Articles Tagged With:
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.
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Vaccine Challenge Trials Present Ethical Issues to IRBs, HRPPs
Bioethicists and researchers say it may be possible to shorten the typical 15-year-plus vaccine timeline through a challenge trial. In this model, participants receive the study vaccine, the are deliberately exposed to SARS-CoV-2. Safety and efficacy are important, but the risk-benefit balance for study participants is weighed more heavily in favor of the greater public good.
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Endovascular Treatment for Acute Basilar Artery Occlusion Is Safe and Effective
Patients with acute basilar artery occlusion treated by endovascular therapy within 24 hours of occlusion time had better functional outcomes and reduced mortality compared to those treated with medical therapy alone.
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COVID-19: Pandemic 2020
Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease, and our knowledge is rapidly growing.
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MRI and Clinical Correlation in Lumbar Arachnoiditis
Arachnoiditis, a feared complication of various spinal surgeries and procedures, shows a variety of nonspecific abnormalities on magnetic resonance imaging investigation, but there are no specific imaging features that predict prognosis.
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Deep Brain Stimulation of the Cortico-Striato-Thalamo-Cortical Network May Be an Option for Refractory OCD
Deep brain stimulation can be a treatment option for refractory obsessive-compulsive disorder, but the results are not significantly better than lesioning procedures. Small sample sizes, diverse targets of stimulation, and inconsistencies in rating scales are limiting factors in the studies of this modality.
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Preventing and Treating Medication Overuse Headache
Patients with migraine who have an insufficient response to acute treatment medications, including triptans, risk developing medication overuse headache (MOH). The most successful treatment for MOH is withdrawal of the offending acute pain medications combined with early use of a migraine preventative medication.