Adherence to home exercise is important to achieve upper limb recovery after stroke. However, adherence is typically low. Therefore, a new home exercise program with an Apple Watch and iPhone app was created to improve adherence to upper limb exercises for stroke survivors at home. Participants will come to our lab to experience the new home exercise program. Participants who opt for home use will bring the device home to try the new home exercise program at home. The purpose of this study is for researchers to examine usability and feasibility of participants using the new home exercise program.
The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.
At least 60 subjects will take part in this research at approximately 7 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.
This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to your skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they will be treated with Qutenza 8% capsaicin topical system and can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if you will need to be retreated at each visit based on your symptoms). This is an open-label study and all participants will receive Qutenza 8% capsaicin topical system. The study visits are estimated to take 90 minutes upwards to 120 minutes.
This study is enrolling subjects with an abnormal heart rhythm called ventricular tachycardia (VT - rapid heart beat coming from the bottom of the heart) that has come back despite treatment. This is a randomized study meaning subjects will be assigned to one of two groups and then undergo either a standard catheter ablation or a new treatment called cardiac radioablation for their VT. You will have a 50:50 chance of being assigned to either group. A standard catheter ablation is done by placing catheters (long hollow tubes) into a large blood vessel at the top of the leg, guiding them to the heart to first identify the signals causing the VT and then use radiofrequency (heat) energy to burn and stop these signals to stop the VT. The cardiac radioablation is an investigational treatment meaning it is not yet approved for routine clinical use by the Food and Drug Administration (FDA). Cardiac radioablation is performed in the radiation oncology department and uses radiation therapy to treat the signals causing the VT. Participation in this study will last up to 5 years and inlcude about 15 visits. Study related procedures include medical record review and data collection, electrocardiogram (tracing of heart's electrical activity), echocardiogram (ultrasound test of the heart), CT scans, blood work, questionnaires, implantable cardioverter defibrillation (ICD - device implanted in your chest that monitors and treats abnormal heart rhythms), and ablation procedure per randomization. Risks include fatigue, changes in the appearance of the lungs in the cardiac radioablation group, fatigue, pain, low or high blood pressure or excessive bruising or bleeding at the catheter insertion side in the cardiac ablation arm. There are also study procedure related risks, and risks that are not known. There is potential benefit to you and to others in learning how to better treat others in the future with this condition.
The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).
AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).
The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.
This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.
This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.
This study is for adults with HIV who are currently being treated with Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF]). The purpose of the research is to compare the effectiveness of B/F/TAF and the investigational once-daily medication Bictegravir/Lenacapavir (BIC/LEN). Participants will either continue taking B/F/TAF or switch to BIC/LEN for at least 48 weeks. The study will also look at the long-term effectiveness of BIC/LEN. Participants will be given the option of participating in an open-label phase of the study (where both the provider and participant know which drug they are on) where all participants receive BIC/LEN.
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 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.
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.