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REFLECT Scoliosis System Post Approval Study
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
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Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
The aims are to determine whether 1) an incentive based on behaviorally-enhanced gamification and social incentives and 2) health coaching can promote adherence to exercise and physical activity after physical therapy for osteoarthritis of the knee (KOA). The research design is a randomized clinical trial with factorial design This randomized clinical trial of 254 patients using a factorial design will leverage a clinical trial platform developed through the University of Pennsylvania that allows for the remotely capture important patient-reported outcomes and other interaction through a participant's smart phone. The investigators will randomize participants to receive social...
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Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
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Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.
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Salt Water Gargling on Swallowing Following ACDF
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is: If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water. Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves...
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Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
This study aims to explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. The study consists of 2 magnetic resonance imaging (MRI) visits that involve brain neuroimaging for fMRI neurofeedback tasks, as well as 8 weekly intervention sessions with a pain psychologist. Patients will be randomized to either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups.
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Short-term and Intermediate-term Effects of Self-applied Joint Mobilization Versus Clinician-applied Joint Mobilization in Addition to Exercise in Patients With Knee Osteoarthritis: A Randomized Clinical Trial
The goal of this clinical trial is to learn if a combination of patient self-administered joint mobilization and exercise works to treat knee osteoarthritis in adults. The main questions it aims to answer are: - Does self-administered joint mobilization improve the ability to perform regular daily activities? - Does self-administered joint mobilization improve knee motion? - Does self-administered joint mobilization improve hip strength? Researchers will compare the program of self-administered joint mobilization to a joint mobilization administered by a physical therapist. Participants will: - Attend 8-12 physical therapy clinic visits over 6 - 8...
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Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)
This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).
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Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis
Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) are diseases that weaken the immune system. DM and JDM can affect the muscles, skin, joints, and lungs and cause skin rashes and muscle inflammation. Symptoms include weakness, pain, fatigue, and rash. Not everyone responds to current treatments. The FDA has approved a drug called deucravacitinib to treat people with plaque psoriasis. Researchers want to find out if this drug can help people with DM or JDM, too. Objective: To test deucravacitinib in people with DM or JDM. Eligibility: People aged 18 years and older with DM or JDM. Design: Participants will have 9 clinic visits over 28...
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Study of Ravulizumab in Pediatric Participants With Primary IgAN
The primary objective of this study is to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population.
