|
ARROW study: Weight loss study
Research study looking at your body's response to dietary changes after completing a free weight loss program....more > Protocol #: 18-0091 |
|
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...more > Protocol #: 19-0546 |
|
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...more > Protocol #: 18-2607 |
|
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...more > Protocol #: 19-1423 |
|
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...more > Protocol #: 18-2258 |
|
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...more > Protocol #: 19-2323 |
|
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study for Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women
This study will look at the effect of Filgrastim on women who are menopausal and are experiencing hot flashes. We expect a reduction in the number of hot flashes the participants experience if they receive the study medication. ...more > Protocol #: 18-1254 |
|
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 • Do not h...more > Protocol #: 19-0856 |
|
Microfluidic models of bleeding and thrombosis
This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. ...more > Protocol #: 19-2408 |
|
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...more > Protocol #: 20-1672 |
|
Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients ?with Clinically Important Myocardial Dysfunction
This study plans to learn more about coronavirus infection in the heart. We wish to investigate whether the coronavirus that causes COVID-19 directly infects heart muscle tissue, and if so, how this might occur. The hope is that once we better understand how this process occurs, that we ma...more > Protocol #: 20-0852 |
|
Cannabis in Adolescents Study
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 the University of Colorado Hospital. You will be asked questions; complete questionnaires; and give urine, blood, ...more > Protocol #: 20-0553 |
|
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....more > Protocol #: 15-1774 |
|
Predictors of physical activity maintenance in colorectal cancer survivors
Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions....more > Protocol #: 18-2436 |
|
Birth Control Hormonal Injection/Shot Study
-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3...more > Protocol #: 19-2820 |
|
Birth Control Hormonal Pill Study
-9 visits over 13.5 months -Physical exam, pelvic exam -Trans-vaginal ultrasound, blood draws -Daily e-diary completion...more > Protocol #: 19-2895 |
|
Nexplanon Extension Trial Study
-11 visits over 27 months -Physical exam, pelvic exam, Pap smear (if needed), STI screening -Blood draws -Daily e-diary completion ...more > Protocol #: 20-2734 |
|
The effect of rifampin on etonogestrel concentrations in contraceptive implant users
-2 visits lasting 30 minutes -Visit includes a blood draw, pregnancy test, and vital measurements....more > Protocol #: 19-2829 |
|
Healthy Behaviors Study
How do childhood experiences shape health behaviors in adulthood? ...more > Protocol #: 20-0578 |
|
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...more > Protocol #: 20-1033 |
|
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....more > Protocol #: 17-0356 |
|
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...more > Protocol #: 20-2179 |
|
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...more > Protocol #: 16-2706 |
|
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. ...more > Protocol #: 20-2232 |
|
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...more > Protocol #: 16-1479 |
|
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 ...more > Protocol #: 20-1659 |
|
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...more > Protocol #: 21-3936 |
|
Effects of Your Genetics on the Contraceptive Implant (Nexplanon®)
1 visit lasting 30 minutes. Visit includes a questionnaire and a blood draw....more > Protocol #: 16-2462 |
|
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...more > Protocol #: 18-1317 |
|
University of Colorado Age-Related Macular Degeneration Registry
Do you have early or intermediate Age-Related Macular Degeneration (AMD)? If yes, you may be eligible to participate in our research study....more > Protocol #: 14-0740 |
|
Improving Sleep in Healthcare Providers: Effects of Bose Noise-Masking Sleepbuds (Better Sleep Research Study)
Study participants will: 1. Take part in 3 study phases lasting up to 10 days total, a baseline assessment, an at-home intervention, and a post-intervention visit 2. Collect sleep data remotely 3. Complete interviews and questionnaires 4. Get to keep the Bose Noise-Masking Sleepbuds...more > Protocol #: 21-2676 |
|
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 ...more > Protocol #: 21-3018 |
|
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...more > Protocol #: 21-3094 |
|
A Phase 3b/4, Double-masked, randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab Protocol Number: HZNP-TEP-402
Patients are “randomized” (assigned by chance) to receive one of the following study treatment lengths: • 4 infusions of TEPEZZA (teprotumumab) (Cohort [Group] 1), followed by either 4 infusions of TEPEZZA or 4 infusions of placebo (Placebo looks like the study drug, but does not inclu...more > Protocol #: 21-3831 |
|
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. ...more > Protocol #: 21-2624 |
|
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...more > Protocol #: 17-0585 |
|
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...more > Protocol #: 19-1103 |
|
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...more > Protocol #: 18-0520 |
|
The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function
Meibomian gland dysfunction (MGD) is a leading cause of dry eye symptoms. Warm compresses are a standard treatment recommended by physicians to treat patients diagnosed with MGD. Specifically, we will investigate whether the TearRestore™ mask affects Meibomian gland function and dry eye sy...more > Protocol #: 18-1960 |
|
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...more > Protocol #: 21-3622 |
|
Guided Breathing Sleep Study
A research study for those struggling to fall asleep due to interfering thoughts....more > Protocol #: 21-3977 |
|
A PROSPECTIVE FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF QR-1123 IN SUBJECTS WITH AUTOSOMAL DOMINANT RETINITIS PIGMENTOSA (adRP) DUE TO THE P23H MUTATION IN THE RHO GENE
Currently there is no approved treatment for Retinitis Pigmesntosa due to the P23H mutation. The study drug is designed to repair the problem that causes vision loss due to this mutation. ...more > Protocol #: 19-2294 |
|
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...more > Protocol #: 19-2383 |
|
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...more > Protocol #: 20-0130 |
|
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...more > Protocol #: 20-0637 |
|
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...more > Protocol #: 20-1186 |
|
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...more > Protocol #: 20-2477 |
|
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...more > Protocol #: 20-2835 |
|
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...more > Protocol #: 21-3923 |
|
Feasibility of VR Programs for Anxiety Related Disorders in an Outpatient Care Setting
For this project, semi-structured interviews will be conducted with up to 10 providers specializing in mental health care for adolescents and up to 20 adolescents, ages 14-18, with mild to moderate social anxiety symptoms. Adolescent interviews will focus on using the VR program and provi...more > Protocol #: 21-4407 Location: Department Specific Free Standing Clinic |
|
NRG-BN010: A SAFETY RUN-IN AND PHASE II STUDY EVALUATING THE EFFICACY, SAFETY, AND IMPACT ON THE TUMOR MICROENVIRONMENT OF THE COMBINATION OF TOCILIZUMAB, ATEZOLIZUMAB, AND FRACTIONATED STEREOTACTIC RADIOTHERAPY IN RECURRENT GLIOBLASTOMA
Protocol #: 21-4799 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
|
Impact of SomaSignal Tests on the choice of glucose-lowering medications: An Adaptive Implementation Study
This study plans to learn more about using a protein based test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients. The SomaSignal CVD-T2D Test is a specialized blood test that measures the levels of 27 different proteins i...more > Protocol #: 21-4510 Location: Outpatient CTRC |
|
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
For more information, please email the research team at alcoholstudy@ucdenver.edu or use the link to fill out the study contact information form: https://redcap.link/TrAIL_Lab For participating in the research study, you will be paid up to a total of $595.00. Payments will be pro-rated...more > Protocol #: 21-4460 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |
|
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 ...more > Protocol #: 21-4267 Location: Comprehensive Women's Health Center |
|
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 |
|
A Randomized, Placebo-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 |
|
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 ...more > Protocol #: 21-3870 Location: Childrens Hospital Colorado |
|
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 |
|
Clinical Evaluation of Daily Application of Nestorone? (NES) and Testosterone (T) Combination Gel for Male Contraception
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Population Council (PC) have a mission to develop safe and effective contraceptives for both men and women. Many women cannot use hormonal contraception and decide to rely on their male pa...more > Protocol #: 21-3956 Location: Comprehensive Women's Health Center |
|
Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double-blind placebo-controlled trial JHM IRB
To investigate the use of Orilissa to treat endometriosis prior to in-vitro fertilization procedures....more > Protocol #: 19-3115 Location: Outpatient CTRC |
|
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 |
|
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 |
|
A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma
Protocol #: 21-3617 Location: University of Colorado Hospital |
|
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 Location: Denver Health and Hospital Authority |
|
Impact of SARS CoV2 on Post-Hospital Recovery of Carbohydrate and Muscle Metabolism: Role of Endothelial Injury
Up to 6 in person visits with study staff and 3 virtual visits over 14 weeks. A variety of tests will occur including physical exams, blood draws, MRI scans, and tests called Oral Glucose Tolerance Test (OGTT), Sublingual Intravital Microscopy, Maximal Voluntary Contraction determination, ...more > Protocol #: 21-3711 Location: Denver Health and Hospital Authority, Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 21-2835 Location: Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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 |
|
PHASE 1/2a DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY
Protocol #: 21-3529 Location: Lone Tree Medical Center, University of Colorado Hospital |
|
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...more > Protocol #: 21-3116 Location: Childrens Hospital Colorado |
|
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...more > Protocol #: 21-3530 Location: Brain Imaging Center (BIC), Outpatient CTRC |
|
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF OTO-313 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL SUBJECTIVE TINNITUS
If you are to take part in this study, you would be able to come to the clinic for 6 visits which lasts about 110 days. Visit 1 (Screening) and 2 (Baseline) will have about the same procedures done: 1. We will ask about your demographics, medical history, and current medications and che...more > Protocol #: 21-3418 Location: University of Colorado Hospital |
|
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...more > Protocol #: 21-3447 Location: University of Colorado Hospital |
|
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) |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Premature Vascular Aging in Women following an In Vitro Fertilization Pregnancy
Main Procedures Involved: Ultrasound of blood vessels, blood draws, 24-hour blood pressure monitoring, sleep monitoring, body composition testing...more > Protocol #: 21-2903 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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....more > Protocol #: 20-3097 Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, University of Colorado Hospital |
|
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...more > Protocol #: 21-2876 Location: University of Colorado Hospital |
|
Using Oscillometry in Toddler Aerodigestive Patients to Monitor Lung Function Response to Treatment
This study plans to learn more about how a breathing test called oscillometry can help clinical care providers monitor lung health in young children. Oscillometry is an effort-independent lung function test that measures airway resistance and obstruction and lung stiffness during normal br...more > Protocol #: 21-2637 Location: Childrens Hospital Colorado |
|
Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children with Cow's Milk Allergy
This is a multi-center, randomized, double-blind, placebo-controlled food challenge (DBPCFC) to be conducted in infants or children with confirmed IgE-mediated cow’s milk allergy (CMA), followed by a 7-day open feeding of the experimental formula...more > Protocol #: 21-2701 Location: Childrens Hospital Colorado |
|
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 |
|
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 |
|
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...more > Protocol #: 21-2474 Location: Barbara Davis Center, University of Colorado Hospital |
|
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....more > Protocol #: 20-2825 Location: Childrens Hospital Colorado |
|
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. ...more > Protocol #: 20-3010 Location: Renal Research Center, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 20-2899 Location: Outpatient CTRC, University of Colorado Hospital |
|
Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function, skeletal muscle function by biopsy, MRIs, and exercise testing. Participants will then complete a 15 week exercise training program, and all testing will be repeated. There are 11 study visits total, and partici...more > Protocol #: 20-2723 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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. ...more > Protocol #: 20-2821 Location: Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 20-2720 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado |
|
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 |
|
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 |
|
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...more > Protocol #: 20-2692 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-2545 Location: Memorial Hospital Central, Memorial Hospital North |
|
A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Cisplatin-Ineligible Participants with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Protocol #: 20-2607 Location: Highlands Ranch Hospital, University of Colorado Hospital |
|
eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.
Caregivers and their patients must agree to participate. The interventions will last 8-10 weeks and study participation will 12 months. Caregivers in all 3 groups (TAU, Virtual-PEPRR, or Pep-Pal) will provide biomarker samples (hair and saliva) that they will collect themselves at home, to...more > Protocol #: 20-2458 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |
|
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. ...more > Protocol #: 19-2394 Location: University of Colorado Hospital |
|
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 |
|
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 |
|
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...more > Protocol #: 20-2433 Location: Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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 |
|
A single-arm, prospective, multi-center, study to explore maintained efficacy with ofatumumab therapy in patients with relapsing Multiple Sclerosis who discontinue
intravenously delivered anti-CD20 monoclonal antibody (aCD20 mAb) therapy (OLIKOS)
Protocol #: 20-2135 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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....more > Protocol #: 20-0593 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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 |
|
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 |
|
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Protocol #: 20-2167 Location: University of Colorado Hospital |
|
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 |
|
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 |
|
Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)
Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)...more > Protocol #: 20-2227 Location: Memorial Hospital Central, Memorial Hospital North |
|
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 |
|
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 |
|
Evaluation of Compensatory Reserve in Obstetrical Patients
A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....more > Protocol #: 14-1996 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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: University of Colorado Hospital |
|
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. ...more > Protocol #: 20-1681 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-1900 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-1854 Location: Outpatient CTRC, University of Colorado Hospital |
|
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
1. Women who desire a COC for contraception will be willing to initiate and continue an ENG implant as a continuous back-up method. 2. Women using a COC concomitantly with ENG implant will have low rates (<5%) of ENG discontinuation for bleeding complaints. 3. A high percentage of wome...more > Protocol #: 20-1945 Location: Comprehensive Women's Health Center |
|
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 |
|
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 ...more > Protocol #: 19-1226 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations
Protocol #: 20-1757 Location: Childrens Hospital Colorado |
|
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...more > Protocol #: 20-1690 Location: University of Colorado Hospital |
|
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Protocol #: 20-1555 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-1074 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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...more > Protocol #: 20-1260 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
|
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 ...more > Protocol #: 20-1641 Location: University of Colorado Hospital |
|
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. ...more > Protocol #: 20-1399 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-1390 Location: University of Colorado Hospital |
|
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Protocol #: 20-0746 Location: University of Colorado Hospital |
|
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 |
|
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 |
|
A prospective randomized trial of antibiotic duration in post-appendectomy abscess
Evaluating 8-day course and 4-day course of antibiotics at drainage for patients who develop a post-appendectomy abscess...more > Protocol #: 20-1008 Location: Childrens Hospital Colorado |
|
A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcome (OLIE)
Protocol #: 20-1210 Location: Childrens Hospital Colorado |
|
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 ...more > Protocol #: 20-1341 Location: University of Colorado Hospital |
|
AN OPEN-LABEL, SAFETY AND TOLERABILITY PHASE 1b TRIAL OF CAN04, A FULLY HUMANIZED ANTI-IL1RAP MONOCLONAL ANTIBODY, IN COMBINATION WITH PEMBROLIZUMAB IN SUBJECTS WITH SOLID TUMORS PROGRESSING ON PD-1/PD-L1 INHIBITOR-CONTAINING REGIMENS
Protocol #: 20-0605 Location: Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 20-1262 Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital |
|
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...more > 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, Long's 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 |
|
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). ...more > Protocol #: 20-6019 Location: Memorial Hospital Central |
|
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. ...more > Protocol #: 20-6505 Location: Memorial Hospital Central, Memorial Hospital North |
|
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 |
|
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...more > Protocol #: 20-0941 Location: Outpatient CTRC, University of Colorado Hospital |
|
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, Long's 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 |
|
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 |
|
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 |
|
The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections....more > Protocol #: 20-0751 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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, University of Colorado Hospital |
|
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 |
|
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 |
|
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. ...more > Protocol #: 20-0572 Location: Childrens Hospital Colorado, Outpatient CTRC |
|
A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)
Protocol #: 20-0589 Location: Outpatient CTRC, University of Colorado Hospital |
|
A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)
Protocol #: 20-0580 Location: Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
|
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene
Protocol #: 20-0346 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin
Protocol #: 20-0360 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
|
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...more > Protocol #: 20-0288 Location: University of Colorado Hospital |
|
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...more > Protocol #: 19-1526 Location: Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
|
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...more > Protocol #: 20-0254 Location: University of Colorado Hospital |
|
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 |
|
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 |
|
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, Long's 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 |
|
NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A PHASE III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB
Protocol #: 19-2514 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
|
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....more > Protocol #: 19-2794 Location: Childrens Hospital Colorado |
|
A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopaedic 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...more > Protocol #: 19-3107 Location: Medical Center of the Rockies |
|
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 |
|
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...more > Protocol #: 19-3097 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-3096 Location: University of Colorado Hospital |
|
A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T greater than 5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)
Protocol #: 19-3018 Location: Rocky Mountain Regional VA Medical Center |
|
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...more > Protocol #: 19-2935 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-2902 Location: Renal Research Center, University of Colorado Hospital |
|
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
Protocol #: 19-2721 Location: Highlands Ranch Hospital, University of Colorado Hospital |
|
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...more > Protocol #: 19-2824 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-2782 Location: Brain Imaging Center (BIC), Outpatient CTRC, Renal Research Center, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 19-6129 Location: Harmony Campus, Medical Center of the Rockies |
|
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...more > Protocol #: 19-2499 Location: Boulder Sports Clinic, CU Sports Medicine - Denver, University of Colorado Hospital |
|
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...more > Protocol #: 19-1757 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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...more > Protocol #: 19-2288 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
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. ...more > Protocol #: 19-2401 Location: University of Colorado Hospital |
|
Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)
CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard...more > Protocol #: 19-2362 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
|
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...more > Protocol #: 19-2335 Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
|
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, Steadman Hawkins Clinic - Denver, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital |
|
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 |
|
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....more > Protocol #: 19-2109 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 19-2092 Location: Childrens Hospital Colorado |
|
Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts th...more > Protocol #: 17-0464 Location: Childrens Hospital Colorado |
|
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 |
|
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)...more > Protocol #: 19-1978 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors
Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compen...more > Protocol #: 19-1974 Location: Outpatient CTRC, University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 19-1874 Location: University of Colorado Hospital |
|
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 |
|
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...more > Protocol #: 19-1823 Location: University of Colorado Hospital |
|
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 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX wit Bevacizumab (LYNK-003)
Protocol #: 19-6102 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
|
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation...more > Protocol #: 19-6101 Location: Harmony Campus, Medical Center of the Rockies |
|
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 |
|
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 |
|
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...more > Protocol #: 19-1658 Location: Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-1362 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-0461 Location: University of Colorado Hospital |
|
A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.
Protocol #: 19-1337 Location: Lone Tree Medical Center, University of Colorado Hospital |
|
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....more > Protocol #: 19-1403 Location: Childrens Hospital Colorado |
|
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...more > Protocol #: 19-0619 Location: Childrens Hospital Colorado |
|
reST Registry
remede System Therapy in patients with central sleep apnea...more > Protocol #: 19-6087 Location: Harmony Campus, Medical Center of the Rockies |
|
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Protocol #: 19-1152 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 |
|
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 |
|
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 |
|
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. ...more > Protocol #: 19-1213 Location: Department Specific Free Standing Clinic |
|
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 |
|
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...more > Protocol #: 19-0460 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
|
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...more > Protocol #: 19-1148 Location: Outpatient CTRC, University of Colorado Hospital |
|
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...more > Protocol #: 19-1141 Location: CTRC Inpatient, University of Colorado Hospital |
|
A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer
Protocol #: 19-6065 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
|
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. ...more > Protocol #: 19-0968 Location: Dental Clinic, UCD Dental Clinic |
|
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Protocol #: 19-0905 Location: Lone Tree Medical Center, University of Colorado Hospital |
|
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 |
|
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....more > Protocol #: 19-0636 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
|
Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and,
harmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from 1 month to < 18 years of age with
heart failure due to systemic left ventricle systolic dysfunction
Protocol #: 16-0994 Location: Childrens Hospital Colorado |
|
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...more > Protocol #: 19-0400 Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
|
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...more > Protocol #: 19-0422 Location: Childrens Hospital Colorado, University of Colorado Hospital |
|
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D)
Protocol #: 19-0489 Location: Barbara Davis Center, Outpatient CTRC, UCD Barbara Davis Center, University of Colorado Hospital |
|
ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics
The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cy...more > Protocol #: 19-0510 Location: Outpatient CTRC, University of Colorado Hospital, University of Pittsburgh Cancer Institute |
|
AMPLATZERTM PFO Occluder Post
Approval Study
This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting...more > Protocol #: 19-6502 Location: Memorial Hospital Central |
|
SANDIA: Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control
This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline to controller therapy in obese late onset asthmatics: a) improves asthma control, and b) increases FeNO levels. Secondary research questions are to determine if L-citrull...more > Protocol #: 19-0219 Location: Outpatient CTRC, University of Colorado Hospital |
|
Total Joint Arthroplasty in a Pediatric Population
Involves two surveys for approximately 10 mintues...more > Protocol #: 19-0306 Location: Childrens Hospital Colorado |
|
A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale
Protocol #: 19-0396 Location: Childrens Hospital Colorado |
|
SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.
This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks. ...more > Protocol #: 19-0347 Location: University of Colorado Hospital |
|
LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Protocol #: 19-0267 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 |
|
Multiomics Investigation of Marijuana Use
This research study seeks to learn more about biomarkers and biological pathways associated with marijuana use. We are enrolling adults who are marijuana users or non-users. The study involves filling out online surveys and one on-campus visit to give a blood, urine, and hair sample. If yo...more > Protocol #: 18-0853 Location: Outpatient CTRC, University of Colorado Hospital |
|
Phase 1/2 Study to Evaluate The Safety and Pharmacokinetics of Palbociclib (Ibrance?) in Combination With Irinotecan And Temozolomide or in Combination With Topotecan and Cyclophosphamide in Pediatric Patients With Recurrent or Refractory Solid Tumor
Protocol #: 19-0299 Location: Childrens Hospital Colorado |
|
|
|
GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting....more > Protocol #: 19-6030 Location: Harmony Campus, Medical Center of the Rockies |
|
Gene Expression of Cerebral Aneurysms
In this study, we will collect tissue and blood from participants during their epilepsy surgery. ...more > Protocol #: 19-0182 Location: University of Colorado Hospital |
|
Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ...more > Protocol #: 19-0149 Location: Renal Research Center, University of Colorado Hospital |
|
ULTRA-T2D Study: Uric acid lowering trial in youth onset T2D
This is a pilot study evaluating the effect of uric acid lowering by a single dose of pegloticase (a uricase) on markers of cardiovascular and renal health in ten young men ages 18-25 years with youth-onset type 2 diabetes (diagnosed at less than 21 years of age) over 7 days. Previous rese...more > Protocol #: 18-1700 Location: Childrens Hospital Colorado |
|
The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER
Protocol #: 18-2604 Location: University of Colorado Hospital |
|
CLINICAL TRIALS IN ORGAN TRANSPLANTATION
CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation
This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the ...more > Protocol #: 18-2679 Location: Outpatient CTRC, University of Colorado Hospital |
|
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Protocol #: 18-2692 Location: University of Colorado Hospital |
|
A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study dru...more > Protocol #: 18-6511 Location: Memorial Hospital Central |
|
Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab
Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase ...more > Protocol #: 18-2286 Location: Childrens Hospital Colorado |
|
Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018
This research study is investigating the roles of estrogen (female sex hormone) and FSH, or follicle-stimulating hormone, on cortisol (a stress hormone), fat gain, and disease risk....more > Protocol #: 18-2483 Location: Outpatient CTRC, University of Colorado Hospital |
|
Destination Therapy Post Approval Study - Medtronic HVAD System
LVAD registry...more > Protocol #: 18-2576A Location: University of Colorado Hospital |
|
Ultrarapid Culture Independent Identification and Antibiotic Suspectibility Testing of High-Priority Carbapenem Resistant Enterobacteriaceae Directly from Blood and Urine in Patients with Suspected Bacteremia V: 02 Feb 2017
Protocol #: 16-0086 Location: Outpatient CTRC, University of Colorado Hospital |
|
A Phase 3, randomized, double-blind, parallel group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.
Protocol #: 18-2534 Location: University of Colorado Hospital |
|
A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.
Protocol #: 18-1223 Location: Childrens Hospital Colorado |
|
Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer
Protocol #: 18-2209 Location: University of Colorado Hospital |
|
PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations
This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dos...more > Protocol #: 18-2432 Location: Childrens Hospital Colorado |
|
Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naive
Protocol #: 18-2284 Location: University of Colorado Hospital |
|
PHASE 1/2 DOSE ESCALATION AND PRELIMINARY EFFICACY OF CD19 DIRECTED CAR T CELLS GENERATED USING THE MILTENYI CLINIMACS PRODIGY SYSTEM (UCD19 CART) IN PEDIATRIC PATIENTS WITH REPLASED AND/OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) AND B-CELL NON-HODGKIN'S LYMPHOMA (B-NHL)
Protocol #: 18-2424 Location: Childrens Hospital Colorado |
|
S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER
Protocol #: 18-2252 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
|
Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Protocol #: 18-2337 Location: Childrens Hospital Colorado |
|
Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)
Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery. ...more > Protocol #: 18-2012 Location: Childrens Hospital Colorado |
|
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who...more > Protocol #: 18-2298 Location: University of Colorado Hospital |
|
CU Faces of Hope-Genetics of Craniofacial and Dental Development Research Study
This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors ...more > Protocol #: 18-1916 Location: Childrens Hospital Colorado |
|
Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)
The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determin...more > Protocol #: 18-2129 Location: Medical Center of the Rockies, Memorial Hospital Central, University of Colorado Hospital |
|
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula Repair
Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure....more > Protocol #: 18-1823 Location: Childrens Hospital Colorado |
|
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red blood cells in Subjects undergoing Complex Cardiac Surgery Procedures (the ReCePI study)
Protocol #: 18-2032 Location: University of Colorado Hospital |
|
PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High-Dose Inhaled Corticosteroid plus Long-acting 946;2 Agonist and Chronic Oral Corticosteroid Therapy
This is an open-label, multicenter study designed to evaluate the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of a 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks (Q4W) up until the third dose of benralizumab and then every 8...more > Protocol #: 18-1978 Location: Outpatient CTRC, University of Colorado Hospital |
|
A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative
Protocol #: 18-1893 Location: Childrens Hospital Colorado |
|
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years. ...more > Protocol #: 18-1795 Location: Colorado Research Center, Renal Research Center |
|
A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study
Protocol #: 18-1336 Location: University of Colorado Hospital |
|
A 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group,
Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 ig Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase
Protocol #: 18-1445 Location: Childrens Hospital Colorado |
|
An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects 1 and 30 Years of Age with Relapsed/Refractory Precursor B-cell or T-cell Acute Lympholastic Leukemia or Lymphoblastic Lymphoma
Protocol #: 18-0867 Location: Childrens Hospital Colorado |
|
AN OPEN-LABEL, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON HODGKIN LYMPHOMA
Protocol #: 18-1439 Location: Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
|
VA Protocol: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Adults diagnosed with schizophrenia are needed for a clinical trial to learn more about how a new medication may affect the brain. Study participants will complete MRI scans, clinical interviews, and cognitive tests. Duration of participation: 14 weeks. Participants will be compensated for...more > Protocol #: 16-1831 Location: Outpatient CTRC, University of Colorado Hospital |
|
The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compa...more > Protocol #: 18-1297 Location: University of Colorado Hospital |
|
Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
Protocol #: 18-1137 Location: University of Colorado Hospital |
|
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)
This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting...more > Protocol #: 18-1003 Location: Outpatient CTRC, University of Colorado Hospital |
|
A study of the genetics of pulmonary fibrosis
This study plans to learn more about pulmonary fibrosis and determine if some diseases that cause scarring in the lung might be inherited diseases. We are especially interested in the genetics of pulmonary fibrosis and cases where it might run in families. What we learn may be helpful in...more > Protocol #: 15-1147 Location: University of Colorado Hospital |
|
PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another ...more > Protocol #: 18-0761 Location: University of Colorado Hospital |
|
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")
Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site hea...more > Protocol #: 18-0505 Location: University of Colorado Hospital |
|
A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer
This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. ...more > Protocol #: 18-0567 Location: Fox Chase Cancer Center, University of Colorado Hospital, University of Pennsylvania, University of Pittsburgh Cancer Institute |
|
Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at we...more > Protocol #: 17-2349 Location: Outpatient CTRC, University of Colorado Hospital |
|
Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherence
Protocol #: 18-0715 Location: University of Colorado Hospital |
|
Narcotic consumption in discectomies: microscopic versus endoscopic
In this study a member of the study team will review consenting patient's medical records at pre-op, spine surgery, recovery, follow up visits at 3 months and 12 months...more > Protocol #: 18-0830 Location: University of Colorado Hospital |
|
PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)
This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function....more > Protocol #: 18-0637 Location: Outpatient CTRC, University of Colorado Hospital |
|
Defining Molecular Phenotypes of Exacerbation-Prone Asthmatics (ENIGMA)
We want to learn more about asthma and how stuff in the air, like pollution and allergens, can make asthma worse in children. To do this we want to look at kids with and without asthma. If you join the study, you will participate in a remote consent visit, a clinic visit and a remote home...more > Protocol #: 17-1416 Location: Childrens Hospital Colorado |
|
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)
Protocol #: 18-0461 Location: Childrens Hospital Colorado |