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This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Investigating, developing and implementing a collateral therapeutic is a major objective in stroke research. The aim is to increase the amount of potentially salvageable penumbral tissue and expand the tissue time window, thus increasing the efficacy of reperfusion therapies and improving clinical outcomes. Head down tilt 15° (HDT15) is a positional therapy consisting of tilting the patient with the head 15 degrees below the rest of the body. Experimental studies from an Italian-French group (Dr. Simone Beretta, Fondazione IRCCS San Gerardo dei Tintori and Prof. Tae-Hee Cho, Hospices Civils de Lyon) showed that HDT15 increased cerebral blood flow and improved functional outcome and infarct volume in randomised rats with middle cerebral artery (MCA) occlusion followed by reperfusion. Subsequent perfusion MRI experiments using the same stroke model by our group confirmed that HDT15 application for 60 minutes significantly increases collateral flow in the ischemic area. There is no consensus in current clinical practice regarding the most appropriate head position for acute ischemic stroke (AIS) patients. The sitting position at +30° is the most common. An international cluster-randomised trial, HeadPoST, randomised over 11000 patients with acute stroke (85% ischemic) to either a lying-flat position or a sitting-up position (head elevated to at least 30°), maintained for 24 hours. No difference in the primary efficacy outcome (disability at 90 days measured with the modified Rankin Scale (mRS)), mortality, or rates of other serious adverse events, including pneumonia, were observed. However, the HeadPoST trial primarily targeted patients with mild symptoms without a large vessel occlusion (LVO), who were randomised beyond the usual time window of reperfusion therapies. One retrospective study (pre-thrombectomy era) compared two cohorts of AIS patients with a LVO: patients with a standard position (0 to 30°; N=119), versus those with a HDT15 position (0 to -15°; N=90). The results suggested that HDT15 promotes neurological improvement compared to the standard position. No difference in serious adverse events was observed between the two cohorts. A recent randomized, pilot clinical trial showed promising results of -20° head down positioning on long-term disability and an excellent safety profile. Thus, the available clinical evidence raised no safety concern for HDT15 in AIS patients, but data on its efficacy, notably among AIS patients treated by MT, remains insufficient. HDT15, for its simplicity, low cost and feasibility, might be an optimal collateral therapeutic candidate to prolong the survival of the ischemic penumbra and improve the clinical benefit from reperfusion therapies with disability reduction. HDT15 is readily feasible by Emergency Services in the prehospital phase of AIS, before reperfusion therapies. The DOWN-SUITE study will be the first multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with AIS treated with an in-hospital application of HDT15 versus usual positioning before MT. The duration of HDT15 application (approximately 60-90 minutes) is expected to be long enough to detect significant changes in cerebral hemodynamics. Building from preclinical experiments on rodent and non-human primate stroke models carried out by our French-Italian group, it will provide for the first time the translation of HDT15 efficacy on cerebral hemodynamics and clinical outcome from animal models to AIS patients. No therapeutic intervention is currently available to enhance collaterals in AIS. The DOWN-SUITE trial will provide robust, high-quality evidence on the safety, feasibility and efficacy of HDT15 as a low-cost collateral therapeutic for AIS. The investigators hypothesise that HDT15 (-10° to -15°), applied in AIS patients with an LVO, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from MT compared with standard of care (usual positioning: 0° to +30°). The investigators aim to perform a prospective, multicenter, proof of concept, randomised, controlled, open-label study. As a double-blind is not possible, a blinded central imaging core lab, whose members will be unaware of the procedure assignments, will assess all imaging outcomes, including the primary efficacy outcome. This study will involve adult patients who are eligible for MT and who have AIS due to left or right MCA occlusion (M1 segment). Benefit/risk ratio The investigators hypothesise that HDT15 would improve cerebral collaterals in patients randomised in the intervention group, which could subsequently reduce the ischemic injury and improve the clinical outcome. No harm from participating in DOWN-SUITE is expected for patients in the intervention or control groups. Previous clinical data on HDT15 raised no safety concerns. No difference in post-stroke complications, including cerebral oedema or haemorrhage, pneumonia or mortality, was observed in a retrospective observational study. HDT15 is not expected to interfere with standard care, including the procedural steps of MT. Mild discomfort related to the tilted position may occur in some patients. The treating physician will continuously monitor all patients during the entire duration of the HDT15 application. No additional risk is expected in patients in the control group, as they will receive standard care. Overall, this study's benefit/risk ratio is considered very favourable. This study could potentially establish HDT15 as the first evidence-based collateral therapeutic for AIS. No therapeutic intervention is currently available to enhance collaterals in the acute phase of ischemic stroke. Such a collateral-enhancing therapy is necessary to expand the time window and increase the probability of successful reperfusion with IVT and MT, resulting in better clinical outcomes. The results of the DOWN-SUITE trial may pave the way for larger randomised controlled trials of HDT15 in a wider stroke patient population, such as patients transferred from spoke hospitals to hub stroke centers to receive thrombectomy and unselected patients with suspected AIS in the prehospital setting.

Researchers are investigating whether fremanezumab treatment can reduce the emotional burden and stress experienced by caregivers of migraine patients who also have depressive symptoms. The study focuses on measuring changes in caregiver stress using the Relative Stress Scale (RSS) over a period of six months following the first injection of fremanezumab. This research aims to improve the perception of stress and the mutual relationship between caregivers and patients in real-life conditions. The treatment being studied is fremanezumab, administered as a subcutaneous injection either monthly at 225 mg or quarterly at 675 mg. The study includes adult migraine patients with depressive symptoms who start fremanezumab to prevent migraine, along with their informal caregivers who live with and support them. Both patients and caregivers are monitored throughout the study period. Participants will be followed for six months after beginning fremanezumab therapy. Caregiver stress levels will be assessed at the start and after six months using the RSS. Patients' migraine history and frequency will be recorded, and compliance with study diaries and scales will be tracked. The main outcome measured is the change in caregiver stress from baseline to six months post-treatment. The study also emphasizes obtaining informed consent and ensuring participant ability to complete assessments.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

This research aims to evaluate the effectiveness, safety, and tolerability of atogepant, a medicine approved for preventing migraine, when used to treat migraine attacks quickly. The study focuses on adults aged 18 to 75 years who have a history of moderate to severe migraine attacks. It includes a double-blind phase where neither participants nor doctors know who receives atogepant or placebo, followed by an open-label phase where everyone receives atogepant. The study is conducted at about 160 sites worldwide with around 1300 participants. Participants will receive both atogepant and placebo in a random sequence to treat qualifying migraine attacks during the double-blind phase. After treating four migraine attacks this way, participants will enter an open-label phase lasting until week 24, during which they will receive atogepant for any additional migraine attacks. Treatments are given as oral tablets. Throughout the study, participants will attend regular hospital or clinic visits and telephone check-ins. They will complete electronic diaries with questionnaires about their migraines and treatment effects. Medical assessments, blood tests, and monitoring for side effects will be conducted. The main outcome measured is the percentage of participants who experience freedom from pain two hours after taking the study medication for their first treated migraine attack, observed over about 16 weeks.

The TELECONNECT-SVD study is a prospective, randomized, multicenter trial aimed at testing the efficacy of a remotely delivered exercise protocol on brain functional connectivity in patients with small vessel disease (SVD)-related ischemic stroke. The study will recruit patients aged ≥60 with a history of lacunar stroke, minimal disability (modified Rankin Scale score 0-1), and low physical activity levels. The trial will include 60 participants randomized 1:1 to either a 24-week telecoached exercise intervention or usual care. The exercise program consists of multicomponent physical exercises delivered remotely twice a week. Assessments will be conducted at baseline, 12 weeks, 24 weeks, and 48 weeks. Primary outcomes include changes in brain functional connectivity assessed by high-density EEG and improvements in physical fitness measured by the Senior Fitness Test. Secondary outcomes encompass changes in physical activity levels, anthropometric measurements, and vital signs. The study employs a "wait list" design, where the control group receives the intervention after the initial 24-week period. This approach allows for assessment of the intervention's immediate effects and the retention of benefits after cessation. Key features of the protocol include: * Use of telecoaching to enhance adherence to the exercise program * Comprehensive assessment of brain connectivity using advanced EEG analysis techniques * Focus on patients with SVD, who may benefit significantly from exercise interventions * Evaluation of both neurophysiological and clinical outcomes The study aims to provide evidence for the potential benefits of exercise in enhancing brain connectivity and physical fitness in SVD patients, potentially informing future treatment guidelines and preventive strategies for this population.