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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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Effects of complementary feeding on infant growth and gut health
Your baby may be eligible if they are: - Breastfed and/or formula fed - Younger than five months of age - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a seven month-long study, from 5 to 12 months of age, with visits occurring every month. ... Protocol #: 20-2232 |
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Blueberry intake and infant gut health
Your breastfed baby may be eligible if they are: - Younger than six months of age - Exclusively breastfed - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a 7-month long study, with visits occurring once every other month. The first and last ... Protocol #: 20-1659 |
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Early iron exposure on the gut microbiota in young infants
This is a four month-long study, beginning at birth. The first study visit is conducted at the University of Colorado Hospital and the last visit takes place at Children’s Hospital Colorado. The other four visits are conducted in your home. Formula is provided to all study participants for... Protocol #: 18-1317 |
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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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Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado
This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to iden... Protocol #: 22-0588 Location: Childrens Hospital Colorado |
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Defining Molecular Phenotypes of Exacerbation-Prone Asthmatics (ENIGMA)
We want to learn more about asthma and how stuff in the air, like pollution and allergens, can make asthma worse in children. To do this we want to look at kids with and without asthma. If you join the study, you will participate in a remote consent visit, a clinic visit and a remote home... Protocol #: 17-1416 Location: Childrens Hospital Colorado |
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A 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group,
Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 ig Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase
Protocol #: 18-1445 Location: Childrens Hospital Colorado |
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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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PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)
PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a... Protocol #: 19-0619 Location: Childrens Hospital Colorado |
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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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Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado.... Protocol #: 20-0593 Location: Childrens Hospital Colorado, Highlands Ranch Hospital, 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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A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and
Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection (GS-US-528-9023)
Protocol #: 21-3252 Location: Outpatient CTRC, Outpatient CTRC |
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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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Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers
We are studying how asthma develops in early childhood to help doctors provide better asthma treatments for children. If you decide to participate, your child will complete up to five research visits. There will be one visit per year over 4 years. During the visits your child will d... Protocol #: 21-3116 Location: Childrens Hospital Colorado |
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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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A Phase 4, Multicenter, Open-label, Efficacy and Safety Trial of Pegloticase and Methotrexate Co-administered in Patients with Uncontrolled Gout who have Previously Received Pegloticase Monotherapy but did not Maintain a Serum Uric Acid Response
Protocol #: 21-3601 Location: Barbara Davis Center, University of Colorado Hospital |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ... Protocol #: 21-3844 Location: Childrens Hospital Colorado, 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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A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study with 6 month treatment phase and 6 month observation phase. ... Protocol #: 23-0534 Location: Childrens Hospital Colorado |