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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 |
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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 |
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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 |
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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 |
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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 |
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The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT
The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may... Protocol #: 16-1479 |
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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 |
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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 |
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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 |
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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 |
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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 |
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An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene
This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in fema... Protocol #: 20-0130 |
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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 |
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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 |
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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 |
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Prolonged Sedentary Behavior in Older Women with and without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk
Are you interested in participating in a research study to understand the health effects of the time we spend sitting? The ACTIVE Research Lab is looking for: • Women • 60 to 75 years of age • Non-smoker • If Type 2 Diabetes, not being treated with insulin • BMI 25-40 kg/m2 (check ... Protocol #: 19-2758 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (Pregnancy Arm)
This study is looking at the long-term implications of COVID-19 infection in pregnant patients. Study participants may be asked to answer sets of questions about ongoing symptoms, give samples such as blood and urine and possibly have some other imaging tests. ... Protocol #: 22-2323 |
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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 |
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Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)
The purpose of this research study is to learn more about the safety and effectiveness of a drug called sargramostim for improving cognitive function and memory in people with Alzheimer’s disease. ... Protocol #: 19-2727 |
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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 |
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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 |
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Efficacy and safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c.
(CagriSema s.c. 2.4 mg/2.4 mg) once-weekly compared to tirzepatide 15 mg s.c. once-weekly in participants with obesity
Subjects will be randomly assigned to study medication and receive dietary counseling and be followed over 78 weeks.... Protocol #: 23-1695 Location: Anschutz Health and Wellness, Outpatient CTRC |
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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 |
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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 |
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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: Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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Designing with dissemination in mind: Development and evaluation of a theory-based physical activity intervention using the Multiphase Optimization Strategy: Aim 2
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 Location: Anschutz Health and Wellness, Outpatient CTRC, University of Colorado Hospital |
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Protocol S1900G, "A Randomized Phase II Study of INC280 (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 |
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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 |
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A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B
Protocol #: 22-2055B Location: University of Colorado Hospital |
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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 |
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The Prevalence of Low Residue Diet in Patients with Inflammatory Bowel Disease
Protocol #: 23-0296 Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Northfield Medical Center, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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A Randomized, Double-blind, Placebo-controlled, Phase 1/2 Study to Evaluate
the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory
Efficacy of AOC 1020 Administered Intravenously to Adult Participants with
Facioscapulohumeral Muscular Dystrophy (FSHD)
Protocol #: 22-2179 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 (NCT04929041)
Protocol #: 22-1109 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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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 |
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A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)
Protocol #: 22-1449 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma
Protocol #: 22-1202 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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 |
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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 |
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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, University of Colorado Hospital |
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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 |
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OMNIA-1, A Phase 1/2 Study of ANV419 as Monotherapy or in Combination With Anti PD-1 or Anti-CTLA-4 Antibody Following Anti PD 1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma
Protocol #: 22-1121 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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 |
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A PHASE 1, OPEN-LABEL STUDY OF THE SAFETY, TOLERABILITY, AND PRELIMINARY CLINICAL ACTIVITY OF ALLOGENEIC INVARIANT NATURAL KILLER T (INKT) CELLS (AGENT-797) AS A SINGLE AGENT AND IN COMBINATION WITH APPROVED IMMUNE CHECKPOINT INHIBITORS IN SUBJECTS WITH RELAPSED/REFRACTORY SOLID TUMORS
Protocol #: 22-0878 Location: CTRC Inpatient, University of Colorado Hospital |
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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 |
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Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
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 Location: Outpatient CTRC |
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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 |
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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS)
Protocol #: 22-0513 Location: Childrens Hospital Colorado |
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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 |
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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 |
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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 |
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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 |
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First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS viral oncogene homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Protocol #: 22-0293 Location: CTRC Inpatient, University of Colorado Hospital |
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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 |
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Libre 2 CGM plus Glycemic Excursion MIniMization (GEM) in the Treatment of PrEDiabeteE: The IMPEDE Study
For people with prediabetes, it may be possible to delay or prevent the progression to diabetes by reducing postprandial glucose (PPG). Our Glycemic Excursion Minimization (GEM) lifestyle intervention guide can reduce PPG in people with type 2 diabetes and has been studied in this populati... Protocol #: 21-4931 Location: Outpatient CTRC |
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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 |
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A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
Protocol #: 21-4929 Location: Outpatient CTRC, University of Colorado Hospital |
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AUGMENT-102: A Phase 1, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination with Chemotherapy in Patients with Relapsed/Refractory Leukemias Harboring a KMT2A/MLL Gene Rearrangement or Nucleophosmin 1 Mutation (mNPM1)
Protocol #: 21-4798 Location: Childrens Hospital Colorado |
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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 |
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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 |
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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 |
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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 |
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PEERLESS Study
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. The study will collect data on demograp... Protocol #: 21-4920 Location: University of Colorado Hospital |
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Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting
BRIGHT - Digital therapeutic Based Randomized Investigation to improve Glycemic control in patients with type 2 diabetes and residual Hyperglycemia on stable medical Therapy
Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa... Protocol #: 21-4891 Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Northfield Medical Center, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex?), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function
Protocol #: 21-4360 Location: Outpatient CTRC, Outpatient CTRC |
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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 |
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Respiratory Virus Transmission Network (RVTN)
The study will collect information from you and other household members on symptoms and patterns of contacts to learn how the virus is transmitted. Your household will be compensated for participating in this study.... Protocol #: 21-4270 Location: Childrens Hospital Colorado |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 with and without NBUVB in Vitiligo: A Phase 2A Randomized Double Blind, Vehicle-Controlled Clinical Trial
This is a randomized, double blind, vehicle-controlled clinical trial that includes 64 vitiligo patients. Study patients will be randomly assigned to receive active drugs (crisaborole or PF-07038124 ointment) or vehicle ointment, in combination with active NBUVB or sham-NBUVB. ... Protocol #: 21-4837 Location: CTRC Inpatient, University of Colorado Hospital |
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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 |
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PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Protocol #: 21-3558 Location: University of Colorado Hospital |
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A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination with Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Protocol #: 21-3603 Location: Memorial Hospital Central, Memorial Hospital North |
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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 |
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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 |
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Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers
We are studying how asthma develops in early childhood to help doctors provide better asthma treatments for children. If you decide to participate, your child will complete up to five research visits. There will be one visit per year over 4 years. During the visits your child will d... Protocol #: 21-3116 Location: Childrens Hospital Colorado |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
This phase III, double-blind study will have two arms: Experimental-Participants will receive obinutuzumab 1000 mg IV infusions on Day 1 and at Weeks 2, 24 and 26; Placebo Comparator-Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26. The tri... Protocol #: 21-3268 Location: Barbara Davis Center, University of Colorado Hospital |
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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 |
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A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and
Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection (GS-US-528-9023)
Protocol #: 21-3252 Location: Outpatient CTRC, Outpatient CTRC |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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: University of Colorado Hospital |
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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 |
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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 |
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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 |
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AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged Greater than or equal to 1 to < 31 Years Old with First Relapse
Protocol #: 21-3049 Location: Childrens Hospital Colorado |
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A081801 - INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO
Protocol #: 20-2646 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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Improving the Timeliness and Quality of Care for Rural Lung and Head-and-Neck Cancer Patients
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 |
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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 |
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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 |
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A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.
A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline. It has been designed to further evaluate whether la... Protocol #: 21-2474 Location: Barbara Davis Center, University of Colorado Hospital |
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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) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.
Caregivers and patients must agree to participate. Caregivers are defined as people married to or partnered with cancer patients who play a role in the patient's treatment and personal care. The interventions will last 8-12 weeks and study participation will last 12 months. Caregivers in a... Protocol #: 20-2458 Location: Department Specific Free Standing Clinic, Grandview Hospital, Greeley Campus, Harmony Campus, Kaiser Permanente of Colorado, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, UCHealth - Scottsbluff, University of Colorado Hospital, Yampa Valley Medical Center |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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, Pathology - SOM, University of Colorado Hospital |
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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 |
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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 |
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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 & 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 |
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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 |
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A randomized, two condition, crossover trial assessing appetite, energy metabolism, blood biomarker and ad libitum food intake responses to a mid-morning pecan snack vs. an equicaloric high carbohydrate savory snack in healthy volunteers with overweight/obesity.
Protocol #: 20-0048 Location: Anschutz Health and Wellness, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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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 |
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A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188-MS-101
Protocol #: 20-0454 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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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 & 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Pharmacology of Marijuana During Pregnancy
This study will enroll pregnant women who use marijuana during their pregnancy and ask them to provide urine and blood samples at two prenatal visits. At delivery they will again be asked to provide blood and urine samples, the placenta, as well as blood from the baby's umbilical cord. Sur... Protocol #: 19-1757 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)
Protocol #: 19-1154 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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 |
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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 |
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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 |
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IMPAACT 2021: Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age, Version 1.0
Protocol #: 19-0915 Location: Childrens Hospital Colorado |
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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 |
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Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)
The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study.... Protocol #: 19-0636 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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ULTRA-T2D Study: Uric acid lowering trial in youth onset T2D
This is a pilot study evaluating the effect of uric acid lowering by a single dose of pegloticase (a uricase) on markers of cardiovascular and renal health in ten young men ages 18-25 years with youth-onset type 2 diabetes (diagnosed at less than 21 years of age) over 7 days. Previous rese... Protocol #: 18-1700 Location: Childrens Hospital Colorado |
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Protocol #: 18-2692 Location: University of Colorado Hospital |
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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 |