Research Studies

Protocol #: 20-0620

Location: University of Colorado Hospital

Protocol #: 15-0813

Location: University of Colorado Hospital

Protocol #: 20-0226

Location: Childrens Hospital Colorado

Protocol #: 20-0104

Location: University of Colorado Hospital

Protocol #: 20-0052

Location: Childrens Hospital Colorado

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 #: 19-2323

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 #: 19-2760

Location: University of Colorado Hospital

Protocol #: 19-2950

Location: Childrens Hospital Colorado

Protocol #: 19-2846

Location: University of Colorado Hospital

Protocol #: 19-2828

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

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

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 #: 19-2598

Location: University of Colorado Hospital

Protocol #: 19-2744

Location: Childrens Hospital Colorado

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 #: 19-2560

Location: University of Colorado Hospital

You are being asked to participate in this research study because you have been diagnosed with heart failure and you are implanted with a commercially approved Boston Scientific Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. Inside your device are sensors that monitor your heart failure condition. The purpose of this study is to better understand how sensor readings from your device relate to specific clinical events that you may experience during the time you are in the study. This information may be able to detect when your heart failure is getting worse earlier and with more accuracy. This could help your doctor treat your heart failure timely and with the appropriate treatments.

Protocol #: 19-6516

Location: Memorial Hospital Central

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

Location: Department Specific Free Standing Clinic

Protocol #: 19-2445

Location: University of Colorado Hospital

Protocol #: 19-2521

Location: University of Colorado Hospital

Protocol #: 19-2529

Location: University of Colorado Hospital

Protocol #: 19-1896

Location: Childrens Hospital Colorado

Protocol #: 19-6066

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

Protocol #: 19-2475

Location: Childrens Hospital Colorado

Protocol #: 19-2344

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 #: 19-2357

Location: Childrens Hospital Colorado

Protocol #: 19-2134

Locations: UCHealth Stapleton Medical Center; University of Colorado Hospital

Protocol #: 19-2255

Location: University of Colorado Hospital

Protocol #: 19-1913

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 #: 19-1613

Location: Childrens Hospital Colorado

Protocol #: 19-6114

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

Protocol #: X19-9999

Locations: Department Specific Free Standing Clinic; Highlands Ranch Hospital; University of Colorado 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 #: 15-1141

Location: Childrens Hospital Colorado

Protocol #: 14-1413

Location: Childrens Hospital Colorado

Protocol #: 18-1076

Location: Childrens Hospital Colorado

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

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 #: 19-1809

Location: University of Colorado Hospital

Protocol #: 15-1434

Location: Childrens Hospital Colorado

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 #: 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 #: 19-2412

Location: Childrens Hospital Colorado

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 #: 19-1597

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 #: 15-0140

Location: Childrens Hospital Colorado

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

Protocol #: 19-1717

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 19-1620

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 #: 19-1461

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 #: 19-1317

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 #: 19-1458

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 #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

Protocol #: 16-1270

Locations: Denver Health Medical Center; University of Colorado Hospital

Protocol #: 19-1282

Locations: Childrens Hospital Colorado; 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 #: 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

Location: 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

Location: 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 #: 19-1151

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Protocol #: 19-1040

Location: University of Colorado Hospital

Protocol #: 19-1147

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 #: 19-0967

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

Location: 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

Protocol #: 19-0556

Location: University of Colorado Hospital

Protocol #: 19-0632

Locations: 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 #: 19-0591

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 #: 19-0536

Location: Childrens Hospital Colorado

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

A Prospective, Multi-Center, Single Arm Study to obtain “Real World” Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils for the Endovascular Treatment of Intracranial Aneurysms

Protocol #: 19-6503

Location: Memorial Hospital Central

Protocol #: 19-0414

Location: University of Colorado Hospital

Protocol #: 19-0478

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

Location: 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

Protocol #: 19-6041

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

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 #: 19-0327

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

Protocol #: 19-0363

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

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study

Protocol #: 19-6501

Location: Memorial Hospital Central

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

Protocol #: 19-0323

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

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: Children?s Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 19-0207

Location: University of Colorado Hospital

Protocol #: 19-0233

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 #: 19-0159

Location: University of Colorado Hospital

This study is designed to test the effectiveness of the oral drug Apremilast in patients with mild to moderate Plaque Psoriasis. The study lasts ~36 weeks (around 9 months) from start to finish for each participant. There are around 11 scheduled visits throughout the 36 weeks that participants are asked to come to the clinic to see the research team. There are treatment groups and a placebo group in this study. After the first 16 weeks of the study, everyone from the placebo group will be placed into one of the treatment groups. Please direct any further questions or inquries to the Dermatology Clinical Research Team @ 720-848-0556 or diane.ladell@cuanschutz.edu OR daniel.uy@cuanschutz.edu

Protocol #: 18-2578

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

Protocol #: 18-2435

Location: University of Colorado Hospital

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

Location: 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 #: 18-6128

Location: Memorial Hospital Central

Protocol #: 18-2089

Location: University of Colorado Hospital

Protocol #: 18-2529

Location: University of Colorado Hospital

Protocol #: 11-0674

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 18-2646

Location: University of Colorado Hospital

Protocol #: 18-2357

Locations: Lone Tree Medical Center; 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 #: 18-2487

Location: University of Colorado Hospital

Protocol #: 18-2466

Location: University of Colorado Hospital

Protocol #: 18-2488

Location: University of Colorado Hospital

Protocol #: 16-0086

Location: University of Colorado Hospital

A comparison of M6620 + Carboplatin versus Docetaxel + Carboplatin in metastatic castrate-resistant prostate cancer

Protocol #: 18-2398

Location: University of Colorado Hospital

Protocol #: 18-2534

Location: University of Colorado Hospital

Protocol #: 18-2341

Location: University of Colorado Hospital

Protocol #: 18-2482

Location: University of Colorado Hospital

Protocol #: 18-2258

Locations: 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 #: 18-2334

Location: 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 #: 18-2219

Location: University of Colorado Hospital

Protocol #: 18-2284

Location: University of Colorado Hospital

Protocol #: 18-2198

Location: University of Colorado Hospital

Protocol #: 18-1816

Location: University of Colorado Hospital

Protocol #: 18-2451

Location: University of Colorado Hospital

Protocol #: 18-2152

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

Protocol #: 18-2309

Location: Childrens Hospital Colorado

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 #: 18-1858

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

Protocol #: 18-2100

Location: Childrens Hospital Colorado

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

The study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug.

Protocol #: 18-1706

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; 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 #: 18-1659

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; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 18-1431

Location: University of Colorado Hospital

Protocol #: 18-0867

Location: Childrens Hospital Colorado

Protocol #: 18-1439

Location: 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 #: 18-0997

Location: University of Colorado Hospital

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

Protocol #: 18-1203

Locations: Memorial Hospital Central; Memorial Hospital North

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

In this study we will be evaluating how your brain responds to food images, as well as how your behaviors and hormones change with a 12-week resistance training intervention.

Protocol #: 18-1298

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

Assess the safety and potential efficacy of CLBS03 to modify the T1DM disease course, including preservation of a-cell function and improvements in measures of disease severity, as compared with placebo, in adolescents with recent onset T1DM.

Protocol #: 16-0905

Locations: Barbara Davis Center; UCD Barbara Davis Center

Protocol #: 18-6055

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

Protocol #: 18-0708

Locations: City of Hope Cancer Center; Thomas Jefferson University Hospital Cancer Center; University of Colorado Hospital

Protocol #: 18-1281

Location: Childrens Hospital Colorado

TARGET-NASH encompasses a unique retrospective/prospective longitudinal cohort design that will define the natural history of NASH, establish important patient level baseline disease characteristics against which to judge subsequent interventions, and evaluate the safety and effectiveness of novel therapies as they are utilized in the post-marketing environment.

Protocol #: 17-0051

Location: University of Colorado Hospital

Protocol #: 15-1868

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

The aim of the study is to show that the device demonstrates continued performance and safety in a commercial setting. Efficacy of the Six Month Obalon Balloon System will be evaluated utilizing the standard weight loss metrics. Patients will be followed for 12 months (6- months Device therapy and 6-months post-removal). The primary objective is to collect additional safety data with the Obalon Balloon System and confirm the existing safety profile results gathered in PTL-1100-0013, the Obalon Pivotal Study.

Protocol #: 18-1209

Location: University of Colorado Hospital

Protocol #: 18-0995

Location: University of Colorado Hospital

Protocol #: 18-1093

Location: University of Colorado Hospital

Protocol #: 18-0973

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

We are looking for healthy men to participate in a research study on the effects of sleep restriction on bone. The purpose of this research is to understand how shortened sleep affects bone metabolism. The study includes an intervention phase consisting of a 1-week outpatient and 8-night inpatient stay. Participants will be observed after discharge from the intervention phase for 3 weeks. Principal Investigator, Christine Swanson, MD, MCR (COMIRB #18-0015)

Protocol #: 18-0015

Location: University of Colorado Hospital

Protocol #: 18-1150

Location: University of Colorado Hospital

Protocol #: 18-1049

Location: University of Colorado Hospital

This is a double-blind, placebo-controlled, parallel-arm, multicenter study comparing the safety, tolerability, and efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent CDI. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be randomized to study drug. Approximately 200 subjects (100 subjects per treatment group) will be randomized in a 1:1 ratio to receive CP101 (6  1011 bacteria) or placebo. The treatment duration will be 1 day, including active drug (CP101) and placebo. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following Randomization. The primary efficacy and safety endpoints will be evaluated at 8 weeks post-treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI. To qualify for the study, subjects must be experiencing recurrent CDI defined as: a)  3 episodes of CDI, with 2 episodes occurring within the previous 12 months (inclusive of the current episode); OR b) 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) AND 65 years of age or older. Additionally, to qualify, recurrent CDI subjects must have received standard-of-care CDI antibiotics for the most recent CDI episode (for 10-21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator) and have an adequate clinical response, defined as  3 unformed stools in 24 hours for 2 or more consecutive days immediately prior to Randomization.

Protocol #: 18-1166

Location: University of Colorado Hospital

The objective of the LESS-VT Clinical Trial is to demonstrate that substrate ablation with the FlexAbility SE catheter is safe and effective in reducing the occurrence of MMVT in patients in whom VT recurs despite antiarrhythmic drug therapy or when AAD are not tolerated or desired.

Protocol #: 18-1148

Location: University of Colorado Hospital

The primary objective of this study is:  To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.

Protocol #: 18-1121

Location: University of Colorado Hospital

Protocol #: 18-1144

Location: University of Colorado Hospital

Protocol #: 18-1137

Location: University of Colorado Hospital

Protocol #: 16-2308

Location: University of Colorado Hospital

Protocol #: 18-1095

Locations: Memorial Hospital Central; University of Colorado Hospital

Protocol #: 18-0709

Location: University of Colorado Hospital

Protocol #: 18-0606

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

Protocol #: 18-0965

Location: University of Colorado Hospital

Protocol #: 17-2215

Location: University of Colorado Hospital

Protocol #: 17-2378

Location: Childrens Hospital Colorado

Protocol #: 18-0857

Location: Childrens Hospital Colorado

This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor, recruited globally from specified transplant centers.

Primary Objectives: 1. To assess the safety and reactogenicity of HB-101 2. To assess the immunogenicity of HB-101 Secondary Objectives: 1. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in mitigating CMV DNAemia/viremia for patients followed by CMV preemptive therapy post-transplant 2. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in decreasing the use of anti-virals at treatment dose for patients to be treated prophylactically for CMV post-transplant 3. To assess additional immunogenicity parameters of HB-101

Protocol #: 18-1003

Location: University of Colorado Hospital

Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks.

Protocol #: 18-0926

Location: University of Colorado Hospital

Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks.

Protocol #: 18-0925

Location: University of Colorado Hospital

Protocol #: 18-0971

Location: Childrens Hospital Colorado

To determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms.

Protocol #: 18-6052

Location: Memorial Hospital Central

Protocol #: 18-0685

Location: University of Colorado Hospital

Protocol #: 18-0627

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

A comparison of Talazoparib plus enzalutamide vs placebo plus enzalutamide

Protocol #: 18-0884

Location: University of Colorado Hospital

If you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.

Protocol #: 18-6051

Location: Memorial Hospital Central

Protocol #: 18-0947

Location: Childrens Hospital Colorado

Protocol #: 18-0756

Location: University of Colorado Hospital

The study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg ANG-3777 or placebo (normal saline).

Primary Objective: ? To demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft with DGF Secondary Objectives: ? To demonstrate the efficacy of ANG-3777 in optimizing renal function in recipients of a deceased donor renal allograft with DGF ? To demonstrate the efficacy of ANG-3777 in reducing length of hospital stay in recipients of a deceased donor renal allograft with DGF

Protocol #: 16-1038

Location: University of Colorado Hospital

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with CO2 laser ablation or ultrasonic aspiration. Women referred for treatment following diagnosis of VIN II/III will be randomized to receive CO2 laser ablation (typical treatment for these cases) or ultrasonic aspiration (approved treatment providing a more targeted technique). Secondary objectives will examine incidences of pain, scarring, and sexual and psychosocial distraught following treatment for high-grade dysplasia.

Protocol #: 16-0701

Locations: Denver Health Medical Center; University of Colorado Hospital; University of Oklahoma

A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini.

To measure contraceptive efficacy of the test product

Protocol #: 17-0225

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

Protocol #: 16-0121

Location: University of Colorado Hospital

This study plans to learn more about pulmonary fibrosis and determine if some diseases that cause scarring in the lung might be inherited diseases. We are especially interested in the genetics of pulmonary fibrosis and cases where it might run in families. What we learn may be helpful in the future to people with pulmonary fibrosis and their family members.

Protocol #: 15-1147

Location: University of Colorado Hospital

Study is double blind and placebo controlled.

Protocol #: 18-0829

Location: University of Colorado Hospital

This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another 12 weeks of treatment. (If the subject received active drug in the first 12 weeks he/she will receive placebo during this 12 weeks and previous placebo subjects will receive active drug. Procedures that will be conducted during the study are: completion of quality of life questionnaires, EKGs, laboratory assessments, Pulmonary Function tests, and 6 minute walk tests. Each visit will take approximately 2 hours.

Protocol #: 18-0761

Location: University of Colorado Hospital

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

A comparison of Neoadjuvant Nivolumab with versus without Urelumab in patients with cisplatin-ineligible bladder cancer

Protocol #: 18-0760

Location: University of Colorado Hospital

Protocol #: 18-0834

Location: Childrens Hospital Colorado

Protocol #: 18-0803

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Protocol #: 18-0850

Location: University of Colorado Hospital

Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria, and be approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial. Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site. Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device.

Protocol #: 18-0505

Location: University of Colorado Hospital

Protocol #: 18-0836

Locations: University of Colorado Hospital; University of Colorado, Boulder

Protocol #: 18-0498

Location: Childrens Hospital Colorado

Protocol #: 18-0686

Location: Childrens Hospital Colorado

Protocol #: 13-2415

Protocol #: 15-1041

Location: University of Colorado Hospital

This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer.

Protocol #: 18-0567

Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania

Protocol #: 18-6020

Location: Medical Center of the Rockies

Protocol #: 18-0482

Location: University of Colorado Hospital

Protocol #: 18-0501

Location: Childrens Hospital Colorado

Protocol #: 18-0052

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

Protocol #: 18-0524

Location: Childrens Hospital Colorado

This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at week 2, 4 and 6 via the telephone.

Protocol #: 17-2349

Location: University of Colorado Hospital

Protocol #: 18-0715

Location: University of Colorado Hospital

In this study a member of the study team will review consenting patient's medical records at pre-op, spine surgery, recovery, follow up visits at 3 months and 12 months

Protocol #: 18-0830

Location: University of Colorado Hospital

This is a 12 week observational study of cognitive and blood vessel functioning 2 weeks and 12 weeks after an acute kidney injury.

Protocol #: 18-0654

Location: University of Colorado Hospital

Protocol #: 18-6038

Location: Memorial Hospital Central

This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function.

Protocol #: 18-0637

Location: University of Colorado Hospital

Protocol #: 18-0461

Location: Childrens Hospital Colorado

Protocol #: 18-0582

Location: University of Colorado Hospital

Protocol #: 18-0285

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

Protocol #: 18-0559

Location: University of Colorado Hospital

Patients randomized to the fever prevention group will have ArcticGel Pads placed on their body. These will be connected to the Arctic Sun System. The system will be programmed to keep the patient's body temperature at 98.6. Treatment will last for 14 days or until ready to be discharged from the ICU. Standard of care patients will receive standard medical care as prescribed by the medical team.

Protocol #: 18-0548

Location: University of Colorado Hospital

Over the past 25 years, RALS has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion. Despite the limitations of current diagnostic tests and therapeutic strategies, recent advances in gastoresophageal reflux disease offer tremendous potential for RALS diagnosis and treatment. Newer diagnostic tools are able to assess physiologic properties of RALS. Thus, this study will address three crucial gaps impacting the clinical approach to RALS: 1) Paucity of diagnostic tests that predict clinically relevant outcomes, 2) undefined clinical role of UES augmentation, and 3) deficiency or cost-effective and personalized approaches.

Protocol #: 18-0205

Location: University of Colorado Hospital

Protocol #: 18-0167

Location: Rocky Mountain Regional VA Medical Center

The purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery

Protocol #: 18-0546

Location: University of Colorado Hospital

Protocol #: 17-2186

Location: University of Colorado Hospital

Protocol #: 18-0504

Location: University of Colorado Hospital

Protocol #: 18-0198

Location: Childrens Hospital Colorado

Protocol #: 18-0286

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

Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total.

To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.

Protocol #: 18-0392

Locations: Highlands Ranch Hospital; University of Colorado Hospital

Protocol #: 18-0385

Location: University of Colorado Hospital

The goals of this study are (1) to test the hypothesis that HR reduction is an important underlying antecedent for reverse remodeling, and (2) to identify components of the beta1-GSN responsible for reverse remodeling caused by HR reduction using ivabradine, which could allow for better drug targeting. This study will also yield hypothesis-generating data on whether ivabradine might be useful in earlier stage HFrEF patients than the current indication.

Protocol #: 16-1363

Location: University of Colorado Hospital

Protocol #: 17-2334

Location: University of Colorado Hospital

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial. Phase I will be non-randomized. Phase II will be randomized.

1) To evaluate and optimize HeartLogic? Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II)

Protocol #: 18-6028

Locations: Memorial Hospital Central; Memorial Hospital North

Protocol #: 16-2322

Location: Childrens Hospital Colorado

The purpose of this study is to determine if a newer type of metal stent with a plastic covering, called the AXIOSTM stent, is safe and effective in draining your WON.

Protocol #: 18-0442

Location: University of Colorado Hospital

Protocol #: 18-0374

Locations: Colorado Research Center; Renal Research Center; University of Colorado Hospital

Protocol #: 18-0251

Location: University of Colorado Hospital

Protocol #: 17-6220

Location: Memorial Hospital Central

Protocol #: 17-6205

Location: Memorial Hospital Central

The primary aim of this study is to determine rates of stroke for BCVI overall and by grade of injury and predictors of BCVI related stroke formation.

Protocol #: 18-6029

Location: Medical Center of the Rockies

Protocol #: 18-0154

Location: University of Colorado Hospital

Protocol #: 17-0466

Location: University of Colorado Hospital

Protocol #: 18-0393

Locations: Childrens Hospital Colorado; University of Colorado Hospital

WATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial.

Protocol #: 18-6002

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 15-2388

Location: University of Colorado Hospital

1).Optimize tACS parameters for duration, intensity and frequencies via utilization of EEG data recorded during tACS stimulation. 2)Determine whether recording artifacts introduced by tACS can confidently be removed from EEG signals. 3). Determine effects of tACS delivered with nested frequencies(multi-frequency signal) vs single frequency tACS, with regard to intrinsic EEG signal, for modulation of SWA coherence and power, as recorded in our overnight EEG sleep data. 4). Determine the cumulative effects of tACS delivered in multiple, consecutive nights on underlying EEG signals, sleep architecture, sleep quality and cognitive function among patients with MCI. 5). Determine if tACS is a viable treatment for disturbances of sleep and cognitive performance among patients with MCI. 6). Generate pilot data and manuscripts to support applications for larger randomized placebo-controlled clinical trials.

Protocol #: 16-1875

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

Protocol #: 18-0226

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

Protocol #: 18-0320

Location: Childrens Hospital Colorado

Protocol #: 18-0017

Location: Childrens Hospital Colorado

Protocol #: 17-2111

Location: Childrens Hospital Colorado

Protocol #: 17-2208

Location: University of Colorado Hospital

Protocol #: 18-0216

Location: University of Colorado Hospital

Protocol #: 18-0187

Location: University of Colorado Hospital

The safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk.

Protocol #: 16-0066

Location: University of Colorado Hospital

Protocol #: 18-0020

Location: University of Colorado Hospital

Protocol #: 17-1809

Location: Childrens Hospital Colorado

Protocol #: 18-0183

Location: University of Colorado Hospital

Protocol #: 18-0033

Location: University of Colorado Hospital

This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers that do not perform protocol surveillance biopsies. This registry study does not provide any medical care. Outcomes in this sub-cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes of the test and control cohorts.

Primary Safety Objective: To test the hypothesis that a strategy of monitoring for rejection that introduces AlloSure into clinical practice does not lead to inferior renal allograft outcomes when compared to a strategy of monitoring for rejection that does not include AlloSure. Primary Efficacy Objective: To test the hypothesis that a strategy of monitoring for rejection that introduces non-invasive AlloSure testing as part of clinical care results in a reduction in the number of renal biopsies performed when compared to a strategy of clinical care without the use of AlloSure testing. Secondary Safety Objectives: Include the assessment of other safety endpoints such as graft survival and graft function. Secondary Efficacy Objectives: To confirm AlloSure test performance characteristics in discrimination of active rejection and to describe the impact of AlloSure use and results on patient management.

Protocol #: 17-2267

Location: University of Colorado Hospital

Protocol #: 17-1543

Location: Childrens Hospital Colorado

This study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 12 months thereafter to determine whether there is an improvement in walking distance, future heart attacks or hospitalizations, and/or survival.

Protocol #: 18-0158

Location: University of Colorado Hospital

Protocol #: 18-0153

Location: University of Colorado Hospital

DUR-928 (investigational drug)

Protocol #: 18-0123

Location: University of Colorado Hospital

Protocol #: 15-0170

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

Protocol #: 17-2216

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

Protocol #: 18-0031

Location: University of Colorado Hospital

Protocol #: 17-2451

Location: University of Colorado Hospital

There will be 6 study visits over about a year. They will take place over 2 days before starting testosterone and then 1 month and 12 months after starting testosterone. The first study visit will involve a blood draw, an oral glucose tolerance test (sugar drink) and answering questionnaires. The second day will involve an ultrasound of the arteries in the arm, abdominal MRI, exercise bike test and a body scan to evaluate fat and bone density. Participants will wear a sleep and activity monitor for a week after the second visit day.

Protocol #: 17-2328

Locations: Childrens Hospital Colorado; University of Colorado Hospital