Keywords: FDA، اداره غذا و دارو ایالات متحده; FDA, U.S. Food and Drug Administration; TBI, traumatic brain injury; NAM, nicotinamide; PARP, poly(ADP-ribose)polymerase-1; NAD+, nicotinamide-adenine dinucleotide; ATP, adenosine triphosphate; DNA, deoxyribonucleic acid; PLP, pyridoxal 5′-phosphate; MWM,
مقالات ISI FDA، اداره غذا و دارو ایالات متحده (ترجمه نشده)
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Keywords: FDA، اداره غذا و دارو ایالات متحده; computed tomography; FDA advisory; implantable cardioverter-defibrillator; pacemakersAAPM, American Association of Physicists in Medicine; CRM, cardiac rhythm management; CT, computed tomography; FDA, U.S. Food and Drug Administration; ICD, implantable ca
Keywords: FDA، اداره غذا و دارو ایالات متحده; cancer; cardiomyopathy; cardioprotection; chemotherapy; doxorubicin; heart failureACE, angiotensin-converting enzyme; ALL, acute lymphoblastic leukemia; ARB, angiotensin receptor blocker; DNA, deoxyribonucleic acid; FDA, U.S. Food and Drug Administration;
Keywords: FDA، اداره غذا و دارو ایالات متحده; FDA, U.S. Food and Drug Administration; PEG, percutaneous endoscopic gastrostomy; SEMS, self-expandable metal stent; UES, upper esophageal sphincter
Keywords: FDA، اداره غذا و دارو ایالات متحده; ANOVA, analysis of variance; CMH, Cochran-Mantel-Haenszel; FDA, U.S. Food and Drug Administration; ITT, intent-to-treat; OSS, oral sulfate solution; PEG-EA, polyethylene glycol electrolyte lavage solution with ascorbic acid; PEG-ELS, polyethylene glycol e
Keywords: FDA، اداره غذا و دارو ایالات متحده; ANOVA, analysis of variance; FDA, U.S. Food and Drug Administration; ITT, intent-to-treat; OSS, oral sulfate solution; PEG-ELS, polyethylene glycol electrolyte lavage solution; SP+MC, sodium picosulfate plus magnesium citrate
Keywords: FDA، اداره غذا و دارو ایالات متحده; clinical trial; placebo effect; public health; random allocation; reporting; research design; statistical analysisCABG, coronary artery bypass graft; CI, confidence interval; CV, cardiovascular; FDA, U.S. Food and Drug Administration; GPI, glycoprotein II
Keywords: FDA، اداره غذا و دارو ایالات متحده; Salvia officinalis; Phenolic diterpenes; Melanin; Acetylcholine esteraseS. officinalis, Salvia officinalis; AChE, acetylcholine esterase; AD, Alzheimer's disease; AChEIs, acetylcholine esterase inhibitors; FDA, U.S. food and drug administration; Aβ, amylo
Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System
Keywords: FDA، اداره غذا و دارو ایالات متحده; bioresorbable vascular scaffold; U.S. Food and Drug AdministrationBMS, bare-metal stent(s); BVS, bioresorbable vascular scaffold; DES, drug-eluting stent(s); FDA, U.S. Food and Drug Administration; MI, myocardial infarction; PMA, pre-market approval appli
Drugs, Devices, and the FDA: Part 1 : An Overview of Approval Processes for Drugs
Keywords: FDA، اداره غذا و دارو ایالات متحده; drug approval; FDA; investigational new drugCDER, Center for Drug Evaluation and Research; EIND, emergency investigational new drug; FDA, U.S. Food and Drug Administration; IND, investigational new drug; NDA, new drug application
Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel
Keywords: FDA، اداره غذا و دارو ایالات متحده; acute coronary syndrome; dual antiplatelet therapy; genetics; plateletsACS, acute coronary syndrome; CI, confidence interval; CYP, cytochrome P450; EM, extensive metabolizer(s); FDA, U.S. Food and Drug Administration; HR, hazard ratio; MI, myocardial infa
Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment
Keywords: FDA، اداره غذا و دارو ایالات متحده; urinary bladder; urinary incontinence; nocturiaAE, adverse event; AHRQ, Agency for Healthcare Research and Quality; FDA, U.S. Food and Drug Administration; OAB, overactive bladder; PTNS, peripheral tibial nerve stimulation; PVR, post-void residual; QoL, q
Compendium of aberrant DNA methylation and histone modifications in cancer
Keywords: FDA، اداره غذا و دارو ایالات متحده; K, lysine; ac, acetylation; me1, mono-methylation; me2, di-methylation; me3, tri-methylation; DNMT, DNA methyltransferase; FDA, U.S. Food and Drug Administration; POC, proof-of-conceptCancer; Epigenetics; DNA methylation; Histone modification
Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT : Results From the NCDR
Keywords: FDA، اداره غذا و دارو ایالات متحده; cardiac resynchronization therapy; men; QRS duration; QRS morphology; womenCRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; FDA, U.S. Food and Drug Administration; ICD, implantable cardioverter defibrillator;
Safety of Dronedarone in Routine Clinical Care
Keywords: FDA، اداره غذا و دارو ایالات متحده; adverse event(s); atrial fibrillation; dronedarone; liver function; mortalityAF, atrial fibrillation; CI, confidence interval; EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; HR, hazard ratio; SMR, standardized mortality ratio
Predictive validity of a MK-801-induced cognitive impairment model in mice: Implications on the potential limitations and challenges of modeling cognitive impairment associated with schizophrenia preclinically
Keywords: FDA، اداره غذا و دارو ایالات متحده; CIAS, cognitive impairment associated with schizophrenia; IA, inhibitory avoidance; MK-IA, MK-801 inhibitory avoidance; NMDA, N-methyl-d-aspartate; FDA, U.S. Food and Drug Administration; PCP, phencyclidine; IP, intraperitoneal; CNS, central nervous syste
Multiple-Day Drainage when Using Bone Morphogenic Protein for Long-Segment Thoracolumbar Fusions Is Associated with Low Rates of Wound Complications
Keywords: FDA، اداره غذا و دارو ایالات متحده; Bone morphogenetic protein; Complications; Drainage; Infection; SeromaBMP, Bone morphogenic protein; FDA, U.S. Food and Drug Administration
The P-Glycoprotein Transport System and Cardiovascular Drugs
Keywords: FDA، اداره غذا و دارو ایالات متحده; adverse drug event(s); drug-drug interaction; P-glycoprotein; pharmacologyATP, adenosine triphosphate; CrCl, creatinine clearance; CYP, cytochrome P450; FDA, U.S. Food and Drug Administration; MDR1, multidrug resistance-1; P-gp, permeability glycoprotein
Validation of an LC–MS bioanalytical method for quantification of phytate levels in rat, dog and human plasma
Keywords: FDA، اداره غذا و دارو ایالات متحده; ACN, acetonitrile; CV, coefficient of variation; EDTA, ethylenediaminetetraacetic acid; ESI, electrospray ionization; FDA, U.S. Food and Drug Administration; HPLC, high performance liquid chromatography; IP6, myo-inositol hexaphosphate or phytate; LC–MS,
Transcatheter Device Closure of Atrial Septal Defects : A Safety Review
Keywords: FDA، اداره غذا و دارو ایالات متحده; atrial septal defect; devices; erosionsASD, atrial septal defect(s); ASO, Amplatzer septal occluder; CCISC, Congenital Cardiovascular Interventional Study Consortium; FDA, U.S. Food and Drug Administration; HSO, Helex septal occluder; IMPACT, Improving Pe
Navigating Conflicts of Interest for the Medical Device Entrepreneur
Keywords: FDA، اداره غذا و دارو ایالات متحده; Medical devices; Conflicts of interest; Management strategy; Cardiovascular diseaseCOI, conflict of interest; FDA, U.S. Food and Drug Administration; FIH, First in Human; IDE, Investigative Device Exemption; IRB, Institutional Review Board
A Multicenter, Single-Blind, Prospective Randomized Trial to Evaluate the Safety of a Polyethylene Glycol Hydrogel (Duraseal Dural Sealant System) as a Dural Sealant in Cranial Surgery
Keywords: FDA، اداره غذا و دارو ایالات متحده; Cranial surgery; CSF leak; DuraSeal; Dural sealant; PEG hydrogelCSF, Cerebrospinal fluid; FDA, U.S. Food and Drug Administration; PEG, Polyethylene glycol
Drug–Drug Interactions in Cardiovascular Catheterizations and Interventions
Keywords: FDA، اداره غذا و دارو ایالات متحده; anticoagulants; drug-drug interactions; polypharmacyACS, acute coronary syndromes; AUC, area under the curve; CCB, calcium channel blocker; COX, cyclooxygenase; DDI, drug–drug interactions; DHP, dihydropyridine; FDA, U.S. Food and Drug Administration; GI,
Translational research in infectious disease: current paradigms and challenges ahead
Keywords: FDA، اداره غذا و دارو ایالات متحده; 2-DE, 2-dimensional electrophoresis; 2-D DIGE, 2-dimensional differential in-gel electrophoresis; CF, cystic fibrosis; CTSA, Clinical and Translational Science Awards program; EBV, Epstein-Barr virus; FDA, U.S. Food and Drug Administration; GWAS, genome-w
Computer-assisted personalized sedation
Keywords: FDA، اداره غذا و دارو ایالات متحده; ARM, automated responsiveness monitor; ASA, American Society of Anesthesiologists; ASGE, American Society for Gastrointestinal Endoscopy; BMU, bedside monitoring unit; CAPS, computer-assisted personalized sedation; FDA, U.S. Food and Drug Administration;
Future of Outcomes Measurement: Impact on Research in Medical Rehabilitation and Neurologic Populations
Keywords: FDA، اداره غذا و دارو ایالات متحده; Outcome measures; RehabilitationCAT, computer adaptive testing; CER, comparative effectiveness research; FDA, U.S. Food and Drug Administration; HRQOL, health-related quality of life; IRT, item response theory; Neuro-QOL, Quality of Life in Neurological D
Acute Adverse Reactions to Gadolinium-Based Contrast Agents in CMR : Multicenter Experience With 17,767 Patients From the EuroCMR Registry
Keywords: FDA، اداره غذا و دارو ایالات متحده; cardiac magnetic resonance; gadolinium; “off-label” use; safetyCMR, cardiac magnetic resonance; FDA, U.S. Food and Drug Administration
Medical Therapy for Ischemic Stroke: Review of Intravenous and Intra-Arterial Treatment Options
Keywords: FDA، اداره غذا و دارو ایالات متحده; Acute cerebral ischemia; Fibrinolytic therapy; Stroke; ThrombolysisCT, Computed tomography; FDA, U.S. Food and Drug Administration; ICH, Intracerebral hemorrhage; MCA, Middle cerebral artery; mRS, Modified Rankin Scale; NINDS, National Institute of Neurol
Saphenous Vein Graft Intervention
Keywords: FDA، اداره غذا و دارو ایالات متحده; percutaneous coronary intervention; saphenous vein graft; stentBMS, bare-metal stent(s); CI, confidence interval; CK-MB, creatine kinase-myocardial band; DES, drug-eluting stent(s); FDA, U.S. Food and Drug Administration; FFR, fractional flow reserve; HR,
Outcomes of Transcatheter Occlusion of Patent Ductus Arteriosus in Infants Weighing ≤6 kg
Keywords: FDA، اداره غذا و دارو ایالات متحده; congenital heart disease; patent ductus arteriosus; pediatric cardiac catheterizationADO, Amplatzer Ductal Occluder; FDA, U.S. Food and Drug Administration; PDA, patient ductus arteriosus
The role of the U.S. Food and Drug Administration in device evaluation and monitoring
Keywords: FDA، اداره غذا و دارو ایالات متحده; CDRH, Center for Devices and Radiological Health; FDA, U.S. Food and Drug Administration; GMPs, Good Manufacturing Practices; IDE, Investigational Device Exemption; MDR, Medical Device Report; PMA, premarket approval
A Retrospective Comparison of Mortality in Critically Ill Hospitalized Patients Undergoing Echocardiography With and Without an Ultrasound Contrast Agent
Keywords: FDA، اداره غذا و دارو ایالات متحده; ultrasound contrast agent; Food and Drug Administration; black box warning; OptisonCCU, coronary care unit; DM-CCI, Deyo-modified Charlson comorbidity index; FDA, U.S. Food and Drug Administration; ICD-9-CM, International Classification of Diseases, Clini
Combination drug–diet therapies for dyslipidemia
Keywords: FDA، اداره غذا و دارو ایالات متحده; apoB, apolipoprotein B; DHA, docosahexaenoic acids; EPA, eicosapentaenoic; FDA, U.S. Food and Drug Administration; GRAS, generally recognized as safe; HDL, high-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; VLDL, very low-density lipopr
Use of a fully covered self-expandable metal stent for the treatment of benign esophageal diseases
Keywords: FDA، اداره غذا و دارو ایالات متحده; FDA, U.S. Food and Drug Administration; FCSEMS, fully covered self-expandable metal stent; SEMS, self-expandable metal stent; SEPS, self-expandable plastic stent
Long-Term Clinical Outcomes With Zotarolimus-Eluting Versus Bare-Metal Coronary Stents
Keywords: FDA، اداره غذا و دارو ایالات متحده; catheterization; coronary disease; stents; thrombusARC, Academic Research Consortium; BMS, bare-metal stent(s); DAPT, dual antiplatelet therapy; DES, drug-eluting stent(s); FDA, U.S. Food and Drug Administration; ZES, zotarolimus-eluting stent(s)
Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases
Keywords: FDA، اداره غذا و دارو ایالات متحده; cardiovascular agents; complementary therapies; drug approval; herbal medicine; herb–drug interactionBPH, benign prostatic hypertrophy; CAM, complementary and alternative medicine; CHF, congestive heart failure; FDA, U.S. Food and Drug Administration
ICAS-PAT: A software for design, analysis and validation of PAT systems
Keywords: FDA، اداره غذا و دارو ایالات متحده; DOF, degree of freedom; FDA, U.S. Food and Drug Administration; ICAS, integrated computer-aided system; MoT, modeling testbed; PAT, process analytical technology; PI, proportional integral; rpm, revolutions per minuteProcess monitoring; Quality control; P
The Viracept-EMS case: Impact and outlook
Keywords: FDA، اداره غذا و دارو ایالات متحده; DDR, DNA damage response(s); EMEA, European Medicines Agency; EMS, ethyl methanesulfonate; ENU, ethylnitrosourea; EO, ethylene oxide; EPA, U.S. Environmental Protection Agency; FDA, U.S. Food and Drug Administration; Hprt, hypoxanthine–guanine phosphoribo
Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial
Keywords: FDA، اداره غذا و دارو ایالات متحده; FDA, U.S. Food and Drug Administration; SEMS, self-expanding metal stent
Safety of Contrast Agent Use During Stress Echocardiography : A 4-Year Experience From a Single-Center Cohort Study of 26,774 Patients
Keywords: FDA، اداره غذا و دارو ایالات متحده; contrast agent safety; echocardiography; ultrasonographyCI, confidence interval; FDA, U.S. Food and Drug Administration; HR, hazard ratio; ICD-9, International Classification of Diseases-Ninth Revision; MI, myocardial infarction; SE, stress echocardiograp
Drug development for orphan diseases in the context of personalized medicine
Keywords: FDA، اداره غذا و دارو ایالات متحده; FDA, U.S. Food and Drug Administration; IRB, Institutional Review Board; NDA, new drug application; NIH, National Institutes of Health; NORD, National Organization for Rare Diseases; ORD, NIH Office of Rare Diseases; SQNS, semiquantitative neurologic scor
Genomic and personalized medicine: foundations and applications
Keywords: FDA، اداره غذا و دارو ایالات متحده; AHIC, American Health Information Community; CDS, clinical decision support; CMS, Centers for Medicare and Medicaid Services; FDA, U.S. Food and Drug Administration; FHH, family health history; HIT, health information technology; HRA, health risk assessme
Intra-articular botulinum toxin A for refractory shoulder pain: a randomized, double-blinded, placebo-controlled trial
Keywords: FDA، اداره غذا و دارو ایالات متحده; ANCOVA, analyses of covariance; BoNT/A, botulinum toxin A; FDA, U.S. Food and Drug Administration; IA, intra-articular; SPADI, Shoulder Pain and Disability Index; SF-36, short form 36; VAS, visual analog scale
Model-based computer-aided framework for design of process monitoring and analysis systems
Keywords: FDA، اداره غذا و دارو ایالات متحده; DO, dissolved oxygen; DOF, degree of freedom; FDA, U.S. Food and Drug Administration; ICAS, integrated computer aided system; MoT, modeling tested; NIR, near infrared; PAT, process analytical technology; PI, proportional integral; rpm, revolution per minu
Thalidomide suppressed interleukin-6 but not tumor necrosis factor-alpha in volunteers with experimental endotoxemia
Keywords: FDA، اداره غذا و دارو ایالات متحده; AUC, area under the curve; ELISA, enzyme-linked immunosorbent assay; ENL, erythema nodosum leprosum; FDA, U.S. Food and Drug Administration; HUVEC, human umbilical vein endothelial cell; IFN-γ, interferon-gamma; IL, interleukin; LPS, lipopolysaccharide; T
A Survey of the Current Approaches to Diagnosis and Management of Oral Premalignant Lesions
Keywords: FDA، اداره غذا و دارو ایالات متحده; Oral premalignant lesions; leukoplakia; erythroplakia; diagnosis; managementABOM, American Board of Oral Medicine; FDA, U.S. Food and Drug Administration; OPL, Oral premalignant lesion; OSCC, Oral squamous cell carcinoma; WHO, World Health Organization
Preventing percutaneous injuries among dental health care personnel
Keywords: FDA، اداره غذا و دارو ایالات متحده; Dentistry; occupational exposure; safety devices; blood-borne pathogens; infection controlCDC, Centers for Disease Control and Prevention; FDA, U.S. Food and Drug Administration; HCP, Health care personnel; HCV, Hepatitis C virus; NaSH, National Surveilla
NAC for noise: From the bench top to the clinic ∗
Keywords: FDA، اداره غذا و دارو ایالات متحده; NAC; NIHL; Acute acoustic trauma; Hearing loss; TreatmentNIHL, noise-induced hearing loss; HPDs, hearing protection devices; NAC, N-acetylcysteine; AAT, acute acoustic trauma; FDA, U.S. Food and Drug Administration; ROS, reactive oxygen species; RNS, reac
Drug Treatment of the Overweight Patient
Keywords: FDA، اداره غذا و دارو ایالات متحده; BMI, body mass index; CI, confidence interval; FDA, U.S. Food and Drug Administration; GLP-1, Glucagon-like peptide-1; HDL, high-density lipoprotein; LDL, low-density lipoprotein; NPY, neuropeptide Y; RIO, Rimonabant in Obesity
Evaluation of a biosensor assay to quantify polyclonal IgG in ovine serum used for the production of biotherapeutic antibody fragments
Keywords: FDA، اداره غذا و دارو ایالات متحده; CM5, carboxymethylated dextran coated biosensor chip (Biacore®); CV, coefficient of variation; EDC, N-ethyl-N′-[(3-diethylamino)-propyl] carbodimide hydrochloride; FDA, U.S. Food and Drug Administration; GLP, good laboratory practice; GMP, good manufactur