Filtered By:
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of relevance.

Order by Relevance | Date

Total 621 results found since Jan 2013.

Patent Foramen Ovale and Cryptogenic Stroke: The Hole Story Emerging Therapy Critiques
Despite 3 recent randomized clinical trials, the management of patients with cryptogenic stroke and patent foramen ovale remains unsettled. The primary results of Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale (CLOSURE), Percutaneous Closure of Patent Foramen Ovale in Cryptogenic Stroke (PC), and Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) were the same; the intent to treat analysis for the primary end point in all 3 ...
Source: Stroke - August 26, 2013 Category: Neurology Authors: Furlan, A. J., Jauss, M. Tags: Other Stroke Treatment - Medical, Other Stroke Emerging Therapy Critiques Source Type: research

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke Advances in Interventional Cardiology
Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent For...
Source: Circulation: Cardiovascular Interventions - March 16, 2018 Category: Cardiology Authors: Wiktor, D. M., Carroll, J. D. Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research

Enhanced phasic GABA inhibition during the repair phase of stroke: a novel therapeutic target
Ischaemic stroke is the leading cause of severe long-term disability yet lacks drug therapies that promote the repair phase of recovery. This repair phase of stroke occurs days to months after stroke onset and involves brain remapping and plasticity within the peri-infarct zone. Elucidating mechanisms that promote this plasticity is critical for the development of new therapeutics with a broad treatment window. Inhibiting tonic (extrasynaptic) GABA signalling during the repair phase was reported to enhance functional recovery in mice suggesting that GABA plays an important function in modulating brain repair. While tonic G...
Source: Brain - January 29, 2016 Category: Neurology Authors: Hiu, T., Farzampour, Z., Paz, J. T., Wang, E. H. J., Badgely, C., Olson, A., Micheva, K. D., Wang, G., Lemmens, R., Tran, K. V., Nishiyama, Y., Liang, X., Hamilton, S. A., ORourke, N., Smith, S. J., Huguenard, J. R., Bliss, T. M., Steinberg, G. K. Tags: CNS Injury and Stroke Original Articles Source Type: research

IV tPA for acute ischemic stroke: Times are changing
Based on evidence that the administration of IV tissue plasminogen activator (tPA) improved the outcomes of selected patients with acute ischemic stroke, the US Food and Drug Administration (FDA) approved its use for this purpose in 1996, leading to a revolution in stroke care.1 Following its introduction into routine clinical practice, stroke began to be viewed as a medical emergency, similar to myocardial infarction, with effective treatment dependent or early symptom recognition and patient transport to facilities capable of conducting rapid evaluations and IV tPA administration. There were, however, considerable barrie...
Source: Neurology - November 20, 2016 Category: Neurology Authors: Goldstein, L. B. Tags: Medical care, All Cerebrovascular disease/Stroke, All epidemiology EDITORIALS Source Type: research

Recycled Translation: Repurposing Drugs for Stroke
AbstractStroke, which continues to be a leading cause of death and long-term disability worldwide, has often been described as a clinical graveyard. While multiple small molecule therapeutics have undergone clinical trials in stroke, currently only one Food and Drug Administration (FDA)-approved medication exists for the treatment of stroke, the biological, recombinant tissue plasminogen activator (rt-PA). Repurposing of therapeutics which have previously gained FDA approval for alternative indications serves as a prospective option for stroke therapeutic translation. In contrast to de novo drug development, repurposing st...
Source: Translational Stroke Research - February 26, 2022 Category: Neurology Source Type: research

IV tissue plasminogen activator use in acute stroke: What are neurologists thinking?
Stroke remains among the top 4 causes of death in the United States and, despite advances in inpatient care and rehabilitation, the leading cause of severe disability. Furthermore, despite being a proven effective therapy, tissue plasminogen activator (tPA) use remains dramatically low, in ~2% of all stroke patients in a community setting.1 In this issue of Neurology®, Shamy2 addresses the use of tPA in appropriate clinical settings and neurologists' rationale for their decisions. Given the mortality and morbidity associated with stroke, the data for substantial benefit with tPA use, and Food and Drug Administration ap...
Source: Neurology - September 23, 2013 Category: Neurology Authors: Boissy, A. R. Tags: All Cerebrovascular disease/Stroke EDITORIALS Source Type: research

Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients
AbstractAcute ischemic stroke (AIS) is a major medical challenge in China. Thrombolytic drugs recommended for the treatment of AIS usually have a narrow time window. Human urinary kallidinogenase (HUK) was approved by the China Food and Drug Administration (CFDA) in 2005 for the treatment of mild to moderate AIS, and it is thus widely used in China. However, large-scale clinical study data for a more complete understanding of various aspects of its safety and efficacy characteristics are still unavailable. The ongoing Reevaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK) trial is designed to reevaluate...
Source: Translational Stroke Research - March 5, 2017 Category: Neurology Source Type: research

A call for formal telemedicine training during stroke fellowship
During the 20 years since US Food and Drug Administration approval of IV tissue plasminogen activator for acute ischemic stroke, vascular neurology consultation via telemedicine has contributed to an increased frequency of IV tissue plasminogen activator administration and broadened geographic access to the drug. Nevertheless, a growing demand for acute stroke coverage persists, with the greatest disparity found in rural communities underserved by neurologists. To provide efficient and consistent acute care, formal training in telemedicine during neurovascular fellowship is warranted. Herein, we describe our experiences in...
Source: Neurology - May 8, 2016 Category: Neurology Authors: Jagolino, A. L., Jia, J., Gildersleeve, K., Ankrom, C., Cai, C., Rahbar, M., Savitz, S. I., Wu, T.-C. Tags: All Health Services Research, All Cerebrovascular disease/Stroke, All Education CONTEMPORARY ISSUES: INNOVATIONS IN EDUCATION Source Type: research

Republished:Aspiration catheter failure leading to carotid-cavernous fistula during stroke thrombectomy
We present a case of a previously unreported complication related to malfunction of a Penumbra aspiration catheter during stroke thrombectomy resulting in a carotid-cavernous fistula.
Source: Journal of NeuroInterventional Surgery - February 14, 2023 Category: Neurosurgery Authors: Agrait, M., Kee-Sampson, J., Brzezicki, G., Bashir, S., Matteo, J., Meyer, T., Siragusa, D. Tags: Ischemic stroke Source Type: research

Study Of Brain Cooling And Clot-Busting Drug Therapy For Stroke Receives FDA OK To Expand
An international multicenter clinical trial led by a Cedars-Sinai neurologist on the combination of brain cooling and "clot-busting" drug therapy after stroke has received Food and Drug Administration approval to expand from 50 patients to 400. � "This approval is highly significant because, after reviewing our initial safety data, the Food and Drug Administration approved us to include more patients in our study," said Patrick D. Lyden, MD, chair of the Department of Neurology at Cedars-Sinai Medical Center and the study's overall principal investigator...
Source: Health News from Medical News Today - February 8, 2013 Category: Consumer Health News Tags: Stroke Source Type: news

1H NMR-Based Metabolomics Reveals Refined-Huang-Lian-Jie-Du-Decoction (BBG) as a Potential Ischemic Stroke Treatment Drug With Efficacy and a Favorable Therapeutic Window
This study was carried out in accordance with the recommendations of Animal Ethics Committee of China Pharmaceutical University. The protocol was approved by Animal Ethics Committee of China Pharmaceutical University. Author Contributions JW, MY, and LK conceived the experiments and helped to coordinate support and funding. XF performed the research and drafted the manuscript. SL, YL, and DX participated in the experiments. JW analyzed the data and edited the paper. All authors read and approved the final manuscript. Conflict of Interest Statement The authors declare that the research was conducted in the absence of an...
Source: Frontiers in Pharmacology - April 11, 2019 Category: Drugs & Pharmacology Source Type: research

UCLA Comprehensive Stroke Center honored for stroke care
The UCLA Comprehensive Stroke Center at Ronald Reagan UCLA Medical Center has received a Get With The Guidelines - Stroke award for implementing specific quality improvement measures outlined by the American Heart Association/American Stroke Association for the treatment of stroke patients. Get With The Guidelines - Stroke helps hospital teams provide the most up-to-date, research-based guidelines with the goal of speeding recovery and reducing death and disability for stroke patients. UCLA earned the Gold-Plus Quality Achievement Award award for measures that include aggressive use of medications and risk-reduction therap...
Source: UCLA Newsroom: Health Sciences - October 31, 2014 Category: Universities & Medical Training Source Type: news

Researcher Studies Statins for Stroke Therapy
Stacy Pigott A $2.8 million grant may help develop an improved therapeutic treatment for acute ischemic stroke patients to let them recover faster with fewer long-term complications. The protocol hinges on effectively delivering statins to the brain, where their neuroprotective properties can help save tissue damaged by stroke. Aug. 7, 2020 University of Arizona Health Sciencesnhg-PATRICK-RONALDSON_DSC6492-web.jpg Patrick Ronaldson (right), associate professor in the College of Medicine – Tucson's Department of Pharmacology, and doctoral students Erica Williams and Robert Betterton discuss their latest researc...
Source: The University of Arizona: Health - August 6, 2020 Category: Universities & Medical Training Authors: mittank Source Type: research

UCLA Stroke Center awarded 'comprehensive stroke center' certification
The UCLA Stroke Center has been certified as a comprehensive stroke center by the Joint Commission and the American Heart Association/American Stroke Association. The center, part of UCLA Health and the UCLA Department of Neurology, is one of the first 12 stroke centers in the nation to receive the prestigious designation.   The certification, which confirms that the UCLA Stroke Center has met the highest national standards for safety and quality of care, further enhances the center's national reputation as an innovator in clinical care.   "This is a true team effort, reflecting the efforts of over 200 physicians...
Source: UCLA Newsroom: Health Sciences - March 12, 2013 Category: Universities & Medical Training Source Type: news

Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study
Discussion: The results of the TRACE study will provide preliminary evidence for the relationship between XNJI used within 24 h of onset and the presence of END on the third day after stroke onset; it will aid in improving the current knowledge regarding the early use of XNJI for stroke first aid.Clinical Trial Registration:clinicaltrials.gov, identifier NCT04275349
Source: Frontiers in Pharmacology - August 29, 2022 Category: Drugs & Pharmacology Source Type: research