Your search for "All Studies" found 996 matches:
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Protocol #: 19-1113

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

Sex effects on the neurobiology of eating behaviors in Veterans with overweight/obesity

Protocol #: 19-0940

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

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Protocol #: 20-0124

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

Cerebrovascular Function in CKD and ADPKD: A Cross-Sectional Study

Protocol #: 17-2135

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

Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balance

Protocol #: 19-2960

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

Study on the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients with High Potassium and Metabolic Acidosis Due to Chronic Kidney Disease (NEUTRALIZE)

Protocol #: 21-2470

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

The effects of cardiorespiratory fitness, physical activity and sedentary behavior on insulin resistance among breast cancer survivors being treated with anti-estrogen endocrine therapies.

Protocol #: 21-3245

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

Single Patient Treatment for Stryker Orthopaedics' Right Flanged Acetabular Cup with Locking Screws and GMRS to Restoration Modular Adapter for treatment of failed acetabular reconstruction in patient L.A.

Protocol #: 22-0150

Location: University of Colorado Hospital

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

Single Patient IDE for the Use of Atrial Flow Regulator (AFR) in patient JT (U210464)

Protocol #: 21-4942

Location: Childrens Hospital Colorado

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

An Evaluation of Recurrent Clostridiodes Difficile Infections in Lung and Heart Transplant Recipients Who Received Secondary Prophylaxis with Vancomycin or Fidaxomicin

Protocol #: 21-4519

Effects of SGLT2 inhibition on early diabetic kidney disease: interrogation of renal energetics by functional imaging and single-cell transcriptomics- an ancillary study to the ATTEMPT trial (COMIRB #19-2947)

Protocol #: 21-4373

Location: Childrens Hospital Colorado

PANDEMIC RESPONSE REPOSITORY - MICROBIAL AND IMMUNE SURVEILLANCE AND EPIDEMIOLOGY (PREMISE): ENTEROVIRUS D68 (EV-D68) PILOT STUDY

Protocol #: 21-3488

Location: Childrens Hospital Colorado

PICCOLO: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Protocol #: 21-4369

Location: 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

Temporally Optimized Patterned Stimulation for use with Medtronic Activa DBS System.

Protocol #: 21-4042

Location: University of Colorado Hospital

Using intracranial recordings to study the role of the piriform cortex in epilepsy.

Protocol #: 21-3827

Location: University of Colorado Hospital

Evaluation of COVID-19 humoral and cellular immune response in immunosuppressed patients with autoimmune neurological conditions

Protocol #: 21-4092

Location: Department Specific Free Standing Clinic, University of Colorado Hospital

Hypocalcemia, acidosis, and coagulopathy in trauma: a retrospective analysis

Protocol #: 21-4131

Location: University of Colorado Hospital

SPHERES Neuromyelitis Optica Spectrum Disorder (NMOSD) Registry

Protocol #: 21-3763

Location: University of Colorado Hospital

Young Women's Breast Cancer Awareness and Survivorship Needs in Underserved Communities

Protocol #: 21-3898

Location: Cherry Creek Medical Center, Lone Tree Medical Center, University of Colorado Hospital

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

An Open-Label, Multicenter, Phase 1a Study of AN2025 and AN0025 in Double Combination with Atezolizumab and in Triple Combination with Atezolizumab in Patients with Advanced Solid Tumors

Protocol #: 21-4026

Location: University of Colorado Hospital

Single Patient IDE for the use of Custom Made Covered Stent for patient RW

Protocol #: 21-4007

Location: Childrens Hospital Colorado

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

EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Protocol #: 21-3855

Location: Highlands Ranch Hospital, University of Colorado Hospital

Single Patient Protocol for Bacteriophage Treatment of Mycobacteria abscessus Through An Investigational New Drug Application (IND) in pt JLJ

Protocol #: 21-3934

Location: 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

Single patient compassionate use for treatment with patient-specific ulna prosthesis in patient TM

Protocol #: 21-3948

Location: University of Colorado Hospital

This is our 2020R3 upgrade testing protocol

Protocol #: X21-9999

Location: Barbara Davis Center, Childrens Hospital Colorado, Department Specific Free Standing Clinic

NRG-CC009: Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer

Protocol #: 21-3608

Location: Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

Characterization of SARS-CoV-2 Immune Responses Among Persons Living with HIV (PWH)

Protocol #: 21-3832

Location: Outpatient CTRC, University of Colorado Hospital

Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Protocol #: 21-3574

Location: University of Colorado Hospital

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

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in subjects with Acute Traumatic Cervical Spinal Cord Injury

Protocol #: 21-3382

Location: University of Colorado Hospital

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

Single Patient IND for the Emergency use of Atrial Flow Regulator (AFR) in a patient with severe pulmonary hypertension - Patient KP

Protocol #: 21-3829

Location: Childrens Hospital Colorado

Decision making for urinary diversion in patients with bladder cancer

Protocol #: 21-3661

Location: 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

Influence of NT5c1A antibodies on disease progression, clinical phenotype and blood and muscle biomarkers in sporadic Inclusion Body Myositis - A prospective evaluation

Protocol #: 21-3383

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

Personalized seizure detection: leveraging wearable sensor data from the epilepsy monitoring unit to guide detection device recommendations

Protocol #: 21-3405

Location: University of Colorado Hospital

BIOREPOSITORY FOR CENTRAL VEIN SIGN: A DIAGNOSTIC BIOMARKER IN MULTIPLE SCLEROSIS

Protocol #: 21-3715

Location: 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

Intravascular access in hypotensive trauma patients: an Eastern Association for the Surgery of Trauma multicenter prospective observational trial using trauma video review

Protocol #: 21-3676

Location: University of Colorado Hospital

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics

Protocol #: 21-3590

Location: Outpatient CTRC, University of Colorado Hospital

Phase 1/1b Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients with Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)

Protocol #: 21-2578

Location: 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

A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients with Advanced Solid Tumors

Protocol #: 21-3561

Location: University of Colorado Hospital

A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer

Protocol #: 21-3585

Location: University of Colorado Hospital

Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Protocol #: 21-3576

Location: University of Colorado Hospital

Impact of quantitative measurements of postoperative activity on clinical outcomes

Protocol #: 21-3611

Location: University of Colorado Hospital

Evaluating a New Gonadotoxic Risk Stratification System

Protocol #: 21-3084

Location: Childrens Hospital Colorado, 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

Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

Protocol #: 21-3534

Location: Outpatient CTRC, University of Colorado Hospital

Advanced Planning for Online Accounts and Data

Protocol #: 21-3375

Location: 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

A Phase 1/2 study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Subjects with ALK+ Advanced or Metastatic NSCLC

Protocol #: 21-3413

Location: 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

Phase II Study of Radiotherapy in Combination with Chemotherapy and Immunotherapy in Patients with PD-L1-Positive Metastatic Triple-Negative Breast Cancer

Protocol #: 21-3117

Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy

Protocol #: 21-3416

Location: University of Colorado Hospital

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

Identifying novel therapeutic targets in MCTO by unbiased proteomics of patient plasma

Protocol #: 21-3367

Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic

A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

Protocol #: 21-3431

Location: University of Colorado Hospital

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA

Protocol #: 21-3370

Location: University of Colorado Hospital

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

Protocol #: 20-3007

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

ELEVATE 2 (RVT-1201-2002): A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension

Protocol #: 21-3433

Location: Outpatient CTRC, University of Colorado Hospital

Mama Brain Study

Protocol #: 21-3266

Location: Childrens Hospital Colorado, University of Colorado Hospital

ICU Provider Perceptions Surrounding TBI and Trauma Oxygenation

Protocol #: 21-3428

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 Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

Protocol #: 21-3366

Location: University of Colorado Hospital

A071702 A PHASE II STUDY OF CHECKPOINT BLOCKADE IMMUNOTHERAPY IN PATIENTS WITH SOMATICALLY HYPERMUTATED RECURRENT GLIOBLASTOMA

Protocol #: 21-3021

Location: University of Colorado Hospital

A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Protocol #: 21-3254

Location: Outpatient CTRC, University of Colorado Hospital

A091902 - A MULTICENTER PHASE II TRIAL OF PACLITAXEL WITH AND WITHOUT NIVOLUMAB IN TAXANE NAIVE, AND NIVOLUMAB AND CABOZANTINIB IN TAXANE PRETREATED SUBJECTS WITH ANGIOSARCOMA

Protocol #: 20-3096

Location: University of Colorado Hospital

S2000 - A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab Vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma with Brain Metastases

Protocol #: 21-2584

Location: University of Colorado Hospital

A Phase 1, First-in-human Study of the Safety, Single- and Multiple-Dose Pharmacokinetics, and Preliminary Activity of Escalating Doses of RBN-2397, an Oral PARP7 Inhibitor, in Patients with Solid Tumors

Protocol #: 21-3286

Location: University of Colorado Hospital

Therapeutics for Severely ill Inpatients with COVID-19

Protocol #: 21-3177-DH

Location: Denver Health and Hospital Authority

A North American study of the digestive manifestations of COVID-19-II

Protocol #: 21-3335

Location: University of Colorado Hospital

Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis

Protocol #: 21-3289

Location: CTRC Inpatient, University of Colorado Hospital

Observational Protocol: Trametinib therapy for Symptomatic Patients with RAS/MAPK-Pathway Mutation-Positive Disorders

Protocol #: 21-3183

Location: Childrens Hospital Colorado

ALLFTD: ARTFL-LEFFTDS LONGITUDINAL FRONTOTEMPORAL LOBAR DEGENERATION

Protocol #: 21-2833

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

Cognitive Outcomes for medium-giant sub-frontal meningiomas after a unilateral tailored approach

Protocol #: 21-3166

Location: University of Colorado Hospital

Effect of Electrical Posterior Wall Isolation on Left Atrial Ejection Fraction

Protocol #: 21-2651

Location: Harmony Campus, Medical Center of the Rockies, Poudre Valley 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

First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors

Protocol #: 21-3039

Location: University of Colorado Hospital

A Phase 1 Study of RTX-321 for the Treatment of Patients with Advanced Malignancies Associated with Human Papillomavirus-16 Infection

Protocol #: 21-3219

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Anti-PD-1 in Patients with Metastatic Solid Tumors

Protocol #: 20-2976

Location: University of Colorado Hospital

Comparative analysis of radiographical and clinical outcomes after cervical disc replacement with Mobi-C and M6-C implants

Protocol #: 21-3236

Location: Highlands Ranch Hospital, Memorial Hospital North, University of Colorado Hospital

THE EVALUATION OF IMMUNE RESPONSES TO SARS-COV-2 MRNA VACCINES IN MULTIPLE SCLEROSIS PATIENTS ON OCRELIZUMAB

Protocol #: 21-3126

Location: Outpatient CTRC, University of Colorado Hospital

Pediatric Polyposis Syndromes

Protocol #: 20-2981

Location: Childrens Hospital Colorado

Communication and Knowledge of Palliative Care for Older LGBT Adult Dyads and Palliative Care Clinicians

Protocol #: 21-3134

Location: Highlands Ranch Hospital, University of Colorado Hospital

AN OPEN-LABEL, PHASE 1b/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FRUQUINTINIB IN COMBINATION WITH TISLELIZUMAB IN PATIENTS WITH ADVANCED TRIPLE NEGATIVE BREAST CANCER

Protocol #: 21-3064

Location: Lone Tree Medical Center, University of Colorado Hospital

A retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe PROVE (Retrospective Cefiderocol Chart Review Study)

Protocol #: 21-3197

Location: University of Colorado Hospital

Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)

Protocol #: 20-3013

Location: Outpatient CTRC, University of Colorado Hospital

Evaluating Factors Predicting the Efficacy of Brief Parenting Group for Children's Behavioral Concerns

Protocol #: 21-3184

Location: Childrens Hospital Colorado

Opioid modulation and neural reward activation in healthy adults

Protocol #: 21-2886

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

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

Seroprevalence and Sequence Variants of SARS-CoV-2 in children.

Protocol #: 21-3118

Location: Childrens Hospital Colorado

A Phase 1b, Open-Label, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults (Aged 18-31 Years) with Complex Lymphatic Malformations

Protocol #: 21-3050

Location: Childrens Hospital Colorado

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

A Randomized Phase II Trial of Cabozantinib Combined with PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma

Protocol #: 21-2726

Location: University of Colorado Hospital

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

Protocol #: 21-2951

Location: 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

Characteristics, interventions, and responses to treatment of sexual concerns in women seen at the Women's Sexual Health Consultation Service at University of Colorado School of Medicine

Protocol #: 21-2834

Location: CU Advanced Reproductive Medicine (Denver), University of Colorado Hospital

Implementation of a novel protocol to measure hypothalamic insulin sensitivity in vivo in human adults

Protocol #: 21-2939

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

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

S1914 A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Protocol #: 21-2852

Location: Rocky Mountain Regional VA Medical Center

Hip Morphological and Biochemical Changes after Long-Term Prosthesis Use

Protocol #: 21-2919

Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, University of Colorado Hospital

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Protocol #: 20-2832

Location: 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

Exploring barriers to and improving the quality of parental updates in the Neonatal Intensive Care Unit

Protocol #: 20-2966

Location: Childrens Hospital Colorado

CMV and CMV-Immune Responses in Geriatric Conditions Post-Kidney Transplant (CMV-GeriKT)

Protocol #: 21-2602

Location: Outpatient CTRC

HAI Consortium Research Network: Registry of Hepatic Artery Infusion (HAI)

Protocol #: 21-2794

Location: Highlands Ranch Hospital, University of Colorado Hospital

PEPN1924: A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# TBD) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA

Protocol #: 21-2749

Location: Childrens Hospital Colorado

A PHASE 2, MULTICENTER, RANDOMIZED STUDY OF TRASTUZUMAB ERUXTECAN IN HER2-MUTATED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) [DESTINY-LUNG02]

Protocol #: 21-2686

Location: Outpatient CTRC, University of Colorado Hospital

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device

Protocol #: 20-3160

Location: Harmony Campus, Medical Center of the Rockies

Human intravenous Interferon Beta-Ia Safety and preliminary efficacy in hospitalized subjects with CoronavirUS (HIBISCUS)

Protocol #: 21-2690

Location: Outpatient CTRC, University of Colorado Hospital

Double blind randomized trial of post-operative cesarean continuous infusion of bupivacaine for local incisional pain control

Protocol #: 21-2810

Location: Childrens Hospital Colorado

Shwachman Diamond Syndrome Registry and Study

Protocol #: 20-3174

Location: Childrens Hospital Colorado

A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

Protocol #: 20-3032

Location: Outpatient CTRC, 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

REMODEL - Renal mode of action of semaglutide in patients with type 2 diabetes and chronic kidney disease

Protocol #: 21-2645

Location: Barbara Davis Center, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

A Phase II study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Protocol #: 21-2687

Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

A PHASE 1 OPEN-LABEL STUDY OF KPT-9274 IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE MYELOID LEUKEMIA

Protocol #: 20-2350

Location: Lone Tree Medical Center, University of Colorado Hospital

A PHASE 3, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RELDESEMTIV IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

Protocol #: 21-2598

Location: University of Colorado Hospital

Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression on a PD-1 Inhibitor

Protocol #: 21-2670

Location: Outpatient CTRC, University of Colorado Hospital

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex Performer (The Leaflex Early Feasibility Study)

Protocol #: 20-3164

Location: Harmony Campus, Medical Center of the Rockies

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

A RANDOMIZED, PARALLEL-ARM, ACTIVE CONTROL, MULTICENTER STUDY ASSESSING THE SAFETY AND EFFICACY OF DEXTENZA? FOR THE TREATMENT OF OCULAR PAIN AND INFLAMMATION FOLLOWING SURGERY FOR PEDIATRIC ATARACT

Protocol #: 21-2605

Location: Childrens Hospital Colorado

Multicentric Carpotarsal Osteolysis (MCTO): Natural History Study

Protocol #: 21-2606

Location: Childrens Hospital Colorado

Mind Body Balance for Pediatric Migraine

Protocol #: 21-2568

Location: Childrens Hospital Colorado

A randomized registry trial of adjuvant mitotane vs. mitotane with cisplatin/etoposide after primary surgical resection of localized adrenocortical carcinoma with high risk of recurrence (ADIUVO-2 Trial)

Protocol #: 20-2214

Location: University of Colorado Hospital

Protocol MK-5475-007: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension

Protocol #: 21-2564

Location: Outpatient CTRC, 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

MicroRNA as a Maternal and Neonatal Biomarker to Predict Congenital Diaphragmatic Hernia Severity

Protocol #: 21-2481

Location: Childrens Hospital Colorado, University of Colorado Hospital

Lessening caregiver burden in fibrotic interstitial lung disease: a dyadic, mixed-methods approach to improving symptoms and quality of life for patients and caregivers

Protocol #: 20-0214

Location: University of Colorado Hospital

Grow Up Formula Versus Nutritional Supplements: Effects on Catch Up Growth, Micronutrients Status and Solid Foods Intake in Toddlers with Mild Malnutrition

Protocol #: 20-3082

Location: Childrens Hospital Colorado

Neurocognitive Function in the Pediatric Hematology Oncology Population

Protocol #: 20-2765

Location: Childrens Hospital Colorado

Neuropalliative care to improve quality of life measures in persons with drug resistant epilepsy - a needs assessment

Protocol #: 20-2627

Location: University of Colorado Hospital

Comparison group experimental design of effectiveness of two resiliency interventions for nurses

Protocol #: 20-2689

Location: Greeley Campus, Medical Center of the Rockies, Poudre Valley Hospital, Yampa Valley Medical Center

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 Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)

Protocol #: 20-2995

Location: University of Colorado Hospital

A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients

Protocol #: 20-2986

Location: University of Colorado Hospital

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

Acute application of intrawound antibiotic powder in open extremity fracture wounds

Protocol #: 20-2957

Location: University of Colorado Hospital

Pediatric Peritoneal Dialysis Telehealth Survey

Protocol #: 20-3009

Location: Childrens Hospital Colorado

Engaging practices and communities in the development of interventions to promote HPV vaccine uptake

Protocol #: 18-0338

Location: Department Specific Free Standing Clinic

The ENCIRCLE high-risk trial: SAPIEN M3 system TransCatheter mitral valve ReplaCement vis TransseptaL AccEss

Protocol #: 20-2889

Location: Medical Center of the Rockies

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

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)

Protocol #: 20-2972

Location: Outpatient CTRC, University of Colorado Hospital

A single arm, multicenter, prospective, clinical study on a novel minimally invasive posterier sacroiliac fusion device

Protocol #: 20-2971

Location: Medical Center of the Rockies

A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS)

Protocol #: 20-2721

Location: Outpatient CTRC, University of Colorado Hospital

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)

Protocol #: 19-2727

Location: Brain Imaging Center (BIC), C-TRIC, 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 RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNA-GUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, STAGE II-III, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

Protocol #: 20-2773

Location: Lone Tree Medical Center, University of Colorado Hospital

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Protocol #: 20-2818

Location: University of Colorado Hospital

APEC1621I: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)-PHASE 2 SUBPROTOCOL OF PALBOCICLIB IN PATIENTS WITH TUMORS HARBORING ACTIVATING ALTERATIONS IN CELL CYCLE GENES

Protocol #: 17-2168I

Location: Childrens Hospital Colorado

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 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

Protocol #: 20-2793

Location: Childrens Hospital Colorado

A Phase I-II multicenter, open label trial of H3B-6545, a covalent antagonist of estrogen receptor alpha, in women with locally advanced or metastatic estrogen receptor-positive, HER2 negative breast cancer

Protocol #: 20-2675

Location: Lone Tree Medical Center, 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

Department of Otolaryngology Inner Ear Biobank

Protocol #: 19-1340

Location: Childrens Hospital Colorado, 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

PFAS Exposure and Health Effects in El Paso County

Protocol #: 20-2625

Location: Department Specific Free Standing Clinic

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study

Protocol #: 20-2772

Location: University of Colorado Hospital

Physician Selected Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma

Protocol #: 20-2202

Location: University of Colorado Hospital

CRI and Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Protocol #: 20-2755

Location: Childrens Hospital Colorado, Childrens National Medical Center

Maternal Perspectives on Postpartum Depression Screens: Beliefs, Concerns, and Level of Comfort Within and Across Racial Identities

Protocol #: 20-1436

Location: Childrens Hospital Colorado, Denver Health and Hospital Authority, UCHealth Central Park Medical Center

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1

Protocol #: 20-2697

Location: University of Colorado Hospital

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

Prehospital nasal cannula ETCO2 's ability determine the need for emergent lifesaving intervention, massive transfusion and death in the non-intubated patient

Protocol #: 20-2688

Location: Denver Health and Hospital Authority, 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

Assessing the Transcriptional Response in Nasal Epithelium to the Triple CFTR modulator (ARNET)

Protocol #: 20-2738

Location: Childrens Hospital Colorado

Pediatric Brain Injury Caregiver Education Program

Protocol #: 20-0272

Location: Childrens Hospital Colorado

Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure

Protocol #: 18-1270

Location: Childrens Hospital Colorado

Perceptions of the esthetics of the anterior-posterior position of maxillary central incisors in individuals of four ethnicities as evaluated by orthodontists and four ethnicities of layperson

Protocol #: 19-0741

Location: Dental Clinic

Intermediate-size Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline Gliomas

Protocol #: 20-2681

Location: Childrens Hospital Colorado

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Protocol #: 20-6512

Location: Memorial Hospital Central, Memorial Hospital North

An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN

Protocol #: 20-2106

Location: Childrens Hospital Colorado, University of Colorado Hospital

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

Symptom Screening Linked to Care Pathways for Children with Cancer: a Cluster Randomized Trial

Protocol #: 20-2525

Location: Childrens Hospital Colorado

Evolutionary Inspired Therapy For Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Protocol #: 20-1537

Location: Childrens Hospital Colorado

Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens (PICKUP)

Protocol #: 20-1510

Location: Outpatient CTRC, University of Colorado Hospital

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

Sleep assessed by actigraphy and direct recordings of the subthalamic nucleus in Parkinson's Disease.

Protocol #: 20-2508

Location: Lone Tree Medical Center, 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

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Protocol #: 20-2584

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

Cerebrospinal fluid-biomarkers-based diagnostic and prognostic models for multiple sclerosis (SPINCOMS)

Protocol #: 20-1025

Location: Brain Imaging Center (BIC), University of Colorado Hospital

TOPPLE T1D - A multiple ascending dose trial investigating safety, tolerability and pharmacokinetics of NNC0361-0041 administered subcutaneously to patients with type 1 diabetes mellitus

Protocol #: 20-2610

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program (PHP)

Protocol #: 20-2566

Location: Childrens Hospital Colorado

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 PHASE 1 STUDY OF TJ210001 ADMINISTERED IN SUBJECTS WITH RELAPSED OR REFRACTORY ADVANCED SOLID TUMORS

Protocol #: 20-2541

Location: University of Colorado Hospital

Biomarker Development for Sepsis in Pediatric Oncology Patients

Protocol #: 20-2374

Location: Childrens Hospital Colorado

A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment

Protocol #: 20-2383

Location: 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

Post-Intensive Care Syndrome - pediatrics (PICS-p): Longitudinal Cohort Study

Protocol #: 20-2512

Location: Childrens Hospital Colorado

A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Protocol #: 20-2340

Location: 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

PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer

Protocol #: 20-6514

Location: Memorial Hospital Central, Memorial Hospital North

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Protocol #: 20-1994

Location: University of Colorado Hospital

A Phase 1/2 Study of M3814 (peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

Protocol #: 20-2093

Location: University of Colorado Hospital

Paired Germline/Tumor Genetic Testing Outcomes

Protocol #: 20-2287

Location: Childrens Hospital Colorado, Childrens Hospital Colorado at Memorial

EF-32 (TRIDENT): A PIVOTAL RANDOMIZED, OPEN-LABEL STUDY OF OPTUNE? (TTFIELDS, 200KHZ) CONCOMITANT WITH RADIATION THERAPY AND TEMOZOLOMIDE FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA

Protocol #: 20-2112

Location: University of Colorado Hospital

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

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Protocol #: 20-2414

Location: Childrens Hospital Colorado

NRG-LU007: Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

Protocol #: 20-2369

Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

Protocol #: 20-2411

Location: Childrens Hospital Colorado

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200273, Pt M.W. (2)

Protocol #: 20-2410

Location: University of Colorado Hospital

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200272, Pt M.W. (1)

Protocol #: 20-2407

Location: University of Colorado Hospital

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Protocol #: 20-2294

Location: Rocky Mountain Regional VA Medical Center

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200271, Pt L.I.

Protocol #: 20-2406

Location: 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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Protocol #: 20-2113

Location: Childrens Hospital Colorado

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

Protocol #: 20-2005

Location: CTRC Inpatient, Outpatient CTRC, 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

Sexuality and breast cancer: Developing appropriate education for women going through treatment

Protocol #: 20-1789

Location: University of Colorado Hospital

GlobalSurg-CovidSurg Week: Determining the optimal timing for surgery following SARS-CoV-2 infection

Protocol #: 20-6083

Location: Medical Center of the Rockies

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

A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer

Protocol #: 20-2228

Location: University of Colorado Hospital

Assessing the Impact of Therapy on Localized Intravascular Coagulopathy in Vascular Anomalies

Protocol #: 20-2139

Location: Childrens Hospital Colorado

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

Vascular Anomalies Biobank: Collection and Banking of Biological Specimens and Data from patients with vascular anomalies

Protocol #: 20-0113

Location: Childrens Hospital Colorado

STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE)

Protocol #: 20-0141

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

Real World Observational Study using clonoSEQ? Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry

Protocol #: 20-2108

Location: University of Colorado Hospital

A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Protocol #: 20-2042

Location: Outpatient CTRC, University of Colorado Hospital

Clinical Survey Study to Evaluate Biomarkers and Clinical Manifestations in Individuals with Glycogen Storage Disease Type III (GSD III)

Protocol #: 20-2123

Location: Childrens Hospital Colorado

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

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

Protocol #: 20-1948

Location: Rocky Mountain Regional VA Medical Center

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

Personalized Spine Study Group Registry

Protocol #: 20-2016

Location: University of Colorado Hospital

ENVASARC: A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY

Protocol #: 20-1892

Location: University of Colorado Hospital

An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination with Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients with Advanced Solid Tumor Malignancies

Protocol #: 20-1878

Location: University of Colorado Hospital

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS

Protocol #: 20-1787

Location: 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

A Phase 1 Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of BXQ-350 in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

Protocol #: 20-1447

Location: Childrens Hospital Colorado

LUNGMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

Protocol #: 20-1813

Location: Rocky Mountain Regional VA Medical Center

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

Improving Contraceptive and Pregnancy Counseling in Rheumatology Clinics

Protocol #: 20-1332

Location: 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

A Phase 2 Open-Label Study of PTR-01 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Protocol #: 20-1938

Location: Childrens Hospital Colorado

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

Protocol #: 20-1837

Location: University of Colorado Hospital

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Protocol #: 20-1845

Location: University of Colorado Hospital

AAML1831 - A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Protocol #: 20-1864

Location: Childrens Hospital Colorado

AN EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC

Protocol #: 20-1830

Location: University of Colorado Hospital

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

A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple CombinationTherapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age

Protocol #: 20-1827

Location: Childrens Hospital Colorado

Patient Perpetrated Workplace Violence and the Effects on Patient Outcomes

Protocol #: 20-6057

Location: Memorial Hospital Central

ColorAdo ReseArch on Menopause & Early Life Stress Study: Remote Participation (The "CARAMELS at Home" Study)

Protocol #: 20-1715

Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic

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

S1714: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane Induced Peripheral Neuropathy in Cancer Patients

Protocol #: 19-2216

Location: Rocky Mountain Regional VA Medical Center

S1827: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Protocol #: 20-1704

Location: Rocky Mountain Regional VA Medical Center

Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases from ALK+ Lung Cancer

Protocol #: 19-2862

Location: City of Hope Cancer Center, Mayo Clinic, Rochester, University of Colorado Hospital

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Protocol #: 20-1667

Location: Lone Tree Medical Center, University of Colorado Hospital

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

Protocol #: 20-1736

Location: University of Colorado Hospital

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

Protocol #: 20-0680

Location: Childrens Hospital Colorado

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

Comparison of Nasopharyngeal specimens to Midturbinate Specimens for Detection of SARS-CoV-2 in Pediatric Patients

Protocol #: 20-1721

Location: Childrens Hospital Colorado

Dystonia Coalition Projects-3

Protocol #: 20-0290

Location: Department Specific Free Standing Clinic, 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

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN)

Protocol #: 20-1602

Location: Childrens Hospital Colorado

Genetics of CMT - Modifiers of CMT1A, New Causes of CMT

Protocol #: 20-1525

Location: Outpatient CTRC, 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

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (mRNA-1273-P301)

Protocol #: 20-1619

Location: Outpatient CTRC, University of Colorado Hospital

Pilot Trial of Hypnosis and Enhanced Communication Training to Reduce Anxiety, Improve Patient Satisfaction, and Decrease Movement for Patients Undergoing Magnetic Resonance Imaging

Protocol #: 20-1576

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

Early detection of metastatic disease in US Veterans following surgery for early stage lung cancer

Protocol #: 20-1548

Location: Rocky Mountain Regional VA Medical Center

Evaluation of Long-term Safety in Paediatric Patients With B-precursor Acute Lymphoblastic Leukemia (ALL) who Have Been Treated With Either Blinatumomab or Chemotherapy, Followed by Transplantation

Protocol #: 20-1442

Location: Childrens Hospital Colorado

A Phase I study of the ADAM-10 inhibitor, INCB007839 in children with recurrent/progressive high-grade gliomas to target microenvironmental neuroligin-3

Protocol #: 20-1487

Location: Childrens Hospital Colorado

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK-3β) Inhibitor, as a Single Agent or with Irinotecan, Temozolomide/Irinotecan or Cyclophosphamide/Topotecan in Pediatric Patients with Refractory Malignancies

Protocol #: 20-1445

Location: Childrens Hospital Colorado

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Protocol #: 20-1438

Location: University of Colorado Hospital

A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy for HER2+ gastrointestinal cancers

Protocol #: 20-1453

Location: 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 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis

Protocol #: 20-1490

Location: Barbara Davis Center, University of Colorado Hospital

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02C

Protocol #: 20-0253

Location: University of Colorado Hospital

Endovascular treatment of acutely ruptured shallow intradural aneurysms not amendable to clipping and coiling with the pipeline vantage embolization device

Protocol #: 20-1254

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 TRIAL OF THE CD123 X CD3 DART? MOLECULE FLOTETUZUMAB (NSC#808294, IND#145986) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

Protocol #: 20-1106

Location: Childrens Hospital Colorado

An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies

Protocol #: 20-1380

Location: Childrens Hospital Colorado

Novel Approaches to Observationally Assessing Cannabis-Impaired Driving

Protocol #: 20-0949

Location: Denver Health and Hospital Authority, University of Colorado Hospital

Patient Preferences in Deep Brain Stimulation Products

Protocol #: 19-3015

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

The Parkinson's Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort

Protocol #: 20-1204

Location: Brain Imaging Center (BIC), Outpatient CTRC, 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 Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio?) in participants with relapsing forms of multiple sclerosis (GEMINI 1)

Protocol #: 20-1101

Location: Brain Imaging Center (BIC), University of Colorado Hospital

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on Recovery (DISCOVERY)

Protocol #: 20-0638

Location: Outpatient CTRC, University of Colorado Hospital

Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

Protocol #: 20-6034

Location: Medical Center of the Rockies

Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic Anemia

Protocol #: 20-1333

Location: Childrens Hospital Colorado

ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Protocol #: 19-2469

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

TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Protocol #: 20-1306

Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb?23104 in Subjects with Selected Advanced Solid Tumors (DUET-3)

Protocol #: 20-1289

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

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Protocol #: 20-0656

Location: 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

A Prospective Natural History Study of Angelman Syndrome for Therapeutic Development

Protocol #: 20-1338

Location: Childrens Hospital Colorado

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

SARS-CoV-2 specific T cell responses in HIV-positive and negative individuals after resolution of COVID-19 viral infection.

Protocol #: 20-1219

Location: Outpatient CTRC, University of Colorado Hospital

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 1 study of temozolomide in combination with targeted therapy for NSCLC patients with CNS progression on either osimertinib or lorlatinib

Protocol #: 20-0138

Location: University of Colorado Hospital

A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction based on Time of Discharge

Protocol #: 20-1055

Location: Highlands Ranch Hospital, University of Colorado Hospital

Evaluation of ultra-early microRNA and metabolomic biomarkers in acute ischemic stroke.

Protocol #: 20-1088

Location: University of Colorado Hospital

DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Impaired Renal Function

Protocol #: 20-0902

Location: Outpatient CTRC, University of Colorado Hospital

SLEEP-DISORDERED BREATHING IN INFANTS WITH MYELOMENINGOCELE

Protocol #: 20-0996

Location: Childrens Hospital Colorado

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

Molecular and Genomic Studies of Bone Marrow Failure and Myelodysplastic Syndromes

Protocol #: 16-1438

Location: Childrens Hospital Colorado

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

Creation of a Registry Via Patient and Provider Surveys to Assess Outcomes of Platelet-Rich Plasma (PRP) Injections in Orthopedics

Protocol #: 20-0978

Location: Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITY

Protocol #: 20-0889

Location: Childrens Hospital Colorado

COVID-19: Lung ultrasound implementation in the management of patients with COVID-19

Protocol #: 20-0781

Location: 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

Slow Heart Registry: A prospective observational cohort study of fetal immune-mediated high degree heart block

Protocol #: 20-0820

Location: Childrens Hospital Colorado

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

Evaluation of cannabis perception and usage in patients with epilepsy treated at the University of Colorado Hospital and Clinics

Protocol #: 20-0311

Location: University of Colorado Hospital

A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes

Protocol #: 19-1130

Location: University of Colorado Hospital

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

Protocol #: 20-0579

Location: Childrens Hospital Colorado

Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI

Protocol #: 20-0537

Location: Lone Tree Medical Center, 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

Intervention to Educate and Improve Underrepresented Populations' Participation in Clinical Trials

Protocol #: 20-0590

Location: Department Specific Free Standing Clinic

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

COVID-19 Preparedness Survey

Protocol #: 20-0620

Location: University of Colorado Hospital

A SINGLE-PERIOD, SINGLE-TREATMENT STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EPINEPHRINE AFTER ADMINISTRATION OF INTRANASAL ARS-1 TO PEDIATRIC SUBJECTS WITH SYSTEMIC ALLERGIES

Protocol #: 20-0596

Location: Childrens Hospital Colorado

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

CD80 as a biomarker for kidney disease

Protocol #: 13-2700

Location: Childrens Hospital Colorado

Phase I/II trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF fusion/duplication positive or NF1-associated recurrent or progressive gliomas in children and young adults

Protocol #: 20-0535

Location: Childrens Hospital Colorado

Immune Profiles in CF Fungal Infections

Protocol #: 20-0099

Location: Childrens Hospital Colorado

Impacts of a multitiered breastfeeding support program on breastfeeding duration and achievement of prenatal breastfeeding goals

Protocol #: 20-6027

Location: Long's Peak Hospital, Longs Peak Hospital

Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion

Protocol #: 15-0813

Location: University of Colorado Hospital

International CDKL5 Clinical Research Network

Protocol #: 19-2756

Location: Childrens Hospital Colorado

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

Deep sleep in Parkinson disease and its relationship to cognition, neuroinflammation and neurodegeneration

Protocol #: 20-0347

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

Validation of the Apollo EE Device, Indirect Calorimetry

Protocol #: 20-0317

Location: Anschutz Health and Wellness, 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

Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series

Protocol #: 19-2236

Location: Denver Health and Hospital Authority, High Plains Community Health Center, University of Colorado Hospital

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS 986278 in Participants with Pulmonary Fibrosis

Protocol #: 20-0383

Location: University of Colorado Hospital

A5380: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

Protocol #: 20-0303

Location: Outpatient CTRC, University of Colorado Hospital

Protocol I8F-MC-GPGN(a) The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes

Protocol #: 20-0271

Location: Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

Fungal sinus infections in pediatric cystic fibrosis: impact on treatment

Protocol #: 20-0286

Location: Childrens Hospital Colorado

A Phase 1/2a Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmocokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy

Protocol #: 20-0281

Location: University of Colorado Hospital

Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

Protocol #: 20-0279

Location: Childrens Hospital Colorado

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS

Protocol #: 19-3082

Location: Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Protocol #: 20-0216

Location: Highlands Ranch 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

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma

Protocol #: 19-2345

Location: Childrens Hospital Colorado

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

Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2

Protocol #: 20-0226

Location: Childrens Hospital Colorado, Memorial Hospital Central, 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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

Protocol #: 20-0243

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

The Effect of Primary Palatoplasty Procedure on Underlying Velopharyngeal Anatomy and Physiology

Protocol #: 20-0131

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

Isolation of adult adipose derived stem cells from surgically discarded tissues such as liposuction aspirate and infrapatellar fat pads

Protocol #: 19-2997

Location: Steadman Hawkins Clinic - Denver (Inverness)

ENGOT-ov50 / INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer

Protocol #: 20-0007

Location: University of Colorado Hospital

ALS toolkit project

Protocol #: 20-0127

Location: University of Colorado Hospital

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

PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network

Protocol #: 17-2350

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

Protocol #: 20-0094

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Protocol #: 20-0035

Location: University of Colorado Hospital

Phase Ib/II trial of copanlisib in combination with trastuzumab and pertuzumab after induction treatment of HER2 positive (HER2+ ) metastatic breast cancer (MBC) with PIK3CA mutation or PTEN mutation.

Protocol #: 19-2988

Location: Lone Tree Medical Center, University of Colorado Hospital

Tissue Bank and Clinical Database for the Analysis of arterial thrombosis

Protocol #: 19-2998

Location: University of Colorado Hospital

First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors

Protocol #: 19-3118

Location: Outpatient CTRC, 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

North American Pediatric Renal Trials Collaborative Studies (NAPRTCS)

Protocol #: 19-3007

Location: Childrens Hospital Colorado

My Baby, My Move+: A community wellness intervention

Protocol #: 19-1366

Location: UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, 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 Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection with Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients

Protocol #: 19-2695

Location: Childrens Hospital Colorado

A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections with Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients

Protocol #: 19-2694

Location: Childrens Hospital Colorado

mHealth Development for Apathy among Patients with Mild Cognitive Impairment and their Care Partners

Protocol #: 19-3075

Location: University of Colorado Hospital

Prolonged Sedentary Behavior in Older Women with and without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk

Protocol #: 19-2758

Location: Outpatient CTRC, University of Colorado Hospital

A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease

Protocol #: 19-2833

Location: Memorial Hospital Central, 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

AN OPEN-LABEL, MULTICENTER, PHASE 1B/2 STUDY OF RP1 IN SOLID ORGAN TRANSPLANT RECIPIENTS WITH ADVANCED CUTANEOUS MALIGNANCIES

Protocol #: 19-2987

Location: University of Colorado Hospital

North American Mitrochondrial Disease Consortium Patient Registry and Biorepository

Protocol #: 13-2246

Location: Childrens Hospital Colorado

Pediatric Bone Marrow Failure Tissue Repository

Protocol #: 19-2913

Location: Childrens Hospital Colorado

Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes

Protocol #: 19-2760

Location: University of Colorado Hospital

The Effect of Adjuvant Adipose-Derived Modified Cells for Arthroscopically-Determined Knee Osteoarthritis: A Randomized Controlled Trial

Protocol #: 19-2893

Location: Steadman Hawkins Clinic - Denver (Inverness)

S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

Protocol #: 19-2950

Location: Childrens Hospital Colorado

Randomized Controlled Trial of the Cartilage Forming Potential of Microdrilling versus Lipoaspirate Concentrate for Isolated Articular Cartilage Defects

Protocol #: 19-2838

Location: Steadman Hawkins Clinic - Denver (Inverness)

A PHASE 1/2 STUDY OF TPX-0046, A NOVEL ORAL RET/SRC INHIBITOR IN ADULT SUBJECTS WITH ADVANCED/METASTATIC SOLID TUMORS HARBORING ONCOGENIC RET FUSIONS OR MUTATIONS

Protocol #: 19-2888

Location: University of Colorado Hospital

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

Identifying Novel Molecular Signatures and Pathways for Targeted Therapy in Arthritic Joints Through Synovial Tissue Analysis

Protocol #: 19-2910

Location: Barbara Davis Center, 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

NRG-GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Protocol #: 19-2797

Location: University of Colorado Hospital

A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer

Protocol #: 19-2818

Location: 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

Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Protocol #: 19-2645

Location: Outpatient CTRC, 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

Lipoic acid for Treatment of Progressive Multiple Sclerosis

Protocol #: 19-2525

Location: Brain Imaging Center (BIC), 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

A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study

Protocol #: 19-0795

Location: University of Colorado Hospital

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson's Disease

Protocol #: 19-2471

Location: Outpatient CTRC, University of Colorado Hospital

Phase 1/2 Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults with Relapsed/Refractory Acute Myeloid Leukemia

Protocol #: 19-2405

Location: Childrens Hospital Colorado

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

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

Protocol #: 19-2640

Location: Rocky Mountain Regional VA Medical Center

A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors- ARTISTRY-1

Protocol #: 19-2532

Location: University of Colorado Hospital

A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (DEFI-RDEB)

Protocol #: 19-1972

Location: Childrens Hospital Colorado

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Protocol #: 19-2631

Location: Childrens Hospital Colorado

An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Protocol #: 19-2378

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

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

Neurophysiological investigation of epistemic veracity in the context of ambiguous videographic evidence

Protocol #: 19-2521

Location: University of Colorado Hospital

Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients with Advanced Mycosis Fungoides and Sezary Syndrome

Protocol #: 19-2524

Location: University of Colorado Hospital

Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean Deliveries

Protocol #: 19-1896

Location: Childrens Hospital Colorado

A PHASE 1/2, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY STUDY OF REPOTRECTINIB IN PEDIATRIC AND YOUNG ADULT SUBJECTS WITH ADVANCED OR METASTATIC MALIGNANCIES HARBORING ALK, ROS1, OR NTRK1-3 ALTERATIONS

Protocol #: 19-2438

Location: Childrens Hospital Colorado

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

ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)

Protocol #: 19-2475

Location: Childrens Hospital Colorado

A MULTICENTER, LONGITUDINAL, OPEN-LABEL, SINGLE-ARM STUDY DESCRIBING COGNITIVE PROCESSING SPEED CHANGES IN RELAPSING MULTIPLE SCLEROSIS SUBJECTS TREATED WITH OZANIMOD (RPC-1063)

Protocol #: 19-2420

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

A Prospective Multi-Center Randomized Open-Label Study To Evaluate The Efficacy and Safety of PMX Cartridge in addition to Standard Medical Care for Patients with Endotoxemic Septic Shock: TIGRIS TRIAL

Protocol #: 19-6070

Location: Memorial Hospital Central

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

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

Protocol #: 19-2327

Location: 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

A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Protocol #: 19-2363

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

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Protocol #: 19-2331

Location: University of Colorado Hospital

A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenic Mechanisms

Protocol #: 19-2357

Location: Childrens Hospital Colorado

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis OpticavSpectrum Disorder (NMOSD)

Protocol #: 19-2038

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

Perceived Palliative Care Needs in Early-Onset Dementia

Protocol #: 19-2134

Location: Outpatient CTRC, UCHealth Central Park Medical Center, University of Colorado Hospital

A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with Azacitidine in Patients with Recurrent, Resectable Osteosarcoma

Protocol #: 19-2295

Location: Childrens Hospital Colorado

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

A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS

Protocol #: 19-2242

Location: Outpatient CTRC, University of Colorado Hospital

Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic Sclerosis

Protocol #: 19-1613

Location: Childrens Hospital Colorado

A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients with Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) that are Causing Significant Morbidity

Protocol #: 19-2270

Location: Childrens Hospital Colorado

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

Improving Renal Outcomes Collaborative

Protocol #: 16-2190

Location: Childrens Hospital Colorado

The High-Intensity Exercise to Attenuate Limitations and Train Habits (HEALTH) in Older Adults with HIV

Protocol #: 19-1985

Location: Outpatient CTRC, University of Colorado 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

Prospective Analysis of Gait Following Hemispherectomy

Protocol #: 17-0230

Location: Childrens Hospital Colorado

Gait Analysis of Femoroacetabular Impingement Patients

Protocol #: 16-1934

Location: Childrens Hospital Colorado

International Fetal Cardiac Intervention Registry

Protocol #: 14-0343

Location: Childrens Hospital Colorado

Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)

Protocol #: 14-1413

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #: 18-1076

Location: Childrens Hospital Colorado

A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis

Protocol #: 19-1621

Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

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

E4512: A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Protocol #: 19-1694

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

Investigation of the efficacy of chemotherapy induced nausea/vomiting (CINV) prophylaxis with FOLFOX/FOLFIRI/FOLFIRINOX

Protocol #: 19-1809

Location: University of Colorado Hospital

A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients with Advanced Solid Tumors

Protocol #: 19-1987

Location: University of Colorado Hospital

A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept (Orencia) in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (LIMIT-JIA)

Protocol #: 19-2020

Location: Childrens Hospital Colorado

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

Protocol #: 15-1434

Location: Childrens Hospital Colorado

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

Impact of Novel Therapeutic Music Delivery Device on Drug Use and Recovery in Surgical Patients

Protocol #: 19-6100

Location: Medical Center of the Rockies, Poudre Valley Hospital

COG AAML18P1 - Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Protocol #: 19-1839

Location: Childrens Hospital Colorado

Prospective Analysis of Circulating Tumor Cells in Patients with Metastatic Prostate Cancer.

Protocol #: 19-1687

Location: 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

Orthopedic Infection Registry

Protocol #: 19-0979

Location: University of Colorado Hospital

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

INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

Protocol #: 02-729

Location: Department Specific Free Standing Clinic

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

Rare CFTR Mutation Cell Collection Protocol (RARE)

Protocol #: 16-2412

Location: Childrens Hospital Colorado

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

AN OBSERVATIONAL STUDY OF OCRELIZUMAB TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY)

Protocol #: 19-1600

Location: University of Colorado Hospital

Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease

Protocol #: 19-1787

Location: Childrens Hospital Colorado

The National Myelodysplastic Syndromes (MDS) Study

Protocol #: 19-1696

Location: Rocky Mountain Regional VA Medical Center

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

Pancreatic Duct Stone Therapy in Chronic Pancreatitis

Protocol #: 19-1726

Location: University of Colorado Hospital

COG AREN1721 - A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Protocol #: 19-1467

Location: Childrens Hospital Colorado

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects with A+AVD."

Protocol #: 19-6510

Location: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma

Protocol #: 19-1503

Location: 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

Body Composition in Infants with Klinefelter Syndrome and Effects of Testosterone Treatment

Protocol #: 14-1720

Location: Childrens Hospital Colorado

TRAVERSE

Protocol #: 19-1644

Location: University of Colorado Hospital

A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling

Protocol #: 19-1566

Location: 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

GRASP-LGMD RESEARCH PROTOCOL; Project 1a Defining Clinical Endpoints in LGMD

Protocol #: 19-0506

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Protocol #: 19-1458

Location: University of Colorado Hospital

Regression in Down Syndrome

Protocol #: 19-1418

Location: Childrens Hospital Colorado

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the University of Colorado's Hematology Tissue Bank Protocol

Protocol #: 19-1498

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

Allen CU-UCSD Transition to RA Project: Blood and Flu

Protocol #: 19-1150

Location: Barbara Davis Center, University of Colorado Hospital

Ublituximab as initial therapy for treatment-naive follicular or marginal zone lymphoma with response-driven addition of umbralisib for suboptimal response.

Protocol #: 18-2128

Location: University of Colorado Hospital

Apoyo con Cari?o (Support through Caring): Improving Palliative Care Outcomes for Latinos with Advanced Medical Illness V: 03/20/19

Protocol #: 16-1270

Location: Denver Health and Hospital Authority, University of Colorado Hospital

A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects with Congenital Adrenal Hyperplasia

Protocol #: 19-1230

Location: Childrens Hospital Colorado

CROCODILE Study: Control of Renal Oxygenation, COnsumption, mitochondrial Dysfunction, and InsuLin rEsistance

Protocol #: 19-1282

Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

Informational Meetings for Planning And Coordinating Treatment (IMPACT)

Protocol #: 19-1462

Location: Childrens Hospital Colorado

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

A Study of the Pipeline Flex Embolization DeVice with Shield Technology for EndovAscular TreatmeNt of Wide-NeCked Intracranial AnEurysms

Protocol #: 19-1399

Location: University of Colorado Hospital

Using point of care ultrasound to measure perioperative edema in infants with congenital heart disease

Protocol #: 19-1387

Location: Childrens Hospital Colorado, University of Colorado Hospital

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

GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GCAR-7213)

Protocol #: 19-0744

Location: University of Colorado Hospital

Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults after Bariatric Surgery: A Randomized Controlled Pilot Study

Protocol #: 18-2793

Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

Feasibility of the Multiple Sclerosis Performance Test for assessment of functional performance measures in patients with Multiple Sclerosis

Protocol #: 19-1192

Location: University of Colorado Hospital

reST Registry

remede System Therapy in patients with central sleep apnea...more >

Protocol #: 19-6087

Location: Harmony Campus, Medical Center of the Rockies

ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Protocol #: 19-1259

Location: Childrens Hospital Colorado

Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCC

Protocol #: 19-1081

Location: Lone Tree Medical Center, University of Colorado Hospital

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

Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Protocol #: 16-2408

Location: Childrens Hospital Colorado

Multi-Institutional Validation of Trauma Specific Frailty Index

Protocol #: 19-6084

Location: Medical Center of the Rockies

A Phase I/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Protocol #: 19-1277

Location: Childrens Hospital Colorado

The Laboratory for Advanced Medicine (LAM) / Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples (CLiMB)

Protocol #: 19-1272

Location: Outpatient CTRC, University of Colorado Hospital

Neurophysiological Correlates V: 31Jan18

Protocol #: 16-1480

Location: Childrens Hospital Colorado

Natural History of Rett Syndrome and Related Disorders

Protocol #: 15-2332

Location: Childrens Hospital Colorado

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

Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia V: 5; March 20, 2018

Protocol #: 16-1998

Location: Childrens Hospital Colorado

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

Bone Health in Adults with Type 1 Diabetes

Protocol #: 19-1190

Location: Barbara Davis Center, University of Colorado Hospital

The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents with and without Obesity

Protocol #: 19-1171

Location: Outpatient CTRC, University of Colorado Hospital

An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using Zalifrelimab (AGEN1884) and Balstilimab (AGEN2034) for Advanced or Metastatic Soft Tissue Sarcomas

Protocol #: 19-0554

Location: University of Colorado Hospital

Prognostic significance of variants in the CTNNB1 gene and the B-catenin pathway in recurrent high-intermediate risk endometrial cancer

Protocol #: 19-1199

Location: University of Colorado Hospital

A Phase 1/2, Open Label, Dose-Escalation Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors

Protocol #: 19-1118

Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).A screening trial for A081105, E4512 and EA5142

Protocol #: 18-2625

Location: Rocky Mountain Regional VA Medical Center

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors

Protocol #: 19-1069

Location: 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

TOPP-2 registry Tacking Outcomes and Practice in Pediatric Pulmonary Hypertension V: 27 July 2018

Protocol #: 15-0693

Location: Childrens Hospital Colorado

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

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

Protocol #: 19-0561

Location: University of Colorado Hospital

A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)

Protocol #: 19-0967

Location: University of Colorado Hospital

A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Protocol #: 19-0604

Location: University of Colorado Hospital

The prospective association of cadmium exposure and cancer in the San Luis Valley Diabetes Study

Protocol #: 16-2502

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

A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma

Protocol #: 19-0642

Location: University of Colorado 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

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Protocol #: 18-0220

Location: Outpatient CTRC, University of Colorado Hospital

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

Understanding the Barriers to Epilepsy Surgery: A North American Survey

Protocol #: 19-0269

Location: University of Colorado Hospital

Focus Group: Cancer Caregivers and Their Struggle(s) between Work and Family

Protocol #: 19-0963

Ablation versus Stereotactic Body Radiotherapy for Early Stage Hepatocellular Carcinoma Not Amenable to Surgical Treatment

Protocol #: 19-0852

Location: 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

Outcomes after Standardized Testicular Torsion Management and Follow-up

Protocol #: 19-0849

Location: Childrens Hospital Colorado

Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic Sclerosis

Protocol #: 19-0814

Location: Childrens Hospital Colorado

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

Fontan at Altitude Registry (FAR) V: 6-11-14

Protocol #: 14-1072

Location: Childrens Hospital Colorado

A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.

Protocol #: 19-0632

Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Prognostic factors associated with outcomes in colorectal cancer liver metastases

Protocol #: 19-0770

Location: University of Colorado Hospital

CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY

Protocol #: 19-0519

Location: 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

A Comprehensive and Collaborative Review of the Use of Whole Blood at Trauma Centers in the United States

Protocol #: 19-6047

Location: Medical Center of the Rockies, Poudre Valley Hospital

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

Evaluation and Demonstration of Investigational MRI Software and Hardware

Protocol #: 19-0518

Location: Childrens Hospital Colorado

Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Protocol #: 18-2594

Location: 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

A Multi-Center, Open-Label, phase I/Ib, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors

Protocol #: 19-0539

Location: University of Colorado Hospital

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

Protocol #: 19-0493

Location: Highlands Ranch Hospital, University of Colorado Hospital

Phase I trial of ribociclib in combination with everolimus and dexamethasone in children and young adults with relapsed acute lymphoblastic leukemia (DF/HCC Protocol#: 18-328)

Protocol #: 19-0551

Location: Childrens Hospital Colorado

A phase II study to evaluate neoadjuvant osimertinib therapy in patients with surgically resectable, EGFRmutant non-small cell lung cancer

Protocol #: 19-0325

Location: Lone Tree Medical Center, University of Colorado Hospital

A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

Protocol #: 19-0423

Location: 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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis

Protocol #: 19-0444

Location: 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

Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study

Protocol #: 18-2444

Location: Outpatient CTRC, University of Colorado Hospital

Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer

Protocol #: 18-2742

Location: Department Specific Free Standing Clinic, University of Colorado Hospital

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

A Natural History Study of CMT1B, CMT2A, CMT4A and CMT4C

Protocol #: 18-2537

Location: University of Colorado Hospital

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

Impact of surgical intervention on sleep dysfunction in patients with refractory epilepsy

Protocol #: 19-0239

Location: 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

CONNECT1702: A Phase Ib Study of PTC596 in children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma

Protocol #: 19-0223

Location: Childrens Hospital Colorado

A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma

Protocol #: 18-2740

Location: Childrens Healthcare of Atlanta, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

APOGEE

LVAD registry...more >

Protocol #: 18-2576B

Location: University of Colorado Hospital

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

Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Protocol #: 19-0049

Location: Colorado Research Center, Department Specific Free Standing Clinic

Surgery Database Project

Protocol #: 18-2839

Location: University of Colorado Hospital

Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell)

Protocol #: 16-0692

Locations: Anschutz Health and Wellness, UCD Anschutz Health &amp; Wellness Center

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy

Protocol #: 19-0225

Location: University of Colorado Hospital

Randomized phase 2 clinical trial of nab-paclitaxel + durvalumab (MEDI4736) + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) in patients with metastatic triple negative breast cancer

Protocol #: 19-0013

Location: University of Colorado Hospital

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

Moderating effects of sleep on quality of life and fatigue following an exercise program for cancer survivors

Protocol #: 19-0041

Locations: Anschutz Health and Wellness, UCD Anschutz Health &amp; Wellness Center

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

New Graduate Nurse Orientation Using a Staged, Task-Layered Strategy: Implications for Length of Orientation and Self-Reported Confidence

Protocol #: 18-6119

Location: Medical Center of the Rockies, Poudre Valley Hospital

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)

Protocol #: 18-2654

Location: University of Colorado Hospital

Association of depth recordings from the temporal cortex with sleep pattern detection and characterization of sleep dysfunction in patients with refractory epilepsy.

Protocol #: 18-2806

Location: University of Colorado Hospital

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors

Protocol #: 18-2520

Location: Lone Tree Medical Center, 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

Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in left ventricular outflow tract arrhythmias ablation

Protocol #: 18-2772

Location: University of Colorado Hospital

Identifying relevant seizure biomarkers from RNS? System recorded electrocorticography for the development of optimized seizure detection algorithms

Protocol #: 18-2089

Location: University of Colorado Hospital

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Protocol #: 18-2529

Location: Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age, Version 1.0

Protocol #: 18-2714

Location: Childrens Hospital Colorado

A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

Protocol #: 18-2646

Location: University of Colorado Hospital

Study of Attitudes and Factors Effecting PREterm infant care Practices (SAFE PREP)

Protocol #: 18-2402

Location: Childrens Hospital Colorado, University of Colorado Hospital

A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey Results

Protocol #: 18-2562

Location: Cherry Creek Medical Center, Lone Tree Medical Center, 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

A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors

Protocol #: 18-2417

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

Evaluation of Sun Protection Education using the Reveal Imager Photo-aging and the SPA Questionnaire

Protocol #: 17-2424

Location: University of Colorado Cancer Center, University of Colorado Hospital

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

A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)

Protocol #: 18-2354

Location: 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

Metabolic and Renal Effects of Automated Insulin Delivery Systems in Youth with Type 1 Diabetes Mellitus

Protocol #: 18-1558

Location: Childrens Hospital Colorado

A prospective, long term registry of patients with a diagnosis of spinal muscular atrophy V: 1.0; 20March2018

Protocol #: 18-1683

Location: Childrens Hospital Colorado

A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1

Protocol #: 18-2315

Location: Outpatient CTRC, University of Colorado Hospital

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

Hybrid Closed-Loop Therapy in Pregnancies Complicated by Type 1 Diabetes (T1D)

Protocol #: 18-1798

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR)

Protocol #: 18-2051

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

The Associations between EIT and Clinical Measures during Standard of Care Procedures in Patients with Respiratory Disease: A Preliminary Study

Protocol #: 18-1843

Location: Childrens Hospital Colorado

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

Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (DELIVERMS)

Protocol #: 18-1633

Location: University of Colorado Hospital

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

Identifying Predictors of Poor Health-Related Quality-of-Life among Pediatric Hematopoietic Stem Cell Donors

Protocol #: 18-1997

Location: Childrens Hospital Colorado

COG AGCT1532 - Phase 3 Accelerated BEP Trial: A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours

Protocol #: 18-1674

Location: Childrens Hospital Colorado

COG AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Protocol #: 18-1527

Location: Childrens Hospital Colorado

A Phase 3 Study of Eltrombopag vs. Standard First-Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children (ICON3)

Protocol #: 18-1963

Location: Childrens Hospital Colorado

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

Clinical Outcome Measures in Friedreich's Ataxia

Protocol #: 18-1641

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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Protocol #: 18-1672

Location: University of Colorado Hospital

A multicenter, randomized, double-blinded, placebo-controlled, Phase 3 trial of adjuvant Avelumab (anti-PDL-1 antibody) in Merkel cell carcinoma patients with lymph node metastases

Protocol #: 18-1734

Location: University of Colorado Hospital

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer

Protocol #: 18-1728

Location: University of Colorado Hospital

A study to investigate biomarkers in rheumatoid arthritis associated interstitial lung disease

Protocol #: 18-1808

Location: Outpatient CTRC, University of Colorado Hospital

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

A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018

Protocol #: 18-1493

Location: University of Colorado Hospital

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint Blockade

Protocol #: 18-1526

Location: University of Colorado Hospital

COG ACCL1633 - The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Protocol #: 18-1349

Location: Childrens Hospital Colorado

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

Molecular Characterization of Idiopathic Interstitial Pneumonias

Protocol #: 18-1490

Location: University of Colorado Hospital

Peripheral Inflammatory Cytokine Levels in Parkinson Disease

Protocol #: 18-1356

Location: Outpatient CTRC, University of Colorado Hospital

Gut microbiome alterations by ketogenic diet treatment V: 2; July 31, 2018

Protocol #: 18-1391

Location: Childrens Hospital Colorado

Conversational Speech in the Diagnosis of Neurocognitive Disorders

Protocol #: 18-0456

Location: 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

More than a Movement Disorder: Applying Palliative Care to Parkinson?s Disease v: 12/06/2017

Protocol #: 16-1400

Location: Colorado Research Center, Department Specific Free Standing Clinic

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

A Multicenter, Observational, Prospective, Natural History Study of Homocystinuria Due to Cystathionine Beta-synthase Deficiency in Pediatric and Adult Patients

Protocol #: 18-0910

Location: Childrens Hospital Colorado

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Protocol #: 18-6055

Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Study evaluating feasibility of isolating circulating tumor DNA from blood, cerebrospinal fluid, and urine in Pediatric Solid Tumor patients

Protocol #: 18-1281

Location: Childrens Hospital Colorado

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis 14DEC2016

Protocol #: 17-0051

Location: University of Colorado Hospital

Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA)

Protocol #: 15-1868

Location: Barbara Davis Center, UCD Barbara Davis Center, University of Colorado Hospital

Obalon? Balloon System, The Post Approval Study

Protocol #: 18-1209

Location: University of Colorado Hospital

Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults with Advanced Heart Failure

Protocol #: 18-0973

Location: Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study

Protocol #: 18-1148

Location: University of Colorado Hospital

Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain

Protocol #: 16-1063

Location: Childrens Hospital Colorado

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

Neurologic Music Therapy for enhancing fine motor control in Parkinson's Disease 16Apr2018

Protocol #: 16-2308

Location: University of Colorado Hospital

Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (aged 18-59) with Acute Myeloid Leukemia

Protocol #: 18-0709

Location: University of Colorado Hospital

Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients with Previously Untreated High Grade Myelodysplastic Syndromes

Protocol #: 17-2215

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

COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Protocol #: 18-0971

Location: Childrens Hospital Colorado

Ruptured Aneurysms Treated with Hydrogel Coils

Protocol #: 18-6052

Location: Memorial Hospital Central

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

Protocol #: 18-0685

Location: University of Colorado Hospital

A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

Protocol #: 16-0701

Location: Denver Health and Hospital Authority, Regional West Medical Center, University of Colorado Hospital, University of Oklahoma

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

AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

Molecular Endotypes of Chronic Spontaneous Urticaria

Protocol #: 18-0850

Location: Outpatient CTRC, 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

Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction Protocol No.:XEL-CR-03

Protocol #: 18-0444

Location: Childrens Hospital Colorado

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

Protocol #: 18-0836

Location: University of Colorado Hospital, University of Colorado, Boulder

PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

Protocol #: 18-0498

Location: Childrens Hospital Colorado

NANT 2013-01 A Phase I Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed Neuroblastoma with Dinutuximab +/- Lenalidomide. A New Approaches To Neuroblastoma Therapy (NANT) Treatment Protocol

Protocol #: 18-0686

Location: Childrens Hospital Colorado

Automatic measurement of hand movements toward development of an objective assessment of primary motor symptoms in Parkinson?s disease

Protocol #: 15-1041

Location: Outpatient CTRC, 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

NANT 2017-01: A PHASE I STUDY OF 131I-MIBG WITH DINUTUXIMAB +/- VORINOSTAT FOR RELAPSED/REFRACTORY NEUROBLASTOMA (IND# 137554)

Protocol #: 18-0501

Location: Childrens Hospital Colorado

Identifying Environmental Triggers of Smoking Behaviors in Low-income Communities

Protocol #: 18-0052

Location: Department Specific Free Standing Clinic, University of Colorado Cancer Center, University of Colorado Hospital

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