Research Studies

Protocol #: 20-2505

Location: Childrens Hospital Colorado

Protocol #: 20-2414

Location: Childrens Hospital Colorado

Protocol #: 20-1988

Location: University of Colorado Hospital

Protocol #: 20-1864

Location: Childrens Hospital Colorado

To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age

Protocol #: 20-9990

Locations: Greeley Campus; Medical Center of the Rockies; Poudre Valley Hospital

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 oncogenic driver mutations, and who have progressed following first line treatment with PD-1 or PD-L1 targeting agents having previously achieved a best response of stable disease or better measured after 12 weeks.

Protocol #: 20-1690

Location: University of Colorado Hospital

Protocol #: 20-1721

Location: Childrens Hospital Colorado

Protocol #: 20-1619

Location: University of Colorado Hospital

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 20-1487

Location: Childrens Hospital Colorado

Protocol #: 20-1453

Location: University of Colorado Hospital

Protocol #: 20-1106

Location: Childrens Hospital Colorado

The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19.

Protocol #: 20-6506

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 20-1318

Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 20-6034

Location: Medical Center of the Rockies

Protocol #: 19-2469

Location: Childrens Hospital Colorado

Protocol #: 20-0246

Location: University of Colorado Hospital

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 the delivery of care to patients during a pandemic.

Protocol #: 20-6039

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

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).

The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs.

Protocol #: 20-6019

Location: Memorial Hospital Central

Protocol #: 20-1197

Locations: Barbara Davis Center; Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 20-1219

Location: University of Colorado Hospital

Protocol #: 20-1055

Locations: Highlands Ranch Hospital; University of Colorado Hospital

Protocol #: 20-6037

Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 20-0564

Locations: 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

Protocol #: 20-0563

Locations: 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

Protocol #: 20-0880

Location: University of Colorado Hospital

This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections.

This study is to evaluate the effectiveness of Expanded Focused Assessment with Sonography in Trauma (EFAST) in identifying high risk trauma patients with active COVID-19 pulmonary infections.

Protocol #: 20-0751

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 20-0889

Location: Childrens Hospital Colorado

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

Protocol #: 20-6502

Location: Medical Center of the Rockies

Protocol #: 20-6031

Location: Poudre Valley Hospital

Protocol #: 20-0781

Location: University of Colorado Hospital

Protocol #: 20-0820

Location: Childrens Hospital Colorado

Protocol #: 20-0454

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 20-0481

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 20-0584

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital

Collect outcomes data on patients who have been diagnosed with COVID-19 and have undergone surgery.

Protocol #: 20-0614

Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 20-0685

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic; University of Colorado Hospital

Protocol #: 20-0537

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 20-0571

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 20-0589

Location: University of Colorado Hospital

Protocol #: 20-0620

Location: University of Colorado Hospital

Protocol #: 20-0596

Location: Childrens Hospital Colorado

Protocol #: 20-0560

Location: University of Colorado Hospital

Protocol #: 20-0580

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

Protocol #: 13-2700

Location: Childrens Hospital Colorado

What you receive for participating: -Personalized information about your energy expenditure ("metabolism") -Five total days of food -Monetary compensation

Test whether accelerometer-based measures of physical activity from Actigraph and ActivPAL accelerometers can be used to improve the calculation of TEF in whole room calorimeter studies.

Protocol #: 20-0191

Location: University of Colorado Hospital

While you are taking part in in the study, you will see your doctor as usual. Your doctor will make notes (medical records) about your disease and its treatment as he/she normally would. For the next 5 years, a study coordinator at your doctor’s office will collect information from your doctor’s notes about your medical condition and treatments, including any medication changes.

Protocol #: 19-6518

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 20-0535

Location: Childrens Hospital Colorado

Protocol #: 20-0404

Location: University of Colorado Hospital

Protocol #: 20-0099

Location: Childrens Hospital Colorado

Protocol #: 20-6027

Locations: Long's Peak Hospital; Longs Peak Hospital

Protocol #: 15-0813

Location: University of Colorado Hospital

Protocol #: 19-2756

Location: Childrens Hospital Colorado

Protocol #: 20-0346

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 20-0347

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 20-0317

Locations: Anschutz Health and Wellness; University of Colorado Hospital

Protocol #: 20-0357

Location: University of Colorado Hospital

Protocol #: 20-0359

Locations: 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

Protocol #: 20-0365

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

Protocol #: 20-0360

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 20-0262

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-2236

Locations: Denver Health Medical Center; University of Colorado Hospital

Protocol #: 20-0271

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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 consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Protocol #: 20-0288

Location: University of Colorado Hospital

Protocol #: 20-0226

Location: Childrens Hospital Colorado

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 of this investigation is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS.

Protocol #: 20-0254

Location: University of Colorado Hospital

Protocol #: 20-0104

Location: University of Colorado Hospital

Protocol #: 20-0189

Location: Childrens Hospital Colorado

The purpose of this research is to demonstrate a relationship between cortisol measured in hair, cortisol measured in saliva, and the results of self-reported psychological measures (questionnaires).

Protocol #: 20-0025

Location: Department Specific Free Standing Clinic

Protocol #: 20-0052

Location: Childrens Hospital Colorado

This is a 12-week combined aerobic and resistance exercise intervention in breast cancer survivors. Before and after the intervention, women will undergo measures of appetite, energy intake, body composition, and resting metabolic rate.

Protocol #: 19-3032

Location: University of Colorado Hospital

Protocol #: 20-0007

Location: University of Colorado Hospital

Protocol #: 20-0127

Location: University of Colorado Hospital

Protocol #: 20-0124

Location: University of Colorado Hospital

Study B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents ?12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015).

Protocol #: 19-2839

Location: University of Colorado Hospital

Protocol #: 19-3061

Location: University of Colorado Hospital

Protocol #: 20-0035

Location: University of Colorado Hospital

Protocol #: 19-2998

Location: University of Colorado Hospital

Protocol #: 19-3118

Location: University of Colorado Hospital

Protocol #: 19-2514

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

Protocol #: 19-3007

Location: Childrens Hospital Colorado

Protocol #: 19-3011

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-2323

Locations: Anschutz Health and Wellness; University of Colorado Hospital

Protocol #: 19-2999

Location: University of Colorado Hospital

Protocol #: 19-3023

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-2943

Location: University of Colorado Hospital

Protocol #: 19-2758

Location: University of Colorado Hospital

Protocol #: 19-2833

Locations: Memorial Hospital Central; University of Colorado Hospital

Protocol #: 19-2987

Location: University of Colorado Hospital

Protocol #: 13-2246

Location: Childrens Hospital Colorado

Protocol #: 19-2163

Location: Childrens Hospital Colorado

Protocol #: 19-2946

Location: University of Colorado Hospital

Protocol #: 19-2913

Location: Childrens Hospital Colorado

Protocol #: 19-2760

Location: University of Colorado Hospital

Protocol #: 19-2960

Location: University of Colorado Hospital

Protocol #: 19-6517

Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital

Protocol #: 19-2897

Location: University of Colorado Hospital

Protocol #: 19-2898

Location: University of Colorado Hospital

Protocol #: 19-2940

Location: Childrens Hospital Colorado

Protocol #: 19-2893

Location: Steadman Hawkins Clinic - Denver

Protocol #: 19-2950

Location: Childrens Hospital Colorado

Protocol #: 19-2838

Location: Steadman Hawkins Clinic - Denver

Protocol #: 19-2888

Location: University of Colorado Hospital

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 vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.

Protocol #: 19-2935

Location: University of Colorado Hospital

Protocol #: 19-2910

Locations: Barbara Davis Center; University of Colorado Hospital

Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished.

Protocol #: 19-2904

Locations: Renal Research Center; University of Colorado Hospital

If you join the study, you will participate in two study sessions, which can be completed either in-person (at Anschutz Medical Campus, in Aurora, CO) or remotely - over the internet, over the course of 2 months. The first part of the study is the screening session. During this session, the research staff will conduct an interview with you and complete questionnaires about your medical and mental health history, and your mood. The second and last part of the study is the test session. During this session, you will complete surveys about your mood, and you will rate 160 digital images. Forty of those images will be pleasant, 40 will be unpleasant, 40 will be neutral, and 40 will be erotic. You will rate these images on scales of how pleasant/unpleasant and of how arousing/non-arousing you find these images.

To investigate ratings of digital images across the female menstrual cycle

Protocol #: 19-2872

Locations: Department Specific Free Standing Clinic; University of Colorado, Boulder

Protocol #: 19-2797

Location: University of Colorado Hospital

Protocol #: 19-6133

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 19-2818

Location: University of Colorado Hospital

Protocol #: 19-2761

Location: University of Colorado Hospital

Protocol #: 19-2721

Location: University of Colorado Hospital

Protocol #: 19-2795

Location: University of Colorado Hospital

Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.

Protocol #: 19-2854

Location: University of Colorado Hospital

Protocol #: 19-2645

Location: University of Colorado Hospital

Protocol #: 19-2788

Location: University of Colorado Hospital

Protocol #: 19-2326

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

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 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.

Protocol #: 19-2824

Location: University of Colorado Hospital

Your participation in the study would include up to 36 clinic visits over a 9-month period. During your time in the study, you will have physical exams, pelvic exams, breast exams, vital sign assessments, blood tests, pregnancy tests, and possibly a PAP smear. You will also have transvaginal ultrasounds of your ovaries to determine if you are at risk for pregnancy during the study. In addition, you will also be asked about your complete medical history, including your gynecological, menstrual, reproductive and sexual history.

This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception.

Protocol #: 19-2820

Location: Comprehensive Women's Health Center

Protocol #: 19-2525

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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 study finishes.

Protocol #: 19-2782

Locations: Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital

Protocol #: 19-2554

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital

Protocol #: 19-2676

Locations: Anschutz Health and Wellness; University of Colorado Hospital

Protocol #: 19-2744

Location: Childrens Hospital Colorado

Protocol #: 19-0795

Location: University of Colorado Hospital

Protocol #: 19-2471

Location: University of Colorado Hospital

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

Protocol #: 19-6129

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 19-2640

Location: Rocky Mountain Regional VA Medical Center

Protocol #: 19-2707

Location: University of Colorado Hospital

Protocol #: 19-2532

Location: University of Colorado Hospital

Protocol #: 19-2564

Location: University of Colorado Hospital

Protocol #: 19-2377

Location: University of Colorado Hospital

Protocol #: 19-2631

Location: Childrens Hospital Colorado

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

Locations: Department Specific Free Standing Clinic; University of Colorado Hospital

Protocol #: 19-2378

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 19-2333

Location: Childrens Hospital Colorado

Protocol #: 19-2520

Location: University of Colorado Hospital

Protocol #: 19-2445

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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 injection (i.e. steroid injection).

Protocol #: 19-2499

Locations: Boulder Sports Clinic; CU Sports Medicine - Denver; University of Colorado Hospital

Protocol #: 19-2521

Location: University of Colorado Hospital

Protocol #: 19-2524

Location: University of Colorado Hospital

Protocol #: 19-2533

Locations: Barbara Davis Center; University of Colorado Hospital

Protocol #: 19-1896

Location: Childrens Hospital Colorado

Protocol #: 19-2438

Location: Childrens Hospital Colorado

Protocol #: 19-2475

Location: Childrens Hospital Colorado

Protocol #: 19-2420

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 19-2390

Location: University of Colorado Hospital

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 did not take antibiotics during pregnancy. Pregnant women will be recruited between their 35-37th weeks of pregnancy and will complete two surveys, the first prenatally and the second at 6-weeks postpartum.

Protocol #: 19-2288

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-0821

Location: University of Colorado Hospital

Protocol #: 19-2344

Location: University of Colorado Hospital

Protocol #: 19-2311

Location: University of Colorado Hospital

Protocol #: 19-1929

Location: University of Colorado Hospital

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

Protocol #: 19-2363

Location: University of Colorado Hospital

Protocol #: 19-1598

Location: University of Colorado Hospital

Protocol #: 19-1980

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year.

Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation.

Protocol #: 19-2362

Locations: Pathology - SOM; University of Colorado Hospital

Protocol #: 19-2357

Location: Childrens Hospital Colorado

Protocol #: 19-2038

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 19-2134

Locations: UCHealth Central Park Medical Center; University of Colorado Hospital

Protocol #: 19-2295

Location: Childrens Hospital Colorado

Protocol #: 19-2255

Location: University of Colorado Hospital

Protocol #: 19-2242

Location: University of Colorado Hospital

Protocol #: 19-1913

Locations: 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

Protocol #: 19-1613

Location: Childrens Hospital Colorado

Protocol #: 19-2270

Location: Childrens Hospital Colorado

Protocol #: 19-2285

Locations: Boulder Health Center; Broomfield Hospital; Cherry Creek Medical Center; Highlands Ranch Hospital; Lone Tree Medical Center; Steadman Hawkins Clinic - Denver; UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital

Protocol #: 19-6114

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 16-2190

Location: Childrens Hospital Colorado

Protocol #: 19-2095

Location: University of Colorado Hospital

Protocol #: 16-0927

Location: Childrens Hospital Colorado

Protocol #: 17-0230

Location: Childrens Hospital Colorado

i. To compare differences in muscle recruitment, gait patterns (kinematics & kinetics), spaciotemporal variables, functional movements (squats, lunges, sit-to-stand, and single leg steps), and pelvic tilt between patients with femoroacetabular impingement (FAI) and age-matched morphologically normal controls. ii. To compare differences in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt between symptomatic and asymptomatic patients with FAI morphology. iii. To compare changes in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt pre- and post-intra-articular hip injection in symptomatic FAI patients. iv. To test if anatomical variables (alpha angle, center edge angle, FAI version) are predictors of change in gait and movement patterns.

Protocol #: 16-1934

Location: Childrens Hospital Colorado

Protocol #: 14-0343

Location: Childrens Hospital Colorado

Protocol #: 14-1413

Location: Childrens Hospital Colorado

Protocol #: 18-1076

Location: Childrens Hospital Colorado

Protocol #: 19-1621

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Aim 1: Primary outcome measures include lung function measurements from oscillometry and spirometry, change in oscillometry and spirometry measurements after bronchodilator is given, and results from a Six-Minute Walk test. Aim 2: Primary outcome measures are absolute neutrophil count and C-reactive protein in blood. Secondary outcomes to identify an atopic asthma phenotype include eosinophil count, total IgE, allergen specific IgE, and fractional exhaled nitric oxide. Assessment for nicotine exposure via blood cotinine is additional secondary outcome. Aim 3: Primary outcomes are respiratory symptom and quality of life assessments obtained by questionnaires.

Protocol #: 19-2092

Location: Childrens Hospital Colorado

Protocol #: 19-1840

Location: University of Colorado Hospital

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Protocol #: 17-0464

Location: Childrens Hospital Colorado

Protocol #: 19-1589

Location: Rocky Mountain Regional VA Medical Center

Protocol #: 19-1588

Location: Rocky Mountain Regional VA Medical Center

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) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.

To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.

Protocol #: 19-1978

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-1977

Location: University of Colorado Hospital

Protocol #: 19-1809

Location: University of Colorado Hospital

Protocol #: 15-1434

Location: Childrens Hospital Colorado

Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compensation and instruction on resistance exercise.

Protocol #: 19-1974

Location: University of Colorado Hospital

Protocol #: 16-0145

Location: Childrens Hospital Colorado

Protocol #: 19-1925

Location: University of Colorado Hospital

Protocol #: 19-6100

Locations: Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 19-1839

Location: Childrens Hospital Colorado

Protocol #: 19-1481

Location: Childrens Hospital Colorado

Protocol #: 18-1380

Location: Childrens Hospital Colorado

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 patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses.

Protocol #: 19-1874

Location: University of Colorado Hospital

Protocol #: 19-6513

Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital

Protocol #: 19-2412

Location: Childrens Hospital Colorado

A new study is looking at a device that would strengthen the muscles of the mouth to make eating and drinking easier for those who have trouble swallowing. Participants will be randomized to either the group using the investigational device for tongue exercise or the group using standard of care tongue depressors. All participants will receive compensation for participating.

To develop a low-cost device that improves patient outcomes by eliciting the same methods of action of existing higher cost devices. To assess if exercising the tongue with this novel device can achieve increased tongue strength among individuals with Parkinson's disease.

Protocol #: 19-1850

Location: University of Colorado Hospital

Protocol #: 19-1633

Location: Childrens Hospital Colorado

Protocol #: 19-1727

Location: University of Colorado Hospital

Protocol #: 02-729

Location: Department Specific Free Standing Clinic

Protocol #: 19-1711

Location: University of Colorado Hospital

Protocol #: 19-1597

Location: University of Colorado Hospital

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 tricuspid valve surgery.

Protocol #: 19-1823

Location: University of Colorado Hospital

This is a non-interventional, multi-site, specimen collection study for CF patients who have rare CFTR mutations. Once a potentially eligible subject is identified (either self-identified or by their CF care center), and the subject has expressed interest in participating in the study, the subject will be referred to a participating study site to receive additional information about the study and about travel arrangements (if needed). Nasal epithelial cells and blood (to confirm genotype) will be collected from all subjects; additional blood samples and rectal biopsy samples will be optional. The study consists of a single visit, however it is anticipated that many subjects will need to travel so study participation time is estimated at 2 days.

Protocol #: 16-2412

Location: Childrens Hospital Colorado

Protocol #: 19-6102

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes

Protocol #: 19-6101

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 19-1600

Location: University of Colorado Hospital

Protocol #: 15-0140

Location: Childrens Hospital Colorado

Protocol #: 19-1787

Location: Childrens Hospital Colorado

Protocol #: 19-1696

Location: Rocky Mountain Regional VA Medical Center

Protocol #: 19-1697

Location: Rocky Mountain Regional VA Medical Center

Protocol #: 19-1634

Location: Childrens Hospital Colorado

This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.

Protocol #: 19-1679

Location: University of Colorado Hospital

Protocol #: 19-1467

Location: Childrens Hospital Colorado

This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins.

Protocol #: 19-6511

Location: Memorial Hospital Central

Protocol #: 19-6510

Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Protocol #: 19-1703

Location: University of Colorado Hospital

Protocol #: 19-1503

Location: University of Colorado Hospital

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 identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.

The overarching hypothesis of this proposal is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking Alcohol Use Disorder individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, we will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking.

Protocol #: 19-1658

Locations: Department Specific Free Standing Clinic; University of Colorado Hospital

Protocol #: 19-1620

Location: University of Colorado Hospital

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 receive tofacitinib. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis. Participants must attend eight study visits at the University of Colorado Anschutz Medical Campus during the 18-week trial and have a study partner available to attend the visits with them. A blood draw for safety monitoring is required at each visit. Participants will be given tofacitinib at no cost for the duration of the study.

Protocol #: 19-1362

Location: University of Colorado Hospital

Protocol #: 14-1720

Location: Childrens Hospital Colorado

Protocol #: 19-1644

Location: University of Colorado Hospital

Protocol #: 15-0902

Locations: Childrens Hospital Colorado; Colorado Research Center

Protocol #: 19-1566

Location: University of Colorado Hospital

Protocol #: 19-1461

Location: University of Colorado Hospital

Protocol #: 19-1318

Locations: 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

Protocol #: 19-0506

Location: University of Colorado Hospital

Protocol #: 19-1458

Location: University of Colorado Hospital

Protocol #: 19-1455

Location: University of Colorado Hospital

Protocol #: 19-6509

Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital

Protocol #: 19-1418

Location: Childrens Hospital Colorado

Protocol #: 19-1337

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

Protocol #: 16-1270

Locations: Denver Health Medical Center; University of Colorado Hospital

Protocol #: 19-1230

Location: Childrens Hospital Colorado

Protocol #: 19-1282

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-1342

Location: University of Colorado Hospital

Protocol #: 19-1302

Location: University of Colorado Hospital

Protocol #: 19-1423

Location: University of Colorado Hospital

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. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses.

Protocol #: 19-1403

Location: Childrens Hospital Colorado

Protocol #: 19-1399

Location: University of Colorado Hospital

Protocol #: 19-1387

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-0744

Location: University of Colorado Hospital

Protocol #: 18-2793

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-1192

Location: University of Colorado Hospital

remede System Therapy in patients with central sleep apnea

Protocol #: 19-6087

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 19-1259

Location: Childrens Hospital Colorado

This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.

Protocol #: 19-6506

Location: Memorial Hospital Central

Protocol #: 19-1081

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-1297

Location: University of Colorado Hospital

Protocol #: 19-1111

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-1121

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

Protocol #: 19-1152

Locations: 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

Protocol #: 19-1154

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

Protocol #: 19-1132

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-1145

Location: University of Colorado Hospital

Protocol #: 16-2408

Location: Childrens Hospital Colorado

To test the predictive ability of the Trauma Sepcific Frailty Index.

Protocol #: 19-6084

Location: Medical Center of the Rockies

Protocol #: 19-1277

Location: Childrens Hospital Colorado

Protocol #: 19-6076

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 19-1272

Location: University of Colorado Hospital

Protocol #: 16-1480

Location: Childrens Hospital Colorado

Protocol #: 15-2332

Location: Childrens Hospital Colorado

Protocol #: 19-1251

Locations: Brain Imaging Center (BIC); Department Specific Free Standing Clinic

Protocol #: 19-1146

Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

Protocol #: 19-0889

Locations: Brain Imaging Center (BIC); Childrens Hospital Colorado; Colorado Research Center; University of Colorado Hospital

Protocol #: 16-1998

Location: Childrens Hospital Colorado

Protocol #: 19-0675

Location: University of Colorado Hospital

Protocol #: 19-0865

Location: University of Colorado Hospital

Protocol #: 19-1171

Location: University of Colorado Hospital

Protocol #: 19-1113

Location: University of Colorado Hospital

Protocol #: 19-0554

Location: University of Colorado Hospital

Protocol #: 19-1199

Location: University of Colorado Hospital

Protocol #: 19-1118

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-1040

Location: University of Colorado Hospital

Protocol #: 19-1074

Location: University of Colorado Hospital

Protocol #: 18-2625

Location: Rocky Mountain Regional VA Medical Center

Protocol #: 19-1147

Location: University of Colorado Hospital

Protocol #: 19-1069

Location: University of Colorado Hospital

Protocol #: 15-0693

Location: Childrens Hospital Colorado

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 well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.

Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system.

Protocol #: 19-1141

Location: University of Colorado Hospital

Protocol #: 19-0561

Location: University of Colorado Hospital

Protocol #: 19-0967

Location: University of Colorado Hospital

Protocol #: 19-0604

Location: University of Colorado Hospital

Protocol #: 19-6065

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 19-0642

Location: University of Colorado Hospital

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

Locations: Dental Clinic; UCD Dental Clinic

Protocol #: 18-0220

Location: University of Colorado Hospital

Protocol #: 19-0820

Location: University of Colorado Hospital

Protocol #: 19-0905

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-0269

Location: University of Colorado Hospital

Protocol #: 19-6060

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 19-0900

Location: University of Colorado Hospital

Protocol #: 19-0852

Location: University of Colorado Hospital

Protocol #: 19-0376

Locations: 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

Protocol #: 19-0849

Location: Childrens Hospital Colorado

Protocol #: 19-0772

Location: University of Colorado Hospital

Protocol #: 19-0150

Location: University of Colorado Hospital

Protocol #: 19-0814

Location: Childrens Hospital Colorado

Protocol #: 19-0858

Location: Childrens Hospital Colorado

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

This is a 6 month long study with visits occurring once every month. The baseline (5-6 month) and end of study (12 month) visit will be conducted at Children's Hospital Colorado and the other 5 visits will be home visits. Compensation will be provided.

Protocol #: 19-0546

Location: Childrens Hospital Colorado

Protocol #: 14-1072

Location: Childrens Hospital Colorado

Protocol #: 19-0556

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-0632

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-0770

Location: University of Colorado Hospital

Protocol #: 19-0519

Location: University of Colorado Hospital

Protocol #: 19-0520

Location: University of Colorado Hospital

Protocol #: 19-0507

Location: University of Colorado Hospital

Protocol #: 14-1360

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 16-0994

Location: Childrens Hospital Colorado

Compare Whole Blood vs Component Therapy

Protocol #: 19-6047

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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 cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

The Lung PCA BU goals include enrollment of informative retrospective and prospective patients from which informative biospecimens can be collected and processed for advanced analyses of PMLs. Central to this process will be the development of techniques to optimize data production from limited tissues. The generation of a deep and interactive database will be critical to help direct the studies undertaken by the project. Visual maps will serve as the key information hubs and the development of these maps along with the functionality for them to be linked with extensive clinical databases and well annotated metadata will be a major endpoint for the project.

Protocol #: 19-0400

Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital

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, and get a DXA scan.

Protocol #: 19-0422

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Test new MRI scanner sequences in diverse patient population

Protocol #: 19-0518

Location: Childrens Hospital Colorado

Protocol #: 19-0457

Location: University of Colorado Hospital

Protocol #: 18-2594

Location: University of Colorado Hospital

Protocol #: 19-0212

Location: University of Colorado Hospital

Protocol #: 19-0414

Location: University of Colorado Hospital

Protocol #: 19-0489

Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital

Protocol #: 19-0539

Location: University of Colorado Hospital

A double blind comparison of enzalutamide plus pembrolizumab or placebo in patients with metastatic prostate cancer.

Protocol #: 19-0493

Locations: Highlands Ranch Hospital; University of Colorado Hospital

A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer.

Protocol #: 19-0473

Locations: Highlands Ranch Hospital; University of Colorado Hospital

Protocol #: 19-0549

Location: Childrens Hospital Colorado

Protocol #: 18-6062

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 19-0325

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 19-0476

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

Protocol #: 19-0423

Location: University of Colorado Hospital

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (FA) (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. We hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics. This study will consist of 24 weeks (12 weeks placebo treatment and 12 weeks of CXA-10 treatment) in a randomized crossover fashion. There will be an approximate 4 week washout period.

Primary aim includes: To determine the efficacy of CXA-10 in reducing bronchial responsiveness, determined by the change in methacholine dose necessary to achieve a 20% reduction in FEV1 from baseline (PC20) Secondary aims include: - To investigate the effect of CXA-10 on differential gene expression in fresh airway epithelial cells Exploratory aims include: - To explore the efficacy of CXA-10 in improving lung function measured by FEV1, FEV1/FVC ratio and FEV1 % reversal and exhaled nitric oxide (FeNO) concentrations - To explore the efficacy of CXA-10 in improving asthma control using the Asthma Control Questionnaire (ACQ) - To explore the effect of CXA-10 on adipokine/cytokines plasma concentrations Safety aims include: - To assess the safety of 12 weeks of treatment with 150mg/day of orally administered CXA-10 in adult obese asthmatic subjects

Protocol #: 19-0510

Locations: University of Colorado Hospital; University of Pittsburgh Cancer Institute

This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting

To demonstrate safety of the AMPLATZERTM PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death and the effective by assessing the rate of recurrent ischemic stroke through 5 years

Protocol #: 19-6502

Location: Memorial Hospital Central

Protocol #: 18-2798

Location: University of Colorado Hospital

Protocol #: 19-0393

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

Protocol #: 18-1695

Location: Childrens Hospital Colorado

Protocol #: 19-0172

Location: University of Colorado Hospital

Protocol #: 19-0444

Location: University of Colorado Hospital

Protocol #: 19-0232

Location: University of Colorado Hospital

Involves two surveys for approximately 10 mintues

To explore the functional ability and quality of life in pediatric patients who undergo joint arthroplasty for non-solid tumor related reasons.

Protocol #: 19-0306

Location: Childrens Hospital Colorado

Protocol #: 18-2444

Location: University of Colorado Hospital

Protocol #: 19-0105

Location: Childrens Hospital Colorado

Protocol #: 18-2742

Locations: Department Specific Free Standing Clinic; University of Colorado Hospital

Protocol #: 19-0396

Location: Childrens Hospital Colorado

Protocol #: 18-2537

Location: University of Colorado Hospital

This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks.

Protocol #: 19-0347

Location: University of Colorado Hospital

Protocol #: 19-0267

Locations: 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

This research study seeks to learn more about biomarkers and biological pathways associated with marijuana use. We are enrolling adults who are marijuana users or non-users. The study involves filling out online surveys and one on-campus visit to give a blood, urine, and hair sample. If you want to learn more about the study please contact Kristen Raymond at kristen.raymond@cuanschutz.edu.

The specific aims of the project are to: 1) Discover biomarkers associated with marijuana use. 2) Discover biological pathways associated with marijuana use. 3) Exploratory Aim: Test whether peripheral endocannabinoid levels vary with marijuana use and predict marijuana craving.

Protocol #: 18-0853

Location: University of Colorado Hospital

Protocol #: 19-0239

Location: University of Colorado Hospital

Protocol #: 19-0299

Location: Childrens Hospital Colorado

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER

Protocol #: 19-0206

Locations: Lone Tree Medical Center; University of Colorado Hospital

Primary Objective: (1) Evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Secondary Objectives: (1) Describe the pharmacokinetics (PK) of losartan when given in combination with sunitinib in pediatric and young adult patients with relapsed or refractory osteosarcoma. (2) Describe the pharmacodynamic (PD) effects of losartan and sunitinib, specifically effects on monocyte migration, plasma CCL2 levels, and changes to the peripheral CCR2+ monocyte population, when given in combination in pediatric and adult patients with relapsed or refractory osteosarcoma. (3) Describe the preliminary antitumor activity of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Exploratory Objectives: (1) Describe changes to peripheral T cell populations including CD4+, CD8+, and regulatory T cells, which occurs with treatment of losartan and sunitinib. (2) Describe changes to peripheral immune-related cytokines/chemokines such as TGF-β, IFNγ and VEGF with treatment of losartan and sunitinib. (3) Characterize tumor-infiltrating leukocytes, micro-vessel density, and immune-related gene expression in resected pulmonary metastases of patients treated with losartan and sunitinib.

Protocol #: 18-2740

Locations: Childrens Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-0207

Location: University of Colorado Hospital

LVAD registry

Protocol #: 18-2576B

Location: University of Colorado Hospital

This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Protocol #: 19-6030

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 18-2513

Location: Childrens Hospital Colorado

Protocol #: 19-0127

Location: University of Colorado Hospital

Protocol #: 19-0049

Locations: Colorado Research Center; Department Specific Free Standing Clinic

Protocol #: 19-0250

Locations: Barbara Davis Center; UCD Barbara Davis Center

To test wireless vital sign monitor in the field and determine feasibility.

Protocol #: 18-6102

Location: Medical Center of the Rockies

Protocol #: 18-2839

Location: University of Colorado Hospital

Protocol #: 16-0692

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

Protocol #: 19-0225

Location: University of Colorado Hospital

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Protocol #: 19-0144

Location: University of Colorado Hospital

In this study, we will collect tissue and blood from participants during their epilepsy surgery.

Protocol #: 19-0182

Location: University of Colorado Hospital

This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily doses of the study drug. During the 3 month study period there are every 2 week visits to evaluate blood pressure. Optional testing includes cerebral artery testing and cognitive testing before after daily doses of nicotinamide riboside.

Protocol #: 19-0149

Locations: Renal Research Center; University of Colorado Hospital

Protocol #: 19-0123

Location: University of Colorado Hospital

Protocol #: 19-0120

Location: University of Colorado Hospital

A comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer

Protocol #: 19-0048

Location: University of Colorado Hospital

A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD

Protocol #: 18-2881

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 18-2607

Location: University of Colorado Hospital

Protocol #: 19-0041

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

Protocol #: 19-0079

Location: Childrens Hospital Colorado

A double blind comparison of MPX versus placebo in men with prostate cancer.

Protocol #: 18-2604

Location: University of Colorado Hospital

Protocol #: 18-2874

Location: University of Colorado Hospital

Protocol #: 18-6515

Location: Memorial Hospital Central

Protocol #: 19-0011

Location: University of Colorado Hospital

Protocol #: 19-0027

Location: Barbara Davis Center

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.

Protocol #: 19-0003

Location: University of Colorado Hospital

Protocol #: 18-6119

Locations: Medical Center of the Rockies; Poudre Valley Hospital

OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis.

Protocol #: 18-2823

Location: University of Colorado Hospital

Protocol #: 18-2654

Location: University of Colorado Hospital

Protocol #: 18-2806

Location: University of Colorado Hospital

Protocol #: 18-2520

Locations: Lone Tree Medical Center; University of Colorado Hospital

This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy.

Primary Safety Objective: This study will evaluate the safety of polyTregs in adult kidney transplant recipients. Secondary Safety Objective: Participants receiving polyTregs will be evaluated for the safety of converting from CNI‐based maintenance therapy to mTOR inhibitors after Treg therapy. Primary Efficacy Objective: This study will evaluate whether polyclonally expanded Tregs (polyTregs) reduce graft inflammation relative to their enrollment biopsy compared to those receiving CNI‐based maintenance therapy with similar baseline biopsy findings. Secondary Efficacy Objective: This study will evaluate whether polyTregs can reduce graft inflammation by 25% or more in the 2 weeks after polyTreg infusion relative to the enrollment biopsy.

Protocol #: 18-2679

Location: University of Colorado Hospital

Protocol #: 18-2569

Location: University of Colorado Hospital

Protocol #: 18-2692

Location: University of Colorado Hospital

Protocol #: 18-2772

Location: University of Colorado Hospital

Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT).

Protocol #: 18-2765

Location: University of Colorado Hospital

Protocol #: 18-2089

Location: University of Colorado Hospital

Protocol #: 18-2529

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 18-2714

Location: Childrens Hospital Colorado

Protocol #: 11-0674

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 18-2646

Location: University of Colorado Hospital

Protocol #: 18-2684

Location: University of Colorado Hospital

Protocol #: 18-2562

Locations: Cherry Creek Medical Center; Lone Tree Medical Center; University of Colorado Hospital

About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years.

Protocol #: 18-6511

Location: Memorial Hospital Central

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.

Protocol #: 18-2672

Location: University of Colorado Hospital

Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase

Protocol #: 18-2286

Location: Childrens Hospital Colorado

This research study is investigating the roles of estrogen (female sex hormone) and FSH, or follicle-stimulating hormone, on cortisol (a stress hormone), fat gain, and disease risk.

Protocol #: 18-2483

Location: University of Colorado Hospital

Protocol #: 18-2346

Location: University of Colorado Hospital

Protocol #: 16-2621

Locations: Denver Health Medical Center; National Jewish Health; University of Colorado Hospital

PASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation

Protocol #: 18-6126

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 18-2404

Location: University of Colorado Hospital

LVAD registry

Protocol #: 18-2576A

Location: University of Colorado Hospital

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

Locations: Anschutz Health and Wellness; Colorado State University; Harmony Campus; Poudre Valley Hospital; UCD Anschutz Health & Wellness Center

Protocol #: 18-2488

Location: University of Colorado Hospital

Protocol #: 16-0086

Location: University of Colorado Hospital

Protocol #: 18-2534

Location: University of Colorado Hospital

Protocol #: 18-2482

Location: University of Colorado Hospital

Protocol #: 18-2258

Locations: Anschutz Health and Wellness; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital

Protocol #: 18-1223

Location: Childrens Hospital Colorado

Protocol #: 17-2424

Locations: University of Colorado Cancer Center; University of Colorado Hospital

Protocol #: 18-2209

Location: University of Colorado Hospital

Protocol #: 18-2382

Location: University of Colorado Hospital

This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dose escalation cohort is designed to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of savolitinib. Once the MTD/RP2D is determined, the enrollment for an efficacy expansion cohort will open for patients whose tumors harbor genetic MET activation as determined by CLIA tests performed at participating sites, and confirmed by FDA approved tests.

Protocol #: 18-2432

Location: Childrens Hospital Colorado

Protocol #: 18-2284

Location: University of Colorado Hospital

Protocol #: 18-2198

Location: University of Colorado Hospital

Protocol #: 18-1816

Location: University of Colorado Hospital

A comparison of standard systemic therapy versus standard systemic therapy plus surgery or radiation therpy

Protocol #: 18-2252

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

Protocol #: 18-2354

Location: University of Colorado Hospital

Protocol #: 18-2337

Location: Childrens Hospital Colorado

Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery.

This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation.

Protocol #: 18-2012

Location: Childrens Hospital Colorado

Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with MMF and corticosteroids as compared to standard of care comprised of tacrolimus, MMF and corticosteroids. -In a maintenance kidney transplant population (6-24 months post-transplant), CFZ533 in combination with MMF with or without corticosteroids, compared to a standard of care control arm of tacrolimus and MMF with or without corticosteroids.

COHORT 1: Primary Objective(s) -To demonstrate that CFZ533 600 mg or 300 mg bi-weekly (Q2W), subcutaneous (SC), are non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite efficacy failure event (Biopsy proven acute rejection (BPAR), Graft Loss or Death) over 12 months post-transplantation. Key secondary objective: -To demonstrate that CFZ533 600 mg or 300 mg Q2W SC are superior to a tacrolimus-based regimen with respect to the mean estimated glomerular filtration rate (eGFR) at 12 months post-transplantation. COHORT 2: Primary Objective(s) -To demonstrate that CFZ533 450 mg Q2W SC is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite event (BPAR, Graft Loss or Death) over 12 months post conversion. Key secondary objective: -To demonstrate that CFZ533 450 mg Q2W SC is superior to a tacrolimus-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion.

Protocol #: 18-2117

Location: University of Colorado Hospital

Protocol #: 18-1558

Location: Childrens Hospital Colorado

Protocol #: 18-1683

Location: Childrens Hospital Colorado

Protocol #: 18-2315

Location: University of Colorado Hospital

The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.

Primary objective: Assess the efficacy of a levonorgestrel 52 mg intrauterine system (LNG20 IUS) as a treatment for heavy menstrual bleeding. Secondary objectives: Assess safety, tolerability, bleeding patterns, and continuation rates of LNG20 IUS in women using LNG20 IUS for heavy menstrual bleeding.

Protocol #: 18-2249

Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Protocol #: 18-2298

Location: University of Colorado Hospital

Protocol #: 18-2230

Location: Childrens Hospital Colorado

Protocol #: 18-0369

Location: University of Colorado Hospital

Protocol #: 18-6510

Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital

Protocol #: 18-2130

Location: Childrens Hospital Colorado

Protocol #: 18-1919

Location: University of Colorado Hospital

Protocol #: 18-1856

Location: University of Colorado Hospital

Protocol #: 18-1768

Location: University of Colorado Hospital

Protocol #: 18-2051

Location: University of Colorado Hospital

This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not.

Protocol #: 18-1916

Location: Childrens Hospital Colorado

The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determine fluid balance in your body. The CardioMEMS HF System is FDA approved for a select group of patients. The study plans to see if it works in more patients. The study will also learn if using the device's data for other indicators of heart failure might reduce worsening heart failure resulting in visits to the hospital to treat heart failure or death. You may be eligible if you are at risk of having episodes of worsening heart failure.

Protocol #: 18-2129

Locations: Medical Center of the Rockies; Memorial Hospital Central; University of Colorado Hospital

Primary outcome: EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified. Secondary outcomes: Regional conductivity changes due to ventilation Waveform for a mesh element Regional conductivity changes due to perfusion Regional pulsatile perfusion imaging at the end of systole Power waveform (computed as the inner product of measured voltages and applied currents)

Protocol #: 18-1843

Location: Childrens Hospital Colorado

Protocol #: 18-2047

Location: University of Colorado Hospital

Protocol #: 18-1875

Location: University of Colorado Hospital

Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure.

Protocol #: 18-1823

Location: Childrens Hospital Colorado

Protocol #: 18-1933

Locations: Lone Tree Medical Center; University of Colorado Hospital

The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments

Protocol #: 18-2021

Location: University of Colorado Hospital

Protocol #: 18-1633

Location: University of Colorado Hospital

Protocol #: 18-2032

Location: University of Colorado Hospital

Protocol #: 18-1997

Location: Childrens Hospital Colorado

Protocol #: 18-6061

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies

Protocol #: 18-2000

Location: Childrens Hospital Colorado

This is an open-label, multicenter study designed to evaluate the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of a 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks (Q4W) up until the third dose of benralizumab and then every 8 weeks (Q8W) thereafter in patients with severe eosinophilic asthma who are receiving high-dose inhaled corticosteroids (ICS)/long-acting β2 agonists (LABAs) and OCS with or without additional asthma controller(s). After they sign the informed consent form, patients will undergo a screening visit (Visit 1) to assess eligibility criteria and laboratory tests. All patients who are not already taking prednisone/prednisolone as their OCS treatment will be switched to prednisone/prednisolone, and the laboratory tests will be delayed 3 to 7 days. Patients still fulfilling inclusion/ sion criteria at Visit 2 (Week 0) will enter the study and receive open-label benralizumab.

Protocol #: 18-1978

Location: University of Colorado Hospital

Protocol #: 18-1641

Location: University of Colorado Hospital

Protocol #: 18-1716

Location: Childrens Hospital Colorado

Protocol #: 18-1672

Location: University of Colorado Hospital

Protocol #: 18-1734

Location: University of Colorado Hospital

Protocol #: 18-1728

Location: University of Colorado Hospital

This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years.

Protocol #: 18-1842

Location: University of Colorado Hospital

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)

Protocol #: 18-6081

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 18-1808

Location: University of Colorado Hospital

Feasibility of the administration of transdermal testosterone alternating with enzalutamide and the effects it has in the treatment of prostate cancer

Protocol #: 18-0821

Location: University of Colorado Hospital

Protocol #: 18-1599

Location: University of Colorado Hospital

Protocol #: 18-1721

Locations: Greeley Campus; Highlands Ranch Hospital; University of Colorado Hospital

This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years.

Protocol #: 18-1795

Locations: Colorado Research Center; Renal Research Center

Protocol #: 18-1740

Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital

Protocol #: 18-1493

Location: University of Colorado Hospital

Protocol #: 18-1461

Location: University of Colorado Hospital

Protocol #: 18-0554

Location: University of Colorado Hospital

Protocol #: 18-1343

Location: University of Colorado Hospital

Protocol #: 18-1654

Location: University of Colorado Hospital

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Protocol #: 18-1624

Location: University of Colorado Hospital

Protocol #: 18-1526

Location: University of Colorado Hospital

Protocol #: 18-1349

Location: Childrens Hospital Colorado

Protocol #: 18-1429

Location: Childrens Hospital Colorado

Protocol #: 18-1336

Location: University of Colorado Hospital

Protocol #: 18-1216

Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 18-1445

Location: Childrens Hospital Colorado

Protocol #: 18-0867

Location: Childrens Hospital Colorado

Protocol #: 18-1439

Locations: Lone Tree Medical Center; University of Colorado Hospital

Protocol #: 18-1490

Location: University of Colorado Hospital

Primary Objective: To evaluate the effectiveness of an 8-week, group-based, Acceptance and Commitment Therapy (ACT) intervention for chronic pain management in cancer survivors who have completed active treatment. Secondary Objective: To evaluate the implementation of an 8-week, group-based, ACT intervention for chronic pain management in cancer survivors who have completed active treatment.

Protocol #: 18-1102

Location: University of Colorado Hospital

Protocol #: 18-1356

Location: University of Colorado Hospital

Protocol #: 18-1391

Location: Childrens Hospital Colorado

Protocol #: 18-0456

Location: University of Colorado Hospital

Protocol #: 13-3192

Location: Adult Infectious Disease Clinical Trials Center

Protocol #: 18-1347

Location: University of Colorado Hospital

Protocol #: 18-1263

Location: University of Colorado Hospital

Participants will come into the clinic for 5 visits which will last 1.5-3.5 hours long. Each visit has an Audiologist and an Otologist component in it. Each participant will need to complete daily diary entries by calling into phone number and answering some questions.

Protocol #: 18-1269

Location: University of Colorado Hospital

Protocol #: 18-1100

Location: University of Colorado Hospital

Protocol #: 16-1400

Locations: Colorado Research Center; Department Specific Free Standing Clinic

The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension.

Protocol #: 18-1297

Location: University of Colorado Hospital

Protocol #: 18-1199

Location: University of Colorado Hospital

Primary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment.

Protocol #: 18-1344

Location: University of Colorado Hospital