The purpose of this phase III study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis, which is not currently approved by the FDA. This study will last approximately 26 weeks, which includes a screening period that includes 1 or 2 visits. Eligible subjects will undergo a 1:1 randomization with the SL 1002 formula or normal saline used as a placebo. After the screening visits and the study drug treatment visit (Day 1), the subject will be required to return to the study site for 5 additional study visits at approximately 1,2,3,4, and 6 months after the study drug treatment (Day 1). These visits will include physical examinations, knee assessments, patient questionnaires, and the collection of vital signs, and blood and urine samples. This study also requires daily electronic data entries from Day 1 to the end of the study.
This is a multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon. The alternative option is called an arterio-venous graft (AVG), where the doctor implants a synthetic/artificial tube under the patient's skin, where one end of the tube connects to a vein and the other to an artery. This tube is then used as the ‘access site' during hemodialysis. Participants with ESRD in need of vascular access, and who agree to be in this study, and also meet all the eligibility criteria for participation, will receive the Xeltis aXess graft, a type of AVG as previously described.
This study is designed to assess the 10-year post-surgery implant survivorship of Total Knee Arthroplasty (TKA) procedures performed using the LEGION Medial stabilized insert, which is FDA approved. Implant survivorship is defined as all of the knee-implanted components without a need for a revision. Questionnaires will be used up to 10 years after surgery to find more about the safety and performance of the device.
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to a placebo in participants aged 6 to under 12 years with moderate-to-severe AD. Participants will be screened within 28 days before the first dose to confirm eligibility. Those who meet the criteria at baseline will be randomized 2:1 to receive either abrocitinib oral suspension (at a 100 mg adult equivalent dose once daily) or a matching placebo. Participants will be stratified by their baseline vIGA score (3 or 4). They will receive either abrocitinib or a matching placebo for 16 weeks. Additionally, participants must use emollients daily and follow standardized background medicated topical therapy (e.g., low to medium potency corticosteroids) according to protocol guidelines throughout the study's treatment period.
The purpose of this research is to explore the effects of participation in a pickleball community-based exercise program on function in people with Parkinson's disease (PwPD). Individuals will engage in an 8-week instructional pickleball exercise program designed specifically by Movement Disorder Specialists at the Medical University of South Carolina for PwPD. The pickleball training program involves warm-up exercises, stroke mechanics, fall safety and recovery technique training, effective movement pattern drills, game play strategies, and match play. We aim to quantify the motor function, balance, mobility, and quality of life outcomes through clinical assessments and questionnaires before and after participation in the Pick it Up Pickleball training program. This research will establish an evidence base for pickleball as a therapeutic intervention, opening the door for additional accessible and engaging exercise options for the PD community.
The purpose of this study to help us understand if adding transcranial Direct Current
Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy
improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.
Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and tested via telehealth with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET via telehealth to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting. In the next part of the study, we will offer the adapted version of WET via telehealth to 20 people aged 12 to 18 in our MUSC integrated pediatric primary care clinic. People aged 12 to 18 will take part in five to seven weekly online therapy sessions and three virtual study visits (before therapy, after therapy, and one month later) to better understand who they are as a person and their current mental health symptoms and diagnoses. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.
This is a small, test study to see if mailing buprenorphine works for patients with opioid use disorder and a recent medical hospitalization. It tries to remove some of the existing barriers to make it easier to stay in treatment and make it easier for individuals to keep taking their medicine after discharge. The purpose of this research study is to determine if mailing buprenorphine is possible, acceptable, and look at the early results of how well it works.
This study aims to evaluate the remote delivery of self-regulation assessments in young children with autism and their parents. Parents will complete online surveys. Parents and children will complete two virtual visits. At the second visit, participants will wear a heart rate monitor while completing study tasks. This study will inform research on behavioral therapies for children with autism.