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Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches
Regular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movemen... Protocol #: 16-2706 |
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Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)
What is involved: • Measurements of bone mineral density • Completion of sleep questionnaires/assessments • Randomization to sleep with a simulated night shift schedule or normal sleep schedule • A general physical exam • Activity monitoring with a wrist monitor • Blood/urine collec... Protocol #: 20-3013 |
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to pla... Protocol #: 22-2265 Location: Barbara Davis Center, University of Colorado Hospital |
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A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis
Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)... Protocol #: 22-1850 Location: Renal Research Center, University of Colorado Hospital |
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Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)
The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri... Protocol #: 17-0977 Location: University of Colorado Hospital |
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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)
This study is inviting people who have RA into a study to have an HRCT scan and PFT testing done for the study to learn more about lung disease in RA... Protocol #: 16-1097 Location: Outpatient CTRC, University of Colorado Hospital |
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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017
This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (... Protocol #: 17-0628 Location: Boulder Sports Clinic, University of Colorado Hospital |
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The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compa... Protocol #: 18-1297 Location: University of Colorado Hospital |
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A 2-and-5-year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with or without additional stabilization using the coflex? ? Interlaminar Technology for FDA Actual Conditions of Use Study.
The first objective addresses coflex? performance in actual conditions of use settings at two years and at five years relative to pivotal trial device performance. The second objective compares coflex? performance in actual conditions of use settings to decompression alone using data from ... Protocol #: 22-0695 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3
Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic
Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ... Protocol #: 22-0670 Location: Barbara Davis Center, University of Colorado Hospital |
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In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study
NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee inject... Protocol #: 19-2499 Location: Boulder Sports Clinic, CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopedic Hardware
Screened patients will be briefed of the study protocol and if interested in participating in the study, will complete informed consent. During their regular follow-up visits, patients will have an antenna attached to their affected limb using velcro straps and stand on a flat platform tha... Protocol #: 19-3107 Location: Medical Center of the Rockies |
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Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study
The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp... Protocol #: 19-1526 Location: Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB Suture Anchor, MICRORAPTOR Knotless REGENESORB Suture Anchor and MICRORAPTOR Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
Protocol #: 20-0923 Location: Highlands Ranch Hospital, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).
Protocol #: 20-2357 Location: Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, University of Colorado Hospital |
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Werewolf FLOW 50 During ACL Reconstruction: A Randomized Control Trial
Participation in this study will not affect the pre, post, or intra-operative care of ACL reconstruction in any way other than either the use of the use of the Werewolf FLOW 50 device or not and the performance of MRI at 6 months postoperative. All involvement and participation will be com... Protocol #: 20-2720 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado |
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A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)
Protocol #: 22-0647 Location: Boulder Health Center, Cherry Creek Medical Center, CU Sports Medicine - Denver, Lone Tree Medical Center, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone
or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus
Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
Protocol #: 22-0815 Location: Barbara Davis Center, University of Colorado Hospital |
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Effect of Lower Limb Osseointegration Amputation across Multiple Biomechanical Domains
This study will use a combination of MRI and motion capture data collected in the laboratory to measure forces at the joints during common activities of daily living.... Protocol #: 20-3097 Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, University of Colorado Hospital |
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AN INTERVENTIONAL, MULTI-CENTER INVESTIGATION OF SINGLE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) STABILIZED WITH PEDICLE SCREWS
Protocol #: 21-3281 Location: Broomfield Hospital, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, University of Colorado Hospital |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
This phase III, double-blind study will have two arms: Experimental-Participants will receive obinutuzumab 1000 mg IV infusions on Day 1 and at Weeks 2, 24 and 26; Placebo Comparator-Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26. The tri... Protocol #: 21-3268 Location: Barbara Davis Center, University of Colorado Hospital |
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A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
Protocol #: 21-3663 Location: Barbara Davis Center, University of Colorado Hospital |
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Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA
In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d... Protocol #: 21-4765 Location: University of Colorado Hospital |
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A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate
Approximately 80-100 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-... Protocol #: 22-1077 Location: Barbara Davis Center, University of Colorado Hospital |
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Back in the Game: An Immediate Functional Progression Program for Adolescent Athletes with Spondylolysis: A Randomized Pilot Trial
Patients will be randomized into IFPP and control groups. The IFPP group will begin physical therapy immediately following spondylolysis diagnosis. The control group will begin physical therapy after reporting pain-free during activities of daily living. Patient-reported outcomes as well a... Protocol #: 22-0868 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado |
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A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6- C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopat... Protocol #: 22-0694 Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
During this study, we will enroll n=48 total subjects who have recently sustained an mTBI. Subjects will be randomized to one of two study groups, followed throughout the duration of the 8-week vNDT intervention period, returned for post-intervention period testing, and then followed via m... Protocol #: 22-1352 Location: CU Sports Medicine - Denver, UCHealth Central Park Medical Center |