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Actively Recruiting

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, which can lead to stroke. Patients who have had a stroke caused by bleeding in the brain intracranial bleeding face challenges with blood-thinning medications because these can cause further bleeding. This research compares two approved treatments to prevent stroke in such patients oral anticoagulation medications and a device that closes off a part of the heart called the left atrial appendage LAA. One group of patients will receive a minimally invasive procedure to close the LAA using a CE-marked device called Watchman or Watchman FLX. After closure, patients typically take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may take a short course of anticoagulants before aspirin. The other group will be treated with standard oral anticoagulation therapy as recommended by current guidelines. This study is randomized to fairly compare these two approaches for stroke prevention in patients with atrial fibrillation and prior brain bleeding. Participants will be followed for up to three years after treatment to monitor important outcomes such as survival free from stroke, systemic embolism, cardiovascular death, and bleeding events. Researchers will conduct evaluations to track these events and assess overall safety. The study aims to provide data to guide doctors in choosing the best prevention strategy for stroke in patients with atrial fibrillation who have experienced intracranial bleeding, potentially improving management and outcomes over time.

Age: 18Years +All GendersPhase Not Applicable
33 locations
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Actively Recruiting

Healthy Volunteer

Researchers are investigating the use of spontaneous eye blinking features, such as rate, amplitude, duration, and variability, to improve the diagnosis and prognosis of patients with Disorders of Consciousness DoC following Severe Acquired Brain Injury sABI. The study focuses on differentiating between Unresponsive Wakefulness Syndrome UWS and Minimally Conscious State MCS, which is challenging due to severe cognitive and sensorimotor impairments. This multicenter, prospective observational study involves patients admitted to eight European centers and aims to enroll 70 patients alongside 23 healthy volunteers as a comparison group. Patients diagnosed with DoC after sABI will undergo two 20-minute resting electroencephalogram-electrooculogram EEG-EOG recordings within two weeks of study entry, spaced 24 hours apart. These sessions take place with patients awake, eyes open, in a calm environment, with procedures to encourage arousal if needed. Eye blinks are monitored via EOG, and the level of consciousness is assessed with the Coma Recovery Scale-Revised CRS-R at each session. Follow-up assessment is scheduled six months after enrollment. Healthy volunteers will also complete two similar EEG-EOG sessions. Participants involvement includes EEG and EOG monitoring with electrodes placed on the scalp and around the eyes, following standard protocols to ensure data quality. Clinical evaluations using CRS-R occur alongside blink recordings. Data analysis will compare blink features across diagnostic groups and over time, exploring their relationship with consciousness levels. The main outcome measured at six months is the clinical diagnosis. The study duration is approximately 24 months, including enrollment and follow-up phases.

Age: 18Years +All Genders
8 locations