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https://www.readbyqxmd.com/read/29149281/seroreactivity-to-the-c6-peptide-in-borrelia-miyamotoi-infections-occurring-in-the-northeastern-united-states
#1
Phillip J Molloy, Karen E Weeks, Brittany Todd, Gary P Wormser
Background: There are no Food and Drug Administration (FDA) approved diagnostic tests for Borrelia miyamotoi infection, an emerging tick-borne illness in the United States. The purpose of this study was to evaluate whether the FDA-approved C6 peptide ELISA currently used to diagnose Lyme disease may potentially serve as a diagnostic test for B. miyamotoi infections. Methods: Serum specimens from 30 patients from the Northeastern United States with B. miyamotoi infection established by a polymerase chain reaction assay of a blood specimen were tested using the C6 ELISA...
November 15, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29149222/personalized-medicine-and-hispanic-health-improving-health-outcomes-and-reducing-health-disparities-a-national-heart-lung-and-blood-institute-workshop-report
#2
M Larissa Avilés-Santa, John Heintzman, Nangel M Lindberg, Rafael Guerrero-Preston, Kenneth Ramos, Ana L Abraído-Lanza, Jonca Bull, Adolph Falcón, Mary Ann McBurnie, Ernest Moy, George Papanicolaou, Ileana L Piña, Jennifer Popovic, Shakira F Suglia, Miguel A Vázquez
Persons of Hispanic/Latino descent may represent different ancestries, ethnic and cultural groups and countries of birth. In the U.S., the Hispanic/Latino population is projected to constitute 29% of the population by 2060. A personalized approach focusing on individual variability in genetics, environment, lifestyle and socioeconomic determinants of health may advance the understanding of some of the major factors contributing to the health disparities experienced by Hispanics/Latinos and other groups in the U...
2017: BMC Proceedings
https://www.readbyqxmd.com/read/29149148/current-impact-and-application-of-abuse-deterrent-opioid-formulations-in-clinical-practice
#3
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29148595/determination-of-cefoperazone-and-sulbactam-in-serum-by-hplc-ms-ms-an-adapted-method-for-therapeutic-drug-monitoring-in-children
#4
Xiu-Jun Wu, Xin Huang, Hai-Yan Shi, Xing-Kai Chen, Qian Dong, Guo-Xiang Hao, Yan Li, Yi Zheng, Wei Zhao
A rapid, accurate and specific high-performance liquid chromatographic -tandem mass spectrometry method has been validated for the simultaneous determination of cefoperazone and sulbactam in a small volume sample for children. A Shim-pack XR-ODS C18 column with gradient elution of water (0.1% formic acid) and acetonitrile (0.1% formic acid) solution was used for separation at a flow rate of 0.3 mL/min. The calibration curves of two analytes in serum showed excellent linearity over the concentration ranges of 0...
November 17, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29148107/pediatric-drug-information-available-at-the-time-of-new-drug-approvals-a-cross-sectional-analysis
#5
Joel D Hudgins, Matthew A Bacho, Karen L Olsen, Florence T Bourgeois
PURPOSE: Greater than 50% of drugs lack pediatric labeling information, resulting in widespread "off-label" use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in 2003, requiring new drug applications to include pediatric assessments. We evaluated the study of new drugs in children since PREA was implemented. METHODS: We performed a cross-sectional analysis of new drug applications submitted to the FDA from December 2003 to July 2012, using publicly available documents at Drugs@FDA...
November 17, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29147628/trial-watch-adoptively-transferred-cells-for-anticancer-immunotherapy
#6
REVIEW
Carole Fournier, François Martin, Laurence Zitvogel, Guido Kroemer, Lorenzo Galluzzi, Lionel Apetoh
Immunotherapies aimed at strengthening immune effector responses against malignant cells are growing at exponential rates. Alongside, the impressive benefits obtained by patients with advanced melanoma who received adoptively transferred tumor-infiltrating lymphocytes (TILs) have encouraged the scientific community to pursue adoptive cell transfer (ACT)-based immunotherapy. ACT involves autologous or allogenic effector lymphocytes that are generally obtained from the peripheral blood or resected tumors, expanded and activated ex vivo, and administered to lymphodepleted patients...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/29146621/effect-of-fda-investigation-on-opioid-prescribing-to-children-after-tonsillectomy-adenoidectomy
#7
Kao-Ping Chua, Mark G Shrime, Rena M Conti
BACKGROUND: In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013. The objective of this study was to evaluate the association between the investigation and opioid prescribing to children undergoing these surgeries. METHODS: We identified 362 992 privately insured children in the 2010-2015 Truven MarketScan Commercial Claims and Encounters database who underwent tonsillectomy and/or adenoidectomy...
November 16, 2017: Pediatrics
https://www.readbyqxmd.com/read/29146569/found-in-translation-how-preclinical-research-is-guiding-the-clinical-development-of-the-bcl2-selective-inhibitor-venetoclax
#8
REVIEW
Joel D Leverson, Deepak Sampath, Andrew J Souers, Saul H Rosenberg, Wayne J Fairbrother, Martine Amiot, Marina Konopleva, Anthony Letai
Since the discovery of apoptosis as a form of programmed cell death, targeting the apoptosis pathway to induce cancer cell death has been a high-priority goal for cancer therapy. After decades of effort, drug-discovery scientists have succeeded in generating small-molecule inhibitors of antiapoptotic BCL2 family proteins. Innovative medicinal chemistry and structure-based drug design, coupled with a strong fundamental understanding of BCL2 biology, were essential to the development of BH3 mimetics such as the BCL2-selective inhibitor venetoclax...
November 16, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/29146245/repurposing-cationic-amphiphilic-drugs-as-adjuvants-to-induce-lysosomal-sirna-escape-in-nanogel-transfected-cells
#9
Freya Joris, Lynn De Backer, Thijs Van de Vyver, Chiara Bastiancich, Stefaan C De Smedt, Koen Raemdonck
Cytosolic delivery remains a major bottleneck for siRNA therapeutics. To facilitate delivery, siRNAs are often enclosed in nanoparticles (NPs). However, upon endocytosis such NPs are mainly trafficked towards lysosomes. To avoid degradation, cytosolic release of siRNA should occur prior to fusion of endosomes with lysosomes, but current endosomal escape strategies remain inefficient. In contrast to this paradigm, we aim to exploit lysosomal accumulation by treating NP-transfected cells with low molecular weight drugs that release the siRNA from the lysosomes into the cytosol...
November 13, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/29144822/testosterone-levels-achieved-by-medically-treated-transgender-women-in-a-united-states-endocrinology-clinic-cohort
#10
Jennifer J Liang, Divya Jolly, Kelly J Chan, Joshua D Safer
OBJECTIVE: Most transgender women depend on medical treatment alone to lower testosterone levels in order to align physical appearance with gender identity. The medical regimen in the United States typically includes spironolactone and estrogens. The purpose of this cross-sectional study was to assess the testosterone suppression achieved among transgender women treated with spironolactone and estrogens. METHODS: Testosterone and estradiol levels were extracted from the electronic medical records of 98 anonymized transgender women treated with oral spironolactone and oral estrogen therapy at the Endocrinology Clinic at Boston Medical Center...
November 16, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/29144717/review-of-non-invasive-vagus-nerve-stimulation-gammacore-efficacy-safety-potential-impact-on-comorbidities-and-economic-burden-for-episodic-and-chronic-cluster-headache
#11
Mkaya Mwamburi, Eric J Liebler, Andrew T Tenaglia
The FDA has cleared gammaCore (non-invasive vagus nerve stimulator [nVNS]) for the treatment of episodic cluster headache (eCH). With the exception of subcutaneous sumatriptan, all other treatments are used off label and have many limitations. The FDA approval process for devices differs from that of drugs. We performed a review of the literature to evaluate new evidence on various aspects of gammaCore treatment and impact. The ACute Treatment of Cluster Headache Studies (ACT1 and ACT2), both double-blind sham-controlled randomized trials, did not meet the primary endpoints of the trials but each demonstrated significant superiority of gammaCore among patients with eCH...
November 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/29143689/examination-of-the-susceptibility-gap-in-the-treatment-of-canine-heartworm-infection
#12
REVIEW
Dwight D Bowman, Jason Drake
BACKGROUND: The "susceptibility gap" in a dog diagnosed with adult heartworms has been defined as the period of time in which some Dirofilaria immitis stages are not susceptible to treatment with either macrocyclic lactones or melarsomine dihydrochloride. This was previously defined within the American Heartworm Society guidelines as a period of about 3 months "as per product labels." It can be postulated, however, that a susceptibility gap does not exist with the combination of continued macrocyclic lactone therapy coupled with a three-dose melarsomine dihydrochloride protocol where the first intramuscular treatment is near the time of first diagnosis...
November 9, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/29143657/clinical-benefits-of-incorporating-doxycycline-into-a-canine-heartworm-treatment-protocol
#13
C Thomas Nelson, Elizabeth S Myrick, Thomas A Nelson
BACKGROUND: The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA), in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated...
November 9, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/29143648/a-statistical-approach-for-evaluating-the-effectiveness-of-heartworm-preventive-drugs-what-does-100-efficacy-really-mean
#14
Anand N Vidyashankar, Pablo D Jimenez Castro, Ray M Kaplan
BACKGROUND: Initial studies of heartworm preventive drugs all yielded an observed efficacy of 100% with a single dose, and based on these data the US Food and Drug Administration (FDA) required all products to meet this standard for approval. Those initial studies, however, were based on just a few strains of parasites, and therefore were not representative of the full assortment of circulating biotypes. This issue has come to light in recent years, where it has become common for studies to yield less than 100% efficacy...
November 9, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/29143642/a-diagnostic-algorithm-for-evaluating-cases-of-potential-macrocyclic-lactone-resistant-heartworm
#15
Andrew R Moorhead, Christopher C Evans, Ray M Kaplan
BACKGROUND: The emergence of macrocyclic lactone resistance in canine heartworm poses a substantial threat to what is currently the only effective, FDA-approved available method of prevention. Further study of the biotypes is necessary to understand the mechanism of resistance and evaluate novel prevention options. Identifying cases of drug-resistant infection remains problematic, however, especially when poor compliance and insufficient testing are concerns. Furthermore, a definitive demonstration of resistance requires experimental infection and treatment, which is prohibitively costly...
November 9, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/29143249/next-generation-chimeric-antigen-receptor-t-cell-therapy-going-off-the-shelf
#16
Marco Ruella, Saad S Kenderian
Autologous, patient-specific chimeric antigen receptor T-cell (CART) therapy has emerged as a powerful and potentially curative therapy for cancer, especially for CD19-positive hematological malignancies. Indeed, on August 30, 2017, the University of Pennsylvania-designed CD19-directed CART (CART-19) cell therapy (CTL019, tisagenlecleucel-t, Kymriah - Novartis) became the first CART therapy approved by the Food and Drug Administration (FDA) for acute lymphoblastic leukemia. However, the development of CART technology and its wider application is partly limited by the patient-specific nature of such a platform and by the time required for manufacturing...
November 16, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29142396/antioxidant-and-cholinesterase-inhibitory-activities-of-ethyl-acetate-extract-of-terminalia-chebula-cell-free-in-vitro-and-in-silico-studies
#17
Mohamed Asik Rajmohamed, Suganthy Natarajan, Premkumar Palanisamy, Akbarsha Mohammad Abdulkader, Archunan Govindaraju
Background: Alzheimer's disease (AD) is a progressive neurodegenerative disorder clinically characterized by memory loss and impaired cognitive function. Cholinergic enzyme deficiency and oxidative stress are the two major factors implicated in the pathogenesis of AD. The symptomatic treatment, as of now, is the use of cholinesterase inhibitors toward cholinergic "downturn." Therefore, there is a search for compounds that will be useful in focused therapies. There has been suggestion that Terminalia chebula fruit would be a potential source...
October 2017: Pharmacognosy Magazine
https://www.readbyqxmd.com/read/29142077/syndromic-panel-based-testing-in-clinical-microbiology
#18
REVIEW
Poornima Ramanan, Alexandra L Bryson, Matthew J Binnicker, Bobbi S Pritt, Robin Patel
The recent development of commercial panel-based molecular diagnostics for the rapid detection of pathogens in positive blood culture bottles, respiratory specimens, stool, and cerebrospinal fluid has resulted in a paradigm shift in clinical microbiology and clinical practice. This review focuses on U.S. Food and Drug Administration (FDA)-approved/cleared multiplex molecular panels with more than five targets designed to assist in the diagnosis of bloodstream, respiratory tract, gastrointestinal, or central nervous system infections...
January 2018: Clinical Microbiology Reviews
https://www.readbyqxmd.com/read/29140753/a-mutated-recombinant-subunit-vaccine-protects-mice-and-guinea-pigs-against-botulinum-type-a-intoxication
#19
Chi Ho Yu, Dong Hyun Song, Jun Young Choi, Hae Eun Joe, Woo Hyeon Jeong, Gyeung Haeng Hur, Young Kee Shin, Seong Tae Jeong
Botulinum neurotoxins (BoNTs) are the most potent toxins to mammals. A toxoid vaccine was previously used for prevention of botulinum intoxication; however, this vaccine is no longer available. Currently, no approved botulinum vaccines are available from the Food and Drug Administration (FDA). Recently, a recombinant host cell receptor-binding subunit created for use as a potential vaccine completed phase 2 clinical trials. The current study designed a vaccine candidate against BoNT type A (BoNT/A) using a structural design...
November 15, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29140657/sunlight-and-other-disinfectants-disclosure-obligations-under-the-federal-securities-and-drug-regulatory-regimes
#20
Joseph G Milner
Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public...
2017: Food and Drug Law Journal
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