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  • A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-Study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke (RESTORE) Jacksonville, Fla.

    This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

  • Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II): A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage (ATACH-II) Jacksonville, Fla.

    The specific aims of this study are to:

    1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
    2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
    3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of > 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.
    4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.
  • Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) Jacksonville, Fla.

    The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

  • Intraventricular Nicardipine for Aneurysmal Subarachnoid Hemorrhage Related Vasospasm: Assessment on Clinical Outcomes of Stroke by 30 & 90 Days Jacksonville, Fla.

    The purpose is to study the effects of intraventricular nicardipine, a vasodilatory agent, on VP and secondary outcomes of stroke and functional outcome at 30 and 90 days compared to those not treated with this agent.

  • Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage (NEWTON2) Jacksonville, Fla.

    The purpose of this study is to compare the effectiveness and safety of EG-1962 to the standard of care oral nimodipine for the treatment of adult patients who have an aneurysmal subarachnoid hemorrhage.

  • Stroke-Related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial 2 (SETPOINT2) Jacksonville, Fla.

    The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation. 

     

     

    Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.

  • Use of the Better Mobile Health App after Post-Stroke Hospital Discharge Jacksonville, Fla.

    The purpose of this study is to assess the effectiveness of the Better Mobile Health App for use by patients after hospital discharge for a stroke by using satisfaction survey ratings and hospital readmission rates. The Better App provides a personal health assistant who assists in coordination of care. The app is provided in addition to standard care and compared to the use of standard care alone.

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