response rates. We retrospectively evaluated the safety and efficacy of pazopanib plus vorinostat, everolimus, lapatinib or trastuzumab, and MEK inhibitor in patients with advanced sarcoma...
November 21, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29162426/current-status-and-unanswered-questions-for-food-allergy-treatments
#20
Rima Rachid, Corinne A Keet
Although there is no FDA approved therapy for food allergy, over the past decades, several routes of immunotherapy have been investigated for food allergy. Thus far, these therapies have shown variable levels of efficacy at desensitizing to foods, with oral immunotherapy (OIT) far more successful than sublingual immunotherapy (SLIT) or epicutaneous immunotherapy (EPIT). However, desensitization tends to be temporary, and safety remains a major concern with OIT. Moreover, although it seems logical that desensitization will result in fewer reactions, it is not clear whether OIT or other immunotherapies are associated with an overall lower or higher risk of reactions over the long term...
November 18, 2017: Journal of Allergy and Clinical Immunology in Practice
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