Research Studies

Protocol #: 19-0741

Location: Dental Clinic

Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included.

Protocol #: 20-1681

Location: Childrens Hospital Colorado

This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints (baseline and 12 months later). Research visits will include a physical exam, questionnaires, a blood draw, drinking a sugary drink, ultrasounds of the head, neck and arm, riding an exercise bike and a body scan.

Protocol #: 19-1226

Locations: Childrens Hospital Colorado; University of Colorado Hospital

The purpose of the study is to find out the experiences of nurses who cared or prepared to care for COVID-19 patients. If you join the study you will help us learn about what nurses are going through during this pandemic time. You will provide insight to how nurses can improve or change the delivery of care to patients during a pandemic.

Protocol #: 20-6039

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

Protocol #: 20-0317

Locations: Anschutz Health and Wellness; University of Colorado Hospital

Protocol #: 19-3006

Locations: CHOC ? Children?s Hospital of Orange County; UCLA - University of California; UCLA, Jonsson Cancer Center; University of Colorado Hospital

Protocol #: 20-0104

Location: University of Colorado Hospital

Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart disease o Non-smoker (or quit at least one year ago)

This study is examining how gender-affirming hormone therapy affects the health of blood vessels and impacts cardiovascular disease risk in transgender men.

Protocol #: 19-2323

Locations: Anschutz Health and Wellness; University of Colorado Hospital

This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments.

Protocol #: 19-2408

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

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 #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

Veterans are needed for a study that aims to learn more about how men and women differ in the way their brains respond to food and hunger. It also plans to learn more about how hormones and the menstrual cycle affect these responses.

Protocol #: 19-0940

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

Protocol #: 16-1480

Location: Childrens Hospital Colorado

This study plans to learn more about how age affects the way we process sounds we hear. If you join the study, you will come into our Auditory Lab on the Anschutz Medical Campus 4-6 times and complete hearing assessments and questionnaires.

To learn more about how age affects the way we process sounds we hear.

Protocol #: 19-1213

Location: Department Specific Free Standing Clinic

Protocol #: 19-1171

Location: University of Colorado Hospital

This study aims to learn more about how men and women differ in the way their brains respond to food and hunger. It also plans to learn more about how hormones and the menstrual cycle affect these responses.

Protocol #: 19-1148

Location: University of Colorado Hospital

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 #: 18-0220

Location: University of Colorado Hospital

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

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

Protocol #: 18-0853

Location: University of Colorado Hospital

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

Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart disease o Non-smoker (or quit at least one year ago)

This study is examining how gender-affirming hormone therapy affects the health of blood vessels and impacts cardiovascular disease risk in transgender women.

Protocol #: 18-2258

Locations: Anschutz Health and Wellness; Rocky Mountain Regional VA Medical Center; 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 #: 18-0369

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

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 #: 18-1997

Location: Childrens Hospital Colorado

Protocol #: 18-1740

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

Protocol #: 15-1868

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

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 #: 18-0052

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

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

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

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

As we get older, our cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men and women. Also we want to find out what happens to the cardiovascular system when we take a dietary antioxidant supplement for a short period of time. Specifically, we want to see if the antioxidant supplement will improve cardiovascular health in older men and women because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand whether improvements in mitochondrial function will also improve cardiovascular health in older men and women.

Protocol #: 17-1782

Location: University of Colorado Hospital

Protocol #: 17-2033

Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital

Protocol #: 16-2203

Location: University of Colorado Hospital

Protocol #: 17-1047

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

Protocol #: 17-0092

Location: University of Colorado Hospital

Protocol #: 16-2739

Location: University of Colorado Hospital

Additional information about this study can be found at www.trisome.org.

Designed to be the largest and most comprehensive study of its kind, The Human Trisome Project will help us understand why individuals with Down syndrome (caused by trisomy of chromosome 21) are protected from some medical conditions, such as cancer, while highly predisposed to others, such as Alzheimer's disease and autoimmune disorders.

Protocol #: 15-2170

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Participants needed for a research study that plans to examine the effects of age and body weight on food intake, appetite regulation, and brain responses to food.

Protocol #: 15-1511

Location: University of Colorado Hospital

The proposed project is a within-subject consecutive design examining 14 healthy individuals after baseline and after 4 nights of insufficient sleep. Following 7 days of at-home habitual sleep of 9 hours/night and a 3-day lead-in energy balanced diet, participants will be admitted for a 6-night inpatient stay at the UC Denver. Sleep schedules will be verified via sleep logs, time-stamped voice-recorder of bed and wake times, and wrist actigraphy recordings. On the morning after the 1st night in the lab, subjects will undergo including saliva sampling, endothelial function testing, muscle biopsy, fat biopsy, hyperinsulinemic euglycemic clamp.

Protocol #: 17-0533

Locations: CTRC-UC Boulder; University of Colorado Hospital

This study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise. This study will evaluate & compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects).

Protocol #: 17-0356

Location: University of Colorado Hospital

If you join the study, you will complete the following research procedures over the course of 2 study visits: Informed consent, physical exam and medical history, body composition test, blood draw and fat biopsy.

This research study plans to learn more about where the fat cells in your body come from. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more "unhealthy" than other fat.

Protocol #: 15-1779

Location: University of Colorado Hospital

This study plans to learn more about the relationship between fertility and obesity.

Protocol #: 15-0474

Location: University of Colorado Hospital

Protocol #: 15-1052

Location: University of Colorado Hospital

Protocol #: 16-0614

Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center

The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. However, whether E2 status affects BAT activity in women has not been studied. In this research, we will study 1) the contribution of BAT to REE under basal (room temperature) and stimulated conditions (mild cold-exposure); and 2) whether these responses are modulated by E2 status.

Protocol #: 16-1479

Locations: CTRC-adult; University of Colorado Hospital

Protocol #: 16-1635

Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital

Protocol #: 15-1162

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

Protocol #: 16-2138

Location: University of Colorado Hospital

PRIMARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on spontaneous chronic spine pain relief, as measured by change in score on the 10-point Numeric Rating Scale (NRS); (2) To compare the effects of cannabis versus oxycodone versus placebo on experimental pain analgesia, as measured by change in Experimental Pain Threshold (EPTh), in both patients with chronic spine pain and healthy controls. SECONDARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on chronic spine pain, as measured by the Patient Global Impression of Change (PGIC) scale; (2) To compare the effects of cannabis versus oxycodone versus placebo on subjective reports of drug effects, psychoactive effects, and mood; (3) To compare the effects of cannabis versus oxycodone versus placebo on tests of neurocognitive functioning (Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test, the Hopkins Verbal Learning Test Revised (HVLT), and the Grooved Pegboard Test); (4) To compare the effects of cannabis versus oxycodone versus placebo on Standardized Field Sobriety Tests (SFST).

Protocol #: 14-1909

Locations: CTRC-adult; University of Colorado Hospital

Protocol #: 15-1110

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