A5101527520- Acute Ischemic Stroke Management
- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Cerebrovascular and Carotid Artery Diseases
- Advanced Causal Inference Techniques
- Stroke Rehabilitation and Recovery
- Meta-analysis and systematic reviews
- Intracranial Aneurysms: Treatment and Complications
- Statistical Methods and Bayesian Inference
- Venous Thromboembolism Diagnosis and Management
- Congenital Heart Disease Studies
- Cardiac, Anesthesia and Surgical Outcomes
- Cardiovascular Health and Disease Prevention
- Gene expression and cancer classification
- Breast Cancer Treatment Studies
- Antioxidant Activity and Oxidative Stress
- Hepatitis B Virus Studies
- Cervical Cancer and HPV Research
- Global Cancer Incidence and Screening
- Intensive Care Unit Cognitive Disorders
- Spinal Hematomas and Complications
- Acute Kidney Injury Research
- Airway Management and Intubation Techniques
- Neurosurgical Procedures and Complications
- Pharmacovigilance and Adverse Drug Reactions
Medical University of South Carolina
2014-2023
University of St. Francis
2017
University of Calgary
2014-2016
National Institute of Neurological Disorders and Stroke
2016
University of Miami
2016
University of Cincinnati Medical Center
1989-2014
Columbia University Irving Medical Center
2014
Temple University
2014
University of Cincinnati
2012-2014
University of Iowa
2014
Background and Purpose— The ALIAS (Albumin in Acute Ischemic Stroke) part 1 2 trials evaluated whether 25% human serum albumin improves clinical outcomes after acute ischemic stroke above beyond standard of care using similar protocols. trial ended prematurely because safety concerns, the terminated early futility finding a statistically significant effect over saline (control) administration. We combine subject-level data to reevaluate efficacy with larger sample size. Methods— combined...
The role of endovascular therapy for acute M2 trunk occlusions is debatable. Through a subgroup analysis Prolyse in Acute Cerebral Thromboembolism-II, we compared outcomes treatment and control arms.Solitary were identified from the Thromboembolism-II database. Primary endpoints successful angiographic reperfusion (TICI 2-3) at 120 minutes functional independence (mRS 0-2) 90 days.Forty-four patients with solitary occlusions, 30 arm 14 arm, identified. Successful was achieved 53.6% 16.7%...
Interventional Management of Stroke III did not show that combining IV recombinant tissue plasminogen activator (rt-PA) with endovascular therapies (EVTs) is better than rt-PA alone.To report efficacy and safety results for EVT intracranial internal carotid artery (ICA) middle cerebral trunk (M1) occlusion.Five revascularization methods persistent occlusions after treatment were evaluated prespecified primary secondary endpoints, accounting differences in key baselines variables using...
Small iatrogenic brain infarcts are often seen on diffusion-weighted MRI (DWI) following surgical or endovascular procedures, but there few data their clinical effects. We examined the association of with outcomes in ENACT (Evaluating Neuroprotection Aneurysm Coiling Therapy) randomized controlled trial nerinetide patients undergoing repair intracranial aneurysms.In this post hoc analysis, we used multivariable models to evaluate presence and number DWI neurologic impairment (NIH Stroke...
The Interventional Management of Stroke (IMS) III study tested the effect intravenous tissue-type plasminogen activator (tPA) alone when compared with tPA followed by endovascular therapy and collected cost data to assess economic implications 2 therapies. This report describes factors affecting costs initial hospitalization for acute stroke subjects from United States.Prospective analysis US was treated or in IMS trial. Results were expected Medicare payments.The adjusted a admission $35...
Abstract There is increasing evidence that molecular detection of micrometastatic breast cancer in the axillary lymph nodes (ALN) patients can improve staging. Molecular analyses samples obtained from Minimally Invasive Staging Breast Cancer Trial (n = 489 patients) indicate whereas majority markers are informative for metastatic (significant disease burden), only a few sensitive (limited burden). Frequency distribution and linear regression reveal relative levels gene expression highly...
Stroke is a serious global illness. Human albumin has emerged as putative therapy for ischaemic stroke based on strong evidence from animal models. Following confirmation of the safety and feasibility high-dose treatment acute in pilot study, Albumin Acute trial, phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate efficacy compared saline control within 5 h onset.The will enrol 1800 patients two cohorts--a thrombolytic nonthrombolytic arm....
The goals of phase II clinical trials are to gain important information about the performance novel treatments and decide whether conduct a larger III trial. This can be complicated in cases when trial objective is identify treatment having several factors. Such multifactor scenarios explored using fixed sample size trials. However, alternative design could response adaptive randomization with interim analyses additionally, longitudinal modeling whereby more data used estimation process....
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....
Interventional Management of Stroke (IMS) III is a randomized, parallel arm trial comparing the approach intravenous tissue-type plasminogen activator followed by endovascular treatment with alone in patients acute ischemic stroke presenting <3 hours symptom onset. The intended to enroll 900 subjects ensure adequate statistical power detect an absolute 10% difference percentage good outcome, defined as modified Rankin Scale score 0 2 at 3 months. In April 2012, after 656 were further...
Ordinal outcomes collected at multiple follow-up visits are common in clinical trials. Sometimes, one visit is chosen for the primary analysis and scale dichotomized amounting to loss of information. Multistate Markov models describe how a process moves between states over time. Here, simulation studies performed investigate type I error power characteristics multistate panel data with limited non-adjacent state transitions. The results suggest that preserve adequate achieved modest sample sizes
In this paper, we consider the National Football League's rules for overtime.We use Markov chain models to represent sudden death, modified death 15-minute overtime, newly changed 10-minute and our theoretical alternative death.Through model analysis, find average length of overtime probability team possessing ball first during winning game.Our analysis shows that rule change increased from 7 minutes 1 second 37 seconds decreased 59.9% 55.4%.Furthermore, predict will result in 54.1% time a...
Obesity and diabetes mellitus, or diabetes, are independently associated with post-ischemic stroke outcomes (e.g., functional disability all-cause mortality). Although obesity also outcomes, the joint effect of on these has not been explored previously. The purpose current study was to explore whether differed by status in a cohort acute ischemic subjects at least moderate severity. Data from Interventional Management Stroke (IMS) III clinical trial analyzed for this post-hoc analysis. A...
Historically, ordinal measures of functional outcome have been dichotomized for the primary analysis in acute stroke therapy trials. A number alternative methods to analyze scales proposed, with an emphasis on maintaining structure as much possible. In addition, despite availability longitudinal data many trials, consists a single endpoint. Inclusion information about course disease progression allows more complete understanding treatment effect. Multistate Markov modeling, which full scale...
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...