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The ROSIE Study

Two, in-person visits between 1-2 hours over approximately a 3-month period....more >

Protocol #23-1234

Location: Outpatient CTRC, University of Colorado Hospital

Study of cladribine+venetoclax after failure of venetoclax+hypomethylating agent in monocytic AML

Protocol #23-0273

Location: University of Colorado Hospital

Stress Response to Glaucoma Visual Field Testing

The primary outcome measures will be change in heart rate, blood pressure, salivary cortisol levels, and state anxiety pre- and post-visual field testing and the difference in these responses between HVF and VRVF...more >

Protocol #24-0324

Location: Outpatient CTRC, University of Colorado Hospital

Relationship between Cardiac Health and Exercise Capacity in Men and Women with and without Type 2 Diabetes

Participants will undergo baseline testing of their heart, blood vessel, and skeletal muscle function, and perform tests to determine exercise ability. Participants will then do exercise training for 15 weeks, and all testing will be repeated....more >

Protocol #20-2723

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

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

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, trial evaluating the objective response rate and the safety and tolerability, biodistribution,...more >

Protocol #19-2987

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

Oral Acetate Supplementation for Improving Age-Related Arterial Dysfunction

We want to see if oral supplementation with the short-chain fatty acid acetate versus a placebo is effective at improving age-related arterial dysfunction. Acetate is a naturally occurring substance that is produced by bacteria that live in your gut when you eat fiber. A placebo is an inac...more >

Protocol #22-0473

Location: Anschutz Health and Wellness, Department Specific Free Standing Clinic

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

Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease B...more >

Protocol #21-4846

Location: CTRC Inpatient, University of Colorado Hospital

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

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

Protocol #21-4668

Location: Childrens Hospital Colorado

Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA

In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d...more >

Protocol #21-4765

Location: University of Colorado Hospital

OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c...more >

Protocol #20-0288

Location: University of Colorado Hospital

How When you Eat and Exercise Affect Metabolism in Adults

As a participant in this study, you will be assigned to 4 different diet and exercise groups where the time of your meals and when you exercise will be different. This will last for 4 consecutive days, and you will be provided meals on 2-3 of the days. On the 5th day of each exercise and d...more >

Protocol #23-1388

Location: CTRC Inpatient

S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: ...more >

Protocol #20-0359

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

Does when you exercise matter? Healthy adults needed for study looking at differences between morning exercise and nighttime exercise.

You will be asked to attend several screening visits to make sure you are eligible to be in the research study and that it is safe for you to participate. Research study participants will be randomized to exercise either in the morning or the evening. Randomization is like flipping a coin,...more >

Protocol #21-3094

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

Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Clinical outcomes following standard of care therapy for resectable esophageal and gastroesophageal junction adenocarcinoma are suboptimal, with low rates of pathologic complete response (pCR) to current neoadjuvant treatment strategies. Although significant progress has been made by incor...more >

Protocol #19-0376

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

Phase I clinical trial utilizing direct peritoneal resuscitation in liver transplant recipient population at increased risk of return to the operating room and early allograft dysfunction.

This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreci...more >

Protocol #21-4214

Location: University of Colorado Hospital

Cardiometabolic consequences of the loss of ovarian function (LILAC Study)

We are inviting premenopausal women (women with regular menstrual periods) to participate in a study looking at the effects of estrogen and menopause on body composition and vascular function. ...more >

Protocol #23-1518

Location: Outpatient CTRC, University of Colorado Hospital

A Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover Phase 1/2a Study to Test the Safety and Efficacy of Advair HFA (Salmeterol and Fluticasone) in Resting and Exercising Healthy and High Altitude Pulmonary Edema (HAPE) Predisposed Subjects

The study involves two separate study periods of 12 days each, where you will: • Take the study drug or placebo through a puffer for 7 days. You will not know which drug you are taking during which period • Wear a continuous heart monitor for 12 days • Have blood tests drawn during 5 vi...more >

Protocol #23-0463

Location: CTRC Inpatient, Outpatient CTRC

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

PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivatio...more >

Protocol #22-0175

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

Protocol NRG-LU008, "Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer"

PRIMARY OBJECTIVES: I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (arm 1) or after image guided, motion-...more >

Protocol #23-1258

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

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

PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measu...more >

Protocol #21-3608

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

Inspiring New Science in Guiding Healthcare in Turner Syndrome (INSIGHTS) Registry

Participants who join the INSIGHTS Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. In addition to the basic registry, individuals can join a recruitment list f...more >

Protocol #19-3027

Locations: Ann &amp; Robert H. Lurie Children's Hospital of Chicago, Childrens Hospital Colorado, Childrens Hospital of Philadelphia, Childrens National Medical Center, University of North Carolina Children's Hospital, University of Texas Health Science Center at Houston

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

PRIMARY OBJECTIVES: I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to s...more >

Protocol #21-4429

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

Rehabbing with Peloton: Commercially Available Fitness mHealth for Cardiac Rehabilitation among Individuals Recovering from Transcatheter Aortic Valve Replacement

Rehabbing with Peloton (RWP) is an 8-week intervention beginning immediately upon referral to cardiac rehabilitation (CR), designed to be initiated while patients are placed on CR waitlists. Transcatheter aortic valve replacement (TAVR) recipients engage with Peloton walking, strength, and...more >

Protocol #24-0628

Location: University of Colorado Hospital

CLEAN-PE: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism

Prospective, single-arm, multicenter study. Approximately 125 subjects will be screened for 105 enrolled at up to 15 investigational sites in the United States....more >

Protocol #24-0526

Location: Outpatient CTRC, University of Colorado Hospital

Menstrual profiles and cardiovascular disease risk among female adolescent athletes with and without menstrual irregularities

Participants will undergo a bone scan, 15 minutes of metabolic testing, and blood draw to assess markers of cardiovascular disease as well as hormone levels. ...more >

Protocol #22-1372

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

Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury: Prospective Observational Study

Blood, urine, and bone marrow will be collected to analyze biomarkers of acute kidney injury risk. Sublingual microscopy will be used to collect images in the mouth. This is to study the following aims: Aim 1: Determine the effect of pulsatility during CPB on endothelial function. We wil...more >

Protocol #20-2465

Location: University of Colorado Hospital