STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE)Protocol #: 20-0141 Locations: Barbara Davis Center; University of Colorado Hospital |
Disordered Eating, Energy Availability, and Quality of Life in Adolescent AthletesParticipants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. Protocol #: 20-1681 Location: Childrens Hospital Colorado |
Slow Heart Registry: A prospective observational cohort study of fetal immune-mediated high degree heart blockProtocol #: 20-0820 Location: Childrens Hospital Colorado |
Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) studyThe 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 radiographic sacroiliitis or magnetic resonance imaging (MRI) features of inflammation in the sacroiliac joints (SIJ) plus one clinical feature of spondyloarthritis (SpA), and a "clinical arm" that requires presence of the HLA B27 protein plus 2 clinical features of SpA. To validate the performance of the current ASAS classification criteria in a prospective combined cohort of patients presenting to a rheumatologist in North America and outside North America with undiagnosed current back pain of ≥3 months duration with onset ≤45years of age. Protocol #: 19-1526 Locations: Barbara Davis Center; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
The Effect of Adjuvant Adipose-Derived Modified Cells for Arthroscopically-Determined Knee Osteoarthritis: A Randomized Controlled TrialProtocol #: 19-2893 Location: Steadman Hawkins Clinic - Denver |
Randomized Controlled Trial of the Cartilage Forming Potential of Microdrilling versus Lipoaspirate Concentrate for Isolated Articular Cartilage DefectsProtocol #: 19-2838 Location: Steadman Hawkins Clinic - Denver |
In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot StudyNanoScope 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 injection (i.e. steroid injection). Protocol #: 19-2499 Locations: Boulder Sports Clinic; CU Sports Medicine - Denver; University of Colorado Hospital |
A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD TherapyProtocol #: 19-2533 Locations: Barbara Davis Center; University of Colorado Hospital |
Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic SclerosisProtocol #: 19-1613 Location: Childrens Hospital Colorado |
Gait Analysis of Femoroacetabular Impingement Patientsi. To compare differences in muscle recruitment, gait patterns (kinematics & kinetics), spaciotemporal variables, functional movements (squats, lunges, sit-to-stand, and single leg steps), and pelvic tilt between patients with femoroacetabular impingement (FAI) and age-matched morphologically normal controls. ii. To compare differences in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt between symptomatic and asymptomatic patients with FAI morphology. iii. To compare changes in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt pre- and post-intra-articular hip injection in symptomatic FAI patients. iv. To test if anatomical variables (alpha angle, center edge angle, FAI version) are predictors of change in gait and movement patterns. Protocol #: 16-1934 Location: Childrens Hospital Colorado |
Allen CU-UCSD Transition to RA Project: Blood and FluProtocol #: 19-1150 Locations: Barbara Davis Center; University of Colorado Hospital |
Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic SclerosisProtocol #: 19-0814 Location: Childrens Hospital Colorado |
Total Joint Arthroplasty in a Pediatric PopulationInvolves two surveys for approximately 10 mintues To explore the functional ability and quality of life in pediatric patients who undergo joint arthroplasty for non-solid tumor related reasons. Protocol #: 19-0306 Location: Childrens Hospital Colorado |
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus ErythematosusProtocol #: 19-0027 Location: Barbara Davis Center |
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)Protocol #: 18-2346 Location: University of Colorado Hospital |
The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot StudyThe 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 compartment thickness at its largest dimension. Protocol #: 18-1297 Location: University of Colorado Hospital |
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA)Protocol #: 15-1868 Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital |
An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical ProcedureThe purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery Protocol #: 18-0546 Location: University of Colorado Hospital |
Combining Testosterone Therapy and Exercise to Improve Function Post Hip FractureProtocol #: 17-2186 Location: University of Colorado Hospital |
Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017This 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 (surgery + post-op physical therapy) and non-operative treatment (physical therapy only without surgery). Protocol #: 17-0628 Locations: Boulder Sports Clinic; University of Colorado Hospital |
A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndromeProtocol #: 17-2000 Location: University of Colorado Hospital |
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: University of Colorado Hospital |
Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approachesRegular 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 movement the person does. This is done with equations that use the data collected by the activity monitors. However, these equations are usually developed using measurements on healthy people. People who have movement disorders related to diseases such as Parkinson?s and Multiple Sclerosis, or conditions such as knee replacement, stroke, or arthritis have very different movement patterns than people without these diseases. Thus, the equations used to convert activity monitor data will not work well in people with these diseases or conditions. The purpose of this study is to develop equations to measure physical activity using activity monitors in people with movement limitations. Rather than creating specific equations for each individual disease and condition, we will perform simple tests to measure upper and lower body function, and then group people into different clusters based on these tests. Our preliminary studies show that these equations are more accurate than equations based on specific diseases or conditions. Protocol #: 16-2706 Locations: CTRC-adult; University of Colorado Hospital |
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 spondyloarthritis and study these individuals in a longitudinal manner in order to better understand the development of spondyloarthritis. Results from this study may provide information that contributes to our understanding of the complex relationships among immune dysregulation, genetic risk, subclinical phenotypes, and established spondyloarthritis phenotypes. Protocol #: 17-0977 Location: University of Colorado Hospital |
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older WomenIf you join the study, you will be placed by chance into one of two research groups: 1) exercise and a study pill or 2) no exercise and a study pill. The study pill could be DHEA (50 mg/day) or a placebo. A placebo is a pill that looks like medicine but is not real. DHEA is a naturally occurring hormone that declines with age. In postmenopausal women, nearly all estrogen and most testosterone comes from DHEA. DHEA is considered a food supplement. Protocol #: 16-2427 Location: University of Colorado Hospital |
Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung diseaseProtocol #: 17-1226 Location: University of Colorado Hospital |
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing SpondylitisThis study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls. To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls. Protocol #: 14-1507 Locations: Colorado Research Center; Denver Health Medical Center; University of Colorado Hospital |
Analysis of Discarded Spinal Tissues from Individuals with Spinal ConditionsProtocol #: 17-0687 Location: University of Colorado Hospital |
A double-blind, placebo-controlled crossover study comparing the analgesic efficacy of cannabis versus oxycodonePRIMARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on spontaneous chronic spine pain relief, as measured by change in score on the 10-point Numeric Rating Scale (NRS); (2) To compare the effects of cannabis versus oxycodone versus placebo on experimental pain analgesia, as measured by change in Experimental Pain Threshold (EPTh), in both patients with chronic spine pain and healthy controls. SECONDARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on chronic spine pain, as measured by the Patient Global Impression of Change (PGIC) scale; (2) To compare the effects of cannabis versus oxycodone versus placebo on subjective reports of drug effects, psychoactive effects, and mood; (3) To compare the effects of cannabis versus oxycodone versus placebo on tests of neurocognitive functioning (Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test, the Hopkins Verbal Learning Test Revised (HVLT), and the Grooved Pegboard Test); (4) To compare the effects of cannabis versus oxycodone versus placebo on Standardized Field Sobriety Tests (SFST). Protocol #: 14-1909 Locations: CTRC-adult; University of Colorado Hospital |