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clinical trial
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This is a multi-center first-in-human, Phase 1, open-label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of single ascending doses of SBT777101 administered intravenously (IV) in subjects with active rheumatoid arthritis (RA) and an inadequate response to at least 2 prior biologic or targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) therapies with different mechanisms of action.

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The purpose of the study is to assess whether the addition of a TNFi-biologic (tumor necrosis factor inhibitor) medication to methotrexate (MTX) is superior to adding a targeted synthetic DMARD (disease-modifying anti-rheumatic) medication to MTX for people with active RA despite current MTX treatment.

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The objective of the trial is to assess the efficacy, safety, and tolerability of BI 685509 compared with placebo on a background of local standard of care (SOC) therapy in the treatment of adult patients with early progressive dcSSc and vasculopathy

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The purpose of this clinical research study is to learn more about the use of the study drug, amnion suspension allograft (written as ‘ASA’ in this form), for the potential treatment of osteoarthritis (OA) of the knee. The ASA injection is being studied to see if it improves the knee pain and function in people with knee OA

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This study is looking at home cooking patterns in people seen at the Tufts GI clinic with IBD and those without IBD. Participants will be given a questionnaire that will ask about different parts of the participants' home cooking patterns including attitudes, self-efficacy, and knowledge. By taking the responses to the questionnaire, we plan to examine different variables linked to home cooking pattern and how they differ between people seen at the GI clinic here at Tufts with IBD, and people seen at the clinic without IBD.

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The objectives of this dose escalation study are to confirm the optimal dose of transplanted hepatocytes to safely achieve adequate allogeneic hepatocyte (AH) engraftment into the periduodenal lymph nodes (PDLNs) via endoscopic ultrasound (EUS) in subjects with end-stage liver disease.

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This is a 10-year, longitudinal, observational study of patients with PSC to address knowledge gaps in the clinical presentation, natural history, epidemiology, progression, and outcomes of PSC. In addition, the study will address prognostic models and biomarker development. There will be an option to participate in specimen repository at each site for translational studies of genomics and novel biomarkers discovery.

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This study will evaluate the safety and effectiveness outcomes of FRED X device in a population of patients that aligns with the indications for use of the FRED device. The data generated from this study will be compared to the safety and effectiveness of the FRED device by meeting the same performance goals established for the FRED pivotal study.

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To confirm the longer-term safety and effectiveness of the LVIS Device. The aim of this study is to collect and provide FDA with longer term clinical performance of the LVIS device.

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The objective of this study is to compare the safety and effectiveness of the Route 92 Medical Reperfusion System to predicate AXS Vecta Aspiration System.

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ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score.

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The purpose of this study is to learn if asundexian is safe for the participants, how it affects the body, and to look at how well it works to prevent future ischemic strokes in participants who already had had an acute non-cardioembolic ischemic stroke or high-risk TIA.

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ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

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The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.

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The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

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The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraines who are switching or initiating a pharmacologic treatment for migraine prevention. This is an observational study which means there will be no treatment added or taken away.

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The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE)

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