This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.
This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.
The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.
This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.
The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.
The purpose of this clinical trial is to evaluate the safety and effectiveness of ONO-2808 in patients with Multiple System Atrophy with cerebellar variant (MSA-C)and Multiple System Atrophy with parkinsonian variant (MSA-P).MSA is a rare, rapidly progressing, fatal, adult-onset neurodegenerative disorder of the central and autonomic nervous systems that is characterized clinically by a variable combination of parkinsonism, cerebellar impairment, and autonomic and motor dysfunctions ONO-2808 is an investigational drug meaning that its safety, effects, and how it works are still being studied. This is a randomized (assigned by chance), placebo-controlled study, which means that some participants will receive a fake treatment (placebo) while others get the real treatment. The placebo treatment looks like the ONO-2808 medications but doesn't contain any active ingredient. The medication is in pill form and will be administered orally. This research is also double-blind, meaning that neither the participants nor the researcher will know which treatment they will be receiving. If participants choose to take part in the study they will be asked to attend up to 16 visits and the study will take up to 34 weeks. During the study, participants will be asked to go through a screening period (up to 6 weeks). The purpose of this screening period is to make sure study participants meet all the study criteria. If participants meet all study criteria, they may be asked to volunteer for the double-blind treatments. The duration of the double-blind treatment is 24 weeks which consists of 14 visits, some visits will be done at the study center/ hospital and the remaining visits will be done by a nurse from IQVIA's Research Nurse and Phlebotomy Solutions (RNPS) at participants' home. During visits, participants should anticipate tests including electrocardiograms (ECGs), vitals measurements (including temperature, blood pressure, and heart rate), and a physical/neurological examination. Some of the risks include nausea, vomiting, abdominal pain, loss of appetite, dark urine, yellow eyes, and persistent fatigue.
This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.
This is a multi-center study that we have been invited to join that will evaluate the LVAD pump function in relation to adverse events. We are the 8th largest implanting center for LVADs in the United States and feel it is important to be a part of this.
Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way you perceive pain. We will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster