Your search for "All Studies" found 925 matches:
ARROW study: Weight loss study

Research study looking at your body's response to dietary changes after completing a free weight loss program....

Protocol #18-0091

Solid foods and infant growth

Your baby may be eligible if they are: - Exclusively breastfed - Younger than six months of age - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a 7-month long study, with visits occurring once every month. The first visit, 9-month visit, an...

Protocol #19-0546

Microfluidic models of bleeding and thrombosis

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

Protocol #19-2408

Cannabis in Adolescents Study

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

Protocol #20-0553

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

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

Protocol #15-1774

Birth Control Hormonal Injection/Shot Study

-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3...

Protocol #19-2820

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

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

Protocol #16-2706

Effects of complementary feeding on infant growth and gut health

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

Protocol #20-2232

Blueberry intake and infant gut health

Your breastfed baby may be eligible if they are: - Younger than six months of age - Exclusively breastfed - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a 7-month long study, with visits occurring once every other month. The first and last ...

Protocol #20-1659

Early iron exposure on the gut microbiota in young infants

This is a four month-long study, beginning at birth. The first study visit is conducted at the University of Colorado Hospital and the last visit takes place at Children’s Hospital Colorado. The other four visits are conducted in your home. Formula is provided to all study participants for...

Protocol #18-1317

University of Colorado Age-Related Macular Degeneration Registry

Do you have dry Age-Related Macular Degeneration (AMD)? If yes, you may be eligible to participate in our research study....

Protocol #14-0740

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

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

Protocol #21-3018

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

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

Protocol #21-3094

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

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

Protocol #21-3622

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

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

Protocol #21-3923

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

Protocol #21-3711

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

Protocol #19-3115

REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes

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

Protocol #20-2723

Research about the Potential for the Contraceptive Implant as Emergency Contraception

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

Protocol #21-5026

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

The purpose of this study is to understand the health effects of the time we spend sitting. We are recruiting women between the ages of 60 and 75 years either with or without a type 2 diabetes diagnosis. Individuals diagnosed with type 2 diabetes may not be treated with insulin in order to...

Protocol #19-2758

Inhaled Cannabis, Oxidative Stress and the Pulmonary Innate Immune Response

This study evaluates the effect of long term cannabis/marijuana smoking on lung health. Volunteers should be between ages 21-55 No history of alcohol abuse, tobacco, or other recreational drug abuse No chronic medical conditions Healthy Cannabis users between ages 21 and 55 years: ...

Protocol #14-1957

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

We are recruiting individuals who experience PTSD-associated nightmares to participate in a research study to help us understand if improving sleep quality, by reducing the impact of nightmares can improve cardiovascular health....

Protocol #21-5027

Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)

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

Protocol #20-3013

Contraceptive Hormone and Reward Measurement (CHARM Study)

Protocol #21-3530

Social Information Processing in Teens (SIP Study)

Interested in how irritability affects social information processing in teens? Our goal is to learn more about how people commonly react to social ambiguity and how irritable mood may relate to negative interpretations of social signals in adolescence....

Protocol #20-2633

Conversational Speech in the Diagnosis of Neurocognitive Disorders

Using elements of conversational speech such as tone of voice and duration of speaking is a cheap, non-invasive way to gather information, which can be used to direct medical interventions that will help slow or prevent the progression of neurological disease. ...

Protocol #18-0456

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

The purpose of MoTrPAC is to learn about how exercise benefits health. We know that being physically active is good for our health, but we don’t completely understand how it changes the cells in our bodies. Understanding the cellular benefits of exercise could help scientists develop new...

Protocol #18-0220

The short-chain fatty acid acetate for improving age-associated arterial dysfunction

Specific Aim: To determine the following before and after 12 weeks of oral supplementation with calcium acetate vs. placebo (calcium citrate) in healthy men and women 50+ years of age: a) Endothelium-dependent dilation, assessed as brachial artery flow-mediated dilation (FMDBA) [primary o...

Protocol #22-0473

Cannabis Teens and Choice Study (CATCH Study)

We are currently seeking participants ages 14-21 for a two visit (one remote, one on campus) study at CU Anschutz. The purpose of this research is to better understand the effects of substance use on decision making and biologic-systems in adolescents. Compensation is provided. ...

Protocol #22-0101

The Child Bipolar Disorder Network (CBN): A Collaborative Treatment Study of Youth With or at High Risk for Bipolar Disorder

Does your child have symptoms of bipolar disorder? We are looking for children, teens, and young adults (ages 9 to 21 years) who have moods that alternate between depression and periods of excessive energy and activity for this study. Participants will get a full diagnostic evaluation fro...

Protocol #22-0853

Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

This research studies how hormones impact headache and how different parts of the brain talk to each other. You are invited to participate if you are (or your child is): • 9 years to 20 years of age • With or without history of headache • Male sex, male gender identity • Health...

Protocol #20-1824

MitoQ supplementation for restoring aerobic exercise training effects on endothelial function in postmenopausal women

The purpose of this research study is to see if we can improve exercise training responses on heart health in postmenopausal women....

Protocol #22-1521

Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

Our study is seeking individuals aged 18-60, who have been diagnosed with a traumatic brain injury (TBI) to participate. The study plans to learn more about the impacts of cannabidiol (CBD) on individuals with TBI. The 12-weeks of the study will involve using CBD or placebo....

Protocol #22-1427

BURST2D Study: Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes

The purpose of the study is to compare two different physical activity interventions (BREAK or ONE) to learn about their effects on blood sugar and metabolism. Participants will be randomized to one of two interventions: ONE (45-minutes of brisk walking at least 5 days per week) and BREAK ...

Protocol #20-1900

Research about a birth control pill for emergency contraception

To research how a single dose of an oral contraceptive pill, Drospirenone, affects ovulation (the process of egg release from the ovary)....

Protocol #22-2178

Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***

This multi-center trial will enroll 200 participants across two sites. During the randomized, controlled phase of the study, participants will receive either a single 25mg oral ‘high’ dose of psilocybin or an active placebo (100mg niacin), alongside psychotherapy. During the open-label ...

Protocol #22-1207

uHoWL Research Study

Are you interested in a research study on women's reproductive hormones? We are conducting a study among women aged 18-40 who have regular menstrual cycles, are not using hormonal birth control, and have a body mass index between 27-45. ...

Protocol #21-3957

PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life - The PROMISE Study

The environment during pregnancy may contribute to the risk of islet autoimmunity (IA) in the baby. Having IA increases the risk of type 1 diabetes (T1D) in the child. Illnesses such as viruses could contribute to IA and T1D risk. Pregnancy history may also influence IA and T1D risk. Ha...

Protocol #22-1840

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD).

Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. Sargramostim has been approved by the FDA for the past thirty years to treat patients who have had chemotherapy to boost the body’s innate immune system. This research study hopes to ...

Protocol #19-2727

CU-GENES (Genetic Engagement, Education, and Screening)

Inclusion Criteria: • Over the age of 25 • At least one grandparent of Jewish ancestry OR be of Spanish ancestry with roots in the San Luis Valley • No prior genetic testing • No personal history of bone marrow transplants or blood cancers • Currently live in Colorado OR New Mexico ...

Protocol #23-0584

Neuronal and behavioral effects of an implicit priming approach to improve eating behaviors in obesity

What is involved: -A 12-week intervention involving viewing food or food images (study visits once per week) -Study days before and after the intervention to measure brain responses to food images -Measures of body composition, mood, physical activity, and eating behaviors St...

Protocol #20-2821

Substance, Trauma, And Recovery - STAR Study

Eligible participants will be randomly assigned to RRFT or Encompass. Participation in this study includes approximately 18 treatment sessions and 4 research visits over the course of one year. ...

Protocol #21-3736

The ROSIE Study

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

Protocol #23-1234

Novel Approaches to Observationally Assessing Cannabis-Impaired Driving

Please contact for more information...

Protocol #20-0949

The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) Trial

Protocol #22-2041

Lipids to Energy (LTE) Research Study

The Lipids to Energy (LTE) study at the University of Colorado – AMC is recruiting males aged 15-30 years old with or without a diagnosis of Klinefelter Syndrome (KS). Research study participation starts with a 2.5-3 hour screening visit that includes a blood draw, physical exam, DXA bo...

Protocol #21-2860

Ovaprene: Non-hormonal Vaginal Ring Birth Control Study

Clinical trial looking at a monthly, non-hormonal vaginal product as birth control. The vaginal product, called Ovaprene, is a round piece of woven material surrounded by a soft, flexible rubber ring. The material in the vaginal product is released slowly to create an environment that make...

Protocol #23-1580

Integrated Lifestyle Intervention to Promote Weight Loss Study (COMIRB 23-1154)

If you join the study, you will undergo 2-3 screening visits to see if you are eligible to be in the study. If you are eligible to be in the study, you will receive a 6-month integrated lifestyle intervention program. This integrated program includes PreventT2 (formally known as the Diabet...

Protocol #23-1154

Effect of weight loss on intermuscular adipose tissue (IMAT) signaling

Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were complete...

Protocol #23-0545

ExCITES-PD: Exercise-Induced Cognitive Improvement Through Enhanced Sleep in Parkinson’s Disease

The purpose of this study is to examine the impact of exercise on sleep and cognition in Parkinson’s Disease. Inclusion criteria, Parkinson’s Disease (PD) group: • 45 years of age or older • Diagnosis of Parkinson’s • No contraindications to exercise Exclusion criteria, PD group:...

Protocol #22-1685

Location: CTRC-adult

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

Protocol #22-1894

Neurologic Music Therapy for Enhancing fine motor control in Parkinson’s Disease

The study involves 2 visits on the Anschutz campus and a 5-week therapy fine motor training regimen (music therapy or occupational therapy). The Anschutz visits include quality of life and motor assessments, and a type of non-invasive brain scan called magnetoencephalography (MEG). Therap...

Protocol #16-2308

Reducing Pain and Opioid Use with CBD

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

Protocol #21-5122

An Interactive Decision Aid to Improve Shared Decision-Making for Women with Parkinson's Disease

Protocol #23-2390

Location: University of Colorado Hospital

Can a Treatment Algorithm for Common Shoulder Complaints Produce a Reliable Initial Diagnosis and Treatment Plan?

Protocol #23-2543

Location: Broomfield Hospital, CU Sports Medicine - Denver, Highlands Ranch Hospital, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

Protocol #23-2282

Location: Medical Center of the Rockies

NIH-K01: Investigating Cognitive-Motor Variability to Predict Driving Performance in Stroke Survivors with MCI

Protocol #23-2556

Location: University of Colorado Hospital

Protocol 10559 "A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with FGFR-TACC Gene Fusion," (NCT05859334)

Protocol #23-2578

Location: University of Colorado Hospital

Postoperative Utilization of Incentive Spirometry with and without Electronic Patient Reminders

All eligible patients arriving to the PACU every day will be provided with a Vyaire Medical's AirLife volumetric incentive spirometer and instructions to perform 3 IS breaths every 20 minutes until discharge from PACU. The IS device will be set up with the breath volume considered adequate...

Protocol #23-2470

Location: University of Colorado Hospital

Assessing trends in patient depression, surgical expectations, satisfaction, and effects of health literacy before and after male urinary incontinence surgery.

Protocol #23-2538

Location: University of Colorado Hospital

Protocol S2210, "A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Localized Prostate Cancer with Germline BRCA1/2 Mutations," NCT# 05806515

Protocol #23-2420

Location: University of Colorado Hospital

Assessing patient satisfaction, outcomes, and surgical expectations following paraurethral balloons placement for male urinary incontinence.

Protocol #23-2500

Location: University of Colorado Hospital

The time course of the therapeutic influence of a single exercise bout on cancer-related fatigue

Protocol #23-1789

Location: Harmony Campus

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Protocol #23-1919

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

An open-label phase 1 study to investigate SGN-CEACAM5C in adults with advanced solid tumors

Protocol #23-2329

Location: University of Colorado Hospital

A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Patients With Solid Malignancies

Protocol #23-2253

Location: CTRC Inpatient, University of Colorado Hospital

Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias

CU OB-Gyn providers are committed to addressing racial inequities in healthcare. We invite patients, advocates and members of the community who identify as Black, African American, African, Afro-Latinx or Afro-Caribbean to share your experiences and feedback, especially those that have rec...

Protocol #23-2269

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

Protocol CCTG-NE.1 "NET RETREAT: A phase II study of 177Lutetium-DOTATATE retreatment vs. everolimus in metastatic/unresectable midgut NET"

Protocol #23-1917

Location: University of Colorado Hospital

FONTANA: A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors

Protocol #23-2128

Location: CTRC Inpatient, University of Colorado Hospital

Multisite Naturalistic Driving Study

Protocol #23-2156

Location: University of Colorado Hospital

Positive Emotion Dysregulation (PED) in Bipolar Disorder Onset and Illness Course in Emerging Adults

Protocol #23-2067

Location: Brain Imaging Center - BIC, START Center, University of Colorado, Boulder

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age with Achondroplasia: PROPEL 3

Protocol #23-2112

Location: Childrens Hospital Colorado

Early-life determinants of child health: A new Denver-based cohort

This study will focus on collecting information from moms and their babies to understand how the environment and things that happen early in children's life (including before they are conceived or born) influence a broad range of child health outcomes, including their development, health a...

Protocol #23-1622

Location: Department Specific Free Standing Clinic, Highlands Ranch Hospital, 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

The Effects of Hemp-Derived CBD on the Neural Basis of Cannabis-Cue and Emotion Related Processing

We will recruit young adults (ages 18-25). Participants will be selected to achieve a diverse gender and ethnic sample, with roughly balanced male/female participation We will enroll up to 75 participants to achieve a sample size of ~52 participants with usable data. ...

Protocol #23-2098

Location: Brain Imaging Center - BIC, Outpatient CTRC

Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults with Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a randomized, open-label, cross-over trial

This research is being done to better understand Cystic-Fibrosis Related Diabetes (CFRD) and to see the effects of GLP-1 (dulaglutide) in individuals with abnormal glucose tolerance. GLP-1 (dulaglutide) helps the pancreas release insulin, which controls blood sugar levels from getting too...

Protocol #23-1267

Location: Childrens Hospital Colorado

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Protocol #23-1949

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

A phase I/II study of VLS-1488 (an oral KIF18A inhibitor) in subjects with advanced cancer

Protocol #23-1991

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Protocol #23-1990

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

A First-in-Human Phase I Study of ATG-031 in Patients with Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Protocol #23-1892

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

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Protocol #23-1812

Location: CTRC Inpatient, Highlands Ranch Hospital, University of Colorado Hospital

EMERALD-Y90: Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy

Protocol #23-1827

Location: University of Colorado Hospital

Accelerating Medicines Partnership: Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis

If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove...

Protocol #23-0022

Location: Barbara Davis Center, University of Colorado Hospital

Phase 1/2 trial of radiotherapy in combination with TTI-101 in patients with borderline resectable pancreatic cancer

Protocol #22-0734

Location: University of Colorado Hospital

Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults with Prediabetes

Baseline (no exercise) will be performed first with testing done on the fourth day of this condition. Testing will include a full day at the Anschutz Health Science Building Clinical and Translational Research Core clinic and will involve direct measurements of insulin action on the body, ...

Protocol #23-1721

Location: Anschutz Health and Wellness, Outpatient CTRC

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Protocol #23-1465

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

The ME&MG digital solution for autonomous assessment of Myasthenia Gravis: a validation study

Protocol #23-1307

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

A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED, PARALLEL-GROUP PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EPITHELIUM-ON CORNEAL CROSS-LINKING IN SUBJECTS 8 TO 45 YEARS OF AGE WITH KERATOCONUS (APRICITY-B)

To evaluate the efficacy of the riboflavin-sodium iodide solution followed by ultraviolet A (UVA) exposure and epithelium-on corneal crosslinking (CXL) assessed by visual acuity measurement in subjects with keratoconus....

Protocol #23-1425

Location: University of Colorado Hospital

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport? for the Prevention of Chronic Migraine in Adult Participants

Protocol #23-1244

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

A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes

Protocol #23-1527

Location: Brain Imaging Center - BIC, Outpatient CTRC

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"

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

TEMPUS SCLC OBSERVATIONAL STUDY: A Tissue and Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients with Small Cell Lung Cancer (SCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays

Protocol #23-1448

Location: Lone Tree Medical Center, University of Colorado Hospital

A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl...

Protocol #23-1287

Location: Outpatient CTRC

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Protocol #23-1322

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

Protocol EAY191 Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Protocol #23-1254

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

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

The study will randomize 200 adults diagnosed with T2D within the last 12 months. Participants will be randomized to individualized RC or RC paired with individualized post-nutrient glucose excursion minimization (GEM) (RC+GEM). A Randomized Control Trial (RCT) with 1:1 randomization will ...

Protocol #23-1398

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study To Evaluate EDP-938 Regimens In Subjects Aged 28 Days To 36 Months Infected With Respiratory Syncytial Virus (RSV)

Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries...

Protocol #23-1409

Location: Childrens Hospital Colorado

A Randomized, Double-Blind, Phase 2 Pilot Study of VLX-1005 Versus Placebo in Participants with Suspected Heparin Induced Thrombocytopenia Treated with Background Standard of Care

Protocol #23-1265

Location: University of Colorado Hospital

AttaCH: A Phase 2, Multicenter, Long-Term, Open Label Extension Trial Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children and Adolescents with Achondroplasia

Protocol #23-0807

Location: Childrens Hospital Colorado

Protocol A012103, "OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy"

Protocol #23-1255

Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec...

Protocol #23-1332

Location: Barbara Davis Center, University of Colorado Hospital

A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCSZ11 as a Monotherapy and in Combination in Patients with Advanced or Metastatic Solid Tumors

Protocol #23-1383

Location: CTRC Inpatient, University of Colorado Hospital

Efficacy and mechanisms of dapagliflozin in promoting kidney function and cardiovascular health in kidney transplant recipients

Main procedures done in the study: - Physical exam and medical history - Blood draw - Blood pressure - Blood vessel function testing - Urine collection - Kidney function measures - Kidney and cardiac MRI You will take study drug daily for 12 months You will have approximately ...

Protocol #23-1360

Location: Renal Research Center, University of Colorado Hospital

Table Tennis as neurologic rehabilitation (NeuroPongTM Program) in people with Multiple Sclerosis

Protocol #23-1355

Location: University of Colorado Hospital

A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients with MGMT Unmethylated Glioblastoma

Protocol #23-1257

Location: University of Colorado Hospital

Protocol S1900G, "A Randomized Phase II Study of Capmatinib plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"

Protocol #23-0936

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

A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants with Thyroid Eye Disease

The purpose of this dose ranging study is to study the efficacy and safety of TOUR006 SC compared with placebo in participants with moderate to severe TED....

Protocol #23-1181

Location: University of Colorado Hospital

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

Protocol #23-1196

Location: Outpatient CTRC, University of Colorado Hospital

A randomized, sham-controLled, blinded (paTient and evaluators) Feasibility triaL Of the EdWards APTURE transcatheter shunt system

A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System...

Protocol #23-1264

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

Alliance Protocol A212102, "Blinded Reference Set for Multicancer Early Detection Blood Tests

Protocol #23-1087

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

A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Protocol #23-0692

Location: University of Colorado Hospital

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Protocol #23-1122

Location: Highlands Ranch Hospital, University of Colorado Hospital

A Long-Term, Prospective, Observational, Registry of Patients with Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated with Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)

Protocol #23-0935

Location: University of Colorado Hospital

CALIBRATE: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)...

Protocol #23-1163

Location: Childrens Hospital Colorado

S2302, PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Protocol #23-0867

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

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Protocol #22-2276

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

Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

This study plans to investigate if taking a protein nutrition supplement (EAA) for 8 weeks may reduce fat that is stored in the liver. This will be compared to 8 weeks of placebo (a “fake” supplement that does not contain protein). Participants will be assigned randomly either the protein ...

Protocol #23-0690

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

NRG-BR008, "A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

Protocol #23-0798

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

A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects with Ovarian Cancer (NXP800-101; ENGOTGYN5/ NCRI/NXP800-101; GOG-3087)

Protocol #23-0966

Location: CTRC Inpatient, University of Colorado Hospital

Expanded Access Program of Palopegteriparatide in Patients with Hypoparathyroidism

Protocol #23-0510

Location: Greeley Campus

An Open-Label Phase 1 Study to evaluate the safety and Efficacy of AB-1015 in Patients with Platinum-Resistant Epithelial Ovarian Cancer

Protocol #23-0956

Location: CTRC Inpatient, University of Colorado Hospital

Validation of Instruments Measuring Caregiver Experiences (Caregiver VOICE Study)

Attention, Dementia Caregiving Dementia caregivers have important roles in supporting someone with Dementia. We are interested in hearing the voices of those caregivers. Participation in this telephone based study will take approx. 30-45 minutes. We are interested in your perspective o...

Protocol #23-0854

Location: Lone Tree Medical Center, University of Colorado Hospital

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections - Appendix E-2: Immune Modulation Strategy Trial

Protocol #23-0870

Location: Outpatient CTRC, University of Colorado Hospital

Biomarkers in Pediatric and Young-Adult Autoimmune Encephalitis and Epilepsy

Protocol #22-2311

Location: Childrens Hospital Colorado, University of Colorado Hospital

A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease

Protocol #23-0784

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

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)

Protocol #23-0648

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

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA

Protocol #23-0832

Location: Highlands Ranch Hospital, University of Colorado Hospital

Characterization of Mpox Antibody Response after JYNNEOS Vaccination Among Persons with HIV

Protocol #23-0776

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...

Protocol #23-0463

Location: CTRC Inpatient, Outpatient CTRC

Venous Thromboembolism (VTE) Prevention and Diagnosis in COVID-19 Patients: Practice Patterns and Clinical Outcomes: A Multi-Center Observational Study

Protocol #20-2065

A Phase 1A/B Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours

Protocol #23-0580

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 1, Open-label Study of Oral BDTX-4933 in Patients with KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

Protocol #23-0675

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

ELACESTRANT in Women and Men with CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)

Protocol #23-0641

Location: University of Colorado Hospital

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients with Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement

Study participants will undergo testing to identify patterns of right ventricular dysfunction. If a study participant decides to participate in exercise training, the participant will complete an optional Part 2 of the study. Optional Part 2 includes an exercise training intervention follo...

Protocol #23-0516

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of BION-1301 in Adults with IgA Nephropathy

The medication is taken by injection every 2 weeks for two years. ...

Protocol #23-0695

Location: Renal Research Center

Protocol 10522, Phase I Clinical Trial of CA-4948 in Combination with Gemcitabine and Nab-Paclitaxel in Metastatic on Unresectable Pancreatic Ductal Carcinoma

Protocol #23-0613

Location: CTRC Inpatient, University of Colorado Hospital

Protocol 10483: Phase Ib trial of Erdafitinib combined with Enfortumab Vedotin following platinum and PD1/L1 inhibitors for metastatic urothelial carcinoma with FGFR2/3 genetic alterations

Protocol #23-0518

Location: University of Colorado Hospital

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Protocol #23-0309

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

An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects 2 to < 5 Years of Age With Osteogenesis Imperfecta Types I, III or IV

Protocol #23-0369

Location: Childrens Hospital Colorado

Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ Dysfunction

Blood draws will be completed at baseline, 6-24 hours after arrival, and then daily through study day 7 to evaluate fibrinogen levels and response to trauma....

Protocol #23-0581

Location: University of Colorado Hospital

Effects of Inspiratory muscle strength training on exercise capacity in Type 2 Diabetes

Protocol #23-0493

Location: Outpatient CTRC

Evaluation of Basal Insulin Initialization and Titration in People with Type 2 Diabetes wearing a Dexcom G6 Sensor

Protocol #23-0393

Location: Anschutz Health and Wellness, Lone Tree Medical Center

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study with 6 month treatment phase and 6 month observation phase. ...

Protocol #23-0534

Location: Childrens Hospital Colorado

A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)

Protocol #23-0426

Location: Brain Imaging Center (BIC), Outpatient CTRC

Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator's Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03)

Protocol #23-0452

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

Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Protocol #23-0488

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

An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first-line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura

Protocol #23-0481

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)

Protocol #23-0376

Location: CTRC Inpatient, University of Colorado Hospital

Safety and Efficacy of the Omnipod? 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes

This single-arm, multi-center, prospective study will evaluate the safety (primary) and efficacy (secondary) of the Omnipod? 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy....

Protocol #23-0388

Location: Anschutz Health and Wellness, Barbara Davis Center, Lone Tree Medical Center

A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Protocol #23-0396

Location: Outpatient CTRC, University of Colorado Hospital

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Protocol #23-0395

Location: Outpatient CTRC, University of Colorado Hospital

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with associated Inferior vena cava tumor thrombus (NEOPAX)

The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can decrease the IVC TT burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patie...

Protocol #22-1669

Location: University of Colorado Hospital

TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes

This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. We are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with docu...

Protocol #23-0398

Location: Barbara Davis Center, University of Colorado Hospital

ACNS1821- A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Protocol #23-0048

Location: Childrens Hospital Colorado

Prospective Clinical Assessment Study in Children with Achondroplasia: The PROPEL Trial

Protocol #23-0416

Location: Childrens Hospital Colorado

Randomized, controlled trial of Rybelsus (semaglutide) among adults with AUD

You will be randomly assigned to one of two groups. You will have a 50% (1 in 2) chance of receiving semaglutide and a 50% chance of receiving placebo. This is a double-blind study, which means neither you nor the study investigator will make the choice to which group you are assigned, an...

Protocol #23-0261

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

Protocol #23-0328

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

An Observational Pregnancy Safety Study in Women with Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA? (inebilizumab-cdon) during Pregnancy

Protocol #23-0315

Location: Department Specific Free Standing Clinic

A212102: Blinded Reference Set for Multicancer Early Detection Blood Tests

Protocol #23-0258

Location: Rocky Mountain Regional VA Medical Center

A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in combination with nivolumab in adults with advanced solid tumors

Protocol #23-0324

Location: University of Colorado Hospital

MEASURE: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events

Protocol #23-0054

Location: CTRC Inpatient, University of Colorado Hospital

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

Protocol #23-0008

Location: Outpatient CTRC

S2302: PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Protocol #23-0174

Location: Rocky Mountain Regional VA Medical Center

Phase 1 study of venetoclax/azacitidine or venetoclax in combination with ziftomenib (KO-539) or standard induction cytarabine/daunorubicin (7+3) chemotherapy in combination with ziftomenib for the treatment of patients with acute myeloid leukemia

Protocol #23-0061

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

A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high risk for relapse and are ineligible for high-dose cisplatin

Protocol #23-0137

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

Development and Validation of an Ancillary Diagnostic Test for Mycosis Fungoides (SIGNAL-MF)

Protocol #22-1708

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

S2107, "Randomized Phase II trial of encorafenib and cetuximab with or without nivolumab (NSC #748726) for patients with previously treated, microsatellite stable, BRAFV600E metastatic and/or unresectable colorectal cancer," (NCT #05308446)

Protocol #23-0193

Location: Cherry Creek Medical Center, 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

First-in-Human Study of STX-478, a Mutant Selective PI3K alpha Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor

Protocol #23-0200

Location: CTRC Inpatient, University of Colorado Hospital

Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET)

Protocol #23-0145

Location: University of Colorado Hospital

A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature? Status

Protocol #23-0115

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Protocol #23-0053

Location: Outpatient CTRC, University of Colorado Hospital

EA8212, "A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naive High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)"

Protocol #23-0074

Location: University of Colorado Hospital

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Protocol #22-1819

Location: Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis

Protocol #22-2421

Location: Brain Imaging Center (BIC), Outpatient CTRC

Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma

Protocol #23-0111

Location: University of Colorado Hospital

PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER

Protocol #22-2036

Location: Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)

Protocol #22-2391

Location: Outpatient CTRC

Expanded Access to the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered, Relapsed or Refractory Low-Grade Glioma

Protocol #22-2288

Location: Childrens Hospital Colorado

A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation with Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients with Severe Aplastic Anemia

Protocol #22-1969

Location: Childrens Hospital Colorado

A phase 2, randomized, double-blind, placebo-controlled, efficacy and safety study of daxdilimab subcutaneous injection in adult participants with adequately controlled dermatomyositis or anti-synthetase inflammatory myositis

This study is a phase 2, randomized controlled proof of concept study to assess the efficacy and safety of daxdilimab in participants 18 to 75 years old with DM or ASIM. The estimated total study duration is 60 weeks with visits to clinic every 4 weeks. Participants will be randomized in a...

Protocol #23-0062

Location: Barbara Davis Center, University of Colorado Hospital

Acute Equol Supplementation and Vascular Function in Postmenopausal Women with and without CKD

-One screening visit (1.5 hours) and two testing visits (each 5 hours) -Testing visits will include a blood draw and non-invasive testing of blood vessel function -All visits will take place at CU Anschutz As a volunteer, you will receive the following information about your health: ...

Protocol #23-0070

Location: Renal Research Center, University of Colorado Hospital

A 36-week, single-arm, open-label study to evaluate the safety and tolerability of ferric citrate in children with hyperphosphatemia related to chronic kidney disease.

A single arm trial evaluating efficacy of ferric citrate over 36 weeks in pediatric patients with hyperphosphatemia related to CKD....

Protocol #23-0073

Location: Childrens Hospital Colorado

Boomerang Early Feasibility Study: Prospective, multi-center, single-arm early feasibility study (EFS)

Researchers in the BOOM-IBD Clinical Trial are studying whether nerve stimulation can be effective in treating patients with Crohn's disease and ulcerative colitis....

Protocol #23-0063

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 1 / 2, Open Label, Study of Amivantamab (JNJ-61186372) Among Participants with Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination with Tyrosine Kinase Inhibitors

Protocol #22-1450

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

A single and repeat dosing study of the safety, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis

A single and repeat dosing study of the safety, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis...

Protocol #23-0025

Location: Outpatient CTRC, University of Colorado Hospital

The Impact of Auditory Access on the Development of Speech Perception

Both infants with and without hearing loss can be enrolled. Infants will complete non-invasive research procedures (i.e., hearing tests, EEG measurements) from 1 month of age up to a year following enrollment. Infants will complete research procedures throughout up to 4 scheduled study vis...

Protocol #22-2374

Location: Cherry Creek Medical Center, Childrens Hospital Colorado, Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital

Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy

We are recruiting individuals with or without prostate cancer to participate in a research study to help us understand how androgen deprivation therapy affects cardiovascular health. Men with prostate cancer will be studied at the start and after 2 months of androgen deprivation therapy. H...

Protocol #22-2201

Location: Outpatient CTRC

Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase

This study involves interviews with couples facing metastatic colorectal cancer to learn about their experiences and challenges in coping with this disease. From what we learn, we will develop a mindfulness program for couples to lower their stress and help them cope better. ...

Protocol #22-2246

Location: University of Colorado Hospital

4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults

Protocol #22-2217

Location: Department Specific Free Standing Clinic

A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX?

Protocol #22-2188

Location: Rocky Mountain Regional VA Medical Center

S2101: Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Protocol #22-2225

Location: Rocky Mountain Regional VA Medical Center

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic

Protocol #22-2095

Location: Memorial Hospital Central, Memorial Hospital North

A032101: A PHASE 2 TRIAL OF ADT INTERRUPTION IN PATIENTS RESPONDING EXCEPTIONALLY TO AR-PATHWAY INHIBITOR IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC): A-DREAM

Protocol #22-1383

Location: Rocky Mountain Regional VA Medical Center

PEPN2113: A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy

Protocol #22-1539

Location: Childrens Hospital Colorado

FORTE: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Protocol #22-1661

Location: Rocky Mountain Regional VA Medical Center

A 2-part Phase 2 Study of Safety, Pharmacokinetics and Biomarkers in Children with Duchenne Muscular Dystrophy including a Randomized, Double-Blind, Placebo-Controlled Part A, Followed by an Open-Label Part B

This is a 2-part multi-center, Phase 2 study to evaluate the effect of EDG-5506 on safety, PK and biomarkers of muscle damage in approximately 27 children with DMD treated with oral, once daily EDG-5506 for 12 months. Part A will include a 12-week, randomized, double-blind, placebo-contr...

Protocol #22-1823

Location: Childrens Hospital Colorado

DEFIANCE: ClotTriever vs. Anticoagulation for DVT

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservativ...

Protocol #22-1788

Location: Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital

Phase II Open Label Multicenter Study of Early REinFusion of Tisagenlecleucel to Promote Durable B-CEll ApLasia in Pediatric and Young Adult Patients with Relapsed/Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia (REFUEL)

The primary objective of this phase 2 trial is to decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-...

Protocol #22-1340

Location: Childrens Hospital Colorado

S2013, "Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study"

Protocol #22-1162

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

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves

Protocol #22-1553

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

Protocol #22-1372

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

A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months. Sponsor Protocol No. mRNA-1273-P206 (BabyCOVE)

The BabyCOVE Study is evaluating an investigational bivalent vaccine. The investigational vaccine cannot make someone sick with COVID-19 and is not a gene therapy, which means it does not cross the nucleus of a cell to integrate with the host genome. The total duration of participation is...

Protocol #22-1736

Location: Childrens Hospital Colorado

Randomized Controlled Multicenter Clinical Trial of Multi-Periscopic Prism Glasses for Homonymous Hemianopia

In this research study we want to learn more about prism glasses for people with hemianopia (the loss of one half of the field of vision on the same side in both eyes). We will compare a new design of high power prism glasses (called multi-periscopic prisms or MPP glasses) to commercially...

Protocol #22-0887

Location: University of Colorado Hospital

Mothers Optimizing Resources Everyday (MORE)

This study plans to learn more about perinatal mood disorders and sources of support for pregnant and postpartum individuals. Personal and social resources can help individuals cope with the demands associated with the transition to motherhood. Interventions that support personal resources...

Protocol #22-1725

Location: University of Colorado Hospital

A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE PHARMACODYNAMICS, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF RO7204239 IN PARTICIPANTS WITH FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY

Protocol #22-1495

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

Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing Anti- D22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Protocol #22-1502

Location: CTRC Inpatient, University of Colorado Hospital

Detecting depression and anxiety in people with adult-onset idiopathic dystonia: a diagnostic accuracy study

Protocol #22-1129

Location: Outpatient CTRC, University of Colorado Hospital

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Protocol #22-1554

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

NRG-BN011, A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)

Protocol #22-1113

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

NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IB-III NON-SMALL CELL LUNG CANCER

Protocol #22-1484

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

Protocol #22-1621

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis

Protocol #22-1330

Location: Outpatient CTRC, University of Colorado Hospital

Defining Endpoints in Becker Muscular Dystrophy

Protocol #22-1278

Location: Outpatient CTRC, University of Colorado Hospital

TELLTALE- NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

Transcatheter aortic valve implantation (TAVR) may cause life threatening coronary artery obstruction, whether implanted in native aortic stenosis or bioprosthetic aortic valve failure. Transmural Systems and NHLBI have developed a purpose-built electrosurgical guidewire system (TELLTAL...

Protocol #22-0067

Location: Medical Center of the Rockies

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease

Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ...

Protocol #22-0797

Location: Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital

A082002: A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or without SBRT for PD-L1-Negative, Advanced Non-small Cell Lung Cancer

Protocol #22-1109

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

Patient perspectives regarding dupilumab initiation for eosinophilic esophagitis

Protocol #22-1510

Location: Childrens Hospital Colorado

Assessing the Risk for Hereditary Cancer in Transmasculine Individuals that are Assigned-Female-at-Birth and the Influence of Genetic Counseling on Surgery Decision

Protocol #22-1357

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

A Phase II Study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer

Protocol #22-1407

Location: Outpatient CTRC, University of Colorado Hospital

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors

Protocol #22-1490

Location: University of Colorado Hospital

NRG-CC005. FORTE: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Protocol #22-1526

Location: Cherry Creek Medical Center, University of Colorado Hospital

A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Protocol #22-1394

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

Quality of Life evaluation of interventions for chronic pancreatitis

Protocol #16-1816

Location: University of Colorado Hospital

Distinguishing REM Sleep Behavior Disorder from Trauma Associated Sleep Disorder

Protocol #22-1244

Location: Outpatient CTRC, University of Colorado Hospital

A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Protocol #22-1245

Location: CTRC Inpatient, University of Colorado Hospital

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

During this study, we will enroll n=48 total subjects who have recently sustained an mTBI. Subjects will be randomized to one of two study groups, followed throughout the duration of the 8-week vNDT intervention period, returned for post-intervention period testing, and then followed via m...

Protocol #22-1352

Location: CU Sports Medicine - Denver, Department Specific Free Standing Clinic, UCHealth Central Park Medical Center

A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6- C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopat...

Protocol #22-0694

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

A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination with the CDK4/6 Inhibitor Ribociclib or with the PI3K Inhibitor Alpelisib in Adult Subjects with Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer

Protocol #22-1277

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

SAXON-PC: A Phase II randomized trial of Stereotactic Body Radiation Therapy (SBRT) And Radium (Ra-223) Dichloride for Oligorecurrent, Non-castrate Resistant Prostate Cancer

Protocol #22-1226

Location: University of Colorado Hospital

Effects of high- vs. low-dose edible THC on alcohol consumption and neural correlates of reward and aversion

Alcohol and cannabis are often used together such that their effects overlap. Such simultaneous use is associated with greater risk for negative consequences, but little is known about the neural mechanisms that underlie simultaneous use. Legal-market cannabis products such as cannabis edi...

Protocol #22-1314

Location: Brain Imaging Center (BIC), Outpatient CTRC

A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary

Protocol #22-1234

Location: Outpatient CTRC, University of Colorado Hospital

Back in the Game: An Immediate Functional Progression Program for Adolescent Athletes with Spondylolysis: A Randomized Pilot Trial

Patients will be randomized into IFPP and control groups. The IFPP group will begin physical therapy immediately following spondylolysis diagnosis. The control group will begin physical therapy after reporting pain-free during activities of daily living. Patient-reported outcomes as well a...

Protocol #22-0868

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

A PHASE 1/2, OPEN LABEL, DOSE ESCALATION AND EXPANSION STUDY OF TAC-001 IN PATIENTS WITH SELECT ADVANCED OR METASTATIC SOLID TUMORS

Protocol #22-1188

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-Cell Acute Lymphoblastic Leukemia (IDEAL2)

Protocol #22-0837

Location: Childrens Hospital Colorado

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO ASSESS SAFETY AND EFFICACY OF SLS-005 (TREHALOSE INJECTION, 90.5 MG/ML FOR INTRAVENOUS INFUSION) FOR THE TREATMENT OF ADULTS WITH SPINOCEREBELLAR ATAXIA

Protocol #22-1127

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

Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men

Protocol #22-1180

Location: Outpatient CTRC, University of Colorado Hospital

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Protocol #22-1050

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

Single Dose Aminoglycosides for Complicated Cystitis

Protocol #22-1009

Location: University of Colorado Hospital

S2013: IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY

Protocol #22-2134

Location: Rocky Mountain Regional VA Medical Center

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Protocol #22-1125

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

Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic Resonance Imaging (TREASURE-CKD)

Protocol #22-1117

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

Comparison of Methods In Post Operative Knee Arthroscopy Rehabilitation

1:1 randomized clinical trial following post-op ACL patients during their recovery...

Protocol #22-1052

Location: CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness)

Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma

Protocol #22-1132

Location: Highlands Ranch Hospital - CU Med Clinics, University of Colorado Hospital

NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)

Protocol #22-0916

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

A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Protocol #22-0805

Location: Highlands Ranch Hospital, Highlands Ranch Hospital - CU Med Clinics, University of Colorado Hospital

Neuroliten MVP System Clinical Observation Study

Protocol #22-1062

Location: Harmony Campus, Medical Center of the Rockies

A PHASE 1b STUDY OF ZN-c3 IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN, PERITONEAL, OR FALLOPIAN TUBE CANCER

Protocol #22-0890

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

DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes

If you choose to participate, you will take the study medication, ertugliflozin, or placebo over 4 so-called treatment blocks of 20 days each. You will be recommended foods based on a sodium-controlled diet for approximately 23 weeks. There will be 5 study visits total over 23 weeks, which...

Protocol #22-0224

Location: Outpatient CTRC, University of Colorado Hospital

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Protocol #22-1027

Location: Outpatient CTRC, University of Colorado Hospital

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2, 6-MONTH STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EXPLORATORY EFFICACY OF CT1812 IN SUBJECTS WITH MILD TO MODERATE DEMENTIA WITH LEWY BODIES

Protocol #22-0669

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

A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS,AND EFFICACY OF MOSUNETUZUMAB OR GLOFITAMAB IN COMBINATION WITH CC-220 AND CC-99282 IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA

Protocol #22-0939

Location: CTRC Inpatient, University of Colorado Hospital

The Nephrotic Syndrome Study Network (NEPTUNE)

Collection of blood, urine and tissue (optional)...

Protocol #22-0895

Location: Renal Research Center, University of Colorado Hospital

A PHASE I/II, OPEN-LABEL, MULTI-COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CEVOSTAMAB IN PRIOR B CELL MATURATION ANTIGEN-EXPOSED PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Protocol #22-0931

Location: CTRC Inpatient, University of Colorado Hospital

APAL2020SC - Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Protocol #22-0828

Location: Childrens Hospital Colorado

Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

A double-blind, placebo-controlled trial of investigational agent combined with MMF....

Protocol #22-0596

Location: Renal Research Center, University of Colorado Hospital

Molecular Mechanisms of SGLT2 inhibition in diabetic kidney disease

Protocol #22-0668

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

A PHASE 1 MULTICENTER STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GCC19CART IN SUBJECTS WITH RELAPSED OR REFRACTORY METASTATIC COLORECTAL CANCER (CARAPIA-1 Study)

Protocol #22-0697

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

Feasibility study of empagliflozin in patients with autosomal dominant polycystic kidney disease

Participation involves taking the study drug empagliflozin or a placebo for 12 months. Blood sample collection, magnetic resonance imaging (MRI) of the kidneys and blood vessel stiffness testing during visits at baseline, 3-month and 12-month to the Renal Research Clinic located at the...

Protocol #22-0616

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

An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

Protocol #22-0565

Location: University of Colorado Hospital

A mixed methods approach to examining decisional needs and contextual factors influencing fertility status assessment outcomes among young female survivors of childhood cancer

This study involves answering online survey questions. These questions will ask about how you feel during this time in your life, your reproductive health and sexual behaviors, if you’ve seen a reproductive specialist, and how you feel about your future fertility....

Protocol #21-4897

Location: Childrens Hospital Colorado

PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER

Protocol #21-5033

Location: CTRC Inpatient, Department Specific Free Standing Clinic, LSU Health Sciences Center, Mt. Sinai Comprehensive Cancer Center, University of Colorado Hospital, USD Moores Cancer Center, UW Carbone Cancer Center

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

Prospective, single arm, multicenter study...

Protocol #22-0486

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

(PEAK) A PHASE 3 RANDOMIZED, OPEN-LABEL, MULTICENTER CLINICAL STUDY OF CGT9486+SUNITINIB VS SUNITINIB IN SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC GASTROINTESTINAL STROMAL TUMORS

Protocol #22-0333

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

Naturalistic sleep assessed by wearable devices in Parkinson's disease

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

Protocol #22-0393

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

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

Protocol #22-0175

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

A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY

Protocol #21-4960

Location: Renal Research Center, University of Colorado Hospital

Pathogenesis of kidney disease in type 1 diabetes: a modern kidney biopsy cohort (The PANDA Study)

Protocol #22-0250

Location: Childrens Hospital Colorado, Outpatient CTRC

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

Protocol #22-0306

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

Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)

Protocol #22-0360

Location: Childrens Hospital Colorado

GALAXY: Generating Advancements through Longitudinal Analysis in X and Y Syndromes

Participants who join the GALAXY 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. If participants are seen outside of Children’s Colorado, they can sign a Releas...

Protocol #20-0482

Location: Childrens Hospital Colorado, Outpatient CTRC

Understanding How Sleep Health Affects Recovery from Adolescent Concussion

We will conduct a prospective cohort study, with two groups (concussed and control). They will undergo an initial assessment (within 14 days of concussion) and a follow up ~28 days post-concussion. Controls will follow a similar timeline. During the ~two-week period between Visits 1 & 2, p...

Protocol #22-0316

Location: Boulder Health Center, Childrens Hospital Colorado

A PHASE I AND EXPANSION COHORT STUDY OF SELINEXOR AND VENETOCLAX IN COMBINATION WITH CHEMOTHERAPY IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

Protocol #21-3910

Location: Childrens Hospital Colorado

Feasibility of VR Programs for Anxiety Related Disorders in an Outpatient Care Setting

For this project, semi-structured interviews will be conducted with up to 10 providers specializing in mental health care for adolescents and up to 20 adolescents, ages 14-18, with mild to moderate social anxiety symptoms. Adolescent interviews will focus on using the VR program and provi...

Protocol #21-4407

Location: Department Specific Free Standing Clinic

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

Protocol #21-5143

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

EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Protocol #21-5082

Location: University of Colorado Hospital

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

Protocol #21-3486

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

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

Protocol #21-4582

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

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

Protocol #21-4778

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

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

Protocol #21-4129

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

An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis

Protocol #21-4875

Location: Childrens Hospital Colorado

Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies

Protocol #21-4807

Location: Childrens Hospital Colorado

A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

Protocol #21-4825

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

AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of fatumumab 20mg SC Monthly in Treatment Naive, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

Protocol #21-4783

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

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

Protocol #21-4822

Location: CTRC Inpatient, University of Colorado Hospital

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

Protocol #21-4901

Location: Childrens Hospital Colorado

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

Protocol #21-4711

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

The American Lung Association (ALA) Lung Health Cohort

Protocol #21-4835

Location: University of Colorado Hospital

Comparison of Methods in Post-Operative Hip Arthroscopy Rehabilitation

Inquire within...

Protocol #21-4753

Location: UCHealth Steadman Hawkins Clinic - Denver (Inverness)

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...

Protocol #21-4765

Location: University of Colorado Hospital

LIMA: LIPID ANTI-FLAMMATORY MEDIATORS IN ASTHMA TO REDUCE HYPERRESONSIVENESS IN OBESE ASTHMATICS

The research plan is designed to test the beneficial metabolic and anti-inflammatory actions of an endogenously present class of modified fats, termed nitro-fatty acids. This project provides a novel precision pharmacology therapy, oral CXA-10, for the treatment of obese asthma, a disease ...

Protocol #21-3959

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

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

Protocol #21-4725

Location: University of Colorado Hospital

A prospective, randomized, multi-center evaluation of the Safety and Effectiveness of the STREAMLINE?SURGICAL SYSTEM compared to iStent Inject W? in Patients with Open-Angle Glaucoma

The STREAMLINE? Surgical System consists of a surgical grade stainless steel disposable cannula (hollow tube) and a manual handset. The stainless steel cannula (hollow tube) is placed along the drainage duct of the eye (also called the trabecular meshwork) and a button is pressed that acti...

Protocol #21-4696

Location: University of Colorado Hospital

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

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

Protocol #21-4551

Location: Renal Research Center

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

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

Protocol #21-4712

Location: Childrens Hospital Colorado

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Protocol #21-4384

Location: Memorial Hospital Central, Memorial Hospital North

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

Protocol #21-4447

Location: Childrens Hospital Colorado

ANHL1931- A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Protocol #21-4667

Location: Childrens Hospital Colorado

A Phase 1/2, dose escalation, dose expansion, and dose optimization study of the safety, tolerability, and anti-tumor activity of SAR444881 administered alone and in combination with pembrolizumab, cetuximab, and/or chemotherapy in participants with advanced solid tumors

Protocol #21-4633

Location: University of Colorado Hospital

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

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

Protocol #21-4668

Location: Childrens Hospital Colorado

An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

Protocol #21-4586

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

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

Protocol #21-4641

Location: University of Colorado Hospital

(Cohort J) TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

Protocol #20-2114J

Location: Childrens Hospital Colorado

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

Protocol #21-4639

Location: University of Colorado Hospital

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

Protocol #21-4429

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

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy

Protocol #21-4569

Location: Childrens Hospital Colorado, University of Colorado Hospital

Multidisciplinary Assessment of Intraoperative Margins in Breast Conserving Surgery - A Pilot Study

Protocol #21-4565

Location: University of Colorado Hospital

SARC041: Phase 3 Randomized Double-Blind Study of Abemaciclib versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

Protocol #21-4502

Location: University of Colorado Hospital

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

Protocol #21-4519

Location: University of Colorado Hospital

Effects of SGLT2 inhibition on early diabetic kidney disease: interrogation of renal energetics by functional imaging and single-cell transcriptomics- an ancillary study to the ATTEMPT trial (COMIRB #19-2947)

Protocol #21-4373

Location: Childrens Hospital Colorado

ACNS2021-A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Protocol #21-4345

Location: Childrens Hospital Colorado

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

Protocol #21-3488

Location: Childrens Hospital Colorado

Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients with Recurrent Medulloblastoma and Ependymoma

Stratum1 - This study is being done to see if we can lower the chance of the brain tumor growing or spreading by adding a new drug called 131I-omburtamab to the usual combination of chemotherapy drugs? We are doing this study because we want to find out if this approach is better or worse ...

Protocol #21-4342

Location: Childrens Hospital Colorado

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

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

Protocol #21-3533

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

PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)

The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...

Protocol #21-3844

Location: Childrens Hospital Colorado, University of Colorado Hospital

Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases

This is a prospective, multicenter phase II study designed to evaluate the outcomes of patients with bone marrow failure diseases (BMFD) undergoing HLA-matched related, HLA-matched unrelated, or single HLA-class 1 allele or HLA-DQB1 antigen or allele mismatched unrelated hematopoietic cell...

Protocol #21-3994

Location: Childrens Hospital Colorado

A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling

There are two parts planned for this study, the Phase 1 that will test different doses of avapritinib to identify the recommended dose of avapritinib for the Phase 2. The Phase 2 will continue to test this recommended dose of avapritinib to determine if it is a tolerable, safe, and effecti...

Protocol #21-4262

Location: Childrens Hospital Colorado

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

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

Protocol #21-4267

Location: Comprehensive Women's Health Center

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

This is a natural history study. ...

Protocol #21-4206

Location: Childrens Hospital Colorado

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

Protocol #21-3827

Location: University of Colorado Hospital

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

Protocol #21-4199

Location: Cancer Care Northwest, Duke University Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

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

Protocol #21-4100

Location: University of Colorado Hospital

The Intersection of Oncology Care and Worker Well-Being

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

Protocol #21-4139

Location: Grandview Hospital, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Saint Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH ACTIVE CLASS III OR IV LUPUS NEPHRITIS

Protocol #21-4110

Location: Childrens Hospital Colorado

SPHERES Neuromyelitis Optica Spectrum Disorder (NMOSD) Registry

Protocol #21-3763

Location: University of Colorado Hospital

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

Protocol #21-4033

Location: Childrens Hospital Colorado

Pilot Study to Compare Patient-Reported and Provider Completed G8 Frailty Questionnaires in Patients with Cancer Age 65 and Over

Protocol #21-3954

Location: University of Colorado Hospital

Young Women's Breast Cancer Awareness and Survivorship Needs in Underserved Communities

Protocol #21-3898

Location: Cherry Creek Medical Center, Lone Tree Medical Center, University of Colorado Hospital

An Open-Label, Multicenter, Phase 1a Study of AN2025 and AN0025 in Double Combination with Atezolizumab and in Triple Combination with Atezolizumab in Patients with Advanced Solid Tumors

Protocol #21-4026

Location: University of Colorado Hospital

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

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

Protocol #21-3870

Location: Childrens Hospital Colorado

Enhancing Skeletal Adaptation to Exercise by Attenuating the Acute Disruption of Calcium Homeostasis During Exercise

Protocol #21-3163

Location: Outpatient CTRC, Rocky Mountain Regional VA Medical Center

EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Protocol #21-3855

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

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

Protocol #21-3876

Location: Childrens Hospital Colorado, University of Colorado Hospital

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

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

Protocol #20-3142

Location: Department Specific Free Standing Clinic

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

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

Protocol #21-3666

Location: Childrens Hospital Colorado

This is our 2020R3 upgrade testing protocol

Protocol #X21-9999

Location: Barbara Davis Center, Childrens Hospital Colorado, Department Specific Free Standing Clinic

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

Protocol #21-3608

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

Characterization of SARS-CoV-2 Immune Responses Among Persons Living with HIV (PWH)

Protocol #21-3832

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

Alarm Fatigue in Medical-Surgical Nurses

Protocol #21-3868

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

Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Protocol #21-3574

Location: University of Colorado Hospital

NAVEG test administration for Cerebral Vision Impairment (CVI) in premature infants

Protocol #21-3043

Location: Childrens Hospital Colorado

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

Protocol #21-3747

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

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in subjects with Acute Traumatic Cervical Spinal Cord Injury

Protocol #21-3382

Location: University of Colorado Hospital

S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations

Protocol #21-3607

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

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

Protocol #21-3774

Location: CTRC Inpatient, University of Colorado Hospital

A Phase 1/2, Open-Label Study of the Pressure-Enabled Hepatic Artery Infusion of SD-101, a TLR9 Agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Metastatic Uveal Melanoma

Protocol #21-3200

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

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

Protocol #21-3724

Location: CTRC Inpatient, University of Colorado Hospital

Decision making for urinary diversion in patients with bladder cancer

Protocol #21-3661

Location: University of Colorado Hospital

Influence of NT5c1A antibodies on disease progression, clinical phenotype and blood and muscle biomarkers in sporadic Inclusion Body Myositis - A prospective evaluation

Protocol #21-3383

Location: University of Colorado Hospital

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

Protocol #21-3694

Location: Memorial Hospital Central, Memorial Hospital North

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

Protocol #21-3728-DH

Location: Denver Health and Hospital Authority

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

In the best standard of care (control) arm, each patient will receive best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk‑benefit assessment, institutional protocols, the local Prescribing Information, local regulations o...

Protocol #21-3552

Location: Outpatient CTRC, University of Colorado Hospital

BIOREPOSITORY FOR CENTRAL VEIN SIGN: A DIAGNOSTIC BIOMARKER IN MULTIPLE SCLEROSIS

Protocol #21-3715

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

Intravascular access in hypotensive trauma patients: an Eastern Association for the Surgery of Trauma multicenter prospective observational trial using trauma video review

Protocol #21-3676

Location: University of Colorado Hospital

A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

The ASSERVO study is testing a potential medicine for infants to see if it may help prevent lower respiratory infections caused by RSV. Study participation includes 1 dose of the medicine or placebo, approximately 3 blood draws, e-diary entries, and nasal swabs collected during any respir...

Protocol #21-3387

Location: Childrens Hospital Colorado

Harnessing Cells from Human Milk; Linking Lactation to Metabolism

In this study: - Participants will complete 2 study visits (in late pregnancy & 2 wks postpartum) - Participants will have their milk production measured and provide blood and breastmilk samples If you join the study, you will be part of the study for up to a month and a half, lasting...

Protocol #21-2835

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

Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Protocol #21-3576

Location: University of Colorado Hospital

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

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

Protocol #21-3374

Location: Childrens Hospital Colorado

Impact of quantitative measurements of postoperative activity on clinical outcomes

Protocol #21-3611

Location: University of Colorado Hospital

Genetic and epigenomic determinants of hearing loss in Hispanic populations

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

Protocol #21-3609

Location: Boulder Health Center, Childrens Hospital Colorado, University of Colorado Hospital

Evaluating a New Gonadotoxic Risk Stratification System

Protocol #21-3084

Location: Childrens Hospital Colorado, University of Colorado Hospital

Protocol A011-13 (HYPERION): A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

Protocol #21-3600

Location: University of Colorado Hospital

Advanced Planning for Online Accounts and Data

Protocol #21-3375

Location: University of Colorado Hospital

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

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

Protocol #21-3544

Location: University of Colorado Hospital

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

Protocol #21-3367

Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic

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

Protocol #21-3483

Location: Barbara Davis Center, Childrens Hospital Colorado

Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE)

The Applied Biomarkers of Late Effects of Childhood Cancer (ABLE) study, in collaboration with the Pediatric Transplantation & Cellular Therapy Consortium (PTCTC), have recently focused on biological correlates (such as T- and B-cells and their respective subsets, NK cells and their subset...

Protocol #21-3395

Location: Childrens Hospital Colorado

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

Protocol #21-3466

Location: University of Colorado Hospital

Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil...

Protocol #21-3447

Location: Renal Research Center, University of Colorado Hospital

Mama Brain Study

Protocol #21-3266

Location: Childrens Hospital Colorado, University of Colorado Hospital

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

Protocol #20-2614

Location: Childrens Hospital Colorado

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

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

Protocol #21-2520

Location: Childrens Hospital Colorado

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

Protocol #21-2970

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

A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Protocol #21-3254

Location: Outpatient CTRC, University of Colorado Hospital

S2000 - A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab Vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma with Brain Metastases

Protocol #21-2584

Location: University of Colorado Hospital

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

Protocol #21-3325

Location: Childrens Hospital Colorado

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

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

Protocol #20-2018

Location: Childrens Hospital Colorado

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

Protocol #21-2662

Location: Childrens Hospital Colorado

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

Protocol #20-3038

Location: Outpatient CTRC, University of Colorado Hospital

Therapeutics for Severely ill Inpatients with COVID-19

Protocol #21-3177-DH

Location: Denver Health and Hospital Authority

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

Protocol #21-3281

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

A North American study of the digestive manifestations of COVID-19-II

Protocol #21-3335

Location: University of Colorado Hospital

Observational Protocol: Trametinib therapy for Symptomatic Patients with RAS/MAPK-Pathway Mutation-Positive Disorders

Protocol #21-3183

Location: Childrens Hospital Colorado

ALLFTD: ARTFL-LEFFTDS LONGITUDINAL FRONTOTEMPORAL LOBAR DEGENERATION

Protocol #21-2833

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

Cognitive Outcomes for medium-giant sub-frontal meningiomas after a unilateral tailored approach

Protocol #21-3166

Location: University of Colorado Hospital

PWI LAEF- Effect of Electrical Posterior Wall Isolation on Left Atrial Ejection Fraction

Protocol #21-2651

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

A MULTICENTER PROSPECTIVE STUDY EVALUATING OUTCOMES OF ENDOSCOPIC ERADICATION THERAPY IN PATIENTS WITH BARRETT'S ESOPHAGUS ASSOCIATED NEOPLASIA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM

Protocol #14-2371

Location: Moffit Cancer Center, University of South Florida, Northwestern University, UCLA - University of California, University of Colorado Hospital, University of Kansas Cancer Center, Washington University, Siteman Cancer Center

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

Protocol #21-2770

Location: Childrens Hospital Colorado

Pediatric Polyposis Syndromes

Protocol #20-2981

Location: Childrens Hospital Colorado

Communication and Knowledge of Palliative Care for Older LGBT Adult Dyads and Palliative Care Clinicians

Protocol #21-3134

Location: Highlands Ranch Hospital, University of Colorado Hospital

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

Protocol #21-3149

Location: University of Colorado Hospital

A retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe PROVE (Retrospective Cefiderocol Chart Review Study)

Protocol #21-3197

Location: University of Colorado Hospital

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

Protocol #21-3184

Location: Childrens Hospital Colorado

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

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

Protocol #21-3000

Location: Brain Imaging Center - BIC, University of Colorado Hospital

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/ Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Protocol #21-3077

Location: Cherry Creek Medical Center, University of Colorado Hospital

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

Protocol #21-2955

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

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

Protocol #21-3118

Location: Childrens Hospital Colorado

Evaluating the peripheral vascular blood flow and oxygenation responses to exercise in type 2 diabetes with time-resolved, quantitative MRI

Protocol #21-3080

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

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB, COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS.

Protocol #21-2663

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

An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, with or without BI 754091, in Patients with Stage IV Colorectal Cancer

Protocol #21-3062

Location: CTRC Inpatient, University of Colorado Hospital

Characteristics, interventions, and responses to treatment of sexual concerns in women seen at the Women's Sexual Health Consultation Service at University of Colorado School of Medicine

Protocol #21-2834

Location: CU Advanced Reproductive Medicine (Denver), University of Colorado Hospital

Effect of Lower Limb Osseointegration Amputation across Multiple Biomechanical Domains

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

Protocol #20-3097

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

S1914 A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Protocol #21-2852

Location: Rocky Mountain Regional VA Medical Center

Comparison of Exercise Mode on Disruptions in Calcium Homeostasis

Protocol #21-2580

Location: Outpatient CTRC, Rocky Mountain Regional VA Medical Center

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

Protocol #21-2827

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

Exploring barriers to and improving the quality of parental updates in the Neonatal Intensive Care Unit

Protocol #20-2966

Location: Childrens Hospital Colorado

HAI Consortium Research Network: Registry of Hepatic Artery Infusion (HAI)

Protocol #21-2794

Location: Highlands Ranch Hospital, University of Colorado Hospital

PEPN1924: A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# TBD) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA

Protocol #21-2749

Location: Childrens Hospital Colorado

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

Protocol #21-2851

Location: Childrens Hospital Colorado, University of Colorado Hospital

TRISCEND II- Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device

Protocol #20-3160

Location: Harmony Campus, Medical Center of the Rockies

Double blind randomized trial of post-operative cesarean continuous infusion of bupivacaine for local incisional pain control

Protocol #21-2810

Location: Childrens Hospital Colorado

Shwachman Diamond Syndrome Registry and Study

Protocol #20-3174

Location: Childrens Hospital Colorado

Using Oscillometry in Toddler Aerodigestive Patients to Monitor Lung Function Response to Treatment

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

Protocol #21-2637

Location: Childrens Hospital Colorado

REMODEL - Renal mode of action of semaglutide in patients with type 2 diabetes and chronic kidney disease

Protocol #21-2645

Location: Barbara Davis Center, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

A PHASE 1 OPEN-LABEL STUDY OF KPT-9274 IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE MYELOID LEUKEMIA

Protocol #20-2350

Location: Lone Tree Medical Center, University of Colorado Hospital

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

Protocol #21-2670

Location: Outpatient CTRC, University of Colorado Hospital

A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

Protocol #21-2558

Location: Cherry Creek Medical Center, 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

Improving the Timeliness and Quality of Care for Rural Cancer Patients with Solid Tumors

Protocol #21-2666

Location: Greeley Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, Pueblo, San Juan Cancer Center, St. Marys Hospital, Grand Junction, University of Colorado Hospital, Yampa Valley Medical Center

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

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

Protocol #20-3065

Location: Childrens Hospital Colorado

Multicentric Carpotarsal Osteolysis (MCTO): Natural History Study

Protocol #21-2606

Location: Childrens Hospital Colorado

Mind Body Balance for Pediatric Migraine

Protocol #21-2568

Location: Childrens Hospital Colorado

Protocol MK-5475-007: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension

Protocol #21-2564

Location: Outpatient CTRC, University of Colorado Hospital

Microbiome and Neutrophil associated factors in Rheumatoid Arthritis and Autoimmune-related Interstitial Lung Disease (MINERAL)

Protocol #20-2769

Location: Barbara Davis Center, Childrens Hospital Colorado, Denver Health and Hospital Authority, National Jewish Health, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

MicroRNA as a Maternal and Neonatal Biomarker to Predict Congenital Diaphragmatic Hernia Severity

Protocol #21-2481

Location: Childrens Hospital Colorado, University of Colorado Hospital

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

Protocol #20-2649

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

Lessening caregiver burden in fibrotic interstitial lung disease: a dyadic, mixed-methods approach to improving symptoms and quality of life for patients and caregivers

Protocol #20-0214

Location: University of Colorado Hospital

Grow Up Formula Versus Nutritional Supplements: Effects on Catch Up Growth, Micronutrients Status and Solid Foods Intake in Toddlers with Mild Malnutrition

Protocol #20-3082

Location: Childrens Hospital Colorado

Neuropalliative care to improve quality of life measures in persons with drug resistant epilepsy - a needs assessment

Protocol #20-2627

Location: University of Colorado Hospital

A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)

SIngle-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patieths with aHUS....

Protocol #20-2595

Location: Childrens Hospital Colorado

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

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

Protocol #20-2825

Location: Childrens Hospital Colorado

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Protocol #22-0815

Location: Barbara Davis Center, University of Colorado Hospital

A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Each patient will go through a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period. ...

Protocol #20-3010

Location: Renal Research Center, University of Colorado Hospital

Pediatric Peritoneal Dialysis Telehealth Survey

Protocol #20-3009

Location: Childrens Hospital Colorado

Treatment for Alcohol Use Disorder: Emotion Regulation and Brain Function

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

Protocol #20-3000

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

A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)

Protocol #22-0647

Location: Boulder Health Center, Cherry Creek Medical Center, CU Sports Medicine - Denver, Lone Tree Medical Center, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

This is a phase 3 double-blind (DB), randomized, placebo-controlled study with an open-label long term extension (LTE) evaluating the efficacy and safety of Elafibranor 80 mg once daily versus placebo in patients with PBC and inadequate response or intolerance to ursodeoxycholic acid (UD...

Protocol #20-2899

Location: Outpatient CTRC, University of Colorado Hospital

A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNA-GUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

Protocol #20-2773

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

A Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

Protocol #20-2793

Location: Childrens Hospital Colorado

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...

Protocol #20-2465

Location: University of Colorado Hospital

Hemodynamic Monitoring to Support Intraprocedural Management of Ventricular Tachycardia Ablation

Protocol #20-1608

Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

Werewolf FLOW 50 During ACL Reconstruction: A Randomized Control Trial

Participation in this study will not affect the pre, post, or intra-operative care of ACL reconstruction in any way other than either the use of the use of the Werewolf FLOW 50 device or not and the performance of MRI at 6 months postoperative. All involvement and participation will be com...

Protocol #20-2720

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

PFAS Exposure and Health Effects in El Paso County

Protocol #20-2625

Location: Department Specific Free Standing Clinic

A Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients

Protocol #19-1536

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

CRI and Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Protocol #20-2755

Location: Childrens Hospital Colorado, Childrens National Medical Center

Maternal Perspectives on Postpartum Depression Screens: Beliefs, Concerns, and Level of Comfort Within and Across Racial Identities

Protocol #20-1436

Location: Childrens Hospital Colorado, Denver Health and Hospital Authority, UCHealth Central Park Medical Center

NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]

Protocol #20-2079

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

Prehospital nasal cannula ETCO2 's ability determine the need for emergent lifesaving intervention, massive transfusion and death in the non-intubated patient

Protocol #20-2688

Location: Denver Health and Hospital Authority, University of Colorado Hospital

Assessing the Transcriptional Response in Nasal Epithelium to the Triple CFTR modulator (ARNET)

Protocol #20-2738

Location: Childrens Hospital Colorado

Pediatric Brain Injury Caregiver Education Program

Protocol #20-0272

Location: Childrens Hospital Colorado

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

Protocol #20-2357

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

Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure

Protocol #18-1270

Location: Childrens Hospital Colorado

Perceptions of the esthetics of the anterior-posterior position of maxillary central incisors in individuals of four ethnicities as evaluated by orthodontists and four ethnicities of layperson

Protocol #19-0741

Location: Dental Clinic

Intermediate-size Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline Gliomas

Protocol #20-2681

Location: Childrens Hospital Colorado

ALZHEIMER'S CLINICAL TRIAL CONSORTIUM FOR DOWN SYNDROME (ACTC-DS) TRIAL-READY COHORT - DOWN SYNDROME (TRC-DS)

TRC-DS is part of a larger movement working with people with Down syndrome to advance Alzheimer's disease therapies and potential cures for this population. The Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS) is a large collaboration of researchers conducting clinical trials...

Protocol #20-2692

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

Symptom Screening Linked to Care Pathways for Children with Cancer: a Cluster Randomized Trial

Protocol #20-2525

Location: Childrens Hospital Colorado

Evolutionary Inspired Therapy For Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Protocol #20-1537

Location: Childrens Hospital Colorado

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis

What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin...

Protocol #22-1945

Location: University of Colorado Hospital

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Protocol #20-2584

Location: University of Colorado Hospital

TOPPLE T1D - A multiple ascending dose trial investigating safety, tolerability and pharmacokinetics of NNC0361-0041 administered subcutaneously to patients with type 1 diabetes mellitus

Protocol #20-2610

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program (PHP)

Protocol #20-2566

Location: Childrens Hospital Colorado

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

Protocol #20-0280

Location: Childrens Hospital Colorado

S1823 - A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS

Protocol #20-2392

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

A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis

This study will be conducted in 2 sequential stages. You are being invited to participate in both stages of this study. The entire study period will be of approximately 39 months. Stage 1 (Phase 2b) will include approximately 315 patients and will consist of a screening period (about 2...

Protocol #20-2433

Location: Outpatient CTRC, University of Colorado Hospital

Post-Intensive Care Syndrome - pediatrics (PICS-p): Longitudinal Cohort Study

Protocol #20-2512

Location: Childrens Hospital Colorado

A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease Study of Tecovirimat for Human Monkeypox Virus (STOMP)

Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br...

Protocol #22-1761

Location: Childrens Hospital Colorado

A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months

Protocol #20-2082

Location: Childrens Hospital Colorado

A Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NS-089/NCNP-02 in Boys with Duchenne Muscular Dystrophy (DMD)

Treatment of Duchenne muscular dystrophy (DMD) with dystrophin deletion amenable to exon 44 skipping...

Protocol #22-0121

Location: Childrens Hospital Colorado

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Protocol #20-2414

Location: Childrens Hospital Colorado

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

Protocol #20-2389

Location: Childrens Hospital Colorado

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS

Protocol #20-2036

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

Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants

Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....

Protocol #20-0593

Location: Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

Protocol #20-2156

Location: Childrens Hospital Colorado

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

Protocol #20-1789

Location: University of Colorado Hospital

S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab(NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Protocol #20-2083

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

TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

Protocol #20-2114

Location: Childrens Hospital Colorado

Assessing the Impact of Therapy on Localized Intravascular Coagulopathy in Vascular Anomalies

Protocol #20-2139

Location: Childrens Hospital Colorado

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Protocol #20-1852

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

Vascular Anomalies Biobank: Collection and Banking of Biological Specimens and Data from patients with vascular anomalies

Protocol #20-0113

Location: Childrens Hospital Colorado

STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE)

Protocol #20-0141

Location: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

Evaluation of Compensatory Reserve in Obstetrical Patients

A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....

Protocol #14-1996

Location: Childrens Hospital Colorado, University of Colorado Hospital

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

Protocol #20-1948

Location: Rocky Mountain Regional VA Medical Center

Personalized Spine Study Group Registry

Protocol #20-2016

Location: University of Colorado Hospital

A Phase 1 Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of BXQ-350 in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

Protocol #20-1447

Location: Childrens Hospital Colorado

A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

Protocol #23-1150

Location: Memorial Hospital Central, Memorial Hospital North

LUNGMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

Protocol #20-1813

Location: Rocky Mountain Regional VA Medical Center

Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

Aerobic exercise is a vital treatment for people living with Parkinson's disease. Although anti-parkinsonian medication helps alleviate Parkinson's symptoms, it is not known to slow the rate of disease progression. Aerobic exercise is a treatment with the most compelling evidence for its p...

Protocol #20-1854

Location: Outpatient CTRC, University of Colorado Hospital

Improving Contraceptive and Pregnancy Counseling in Rheumatology Clinics

Protocol #20-1332

Location: University of Colorado Hospital

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)

Protocol #21-4907

Location: University of Colorado Hospital

Clonal hematopoiesis, mild cognitive impairment and kidney function decline.

CH is a common aging-associated biological state that predisposes to subsequent cardiovascular death, however, whether it plays a role in MCI, dementia and kidney disease progression is unknown and understanding this novel risk factor may uncover new ways to reduce the burden of cognitiv...

Protocol #22-0288

Location: Renal Research Center, University of Colorado Hospital

AAML1831 - A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Protocol #20-1864

Location: Childrens Hospital Colorado

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)

This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints ...

Protocol #19-1226

Location: Childrens Hospital Colorado, University of Colorado Hospital

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

Protocol #21-5060

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

S1714: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane Induced Peripheral Neuropathy in Cancer Patients

Protocol #19-2216

Location: Rocky Mountain Regional VA Medical Center

S1827: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Protocol #20-1704

Location: Rocky Mountain Regional VA Medical Center

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

Protocol #20-0680

Location: Childrens Hospital Colorado

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

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

Protocol #20-1690

Location: University of Colorado Hospital

Comparison of Nasopharyngeal specimens to Midturbinate Specimens for Detection of SARS-CoV-2 in Pediatric Patients

Protocol #20-1721

Location: Childrens Hospital Colorado

Dystonia Coalition Projects-3

Protocol #20-0290

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

Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy

This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a...

Protocol #20-1074

Location: Childrens Hospital Colorado, University of Colorado Hospital

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN)

Protocol #20-1602

Location: Childrens Hospital Colorado

Genetics of CMT - Modifiers of CMT1A, New Causes of CMT

Protocol #20-1525

Location: Outpatient CTRC, University of Colorado Hospital

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus

Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be ...

Protocol #20-1641

Location: University of Colorado Hospital

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

Protocol #12-1549

Location: Childrens Hospital Colorado

Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995

Protocol #14-1869

Location: Childrens Hospital Colorado

Pilot Trial of Hypnosis and Enhanced Communication Training to Reduce Anxiety, Improve Patient Satisfaction, and Decrease Movement for Patients Undergoing Magnetic Resonance Imaging

Protocol #20-1576

Location: University of Colorado Hospital

Early detection of metastatic disease in US Veterans following surgery for early stage lung cancer

Protocol #20-1548

Location: Rocky Mountain Regional VA Medical Center

Evaluation of Long-term Safety in Paediatric Patients With B-precursor Acute Lymphoblastic Leukemia (ALL) who Have Been Treated With Either Blinatumomab or Chemotherapy, Followed by Transplantation

Protocol #20-1442

Location: Childrens Hospital Colorado

Embolization of the Middle Meningeal Artery with ONYX(TM) Liquid Embolic System in the Treatment of Subactue and Chronic Subdural Hematoma (EMBOLISE)

The purpose of this study is to evaluate the safety (short and long term side effects) and effectiveness (how well it helps) of Onyx Liquid Embolic System(LES) (study device) embolization of the middle meningeal artery when used in addition to the standard treatment that is used to treat a...

Protocol #20-1390

Location: University of Colorado Hospital

Endovascular treatment of acutely ruptured shallow intradural aneurysms not amendable to clipping and coiling with the pipeline vantage embolization device

Protocol #20-1254

Location: University of Colorado Hospital

Patient Preferences in Deep Brain Stimulation Products

Protocol #19-3015

Location: University of Colorado Hospital

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 and IO-202 + Azacitidine ? Venetoclax in Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Chronic Myelomonocytic Leukemia (CMML) Patients (IO-202-CL-001)

Protocol #20-1388

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

The Parkinson's Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort

Protocol #20-1204

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

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

Protocol #20-0638

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

Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic Anemia

Protocol #20-1333

Location: Childrens Hospital Colorado

NRG-GU011: A PHASE II DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL OF PROSTATE OLIGOMETASTATIC RADIOTHERAPY WITH OR WITHOUT ANDROGEN DEPRIVATION THERAPY IN OLIGOMETASTATIC PROSTATE CANCER (NRG PROMETHEAN)

Protocol #22-0504

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

Myocardial inflammation and thrombosis related to SARS-CoV-2 vaccination

Protocol #21-4055

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

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

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

Protocol #20-1262

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

A Prospective Natural History Study of Angelman Syndrome for Therapeutic Development

Protocol #20-1338

Location: Childrens Hospital Colorado

ARST2032- A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Protocol #23-0047

Location: Childrens Hospital Colorado

SARS-CoV-2 specific T cell responses in HIV-positive and negative individuals after resolution of COVID-19 viral infection.

Protocol #20-1219

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

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...

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

Evaluation of ultra-early microRNA and metabolomic biomarkers in acute ischemic stroke.

Protocol #20-1088

Location: Memorial Hospital Central, University of Colorado Hospital

SLEEP-DISORDERED BREATHING IN INFANTS WITH MYELOMENINGOCELE

Protocol #20-0996

Location: Childrens Hospital Colorado

Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB Suture Anchor, MICRORAPTOR Knotless REGENESORB Suture Anchor and MICRORAPTOR Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair

Protocol #20-0923

Location: Highlands Ranch Hospital, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

Creation of a Registry Via Patient and Provider Surveys to Assess Outcomes of Platelet-Rich Plasma (PRP) Injections in Orthopedics

Protocol #20-0978

Location: UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITY

Protocol #20-0889

Location: Childrens Hospital Colorado

Slow Heart Registry: A prospective observational cohort study of fetal immune-mediated high degree heart block

Protocol #20-0820

Location: Childrens Hospital Colorado

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

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

Protocol #20-0706

Location: Broomfield Hospital, Cherry Creek Medical Center, Childrens Hospital Colorado, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Outpatient CTRC, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

Protocol #20-0579

Location: Childrens Hospital Colorado

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

Protocol #20-0590

Location: Department Specific Free Standing Clinic

PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD

Protocol #20-0277

Location: Childrens Hospital Colorado, Outpatient CTRC

COVID-19 Preparedness Survey

Protocol #20-0620

Location: University of Colorado Hospital

CD80 as a biomarker for kidney disease

Protocol #13-2700

Location: Childrens Hospital Colorado

The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia...

Protocol #21-4972

Locations: Baylor Scott &amp; White Health, Case Western Reserve University, Cleveland Clinic, Main, Columbia University, Dartmouth University, Florida Digestive, Geisinger Medical Center, Johns Hopkins/The Sidney Kimmel Cancer Center, Kaiser Permanente of Colorado, Mayo Clinic, Jacksonville, Mayo Clinic, Rochester, Medical University of South Carolina, Northwestern University, Thomas Jefferson University Hospital Cancer Center, UCLA - University of California, University of Colorado Hospital, University of Michigan, University of North Carolina, University of Pennsylvania, Washington University, Siteman Cancer Center

Phase I/II trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF fusion/duplication positive or NF1-associated recurrent or progressive gliomas in children and young adults

Protocol #20-0535

Location: Childrens Hospital Colorado

Immune Profiles in CF Fungal Infections

Protocol #20-0099

Location: Childrens Hospital Colorado

Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion

Protocol #15-0813

Location: University of Colorado Hospital

International CDKL5 Clinical Research Network

Protocol #19-2756

Location: Childrens Hospital Colorado

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

Protocol #20-0347

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

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

Protocol #20-0359

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS 986278 in Participants with Pulmonary Fibrosis

Protocol #20-0383

Location: University of Colorado Hospital

Meibography in Unilateral Eyelid Paralysis

Protocol #20-0248

Location: University of Colorado Hospital

Protocol I8F-MC-GPGN(a) The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes

Protocol #20-0271

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

Fungal sinus infections in pediatric cystic fibrosis: impact on treatment

Protocol #20-0286

Location: Childrens Hospital Colorado

Crest -2 - CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS

Protocol #19-3082

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

Airway Inflammation Research Development Protocol

Protocol #23-0778

Location: Childrens Hospital Colorado

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

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

Protocol #20-0288

Location: University of Colorado Hospital

Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study

The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp...

Protocol #19-1526

Location: Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2

Protocol #20-0226

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

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective o...

Protocol #20-0254

Location: University of Colorado Hospital

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

Protocol #20-0243

Location: University of Colorado Hospital

The Effect of Primary Palatoplasty Procedure on Underlying Velopharyngeal Anatomy and Physiology

Protocol #20-0131

Location: Childrens Hospital Colorado

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Protocol #20-0052

Location: Childrens Hospital Colorado

PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network

Protocol #17-2350

Location: Outpatient CTRC, University of Colorado Hospital

Tissue Bank and Clinical Database for the Analysis of arterial thrombosis

Protocol #19-2998

Location: University of Colorado Hospital

North American Pediatric Renal Trials Collaborative Studies (NAPRTCS)

Protocol #19-3007

Location: Childrens Hospital Colorado

The use of thoracic epidural, paravertebral nerve blockade and video-assisted intercostal nerve cryoablation for postoperative analgesia after minimally invasive repair of pectus excavatum

The study is to learn more about treating pain after having a minimally invasive repair of pectus excavatum while randomly assigning different pain methods that are typically used for this procedure....

Protocol #19-2794

Location: Childrens Hospital Colorado

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

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

Protocol #19-3107

Location: Medical Center of the Rockies

A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection with Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients

Protocol #19-2695

Location: Childrens Hospital Colorado

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

Protocol #19-2987

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

Pediatric Bone Marrow Failure Tissue Repository

Protocol #19-2913

Location: Childrens Hospital Colorado

The Effect of Adjuvant Adipose-Derived Modified Cells for Arthroscopically-Determined Knee Osteoarthritis: A Randomized Controlled Trial

Protocol #19-2893

Location: UCHealth Steadman Hawkins Clinic - Denver (Inverness)

Randomized Controlled Trial of the Cartilage Forming Potential of Microdrilling versus Lipoaspirate Concentrate for Isolated Articular Cartilage Defects

Protocol #19-2838

Location: UCHealth Steadman Hawkins Clinic - Denver (Inverness)

Identifying Novel Molecular Signatures and Pathways for Targeted Therapy in Arthritic Joints Through Synovial Tissue Analysis

Protocol #19-2910

Location: Barbara Davis Center, University of Colorado Hospital

NRG-GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Protocol #19-2797

Location: University of Colorado Hospital

TRAjectories and Clinical ExpeRiences of ICD Therapy

Protocol #22-2153

Location: Medical Center of the Rockies, Poudre Valley Hospital

Lipoic acid for Treatment of Progressive Multiple Sclerosis

Protocol #19-2525

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

Phase 1/2 Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults with Relapsed/Refractory Acute Myeloid Leukemia

Protocol #19-2405

Location: Childrens Hospital Colorado

CLASP II TR- Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid reg...

Protocol #19-6129

Location: Harmony Campus, Medical Center of the Rockies

Clofazimine for the Treatment of M. tuberculosis

Protocol #RRR17-1765

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Protocol #19-2631

Location: Childrens Hospital Colorado

Executive Functioning Outcome Measures for Down Syndrome

Protocol #19-2576

Location: Childrens Hospital Colorado

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

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

Protocol #19-2499

Location: Boulder Sports Clinic, CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

Neurophysiological investigation of epistemic veracity in the context of ambiguous videographic evidence

Protocol #19-2521

Location: University of Colorado Hospital

Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients with Advanced Mycosis Fungoides and Sezary Syndrome

Protocol #19-2524

Location: University of Colorado Hospital

Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean Deliveries

Protocol #19-1896

Location: Childrens Hospital Colorado

Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recor...

Protocol #18-0254

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

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Protocol #19-2438

Location: Childrens Hospital Colorado

ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)

Protocol #19-2475

Location: Childrens Hospital Colorado

A Prospective Multi-Center Randomized Open-Label Study To Evaluate The Efficacy and Safety of PMX Cartridge in addition to Standard Medical Care for Patients with Endotoxemic Septic Shock: TIGRIS TRIAL

Protocol #19-6070

Location: Memorial Hospital Central

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

Protocol #19-2327

Location: Lone Tree Medical Center, University of Colorado Hospital

A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Protocol #19-2363

Location: University of Colorado Hospital

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Protocol #19-2331

Location: University of Colorado Hospital

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis OpticavSpectrum Disorder (NMOSD)

Protocol #19-2038

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

Research Study 19-2335

This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and tw...

Protocol #19-2335

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

Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic Sclerosis

Protocol #19-1613

Location: Childrens Hospital Colorado

RADIANT:Rare and Atypical Diabetes Network

Protocol #19-2285

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

CAnnabidiol Study in Children with Autism spectrum DisordEr

Protocol #19-2168

Location: Childrens Hospital Colorado

Improving Renal Outcomes Collaborative

Protocol #16-2190

Location: Childrens Hospital Colorado

The High-Intensity Exercise to Attenuate Limitations and Train Habits (HEALTH) in Older Adults with HIV

Protocol #19-1985

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

RELIEF- GORE CARDIOFORM Septal Occluder Migraine Clinical Study

Protocol #20-6000

Location: Harmony Campus, Medical Center of the Rockies

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

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

Protocol #19-2109

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

A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS

Protocol #19-2157

Location: Childrens Hospital Colorado

Prospective Analysis of Gait Following Hemispherectomy

Protocol #17-0230

Location: Childrens Hospital Colorado

Gait Analysis of Femoroacetabular Impingement Patients

Protocol #16-1934

Location: Childrens Hospital Colorado

Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)

Protocol #14-1413

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #18-1076

Location: Childrens Hospital Colorado

A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis

Protocol #19-1621

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

MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME

This study plans to learn more about lung health in children with Down syndrome. Sometimes children with Down syndrome breathe food or liquids into their lungs, which is called aspiration. We want to learn more about how aspiration affects the lungs and quality of life of children with Do...

Protocol #19-2092

Location: Childrens Hospital Colorado

NRG-HN010, A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naive, Unresectable HER2-Positive Salivary Gland Cancer (NCT05408845)

Protocol #22-2363

Location: Highlands Ranch Hospital, University of Colorado Hospital

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D)...

Protocol #19-1978

Location: Childrens Hospital Colorado, University of Colorado Hospital

Investigation of the efficacy of chemotherapy induced nausea/vomiting (CINV) prophylaxis with FOLFOX/FOLFIRI/FOLFIRINOX

Protocol #19-1809

Location: University of Colorado Hospital

A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept (Orencia) in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (LIMIT-JIA)

Protocol #19-2020

Location: Childrens Hospital Colorado

COG AAML18P1 - Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Protocol #19-1839

Location: Childrens Hospital Colorado

Orthopedic Infection Registry

Protocol #19-0979

Location: University of Colorado Hospital

Personalized experiences to inform improved communication for patients with Life Limiting Illness

For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa...

Protocol #19-1874

Location: University of Colorado Hospital

Monitoring and Predicting Outcomes of Birdshot Chorioretinopathy: A Clinicogenomics Study

For patients with BSCR, blood sample draw will be obtained (with option for minimally invasive cheek/saliva swab) in the clinic and clinical data will be collected. There are no planned interventions outside of their normal standard of care. Patients will then be contacted by our clinical...

Protocol #22-1985

Location: University of Colorado Hospital

INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

Protocol #02-729

Location: Department Specific Free Standing Clinic

Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)

The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with t...

Protocol #19-1823

Location: University of Colorado Hospital

Rare CFTR Mutation Cell Collection Protocol (RARE)

Protocol #16-2412

Location: Childrens Hospital Colorado

Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease

Protocol #19-1787

Location: Childrens Hospital Colorado

The National Myelodysplastic Syndromes (MDS) Study

Protocol #19-1696

Location: Rocky Mountain Regional VA Medical Center

COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

Protocol #19-1634

Location: Childrens Hospital Colorado

Pancreatic Duct Stone Therapy in Chronic Pancreatitis

Protocol #19-1726

Location: University of Colorado Hospital

Research Study 19-1658

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

Protocol #19-1658

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

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

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

Protocol #19-1362

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

Body Composition in Infants with Klinefelter Syndrome and Effects of Testosterone Treatment

Protocol #14-1720

Location: Childrens Hospital Colorado

TRAVERSE

Protocol #19-1644

Location: University of Colorado Hospital

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

Protocol #19-0506

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

Regression in Down Syndrome

Protocol #19-1418

Location: Childrens Hospital Colorado

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the University of Colorado's Hematology Tissue Bank Protocol

Protocol #19-1498

Location: University of Colorado Hospital

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

Protocol #19-1150

Location: Barbara Davis Center, University of Colorado Hospital

Financial Burden Associated with Retirement among Cancer Survivors

Protocol #19-1419

Informational Meetings for Planning And Coordinating Treatment (IMPACT)

Protocol #19-1462

Location: Childrens Hospital Colorado

PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)

PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a...

Protocol #19-0619

Location: Childrens Hospital Colorado

Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults after Bariatric Surgery: A Randomized Controlled Pilot Study

Protocol #18-2793

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

Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Protocol #16-2408

Location: Childrens Hospital Colorado

A Phase I/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Protocol #19-1277

Location: Childrens Hospital Colorado

A Pediatric Brain Tumor Consortium Phase I/ II and Surgical Study of CX-4945 in Patients with Recurrent SHH Medulloblastoma

Protocol #19-1278

Location: Childrens Hospital Colorado

A Two-year Prospective Natural History Study Examining the Use of Neuronal Injury Biomarkers in Autoimmune Encephalitis as a Potential Biomarker for Disease Activity and Severity

Protocol #19-0889

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

Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome (PCOS) (RESTORE Study)

For this study, participants will complete a screening visit to determine eligibility. They will collect 4-months of daily urine to determine rates of ovulation prior to starting semaglutide treatment. They will complete an oral sugar tolerance test (drink a sugary drink) to measure their ...

Protocol #21-4941

Location: Childrens Hospital Colorado, Outpatient CTRC

Bone Health in Adults with Type 1 Diabetes

Protocol #19-1190

Location: Barbara Davis Center, University of Colorado Hospital

The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents with and without Obesity

Protocol #19-1171

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

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

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

Protocol #19-1148

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

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

Protocol #19-0561

Location: University of Colorado Hospital

A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)

Protocol #19-0967

Location: University of Colorado Hospital

The prospective association of cadmium exposure and cancer in the San Luis Valley Diabetes Study

Protocol #16-2502

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

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

Protocol #19-0968

Location: Dental Clinic, UCD Dental Clinic

Understanding the Barriers to Epilepsy Surgery: A North American Survey

Protocol #19-0269

Location: University of Colorado Hospital

Focus Group: Cancer Caregivers and Their Struggle(s) between Work and Family

Protocol #19-0963

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

Protocol #19-0376

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

Outcomes after Standardized Testicular Torsion Management and Follow-up

Protocol #19-0849

Location: Childrens Hospital Colorado

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

Protocol #19-0853

Location: Childrens Hospital Colorado

Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic Sclerosis

Protocol #19-0814

Location: Childrens Hospital Colorado

Fontan at Altitude Registry (FAR) V: 6-11-14

Protocol #14-1072

Location: Childrens Hospital Colorado

Prognostic factors associated with outcomes in colorectal cancer liver metastases

Protocol #19-0770

Location: University of Colorado Hospital

The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...

Protocol #19-0400

Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

Evaluation and Demonstration of Investigational MRI Software and Hardware

Protocol #19-0518

Location: Childrens Hospital Colorado

Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Protocol #18-2594

Location: University of Colorado Hospital

CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

Protocol #19-0476

Location: Cherry Creek Medical Center, 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

Effectiveness of nitrous oxide administration prior to intranasal midazolam for moderate sedation in pediatric dental patients

Protocol #19-0404

Location: Childrens Hospital Colorado

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ...

Protocol #22-0670

Location: Barbara Davis Center, University of Colorado Hospital

A Phase 1/2, Multi-regional, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Gene Therapy for Leber's Hereditary Optic Neuropathy (LHON) Associated with ND1 Mutation

The study drug is an investigational gene therapy product. Gene therapy is a technique that uses genes to treat or cure disease. “Investigational” means that the study drug is currently being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States...

Protocol #23-0981

Location: University of Colorado Hospital

SANDIA: Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control

This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline to controller therapy in obese late onset asthmatics: a) improves asthma control, and b) increases FeNO levels. Secondary research questions are to determine if L-citrull...

Protocol #19-0219

Location: Outpatient CTRC, University of Colorado Hospital

Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial

Protocol #23-0619

Location: Outpatient CTRC, University of Colorado Hospital

Total Joint Arthroplasty in a Pediatric Population

Involves two surveys for approximately 10 mintues...

Protocol #19-0306

Location: Childrens Hospital Colorado

A Natural History Study of CMT1B, CMT2A, CMT4A and CMT4C

Protocol #18-2537

Location: University of Colorado Hospital

LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

Protocol #19-0267

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

Multiomics Investigation of Marijuana Use

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 yo...

Protocol #18-0853

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

Impact of surgical intervention on sleep dysfunction in patients with refractory epilepsy

Protocol #19-0239

Location: University of Colorado Hospital

PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE?) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Protocol #19-0299

Location: Childrens Hospital Colorado

A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma

Protocol #18-2740

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

APOGEE

LVAD registry...

Protocol #18-2576B

Location: University of Colorado Hospital

REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)

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

Location: Harmony Campus, Medical Center of the Rockies

Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Protocol #19-0049

Location: Colorado Research Center, Department Specific Free Standing Clinic

Surgery Database Project

Protocol #18-2839

Location: University of Colorado Hospital

Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell)

Protocol #16-0692

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

Randomized phase 2 clinical trial of nab-paclitaxel + durvalumab (MEDI4736) + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) in patients with metastatic triple negative breast cancer

Protocol #19-0013

Location: University of Colorado Hospital

Gene Expression of Cerebral Aneurysms

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

Protocol #19-0182

Location: University of Colorado Hospital

Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD

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 ...

Protocol #19-0149

Location: Renal Research Center, University of Colorado Hospital

Moderating effects of sleep on quality of life and fatigue following an exercise program for cancer survivors

Protocol #19-0041

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

IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)

Study IMVT-1401-3201 is a Phase 3, multi-center, randomized, quadruple‑masked (Sponsor, Investigator, assessor, and participant), placebo‑controlled study was designed to assess the efficacy and safety of batoclimab in adult participants with active, moderate to severe TED. The study durat...

Protocol #22-1591

Location: University of Colorado Hospital

Association of depth recordings from the temporal cortex with sleep pattern detection and characterization of sleep dysfunction in patients with refractory epilepsy.

Protocol #18-2806

Location: University of Colorado Hospital

Identifying relevant seizure biomarkers from RNS? System recorded electrocorticography for the development of optimized seizure detection algorithms

Protocol #18-2089

Location: University of Colorado Hospital

Study of Attitudes and Factors Effecting PREterm infant care Practices (SAFE PREP)

Protocol #18-2402

Location: Childrens Hospital Colorado, University of Colorado Hospital

A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey Results

Protocol #18-2562

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

Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab

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

Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018

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: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Destinatio