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2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future...
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2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
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3D Body Surface Modeling for Scoliosis Monitoring
This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.
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A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
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AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches. The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after...
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Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
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ACDF Using Structural Allograft vs. Tritanium C
This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
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A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
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A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials. Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control...
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ACTHar in the Treatment of Lupus Nephritis
Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).
