A5048803914- Statistical Methods in Clinical Trials
- Atrial Fibrillation Management and Outcomes
- Acute Ischemic Stroke Management
- Stroke Rehabilitation and Recovery
- Statistical Methods and Bayesian Inference
- Health Systems, Economic Evaluations, Quality of Life
- Advanced Causal Inference Techniques
- Optimal Experimental Design Methods
- Meta-analysis and systematic reviews
- Epilepsy research and treatment
- Neuroscience and Neuropharmacology Research
- Pharmacological Effects and Toxicity Studies
- Drug-Induced Hepatotoxicity and Protection
- Muscle activation and electromyography studies
- Liver Disease and Transplantation
- Cerebrovascular and Carotid Artery Diseases
- Pain Management and Treatment
- Botulinum Toxin and Related Neurological Disorders
- Muscle and Compartmental Disorders
- Transcranial Magnetic Stimulation Studies
- Iron Metabolism and Disorders
- Pharmacovigilance and Adverse Drug Reactions
- EEG and Brain-Computer Interfaces
- Trauma, Hemostasis, Coagulopathy, Resuscitation
- Biosimilars and Bioanalytical Methods
Medical University of South Carolina
2017-2023
University of Charleston
2020
The choice of drugs for patients with status epilepticus that is refractory to treatment benzodiazepines has not been thoroughly studied.In a randomized, blinded, adaptive trial, we compared the efficacy and safety three intravenous anticonvulsive agents - levetiracetam, fosphenytoin, valproate in children adults convulsive was unresponsive benzodiazepines. primary outcome absence clinically evident seizures improvement level consciousness by 60 minutes after start drug infusion, without...
Recent data suggest that a thrombogenic atrial substrate can cause stroke in the absence of fibrillation. Such an cardiopathy may explain some proportion cryptogenic strokes.
Patients with acute liver injury or failure (ALI/ALF) experience bleeding complications uncommonly despite an abnormal hemostatic profile. Rotational thromboelastometry (ROTEM), which assesses clot formation in whole blood, was used to determine the nature of hemostasis and whether it contributes events, illness severity, survival.A total 200 patients were recruited from sites ALF Study Group. Blood collected daily for up 5 days analyzed using ROTEM delta devices. Consistent standard...
The liver has an important role in iron homeostasis through the synthesis of serum transporter transferrin and hormone hepcidin. aim this study was to analyze parameters metabolism a multicenter cohort adult patients with acute failure (ALF) acetaminophen (APAP)‐induced ALF mouse model. A representative subset 121 adults (including 66 APAP‐related patients) had baseline samples tested for ferritin, transferrin, iron, Outcomes at 3 weeks after enrollment were categorized as spontaneous...
Abstract Background Post-stroke hand impairment is prevalent and persistent even after a full course of rehabilitation. Hand diminishes stroke survivors’ abilities for activities daily living independence. One way to improve treatment efficacy augment therapy with peripheral sensory stimulation. Recently, novel stimulation, TheraBracelet, has been developed in which imperceptible vibration applied during task practice through wrist-worn device. The objective this trial determine if combining...
A primary goal of a phase II dose‐ranging trial is to identify correct dose before moving forward III confirmatory trial. one that actually better than control. popular model in an independent puts no structure on the dose‐response relationship. Unfortunately, does not efficiently use information from related doses. One very successful alternate improves power using pre‐specified structure. Past research indicates EMAX models are broadly and therefore attractive for designing trials....
Platform trials are well-known for their ability to investigate multiple arms on heterogeneous patient populations and flexibility add/drop treatment due efficacy/lack of efficacy. Because complexity, it is important develop highly optimized, transparent, rigorous designs that cost-efficient, offer high statistical power, maximize benefit, robust changes over time.To address these needs, we present a Bayesian platform trial design based beta-binomial model binary outcomes uses three key...
In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it difficult to robustly identify a while also testing for signal of efficacy that would support III trial. Recent designs have sought be more efficient by exploring multiple doses through use adaptive strategies. However, added flexibility may potentially increase risk making incorrect assumptions and reduce total amount information available across range as function imbalanced sample...
Multi-arm multi-stage designs, in which multiple active treatments are compared to a control and accumulated information from interim data used add or remove arms the trial, may reduce development costs shorten drug timeline. As such, this adaptive update is natural complement Bayesian methodology prior clinical belief sequentially updated using observed probability of success. Simulation often required for planning trials accommodate complexity design optimize key characteristics. This...
Abstract Background Monitoring and reporting of drug safety during a clinical trial is essential to its success. More recent attention has encouraged statistical methods development for monitoring detecting potential signals. This paper investigates the impact process blinded investigator identifying signal, which should be further investigated by Data Safety Board with an unblinded data analysis. Methods In this paper, two-stage Bayesian hierarchical models are proposed signal detection...
Abstract Background Functional task performance requires proper control of both movement and force generation in three-dimensional space, especially for the hand. Control three dimensions, however, is not explicitly treated current physical rehabilitation. To address this gap treatment, we have developed a tool to provide visual feedback on finger force. Our objective examine effectiveness training with restore hand function stroke survivors. Methods Double-blind randomized controlled trial....
An amendment to this paper has been published and can be accessed via the original article.
Background: Atrial cardiopathy (AC) in absence of atrial fibrillation is a suspected cause embolic stroke undetermined source (ESUS). Predictors AC remain incompletely characterized. We hypothesized that demographics, vascular risk factors, and time from presentation to assessment for predict among ESUS patients. Methods: ARCADIA an ongoing, investigator-initiated, NINDS-funded, multicenter, randomized trial standard dose apixaban versus aspirin 81 mg daily consented patients with biomarker...
A priori estimation of sample size and subject accrual in multi‐site, time‐to‐event clinical trials is often challenging. Such are powered based on the number events needed to detect a clinically significant difference. Sample relates expected duration observation time for each subject. Temporal patterns site initiation enrollment ultimately affect when subjects can be accrued into study. Lag times common as start‐up process optimizes, resulting delays that may curtail observational...
Objective: We hypothesize that ESUS patients enrolled in the ARCADIA study are broadly representative and similar to those randomized recent trials returned negative results. Methods: This is a qualitative comparison between characteristics of NAVIGATE RE-SPECT up this point ARCADIA, an ongoing, investigator-initiated, NINDS-funded, multicenter, trial standard dose apixaban versus aspirin 81 mg daily among consented with biomarker evidence atrial cardiopathy. The from included all consented,...
Background: Elevated P-wave terminal force velocity in ECG lead V1 (PTFV1) and N-terminal pro-brain natriuretic peptide (NT-proBNP) are both associated with an increased risk of ischemic stroke atrial fibrillation thought to be markers underlying cardiopathy (AC). These AC being used as entry criteria the ARCADIA trial, testing standard care aspirin vs. apixaban for secondary prevention. Methods: We baseline data from patients embolic undetermined source (ESUS) who consented screening trial...
Background: Recent data suggest biomarkers of atrial cardiopathy (ACP) can potentially identify a subset patients with cryptogenic stroke who may benefit from anticoagulation. However, the specificity these markers for disease and their independence measures more global cardiac dysfunction remain unclear. We hypothesized that ACP collectively reflect left pathology are not strongly affected by coexisting ventricular dysfunction. Methods: ARCADIA is an ongoing multicenter trial comparing...
Introduction: Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) and prolonged P-wave terminal force in V1 (PTFV1) on 12-lead ECG are associated with increased risk of atrial fibrillation stroke. Age is positively NT-proBNP, men have lower levels than women, Blacks Whites. Although both weight height related to fibrillation, negatively NT-proBNP. We explored associations among these variables patients embolic stroke undetermined source (ESUS). Methods: In an ongoing randomized...