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Solid foods and infant growth
Your baby may be eligible if they are: - Exclusively breastfed - Younger than six months of age - 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 month. The first visit, 9-month visit, an... Protocol #: 19-0546 |
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How Does Inflammation Affect the Aging Brain? Research Study Investigates Aging, Memory, and Immune Function.
The University of Colorado Anschutz Medical Campus is looking for interested adults 60 and over to participate in a research study examining how inflammation influences brain health. Data gathered from this study will be used to better understand how inflammation may or may not disrupt thi... Protocol #: 18-2607 |
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ImTAB
Immunity, mTBI, and Alzheimer's Biomarkers
You may qualify if you are: - 65 years or older - Have had a concussion within the past 5 years - Saw a doctor within 1 week of your concussion - Have not been diagnosed with a memory disorder Participants will receive: -Snacks and refreshments -Medical screening (neurological e... Protocol #: 19-1423 |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o... Protocol #: 18-2258 |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart d... Protocol #: 19-2323 |
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The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D
You might be eligible if you: • Are between 20 and 45 years of age and are not obese (body mass index <30 kg/m2) • Do not have a history of cardiovascular disease (heart attack, stroke, coronary bypass surgery or angioplasty) • Are not taking statins for high cholesterol •... Protocol #: 19-0856 |
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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD
This study is a 52 week intervention with visits at the Renal Research Office on the University of Colorado Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment... Protocol #: 20-1672 |
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Cannabis in Adolescents Study
(Arm 1) If you join the study, you will have a total of six study visits over about two months. Half of these visits will be held via Zoom and the other half will be held in person at a clinic on the CU Anschutz Campus in Aurora. You will be asked questions; complete questionnaires; and gi... Protocol #: 20-0553 |
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University of Colorado Alzheimer's and Cognition Center Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD Study)
This study will establish a large bank of samples and data for future research into the causes of and treatments for Alzheimer’s disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems.... Protocol #: 15-1774 |
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Salmon intake and gut health in adults
You may be eligible if: - You are between 30 and 70 years old - Your BMI is between 25 and 40 (check with this BMI calculator https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm) - Exercise 3 hours/week or less - Not on any glucose lowering medications This study co... Protocol #: 20-1033 |
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Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated.... Protocol #: 17-0356 |
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Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls (IDOS)
Participants will complete 2-3 visits- a screening visit and a testing visit. Some participants will be asked to split screening into 2 visits. All visits include blood draws and the testing visit includes blood draws and frequent urine samples. Participants will also be asked to provide a... Protocol #: 20-2179 |
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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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The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT
The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may... Protocol #: 16-1479 |
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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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Research about alternative ways to measure the amount of hormones from a birth control pill
Participation will last up to 22 days and consist of three study visits. Participation will include taking one pack of birth control pills, containing both desogestrel and ethinyl estradiol. Participants will spend one day (8 hours) in clinic and receive an intravenous (IV) catheter for mu... Protocol #: 21-3936 |
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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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Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study
This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ... Protocol #: 21-3018 |
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Does When You Exercise Matter? A Randomized Trial Comparing the Effect of Morning versus Evening Aerobic Exercise on Weight Loss and Compensatory Behaviors
If you join the study, you will undergo screening evaluations to see if you are eligible to be in the study. If you are eligible to be in the study, you will be randomized to one of two study groups. Which group you are assigned to will be chosen by chance by a procedure similar to the t... Protocol #: 21-3094 |
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Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome
The purpose of this study is to compare the safety and effectiveness of tivanisiran sodium ophthalmic solution (eye drops) to placebo for treating signs and symptoms of DED in participants with a documented diagnosis of dry eye associated with Sjögren’s Syndrome. ... Protocol #: 21-2624 |
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Zoster Eye Disease Study (ZEDS):
A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment
This study is looking to see if treatment with 12 months of daily valacyclovir medication reduces the development of certain types of new or worsening eye disease; specifically, infection on the surface of the front of the eye (cornea), inflammation of the cornea, or inflammation inside th... Protocol #: 17-0585 |
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A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long-Term Safety, Tolerability, Pharmocokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
The TEASE studies (Tolerability and Effects of ALK-001 in Stargardt Disease) are a series of clinical trials evaluating an investigational drug called ALK-001 in people who have Stargardt Disease. There are no FDA-approved treatments to slow the progression of Stargardt Disease. Research s... Protocol #: 19-1103 |
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AMD Ryan Initiative Study (ARIS) - Longitudinal Study of Early AMD and Reticular Pseudodrusen
The goal of this project is to better understand the natural history and characteristics of early AMD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD and a certain finding associated with early AMD (Reticular Pseudodrus... Protocol #: 18-0520 |
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Utilization of Virtual Reality Mindfulness Application to Reduce Stress and Promote Wellbeing in University Students
Participants will be provided with Oculus Quest or Oculus Quest 2 VR headsets for the duration of the evaluation period (8-weeks) and will be asked to complete at least one 8-10 minute TRIPP VR mindfulness session 3-5 days per week via the VR headset or their mobile phone. Throughout the c... Protocol #: 21-3622 |
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Usefulness and performance with the IrisVision head-mounted video low vision aid in young individuals with congenital or early onset visual impairment
The IrisVision is a headset that is used by individuals with impaired vision to help them see better. This study plans to learn more about how well the IrisVision works for the younger population. If you meet the following criteria, you may be screened to participate in this study: ? Age... Protocol #: 19-2383 |
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An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene
This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in fema... Protocol #: 20-0130 |
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A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double- Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
This is the second study in which NCX 470 is being given to humans. Based on the results of an earlier study in which 326 subjects with your condition received NCX 470 eye drops (0.021%, 0.042% or 0.065%), the first part of the current study will examine two different concentrations of NCX... Protocol #: 20-0637 |
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A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma
This study is being conducted on patients diagnosed with a type of eye cancer called choroidal melanoma or an indeterminate lesion (a growth in your eye that is suspected to be melanoma), also known as eye melanoma. People who have choroidal melanoma are usually treated with radiation ther... Protocol #: 20-1186 |
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Field Test of Glaucoma Outcomes Survey
The American Glaucoma Society is interested to learn how quality of life improves for patients after minimally invasive glaucoma surgery combined with cataract surgery. They have designed a questionnaire, the Glaucoma Outcomes Survey (GOS), to try to find out how reliable the GOS survey is... Protocol #: 20-2477 |
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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA? in Treating Patients with Chronic (Inactive) Thyroid Eye Disease
This research trial will compare TEPEZZA to a placebo (a “dummy” treatment). The trial drug TEPEZZA contains an active ingredient that is an inhibitor (slows down) of the “insulin-like growth factor 1” or IGF-1 receptor. The placebo looks just like the investigational drug but does not inc... Protocol #: 20-2835 |
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A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
Patients diagnosed with stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) Neurotrophic Keratitis (NK) will take part in this study. Neurotrophic Keratitis (also called neurotrophic keratopathy) is a rare disease of the cornea that occurs when the nerves to the cornea do not... Protocol #: 21-3923 |
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VR Programs for Adolescent Anxiety
Do you treat adolescents who experience anxiety in social situations or are you the parent of an adolescent who experiences anxiety in social situations? If so, we would love to talk to you! Participation involves trialing social engagement content on a virtual reality (VR) headset. Partic... Protocol #: 21-4407 Location: CU Anschutz non-hospital research facilities |
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Research about the Potential for the Contraceptive Implant as Emergency Contraception
Are you a healthy female between the ages of 18-40? Are you interested in starting Nexplanon®, hormonal birth control that goes in your arm? Are you interested in how your body works, specifically in regard to ovulation? This study is determining if when placing an etonogestrel implant ... Protocol #: 21-5026 |
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Prolonged Sedentary Behavior in Older Women with and without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk
Are you interested in participating in a research study to understand the health effects of the time we spend sitting? The ACTIVE Research Lab is looking for: • Women • 60 to 75 years of age • Non-smoker • If Type 2 Diabetes, not being treated with insulin • BMI 25-40 kg/m2 (check ... Protocol #: 19-2758 |
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Research on Computer Training to Help With Mood in Adolescents
This study plans to learn more about Interpretation Bias Training (IBT) in adolescents who are seeking outpatient mental health treatment. It uses a computer to show adolescents with irritability pictures of face emotions. The goal of this study is to test whether the training program that... Protocol #: 17-0464 |
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A Multi-site Observational Study: NIH RECOVER Study of Long COVID in Adults
This is a longitudinal study enrolling individuals with and without SARS-CoV-2 infection at varying stages before and after infection and with or without post-acute sequelae of SARS-CoV-2 (PASC). NOTE: As of July 2022, we are ONLY able to enroll 1) Adults who have never had SARS-CoV-... Protocol #: 21-4528 |
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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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Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens
Eligible participants will be randomly assigned to RRFT or Encompass (TAU) and will complete four research visits over the course of one year.... Protocol #: 21-3736 Location: Department Specific Free Standing Clinic |
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Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Prospective, single arm, multicenter study... Protocol #: 22-0486 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center |
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NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
Protocol #: 22-0175 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
Protocol #: 22-0306 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting
Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa... Protocol #: 22-0325 Location: Harmony Campus, Medical Center of the Rockies |
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A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
Protocol #: 21-4929 Location: Outpatient CTRC, University of Colorado Hospital |
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A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)
Protocol #: 21-5088 Location: University of Colorado Hospital |
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A Pilot Feasibility Test of a Digital Solution for Remote Mental Health Monitoring and Care
If you join the study, you will first complete an initial baseline questionnaire about your mental health, general health, your experience with mental health care services, and demographic information (e.g., gender, age) about you. You will be emailed instructions on how to install the HR ... Protocol #: 21-4903 Location: University of Colorado Hospital |
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NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER
Protocol #: 21-4582 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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PEERLESS Study
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. The study will collect data on demograp... Protocol #: 21-4920 Location: University of Colorado Hospital |
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Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting
BRIGHT - Digital therapeutic Based Randomized Investigation to improve Glycemic control in patients with type 2 diabetes and residual Hyperglycemia on stable medical Therapy
Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa... Protocol #: 21-4891 Location: University of Colorado Hospital |
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EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
Protocol #: 21-4711 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD
A total of 270 patients will be randomized at up to 40 United States study centers and up to 10 centers outside the US (Canada and Europe). A maximum of 90 patients (33% of the total study population) will be randomized outside the United States. A maximum of 40 patients (15% of the to... Protocol #: 21-4436 Location: University of Colorado Hospital |
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A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined with Hormonal Therapy or Chemotherapy in Subjects with Advanced Solid Tumors
Protocol #: 21-4716 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease
Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu... Protocol #: 21-4551 Location: Renal Research Center |
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PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os... Protocol #: 21-4712 Location: Childrens Hospital Colorado |
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ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
Protocol #: 21-4447 Location: Childrens Hospital Colorado |
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Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease
Understanding the impact of gaps in care on healthcare utilization, long-term co-morbidities, and patient reported outcomes are the highest priority topics from patients, families and researchers. Additionally, knowledge about the factors associated with these gaps in care was a key facto... Protocol #: 21-4668 Location: Childrens Hospital Colorado |
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An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
Protocol #: 21-4586 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
Protocol #: 21-4639 Location: University of Colorado Hospital |
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EA2182: A Randomized Phase II Study of De-Intensified Chemo Radiation for Early Stage Anal Squamous Cell Carcinoma(DECREASE)
Protocol #: 21-4429 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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Multicenter, randomized, parallel group, phase 2 study to establish the efficacy and safety of combinations of CBP501, cisplatin, and nivolumab for greater than or equal to 3rd line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3 at screening
Protocol #: 21-5119 Location: University of Colorado Hospital |
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The influence of pediatric irritability on inter-subject neural synchrony while processing ambiguous social information
The Emotion and Development Lab is seeking <b>teen</b> volunteers to research how irritability affects the brain's processing of social information. Our goal is to learn more about how people commonly react to social ambiguity and how irritable mood may relate to negative interpretations o... Protocol #: 20-2633 Location: Brain Imaging Center (BIC) |
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Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss
Aim 1: We will collect samples from of clinically well-characterized trios (products of conception (POC), biological mother, and biological father) with a history of unexplained RPL. Specially, we will recruit a cohort of 1,000 RPL trios that are rigorously-phenotyped and not attributable... Protocol #: 21-3533 Location: Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver |
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An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors
An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors... Protocol #: 21-4364 Location: Memorial Hospital Central, Memorial Hospital North |
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Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex?), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function
Protocol #: 21-4360 Location: Outpatient CTRC, Outpatient CTRC |
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Pilot Study of suction as a mechanism of IUD Expulsion with Concomitant Menstrual Cup Use.
Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences ... Protocol #: 21-4267 Location: Comprehensive Women's Health Center |
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MAGNETISMM-9
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING
REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING
INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN
PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Protocol #: 21-4016 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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Respiratory Virus Transmission Network (RVTN)
The study will collect information from you and other household members on symptoms and patterns of contacts to learn how the virus is transmitted. Your household will be compensated for participating in this study.... Protocol #: 21-4270 Location: Childrens Hospital Colorado |
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A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum-Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)
Protocol #: 21-4100 Location: University of Colorado Hospital |
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The Intersection of Oncology Care and Worker Well-Being
You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor... Protocol #: 21-4139 Location: Saint Joseph Hospital, University of Colorado Hospital |
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A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with head and neck squamous cell carcinoma (HNSCC)
Protocol #: 21-4146 Location: University of Colorado Hospital |
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NRG-GY020: A PHASE III RANDOMIZED TRIAL OF RADIATION +/- PEMBROLIZUMAB (MK-3475) FOR NEWLY DIAGNOSED EARLY STAGE HIGH INTERMEDIATE RISK MISMATCH REPAIR DEFICIENT (dMMR) ENDOMETRIOID ENDOMETRIAL CANCER
Protocol #: 21-3887 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)
Protocol #: 21-4059 Location: Outpatient CTRC, Outpatient CTRC |
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A Randomized, Double-Blind, Placebo-Controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple-Doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) Patients
Protocol #: 21-3032 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors
Interviews will be conducted by a member of the study team at two separate time points. Questions about your treatment and different factors that are important to you when making decisions about your treatment. The interviews will be audio and video recorded by the study team. Only study ... Protocol #: 21-3870 Location: Childrens Hospital Colorado |
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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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EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Protocol #: 21-3855 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients with Myotonic Dystrophy Type 1, Followed by an Open-Label Extension
Protocol #: 21-3397 Location: UCHealth Central Park Medical Center, University of Colorado Hospital |
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Group Cognitive Behavioral Treatment for Anxiety in Adolescents with Autism and Intellectual Disability: A Randomized Controlled Trial
What is the study about? This study investigates an adapted Cognitive Behavior Therapy (CBT) group treatment to determine if it is more effective than therapy services that adolescents with Autism (ASD) and Intellectual Disability (ID) are already receiving. What does the study entail? ... Protocol #: 20-3142 Location: Department Specific Free Standing Clinic |
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Glucose Monitoring in Youth with Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
The purpose of this study is to determine if pulmonary exacerbations in youth with cystic fibrosis cause blood sugars to vary during and after an exacerbation. Blood sugars will be monitored using a continuous glucose monitor (CGM) for 2 weeks both during and 6 weeks after an exacerbation... Protocol #: 21-3666 Location: Childrens Hospital Colorado |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3, PIVOTAL STUDY WITH AN OPEN-LABEL EXTENSION PERIOD TO EVALUATE THE
EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT
PARTICIPANTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG)
ANTIBODY-ASSOCIATED DISEASE (MOG-AD)
Protocol #: 21-3747 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations
Protocol #: 21-3607 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)
Protocol #: 21-3726 Location: Outpatient CTRC, University of Colorado Hospital |
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An Open-label, Fixed-sequence Study to Assess the Effect of Repeated Doses of Capivasertib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Patients With Advanced Solid Tumours Harbouring Alterations in the PI3K/AKT/PTEN Pathway
Protocol #: 21-3737 Location: University of Colorado Hospital |
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EF-36/Keynote B36: A pilot, single arm, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer
Protocol #: 21-3694 Location: Memorial Hospital Central, Memorial Hospital North |
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CONNECTS Master Protocol for Clinical Trials targeting macro-, micro-immuno-thrombosis, vascular hyperinflammation, and hypercoagulability and renin-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)
Protocol #: 21-3728-DH Location: Denver Health and Hospital Authority |
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A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304
Protocol #: 21-3677 Location: University of Colorado Hospital |
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A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)
Protocol #: 21-3616 Location: Highlands Ranch Hospital, Lone Tree Medical 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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Harnessing Cells from Human Milk; Linking Lactation to Metabolism
In this study: - Participants will complete 2 study visits (in late pregnancy & 2 wks postpartum) - Participants will have their milk production measured and provide blood and breastmilk samples If you join the study, you will be part of the study for up to a month and a half, lasting... Protocol #: 21-2835 Location: CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 with and without NBUVB in Vitiligo: A Phase 2A Randomized Double Blind, Vehicle-Controlled Clinical Trial
This is a randomized, double blind, vehicle-controlled clinical trial that includes 64 vitiligo patients. Study patients will be randomly assigned to receive active drugs (crisaborole or PF-07038124 ointment) or vehicle ointment, in combination with active NBUVB or sham-NBUVB. ... Protocol #: 21-4837 Location: CTRC Inpatient, University of Colorado Hospital |
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Phase 1 Trial of Hu5F9-G4 (magrolimab) combined with dinutuximab in children and young adults with relapsed and refractory neuroblastoma or relapsed osteosarcoma
This study is being done to answer the following questions: -Is it safe to give magrolimab with dinutuximab to children, adolescents, and young adults with relapsed/refractory neuroblastoma or relapsed osteosarcoma? -What is the best dose of magrolimab to give with dinutuximab in childre... Protocol #: 21-3374 Location: Childrens Hospital Colorado |
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Genetic and epigenomic determinants of hearing loss in Hispanic populations
This study aims to identify genes and variants that are related to sensorineural hearing loss (SNHL) in children, including Hispanic children from multiple recruitment sites and non-Hispanic children from Colorado who are diagnosed with severe-to-profound congenital SNHL. We will collect D... Protocol #: 21-3609 Location: Boulder Health Center, Childrens Hospital Colorado |
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Protocol A011-13 (HYPERION): A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Protocol #: 21-3600 Location: University of Colorado Hospital |
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Phase I/II trial of radiotherapy in combination with Atezolizumab prior to surgical resection for HPV-unrelated squamous cell carcinoma of the head and neck (HNSCC)
Protocol #: 21-2642 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, 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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Contraceptive Hormone and Reward Measurement (CHARM Study)
The study is examining the effects of hormonal oral contraceptives (OCPs) on brain processes and emotional wellbeing. Study participants will: Participate in 3 study sessions, one online and two in-person, over the course of 2 months. Complete interviews and questionnaires Taking a... Protocol #: 21-3530 Location: Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC |
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Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil... Protocol #: 21-3447 Location: Renal Research 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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Detection of resistance mechanisms in cerebrospinal fluid for EGFR-mutant, ALK- and ROS1-rearranged non-small cell lung cancer patients with central nervous system (CNS) progression after evidence of prior CNS benefit on relevant tyrosine kinase inhibitors
Protocol #: 20-1193 Location: Georgetown University, University of Colorado Hospital, USC (Norris Hospital) |
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A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion
All participants will receive the study drug, larotrectinib. Patients may continue to take the study drug for up to 20 months if there aren't any side effects and their brain tumor does not get worse. Patients will be given a diary to write down the amount of study drugs (number of pills o... Protocol #: 21-2520 Location: Childrens Hospital Colorado |
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NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)
Protocol #: 21-2970 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
This is a prospective phase 1/2 trial designed to assess the hypothesis that vorinostat, in addition to standard graft versus host disease (GVHD) prophylaxis, is feasible and safe in children, adolescent and young adult patients. All subjects will undergo allogeneic BMT according to local ... Protocol #: 20-2018 Location: Childrens Hospital Colorado |
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A Phase II Pilot Study of Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults with High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant: A Multicenter Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) Study (EXCEL Trial)
Protocol #: 21-2662 Location: Childrens Hospital Colorado |
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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 MULTICENTER PROSPECTIVE STUDY EVALUATING OUTCOMES OF ENDOSCOPIC ERADICATION THERAPY IN PATIENTS WITH BARRETT'S ESOPHAGUS ASSOCIATED NEOPLASIA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM
Protocol #: 14-2371 Location: Moffit Cancer Center, University of South Florida, Northwestern University, UCLA - University of California, University of Colorado Hospital, University of Kansas Cancer Center, Washington University, Siteman Cancer Center |
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Assessing feasibility, safety, and efficacy of deploying a closed-loop automated insulin delivery system by community-based primary care physicians and academic endocrinologists, in person and through telehealth.
The purpose of this study is to learn more about the safety and effectiveness of the iLet - Bionic pancreas device for treating Type 1 diabetes when implemented in primary care and endocrinology, and both in-person and via telehealth.... Protocol #: 21-3272 Location: Department Specific Free Standing Clinic, Lone Tree Medical Center, University of Colorado Hospital |
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Assessing diagnostic value of non-invasive FFRCT in coronary care in the emergency department
The overall purpose of this study is to help HeartFlow understand if the use of FFRCT in the ED will help physicians with diagnosis and treatment of chest pain. ... Protocol #: 22-0025 Location: Memorial Hospital Central |
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An Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Solid Tumors OLD TITLE: pen-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Triple Negative Breast Cancer
Protocol #: 21-3064 Location: Lone Tree Medical Center, University of Colorado Hospital |
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Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Protocol #: 20-2670 Location: University of Colorado Hospital |
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Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease
Participants will be instructed in inspiratory muscle strength training (IMST) during baseline and will be evaluated during a 3 month period to see the effects of the device on systolic blood pressure. There will be a "placebo" arm. Participants will not know which arm they are in.... Protocol #: 21-3000 Location: University of Colorado Hospital |
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A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and
Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Protocol #: 21-3077 Location: University of Colorado Hospital |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 2 STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ROZANOLIXIZUMAB IN ADULT STUDY PARTICIPANTS WITH LEUCINE-RICH GLIOMA INACTIVATED 1 AUTOIMMUNE ENCEPHALITIS
Protocol #: 21-2955 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 in Patients with Advanced Cancers Associated with Expression of Delta-Like Canonical Notch Ligand 3 (DLL3) Who Have Failed Standard Available Therapy
Protocol #: 21-2992 Location: University of Colorado Hospital |
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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB, COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS.
Protocol #: 21-2663 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, with or without BI 754091, in Patients with Stage IV Colorectal Cancer
Protocol #: 21-3062 Location: University of Colorado Hospital |
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AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged Greater than or equal to 1 to < 31 Years Old with First Relapse
Protocol #: 21-3049 Location: Childrens Hospital Colorado |
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Associative Threat Learning: Measuring Mechanisms for Treating Threat-based Psychopathologies
This study plans to learn more about how performance on a behavioral task, the Facial Affect Salience Task (FAST, may predict responses to a 12-session course of exposure therapy in young adult females with social anxiety disorder. If the task can predict responses to treatment, we should ... Protocol #: 21-2631 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado |
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A081801 - INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO
Protocol #: 20-2646 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, 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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A Partially-Blind, Randomized, Controlled, Parallel-Group Dose Ranging Study to
Determine the Efficacy, Safety and Tolerability of AeroFactTM (SF-RI 1 surfactant for inhalation combined with a dedicated drug delivery system) in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome
Babies in the Active groups may get up to 4 total doses of AeroFact during the first 96 hours of life, depending on how much oxygen and support from the nCPAP/nIMV your baby needs. Re-dosing with drug can occur as frequently as 2 hours after the start of the previous dose. Babies will no... Protocol #: 21-2876 Location: University of Colorado Hospital |
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Using Oscillometry in Toddler Aerodigestive Patients to Monitor Lung Function Response to Treatment
In this study, we will 1. Assess different mouthpiece options to help make the test easier to do in young children 2. Obtain AOS measurements in children who are patients in the aerodigestive clinic at Children's Hospital Colorado 3. Compare these measurements to those obtained in chil... Protocol #: 21-2637 Location: Childrens Hospital Colorado |
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A PHASE 2 STUDY OF MECBOTAMAB VEDOTIN (BA3011) ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHO HAD PRIOR DISEASE PROGRESSION ON OR ARE INTOLERANT TO A PD-1/L1, EGFR, OR ALK INHIBITOR
Protocol #: 21-2670 Location: Outpatient CTRC, University of Colorado Hospital |
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A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
Protocol #: 21-2558 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T... Protocol #: 20-3065 Location: Childrens Hospital Colorado |
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Microbiome and Neutrophil associated factors in Rheumatoid Arthritis and Autoimmune-related Interstitial Lung Disease (MINERAL)
Protocol #: 20-2769 Location: Barbara Davis Center, Childrens Hospital Colorado, Denver Health and Hospital Authority, National Jewish Health, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.
A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline. It has been designed to further evaluate whether la... Protocol #: 21-2474 Location: Barbara Davis Center, University of Colorado Hospital |
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A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of
Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
This is an international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study in patients with PBC. Approximately 180 subjects will be randomized in 2:1 ratio (seladelpar:placebo) across approximately 150 sites worldwide. Enrolle... Protocol #: 21-2480 Location: University of Colorado Hospital |
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Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Protocol #: 20-2649 Location: Children's Hospital National (CHN), Children's Hospital National (CHN), Childrens Hospital Colorado, Colorado State University, Uniformed Services University of Health Sciences (USUHS), Uniformed Services University of Health Sciences (USUHS) |
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EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
This is a Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and PK of alpelisib in pediatric and adult participants with PROS.... Protocol #: 20-2825 Location: Childrens Hospital Colorado |
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A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
Each patient will go through a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period. ... Protocol #: 20-3010 Location: Renal Research Center, University of Colorado Hospital |
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Treatment for Alcohol Use Disorder: Emotion Regulation and Brain Function
This study plans to learn more about the brain's role alcohol use problems and recovery. Prominent theories about alcohol use disorder suggest that it is a disorder of the brain. However, it remains unclear what parts of the brain work differently in alcohol use disorder. This study intend... Protocol #: 20-3000 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study
Protocol #: 20-2933 Location: Outpatient CTRC, University of Colorado Hospital |
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A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
This is a phase 3 double-blind (DB), randomized, placebo-controlled study with an open-label long term extension (LTE) evaluating the efficacy and safety of Elafibranor 80 mg once daily versus placebo in patients with PBC and inadequate response or intolerance to ursodeoxycholic acid (UD... Protocol #: 20-2899 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease
Protocol #: 20-2626 Location: Childrens Hospital Colorado |
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Neuronal and behavioral effects of an implicit priming approach to improve eating behaviors in obesity
Study participants: -Will watch pictures of food during MRI recording, to measure brain responses to the pictures. -Will complete questionnaires related to food, activity, and mood. -Will complete a once-weekly intervention for 12 weeks that involves viewing food or food images. ... Protocol #: 20-2821 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A PHASE 2, MULTI-COHORT, OPEN-LABEL STUDY OF INTRATUMORAL TAVOKINOGENE TELSEPLASMID PLUS ELECTROPORATION IN COMBINATION WITH INTRAVENOUS PEMBROLIZUMAB THERAPY WITH OR WITHOUT CHEMOTHERAPY IN PATIENTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER.
Protocol #: 20-2737 Location: Lone Tree Medical Center, 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 Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1
Protocol #: 20-2697 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, University of Colorado Hospital |
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NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
Protocol #: 20-2079 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination with Cetuximab in Participants with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with an Immune Checkpoint Inhibitor
Protocol #: 20-2644 Location: Rocky Mountain Regional VA Medical Center |
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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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ALZHEIMER'S CLINICAL TRIAL CONSORTIUM FOR DOWN SYNDROME (ACTC-DS)
TRIAL-READY COHORT - DOWN SYNDROME (TRC-DS)
TRC-DS is part of a larger movement working with people with Down syndrome to advance Alzheimer's disease therapies and potential cures for this population. The Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS) is a large collaboration of researchers conducting clinical trials... Protocol #: 20-2692 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients with Advanced Solid Tumors
This is a Phase I/II trial with at least 17 patients in the dose escalation phase and 26-45 patients in the Phase II portion of the trial. In the Phase I portion of the trial, patients will receive EMB-02 at doses escalating from 6 to 900 mg IV once weekly. Following the evaluation of i... Protocol #: 20-2545 Location: Memorial Hospital Central, Memorial Hospital North |
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A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Participants who are Cisplatin-Ineligible Participants or Decline Cisplatin with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Protocol #: 20-2607 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.
Caregivers and patients must agree to participate. Caregivers are defined as people married to or partnered with cancer patients who play a role in the patient's treatment and personal care. The interventions will last 8-12 weeks and study participation will last 12 months. Caregivers in a... Protocol #: 20-2458 Location: Department Specific Free Standing Clinic, Kaiser Permanente of Colorado, University of Colorado Hospital |
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The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study
This is a non-treatment study that uses a blood test ("Prospera") to measure kidney function following transplant. This study will look at the usefulness of the Prospera testing compared to the usual serum creatinine testing done at regular intervals in kidney transplant recipients. ... Protocol #: 19-2394 Location: University of Colorado Hospital |
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Protocol A011-11 (STELLAR): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Protocol #: 20-2581 Location: University of Colorado Hospital |
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A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)
Protocol #: 20-2471 Location: Childrens Hospital Colorado |
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S1823 - A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS
Protocol #: 20-2392 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
This study will be conducted in 2 sequential stages. You are being invited to participate in both stages of this study. The entire study period will be of approximately 39 months. Stage 1 (Phase 2b) will include approximately 315 patients and will consist of a screening period (about 2... Protocol #: 20-2433 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
Protocol #: 20-2082 Location: Childrens Hospital Colorado |
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A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer
Protocol #: 20-2279 Location: Lone Tree Medical Center, University of Colorado Hospital |
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A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS
Protocol #: 20-2036 Location: Brain Imaging Center (BIC), 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, University of Colorado Hospital |
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S1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Protocol #: 20-2084 Location: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune
Thrombocytopenia (ITP)
Protocol #: 20-2156 Location: Childrens Hospital Colorado |
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A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5)
Protocol #: 20-1026 Location: University of Colorado Hospital |
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S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab(NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
Protocol #: 20-2083 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
Protocol #: 20-1852 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT)
Protocol #: 20-2150 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX)
Protocol #: 20-1907 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes
Participants 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, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes
This randomized control trial examines differences in glycemia and insulin sensitivity, acute and 1-month glucose fluctuations and 1-month glucose disposal pathways between two physical activity strategies: BREAK and ONE. The BREAK strategy consists of 5-minute bouts of brisk walking perf... Protocol #: 20-1900 Location: Outpatient CTRC, University of Colorado Hospital |
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3
Aerobic exercise is a vital treatment for people living with Parkinson's disease. Although anti-parkinsonian medication helps alleviate Parkinson's symptoms, it is not known to slow the rate of disease progression. Aerobic exercise is a treatment with the most compelling evidence for its p... Protocol #: 20-1854 Location: Outpatient CTRC, University of Colorado Hospital |
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A221805: Duloxetine To Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IITo Phase III Study
Protocol #: 20-1705 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)
This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints ... Protocol #: 19-1226 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)
Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable... Protocol #: 20-1690 Location: University of Colorado Hospital |
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Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy
This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a... Protocol #: 20-1074 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Se status, absorption and outcomes in infants born between 22-28 weeks gestation
Neonates born between 22-28 weeks completed gestational age (cGA) are at high risk for complications of prematurity that impair long term health. Optimizing nutrition in extremely preterm infants can provide an effective and inexpensive modification to neonatal care with potential lifelong... Protocol #: 20-1260 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
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A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus
Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be ... Protocol #: 20-1641 Location: University of Colorado Hospital |
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A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (mRNA-1273-P301)
Protocol #: 20-1619 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers
This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. ... Protocol #: 20-1399 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
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Embolization of the Middle Meningeal Artery with ONYX(TM) Liquid Embolic System in the Treatment of Subactue and Chronic Subdural Hematoma (EMBOLISE)
The purpose of this study is to evaluate the safety (short and long term side effects) and effectiveness (how well it helps) of Onyx Liquid Embolic System(LES) (study device) embolization of the middle meningeal artery when used in addition to the standard treatment that is used to treat a... Protocol #: 20-1390 Location: University of Colorado Hospital |
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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 and IO-202 Plus Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients
Protocol #: 20-1388 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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EA1181 (CompassHER2 pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response
Protocol #: 20-1318 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the ... Protocol #: 20-1341 Location: University of Colorado Hospital |
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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn... Protocol #: 20-1262 Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital |
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Colorado Nurses Experience with COVID-19
The purpose of the study is to find out the experiences of nurses who cared or prepared to care for COVID-19 patients. If you join the study you will help us learn about what nurses are going through during this pandemic time. You will provide insight to how nurses can improve or change th... Protocol #: 20-6039 Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver (Inverness), UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital, Yampa Valley Medical Center |
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Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event
The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). ... Protocol #: 20-6019 Location: Memorial Hospital Central |
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Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
This study is designed to collect a repository of resting phase signals from eligible subjects prior to right heart catheterization using the Phase Signal Recorder (PSR) for the purpose of development, testing and optimization of algorithms in the general population. ... Protocol #: 20-6505 Location: Memorial Hospital Central, Memorial Hospital North |
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A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Protocol #: 20-0884 Location: Highlands Ranch Hospital, Lone Tree Medical Center, 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 ISN/RPS 2003 Class III or IV Lupus Nephritis
After a screening period of up to 28 days, eligible subjects will be randomized to receive blinded infusions of obinutuzumab 1000 mg or placebo on Day 1, and weeks 2,24,26,50,52 in three treatment groups. and will be assessed at week 76. Neither the subject or study staff will know which t... Protocol #: 20-0941 Location: Outpatient CTRC, University of Colorado Hospital |
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A Prospective Observational Cohort Trial of outcomes and antibody responses following treatment with High-Titer Anti-SARS-CoV-2 in hospitalized COVID-19 patients.
Protocol #: 20-0986 Location: Denver Health and Hospital Authority, Grandview Hospital, Greeley Campus, Highlands Ranch Hospital, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, St. Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center |
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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, Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patientreported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy (COMB157G23101)
Protocol #: 20-0705 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A randomized, two condition, crossover trial assessing appetite, energy metabolism, blood biomarker and ad libitum food intake responses to a mid-morning pecan snack vs. an equicaloric high carbohydrate savory snack in healthy volunteers with overweight/obesity.
Protocol #: 20-0048 Location: Anschutz Health and Wellness, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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The early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy
What Happens If I Join the Study? - You will have 4 study visits during pregnancy and 1 study visit after your baby is born - You will be asked to prick your finger to monitor blood sugar and blood triglyceride levels 4 times a day for 4 days after each visit (total of 64 finger pokes) ... Protocol #: 20-0706 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC |
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A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188-MS-101
Protocol #: 20-0454 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A PHASE 3, RANDOMIZED, DOUBLE- OR OBSERVER-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
Protocol #: 20-0481 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
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The effects of hormone therapy on renal hemodynamic function in transgender youth
One screening visit to see if you are eligible to participate, then one study visit prior to starting testosterone or estradiol and one study visit 3 months later. ... Protocol #: 20-0572 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC |
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S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"
Protocol #: 20-0359 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c... Protocol #: 20-0288 Location: University of Colorado Hospital |
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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, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective o... Protocol #: 20-0254 Location: University of Colorado Hospital |
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ACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 12 months in prepubertal children with achondroplasia
Protocol #: 20-0142 Location: Childrens Hospital Colorado |
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ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Protocol #: 20-0052 Location: Childrens Hospital Colorado |
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Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations
Protocol #: 19-3063 Location: Boulder Health Center, Broomfield Hospital, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver (Inverness), UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital |
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The use of thoracic epidural, paravertebral nerve blockade and video-assisted intercostal nerve cryoablation for postoperative analgesia after minimally invasive repair of pectus excavatum
The study is to learn more about treating pain after having a minimally invasive repair of pectus excavatum while randomly assigning different pain methods that are typically used for this procedure.... Protocol #: 19-2794 Location: Childrens Hospital Colorado |
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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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A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (TRANSCEND FL)
Protocol #: 19-3011 Location: Lone Tree Medical Center, University of Colorado Hospital |
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A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and clinical benefit of AK002 in adult and adolescent patients with active and biopsy-proven EoE. Patients enrolled in the study will receive 6 infusions of placebo or... Protocol #: 19-3097 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AK002 in patients with EG and/or EoD who have an inadequate response with, lost response to, or were intolerant to standard therapies. Patients enrolled in the study... Protocol #: 19-3096 Location: University of Colorado Hospital |
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial Hypertension
Protocol #: 19-3001 Location: Childrens Hospital Colorado |
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A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the v... Protocol #: 19-2935 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A Multicenter, Comparative Safety and Efficacy Study of ACTHar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy
Each patient will undergo 12 months of treatment with 17 patients randomized to ACTHar gel alone (17 patients) or to ACTHar gel plus oral Tacrolimus (17 patients) Year 2: Follow up and observation for 12 months OFF ACTHar gel or ACTHar gel and Tacrolimus... Protocol #: 19-2902 Location: Renal Research Center, University of Colorado Hospital |
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A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabete... Protocol #: 19-2824 Location: Outpatient CTRC, University of Colorado Hospital |
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A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the st... Protocol #: 19-2782 Location: Brain Imaging Center (BIC), Outpatient CTRC, Renal Research Center, University of Colorado Hospital |
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EA3161: A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC
Protocol #: 19-2554 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid reg... Protocol #: 19-6129 Location: Harmony Campus, Medical Center of the Rockies |
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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, University of Colorado Hospital |
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Pharmacology of Marijuana During Pregnancy
This study will enroll pregnant women who use marijuana during their pregnancy and ask them to provide urine and blood samples at two prenatal visits. At delivery they will again be asked to provide blood and urine samples, the placenta, as well as blood from the baby's umbilical cord. Sur... Protocol #: 19-1757 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Effects of prenatal antibiotics on the infant gut microbiome
Three different bacteria of the infant gut microbiome will be obtained through collection of infant stool samples at birth and at 6 weeks of age. These bacteria will be measured and comparisons made between infants whose mothers took antibiotics during pregnancy and infants whose mothers d... Protocol #: 19-2288 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)
This study assesses whether Lungpacer therapy plus usual medical care can safely improve the chances of patients on a breathing machine to regain the ability to breathe on their own as compared to usual medical care alone. ... Protocol #: 19-2401 Location: University of Colorado Hospital |
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COMT Inhibition as a Potential Therapeutic Target Among Individuals with Comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder
This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and tw... Protocol #: 19-2335 Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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RADIANT:Rare and Atypical Diabetes Network
Protocol #: 19-2285 Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, Outpatient CTRC, Steadman Hawkins Clinic - Denver, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital |
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A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)
Protocol #: 19-6114 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health
This study will involve 4-5 in person visits. There will be screening visit for some patients and then a baseline visit over two days. The first day will involve an IV and drinking a sugary drink with blood draws as well as measuring the resting metabolic rate and answering questionnaires.... Protocol #: 19-2109 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS,
PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION
CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS
AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS
Protocol #: 19-2157 Location: Childrens Hospital Colorado |
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MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME
This study plans to learn more about lung health in children with Down syndrome. Sometimes children with Down syndrome breathe food or liquids into their lungs, which is called aspiration. We want to learn more about how aspiration affects the lungs and quality of life of children with Do... Protocol #: 19-2092 Location: Childrens Hospital Colorado |
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S1803: PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY)
Protocol #: 19-1589 Location: Rocky Mountain Regional VA Medical Center |
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Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D)... Protocol #: 19-1978 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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COG AHOD1822 / Merck MK-3475-667:
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)
Protocol #: 19-1481 Location: Childrens Hospital Colorado |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa... Protocol #: 19-1874 Location: University of Colorado Hospital |
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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Protocol #: 19-1727 Location: University of Colorado Hospital |
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Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with t... Protocol #: 19-1823 Location: University of Colorado Hospital |
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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction (LYNK-003)
Protocol #: 19-6102 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
Protocol #: 19-1634 Location: Childrens Hospital Colorado |
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A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
Protocol #: 19-1748 Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital |
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A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder
Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may... Protocol #: 19-1658 Location: Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome
This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receiv... Protocol #: 19-1362 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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APOL1 Long-term Kidney Transplantation Outcomes Network
APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a pros... Protocol #: 19-0461 Location: University of Colorado Hospital |
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A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV.... Protocol #: 19-1403 Location: Childrens Hospital Colorado |
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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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S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)
Protocol #: 19-1154 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A Two-year Prospective Natural History Study Examining the Use of Neuronal Injury Biomarkers in Autoimmune Encephalitis as a Potential Biomarker for Disease Activity and Severity
Protocol #: 19-0889 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado, Colorado Research Center, University of Colorado Hospital |
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The contributions of age related changes in the sound localization pathway to central hearing loss
This study plans to learn more about how age affects the way we process sounds we hear. If you join the study, you will come into our Auditory Lab on the Anschutz Medical Campus 4-6 times and complete hearing assessments and questionnaires. ... Protocol #: 19-1213 Location: Department Specific Free Standing Clinic |
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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3
Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for
Severe Cerebral Edema following Large Hemispheric Infarction
Protocol #: 19-0675 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS
This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimm... Protocol #: 19-0460 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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Sex-based differences in the neuronal mechanisms of food intake behavior
Participants will: -Complete 2 to 4 MRI scans -Complete food, attention, and mood questionnaires -Complete blood draws for measuring hormones -Receive a free Fitbit... Protocol #: 19-1148 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Cardiopulmonary and Right Ventricular Function in Health and Disease
The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as... Protocol #: 19-1141 Location: CTRC Inpatient, University of Colorado Hospital |
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Prevention of enamel demineralization in fixed appliance orthodontic patients using CPP-ACP-NaF varnish compared to blank varnish base. A randomized split mouth controlled clinical trial
The hypothesis is that casein phosphopeptide stabilized amorphous calcium phosphate fluoride releasing (CPP-ACP-NaF) dental varnish will be more effective at reducing enamel demineralization than the control varnish base that does not contain CPP-ACP-NaF. ... Protocol #: 19-0968 Location: Dental Clinic, UCD Dental Clinic |
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Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Protocol #: 19-0376 Location: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)
The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study.... Protocol #: 19-0636 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c... Protocol #: 19-0400 Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis
The purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, an... Protocol #: 19-0422 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Phase I trial of ribociclib in combination with everolimus and dexamethasone in children and young adults with relapsed acute lymphoblastic leukemia (DF/HCC Protocol#: 18-328)
Protoco |