Your search for "All Studies" found 1004 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....

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...

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...

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...

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...

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...

Protocol #: 19-2323

The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D

You might be eligible if you: • Are between 20 and 45 years of age and are not obese (body mass index <30 kg/m2) • Do not have a history of cardiovascular disease (heart attack, stroke, coronary bypass surgery or angioplasty) • Are not taking statins for high cholesterol •...

Protocol #: 19-0856

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. ...

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...

Protocol #: 20-1672

Cannabis in Adolescents Study

(Arm 1) If you join the study, you will have a total of six study visits over about two months. Half of these visits will be held via Zoom and the other half will be held in person at a clinic on the CU Anschutz Campus in Aurora. You will be asked questions; complete questionnaires; and gi...

Protocol #: 20-0553

University of Colorado Alzheimer's and Cognition Center Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD Study)

This study will establish a large bank of samples and data for future research into the causes of and treatments for Alzheimer’s disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems....

Protocol #: 15-1774

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....

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...

Protocol #: 19-2820

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 ...

Protocol #: 20-2734

Salmon intake and gut health in adults

You may be eligible if: - You are between 30 and 70 years old - Your BMI is between 25 and 40 (check with this BMI calculator https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm) - Exercise 3 hours/week or less - Not on any glucose lowering medications This study co...

Protocol #: 20-1033

Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex

Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated....

Protocol #: 17-0356

Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls (IDOS)

Participants will complete 2-3 visits- a screening visit and a testing visit. Some participants will be asked to split screening into 2 visits. All visits include blood draws and the testing visit includes blood draws and frequent urine samples. Participants will also be asked to provide a...

Protocol #: 20-2179

Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches

Regular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movemen...

Protocol #: 16-2706

Effects of complementary feeding on infant growth and gut health

Your baby may be eligible if they are: - Breastfed and/or formula fed - Younger than five months of age - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a seven month-long study, from 5 to 12 months of age, with visits occurring every month. ...

Protocol #: 20-2232

The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT

The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may...

Protocol #: 16-1479

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 ...

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...

Protocol #: 21-3936

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...

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....

Protocol #: 14-0740

Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study

This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ...

Protocol #: 21-3018

Does When You Exercise Matter? A Randomized Trial Comparing the Effect of Morning versus Evening Aerobic Exercise on Weight Loss and Compensatory Behaviors

If you join the study, you will undergo screening evaluations to see if you are eligible to be in the study. If you are eligible to be in the study, you will be randomized to one of two study groups. Which group you are assigned to will be chosen by chance by a procedure similar to the t...

Protocol #: 21-3094

Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome

The purpose of this study is to compare the safety and effectiveness of tivanisiran sodium ophthalmic solution (eye drops) to placebo for treating signs and symptoms of DED in participants with a documented diagnosis of dry eye associated with Sjögren’s Syndrome. ...

Protocol #: 21-2624

Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment

This study is looking to see if treatment with 12 months of daily valacyclovir medication reduces the development of certain types of new or worsening eye disease; specifically, infection on the surface of the front of the eye (cornea), inflammation of the cornea, or inflammation inside th...

Protocol #: 17-0585

A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long-Term Safety, Tolerability, Pharmocokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

The TEASE studies (Tolerability and Effects of ALK-001 in Stargardt Disease) are a series of clinical trials evaluating an investigational drug called ALK-001 in people who have Stargardt Disease. There are no FDA-approved treatments to slow the progression of Stargardt Disease. Research s...

Protocol #: 19-1103

AMD Ryan Initiative Study (ARIS) - Longitudinal Study of Early AMD and Reticular Pseudodrusen

The goal of this project is to better understand the natural history and characteristics of early AMD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD and a certain finding associated with early AMD (Reticular Pseudodrus...

Protocol #: 18-0520

Utilization of Virtual Reality Mindfulness Application to Reduce Stress and Promote Wellbeing in University Students

Participants will be provided with Oculus Quest or Oculus Quest 2 VR headsets for the duration of the evaluation period (8-weeks) and will be asked to complete at least one 8-10 minute TRIPP VR mindfulness session 3-5 days per week via the VR headset or their mobile phone. Throughout the c...

Protocol #: 21-3622

Usefulness and performance with the IrisVision head-mounted video low vision aid in young individuals with congenital or early onset visual impairment

The IrisVision is a headset that is used by individuals with impaired vision to help them see better. This study plans to learn more about how well the IrisVision works for the younger population. If you meet the following criteria, you may be screened to participate in this study: ? Age...

Protocol #: 19-2383

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene

This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in fema...

Protocol #: 20-0130

A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double- Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

This is the second study in which NCX 470 is being given to humans. Based on the results of an earlier study in which 326 subjects with your condition received NCX 470 eye drops (0.021%, 0.042% or 0.065%), the first part of the current study will examine two different concentrations of NCX...

Protocol #: 20-0637

A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma

This study is being conducted on patients diagnosed with a type of eye cancer called choroidal melanoma or an indeterminate lesion (a growth in your eye that is suspected to be melanoma), also known as eye melanoma. People who have choroidal melanoma are usually treated with radiation ther...

Protocol #: 20-1186

Field Test of Glaucoma Outcomes Survey

The American Glaucoma Society is interested to learn how quality of life improves for patients after minimally invasive glaucoma surgery combined with cataract surgery. They have designed a questionnaire, the Glaucoma Outcomes Survey (GOS), to try to find out how reliable the GOS survey is...

Protocol #: 20-2477

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA? in Treating Patients with Chronic (Inactive) Thyroid Eye Disease

This research trial will compare TEPEZZA to a placebo (a “dummy” treatment). The trial drug TEPEZZA contains an active ingredient that is an inhibitor (slows down) of the “insulin-like growth factor 1” or IGF-1 receptor. The placebo looks just like the investigational drug but does not inc...

Protocol #: 20-2835

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

Patients diagnosed with stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) Neurotrophic Keratitis (NK) will take part in this study. Neurotrophic Keratitis (also called neurotrophic keratopathy) is a rare disease of the cornea that occurs when the nerves to the cornea do not...

Protocol #: 21-3923

VR Programs for Adolescent Anxiety

Do you treat adolescents who experience anxiety in social situations or are you the parent of an adolescent who experiences anxiety in social situations? If so, we would love to talk to you! Participation involves trialing social engagement content on a virtual reality (VR) headset. Partic...

Protocol #: 21-4407

Location: CU Anschutz non-hospital research facilities

Impact of SARS CoV2 on Post-Hospital Recovery of Carbohydrate and Muscle Metabolism: Role of Endothelial Injury

Protocol #: 21-3711

Impact of SomaSignal Tests on the choice of glucose-lowering medications: An Adaptive Implementation Study

Protocol #: 21-4510

Investigational Male Birth Control Gel

This clinical trial is an experimental research study using a potential new form of male birth control who want to avoid a pregnancy with their sexual partner....

Protocol #: 21-3956

Nexplanon Birth Control Implant Use When Primarily Using a Combined Birth Control Pill

Participants will use the birth control pills as their main method of birth control and have the implant as a continuous back-up method. ...

Protocol #: 20-1945

Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double-blind placebo-controlled trial JHM IRB

Protocol #: 19-3115

Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes

Protocol #: 20-2723

Research about the Potential for the Contraceptive Implant as Emergency Contraception

Are you a healthy female between the ages of 18-40? Are you interested in starting Nexplanon®, hormonal birth control that goes in your arm? Are you interested in how your body works, specifically in regard to ovulation? This study is determining if when placing an etonogestrel implant ...

Protocol #: 21-5026

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

Are you interested in participating in a research study to understand the health effects of the time we spend sitting? The ACTIVE Research Lab is looking for: • Women • 60 to 75 years of age • Non-smoker • If Type 2 Diabetes, not being treated with insulin • BMI 25-40 kg/m2 (check ...

Protocol #: 19-2758

Research on Computer Training to Help With Mood in Adolescents

This study plans to learn more about Interpretation Bias Training (IBT) in adolescents who are seeking outpatient mental health treatment. It uses a computer to show adolescents with irritability pictures of face emotions. The goal of this study is to test whether the training program that...

Protocol #: 17-0464

Premature Vascular Aging in Women following an In Vitro Fertilization Pregnancy

Ultrasound of blood vessels, blood draw, 24-hour blood pressure monitoring, body composition and bone mineral density testing Compensation is provided....

Protocol #: 21-2903

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics

Inclusion criteria: - Women aged 18-55 years - Non-smoking - Not taking medications to treat high blood pressure or cholesterol ...

Protocol #: 21-3590

Inhaled Cannabis, Oxidative Stress and the Pulmonary Innate Immune Response

Protocol #: 14-1957

NightWare Therapeutic Platform for improving Cardiovascular Health in Adults With Nightmares Associated with PTSD

Protocol #: 21-5027

A Multi-site Observational Study: NIH RECOVER Study of Long COVID in Adults

This is a longitudinal study enrolling individuals with and without SARS-CoV-2 infection at varying stages before and after infection and with or without post-acute sequelae of SARS-CoV-2 (PASC). NOTE: As of July 2022, we are ONLY able to enroll 1) Adults who have never had SARS-CoV-...

Protocol #: 21-4528

Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)

What is involved: • Measurements of bone mineral density • Completion of sleep questionnaires/assessments • Randomization to sleep with a simulated night shift schedule or normal sleep schedule • A general physical exam • Activity monitoring with a wrist monitor • Blood/urine collec...

Protocol #: 20-3013

Cannabis Teens and Choice Study (CATCH Study)

Protocol #: 22-0101

Location: Outpatient CTRC

Evaluation of Clinical Effectiveness, Cost, and Implementation Factors to Optimize Scalability of Treatment for Co-occurring SUD and PTSD Among Teens

Eligible participants will be randomly assigned to RRFT or Encompass (TAU) and will complete four research visits over the course of one year....

Protocol #: 21-3736

Location: Department Specific Free Standing Clinic

Phase 2 Study of Rogaratinib (BAY 1163877) in the Treatment of Patients with Sarcoma Harboring Alterations in Fibroblast Growth Factor Receptor (FGFR) 1-4 and SDH-deficient Gastrointestinal Stromal Tumor (GIST)

Protocol #: 22-0611

Location: University of Colorado Hospital

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

Prospective, single arm, multicenter study...

Protocol #: 22-0486

Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center

A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Protocol #: 22-0359

Location: University of Colorado Hospital

Naturalistic sleep assessed by wearable devices in Parkinson's disease

Wear a wrist activity monitor and headband at night to monitor sleep....

Protocol #: 22-0393

Location: Boulder Health Center, Lone Tree Medical Center, University of Colorado Hospital

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

Protocol #: 22-0175

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

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Protocol #: 22-0234

Location: University of Colorado Hospital

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Protocol #: 22-0306

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

PHASE 1/2 STUDY OF BLU-451 IN ADVANCED CANCERS WITH EGFR EXON20 INSERTION MUTATIONS

Protocol #: 22-0293

Location: CTRC Inpatient, University of Colorado Hospital

Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting

Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa...

Protocol #: 22-0325

Location: Harmony Campus, Medical Center of the Rockies

Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting

Protocol #: 22-0315

Location: Memorial Hospital Central

WATCHMAN FLX Real World Evidence Protocol

NA...

Protocol #: 22-0299

Location: Memorial Hospital Central

S2011: RANDOMIZED PHASE II TRIAL OF GEMCITABINE, AVELUMAB AND CARBOPLATIN VS. NO NEOADJUVANT THERAPY PRECEDING SURGERY FOR CISPLATIN-INELIGIBLE MUSCLE-INVASIVE UROTHELIAL CARCINOMA: SWOG GAP TRIAL

Protocol #: 22-0172

Location: Highlands Ranch Hospital, University of Colorado Hospital

Use of Modified Covered Stent for patient VP (U220042)

Protocol #: 22-0270

Location: Childrens Hospital Colorado

Single Patient IND for AEVI-007, IND# 159975 , Patient BM

Protocol #: 21-4949

Location: Childrens Hospital Colorado

A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)

Protocol #: 21-4929

Location: Outpatient CTRC, University of Colorado Hospital

Single Patient IDE 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

Integrating Home-Based Video Teleneuropsychology into Clinical Practice: Typical Versus Atypical Alzheimer's Disease

Protocol #: 21-5037

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

Point-of-Care Development and Testing of Digital Health Solutions for Clinical Health and Wellness

Protocol #: 21-5143

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

Reducing Pain and Opioid Use with CBD

Your participation in the research study will be 16 weeks, with 12 weeks of study medication use....

Protocol #: 21-5122

Location: Outpatient CTRC, Outpatient CTRC

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

Protocol #: 21-5088

Location: University of Colorado Hospital

A Pilot Feasibility Test of a Digital Solution for Remote Mental Health Monitoring and Care

If you join the study, you will first complete an initial baseline questionnaire about your mental health, general health, your experience with mental health care services, and demographic information (e.g., gender, age) about you. You will be emailed instructions on how to install the HR ...

Protocol #: 21-4903

Location: University of Colorado Hospital

Use of Fenestrated Atrial Septal Occluder (FASD) in patient ILA (U210560) single patient IDE

Protocol #: 21-5091

Location: University of Colorado Hospital

A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)

Protocol #: 21-4944

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

A First-in-human (FIH), Multicenter, Open Label, Single Arm, Dose Escalation Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

Protocol #: 21-3486

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

NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER

Protocol #: 21-4582

Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics through a Family-Based Community Intervention

Protocol #: 21-4605

Location: Medical Center of the Rockies

An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)

Protocol #: 21-4778

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

A Multicenter, Open-label, Phase 1a/b Study of HC-7366 in Subjects With Advanced Solid Tumors

Protocol #: 21-4887

Location: Outpatient CTRC, University of Colorado Hospital

A Phase II study of induction SBRT and olaparib followed by combination pembrolizumab/olaparib in gastric and gastroesophageal junction (GEJ) cancers

Protocol #: 21-4129

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

PEERLESS Study

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. The study will collect data on demograp...

Protocol #: 21-4920

Location: University of Colorado Hospital

A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors

Protocol #: 21-4822

Location: CTRC Inpatient, University of Colorado Hospital

Single Patient IDE for the use of Custom Made Covered Stent for patient JRR (U210502)

Protocol #: 21-4901

Location: Childrens Hospital Colorado

Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting BRIGHT - Digital therapeutic Based Randomized Investigation to improve Glycemic control in patients with type 2 diabetes and residual Hyperglycemia on stable medical Therapy

Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa...

Protocol #: 21-4891

Location: University of Colorado Hospital

EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

Protocol #: 21-4711

Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

A Phase 3 Study of CG0070 in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Protocol #: 21-4846

Location: CTRC Inpatient, University of Colorado Hospital

The American Lung Association (ALA) Lung Health Cohort

Protocol #: 21-4835

Location: University of Colorado Hospital

Comparison of Methods in Post-Operative Hip Arthroscopy Rehabilitation

Inquire within...

Protocol #: 21-4753

Location: Steadman Hawkins Clinic - Denver (Inverness)

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

A total of 270 patients will be randomized at up to 40 United States study centers and up to 10 centers outside the US (Canada and Europe). A maximum of 90 patients (33% of the total study population) will be randomized outside the United States. A maximum of 40 patients (15% of the to...

Protocol #: 21-4436

Location: University of Colorado Hospital

A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined with Hormonal Therapy or Chemotherapy in Subjects with Advanced Solid Tumors

Protocol #: 21-4716

Location: Highlands Ranch Hospital, University of Colorado Hospital

A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo EVD Catheter

Protocol #: 21-4725

Location: University of Colorado Hospital

Aneurysmal SubArachnoid Hemorrhage - Red Blood Cell Transfusion And Outcome (SAHaRA): A Randomized Controlled Trial

Protocol #: 21-4692

Location: University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease

Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu...

Protocol #: 21-4551

Location: Renal Research Center

PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os...

Protocol #: 21-4712

Location: Childrens Hospital Colorado

ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

Protocol #: 21-4447

Location: Childrens Hospital Colorado

A phase I study with an expansion cohort of duvelisib and nivolumab in mycosis fungoides (MF) and Sezary syndrome (SS)

Protocol #: 21-4327

Location: University of Colorado Hospital

A Phase 1/2, dose escalation and expansion study of the safety, tolerability, and anti-tumor activity of BND-22 administered alone and in combination with pembrolizumab or with cetuximab in patients with advanced solid tumors

Protocol #: 21-4633

Location: University of Colorado Hospital

Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease

Understanding the impact of gaps in care on healthcare utilization, long-term co-morbidities, and patient reported outcomes are the highest priority topics from patients, families and researchers. Additionally, knowledge about the factors associated with these gaps in care was a key facto...

Protocol #: 21-4668

Location: Childrens Hospital Colorado

An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

Protocol #: 21-4586

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

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

Protocol #: 21-4641

Location: University of Colorado Hospital

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)

Protocol #: 21-4639

Location: University of Colorado Hospital

EA2182: A Randomized Phase II Study of De-Intensified Chemo Radiation for Early Stage Anal Squamous Cell Carcinoma(DECREASE)

Protocol #: 21-4429

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

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

Protocol #: 21-4519

A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients

Protocol #: 21-4448

Location: University of Colorado Hospital

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects with Advanced or Metastatic Solid Tumors

Protocol #: 21-4329

Location: University of Colorado Hospital

Multicenter, randomized, parallel group, phase 2 study to establish the efficacy and safety of combinations of CBP501, cisplatin, and nivolumab for greater than or equal to 3rd line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3 at screening

Protocol #: 21-5119

Location: University of Colorado Hospital

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

The influence of pediatric irritability on inter-subject neural synchrony while processing ambiguous social information

The Emotion and Development Lab is seeking <b>teen</b> volunteers to research how irritability affects the brain's processing of social information. Our goal is to learn more about how people commonly react to social ambiguity and how irritable mood may relate to negative interpretations o...

Protocol #: 20-2633

Location: Brain Imaging Center (BIC)

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

Protocol #: 21-3488

Location: Childrens Hospital Colorado

Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss

Aim 1: We will collect samples from of clinically well-characterized trios (products of conception (POC), biological mother, and biological father) with a history of unexplained RPL. Specially, we will recruit a cohort of 1,000 RPL trios that are rigorously-phenotyped and not attributable...

Protocol #: 21-3533

Location: Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver

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

An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors

An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors...

Protocol #: 21-4364

Location: Memorial Hospital Central, Memorial Hospital North

Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex?), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function

Protocol #: 21-4360

Location: Outpatient CTRC, Outpatient CTRC

Pilot Study of suction as a mechanism of IUD Expulsion with Concomitant Menstrual Cup Use.

Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences ...

Protocol #: 21-4267

Location: Comprehensive Women's Health Center

SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION

Protocol #: 21-4079

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

MAGNETISMM-9 A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Protocol #: 21-4016

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

Respiratory Virus Transmission Network (RVTN)

The study will collect information from you and other household members on symptoms and patterns of contacts to learn how the virus is transmitted. Your household will be compensated for participating in this study....

Protocol #: 21-4270

Location: Childrens Hospital Colorado

A Prospective and Retrospective Registry and Biomarker Study to Evaluate the Natural History of Pediatric Patients with Cardiomyopathy due to MYBPC3 Mutations

This is a natural history study. ...

Protocol #: 21-4206

Location: Childrens Hospital Colorado

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

Protocol #: 21-3827

Location: University of Colorado Hospital

A Phase I, Open-Label, Multicenter Study of FT538 in Combination with Monoclonal Antibodies in Subjects with Advanced Solid Tumors

Protocol #: 21-4178

Location: Outpatient CTRC, University of Colorado Hospital

Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients with Brain Metastasis due to HR+/Her2- Breast Cancer

Protocol #: 21-4199

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

A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum-Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)

Protocol #: 21-4100

Location: University of Colorado Hospital

The Intersection of Oncology Care and Worker Well-Being

You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor...

Protocol #: 21-4139

Location: Saint Joseph Hospital, University of Colorado Hospital

A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with head and neck squamous cell carcinoma (HNSCC)

Protocol #: 21-4146

Location: University of Colorado Hospital

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

Phase 1b/2, Open-Label, Multicenter Study of ERAS-007 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Non-Small-Cell Lung Cancer (HERKULES-2)

Protocol #: 21-4032

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

A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma

Protocol #: 21-3986

Location: University of Colorado Hospital

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

Protocol #: 21-4131

Location: University of Colorado Hospital

A Prospective, Randomized Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

Protocol #: 21-3680

Location: Harmony Campus, Medical Center of the Rockies

SPHERES Neuromyelitis Optica Spectrum Disorder (NMOSD) Registry

Protocol #: 21-3763

Location: University of Colorado Hospital

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA)

Protocol #: 21-4033

Location: Childrens Hospital Colorado

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 Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK- 7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies

Protocol #: 21-4054

Location: University of Colorado Hospital

Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

Protocol #: 21-4059

Location: Outpatient CTRC, Outpatient CTRC

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

A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Patients with Metastatic Breast Cancer (mBCA) Who Have Progressed Through Prior Hormonal Therapy

Protocol #: 21-5099

Location: CTRC Inpatient, Lone Tree Medical Center, University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple-Doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) Patients

Protocol #: 21-3032

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

The effect of dronaderone on atrial fibrosis and atrial fibrillation recurrence post-ablation

EDORA is a multicenter, prospective, phase IV, randomized, and single-blinded clinical trial...

Protocol #: 21-3993

Location: Memorial Hospital Central

Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors

Interviews will be conducted by a member of the study team at two separate time points. Questions about your treatment and different factors that are important to you when making decisions about your treatment. The interviews will be audio and video recorded by the study team. Only study ...

Protocol #: 21-3870

Location: Childrens Hospital Colorado

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: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

CLINICAL AND RADIOLOGICAL CHARACTERISTICS OF HYPOPHOSPHATASIA IN ADULTS WITH TYPE 1 DIABETES

Protocol #: 21-3876

Location: Childrens Hospital Colorado, University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients with Myotonic Dystrophy Type 1, Followed by an Open-Label Extension

Protocol #: 21-3397

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

Group Cognitive Behavioral Treatment for Anxiety in Adolescents with Autism and Intellectual Disability: A Randomized Controlled Trial

What is the study about? This study investigates an adapted Cognitive Behavior Therapy (CBT) group treatment to determine if it is more effective than therapy services that adolescents with Autism (ASD) and Intellectual Disability (ID) are already receiving. What does the study entail? ...

Protocol #: 20-3142

Location: Department Specific Free Standing Clinic

Glucose Monitoring in Youth with Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)

The purpose of this study is to determine if pulmonary exacerbations in youth with cystic fibrosis cause blood sugars to vary during and after an exacerbation. Blood sugars will be monitored using a continuous glucose monitor (CGM) for 2 weeks both during and 6 weeks after an exacerbation...

Protocol #: 21-3666

Location: Childrens Hospital Colorado

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, Outpatient CTRC, University of Colorado Hospital

Alarm Fatigue in Medical-Surgical Nurses

Protocol #: 21-3868

Location: Broomfield Hospital, Greeley Campus, Highlands Ranch Hospital, Longs Peak Hospital, Longs Peak Hospital, Poudre Valley Hospital, Yampa Valley Medical Center

Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Protocol #: 21-3574

Location: University of Colorado Hospital

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3, PIVOTAL STUDY WITH AN OPEN-LABEL EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PARTICIPANTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG) ANTIBODY-ASSOCIATED DISEASE (MOG-AD)

Protocol #: 21-3747

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

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

Phase II Study of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16-positive Oropharyngeal Cancer who have experienced disease progression with prior anti-PD-1 therapy

Protocol #: 21-3833

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

A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC)

Protocol #: 21-3774

Location: CTRC Inpatient, University of Colorado Hospital

A PHASE 1/2 STUDY OF REGN5093-M114 (METXMET ANTIBODY-DRUG CONJUGATE) IN PATIENTS WITH MET OVEREXPRESSING ADVANCED CANCER

Protocol #: 21-3772

Location: University of Colorado Hospital

A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

Protocol #: 21-3726

Location: Outpatient CTRC, University of Colorado Hospital

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Protocol #: 21-3724

Location: CTRC Inpatient, University of Colorado Hospital

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

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

EF-36/Keynote B36: A pilot, single arm, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer

Protocol #: 21-3694

Location: Memorial Hospital Central, Memorial Hospital North

CONNECTS Master Protocol for Clinical Trials targeting macro-, micro-immuno-thrombosis, vascular hyperinflammation, and hypercoagulability and renin-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)

Protocol #: 21-3728-DH

Location: Denver Health and Hospital Authority

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304

Protocol #: 21-3677

Location: University of Colorado Hospital

A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)

Protocol #: 21-3616

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

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, Outpatient CTRC, University of Colorado Hospital

Left Atrial Posterior Wall Isolation in Conjunction with Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation

Protocol #: 21-3038

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

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...

Protocol #: 21-2835

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

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 with and without NBUVB in Vitiligo: A Phase 2A Randomized Double Blind, Vehicle-Controlled Clinical Trial

This is a randomized, double blind, vehicle-controlled clinical trial that includes 64 vitiligo patients. Study patients will be randomly assigned to receive active drugs (crisaborole or PF-07038124 ointment) or vehicle ointment, in combination with active NBUVB or sham-NBUVB. ...

Protocol #: 21-4837

Location: CTRC Inpatient, University of Colorado Hospital

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

Phase 1 Trial of Hu5F9-G4 (magrolimab) combined with dinutuximab in children and young adults with relapsed and refractory neuroblastoma or relapsed osteosarcoma

This study is being done to answer the following questions: -Is it safe to give magrolimab with dinutuximab to children, adolescents, and young adults with relapsed/refractory neuroblastoma or relapsed osteosarcoma? -What is the best dose of magrolimab to give with dinutuximab in childre...

Protocol #: 21-3374

Location: Childrens Hospital Colorado

Impact of quantitative measurements of postoperative activity on clinical outcomes

Protocol #: 21-3611

Location: University of Colorado Hospital

Genetic and epigenomic determinants of hearing loss in Hispanic populations

This study aims to identify genes and variants that are related to sensorineural hearing loss (SNHL) in children, including Hispanic children from multiple recruitment sites and non-Hispanic children from Colorado who are diagnosed with severe-to-profound congenital SNHL. We will collect D...

Protocol #: 21-3609

Location: Boulder Health Center, Childrens Hospital Colorado

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, Outpatient CTRC, University of Colorado Hospital

Advanced Planning for Online Accounts and Data

Protocol #: 21-3375

Location: 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...

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

Quantification of Endo- and Phytocannabinoids and Comparison to Pain Medication Requirements for Patients Undergoing Surgery for Cancer

To determine how daily cannabis use affects surgical outcomes....

Protocol #: 21-3544

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...

Protocol #: 21-3530

Location: Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC

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

Protocol #: 21-3367

Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic

MANATEE-T1D: Metformin ANd AutomaTEd insulin delivery system Effects on renal vascular resistance, insulin sensitivity, and cardiometabolic function in youth with Type 1 Diabetes

Protocol #: 21-3483

Location: Barbara Davis Center, Childrens Hospital Colorado

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 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

Protocol #: 21-3466

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...

Protocol #: 21-3447

Location: Renal Research Center, 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

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection (GS-US-528-9023)

Protocol #: 21-3252

Location: Outpatient CTRC, Outpatient CTRC

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Protocol #: 20-2614

Location: Childrens Hospital Colorado

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 Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

All participants will receive the study drug, larotrectinib. Patients may continue to take the study drug for up to 20 months if there aren't any side effects and their brain tumor does not get worse. Patients will be given a diary to write down the amount of study drugs (number of pills o...

Protocol #: 21-2520

Location: Childrens Hospital Colorado

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

A PHASE II STUDY OF CHECKPOINT BLOCKADE IMMUNOTHERAPY IN PATIENTS WITH SOMATICALLY HYPERMUTATED RECURRENT WHO GRADE 4 GLIOMA

Protocol #: 21-3021

Location: University of Colorado Hospital

NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Protocol #: 21-2970

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

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

EVALUATION OF REFERRING PROVIDER- AND PATIENT-LEVEL BARRIERS TO ACCESSING CHIMERIC ANTIGEN RECEPTOR T-CELL (CAR-T) TRIALS

Protocol #: 21-3325

Location: Childrens Hospital Colorado

A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

This is a prospective phase 1/2 trial designed to assess the hypothesis that vorinostat, in addition to standard graft versus host disease (GVHD) prophylaxis, is feasible and safe in children, adolescent and young adult patients. All subjects will undergo allogeneic BMT according to local ...

Protocol #: 20-2018

Location: Childrens Hospital Colorado

A Phase II Pilot Study of Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults with High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant: A Multicenter Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) Study (EXCEL Trial)

Protocol #: 21-2662

Location: Childrens Hospital Colorado

A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 in Patients with Advanced Solid Tumor Malignancies

Protocol #: 20-3038

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

AN INTERVENTIONAL, MULTI-CENTER INVESTIGATION OF SINGLE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) STABILIZED WITH PEDICLE SCREWS

Protocol #: 21-3281

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

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

Assessing feasibility, safety, and efficacy of deploying a closed-loop automated insulin delivery system by community-based primary care physicians and academic endocrinologists, in person and through telehealth.

The purpose of this study is to learn more about the safety and effectiveness of the iLet - Bionic pancreas device for treating Type 1 diabetes when implemented in primary care and endocrinology, and both in-person and via telehealth....

Protocol #: 21-3272

Location: Department Specific Free Standing Clinic, Lone Tree Medical Center, University of Colorado Hospital

Assessing diagnostic value of non-invasive FFRCT in coronary care in the emergency department

The overall purpose of this study is to help HeartFlow understand if the use of FFRCT in the ED will help physicians with diagnosis and treatment of chest pain. ...

Protocol #: 22-0025

Location: Memorial Hospital Central

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

Can pre-operative resiliency training with heart rate variability biofeedback reduce pain scores in patients undergoing periacetabular osteotomy?

Protocol #: 21-2770

Location: Childrens Hospital Colorado

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 Solid Tumors OLD TITLE: pen-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Triple Negative Breast Cancer

Protocol #: 21-3064

Location: Lone Tree Medical Center, University of Colorado Hospital

Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension Protocol# MOM-M281-006

Protocol #: 21-3149

Location: 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

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

Protocol #: 20-2670

Location: University of Colorado Hospital

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

Protocol #: 21-3184

Location: Childrens Hospital Colorado

Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease

Participants will be instructed in inspiratory muscle strength training (IMST) during baseline and will be evaluated during a 3 month period to see the effects of the device on systolic blood pressure. There will be a "placebo" arm. Participants will not know which arm they are in....

Protocol #: 21-3000

Location: University of Colorado Hospital

A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Protocol #: 21-3077

Location: University of Colorado Hospital

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 2 STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ROZANOLIXIZUMAB IN ADULT STUDY PARTICIPANTS WITH LEUCINE-RICH GLIOMA INACTIVATED 1 AUTOIMMUNE ENCEPHALITIS

Protocol #: 21-2955

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

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

Protocol #: 21-3118

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

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

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

Associative Threat Learning: Measuring Mechanisms for Treating Threat-based Psychopathologies

This study plans to learn more about how performance on a behavioral task, the Facial Affect Salience Task (FAST, may predict responses to a 12-session course of exposure therapy in young adult females with social anxiety disorder. If the task can predict responses to treatment, we should ...

Protocol #: 21-2631

Location: Brain Imaging Center (BIC), Childrens Hospital Colorado

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, Outpatient CTRC, University of Colorado Hospital

A081801 - INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO

Protocol #: 20-2646

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

Effect of Lower Limb Osseointegration Amputation across Multiple Biomechanical Domains

This study will use a combination of MRI and motion capture data collected in the laboratory to measure forces at the joints during common activities of daily living....

Protocol #: 20-3097

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

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 Partially-Blind, Randomized, Controlled, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (SF-RI 1 surfactant for inhalation combined with a dedicated drug delivery system) in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome

Babies in the Active groups may get up to 4 total doses of AeroFact during the first 96 hours of life, depending on how much oxygen and support from the nCPAP/nIMV your baby needs. Re-dosing with drug can occur as frequently as 2 hours after the start of the previous dose. Babies will no...

Protocol #: 21-2876

Location: University of Colorado Hospital

SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Protocol #: 21-2827

Location: Broomfield Hospital, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, 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, 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

Do decreased dietary fat and increased fiber reduce recurrence of Clostridioides difficile infection in oncology patients?

Protocol #: 21-2851

Location: Childrens Hospital Colorado, 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

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

In this study, we will 1. Assess different mouthpiece options to help make the test easier to do in young children 2. Obtain AOS measurements in children who are patients in the aerodigestive clinic at Children's Hospital Colorado 3. Compare these measurements to those obtained in chil...

Protocol #: 21-2637

Location: Childrens Hospital Colorado

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

A PHASE 2 STUDY OF MECBOTAMAB VEDOTIN (BA3011) ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHO HAD PRIOR DISEASE PROGRESSION ON OR ARE INTOLERANT TO A PD-1/L1, EGFR, OR ALK INHIBITOR

Protocol #: 21-2670

Location: Outpatient CTRC, University of Colorado Hospital

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

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

AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T...

Protocol #: 20-3065

Location: Childrens Hospital Colorado

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...

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

A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

This is an international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study in patients with PBC. Approximately 180 subjects will be randomized in 2:1 ratio (seladelpar:placebo) across approximately 150 sites worldwide. Enrolle...

Protocol #: 21-2480

Location: University of Colorado Hospital

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Protocol #: 20-2649

Location: Children's Hospital National (CHN), Children's Hospital National (CHN), Childrens Hospital Colorado, Colorado State University, Uniformed Services University of Health Sciences (USUHS), Uniformed Services University of Health Sciences (USUHS)

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

EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

This is a Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and PK of alpelisib in pediatric and adult participants with PROS....

Protocol #: 20-2825

Location: Childrens Hospital Colorado

A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in ambulatory subjects with Duchenne Muscular Dystrophy (DMD)

Protocol #: 20-2929

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) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)

Protocol #: 20-2995

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. ...

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

Treatment for Alcohol Use Disorder: Emotion Regulation and Brain Function

This study plans to learn more about the brain's role alcohol use problems and recovery. Prominent theories about alcohol use disorder suggest that it is a disorder of the brain. However, it remains unclear what parts of the brain work differently in alcohol use disorder. This study intend...

Protocol #: 20-3000

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

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study

Protocol #: 20-2933

Location: Outpatient CTRC, University of Colorado Hospital

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

Protocol #: 20-2971

Location: Medical Center of the Rockies

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...

Protocol #: 20-2899

Location: 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

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. ...

Protocol #: 20-2821

Location: Outpatient CTRC, 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 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

Hemodynamic Monitoring to Support Intraprocedural Management of Ventricular Tachycardia Ablation

Protocol #: 20-1608

Location: Rocky Mountain Regional VA 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...

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: Cherry Creek Medical Center, Highlands Ranch Hospital, 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

A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).

Protocol #: 20-2357

Location: Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, University of Colorado Hospital

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...

Protocol #: 20-2692

Location: Outpatient CTRC, 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...

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: CTRC Inpatient, 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 Participants who are Cisplatin-Ineligible Participants or Decline Cisplatin with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

Protocol #: 20-2607

Location: Highlands Ranch Hospital, University of Colorado Hospital

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 patients must agree to participate. Caregivers are defined as people married to or partnered with cancer patients who play a role in the patient's treatment and personal care. The interventions will last 8-12 weeks and study participation will last 12 months. Caregivers in a...

Protocol #: 20-2458

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

The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study

This is a non-treatment study that uses a blood test ("Prospera") to measure kidney function following transplant. This study will look at the usefulness of the Prospera testing compared to the usual serum creatinine testing done at regular intervals in kidney transplant recipients. ...

Protocol #: 19-2394

Location: University of Colorado Hospital

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

Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)

Protocol #: 20-0280

Location: Childrens Hospital Colorado

A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)

Protocol #: 20-2471

Location: Childrens Hospital Colorado

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

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...

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

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

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

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

Children with Food Allergy: Diet, Microbiome function and structure and Immune outcomes. (FADMI)

Protocol #: 20-2389

Location: Childrens Hospital Colorado

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....

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 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

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

Protocol #: 20-1789

Location: University of Colorado Hospital

A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5)

Protocol #: 20-1026

Location: University of Colorado Hospital

A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors

Protocol #: 20-2199

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)...

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

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....

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: Highlands Ranch Hospital, 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. ...

Protocol #: 20-1681

Location: Childrens Hospital Colorado, Outpatient CTRC, 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

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...

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...

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

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

CC-486 and Venetoclax for Acute Myeloid Leukemia

Protocol #: 20-1319

Location: Lone Tree Medical Center, 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

ColorAdo ReseArch on Menopause & Early Life Stress Study: Remote Participation

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 ...

Protocol #: 19-1226

Location: Childrens Hospital Colorado, University of Colorado Hospital

A Multi-Center, Controlled Study to Evaluate use of CereGate Therapy to Reduce Freezing of Gait in Participants diagnosed with Parkinson's Disease

Protocol #: 21-5060

Location: CTRC Inpatient, Outpatient CTRC, 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

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

A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)

Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable...

Protocol #: 20-1690

Location: University of Colorado Hospital

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, 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...

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...

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 ...

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, Outpatient CTRC, University of Colorado Hospital

A Prospective Natural History Study of Diagnosis, Treatment and Outcomes of Children with SCID Disorders

Protocol #: 12-1549

Location: Childrens Hospital Colorado

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. ...

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...

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

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...

Protocol #: 20-1008

Location: Childrens Hospital Colorado

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

Protocol #: 20-0638

Location: Outpatient CTRC, 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 Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the ...

Protocol #: 20-1341

Location: University of Colorado Hospital

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

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn...

Protocol #: 20-1262

Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital

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...

Protocol #: 20-6039

Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver (Inverness), UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital, Yampa Valley Medical Center

Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event

The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). ...

Protocol #: 20-6019

Location: Memorial Hospital Central

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. ...

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, 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 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...

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, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, St. Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center

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

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, 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

The early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy

What Happens If I Join the Study? - You will have 4 study visits during pregnancy and 1 study visit after your baby is born - You will be asked to prick your finger to monitor blood sugar and blood triglyceride levels 4 times a day for 4 days after each visit (total of 64 finger pokes) ...

Protocol #: 20-0706

Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC

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. ...

Protocol #: 20-0572

Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC

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

Protocol #: 20-0590

Location: Department Specific Free Standing Clinic

PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD

Protocol #: 20-0277

Location: Childrens Hospital Colorado, Outpatient CTRC

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

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: Longs Peak Hospital, Longs 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

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

Protocol #: 20-0347

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

Validation of the Apollo EE Device, Indirect Calorimetry

Protocol #: 20-0317

Location: Anschutz Health and Wellness, Outpatient CTRC, 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

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, 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

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...

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...

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...

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)

Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations

Protocol #: 19-3063

Location: Boulder Health Center, Broomfield Hospital, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver (Inverness), UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital

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

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

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....

Protocol #: 19-2794

Location: Childrens Hospital Colorado

A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopedic Hardware

Screened patients will be briefed of the study protocol and if interested in participating in the study, will complete informed consent. During their regular follow-up visits, patients will have an antenna attached to their affected limb using velcro straps and stand on a flat platform tha...

Protocol #: 19-3107

Location: Medical Center of the Rockies

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...

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...

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

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

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial Hypertension

Protocol #: 19-3001

Location: Childrens Hospital Colorado

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)

A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the v...

Protocol #: 19-2935

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

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...

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 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

Protocol #: 19-2761

Location: 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...

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...

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

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...

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 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

Executive Functioning Outcome Measures for Down Syndrome

Protocol #: 19-2576

Location: Childrens Hospital Colorado

In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study

NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee inject...

Protocol #: 19-2499

Location: Boulder Sports Clinic, CU Sports Medicine - Denver, University of Colorado Hospital

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 (CARE)

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...

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...

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. ...

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

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...

Protocol #: 19-2335

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

GORE? CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF Clinical Study): A Study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale for relief of migraine headaches

Protocol #: 20-6000

Location: Harmony Campus, Medical Center of the Rockies

Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health

This study will involve 4-5 in person visits. There will be screening visit for some patients and then a baseline visit over two days. The first day will involve an IV and drinking a sugary drink with blood draws as well as measuring the resting metabolic rate and answering questionnaires....

Protocol #: 19-2109

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

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

The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function

Study involves 1 - 2 clinic visits that last about 1 hour....

Protocol #: 18-1960

Location: University of Colorado Hospital

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...

Protocol #: 19-2092

Location: Childrens Hospital Colorado

An open-label, long-term study of GFB-887 in Patients with Glomerular Kidney Disease

Protocol #: 22-0267

Location: Renal Research Center

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)...

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 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

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

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...

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...

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 a Fluoropyrimidine in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction (LYNK-003)

Protocol #: 19-6102

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

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

A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder

Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may...

Protocol #: 19-1658

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

Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome

This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receiv...

Protocol #: 19-1362

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

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

APOL1 Long-term Kidney Transplantation Outcomes Network

APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a pros...

Protocol #: 19-0461

Location: University of Colorado Hospital

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

Protocol #: 19-0506

Location: Outpatient CTRC, 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

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

Protocol #: 19-1150

Location: Barbara Davis Center, 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

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

Protocol #: 19-1282

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

Financial Burden Associated with Retirement among Cancer Survivors

Protocol #: 19-1419

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....

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...

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, 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...

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

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

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. ...

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, Outpatient CTRC, 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 PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS

This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimm...

Protocol #: 19-0460

Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital

Sex-based differences in the neuronal mechanisms of food intake behavior

Participants will: -Complete 2 to 4 MRI scans -Complete food, attention, and mood questionnaires -Complete blood draws for measuring hormones -Receive a free Fitbit...

Protocol #: 19-1148

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

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...

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

Prevention of enamel demineralization in fixed appliance orthodontic patients using CPP-ACP-NaF varnish compared to blank varnish base. A randomized split mouth controlled clinical trial

The hypothesis is that casein phosphopeptide stabilized amorphous calcium phosphate fluoride releasing (CPP-ACP-NaF) dental varnish will be more effective at reducing enamel demineralization than the control varnish base that does not contain CPP-ACP-NaF. ...

Protocol #: 19-0968

Location: Dental Clinic, UCD Dental Clinic

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Protocol #: 18-0220

Location: Outpatient CTRC, Outpatient CTRC, 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

A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS 181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Protocol #: 19-0853

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....

Protocol #: 19-0636

Location: Childrens Hospital Colorado, Outpatient CTRC, 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

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...

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...

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 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

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

Protoco