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Stroke, Acute clinical trials

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NCT ID: NCT02864953 Terminated - Stroke, Acute Clinical Trials

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

CHARM
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI. The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

NCT ID: NCT02767778 Terminated - Ischemic Stroke Clinical Trials

Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke

I-NIC
Start date: April 2016
Phase: N/A
Study type: Interventional

The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients. 124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke. The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.

NCT ID: NCT02586415 Terminated - Stroke, Acute Clinical Trials

Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

DEFUSE 3
Start date: April 2016
Phase: N/A
Study type: Interventional

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

NCT ID: NCT02216565 Terminated - Stroke, Acute Clinical Trials

Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase

EASY
Start date: December 1, 2014
Phase: N/A
Study type: Interventional

This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery. The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours. The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

NCT ID: NCT01705353 Terminated - Stroke, Acute Clinical Trials

The Role of HMGB-1 in Chronic Stroke

Start date: September 2012
Phase: N/A
Study type: Observational

The purpose of this study is to measure the presence of HMGB-1 and other proteins in the blood across five time points after stroke, and to determine if their presence correlates with rate of stroke recovery.

NCT ID: NCT01582620 Terminated - Stroke, Acute Clinical Trials

Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals

Telestroke
Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose is to study the clinical, technological and organizational impacts of a telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with the doctor at the local hospital through video- and sound communication. Radiology images are transmitted using the RIS/PACS system. Telestroke consultations may be useful to assess whether the patient needs thrombolysis medication, and also whether there is a need for more advanced specialist neurological or neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit. The study design is a multi-method approach using before-and-after hospital information data as well as registration forms monitoring patient outcome and pathways. The research questions will be approached from medical, organisational and technological perspectives. A telestroke service in North Norway is expected to face other challenges than those reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is low, clinicians have high turnover, technical support is not available 24/7 and severe weather conditions and long distances might add to the transport time. Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and proper treatment Secondary hypothesis: Telestroke leads to improved overall patient treatment

NCT ID: NCT01310114 Terminated - Stroke, Acute Clinical Trials

Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the effect of PDA001 on improvement in clinical function following ischemic stroke.

NCT ID: NCT01123161 Terminated - Stroke, Acute Clinical Trials

The Intravascular Cooling in the Treatment of Stroke 2/3 Trial

ICTuS2/3
Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.

NCT ID: NCT00132509 Terminated - Stroke, Acute Clinical Trials

FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke

Start date: September 2001
Phase: Phase 2
Study type: Interventional

Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours. Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion". This is a study of the outcome at 90 days.