Search Results | Research Studies | School of Medicine


Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19) Protocol #: 20-2972 Location: University of Colorado Hospital Learn More
A single arm, multicenter, prospective, clinical study on a novel minimally invasive posterier sacroiliac fusion device Protocol #: 20-2971 Location: Medical Center of the Rockies Learn More
APEC1621I: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)-PHASE 2 SUBPROTOCOL OF PALBOCICLIB IN PATIENTS WITH TUMORS HARBORING ACTIVATING ALTERATIONS IN CELL CYCLE GENES Protocol #: 17-2168I Location: Childrens Hospital Colorado Learn More
Pediatric Brain Injury Caregiver Education Program Protocol #: 20-0272 Location: Childrens Hospital Colorado Learn More
Perceptions of the esthetics of the anterior-posterior position of maxillary central incisors in individuals of four ethnicities as evaluated by orthodontists and four ethnicities of layperson Protocol #: 19-0741 Location: Dental Clinic Learn More
A PHASE 1 STUDY OF TJ210001 ADMINISTERED IN SUBJECTS WITH RELAPSED OR REFRACTORY ADVANCED SOLID TUMORS Protocol #: 20-2541 Location: University of Colorado Hospital Learn More
Reducing the flow from a Fontan fenestration using Atrial Flow Regulator devices - Patient QW Protocol #: 20-2505 Location: Childrens Hospital Colorado Learn More
Paired Germline/Tumor Genetic Testing Outcomes Protocol #: 20-2287 Locations: Childrens Hospital Colorado; Childrens Hospital Colorado at Memorial Learn More
AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT) Protocol #: 20-2414 Location: Childrens Hospital Colorado Learn More
ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors Protocol #: 20-2411 Location: Childrens Hospital Colorado Learn More
Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200273, Pt M.W. (2) Protocol #: 20-2410 Location: University of Colorado Hospital Learn More
Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200272, Pt M.W. (1) Protocol #: 20-2407 Location: University of Colorado Hospital Learn More
Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200271, Pt L.I. Protocol #: 20-2406 Location: University of Colorado Hospital Learn More
Assessing the Impact of Therapy on Localized Intravascular Coagulopathy in Vascular Anomalies Protocol #: 20-2139 Location: Childrens Hospital Colorado Learn More
EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT) Protocol #: 20-2150 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital Learn More
A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients with Type 1 Diabetes and HLA-DQ8 Protocol #: 20-2220 Location: Barbara Davis Center Learn More
STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE) Protocol #: 20-0141 Locations: Barbara Davis Center; University of Colorado Hospital Learn More
Evaluation of Compensatory Reserve in Obstetrical Patients A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume. Protocol #: 14-1996 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. Protocol #: 20-1681 Location: Childrens Hospital Colorado Learn More
ENVASARC: A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY Protocol #: 20-1892 Location: University of Colorado Hospital Learn More
STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly) Protocol #: 20-1310 Location: Childrens Hospital Colorado Learn More
Single Patient IDE for Medtronic SynchroMed II Pump with Intera Tapered Catheter, IDE# U200202, Pt. MM Protocol #: 20-1988 Location: University of Colorado Hospital Learn More
A Phase 2 Open-Label Study of PTR-01 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Protocol #: 20-1938 Location: Childrens Hospital Colorado Learn More
A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES Protocol #: 20-1845 Location: University of Colorado Hospital Learn More
AAML1831 - A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations Protocol #: 20-1864 Location: Childrens Hospital Colorado Learn More
AN EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC Protocol #: 20-1830 Location: University of Colorado Hospital Learn More
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19 To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults. To see if you qualify for the study, please visit this webpage: http://bit.ly/covid19vaccinestudy Protocol #: 20-9990 Locations: Greeley Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
EA5191: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC Protocol #: 20-1737 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital Learn More
A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple CombinationTherapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age Protocol #: 20-1827 Location: Childrens Hospital Colorado Learn More
Patient Perpetrated Workplace Violence and the Effects on Patient Outcomes Protocol #: 20-6057 Location: Memorial Hospital Central Learn More
ColorAdo ReseArch on Menopause & Early Life Stress Study: Remote Participation (The "CARAMELS at Home" Study) Protocol #: 20-1715 Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic Learn More
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 (baseline and 12 months later). Research visits will include a physical exam, questionnaires, a blood draw, drinking a sugary drink, ultrasounds of the head, neck and arm, riding an exercise bike and a body scan. Protocol #: 19-1226 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases from ALK+ Lung Cancer Protocol #: 19-2862 Locations: City of Hope Cancer Center; University of Colorado Hospital Learn More
A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer Protocol #: 20-1667 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors Protocol #: 20-1736 Location: University of Colorado Hospital Learn More
An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations Protocol #: 20-1757 Location: Childrens Hospital Colorado Learn More
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 oncogenic driver mutations, and who have progressed following first line treatment with PD-1 or PD-L1 targeting agents having previously achieved a best response of stable disease or better measured after 12 weeks. Protocol #: 20-1690 Location: University of Colorado Hospital Learn More
Comparison of Nasopharyngeal specimens to Midturbinate Specimens for Detection of SARS-CoV-2 in Pediatric Patients Protocol #: 20-1721 Location: Childrens Hospital Colorado Learn More
Dystonia Coalition Projects-3 Protocol #: 20-0290 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital Learn More
A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN) Protocol #: 20-1602 Location: Childrens Hospital Colorado Learn More
Genetics of CMT - Modifiers of CMT1A, New Causes of CMT Protocol #: 20-1525 Location: University of Colorado Hospital Learn More
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD This study is a 52 week intervention with visits at the CU Med Building on the Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment of physical function via a questionnaire. Protocol #: 20-1672 Location: Renal Research Center Learn More
In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. Protocol #: 20-1399 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
A Phase I study of the ADAM-10 inhibitor, INCB007839 in children with recurrent/progressive high-grade gliomas to target microenvironmental neuroligin-3 Protocol #: 20-1487 Location: Childrens Hospital Colorado Learn More
Phase 1 study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK-3B) inhibitor, as a single agent or with Irinotecan in pediatric patients with refractory malignancies Protocol #: 20-1445 Location: Childrens Hospital Colorado Learn More
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302) Protocol #: 20-1438 Location: University of Colorado Hospital Learn More
A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy for HER2+ gastrointestinal cancers Protocol #: 20-1453 Location: University of Colorado Hospital Learn More
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Protocol #: 20-0746 Location: University of Colorado Hospital Learn More
A PHASE 1 TRIAL OF THE CD123 X CD3 DART? MOLECULE FLOTETUZUMAB (NSC#808294, IND#145986) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA Protocol #: 20-1106 Location: Childrens Hospital Colorado Learn More
An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies Protocol #: 20-1380 Location: Childrens Hospital Colorado Learn More
ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19. Protocol #: 20-6506 Locations: Memorial Hospital Central; Memorial Hospital North Learn More
A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the MTD or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D) Protocol #: 20-1388 Locations: Pathology - SOM; University of Colorado Hospital Learn More
EA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Protocol #: 20-1318 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital Learn More
The Parkinson's Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort Protocol #: 20-1204 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol Protocol #: 20-6034 Location: Medical Center of the Rockies Learn More
Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic Anemia Protocol #: 20-1333 Location: Childrens Hospital Colorado Learn More
ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias Protocol #: 19-2469 Location: Childrens Hospital Colorado Learn More
EXPANSION AND EVALUATION OF THE UNIVERSITY OF COLORADO STRENGTH (STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH) PREHABILITATION PROGRAM Protocol #: 20-0246 Location: University of Colorado Hospital Learn More
A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb?23104 in Subjects with Selected Advanced Solid Tumors (DUET-3) Protocol #: 20-1289 Location: University of Colorado Hospital Learn More
AN OPEN-LABEL, SAFETY AND TOLERABILITY PHASE 1b TRIAL OF CAN04, A FULLY HUMANIZED ANTI-IL1RAP MONOCLONAL ANTIBODY, IN COMBINATION WITH PEMBROLIZUMAB IN SUBJECTS WITH SOLID TUMORS PROGRESSING ON PD-1/PD-L1 INHIBITOR-CONTAINING REGIMENS Protocol #: 20-0605 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital Learn More
Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19 Protocol #: 20-1227 Location: University of Colorado Hospital Learn More
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 kidneys and amount of fat tissue in the abdomen by MRI. The results of this study will help design a larger study where we can test if restricting hours of eating can slow progression of ADPKD. Protocol #: 20-1262 Locations: Anschutz Health and Wellness; Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital Learn More
Colorado Nurses Experience with COVID-19 The purpose of the study is to find out the experiences of nurses who cared or prepared to care for COVID-19 patients. If you join the study you will help us learn about what nurses are going through during this pandemic time. You will provide insight to how nurses can improve or change the delivery of care to patients during a pandemic. Protocol #: 20-6039 Locations: Boulder Health Center; Broomfield Hospital; Cherry Creek Medical Center; Grandview Hospital; Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Long's Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; Steadman Hawkins Clinic - Denver; UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital; Yampa Valley Medical Center Learn More
Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs. Protocol #: 20-6019 Location: Memorial Hospital Central Learn More
COVID-19 Prospective Observational Cohort Study and Biobank of Health Care Workers and Other Populations Protocol #: 20-1197 Locations: Barbara Davis Center; Childrens Hospital Colorado; University of Colorado Hospital Learn More
SARS-CoV-2 specific T cell responses in HIV-positive and negative individuals after resolution of COVID-19 viral infection. Protocol #: 20-1219 Location: University of Colorado Hospital Learn More
A Phase 1 study of temozolomide in combination with targeted therapy for NSCLC patients with CNS progression on either osimertinib or lorlatinib Protocol #: 20-0138 Location: University of Colorado Hospital Learn More
A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction based on Time of Discharge Protocol #: 20-1055 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection Protocol #: 20-6037 Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital Learn More
S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study) Protocol #: 20-0563 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT Protocol #: 20-0881 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
SLEEP-DISORDERED BREATHING IN INFANTS WITH MYELOMENINGOCELE Protocol #: 20-0996 Location: Childrens Hospital Colorado Learn More
STARS ("STudy of Alteplase for Respiratory failure in SARS-Cov2 (COVID-19)", a Phase IIa Clinical Trial Protocol #: 20-0880 Location: University of Colorado Hospital Learn More
The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections. This study is to evaluate the effectiveness of Expanded Focused Assessment with Sonography in Trauma (EFAST) in identifying high risk trauma patients with active COVID-19 pulmonary infections. Protocol #: 20-0751 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Creation of a Registry Via Patient and Provider Surveys to Assess Outcomes of Platelet-Rich Plasma (PRP) Injections in Orthopedics Protocol #: 20-0978 Locations: Steadman Hawkins Clinic - Denver; University of Colorado Hospital Learn More
NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITY Protocol #: 20-0889 Location: Childrens Hospital Colorado Learn More
OPTION This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation. Protocol #: 20-6502 Location: Medical Center of the Rockies Learn More
COVID-19 Convalescent Plasma sIND in treatment of patient with COVID-19 Protocol #: 20-6031 Location: Poudre Valley Hospital Learn More
COVID-19: Lung ultrasound implementation in the management of patients with COVID-19 Protocol #: 20-0781 Location: University of Colorado Hospital Learn More
A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis Protocol #: 20-0609 Location: University of Colorado Hospital Learn More
Slow Heart Registry: A prospective observational cohort study of fetal immune-mediated high degree heart block Protocol #: 20-0820 Location: Childrens Hospital Colorado Learn More
A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients with Advanced Solid Tumors Protocol #: 20-0727 Location: University of Colorado Hospital Learn More
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 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A PHASE 3, RANDOMIZED, DOUBLE- OR OBSERVER-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY Protocol #: 20-0481 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
EA2187: "A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma" Protocol #: 20-0584 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital Learn More
COVID-19: Surgical Implications Study Collect outcomes data on patients who have been diagnosed with COVID-19 and have undergone surgery. Protocol #: 20-0614 Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes Protocol #: 19-1130 Location: University of Colorado Hospital Learn More
COVID-19 Biobank Protocol #: 20-0685 Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic; University of Colorado Hospital Learn More
Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI Protocol #: 20-0537 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Intervention to Educate and Improve Underrepresented Populations' Participation in Clinical Trials Protocol #: 20-0590 Location: Department Specific Free Standing Clinic Learn More
Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer's disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205 Protocol #: 20-0571 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS) Protocol #: 20-0589 Location: University of Colorado Hospital Learn More
COVID-19 Preparedness Survey Protocol #: 20-0620 Location: University of Colorado Hospital Learn More
A SINGLE-PERIOD, SINGLE-TREATMENT STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EPINEPHRINE AFTER ADMINISTRATION OF INTRANASAL ARS-1 TO PEDIATRIC SUBJECTS WITH SYSTEMIC ALLERGIES Protocol #: 20-0596 Location: Childrens Hospital Colorado Learn More
Virtual reality in cancer patient imaging review Protocol #: 20-0560 Location: University of Colorado Hospital Learn More
A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS) Protocol #: 20-0580 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital Learn More
CD80 as a biomarker for kidney disease Protocol #: 13-2700 Location: Childrens Hospital Colorado Learn More
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS Protocol #: 20-0490 Location: Childrens Hospital Colorado Learn More
Phase I/II trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF fusion/duplication positive or NF1-associated recurrent or progressive gliomas in children and young adults Protocol #: 20-0535 Location: Childrens Hospital Colorado Learn More
Characterization of cannabinoids, endocannabinoids, and biomarkers in adolescents Protocol #: 20-0553 Location: University of Colorado Hospital Learn More
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) Protocol #: 20-0404 Location: University of Colorado Hospital Learn More
Immune Profiles in CF Fungal Infections Protocol #: 20-0099 Location: Childrens Hospital Colorado Learn More
Impacts of a multitiered breastfeeding support program on breastfeeding duration and achievement of prenatal breastfeeding goals Protocol #: 20-6027 Locations: Long's Peak Hospital; Longs Peak Hospital Learn More
Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion Protocol #: 15-0813 Location: University of Colorado Hospital Learn More
International CDKL5 Clinical Research Network Protocol #: 19-2756 Location: Childrens Hospital Colorado Learn More
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Protocol #: 20-0346 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
Deep sleep in Parkinson disease and its relationship to cognition, neuroinflammation and neurodegeneration Protocol #: 20-0347 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
Validation of the Apollo EE Device, Indirect Calorimetry Protocol #: 20-0317 Locations: Anschutz Health and Wellness; University of Colorado Hospital Learn More
A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients with Advanced Clear Cell Renal Cell Carcinoma Protocol #: 20-0357 Location: University of Colorado Hospital Learn More
A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination with AGEN1884 in Patients with Recurrent, Inoperable Angiosarcoma Protocol #: 20-0261 Location: University of Colorado Hospital Learn More
S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer" Protocol #: 20-0359 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin Protocol #: 20-0360 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital Learn More
A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT) Protocol #: 20-0262 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series Protocol #: 19-2236 Locations: Denver Health Medical Center; University of Colorado Hospital Learn More
A5380: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C) Protocol #: 20-0303 Location: University of Colorado Hospital Learn More
Protocol I8F-MC-GPGN(a) The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes Protocol #: 20-0271 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant Protocol #: 20-0279 Location: Childrens Hospital Colorado Learn More
An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) Protocol #: 20-0216 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
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 consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study. Protocol #: 20-0288 Location: University of Colorado Hospital Learn More
A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma Protocol #: 19-2345 Location: Childrens Hospital Colorado Learn More
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 radiographic sacroiliitis or magnetic resonance imaging (MRI) features of inflammation in the sacroiliac joints (SIJ) plus one clinical feature of spondyloarthritis (SpA), and a "clinical arm" that requires presence of the HLA B27 protein plus 2 clinical features of SpA. To validate the performance of the current ASAS classification criteria in a prospective combined cohort of patients presenting to a rheumatologist in North America and outside North America with undiagnosed current back pain of ≥3 months duration with onset ≤45years of age. Protocol #: 19-1526 Locations: Barbara Davis Center; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital Learn More
Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2 Protocol #: 20-0226 Locations: Childrens Hospital Colorado; Memorial Hospital Central; University of Colorado Hospital Learn More
The HPV 9-10 Trial: Early Initiation of HPV Vaccination Protocol #: 19-3006 Locations: CHOC ? Children?s Hospital of Orange County; UCLA - University of California; UCLA, Jonsson Cancer Center; University of Colorado Hospital Learn More
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 of this investigation is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS. Protocol #: 20-0254 Location: University of Colorado Hospital Learn More
The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis in transgender women Protocol #: 20-0104 Location: University of Colorado Hospital Learn More
Multi-center chart review of pregnant women undergoing fetoscopic laser surgery (FLS) for Twin-Twin Transfusion syndrome (TTTS) with a short cervical length. Protocol #: 20-0189 Location: Childrens Hospital Colorado Learn More
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 Learn More
Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE study) This is a 12-week combined aerobic and resistance exercise intervention in breast cancer survivors. Before and after the intervention, women will undergo measures of appetite, energy intake, body composition, and resting metabolic rate. Protocol #: 19-3032 Location: University of Colorado Hospital Learn More
ENGOT-ov50 / INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer Protocol #: 20-0007 Location: University of Colorado Hospital Learn More
ALS toolkit project Protocol #: 20-0127 Location: University of Colorado Hospital Learn More
Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations Protocol #: 19-3063 Locations: Boulder Health Center; Broomfield Hospital; Grandview Hospital; Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Long's Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; Steadman Hawkins Clinic - Denver; UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital Learn More
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions Protocol #: 20-0124 Location: University of Colorado Hospital Learn More
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA Study B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents ?12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015). Protocol #: 19-2839 Location: University of Colorado Hospital Learn More
A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients with Polyneuropathy of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with a V122I or T60A Mutation Protocol #: 19-3061 Location: University of Colorado Hospital Learn More
A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer Protocol #: 20-0036 Location: University of Colorado Hospital Learn More
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer Protocol #: 20-0035 Location: University of Colorado Hospital Learn More
Phase Ib/II trial of copanlisib in combination with trastuzumab and pertuzumab after induction treatment of HER2 positive (HER2+ ) metastatic breast cancer (MBC) with PIK3CA mutation or PTEN mutation. Protocol #: 19-2988 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Tissue Bank and Clinical Database for the Analysis of arterial thrombosis Protocol #: 19-2998 Location: University of Colorado Hospital Learn More
First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors Protocol #: 19-3118 Location: University of Colorado Hospital Learn More
NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab Protocol #: 19-2514 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
North American Pediatric Renal Trials Collaborative Studies (NAPRTCS) Protocol #: 19-3007 Location: Childrens Hospital Colorado Learn More
A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopaedic 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 that is configured with a load cell (i.e. digital scale). The patients will gradually shift their weight from the non-affected limb to the affected limb while a low energy and low frequency electromagnetic field is applied via the antenna. They will repeat the shifting of their weight 5 times to assure robust and repeatable data collection. The device will not be used to guide medical treatments and the effectiveness of the device will be measured against the current gold standard/standard of care for assessing fracture healing. 1.1 To translate our direct electromagnetic coupling (DEC) approach to the clinical milieu via rigorous development and investigation of the technology using multiple testing platforms. 1.2 Firmly establish the physical foundation of the DEC approach and optimize the system s hardware configuration for predicting the course of fracture healing. 1.3 Perform two large animal studies using the DEC approach in order to evaluate its efficacy for predicting the course of fracture healing 1.4 Perform a series of non-invasive patient studies that longitudinally follow specific fracture pattern cohorts in order to evaluate the DEC approach in a clinical setting. 1.5 Develop a telemedicine system wherein the DEC data can be collected by the patient and transmitted for analyses. Protocol #: 19-3107 Location: Medical Center of the Rockies Learn More
A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (TRANSCEND FL) Protocol #: 19-3011 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart disease o Non-smoker (or quit at least one year ago) This study is examining how gender-affirming hormone therapy affects the health of blood vessels and impacts cardiovascular disease risk in transgender men. Protocol #: 19-2323 Locations: Anschutz Health and Wellness; University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991) Protocol #: 19-2999 Location: University of Colorado Hospital Learn More
Biomarker Development in LGMD 2i Protocol #: 19-2943 Location: University of Colorado Hospital Learn More
mHealth Development for Apathy among Patients with Mild Cognitive Impairment and their Care Partners Protocol #: 19-3075 Location: University of Colorado Hospital Learn More
Prolonged Sedentary Behavior in Older Women with and without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk Protocol #: 19-2758 Location: University of Colorado Hospital Learn More
A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease Protocol #: 19-2833 Locations: Memorial Hospital Central; University of Colorado Hospital Learn More
An Open-Label, Multicenter, Phase 1B Study of RP1 in Organ Transplant Recipients with Advanced Cutaneous Squamous Cell Carcinoma Protocol #: 19-2987 Location: University of Colorado Hospital Learn More
North American Mitrochondrial Disease Consortium Patient Registry and Biorepository Protocol #: 13-2246 Location: Childrens Hospital Colorado Learn More
ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Protocol #: 19-2163 Location: Childrens Hospital Colorado Learn More
Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes Protocol #: 19-2760 Location: University of Colorado Hospital Learn More
Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balance Protocol #: 19-2960 Location: University of Colorado Hospital Learn More
An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas Protocol #: 19-6517 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital Learn More
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients Protocol #: 19-2897 Location: University of Colorado Hospital Learn More
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES (REALIZE TRIAL) Protocol #: 19-2898 Location: University of Colorado Hospital Learn More
Development and Content Validation of Instruments to Screen for and Assess Severity of Tinnitus in Young People Protocol #: 19-2940 Location: Childrens Hospital Colorado Learn More
The Effect of Adjuvant Adipose-Derived Modified Cells for Arthroscopically-Determined Knee Osteoarthritis: A Randomized Controlled Trial Protocol #: 19-2893 Location: Steadman Hawkins Clinic - Denver Learn More
S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA Protocol #: 19-2950 Location: Childrens Hospital Colorado Learn More
Randomized Controlled Trial of the Cartilage Forming Potential of Microdrilling versus Lipoaspirate Concentrate for Isolated Articular Cartilage Defects Protocol #: 19-2838 Location: Steadman Hawkins Clinic - Denver Learn More
A PHASE 1/2 STUDY OF TPX-0046, A NOVEL ORAL RET/SRC INHIBITOR IN ADULT SUBJECTS WITH ADVANCED/METASTATIC SOLID TUMORS HARBORING ONCOGENIC RET FUSIONS OR MUTATIONS Protocol #: 19-2888 Location: University of Colorado Hospital Learn More
A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses. Protocol #: 19-2935 Location: University of Colorado Hospital Learn More
Identifying Novel Molecular Signatures and Pathways for Targeted Therapy in Arthritic Joints Through Synovial Tissue Analysis Protocol #: 19-2910 Locations: Barbara Davis Center; University of Colorado Hospital Learn More
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished. Protocol #: 19-2904 Locations: Renal Research Center; University of Colorado Hospital Learn More
NRG-GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum Protocol #: 19-2797 Location: University of Colorado Hospital Learn More
A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer Protocol #: 19-2818 Location: University of Colorado Hospital Learn More
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS Protocol #: 19-2761 Location: University of Colorado Hospital Learn More
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010). Protocol #: 19-2721 Location: University of Colorado Hospital Learn More
LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor Protocol #: 19-2795 Location: University of Colorado Hospital Learn More
A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM) Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period. Protocol #: 19-2854 Location: University of Colorado Hospital Learn More
Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Protocol #: 19-2645 Location: University of Colorado Hospital Learn More
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL) Protocol #: 19-2788 Location: University of Colorado Hospital Learn More
A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study) About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications. Protocol #: 19-2824 Location: University of Colorado Hospital Learn More
A Phase I study to evaluate the pharmacokinetic and pharmacodynamic profile of intramuscular or subcutaneous injections of levonorgestrel butanoate (LB) for female contraception Your participation in the study would include up to 36 clinic visits over a 9-month period. During your time in the study, you will have physical exams, pelvic exams, breast exams, vital sign assessments, blood tests, pregnancy tests, and possibly a PAP smear. You will also have transvaginal ultrasounds of your ovaries to determine if you are at risk for pregnancy during the study. In addition, you will also be asked about your complete medical history, including your gynecological, menstrual, reproductive and sexual history. This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception. Protocol #: 19-2820 Location: Comprehensive Women's Health Center Learn More
Lipoic acid for Treatment of Progressive Multiple Sclerosis Protocol #: 19-2525 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the study finishes. Protocol #: 19-2782 Locations: Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital Learn More
EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC Protocol #: 19-2554 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital Learn More
Feasibility and Acceptability of Morning Versus Evening Exercise for Adults with Overweight and Obesity: A Randomized Pilot Study Protocol #: 19-2676 Locations: Anschutz Health and Wellness; University of Colorado Hospital Learn More
Single Patient IND for Binimetinib, IND# 146690, Patient BLG Protocol #: 19-2744 Location: Childrens Hospital Colorado Learn More
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study Protocol #: 19-0795 Location: University of Colorado Hospital Learn More
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson's Disease Protocol #: 19-2471 Location: University of Colorado Hospital Learn More
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation Protocol #: 19-6129 Locations: Harmony Campus; Medical Center of the Rockies Learn More
A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer Protocol #: 19-2640 Location: Rocky Mountain Regional VA Medical Center Learn More
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation Protocol #: 19-2707 Location: University of Colorado Hospital Learn More
A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors- ARTISTRY-1 Protocol #: 19-2532 Location: University of Colorado Hospital Learn More
A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma Protocol #: 19-2564 Location: University of Colorado Hospital Learn More
A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Protocol #: 19-2377 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy Protocol #: 19-2631 Location: Childrens Hospital Colorado Learn More
Microfluidic models of bleeding and thrombosis This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. Protocol #: 19-2408 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital Learn More
An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis Protocol #: 19-2378 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis Protocol #: 19-2333 Location: Childrens Hospital Colorado Learn More
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy To determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form subjects with Primary Myelofibrosis, post-Polycythemia Vera myelofibrosis , or Post Essential Thrombocythemia Myelofibrosis who were previously treated with approved JAK inhibitor therapy. Protocol #: 19-2520 Location: University of Colorado Hospital Learn More
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies Protocol #: 19-2445 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
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 injection (i.e. steroid injection). Protocol #: 19-2499 Locations: Boulder Sports Clinic; CU Sports Medicine - Denver; University of Colorado Hospital Learn More
Neurophysiological investigation of epistemic veracity in the context of ambiguous videographic evidence Protocol #: 19-2521 Location: University of Colorado Hospital Learn More
Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients with Advanced Mycosis Fungoides and Sezary Syndrome Protocol #: 19-2524 Location: University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy Protocol #: 19-2533 Locations: Barbara Davis Center; University of Colorado Hospital Learn More
Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean Deliveries Protocol #: 19-1896 Location: Childrens Hospital Colorado Learn More
A PHASE 1/2, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY STUDY OF REPOTRECTINIB IN PEDIATRIC AND YOUNG ADULT SUBJECTS WITH ADVANCED OR METASTATIC MALIGNANCIES HARBORING ALK, ROS1, OR NTRK1-3 ALTERATIONS Protocol #: 19-2438 Location: Childrens Hospital Colorado Learn More
ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355) Protocol #: 19-2475 Location: Childrens Hospital Colorado Learn More
A MULTICENTER, LONGITUDINAL, OPEN-LABEL, SINGLE-ARM STUDY DESCRIBING COGNITIVE PROCESSING SPEED CHANGES IN RELAPSING MULTIPLE SCLEROSIS SUBJECTS TREATED WITH OZANIMOD (RPC-1063) Protocol #: 19-2420 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation Protocol #: 19-2390 Location: University of Colorado Hospital Learn More
Effects of prenatal antibiotics on the infant gut microbiome Three different bacteria of the infant gut microbiome will be obtained through collection of infant stool samples at birth and at 6 weeks of age. These bacteria will be measured and comparisons made between infants whose mothers took antibiotics during pregnancy and infants whose mothers did not take antibiotics during pregnancy. Pregnant women will be recruited between their 35-37th weeks of pregnancy and will complete two surveys, the first prenatally and the second at 6-weeks postpartum. Protocol #: 19-2288 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
A Phase I study of Anetumab Ravtansine in Combination with either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma Protocol #: 19-0821 Location: University of Colorado Hospital Learn More
Adenosinergic immune suppression pathway in glioblastoma multiforme tumors Protocol #: 19-2344 Location: University of Colorado Hospital Learn More
A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A 0201-positive Patients with Advanced MAGE-A4-positive Cancer Protocol #: 19-2311 Location: University of Colorado Hospital Learn More
A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Protocol #: 19-1929 Location: University of Colorado Hospital Learn More
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3) This study assesses whether Lungpacer therapy plus usual medical care can safely improve the chances of patients on a breathing machine to regain the ability to breathe on their own as compared to usual medical care alone. Protocol #: 19-2401 Location: University of Colorado Hospital Learn More
A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures Protocol #: 19-2363 Location: University of Colorado Hospital Learn More
An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial Protocol #: 19-1598 Location: University of Colorado Hospital Learn More
CLadribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System BiomarKers in Multiple Sclerosis (CLOCK-MS) Protocol #: 19-1980 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24) CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year. Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation. Protocol #: 19-2362 Locations: Pathology - SOM; University of Colorado Hospital Learn More
A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenic Mechanisms Protocol #: 19-2357 Location: Childrens Hospital Colorado Learn More
A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis OpticavSpectrum Disorder (NMOSD) Protocol #: 19-2038 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
Perceived Palliative Care Needs in Early-Onset Dementia Protocol #: 19-2134 Locations: UCHealth Central Park Medical Center; University of Colorado Hospital Learn More
A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with Azacitidine in Patients with Recurrent, Resectable Osteosarcoma Protocol #: 19-2295 Location: Childrens Hospital Colorado Learn More
A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONS Protocol #: 19-2255 Location: University of Colorado Hospital Learn More
A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS Protocol #: 19-2242 Location: University of Colorado Hospital Learn More
A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE] Protocol #: 19-1913 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic Sclerosis Protocol #: 19-1613 Location: Childrens Hospital Colorado Learn More
A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients with Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) that are Causing Significant Morbidity Protocol #: 19-2270 Location: Childrens Hospital Colorado Learn More
RADIANT:Rare and Atypical Diabetes Network Protocol #: 19-2285 Locations: Boulder Health Center; Broomfield Hospital; Cherry Creek Medical Center; Highlands Ranch Hospital; Lone Tree Medical Center; Steadman Hawkins Clinic - Denver; UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital Learn More
A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA) Protocol #: 19-6114 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
Improving Renal Outcomes Collaborative Protocol #: 16-2190 Location: Childrens Hospital Colorado Learn More
The High-Intensity Exercise to Attenuate Limitations and Train Habits (HEALTH) in Older Adults with HIV Protocol #: 19-1985 Location: University of Colorado Hospital Learn More
A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency Protocol #: 16-0927 Location: Childrens Hospital Colorado Learn More
Prospective Analysis of Gait Following Hemispherectomy Protocol #: 17-0230 Location: Childrens Hospital Colorado Learn More
Gait Analysis of Femoroacetabular Impingement Patients i. To compare differences in muscle recruitment, gait patterns (kinematics & kinetics), spaciotemporal variables, functional movements (squats, lunges, sit-to-stand, and single leg steps), and pelvic tilt between patients with femoroacetabular impingement (FAI) and age-matched morphologically normal controls. ii. To compare differences in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt between symptomatic and asymptomatic patients with FAI morphology. iii. To compare changes in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt pre- and post-intra-articular hip injection in symptomatic FAI patients. iv. To test if anatomical variables (alpha angle, center edge angle, FAI version) are predictors of change in gait and movement patterns. Protocol #: 16-1934 Location: Childrens Hospital Colorado Learn More
International Fetal Cardiac Intervention Registry Protocol #: 14-0343 Location: Childrens Hospital Colorado Learn More
Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS) Protocol #: 14-1413 Location: Childrens Hospital Colorado Learn More
NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis Protocol #: 18-1076 Location: Childrens Hospital Colorado Learn More
A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis Protocol #: 19-1621 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME Aim 1: Primary outcome measures include lung function measurements from oscillometry and spirometry, change in oscillometry and spirometry measurements after bronchodilator is given, and results from a Six-Minute Walk test. Aim 2: Primary outcome measures are absolute neutrophil count and C-reactive protein in blood. Secondary outcomes to identify an atopic asthma phenotype include eosinophil count, total IgE, allergen specific IgE, and fractional exhaled nitric oxide. Assessment for nicotine exposure via blood cotinine is additional secondary outcome. Aim 3: Primary outcomes are respiratory symptom and quality of life assessments obtained by questionnaires. Protocol #: 19-2092 Location: Childrens Hospital Colorado Learn More
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease Protocol #: 19-1840 Location: University of Colorado Hospital Learn More
Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample. Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample. Protocol #: 17-0464 Location: Childrens Hospital Colorado Learn More
S1803: PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY) Protocol #: 19-1589 Location: Rocky Mountain Regional VA Medical Center Learn More
S1815: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE, CISPLATIN, AND NAB-PACLITAXEL VERSUS GEMCITABINE AND CISPLATIN IN NEWLY DIAGNOSED, ADVANCED BILIARY TRACT CANCERS Protocol #: 19-1588 Location: Rocky Mountain Regional VA Medical Center Learn More
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) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. Protocol #: 19-1978 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer Protocol #: 19-1977 Location: University of Colorado Hospital Learn More
Investigation of the efficacy of chemotherapy induced nausea/vomiting (CINV) prophylaxis with FOLFOX/FOLFIRI/FOLFIRINOX Protocol #: 19-1809 Location: University of Colorado Hospital Learn More
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT Protocol #: 15-1434 Location: Childrens Hospital Colorado Learn More
The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compensation and instruction on resistance exercise. Protocol #: 19-1974 Location: University of Colorado Hospital Learn More
An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts Protocol #: 16-0145 Location: Childrens Hospital Colorado Learn More
Neurological Screening of Controls in an Age-Related Macular Degeneration Registry Protocol #: 19-1925 Location: University of Colorado Hospital Learn More
Impact of Novel Therapeutic Music Delivery Device on Drug Use and Recovery in Surgical Patients Protocol #: 19-6100 Locations: Medical Center of the Rockies; Poudre Valley Hospital Learn More
COG AAML18P1 - Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP) Protocol #: 19-1839 Location: Childrens Hospital Colorado Learn More
COG AHOD1822 / Merck MK-3475-667: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) Protocol #: 19-1481 Location: Childrens Hospital Colorado Learn More
The Impact of Pediatric Skin Disorders: The "Big" Study Protocol #: 18-1380 Location: Childrens Hospital Colorado Learn More
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 patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses. Protocol #: 19-1874 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003) Protocol #: 19-6513 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital Learn More
Individual Patient Program for Patients with BRAF V600E/K mutation-positive Metastatic Melanoma and Other Indications with Clinical Evidence of Potential Treatment Efficacy Treatment with Trametinib and Bevacizumab Protocol #: 19-2412 Location: Childrens Hospital Colorado Learn More
ACNS1721 - A Phase 2 Study of Veliparib (ABT-888, IND #139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations Protocol #: 19-1633 Location: Childrens Hospital Colorado Learn More
A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab in HLA-A 02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors Protocol #: 19-1727 Location: University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CheckMate 76K) Protocol #: 19-1581 Location: University of Colorado Hospital Learn More
INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS Protocol #: 02-729 Location: Department Specific Free Standing Clinic Learn More
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Protocol #: 19-1597 Location: University of Colorado Hospital Learn More
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 tricuspid valve surgery. Protocol #: 19-1823 Location: University of Colorado Hospital Learn More
Rare CFTR Mutation Cell Collection Protocol (RARE) This is a non-interventional, multi-site, specimen collection study for CF patients who have rare CFTR mutations. Once a potentially eligible subject is identified (either self-identified or by their CF care center), and the subject has expressed interest in participating in the study, the subject will be referred to a participating study site to receive additional information about the study and about travel arrangements (if needed). Nasal epithelial cells and blood (to confirm genotype) will be collected from all subjects; additional blood samples and rectal biopsy samples will be optional. The study consists of a single visit, however it is anticipated that many subjects will need to travel so study participation time is estimated at 2 days. Protocol #: 16-2412 Location: Childrens Hospital Colorado Learn More
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination with Bevacizumab Compared to Bevacizumab with 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX wit Bevacizumab (LYNK-003) Protocol #: 19-6102 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR) Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes Protocol #: 19-6101 Locations: Harmony Campus; Medical Center of the Rockies Learn More
AN OBSERVATIONAL STUDY OF OCRELIZUMAB TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY) Protocol #: 19-1600 Location: University of Colorado Hospital Learn More
A DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED TRIAL TO STUDY THE VIASKIN MILK EFFICACY AND SAFETY FOR TREATING IgE-MEDIATED COW?S MILK ALLERGY IN CHILDREN (MILES STUDY) Protocol #: 15-0140 Location: Childrens Hospital Colorado Learn More
Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease Protocol #: 19-1787 Location: Childrens Hospital Colorado Learn More
The National Myelodysplastic Syndromes (MDS) Study Protocol #: 19-1696 Location: Rocky Mountain Regional VA Medical Center Learn More
Alliance A081105: Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) Protocol #: 19-1697 Location: Rocky Mountain Regional VA Medical Center Learn More
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 Learn More
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR) This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol. Protocol #: 19-1679 Location: University of Colorado Hospital Learn More
COG AREN1721 - A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups Protocol #: 19-1467 Location: Childrens Hospital Colorado Learn More
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins. Protocol #: 19-6511 Location: Memorial Hospital Central Learn More
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects with A+AVD." Protocol #: 19-6510 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital Learn More
ECG Belt for CRT Response Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV. Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV. Protocol #: 19-1703 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma Protocol #: 19-1503 Location: University of Colorado Hospital Learn More
A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder 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 identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD. The overarching hypothesis of this proposal is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking Alcohol Use Disorder individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, we will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking. Protocol #: 19-1658 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital Learn More
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy Protocol #: 19-1620 Location: University of Colorado Hospital Learn More
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 receive tofacitinib. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis. Participants must attend eight study visits at the University of Colorado Anschutz Medical Campus during the 18-week trial and have a study partner available to attend the visits with them. A blood draw for safety monitoring is required at each visit. Participants will be given tofacitinib at no cost for the duration of the study. Protocol #: 19-1362 Location: University of Colorado Hospital Learn More
Body Composition in Infants with Klinefelter Syndrome and Effects of Testosterone Treatment Protocol #: 14-1720 Location: Childrens Hospital Colorado Learn More
TRAVERSE Protocol #: 19-1644 Location: University of Colorado Hospital Learn More
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD Protocol #: 15-0902 Locations: Childrens Hospital Colorado; Colorado Research Center Learn More
A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling Protocol #: 19-1566 Location: University of Colorado Hospital Learn More
APOL1 Long-term Kidney Transplantation Outcomes Network APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a prospective manner. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African. To test kidney donors and transplant recipients for forms of the APOL1 gene for purposes of evaluating how the various forms may impact both donors and recipients. To determine whether the presence of APOL1 RRVs in a kidney donor shortens death-censored renal allograft survival. Secondary Objectives: 1. Define whether the presence of APOL1 RRVs in a kidney donor is associated with worse renal function or greater proteinuria after transplantation of the kidney; 2. Define whether the presence of APOL1 RRVs is associated with worse renal outcomes in living kidney donors after nephrectomy, and; 3. (if donor APOL1 RRVs are associated with worse kidney function in recipients of renal allografts) identify modifying factors that increase susceptibility for shortened allograft survival, reduced renal allograft function or greater proteinuria in recipients of kidneys from donors with APOL1 high-risk genotypes. Modifying factors may include cause of death in the deceased donor, ischemia time, type of immunosuppression, graft rejection, viral infection, post-engraftment renal dysfunction, etc. Protocol #: 19-0461 Location: University of Colorado Hospital Learn More
AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Protocol #: 19-1461 Location: University of Colorado Hospital Learn More
GRASP-LGMD RESEARCH PROTOCOL; Project 1a Defining Clinical Endpoints in LGMD Protocol #: 19-0506 Location: University of Colorado Hospital Learn More
A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy Protocol #: 19-1458 Location: University of Colorado Hospital Learn More
A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Protocol #: 19-1455 Location: University of Colorado Hospital Learn More
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer Protocol #: 19-6509 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital Learn More
Regression in Down Syndrome Protocol #: 19-1418 Location: Childrens Hospital Colorado Learn More
A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma. Protocol #: 19-1337 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Allen CU-UCSD Transition to RA Project: Blood and Flu Protocol #: 19-1150 Locations: Barbara Davis Center; University of Colorado Hospital Learn More
Ublituximab as initial therapy for treatment-naive follicular or marginal zone lymphoma with response-driven addition of umbralisib for suboptimal response. Protocol #: 18-2128 Location: University of Colorado Hospital Learn More
Apoyo con Cari?o (Support through Caring): Improving Palliative Care Outcomes for Latinos with Advanced Medical Illness V: 03/20/19 Protocol #: 16-1270 Locations: Denver Health Medical Center; University of Colorado Hospital Learn More
Sex effects on the neurobiology of eating behaviors in Veterans with overweight/obesity Veterans are needed for a study that aims to learn more about how men and women differ in the way their brains respond to food and hunger. It also plans to learn more about how hormones and the menstrual cycle affect these responses. Protocol #: 19-0940 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital Learn More
A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects with Congenital Adrenal Hyperplasia Protocol #: 19-1230 Location: Childrens Hospital Colorado Learn More
CROCODILE Study: Control of Renal Oxygenation, COnsumption, mitochondrial Dysfunction, and InsuLin rEsistance Protocol #: 19-1282 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1) Protocol #: 19-1342 Location: University of Colorado Hospital Learn More
A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors Protocol #: 19-1302 Location: University of Colorado Hospital Learn More
ImTAB Immunity, mTBI, and Alzheimer's Biomarkers You may qualify if you are: - 65 years or older - Have had a concussion within the past 5 years - Saw a doctor within 1 week of your concussion - Have not been diagnosed with a memory disorder Participants will receive: -Snacks and refreshments -Medical screening (neurological exam) -Optional review of memory scores with principal investigator after completion of 1 year follow up visit Have You Had a Concussion in the Past 5 Years? Research Study Investigates Concussions and Brain Health in Older Adults 65+ Research Goals: 1)Investigate how a recent concussion relates to brain structure and memory over time 2)Collect and analyze fluid biomarkers for the detection of inflammation and Alzheimer’s disease-related risk factors 3)Examine the relationship between concussion, the immune system, and the aging process Protocol #: 19-1423 Location: University of Colorado Hospital Learn More
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY) MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses. Protocol #: 19-1403 Location: Childrens Hospital Colorado Learn More
A Study of the Pipeline Flex Embolization DeVice with Shield Technology for EndovAscular TreatmeNt of Wide-NeCked Intracranial AnEurysms Protocol #: 19-1399 Location: University of Colorado Hospital Learn More
Using point of care ultrasound to measure perioperative edema in infants with congenital heart disease Protocol #: 19-1387 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GCAR-7213) Protocol #: 19-0744 Location: University of Colorado Hospital Learn More
Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults after Bariatric Surgery: A Randomized Controlled Pilot Study Protocol #: 18-2793 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Feasibility of the Multiple Sclerosis Performance Test for assessment of functional performance measures in patients with Multiple Sclerosis Protocol #: 19-1192 Location: University of Colorado Hospital Learn More
reST Registry remede System Therapy in patients with central sleep apnea Protocol #: 19-6087 Locations: Harmony Campus; Medical Center of the Rockies Learn More
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma Protocol #: 19-1259 Location: Childrens Hospital Colorado Learn More
Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy. Protocol #: 19-6506 Location: Memorial Hospital Central Learn More
Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCC Protocol #: 19-1081 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer Protocol #: 19-1152 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
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 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Protocol #: 19-1132 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 in Patients with Locally Advanced or Metastatic Solid Tumors Protocol #: 19-1145 Location: University of Colorado Hospital Learn More
Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017 Protocol #: 16-2408 Location: Childrens Hospital Colorado Learn More
Multi-Institutional Validation of Trauma Specific Frailty Index To test the predictive ability of the Trauma Sepcific Frailty Index. Protocol #: 19-6084 Location: Medical Center of the Rockies Learn More
A Phase I/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors Protocol #: 19-1277 Location: Childrens Hospital Colorado Learn More
SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer Protocol #: 19-6076 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
The Laboratory for Advanced Medicine (LAM) / Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples (CLiMB) Protocol #: 19-1272 Location: University of Colorado Hospital Learn More
Neurophysiological Correlates V: 31Jan18 Protocol #: 16-1480 Location: Childrens Hospital Colorado Learn More
Natural History of Rett Syndrome and Related Disorders Protocol #: 15-2332 Location: Childrens Hospital Colorado Learn More
Gamma band neural stimulation and its effects on resting state networks Protocol #: 19-1251 Locations: Brain Imaging Center (BIC); Department Specific Free Standing Clinic Learn More
NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK PROTOCOL Protocol #: 19-1146 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital Learn More
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 Locations: Brain Imaging Center (BIC); Childrens Hospital Colorado; Colorado Research Center; University of Colorado Hospital Learn More
Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia V: 5; March 20, 2018 Protocol #: 16-1998 Location: Childrens Hospital Colorado Learn More
The contributions of age related changes in the sound localization pathway to central hearing loss This study plans to learn more about how age affects the way we process sounds we hear. If you join the study, you will come into our Auditory Lab on the Anschutz Medical Campus 4-6 times and complete hearing assessments and questionnaires. To learn more about how age affects the way we process sounds we hear. Protocol #: 19-1213 Location: Department Specific Free Standing Clinic Learn More
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction Protocol #: 19-0675 Location: University of Colorado Hospital Learn More
A Multi-center, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease (PD) Protocol #: 19-0865 Location: University of Colorado Hospital Learn More
The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents with and without Obesity Protocol #: 19-1171 Location: University of Colorado Hospital Learn More
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE) TO HEAL CHRONIC DIABETIC FOOT ULCERS Researchers at the University of Colorado Anschutz Medical Campus are conducting a research study using investigational topical stem cells in the treatment of Diabetic Foot Ulcers (DFU). Protocol #: 19-1113 Location: University of Colorado Hospital Learn More
An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using AGEN1884 and AGEN2034 for Advanced or Metastatic Soft Tissue Sarcomas Protocol #: 19-0554 Location: University of Colorado Hospital Learn More
Prognostic significance of variants in the CTNNB1 gene and the B-catenin pathway in recurrent high-intermediate risk endometrial cancer Protocol #: 19-1199 Location: University of Colorado Hospital Learn More
A Phase 1/2, Open Label, Dose-Escalation Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors Protocol #: 19-1118 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital Learn More
A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SUBCUTANEOUS OCRELIZUMAB ADMINISTRATION IN PATIENTS WITH MULTIPLE SCLEROSIS Protocol #: 19-1040 Location: University of Colorado Hospital Learn More
A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab in Patients with Advanced Solid Tumors Protocol #: 19-1074 Location: University of Colorado Hospital Learn More
A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).A screening trial for A081105, E4512 and EA5142 Protocol #: 18-2625 Location: Rocky Mountain Regional VA Medical Center Learn More
A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE) Protocol #: 19-1147 Location: University of Colorado Hospital Learn More
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors Protocol #: 19-1069 Location: University of Colorado Hospital Learn More
A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimmune responses. Subjects will be administered clazakizumab at a target dose of 12.5 mg (or placebo) by SC injection, Q4W for up to 260 weeks (or until allograft loss or death). Primary Objectives: 1. To evaluate the efficacy of clazakizumab in preventing all-cause composite allograft loss due to CABMR (defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause (including death with functioning allograft). 2. To evaluate the efficacy of clazakizumab in slowing/preventing the progressive loss of kidney function (as measured by eGFR using the MDRD4 equation). 3. To evaluate the safety of clazakizumab. Secondary Objectives: 1. To evaluate the effects of clazakizumab on death-censored allograft loss (defined as return to dialysis, allograft nephrectomy, re-transplantation or eGFR <15 mL/min/1.73 m2 but excluding death from any cause). 2. To evaluate the effects of clazakizumab on albuminuria. 3. To evaluate the effects of clazakizumab on DSA titers and mean fluorescence intensity (MFI) scores. 4. To evaluate the effects of clazakizumab on incidence of acute rejection episodes (TCMR and ABMR). 5. To evaluate the effects of clazakizumab on the histology of kidney biopsies according to the Banff 2015 lesion grading scores. 6. To evaluate the effects of clazakizumab on overall patient survival. 7. To evaluate the effects of clazakizumab on healthcare utilization due to ABMR and patient reported outcomes, including health-related quality of life (HRQoL). Protocol #: 19-0460 Locations: Pathology - SOM; University of Colorado Hospital Learn More
Sex-based differences in the neuronal mechanisms of food intake behavior This study aims to learn more about how men and women differ in the way their brains respond to food and hunger. It also plans to learn more about how hormones and the menstrual cycle affect these responses. Protocol #: 19-1148 Location: University of Colorado Hospital Learn More
TOPP-2 registry Tacking Outcomes and Practice in Pediatric Pulmonary Hypertension V: 27 July 2018 Protocol #: 15-0693 Location: Childrens Hospital Colorado Learn More
Cardiopulmonary and Right Ventricular Function in Health and Disease The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event. Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system. Protocol #: 19-1141 Location: University of Colorado Hospital Learn More
LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS The objectives of this study are as follows: - To assess the risk of delayed adverse events (AEs) following exposure to genemodified (GM) T cells -To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate. -To monitor for generation of replication competent retroviruses (RCR) -To assess long-term efficacy following treatment with GM T cells - Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment -To assess long term health-related quality of life following treatment with GM T cells Protocol #: 19-0561 Location: University of Colorado Hospital Learn More
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY) Protocol #: 19-0967 Location: University of Colorado Hospital Learn More
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors Protocol #: 19-0604 Location: University of Colorado Hospital Learn More
A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer Protocol #: 19-6065 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma Protocol #: 19-0642 Location: University of Colorado Hospital Learn More
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 Locations: Dental Clinic; UCD Dental Clinic Learn More
Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult Protocol #: 18-0220 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse Protocol #: 19-0905 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
Patient and caregiver perspectives in bladder cancer diagnosis and treatment Protocol #: 19-0987 Location: University of Colorado Hospital Learn More
Understanding the Barriers to Epilepsy Surgery: A North American Survey Protocol #: 19-0269 Location: University of Colorado Hospital Learn More
A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVD Protocol #: 19-6060 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital Learn More
Outcomes and Prognostic Factors of Patients with Newly Diagnosed Burkitt Lymphoma (HRP-503c) Protocol #: 19-0900 Location: University of Colorado Hospital Learn More
Ablation versus Stereotactic Body Radiotherapy for Early Stage Hepatocellular Carcinoma Not Amenable to Surgical Treatment Protocol #: 19-0852 Location: University of Colorado Hospital Learn More
Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction Protocol #: 19-0376 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
Outcomes after Standardized Testicular Torsion Management and Follow-up Protocol #: 19-0849 Location: Childrens Hospital Colorado Learn More
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naive Adult Patients With Generalized Myasthenia Gravis Protocol #: 19-0772 Location: University of Colorado Hospital Learn More
An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis Protocol #: 19-0150 Location: University of Colorado Hospital Learn More
Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic Sclerosis Protocol #: 19-0814 Location: Childrens Hospital Colorado Learn More
A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579 Protocol #: 19-0858 Location: Childrens Hospital Colorado Learn More
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 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Solid foods and infant growth This is a 6 month long study with visits occurring once every month. The first and last visit will be conducted at Children's Hospital Colorado and the other 5 visits will be home visits. Compensation will be provided. The researchers want to learn how consuming different types of solid foods during early complementary feeding affects growth, neurodevelopment, sleep, and the bacteria in the gut. If you have a breastfed infant younger than 6 months, you may be eligible to participate. Protocol #: 19-0546 Location: Childrens Hospital Colorado Learn More
Fontan at Altitude Registry (FAR) V: 6-11-14 Protocol #: 14-1072 Location: Childrens Hospital Colorado Learn More
A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors Protocol #: 19-0556 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ. Protocol #: 19-0632 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital Learn More
Prognostic factors associated with outcomes in colorectal cancer liver metastases Protocol #: 19-0770 Location: University of Colorado Hospital Learn More
CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY Protocol #: 19-0519 Location: University of Colorado Hospital Learn More
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure Protocol #: 19-0520 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001) Protocol #: 19-0507 Location: University of Colorado Hospital Learn More
The Perelman Study of IntraUterine Growth Restriction Protocol #: 14-1360 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and, harmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from 1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction Protocol #: 16-0994 Location: Childrens Hospital Colorado Learn More
A Comprehensive and Collaborative Review of the Use of Whole Blood at Trauma Centers in the United States Compare Whole Blood vs Component Therapy Protocol #: 19-6047 Locations: Medical Center of the Rockies; Poudre Valley Hospital Learn More
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 cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs. The Lung PCA BU goals include enrollment of informative retrospective and prospective patients from which informative biospecimens can be collected and processed for advanced analyses of PMLs. Central to this process will be the development of techniques to optimize data production from limited tissues. The generation of a deep and interactive database will be critical to help direct the studies undertaken by the project. Visual maps will serve as the key information hubs and the development of these maps along with the functionality for them to be linked with extensive clinical databases and well annotated metadata will be a major endpoint for the project. Protocol #: 19-0400 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital Learn More
EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis The purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, and get a DXA scan. Protocol #: 19-0422 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
Evaluation and Demonstration of Investigational MRI Software and Hardware Test new MRI scanner sequences in diverse patient population Protocol #: 19-0518 Location: Childrens Hospital Colorado Learn More
Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer Protocol #: 19-0457 Location: University of Colorado Hospital Learn More
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established Type 1 Diabetes Mellitus Protocol #: 19-0606 Location: Barbara Davis Center Learn More
Incidence and Effect of HLA Antibodies in Liver Transplant Recipients Protocol #: 18-2594 Location: University of Colorado Hospital Learn More
Instrumentation of Huntington's Disease Motor Function Assessment Protocol #: 19-0212 Location: University of Colorado Hospital Learn More
A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure Protocol #: 19-0414 Location: University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D) Protocol #: 19-0489 Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital Learn More
A Multi-Center, Open-Label, phase I/Ib, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors Protocol #: 19-0539 Location: University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641) A double blind comparison of enzalutamide plus pembrolizumab or placebo in patients with metastatic prostate cancer. Protocol #: 19-0493 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921) A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer. Protocol #: 19-0473 Locations: Highlands Ranch Hospital; University of Colorado Hospital Learn More
Phase I trial of ribociclib in combination with everolimus and dexamethasone in children and young adults with relapsed acute lymphoblastic leukemia (DF/HCC Protocol#: 18-328) Protocol #: 19-0551 Location: Childrens Hospital Colorado Learn More
AINV18P1: A Phase I Study of Palbociclib (IND# 141416), a CDK4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Protocol #: 19-0549 Location: Childrens Hospital Colorado Learn More
A phase II study to evaluate neoadjuvant osimertinib therapy in patients with surgically resectable, EGFRmutant non-small cell lung cancer Protocol #: 19-0325 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER Protocol #: 19-0476 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma Protocol #: 19-0423 Location: University of Colorado Hospital Learn More
ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (FA) (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. We hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics. This study will consist of 24 weeks (12 weeks placebo treatment and 12 weeks of CXA-10 treatment) in a randomized crossover fashion. There will be an approximate 4 week washout period. Primary aim includes: To determine the efficacy of CXA-10 in reducing bronchial responsiveness, determined by the change in methacholine dose necessary to achieve a 20% reduction in FEV1 from baseline (PC20) Secondary aims include: - To investigate the effect of CXA-10 on differential gene expression in fresh airway epithelial cells Exploratory aims include: - To explore the efficacy of CXA-10 in improving lung function measured by FEV1, FEV1/FVC ratio and FEV1 % reversal and exhaled nitric oxide (FeNO) concentrations - To explore the efficacy of CXA-10 in improving asthma control using the Asthma Control Questionnaire (ACQ) - To explore the effect of CXA-10 on adipokine/cytokines plasma concentrations Safety aims include: - To assess the safety of 12 weeks of treatment with 150mg/day of orally administered CXA-10 in adult obese asthmatic subjects Protocol #: 19-0510 Locations: University of Colorado Hospital; University of Pittsburgh Cancer Institute Learn More
AMPLATZERTM PFO Occluder Post Approval Study This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting To demonstrate safety of the AMPLATZERTM PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death and the effective by assessing the rate of recurrent ischemic stroke through 5 years Protocol #: 19-6502 Location: Memorial Hospital Central Learn More
A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS Protocol #: 18-2798 Location: University of Colorado Hospital Learn More
Detection and Risk in Early MS Protocol #: 19-0393 Locations: Brain Imaging Center (BIC); University of Colorado Hospital Learn More
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Zolmitriptan Nasal Spray for the Treatment of Acute Migraine in Subjects Ages 6 to 11 years, With an Open-Label Extension Protocol #: 18-1695 Location: Childrens Hospital Colorado Learn More
A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA Protocol #: 19-0172 Location: University of Colorado Hospital Learn More
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Protocol #: 19-0444 Location: University of Colorado Hospital Learn More
A Phase 1, open label, first-in-human study of TR1801-ADC, an antibody drug conjugate (ADC), in patients with select solid tumors expressing c-Met Protocol #: 19-0232 Location: University of Colorado Hospital Learn More
Total Joint Arthroplasty in a Pediatric Population Involves two surveys for approximately 10 mintues To explore the functional ability and quality of life in pediatric patients who undergo joint arthroplasty for non-solid tumor related reasons. Protocol #: 19-0306 Location: Childrens Hospital Colorado Learn More
Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study Protocol #: 18-2444 Location: University of Colorado Hospital Learn More
An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis Protocol #: 19-0105 Location: Childrens Hospital Colorado Learn More
Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer Protocol #: 18-2742 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital Learn More
A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale Protocol #: 19-0396 Location: Childrens Hospital Colorado Learn More
A Natural History Study of CMT1B, CMT2A, CMT4A and CMT4C Protocol #: 18-2537 Location: University of Colorado Hospital Learn More
SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks. Protocol #: 19-0347 Location: University of Colorado Hospital Learn More
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 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
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 you want to learn more about the study please contact Kristen Raymond at kristen.raymond@cuanschutz.edu. The specific aims of the project are to: 1) Discover biomarkers associated with marijuana use. 2) Discover biological pathways associated with marijuana use. 3) Exploratory Aim: Test whether peripheral endocannabinoid levels vary with marijuana use and predict marijuana craving. Protocol #: 18-0853 Location: University of Colorado Hospital Learn More
Impact of surgical intervention on sleep dysfunction in patients with refractory epilepsy Protocol #: 19-0239 Location: University of Colorado Hospital Learn More
PHASE 1 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE?) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS (Pfizer Protocol A5481092/ ADVL1921) Protocol #: 19-0299 Location: Childrens Hospital Colorado Learn More
A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER Protocol #: 19-0206 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma Primary Objective: (1) Evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Secondary Objectives: (1) Describe the pharmacokinetics (PK) of losartan when given in combination with sunitinib in pediatric and young adult patients with relapsed or refractory osteosarcoma. (2) Describe the pharmacodynamic (PD) effects of losartan and sunitinib, specifically effects on monocyte migration, plasma CCL2 levels, and changes to the peripheral CCR2+ monocyte population, when given in combination in pediatric and adult patients with relapsed or refractory osteosarcoma. (3) Describe the preliminary antitumor activity of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Exploratory Objectives: (1) Describe changes to peripheral T cell populations including CD4+, CD8+, and regulatory T cells, which occurs with treatment of losartan and sunitinib. (2) Describe changes to peripheral immune-related cytokines/chemokines such as TGF-β, IFNγ and VEGF with treatment of losartan and sunitinib. (3) Characterize tumor-infiltrating leukocytes, micro-vessel density, and immune-related gene expression in resected pulmonary metastases of patients treated with losartan and sunitinib. Protocol #: 18-2740 Locations: Childrens Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital Learn More
An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors Protocol #: 19-0207 Location: University of Colorado Hospital Learn More
APOGEE LVAD registry Protocol #: 18-2576B Location: University of Colorado Hospital Learn More
GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. Protocol #: 19-6030 Locations: Harmony Campus; Medical Center of the Rockies Learn More
Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating Room Protocol #: 18-2513 Location: Childrens Hospital Colorado Learn More
A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCER Protocol #: 19-0127 Location: University of Colorado Hospital Learn More
Investigating cortical networks disruption and rehabilitation after traumatic brain injury Protocol #: 19-0049 Locations: Colorado Research Center; Department Specific Free Standing Clinic Learn More
Randomized, Open label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog? versus Continuous Use of NovoLog in Participants with Type 1 Diabetes Mellitus also Using Insulin Glargine Protocol #: 19-0250 Locations: Barbara Davis Center; UCD Barbara Davis Center Learn More
Caretaker Wireless Vital Sign Monitor Applied in the Field and Transitioned into the Emergency Department: A Quality Initiative Project to Determine the Efficacy of the Caretaker Device Compared to Standard Vital Sign Recordings To test wireless vital sign monitor in the field and determine feasibility. Protocol #: 18-6102 Location: Medical Center of the Rockies Learn More
Surgery Database Project Protocol #: 18-2839 Location: University of Colorado Hospital Learn More
Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell) Protocol #: 16-0692 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center Learn More
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy Protocol #: 19-0225 Location: University of Colorado Hospital Learn More
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderate to Severe Atopic Dermatitis (AD) A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable. Protocol #: 19-0144 Location: University of Colorado Hospital Learn More
Gene Expression of Cerebral Aneurysms In this study, we will collect tissue and blood from participants during their epilepsy surgery. Protocol #: 19-0182 Location: University of Colorado Hospital Learn More
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 doses of the study drug. During the 3 month study period there are every 2 week visits to evaluate blood pressure. Optional testing includes cerebral artery testing and cognitive testing before after daily doses of nicotinamide riboside. Protocol #: 19-0149 Locations: Renal Research Center; University of Colorado Hospital Learn More
DEEP LEARNING BASED FEATURE EXTRACTION ON PANCREAS X-RAY PROJECTION IMAGES Protocol #: 19-0123 Location: University of Colorado Hospital Learn More
Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult US population with type 2 diabetes - a randomized pragmatic clinical trial Protocol #: 19-0120 Location: University of Colorado Hospital Learn More
AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups A comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer Protocol #: 19-0048 Location: University of Colorado Hospital Learn More
A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD Protocol #: 18-2881 Locations: Childrens Hospital Colorado; University of Colorado Hospital Learn More
How Does Inflammation Affect the Aging Brain? Research Study Investigates Aging, Memory, and Immune Function. The University of Colorado Anschutz Medical Campus is looking for interested adults 60 and over to participate in a research study examining how inflammation influences brain health. Data gathered from this study will be used to better understand how inflammation may or may not disrupt thinking and memory. You may qualify if you are: - 60 years or older - In good general health - Have NOT been diagnosed with a memory disorder Protocol #: 18-2607 Location: University of Colorado Hospital Learn More
Moderating effects of sleep on quality of life and fatigue following an exercise program for cancer survivors Protocol #: 19-0041 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center Learn More
An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome Protocol #: 19-0079 Location: Childrens Hospital Colorado Learn More
The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER A double blind comparison of MPX versus placebo in men with prostate cancer. Protocol #: 18-2604 Location: University of Colorado Hospital Learn More
Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patients Protocol #: 18-2874 Location: University of Colorado Hospital Learn More
A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer Protocol #: 18-6515 Location: Memorial Hospital Central Learn More
A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions Protocol #: 19-0011 Location: University of Colorado Hospital Learn More
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus Protocol #: 19-0027 Location: Barbara Davis Center Learn More
Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI) The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit. Protocol #: 19-0003 Location: University of Colorado Hospital Learn More
New Graduate Nurse Orientation Using a Staged, Task-Layered Strategy: Implications for Length of Orientation and Self-Reported Confidence Protocol #: 18-6119 Locations: Medical Center of the Rockies; Poudre Valley Hospital Learn More
A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis. Protocol #: 18-2823 Location: University of Colorado Hospital Learn More
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1) Protocol #: 18-2654 Location: University of Colorado Hospital Learn More
Association of depth recordings from the temporal cortex with sleep pattern detection and characterization of sleep dysfunction in patients with refractory epilepsy. Protocol #: 18-2806 Location: University of Colorado Hospital Learn More
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors Protocol #: 18-2520 Locations: Lone Tree Medical Center; University of Colorado Hospital Learn More
CLINICAL TRIALS IN ORGAN TRANSPLANTATION CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy. Primary Safety Objective: This study will evaluate the safety of polyTregs in adult kidney transplant recipients. Secondary Safety Objective: Participants receiving polyTregs will be evaluated for the safety of converting from CNI‐based maintenance therapy to mTOR inhibitors after Treg therapy. Primary Efficacy Objective: This study will evaluate whether polyclonally expanded Tregs (polyTregs) reduce graft inflammation relative to their enrollment biopsy compared to those receiving CNI‐based maintenance therapy with similar baseline biopsy findings. Secondary Efficacy Objective: This study will evaluate whether polyTregs can reduce graft inflammation by 25% or more in the 2 weeks after polyTreg infusion relative to the enrollment biopsy. Protocol #: 18-2679 Location: University of Colorado Hospital Learn More
PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY Protocol #: 18-2569 Location: University of Colorado Hospital Learn More
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 Learn More
Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in left ventricular outflow tract arrhythmias ablation Protocol #: 18-2772 Location: University of Colorado Hospital Learn More
Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT). Protocol #: 18-2765 Location: University of Colorado Hospital Learn More
Identifying relevant seizure biomarkers from RNS? System recorded electrocorticography for the development of optimized seizure detection algorithms Protocol #: 18-2089 Location: University of Colorado Hospital Learn More
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation Protocol #: 18-2529 Locations: Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital Learn More
IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age, Version 1.0 Protocol #: 18-2714 Location: Childrens Hospital Colorado Learn More
An Exploratory Investigation of the Impact of the Assistive Technology Partners Product Testing Laboratory Protocol #: 11-0674 Locations: Memorial Hospital Central; Memorial Hospital North Learn More
A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma Protocol #: 18-2646 Location: University of Colorado Hospital Learn More
Understanding Barriers to Enrollment in Clinical Trials at the University of Colorado Cancer Center Protocol #: 18-2684 Location: University of Colorado Hospital Learn More
A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey Results Protocol #: 18-2562 Locations: Cherry Creek Medical Center; Lone Tree Medical Center; University of Colorado Hospital Learn More
A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years. Protocol #: 18-6511 Location: Memorial Hospital Central Learn More
GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days. Protocol #: 18-2672 Location: University of Colorado Hospital Learn More
Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase Protocol #: 18-2286 Location: Childrens Hospital Colorado Learn More
Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018 This research study is investigating the roles of estrogen (female sex hormone) and FSH, or follicle-stimulating hormone, on cortisol (a stress hormone), fat gain, and disease risk. Protocol #: 18-2483 Location: University of Colorado Hospital Learn More
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Protocol #: 18-2346 Location: University of Colorado Hospital Learn More
CLASP IID/IIF PASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation Protocol #: 18-6126 Locations: Harmony Campus; Medical Center of the Rockies Learn More
A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer. Protocol #: 18-2404 Location: University of Colorado Hospital Learn More
Destination Therapy Post Approval Study - Medtronic HVAD System LVAD registry Protocol #: 18-2576A Location: University of Colorado Hospital Learn More
A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors Protocol #: 18-2417 Location: University of Colorado Hospital Learn More
Predictors of physical activity maintenance in colorectal cancer survivors Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions. Protocol #: 18-2436 Locations: Anschutz Health and Wellness; Colorado State University; Harmony Campus; Poudre Valley Hospital; UCD Anschutz Health & Wellness Center Learn More
Ultrarapid Culture Independent Identification and Antibiotic Suspectibility Testing of High-Priority Carbapenem Resistant Enterobacteriaceae Directly from Blood and Urine in Patients with Suspected Bacteremia V: 02 Feb 2017 Protocol #: 16-0086 Location: University of Colorado Hospital Learn More
A Phase 3, randomized, double-blind, parallel group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Protocol #: 18-2534 Location: University of Colorado Hospital Learn More
Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age- and BMI-Matched Cisgender Adults Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart disease o Non-smoker (or quit at least one year ago) This study is examining how gender-affirming hormone therapy affects the health of blood vessels and impacts cardiovascular disease risk in transgender women. Protocol #: 18-2258 Locations: Anschutz Health and Wellness; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital Learn More
A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus. Protocol #: 18-1223 Location: Childrens Hospital Colorado Learn More
Evaluation of Sun Protection Education using the Reveal Imager Photo-aging and the SPA Questionnaire Protocol #: 17-2424 Locations: University of Colorado Cancer Center; University of Colorado Hospital Learn More
Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer Protocol #: 18-2209 Location: University of Colorado Hospital Learn More
Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only). Protocol #: 18-2382 Location: University of Colorado Hospital Learn More
PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dose escalation cohort is designed to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of savolitinib. Once the MTD/RP2D is determined, the enrollment for an efficacy expansion cohort will open for patients whose tumors harbor genetic MET activation as determined by CLIA tests performed at participating sites, and confirmed by FDA approved tests. Protocol #: 18-2432 Location: Childrens Hospital Colorado Learn More
Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naive Protocol #: 18-2284 Location: University of Colorado Hospital Learn More
A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003) Protocol #: 18-2198 Location: University of Colorado Hospital Learn More
A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORS Protocol #: 18-1816 Location: University of Colorado Hospital Learn More
S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER A comparison of standard systemic therapy versus standard systemic therapy plus surgery or radiation therpy Protocol #: 18-2252 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital Learn More
A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) Evaluate the safety and tolerability of FOR46 at escalating dose levels and administered intravenously (IV) every 21 days in relapsed/refractory multiple myeloma patients. And determine the maximum-tolerated dose and/or the recommended Phase 2 dose (RP2D) of FOR46 administered IV every 21 days in relapsed/refractory multiple myeloma patients. Protocol #: 18-2354 Location: University of Colorado Hospital Learn More
Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis Protocol #: 18-2337 Location: Childrens Hospital Colorado Learn More
Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II) Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery. This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation. Protocol #: 18-2012 Location: Childrens Hospital Colorado Learn More
A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I) Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with MMF and corticosteroids as compared to standard of care comprised of tacrolimus, MMF and corticosteroids. -In a maintenance kidney transplant population (6-24 months post-transplant), CFZ533 in combination with MMF with or without corticosteroids, compared to a standard of care control arm of tacrolimus and MMF with or without corticosteroids. COHORT 1: Primary Objective(s) -To demonstrate that CFZ533 600 mg or 300 mg bi-weekly (Q2W), subcutaneous (SC), are non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite efficacy failure event (Biopsy proven acute rejection (BPAR), Graft Loss or Death) over 12 months post-transplantation. Key secondary objective: -To demonstrate that CFZ533 600 mg or 300 mg Q2W SC are superior to a tacrolimus-based regimen with respect to the mean estimated glomerular filtration rate (eGFR) at 12 months post-transplantation. COHORT 2: Primary Objective(s) -To demonstrate that CFZ533 450 mg Q2W SC is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite event (BPAR, Graft Loss or Death) over 12 months post conversion. Key secondary objective: -To demonstrate that CFZ533 450 mg Q2W SC is superior to a tacrolimus-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion. Protocol #: 18-2117 Location: University of Colorado Hospital Learn More
Metabolic and Renal Effects of Automated Insulin Delivery Systems in Youth with Type 1 Diabetes Mellitus Protocol #: 18-1558 Location: Childrens Hospital Colorado Learn More
A prospective, long term registry of patients with a diagnosis of spinal muscular atrophy V: 1.0; 20March2018 Protocol #: 18-1683 Location: Childrens Hospital Colorado Learn More
A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1 Protocol #: 18-2315 Location: University of Colorado Hospital Learn More
A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding. Primary objective: Assess the efficacy of a levonorgestrel 52 mg intrauterine system (LNG20 IUS) as a treatment for heavy menstrual bleeding. Secondary objectives: Assess safety, tolerability, bleeding patterns, and continuation rates of LNG20 IUS in women using LNG20 IUS for heavy menstrual bleeding. Protocol #: 18-2249 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital Learn More
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team. Protocol #: 18-2298 Location: University of Colorado Hospital Learn More
The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic Syndrome Protocol #: 18-0369 Location: University of Colorado Hospital Learn More
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma Protocol #: 18-6510 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital Learn More
Genomic Translation for ALS Care Protocol #: 18-1768 Location: University of Colorado Hospital Learn More
Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR) Protocol #: 18-2051 Location: University of Colorado Hospital Learn More
CU Faces of Hope-Genetics of Craniofacial and Dental Development Research Study This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not. Protocol #: 18-1916 Location: Childrens Hospital Colorado Learn More
Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF) The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determine fluid balance in your body. The CardioMEMS HF System is FDA approved for a select group of patients. The study plans to see if it works in more patients. The study will also learn if using the device's data for other indicators of heart failure might reduce worsening heart failure resulting in visits to the hospital to treat heart failure or death. You may be eligible if you are at risk of having episodes of worsening heart failure. Protocol #: 18-2129 Locations: Medical Center of the Rockies; Memorial Hospital Central; University of Colorado Hospital Learn More
The Associations between EIT and Clinical Measures during Standard of Care Procedures in Patients with Respiratory Disease: A Preliminary Study Primary outcome: EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified. Secondary outcomes: Regional conductivity changes due to ventilation Waveform for a mesh element Regional conductivity changes due to perfusion Regional pulsatile perfusion imaging at the end of systole Power waveform (computed as the inner product of measured voltages and applied currents) Protocol #: 18-1843 Location: Childrens Hospital Colorado Learn More
A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Protocol #: 18-2047 Location: University of Colorado Hospital Learn More
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula Repair Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure. Protocol #: 18-1823 Location: Childrens Hospital Colorado Learn More
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments Protocol #: 18-2021 Location: University of Colorado Hospital Learn More
Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (DELIVERMS) Protocol #: 18-1633 Location: University of Colorado Hospital Learn More
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red blood cells in Subjects undergoing Complex Cardiac Surgery Procedures (the ReCePI study) Protocol #: 18-2032 Location: University of Colorado Hospital Learn More
Identifying Predictors of Poor Health-Related Quality-of-Life among Pediatric Hematopoietic Stem Cell Donors Protocol #: 18-1997 Location: Childrens Hospital Colorado Learn More
Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen Protocol #: 18-6061 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies Learn More
COG AGCT1532 - Phase 3 Accelerated BEP Trial: A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours Protocol #: 18-1674 Location: Childrens Hospital Colorado Learn More
COG AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) Protocol #: 18-1527 Location: Childrens Hospital Colorado Learn More
A Phase 3 Study of Eltrombopag vs. Standard First-Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children (ICON3) To determine if the proportion of patients with a platelet response is significantly greater in patients with newly diagnosed ITP treated with eltrombopag than those treated with standard first-line treatments Protocol #: 18-1963 Location: Childrens Hospital Colorado Learn More

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)

Protocol #: 20-2972

Location: University of Colorado Hospital

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A single arm, multicenter, prospective, clinical study on a novel minimally invasive posterier sacroiliac fusion device

Protocol #: 20-2971

Location: Medical Center of the Rockies

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APEC1621I: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)-PHASE 2 SUBPROTOCOL OF PALBOCICLIB IN PATIENTS WITH TUMORS HARBORING ACTIVATING ALTERATIONS IN CELL CYCLE GENES

Protocol #: 17-2168I

Location: Childrens Hospital Colorado

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Pediatric Brain Injury Caregiver Education Program

Protocol #: 20-0272

Location: Childrens Hospital Colorado

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

Protocol #: 19-0741

Location: Dental Clinic

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A PHASE 1 STUDY OF TJ210001 ADMINISTERED IN SUBJECTS WITH RELAPSED OR REFRACTORY ADVANCED SOLID TUMORS

Protocol #: 20-2541

Location: University of Colorado Hospital

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Reducing the flow from a Fontan fenestration using Atrial Flow Regulator devices - Patient QW

Protocol #: 20-2505

Location: Childrens Hospital Colorado

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Paired Germline/Tumor Genetic Testing Outcomes

Protocol #: 20-2287

Locations: Childrens Hospital Colorado; Childrens Hospital Colorado at Memorial

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

Protocol #: 20-2414

Location: Childrens Hospital Colorado

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ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

Protocol #: 20-2411

Location: Childrens Hospital Colorado

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Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200273, Pt M.W. (2)

Protocol #: 20-2410

Location: University of Colorado Hospital

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Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200272, Pt M.W. (1)

Protocol #: 20-2407

Location: University of Colorado Hospital

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Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200271, Pt L.I.

Protocol #: 20-2406

Location: University of Colorado Hospital

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

Protocol #: 20-2139

Location: Childrens Hospital Colorado

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EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT)

Protocol #: 20-2150

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

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A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients with Type 1 Diabetes and HLA-DQ8

Protocol #: 20-2220

Location: Barbara Davis Center

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STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE)

Protocol #: 20-0141

Locations: Barbara Davis Center; University of Colorado Hospital

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Evaluation of Compensatory Reserve in Obstetrical Patients

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

Protocol #: 14-1996

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes

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

Protocol #: 20-1681

Location: Childrens Hospital Colorado

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ENVASARC: A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY

Protocol #: 20-1892

Location: University of Colorado Hospital

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STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)

Protocol #: 20-1310

Location: Childrens Hospital Colorado

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Single Patient IDE for Medtronic SynchroMed II Pump with Intera Tapered Catheter, IDE# U200202, Pt. MM

Protocol #: 20-1988

Location: University of Colorado Hospital

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A Phase 2 Open-Label Study of PTR-01 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Protocol #: 20-1938

Location: Childrens Hospital Colorado

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A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Protocol #: 20-1845

Location: University of Colorado Hospital

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

Protocol #: 20-1864

Location: Childrens Hospital Colorado

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AN EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC

Protocol #: 20-1830

Location: University of Colorado Hospital

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A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults. To see if you qualify for the study, please visit this webpage: http://bit.ly/covid19vaccinestudy

Protocol #: 20-9990

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

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EA5191: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Protocol #: 20-1737

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

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A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple CombinationTherapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age

Protocol #: 20-1827

Location: Childrens Hospital Colorado

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Patient Perpetrated Workplace Violence and the Effects on Patient Outcomes

Protocol #: 20-6057

Location: Memorial Hospital Central

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ColorAdo ReseArch on Menopause & Early Life Stress Study: Remote Participation (The "CARAMELS at Home" Study)

Protocol #: 20-1715

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic

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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 (baseline and 12 months later). Research visits will include a physical exam, questionnaires, a blood draw, drinking a sugary drink, ultrasounds of the head, neck and arm, riding an exercise bike and a body scan.

Protocol #: 19-1226

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases from ALK+ Lung Cancer

Protocol #: 19-2862

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

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A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Protocol #: 20-1667

Locations: Lone Tree Medical Center; University of Colorado Hospital

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CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

Protocol #: 20-1736

Location: University of Colorado Hospital

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An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations

Protocol #: 20-1757

Location: Childrens Hospital Colorado

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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 oncogenic driver mutations, and who have progressed following first line treatment with PD-1 or PD-L1 targeting agents having previously achieved a best response of stable disease or better measured after 12 weeks.

Protocol #: 20-1690

Location: University of Colorado Hospital

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

Protocol #: 20-1721

Location: Childrens Hospital Colorado

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Dystonia Coalition Projects-3

Protocol #: 20-0290

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

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

Protocol #: 20-1602

Location: Childrens Hospital Colorado

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

Protocol #: 20-1525

Location: University of Colorado Hospital

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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD

This study is a 52 week intervention with visits at the CU Med Building on the Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment of physical function via a questionnaire.

Protocol #: 20-1672

Location: Renal Research Center

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In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers

This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth.

Protocol #: 20-1399

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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A Phase I study of the ADAM-10 inhibitor, INCB007839 in children with recurrent/progressive high-grade gliomas to target microenvironmental neuroligin-3

Protocol #: 20-1487

Location: Childrens Hospital Colorado

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Phase 1 study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK-3B) inhibitor, as a single agent or with Irinotecan in pediatric patients with refractory malignancies

Protocol #: 20-1445

Location: Childrens Hospital Colorado

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Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Protocol #: 20-1438

Location: University of Colorado Hospital

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A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy for HER2+ gastrointestinal cancers

Protocol #: 20-1453

Location: University of Colorado Hospital

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A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Protocol #: 20-0746

Location: University of Colorado Hospital

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A PHASE 1 TRIAL OF THE CD123 X CD3 DART? MOLECULE FLOTETUZUMAB (NSC#808294, IND#145986) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

Protocol #: 20-1106

Location: Childrens Hospital Colorado

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An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies

Protocol #: 20-1380

Location: Childrens Hospital Colorado

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ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection

The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19.

Protocol #: 20-6506

Locations: Memorial Hospital Central; Memorial Hospital North

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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 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the MTD or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Protocol #: 20-1388

Locations: Pathology - SOM; University of Colorado Hospital

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EA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response

Protocol #: 20-1318

Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital

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

Protocol #: 20-1204

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

Protocol #: 20-6034

Location: Medical Center of the Rockies

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Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic Anemia

Protocol #: 20-1333

Location: Childrens Hospital Colorado

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ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Protocol #: 19-2469

Location: Childrens Hospital Colorado

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EXPANSION AND EVALUATION OF THE UNIVERSITY OF COLORADO STRENGTH (STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH) PREHABILITATION PROGRAM

Protocol #: 20-0246

Location: University of Colorado Hospital

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A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb?23104 in Subjects with Selected Advanced Solid Tumors (DUET-3)

Protocol #: 20-1289

Location: University of Colorado Hospital

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AN OPEN-LABEL, SAFETY AND TOLERABILITY PHASE 1b TRIAL OF CAN04, A FULLY HUMANIZED ANTI-IL1RAP MONOCLONAL ANTIBODY, IN COMBINATION WITH PEMBROLIZUMAB IN SUBJECTS WITH SOLID TUMORS PROGRESSING ON PD-1/PD-L1 INHIBITOR-CONTAINING REGIMENS

Protocol #: 20-0605

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

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Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19

Protocol #: 20-1227

Location: 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 kidneys and amount of fat tissue in the abdomen by MRI. The results of this study will help design a larger study where we can test if restricting hours of eating can slow progression of ADPKD.

Protocol #: 20-1262

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

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Colorado Nurses Experience with COVID-19

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

Protocol #: 20-6039

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

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Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event

The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event).

The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs.

Protocol #: 20-6019

Location: Memorial Hospital Central

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COVID-19 Prospective Observational Cohort Study and Biobank of Health Care Workers and Other Populations

Protocol #: 20-1197

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

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

Protocol #: 20-1219

Location: University of Colorado Hospital

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A Phase 1 study of temozolomide in combination with targeted therapy for NSCLC patients with CNS progression on either osimertinib or lorlatinib

Protocol #: 20-0138

Location: University of Colorado Hospital

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A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction based on Time of Discharge

Protocol #: 20-1055

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection

Protocol #: 20-6037

Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital

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S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Protocol #: 20-0563

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

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A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT

Protocol #: 20-0881

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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SLEEP-DISORDERED BREATHING IN INFANTS WITH MYELOMENINGOCELE

Protocol #: 20-0996

Location: Childrens Hospital Colorado

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STARS ("STudy of Alteplase for Respiratory failure in SARS-Cov2 (COVID-19)", a Phase IIa Clinical Trial

Protocol #: 20-0880

Location: University of Colorado Hospital

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The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections.

This study is to evaluate the effectiveness of Expanded Focused Assessment with Sonography in Trauma (EFAST) in identifying high risk trauma patients with active COVID-19 pulmonary infections.

Protocol #: 20-0751

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 20-0978

Locations: Steadman Hawkins Clinic - Denver; University of Colorado Hospital

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

Protocol #: 20-0889

Location: Childrens Hospital Colorado

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OPTION

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

Protocol #: 20-6502

Location: Medical Center of the Rockies

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COVID-19 Convalescent Plasma sIND in treatment of patient with COVID-19

Protocol #: 20-6031

Location: Poudre Valley Hospital

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COVID-19: Lung ultrasound implementation in the management of patients with COVID-19

Protocol #: 20-0781

Location: University of Colorado Hospital

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A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis

Protocol #: 20-0609

Location: University of Colorado Hospital

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

Protocol #: 20-0820

Location: Childrens Hospital Colorado

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A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients with Advanced Solid Tumors

Protocol #: 20-0727

Location: University of Colorado Hospital

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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

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A PHASE 3, RANDOMIZED, DOUBLE- OR OBSERVER-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

Protocol #: 20-0481

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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EA2187: "A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma"

Protocol #: 20-0584

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

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COVID-19: Surgical Implications Study

Collect outcomes data on patients who have been diagnosed with COVID-19 and have undergone surgery.

Protocol #: 20-0614

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

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A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes

Protocol #: 19-1130

Location: University of Colorado Hospital

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COVID-19 Biobank

Protocol #: 20-0685

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

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Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI

Protocol #: 20-0537

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 20-0590

Location: Department Specific Free Standing Clinic

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Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer's disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Protocol #: 20-0571

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)

Protocol #: 20-0589

Location: University of Colorado Hospital

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COVID-19 Preparedness Survey

Protocol #: 20-0620

Location: University of Colorado Hospital

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A SINGLE-PERIOD, SINGLE-TREATMENT STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EPINEPHRINE AFTER ADMINISTRATION OF INTRANASAL ARS-1 TO PEDIATRIC SUBJECTS WITH SYSTEMIC ALLERGIES

Protocol #: 20-0596

Location: Childrens Hospital Colorado

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Virtual reality in cancer patient imaging review

Protocol #: 20-0560

Location: University of Colorado Hospital

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A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)

Protocol #: 20-0580

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

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CD80 as a biomarker for kidney disease

Protocol #: 13-2700

Location: Childrens Hospital Colorado

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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Protocol #: 20-0490

Location: Childrens Hospital Colorado

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

Protocol #: 20-0535

Location: Childrens Hospital Colorado

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Characterization of cannabinoids, endocannabinoids, and biomarkers in adolescents

Protocol #: 20-0553

Location: University of Colorado Hospital

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A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

Protocol #: 20-0404

Location: University of Colorado Hospital

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Immune Profiles in CF Fungal Infections

Protocol #: 20-0099

Location: Childrens Hospital Colorado

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Impacts of a multitiered breastfeeding support program on breastfeeding duration and achievement of prenatal breastfeeding goals

Protocol #: 20-6027

Locations: Long's Peak Hospital; Longs Peak Hospital

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Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion

Protocol #: 15-0813

Location: University of Colorado Hospital

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International CDKL5 Clinical Research Network

Protocol #: 19-2756

Location: Childrens Hospital Colorado

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

Protocol #: 20-0346

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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

Protocol #: 20-0347

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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Validation of the Apollo EE Device, Indirect Calorimetry

Protocol #: 20-0317

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients with Advanced Clear Cell Renal Cell Carcinoma

Protocol #: 20-0357

Location: University of Colorado Hospital

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A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination with AGEN1884 in Patients with Recurrent, Inoperable Angiosarcoma

Protocol #: 20-0261

Location: University of Colorado Hospital

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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

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

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NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin

Protocol #: 20-0360

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

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A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)

Protocol #: 20-0262

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series

Protocol #: 19-2236

Locations: Denver Health Medical Center; University of Colorado Hospital

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A5380: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

Protocol #: 20-0303

Location: University of Colorado Hospital

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

Protocol #: 20-0271

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

Protocol #: 20-0279

Location: Childrens Hospital Colorado

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An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Protocol #: 20-0216

Locations: Highlands Ranch 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 consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Protocol #: 20-0288

Location: University of Colorado Hospital

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A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma

Protocol #: 19-2345

Location: Childrens Hospital Colorado

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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 radiographic sacroiliitis or magnetic resonance imaging (MRI) features of inflammation in the sacroiliac joints (SIJ) plus one clinical feature of spondyloarthritis (SpA), and a "clinical arm" that requires presence of the HLA B27 protein plus 2 clinical features of SpA.

To validate the performance of the current ASAS classification criteria in a prospective combined cohort of patients presenting to a rheumatologist in North America and outside North America with undiagnosed current back pain of ≥3 months duration with onset ≤45years of age.

Protocol #: 19-1526

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

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

Protocol #: 20-0226

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

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The HPV 9-10 Trial: Early Initiation of HPV Vaccination

Protocol #: 19-3006

Locations: CHOC ? Children?s Hospital of Orange County; UCLA - University of California; UCLA, Jonsson Cancer 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 of this investigation is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS.

Protocol #: 20-0254

Location: University of Colorado Hospital

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The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis in transgender women

Protocol #: 20-0104

Location: University of Colorado Hospital

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Multi-center chart review of pregnant women undergoing fetoscopic laser surgery (FLS) for Twin-Twin Transfusion syndrome (TTTS) with a short cervical length.

Protocol #: 20-0189

Location: Childrens Hospital Colorado

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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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Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE study)

This is a 12-week combined aerobic and resistance exercise intervention in breast cancer survivors. Before and after the intervention, women will undergo measures of appetite, energy intake, body composition, and resting metabolic rate.

Protocol #: 19-3032

Location: University of Colorado Hospital

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ENGOT-ov50 / INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer

Protocol #: 20-0007

Location: University of Colorado Hospital

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ALS toolkit project

Protocol #: 20-0127

Location: University of Colorado Hospital

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Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations

Protocol #: 19-3063

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

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A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Protocol #: 20-0124

Location: University of Colorado Hospital

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A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Study B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents ?12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015).

Protocol #: 19-2839

Location: University of Colorado Hospital

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A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients with Polyneuropathy of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with a V122I or T60A Mutation

Protocol #: 19-3061

Location: University of Colorado Hospital

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A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer

Protocol #: 20-0036

Location: University of Colorado Hospital

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An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Protocol #: 20-0035

Location: University of Colorado Hospital

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Phase Ib/II trial of copanlisib in combination with trastuzumab and pertuzumab after induction treatment of HER2 positive (HER2+ ) metastatic breast cancer (MBC) with PIK3CA mutation or PTEN mutation.

Protocol #: 19-2988

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Tissue Bank and Clinical Database for the Analysis of arterial thrombosis

Protocol #: 19-2998

Location: University of Colorado Hospital

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First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors

Protocol #: 19-3118

Location: University of Colorado Hospital

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NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Protocol #: 19-2514

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

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North American Pediatric Renal Trials Collaborative Studies (NAPRTCS)

Protocol #: 19-3007

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 Orthopaedic 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 that is configured with a load cell (i.e. digital scale). The patients will gradually shift their weight from the non-affected limb to the affected limb while a low energy and low frequency electromagnetic field is applied via the antenna. They will repeat the shifting of their weight 5 times to assure robust and repeatable data collection. The device will not be used to guide medical treatments and the effectiveness of the device will be measured against the current gold standard/standard of care for assessing fracture healing.

1.1 To translate our direct electromagnetic coupling (DEC) approach to the clinical milieu via rigorous development and investigation of the technology using multiple testing platforms. 1.2 Firmly establish the physical foundation of the DEC approach and optimize the system s hardware configuration for predicting the course of fracture healing. 1.3 Perform two large animal studies using the DEC approach in order to evaluate its efficacy for predicting the course of fracture healing 1.4 Perform a series of non-invasive patient studies that longitudinally follow specific fracture pattern cohorts in order to evaluate the DEC approach in a clinical setting. 1.5 Develop a telemedicine system wherein the DEC data can be collected by the patient and transmitted for analyses.

Protocol #: 19-3107

Location: Medical Center of the Rockies

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A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (TRANSCEND FL)

Protocol #: 19-3011

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults

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

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

Protocol #: 19-2323

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

Protocol #: 19-2999

Location: University of Colorado Hospital

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Biomarker Development in LGMD 2i

Protocol #: 19-2943

Location: University of Colorado Hospital

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mHealth Development for Apathy among Patients with Mild Cognitive Impairment and their Care Partners

Protocol #: 19-3075

Location: University of Colorado Hospital

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

Protocol #: 19-2758

Location: University of Colorado Hospital

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A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease

Protocol #: 19-2833

Locations: Memorial Hospital Central; University of Colorado Hospital

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An Open-Label, Multicenter, Phase 1B Study of RP1 in Organ Transplant Recipients with Advanced Cutaneous Squamous Cell Carcinoma

Protocol #: 19-2987

Location: University of Colorado Hospital

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North American Mitrochondrial Disease Consortium Patient Registry and Biorepository

Protocol #: 13-2246

Location: Childrens Hospital Colorado

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ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Protocol #: 19-2163

Location: Childrens Hospital Colorado

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Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes

Protocol #: 19-2760

Location: University of Colorado Hospital

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Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balance

Protocol #: 19-2960

Location: University of Colorado Hospital

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An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas

Protocol #: 19-6517

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

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A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Protocol #: 19-2897

Location: University of Colorado Hospital

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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES (REALIZE TRIAL)

Protocol #: 19-2898

Location: University of Colorado Hospital

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Development and Content Validation of Instruments to Screen for and Assess Severity of Tinnitus in Young People

Protocol #: 19-2940

Location: Childrens Hospital Colorado

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

Protocol #: 19-2893

Location: Steadman Hawkins Clinic - Denver

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S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

Protocol #: 19-2950

Location: Childrens Hospital Colorado

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

Protocol #: 19-2838

Location: Steadman Hawkins Clinic - Denver

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A PHASE 1/2 STUDY OF TPX-0046, A NOVEL ORAL RET/SRC INHIBITOR IN ADULT SUBJECTS WITH ADVANCED/METASTATIC SOLID TUMORS HARBORING ONCOGENIC RET FUSIONS OR MUTATIONS

Protocol #: 19-2888

Location: University of Colorado Hospital

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A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.

Protocol #: 19-2935

Location: University of Colorado Hospital

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

Protocol #: 19-2910

Locations: Barbara Davis Center; University of Colorado Hospital

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A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished.

Protocol #: 19-2904

Locations: Renal Research Center; University of Colorado Hospital

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

Protocol #: 19-2797

Location: University of Colorado Hospital

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A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer

Protocol #: 19-2818

Location: University of Colorado Hospital

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A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

Protocol #: 19-2761

Location: University of Colorado Hospital

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A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).

Protocol #: 19-2721

Location: University of Colorado Hospital

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LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor

Protocol #: 19-2795

Location: University of Colorado Hospital

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A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.

Protocol #: 19-2854

Location: University of Colorado Hospital

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Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Protocol #: 19-2645

Location: University of Colorado Hospital

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A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)

Protocol #: 19-2788

Location: University of Colorado Hospital

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A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.

Protocol #: 19-2824

Location: University of Colorado Hospital

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A Phase I study to evaluate the pharmacokinetic and pharmacodynamic profile of intramuscular or subcutaneous injections of levonorgestrel butanoate (LB) for female contraception

Your participation in the study would include up to 36 clinic visits over a 9-month period. During your time in the study, you will have physical exams, pelvic exams, breast exams, vital sign assessments, blood tests, pregnancy tests, and possibly a PAP smear. You will also have transvaginal ultrasounds of your ovaries to determine if you are at risk for pregnancy during the study. In addition, you will also be asked about your complete medical history, including your gynecological, menstrual, reproductive and sexual history.

This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception.

Protocol #: 19-2820

Location: Comprehensive Women's Health Center

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Lipoic acid for Treatment of Progressive Multiple Sclerosis

Protocol #: 19-2525

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE

Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the study finishes.

Protocol #: 19-2782

Locations: Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital

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EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC

Protocol #: 19-2554

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

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Feasibility and Acceptability of Morning Versus Evening Exercise for Adults with Overweight and Obesity: A Randomized Pilot Study

Protocol #: 19-2676

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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Single Patient IND for Binimetinib, IND# 146690, Patient BLG

Protocol #: 19-2744

Location: Childrens Hospital Colorado

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A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study

Protocol #: 19-0795

Location: University of Colorado Hospital

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Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson's Disease

Protocol #: 19-2471

Location: University of Colorado Hospital

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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

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

Protocol #: 19-6129

Locations: Harmony Campus; Medical Center of the Rockies

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A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

Protocol #: 19-2640

Location: Rocky Mountain Regional VA Medical Center

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Protocol #: 19-2707

Location: University of Colorado Hospital

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A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors- ARTISTRY-1

Protocol #: 19-2532

Location: University of Colorado Hospital

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A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Protocol #: 19-2564

Location: University of Colorado Hospital

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A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Protocol #: 19-2377

Location: University of Colorado Hospital

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

Protocol #: 19-2631

Location: Childrens Hospital Colorado

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Microfluidic models of bleeding and thrombosis

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

Protocol #: 19-2408

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

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An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Protocol #: 19-2378

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Protocol #: 19-2333

Location: Childrens Hospital Colorado

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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

To determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form subjects with Primary Myelofibrosis, post-Polycythemia Vera myelofibrosis , or Post Essential Thrombocythemia Myelofibrosis who were previously treated with approved JAK inhibitor therapy.

Protocol #: 19-2520

Location: University of Colorado Hospital

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An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

Protocol #: 19-2445

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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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 injection (i.e. steroid injection).

Protocol #: 19-2499

Locations: Boulder Sports Clinic; CU Sports Medicine - Denver; University of Colorado Hospital

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

Protocol #: 19-2521

Location: University of Colorado Hospital

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

Protocol #: 19-2524

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

Protocol #: 19-2533

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 19-1896

Location: Childrens Hospital Colorado

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A PHASE 1/2, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY STUDY OF REPOTRECTINIB IN PEDIATRIC AND YOUNG ADULT SUBJECTS WITH ADVANCED OR METASTATIC MALIGNANCIES HARBORING ALK, ROS1, OR NTRK1-3 ALTERATIONS

Protocol #: 19-2438

Location: Childrens Hospital Colorado

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

Protocol #: 19-2475

Location: Childrens Hospital Colorado

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A MULTICENTER, LONGITUDINAL, OPEN-LABEL, SINGLE-ARM STUDY DESCRIBING COGNITIVE PROCESSING SPEED CHANGES IN RELAPSING MULTIPLE SCLEROSIS SUBJECTS TREATED WITH OZANIMOD (RPC-1063)

Protocol #: 19-2420

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A Phase I/II, Open-Label, Multicenter Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation

Protocol #: 19-2390

Location: University of Colorado Hospital

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Effects of prenatal antibiotics on the infant gut microbiome

Three different bacteria of the infant gut microbiome will be obtained through collection of infant stool samples at birth and at 6 weeks of age. These bacteria will be measured and comparisons made between infants whose mothers took antibiotics during pregnancy and infants whose mothers did not take antibiotics during pregnancy. Pregnant women will be recruited between their 35-37th weeks of pregnancy and will complete two surveys, the first prenatally and the second at 6-weeks postpartum.

Protocol #: 19-2288

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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A Phase I study of Anetumab Ravtansine in Combination with either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

Protocol #: 19-0821

Location: University of Colorado Hospital

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Adenosinergic immune suppression pathway in glioblastoma multiforme tumors

Protocol #: 19-2344

Location: University of Colorado Hospital

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A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A 0201-positive Patients with Advanced MAGE-A4-positive Cancer

Protocol #: 19-2311

Location: University of Colorado Hospital

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A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

Protocol #: 19-1929

Location: University of Colorado Hospital

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A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)

This study assesses whether Lungpacer therapy plus usual medical care can safely improve the chances of patients on a breathing machine to regain the ability to breathe on their own as compared to usual medical care alone.

Protocol #: 19-2401

Location: University of Colorado Hospital

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A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Protocol #: 19-2363

Location: University of Colorado Hospital

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An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial

Protocol #: 19-1598

Location: University of Colorado Hospital

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CLadribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System BiomarKers in Multiple Sclerosis (CLOCK-MS)

Protocol #: 19-1980

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)

CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year.

Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation.

Protocol #: 19-2362

Locations: Pathology - SOM; University of Colorado Hospital

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A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenic Mechanisms

Protocol #: 19-2357

Location: Childrens Hospital Colorado

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

Protocol #: 19-2038

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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Perceived Palliative Care Needs in Early-Onset Dementia

Protocol #: 19-2134

Locations: UCHealth Central Park Medical Center; University of Colorado Hospital

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A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with Azacitidine in Patients with Recurrent, Resectable Osteosarcoma

Protocol #: 19-2295

Location: Childrens Hospital Colorado

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A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONS

Protocol #: 19-2255

Location: University of Colorado Hospital

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A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS

Protocol #: 19-2242

Location: University of Colorado Hospital

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A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]

Protocol #: 19-1913

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

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

Protocol #: 19-1613

Location: Childrens Hospital Colorado

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A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients with Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) that are Causing Significant Morbidity

Protocol #: 19-2270

Location: Childrens Hospital Colorado

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RADIANT:Rare and Atypical Diabetes Network

Protocol #: 19-2285

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

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A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)

Protocol #: 19-6114

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

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Improving Renal Outcomes Collaborative

Protocol #: 16-2190

Location: Childrens Hospital Colorado

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

Protocol #: 19-1985

Location: University of Colorado Hospital

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A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency

Protocol #: 16-0927

Location: Childrens Hospital Colorado

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Prospective Analysis of Gait Following Hemispherectomy

Protocol #: 17-0230

Location: Childrens Hospital Colorado

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Gait Analysis of Femoroacetabular Impingement Patients

i. To compare differences in muscle recruitment, gait patterns (kinematics & kinetics), spaciotemporal variables, functional movements (squats, lunges, sit-to-stand, and single leg steps), and pelvic tilt between patients with femoroacetabular impingement (FAI) and age-matched morphologically normal controls. ii. To compare differences in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt between symptomatic and asymptomatic patients with FAI morphology. iii. To compare changes in muscle recruitment, gait patterns, spaciotemporal variables, functional movements, and pelvic tilt pre- and post-intra-articular hip injection in symptomatic FAI patients. iv. To test if anatomical variables (alpha angle, center edge angle, FAI version) are predictors of change in gait and movement patterns.

Protocol #: 16-1934

Location: Childrens Hospital Colorado

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International Fetal Cardiac Intervention Registry

Protocol #: 14-0343

Location: Childrens Hospital Colorado

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

Protocol #: 14-1413

Location: Childrens Hospital Colorado

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NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #: 18-1076

Location: Childrens Hospital Colorado

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

Protocol #: 19-1621

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME

Aim 1: Primary outcome measures include lung function measurements from oscillometry and spirometry, change in oscillometry and spirometry measurements after bronchodilator is given, and results from a Six-Minute Walk test. Aim 2: Primary outcome measures are absolute neutrophil count and C-reactive protein in blood. Secondary outcomes to identify an atopic asthma phenotype include eosinophil count, total IgE, allergen specific IgE, and fractional exhaled nitric oxide. Assessment for nicotine exposure via blood cotinine is additional secondary outcome. Aim 3: Primary outcomes are respiratory symptom and quality of life assessments obtained by questionnaires.

Protocol #: 19-2092

Location: Childrens Hospital Colorado

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease

Protocol #: 19-1840

Location: University of Colorado Hospital

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Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Protocol #: 17-0464

Location: Childrens Hospital Colorado

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S1803: PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY)

Protocol #: 19-1589

Location: Rocky Mountain Regional VA Medical Center

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S1815: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE, CISPLATIN, AND NAB-PACLITAXEL VERSUS GEMCITABINE AND CISPLATIN IN NEWLY DIAGNOSED, ADVANCED BILIARY TRACT CANCERS

Protocol #: 19-1588

Location: Rocky Mountain Regional VA Medical Center

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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) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.

To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.

Protocol #: 19-1978

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer

Protocol #: 19-1977

Location: University of Colorado Hospital

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

Protocol #: 19-1809

Location: University of Colorado Hospital

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A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

Protocol #: 15-1434

Location: Childrens Hospital Colorado

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The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors

Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compensation and instruction on resistance exercise.

Protocol #: 19-1974

Location: University of Colorado Hospital

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An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts

Protocol #: 16-0145

Location: Childrens Hospital Colorado

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Neurological Screening of Controls in an Age-Related Macular Degeneration Registry

Protocol #: 19-1925

Location: University of Colorado Hospital

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Impact of Novel Therapeutic Music Delivery Device on Drug Use and Recovery in Surgical Patients

Protocol #: 19-6100

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

Protocol #: 19-1839

Location: Childrens Hospital Colorado

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COG AHOD1822 / Merck MK-3475-667: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)

Protocol #: 19-1481

Location: Childrens Hospital Colorado

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The Impact of Pediatric Skin Disorders: The "Big" Study

Protocol #: 18-1380

Location: Childrens Hospital Colorado

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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 patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses.

Protocol #: 19-1874

Location: University of Colorado Hospital

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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

Protocol #: 19-6513

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

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Individual Patient Program for Patients with BRAF V600E/K mutation-positive Metastatic Melanoma and Other Indications with Clinical Evidence of Potential Treatment Efficacy Treatment with Trametinib and Bevacizumab

Protocol #: 19-2412

Location: Childrens Hospital Colorado

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ACNS1721 - A Phase 2 Study of Veliparib (ABT-888, IND #139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations

Protocol #: 19-1633

Location: Childrens Hospital Colorado

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A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab in HLA-A 02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Protocol #: 19-1727

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CheckMate 76K)

Protocol #: 19-1581

Location: University of Colorado Hospital

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INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

Protocol #: 02-729

Location: Department Specific Free Standing Clinic

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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

Protocol #: 19-1597

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 tricuspid valve surgery.

Protocol #: 19-1823

Location: University of Colorado Hospital

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Rare CFTR Mutation Cell Collection Protocol (RARE)

This is a non-interventional, multi-site, specimen collection study for CF patients who have rare CFTR mutations. Once a potentially eligible subject is identified (either self-identified or by their CF care center), and the subject has expressed interest in participating in the study, the subject will be referred to a participating study site to receive additional information about the study and about travel arrangements (if needed). Nasal epithelial cells and blood (to confirm genotype) will be collected from all subjects; additional blood samples and rectal biopsy samples will be optional. The study consists of a single visit, however it is anticipated that many subjects will need to travel so study participation time is estimated at 2 days.

Protocol #: 16-2412

Location: Childrens Hospital Colorado

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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination with Bevacizumab Compared to Bevacizumab with 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX wit Bevacizumab (LYNK-003)

Protocol #: 19-6102

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

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Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes

Protocol #: 19-6101

Locations: Harmony Campus; Medical Center of the Rockies

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AN OBSERVATIONAL STUDY OF OCRELIZUMAB TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY)

Protocol #: 19-1600

Location: University of Colorado Hospital

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A DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED TRIAL TO STUDY THE VIASKIN MILK EFFICACY AND SAFETY FOR TREATING IgE-MEDIATED COW?S MILK ALLERGY IN CHILDREN (MILES STUDY)

Protocol #: 15-0140

Location: Childrens Hospital Colorado

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Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease

Protocol #: 19-1787

Location: Childrens Hospital Colorado

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The National Myelodysplastic Syndromes (MDS) Study

Protocol #: 19-1696

Location: Rocky Mountain Regional VA Medical Center

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Alliance A081105: Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Protocol #: 19-1697

Location: Rocky Mountain Regional VA Medical Center

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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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Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.

Protocol #: 19-1679

Location: University of Colorado Hospital

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COG AREN1721 - A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Protocol #: 19-1467

Location: Childrens Hospital Colorado

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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins.

Protocol #: 19-6511

Location: Memorial Hospital Central

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Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects with A+AVD."

Protocol #: 19-6510

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

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ECG Belt for CRT Response

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Protocol #: 19-1703

Location: University of Colorado Hospital

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A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma

Protocol #: 19-1503

Location: University of Colorado Hospital

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A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder

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 identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.

The overarching hypothesis of this proposal is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking Alcohol Use Disorder individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, we will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking.

Protocol #: 19-1658

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

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy

Protocol #: 19-1620

Location: 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 receive tofacitinib. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis. Participants must attend eight study visits at the University of Colorado Anschutz Medical Campus during the 18-week trial and have a study partner available to attend the visits with them. A blood draw for safety monitoring is required at each visit. Participants will be given tofacitinib at no cost for the duration of the study.

Protocol #: 19-1362

Location: University of Colorado Hospital

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Body Composition in Infants with Klinefelter Syndrome and Effects of Testosterone Treatment

Protocol #: 14-1720

Location: Childrens Hospital Colorado

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TRAVERSE

Protocol #: 19-1644

Location: University of Colorado Hospital

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Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD

Protocol #: 15-0902

Locations: Childrens Hospital Colorado; Colorado Research Center

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A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling

Protocol #: 19-1566

Location: University of Colorado Hospital

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APOL1 Long-term Kidney Transplantation Outcomes Network

APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a prospective manner. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African.

To test kidney donors and transplant recipients for forms of the APOL1 gene for purposes of evaluating how the various forms may impact both donors and recipients. To determine whether the presence of APOL1 RRVs in a kidney donor shortens death-censored renal allograft survival. Secondary Objectives: 1. Define whether the presence of APOL1 RRVs in a kidney donor is associated with worse renal function or greater proteinuria after transplantation of the kidney; 2. Define whether the presence of APOL1 RRVs is associated with worse renal outcomes in living kidney donors after nephrectomy, and; 3. (if donor APOL1 RRVs are associated with worse kidney function in recipients of renal allografts) identify modifying factors that increase susceptibility for shortened allograft survival, reduced renal allograft function or greater proteinuria in recipients of kidneys from donors with APOL1 high-risk genotypes. Modifying factors may include cause of death in the deceased donor, ischemia time, type of immunosuppression, graft rejection, viral infection, post-engraftment renal dysfunction, etc.

Protocol #: 19-0461

Location: University of Colorado Hospital

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AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS

Protocol #: 19-1461

Location: University of Colorado Hospital

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GRASP-LGMD RESEARCH PROTOCOL; Project 1a Defining Clinical Endpoints in LGMD

Protocol #: 19-0506

Location: University of Colorado Hospital

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A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Protocol #: 19-1458

Location: University of Colorado Hospital

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A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Protocol #: 19-1455

Location: University of Colorado Hospital

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Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer

Protocol #: 19-6509

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

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Regression in Down Syndrome

Protocol #: 19-1418

Location: Childrens Hospital Colorado

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A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.

Protocol #: 19-1337

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Allen CU-UCSD Transition to RA Project: Blood and Flu

Protocol #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

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Ublituximab as initial therapy for treatment-naive follicular or marginal zone lymphoma with response-driven addition of umbralisib for suboptimal response.

Protocol #: 18-2128

Location: University of Colorado Hospital

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Apoyo con Cari?o (Support through Caring): Improving Palliative Care Outcomes for Latinos with Advanced Medical Illness V: 03/20/19

Protocol #: 16-1270

Locations: Denver Health Medical Center; University of Colorado Hospital

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Sex effects on the neurobiology of eating behaviors in Veterans with overweight/obesity

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

Protocol #: 19-0940

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

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A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects with Congenital Adrenal Hyperplasia

Protocol #: 19-1230

Location: Childrens Hospital Colorado

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CROCODILE Study: Control of Renal Oxygenation, COnsumption, mitochondrial Dysfunction, and InsuLin rEsistance

Protocol #: 19-1282

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1)

Protocol #: 19-1342

Location: University of Colorado Hospital

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A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors

Protocol #: 19-1302

Location: University of Colorado Hospital

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ImTAB Immunity, mTBI, and Alzheimer's Biomarkers

You may qualify if you are: - 65 years or older - Have had a concussion within the past 5 years - Saw a doctor within 1 week of your concussion - Have not been diagnosed with a memory disorder Participants will receive: -Snacks and refreshments -Medical screening (neurological exam) -Optional review of memory scores with principal investigator after completion of 1 year follow up visit

Have You Had a Concussion in the Past 5 Years? Research Study Investigates Concussions and Brain Health in Older Adults 65+ Research Goals: 1)Investigate how a recent concussion relates to brain structure and memory over time 2)Collect and analyze fluid biomarkers for the detection of inflammation and Alzheimer’s disease-related risk factors 3)Examine the relationship between concussion, the immune system, and the aging process

Protocol #: 19-1423

Location: University of Colorado Hospital

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A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses.

Protocol #: 19-1403

Location: Childrens Hospital Colorado

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A Study of the Pipeline Flex Embolization DeVice with Shield Technology for EndovAscular TreatmeNt of Wide-NeCked Intracranial AnEurysms

Protocol #: 19-1399

Location: University of Colorado Hospital

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Using point of care ultrasound to measure perioperative edema in infants with congenital heart disease

Protocol #: 19-1387

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GCAR-7213)

Protocol #: 19-0744

Location: University of Colorado Hospital

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Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults after Bariatric Surgery: A Randomized Controlled Pilot Study

Protocol #: 18-2793

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Feasibility of the Multiple Sclerosis Performance Test for assessment of functional performance measures in patients with Multiple Sclerosis

Protocol #: 19-1192

Location: University of Colorado Hospital

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reST Registry

remede System Therapy in patients with central sleep apnea

Protocol #: 19-6087

Locations: Harmony Campus; Medical Center of the Rockies

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ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Protocol #: 19-1259

Location: Childrens Hospital Colorado

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Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.

Protocol #: 19-6506

Location: Memorial Hospital Central

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Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCC

Protocol #: 19-1081

Locations: Lone Tree Medical Center; University of Colorado Hospital

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NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Protocol #: 19-1152

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

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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

Locations: 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 Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Protocol #: 19-1132

Locations: Lone Tree Medical Center; University of Colorado Hospital

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An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 in Patients with Locally Advanced or Metastatic Solid Tumors

Protocol #: 19-1145

Location: University of Colorado Hospital

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Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Protocol #: 16-2408

Location: Childrens Hospital Colorado

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Multi-Institutional Validation of Trauma Specific Frailty Index

To test the predictive ability of the Trauma Sepcific Frailty Index.

Protocol #: 19-6084

Location: Medical Center of the Rockies

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A Phase I/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Protocol #: 19-1277

Location: Childrens Hospital Colorado

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SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer

Protocol #: 19-6076

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

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The Laboratory for Advanced Medicine (LAM) / Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples (CLiMB)

Protocol #: 19-1272

Location: University of Colorado Hospital

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Neurophysiological Correlates V: 31Jan18

Protocol #: 16-1480

Location: Childrens Hospital Colorado

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Natural History of Rett Syndrome and Related Disorders

Protocol #: 15-2332

Location: Childrens Hospital Colorado

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Gamma band neural stimulation and its effects on resting state networks

Protocol #: 19-1251

Locations: Brain Imaging Center (BIC); Department Specific Free Standing Clinic

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NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK PROTOCOL

Protocol #: 19-1146

Locations: Memorial Hospital Central; Memorial Hospital North; 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

Locations: Brain Imaging Center (BIC); Childrens Hospital Colorado; Colorado Research Center; University of Colorado Hospital

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Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia V: 5; March 20, 2018

Protocol #: 16-1998

Location: Childrens Hospital Colorado

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The contributions of age related changes in the sound localization pathway to central hearing loss

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

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

Protocol #: 19-1213

Location: Department Specific Free Standing Clinic

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction

Protocol #: 19-0675

Location: University of Colorado Hospital

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A Multi-center, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease (PD)

Protocol #: 19-0865

Location: University of Colorado Hospital

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The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents with and without Obesity

Protocol #: 19-1171

Location: University of Colorado Hospital

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PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Researchers at the University of Colorado Anschutz Medical Campus are conducting a research study using investigational topical stem cells in the treatment of Diabetic Foot Ulcers (DFU).

Protocol #: 19-1113

Location: University of Colorado Hospital

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An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using AGEN1884 and AGEN2034 for Advanced or Metastatic Soft Tissue Sarcomas

Protocol #: 19-0554

Location: University of Colorado Hospital

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Prognostic significance of variants in the CTNNB1 gene and the B-catenin pathway in recurrent high-intermediate risk endometrial cancer

Protocol #: 19-1199

Location: University of Colorado Hospital

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A Phase 1/2, Open Label, Dose-Escalation Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors

Protocol #: 19-1118

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

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A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SUBCUTANEOUS OCRELIZUMAB ADMINISTRATION IN PATIENTS WITH MULTIPLE SCLEROSIS

Protocol #: 19-1040

Location: University of Colorado Hospital

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A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab in Patients with Advanced Solid Tumors

Protocol #: 19-1074

Location: University of Colorado Hospital

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A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).A screening trial for A081105, E4512 and EA5142

Protocol #: 18-2625

Location: Rocky Mountain Regional VA Medical Center

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A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)

Protocol #: 19-1147

Location: University of Colorado Hospital

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A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors

Protocol #: 19-1069

Location: University of Colorado Hospital

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A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS

This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimmune responses. Subjects will be administered clazakizumab at a target dose of 12.5 mg (or placebo) by SC injection, Q4W for up to 260 weeks (or until allograft loss or death).

Primary Objectives: 1. To evaluate the efficacy of clazakizumab in preventing all-cause composite allograft loss due to CABMR (defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause (including death with functioning allograft). 2. To evaluate the efficacy of clazakizumab in slowing/preventing the progressive loss of kidney function (as measured by eGFR using the MDRD4 equation). 3. To evaluate the safety of clazakizumab. Secondary Objectives: 1. To evaluate the effects of clazakizumab on death-censored allograft loss (defined as return to dialysis, allograft nephrectomy, re-transplantation or eGFR <15 mL/min/1.73 m2 but excluding death from any cause). 2. To evaluate the effects of clazakizumab on albuminuria. 3. To evaluate the effects of clazakizumab on DSA titers and mean fluorescence intensity (MFI) scores. 4. To evaluate the effects of clazakizumab on incidence of acute rejection episodes (TCMR and ABMR). 5. To evaluate the effects of clazakizumab on the histology of kidney biopsies according to the Banff 2015 lesion grading scores. 6. To evaluate the effects of clazakizumab on overall patient survival. 7. To evaluate the effects of clazakizumab on healthcare utilization due to ABMR and patient reported outcomes, including health-related quality of life (HRQoL).

Protocol #: 19-0460

Locations: Pathology - SOM; University of Colorado Hospital

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Sex-based differences in the neuronal mechanisms of food intake behavior

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

Protocol #: 19-1148

Location: University of Colorado Hospital

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TOPP-2 registry Tacking Outcomes and Practice in Pediatric Pulmonary Hypertension V: 27 July 2018

Protocol #: 15-0693

Location: Childrens Hospital Colorado

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Cardiopulmonary and Right Ventricular Function in Health and Disease

The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.

Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system.

Protocol #: 19-1141

Location: University of Colorado Hospital

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LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

The objectives of this study are as follows: - To assess the risk of delayed adverse events (AEs) following exposure to genemodified (GM) T cells -To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate. -To monitor for generation of replication competent retroviruses (RCR) -To assess long-term efficacy following treatment with GM T cells - Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment -To assess long term health-related quality of life following treatment with GM T cells

Protocol #: 19-0561

Location: University of Colorado Hospital

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A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)

Protocol #: 19-0967

Location: University of Colorado Hospital

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A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Protocol #: 19-0604

Location: University of Colorado Hospital

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A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer

Protocol #: 19-6065

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

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A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma

Protocol #: 19-0642

Location: 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

Locations: Dental Clinic; UCD Dental Clinic

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Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Protocol #: 18-0220

Location: University of Colorado Hospital

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A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Protocol #: 19-0905

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Patient and caregiver perspectives in bladder cancer diagnosis and treatment

Protocol #: 19-0987

Location: University of Colorado Hospital

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Understanding the Barriers to Epilepsy Surgery: A North American Survey

Protocol #: 19-0269

Location: University of Colorado Hospital

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A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVD

Protocol #: 19-6060

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

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Outcomes and Prognostic Factors of Patients with Newly Diagnosed Burkitt Lymphoma (HRP-503c)

Protocol #: 19-0900

Location: University of Colorado Hospital

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Ablation versus Stereotactic Body Radiotherapy for Early Stage Hepatocellular Carcinoma Not Amenable to Surgical Treatment

Protocol #: 19-0852

Location: University of Colorado Hospital

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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

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

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Outcomes after Standardized Testicular Torsion Management and Follow-up

Protocol #: 19-0849

Location: Childrens Hospital Colorado

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naive Adult Patients With Generalized Myasthenia Gravis

Protocol #: 19-0772

Location: University of Colorado Hospital

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An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Protocol #: 19-0150

Location: University of Colorado Hospital

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Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic Sclerosis

Protocol #: 19-0814

Location: Childrens Hospital Colorado

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A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579

Protocol #: 19-0858

Location: Childrens Hospital Colorado

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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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Solid foods and infant growth

This is a 6 month long study with visits occurring once every month. The first and last visit will be conducted at Children's Hospital Colorado and the other 5 visits will be home visits. Compensation will be provided.

The researchers want to learn how consuming different types of solid foods during early complementary feeding affects growth, neurodevelopment, sleep, and the bacteria in the gut. If you have a breastfed infant younger than 6 months, you may be eligible to participate.

Protocol #: 19-0546

Location: Childrens Hospital Colorado

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Fontan at Altitude Registry (FAR) V: 6-11-14

Protocol #: 14-1072

Location: Childrens Hospital Colorado

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A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors

Protocol #: 19-0556

Locations: Lone Tree Medical Center; University of Colorado Hospital

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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.

Protocol #: 19-0632

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

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Prognostic factors associated with outcomes in colorectal cancer liver metastases

Protocol #: 19-0770

Location: University of Colorado Hospital

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CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY

Protocol #: 19-0519

Location: University of Colorado Hospital

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A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Protocol #: 19-0520

Location: University of Colorado Hospital

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A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Protocol #: 19-0507

Location: University of Colorado Hospital

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The Perelman Study of IntraUterine Growth Restriction

Protocol #: 14-1360

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and, harmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from 1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction

Protocol #: 16-0994

Location: Childrens Hospital Colorado

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A Comprehensive and Collaborative Review of the Use of Whole Blood at Trauma Centers in the United States

Compare Whole Blood vs Component Therapy

Protocol #: 19-6047

Locations: Medical Center of the Rockies; Poudre Valley 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 cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

The Lung PCA BU goals include enrollment of informative retrospective and prospective patients from which informative biospecimens can be collected and processed for advanced analyses of PMLs. Central to this process will be the development of techniques to optimize data production from limited tissues. The generation of a deep and interactive database will be critical to help direct the studies undertaken by the project. Visual maps will serve as the key information hubs and the development of these maps along with the functionality for them to be linked with extensive clinical databases and well annotated metadata will be a major endpoint for the project.

Protocol #: 19-0400

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

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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

The purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, and get a DXA scan.

Protocol #: 19-0422

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Evaluation and Demonstration of Investigational MRI Software and Hardware

Test new MRI scanner sequences in diverse patient population

Protocol #: 19-0518

Location: Childrens Hospital Colorado

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Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer

Protocol #: 19-0457

Location: University of Colorado Hospital

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A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established Type 1 Diabetes Mellitus

Protocol #: 19-0606

Location: Barbara Davis Center

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Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Protocol #: 18-2594

Location: University of Colorado Hospital

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Instrumentation of Huntington's Disease Motor Function Assessment

Protocol #: 19-0212

Location: University of Colorado Hospital

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A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

Protocol #: 19-0414

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D)

Protocol #: 19-0489

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

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A Multi-Center, Open-Label, phase I/Ib, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors

Protocol #: 19-0539

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

A double blind comparison of enzalutamide plus pembrolizumab or placebo in patients with metastatic prostate cancer.

Protocol #: 19-0493

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)

A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer.

Protocol #: 19-0473

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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Phase I trial of ribociclib in combination with everolimus and dexamethasone in children and young adults with relapsed acute lymphoblastic leukemia (DF/HCC Protocol#: 18-328)

Protocol #: 19-0551

Location: Childrens Hospital Colorado

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AINV18P1: A Phase I Study of Palbociclib (IND# 141416), a CDK4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Protocol #: 19-0549

Location: Childrens Hospital Colorado

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A phase II study to evaluate neoadjuvant osimertinib therapy in patients with surgically resectable, EGFRmutant non-small cell lung cancer

Protocol #: 19-0325

Locations: Lone Tree 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

Locations: 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 Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

Protocol #: 19-0423

Location: University of Colorado Hospital

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ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (FA) (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. We hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics. This study will consist of 24 weeks (12 weeks placebo treatment and 12 weeks of CXA-10 treatment) in a randomized crossover fashion. There will be an approximate 4 week washout period.

Primary aim includes: To determine the efficacy of CXA-10 in reducing bronchial responsiveness, determined by the change in methacholine dose necessary to achieve a 20% reduction in FEV1 from baseline (PC20) Secondary aims include: - To investigate the effect of CXA-10 on differential gene expression in fresh airway epithelial cells Exploratory aims include: - To explore the efficacy of CXA-10 in improving lung function measured by FEV1, FEV1/FVC ratio and FEV1 % reversal and exhaled nitric oxide (FeNO) concentrations - To explore the efficacy of CXA-10 in improving asthma control using the Asthma Control Questionnaire (ACQ) - To explore the effect of CXA-10 on adipokine/cytokines plasma concentrations Safety aims include: - To assess the safety of 12 weeks of treatment with 150mg/day of orally administered CXA-10 in adult obese asthmatic subjects

Protocol #: 19-0510

Locations: University of Colorado Hospital; University of Pittsburgh Cancer Institute

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AMPLATZERTM PFO Occluder Post Approval Study

This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting

To demonstrate safety of the AMPLATZERTM PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death and the effective by assessing the rate of recurrent ischemic stroke through 5 years

Protocol #: 19-6502

Location: Memorial Hospital Central

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A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS

Protocol #: 18-2798

Location: University of Colorado Hospital

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Detection and Risk in Early MS

Protocol #: 19-0393

Locations: Brain Imaging Center (BIC); University of Colorado Hospital

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Zolmitriptan Nasal Spray for the Treatment of Acute Migraine in Subjects Ages 6 to 11 years, With an Open-Label Extension

Protocol #: 18-1695

Location: Childrens Hospital Colorado

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A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA

Protocol #: 19-0172

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis

Protocol #: 19-0444

Location: University of Colorado Hospital

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A Phase 1, open label, first-in-human study of TR1801-ADC, an antibody drug conjugate (ADC), in patients with select solid tumors expressing c-Met

Protocol #: 19-0232

Location: University of Colorado Hospital

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Total Joint Arthroplasty in a Pediatric Population

Involves two surveys for approximately 10 mintues

To explore the functional ability and quality of life in pediatric patients who undergo joint arthroplasty for non-solid tumor related reasons.

Protocol #: 19-0306

Location: Childrens Hospital Colorado

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Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study

Protocol #: 18-2444

Location: University of Colorado Hospital

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An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis

Protocol #: 19-0105

Location: Childrens Hospital Colorado

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Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer

Protocol #: 18-2742

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

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A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale

Protocol #: 19-0396

Location: Childrens Hospital Colorado

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A Natural History Study of CMT1B, CMT2A, CMT4A and CMT4C

Protocol #: 18-2537

Location: University of Colorado Hospital

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SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.

This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks.

Protocol #: 19-0347

Location: University of Colorado Hospital

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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

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

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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 you want to learn more about the study please contact Kristen Raymond at kristen.raymond@cuanschutz.edu.

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

Protocol #: 18-0853

Location: University of Colorado Hospital

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Impact of surgical intervention on sleep dysfunction in patients with refractory epilepsy

Protocol #: 19-0239

Location: University of Colorado Hospital

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PHASE 1 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE?) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS (Pfizer Protocol A5481092/ ADVL1921)

Protocol #: 19-0299

Location: Childrens Hospital Colorado

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A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER

Protocol #: 19-0206

Locations: Lone Tree Medical Center; University of Colorado Hospital

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A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma

Primary Objective: (1) Evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Secondary Objectives: (1) Describe the pharmacokinetics (PK) of losartan when given in combination with sunitinib in pediatric and young adult patients with relapsed or refractory osteosarcoma. (2) Describe the pharmacodynamic (PD) effects of losartan and sunitinib, specifically effects on monocyte migration, plasma CCL2 levels, and changes to the peripheral CCR2+ monocyte population, when given in combination in pediatric and adult patients with relapsed or refractory osteosarcoma. (3) Describe the preliminary antitumor activity of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Exploratory Objectives: (1) Describe changes to peripheral T cell populations including CD4+, CD8+, and regulatory T cells, which occurs with treatment of losartan and sunitinib. (2) Describe changes to peripheral immune-related cytokines/chemokines such as TGF-β, IFNγ and VEGF with treatment of losartan and sunitinib. (3) Characterize tumor-infiltrating leukocytes, micro-vessel density, and immune-related gene expression in resected pulmonary metastases of patients treated with losartan and sunitinib.

Protocol #: 18-2740

Locations: Childrens Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital

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An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors

Protocol #: 19-0207

Location: University of Colorado Hospital

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APOGEE

LVAD registry

Protocol #: 18-2576B

Location: University of Colorado Hospital

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GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Protocol #: 19-6030

Locations: Harmony Campus; Medical Center of the Rockies

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Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating Room

Protocol #: 18-2513

Location: Childrens Hospital Colorado

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A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCER

Protocol #: 19-0127

Location: University of Colorado Hospital

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Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Protocol #: 19-0049

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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Randomized, Open label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog? versus Continuous Use of NovoLog in Participants with Type 1 Diabetes Mellitus also Using Insulin Glargine

Protocol #: 19-0250

Locations: Barbara Davis Center; UCD Barbara Davis Center

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Caretaker Wireless Vital Sign Monitor Applied in the Field and Transitioned into the Emergency Department: A Quality Initiative Project to Determine the Efficacy of the Caretaker Device Compared to Standard Vital Sign Recordings

To test wireless vital sign monitor in the field and determine feasibility.

Protocol #: 18-6102

Location: Medical Center of the Rockies

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Surgery Database Project

Protocol #: 18-2839

Location: University of Colorado Hospital

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Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell)

Protocol #: 16-0692

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

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy

Protocol #: 19-0225

Location: University of Colorado Hospital

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A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderate to Severe Atopic Dermatitis (AD)

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Protocol #: 19-0144

Location: University of Colorado Hospital

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Gene Expression of Cerebral Aneurysms

In this study, we will collect tissue and blood from participants during their epilepsy surgery.

Protocol #: 19-0182

Location: University of Colorado Hospital

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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 doses of the study drug. During the 3 month study period there are every 2 week visits to evaluate blood pressure. Optional testing includes cerebral artery testing and cognitive testing before after daily doses of nicotinamide riboside.

Protocol #: 19-0149

Locations: Renal Research Center; University of Colorado Hospital

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DEEP LEARNING BASED FEATURE EXTRACTION ON PANCREAS X-RAY PROJECTION IMAGES

Protocol #: 19-0123

Location: University of Colorado Hospital

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Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult US population with type 2 diabetes - a randomized pragmatic clinical trial

Protocol #: 19-0120

Location: University of Colorado Hospital

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AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

A comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer

Protocol #: 19-0048

Location: University of Colorado Hospital

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A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia

A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD

Protocol #: 18-2881

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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How Does Inflammation Affect the Aging Brain? Research Study Investigates Aging, Memory, and Immune Function.

The University of Colorado Anschutz Medical Campus is looking for interested adults 60 and over to participate in a research study examining how inflammation influences brain health. Data gathered from this study will be used to better understand how inflammation may or may not disrupt thinking and memory. You may qualify if you are: - 60 years or older - In good general health - Have NOT been diagnosed with a memory disorder

Protocol #: 18-2607

Location: University of Colorado Hospital

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Moderating effects of sleep on quality of life and fatigue following an exercise program for cancer survivors

Protocol #: 19-0041

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

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An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome

Protocol #: 19-0079

Location: Childrens Hospital Colorado

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The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER

A double blind comparison of MPX versus placebo in men with prostate cancer.

Protocol #: 18-2604

Location: University of Colorado Hospital

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Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patients

Protocol #: 18-2874

Location: University of Colorado Hospital

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A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer

Protocol #: 18-6515

Location: Memorial Hospital Central

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A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions

Protocol #: 19-0011

Location: University of Colorado Hospital

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A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

Protocol #: 19-0027

Location: Barbara Davis Center

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Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI)

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.

Protocol #: 19-0003

Location: University of Colorado Hospital

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New Graduate Nurse Orientation Using a Staged, Task-Layered Strategy: Implications for Length of Orientation and Self-Reported Confidence

Protocol #: 18-6119

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps

OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis.

Protocol #: 18-2823

Location: University of Colorado Hospital

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A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)

Protocol #: 18-2654

Location: University of Colorado Hospital

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Association of depth recordings from the temporal cortex with sleep pattern detection and characterization of sleep dysfunction in patients with refractory epilepsy.

Protocol #: 18-2806

Location: University of Colorado Hospital

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A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors

Protocol #: 18-2520

Locations: Lone Tree Medical Center; University of Colorado Hospital

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CLINICAL TRIALS IN ORGAN TRANSPLANTATION CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation

This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy.

Primary Safety Objective: This study will evaluate the safety of polyTregs in adult kidney transplant recipients. Secondary Safety Objective: Participants receiving polyTregs will be evaluated for the safety of converting from CNI‐based maintenance therapy to mTOR inhibitors after Treg therapy. Primary Efficacy Objective: This study will evaluate whether polyclonally expanded Tregs (polyTregs) reduce graft inflammation relative to their enrollment biopsy compared to those receiving CNI‐based maintenance therapy with similar baseline biopsy findings. Secondary Efficacy Objective: This study will evaluate whether polyTregs can reduce graft inflammation by 25% or more in the 2 weeks after polyTreg infusion relative to the enrollment biopsy.

Protocol #: 18-2679

Location: University of Colorado Hospital

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PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY

Protocol #: 18-2569

Location: University of Colorado Hospital

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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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Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in left ventricular outflow tract arrhythmias ablation

Protocol #: 18-2772

Location: University of Colorado Hospital

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Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System

Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT).

Protocol #: 18-2765

Location: University of Colorado Hospital

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Identifying relevant seizure biomarkers from RNS? System recorded electrocorticography for the development of optimized seizure detection algorithms

Protocol #: 18-2089

Location: University of Colorado Hospital

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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Protocol #: 18-2529

Locations: Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

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IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age, Version 1.0

Protocol #: 18-2714

Location: Childrens Hospital Colorado

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An Exploratory Investigation of the Impact of the Assistive Technology Partners Product Testing Laboratory

Protocol #: 11-0674

Locations: Memorial Hospital Central; Memorial Hospital North

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A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

Protocol #: 18-2646

Location: University of Colorado Hospital

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Understanding Barriers to Enrollment in Clinical Trials at the University of Colorado Cancer Center

Protocol #: 18-2684

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

Locations: Cherry Creek Medical Center; Lone Tree Medical Center; University of Colorado Hospital

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A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease

About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years.

Protocol #: 18-6511

Location: Memorial Hospital Central

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GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.

Protocol #: 18-2672

Location: University of Colorado Hospital

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Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab

Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase

Protocol #: 18-2286

Location: Childrens Hospital Colorado

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Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018

This research study is investigating the roles of estrogen (female sex hormone) and FSH, or follicle-stimulating hormone, on cortisol (a stress hormone), fat gain, and disease risk.

Protocol #: 18-2483

Location: University of Colorado Hospital

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A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)

Protocol #: 18-2346

Location: University of Colorado Hospital

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CLASP IID/IIF

PASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation

Protocol #: 18-6126

Locations: Harmony Campus; Medical Center of the Rockies

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A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer.

Protocol #: 18-2404

Location: University of Colorado Hospital

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Destination Therapy Post Approval Study - Medtronic HVAD System

LVAD registry

Protocol #: 18-2576A

Location: University of Colorado Hospital

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A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors

Protocol #: 18-2417

Location: University of Colorado Hospital

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Predictors of physical activity maintenance in colorectal cancer survivors

Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions.

Protocol #: 18-2436

Locations: Anschutz Health and Wellness; Colorado State University; Harmony Campus; Poudre Valley Hospital; UCD Anschutz Health & Wellness Center

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Ultrarapid Culture Independent Identification and Antibiotic Suspectibility Testing of High-Priority Carbapenem Resistant Enterobacteriaceae Directly from Blood and Urine in Patients with Suspected Bacteremia V: 02 Feb 2017

Protocol #: 16-0086

Location: University of Colorado Hospital

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A Phase 3, randomized, double-blind, parallel group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.

Protocol #: 18-2534

Location: University of Colorado Hospital

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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age- and BMI-Matched Cisgender Adults

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

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

Protocol #: 18-2258

Locations: Anschutz Health and Wellness; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital

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A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.

Protocol #: 18-1223

Location: Childrens Hospital Colorado

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Evaluation of Sun Protection Education using the Reveal Imager Photo-aging and the SPA Questionnaire

Protocol #: 17-2424

Locations: University of Colorado Cancer Center; University of Colorado Hospital

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Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer

Protocol #: 18-2209

Location: University of Colorado Hospital

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Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only).

Protocol #: 18-2382

Location: University of Colorado Hospital

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PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations

This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dose escalation cohort is designed to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of savolitinib. Once the MTD/RP2D is determined, the enrollment for an efficacy expansion cohort will open for patients whose tumors harbor genetic MET activation as determined by CLIA tests performed at participating sites, and confirmed by FDA approved tests.

Protocol #: 18-2432

Location: Childrens Hospital Colorado

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Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naive

Protocol #: 18-2284

Location: University of Colorado Hospital

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A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)

Protocol #: 18-2198

Location: University of Colorado Hospital

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A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORS

Protocol #: 18-1816

Location: University of Colorado Hospital

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S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER

A comparison of standard systemic therapy versus standard systemic therapy plus surgery or radiation therpy

Protocol #: 18-2252

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

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A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)

Evaluate the safety and tolerability of FOR46 at escalating dose levels and administered intravenously (IV) every 21 days in relapsed/refractory multiple myeloma patients. And determine the maximum-tolerated dose and/or the recommended Phase 2 dose (RP2D) of FOR46 administered IV every 21 days in relapsed/refractory multiple myeloma patients.

Protocol #: 18-2354

Location: University of Colorado Hospital

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Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Protocol #: 18-2337

Location: Childrens Hospital Colorado

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Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)

Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery.

This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation.

Protocol #: 18-2012

Location: Childrens Hospital Colorado

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A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I)

Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with MMF and corticosteroids as compared to standard of care comprised of tacrolimus, MMF and corticosteroids. -In a maintenance kidney transplant population (6-24 months post-transplant), CFZ533 in combination with MMF with or without corticosteroids, compared to a standard of care control arm of tacrolimus and MMF with or without corticosteroids.

COHORT 1: Primary Objective(s) -To demonstrate that CFZ533 600 mg or 300 mg bi-weekly (Q2W), subcutaneous (SC), are non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite efficacy failure event (Biopsy proven acute rejection (BPAR), Graft Loss or Death) over 12 months post-transplantation. Key secondary objective: -To demonstrate that CFZ533 600 mg or 300 mg Q2W SC are superior to a tacrolimus-based regimen with respect to the mean estimated glomerular filtration rate (eGFR) at 12 months post-transplantation. COHORT 2: Primary Objective(s) -To demonstrate that CFZ533 450 mg Q2W SC is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite event (BPAR, Graft Loss or Death) over 12 months post conversion. Key secondary objective: -To demonstrate that CFZ533 450 mg Q2W SC is superior to a tacrolimus-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion.

Protocol #: 18-2117

Location: University of Colorado Hospital

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Metabolic and Renal Effects of Automated Insulin Delivery Systems in Youth with Type 1 Diabetes Mellitus

Protocol #: 18-1558

Location: Childrens Hospital Colorado

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A prospective, long term registry of patients with a diagnosis of spinal muscular atrophy V: 1.0; 20March2018

Protocol #: 18-1683

Location: Childrens Hospital Colorado

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A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1

Protocol #: 18-2315

Location: University of Colorado Hospital

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A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.

Primary objective: Assess the efficacy of a levonorgestrel 52 mg intrauterine system (LNG20 IUS) as a treatment for heavy menstrual bleeding. Secondary objectives: Assess safety, tolerability, bleeding patterns, and continuation rates of LNG20 IUS in women using LNG20 IUS for heavy menstrual bleeding.

Protocol #: 18-2249

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

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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Protocol #: 18-2298

Location: University of Colorado Hospital

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The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic Syndrome

Protocol #: 18-0369

Location: University of Colorado Hospital

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An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Protocol #: 18-6510

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

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Genomic Translation for ALS Care

Protocol #: 18-1768

Location: University of Colorado Hospital

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Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR)

Protocol #: 18-2051

Location: University of Colorado Hospital

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CU Faces of Hope-Genetics of Craniofacial and Dental Development Research Study

This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not.

Protocol #: 18-1916

Location: Childrens Hospital Colorado

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Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determine fluid balance in your body. The CardioMEMS HF System is FDA approved for a select group of patients. The study plans to see if it works in more patients. The study will also learn if using the device's data for other indicators of heart failure might reduce worsening heart failure resulting in visits to the hospital to treat heart failure or death. You may be eligible if you are at risk of having episodes of worsening heart failure.

Protocol #: 18-2129

Locations: Medical Center of the Rockies; Memorial Hospital Central; University of Colorado Hospital

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The Associations between EIT and Clinical Measures during Standard of Care Procedures in Patients with Respiratory Disease: A Preliminary Study

Primary outcome: EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified. Secondary outcomes: Regional conductivity changes due to ventilation Waveform for a mesh element Regional conductivity changes due to perfusion Regional pulsatile perfusion imaging at the end of systole Power waveform (computed as the inner product of measured voltages and applied currents)

Protocol #: 18-1843

Location: Childrens Hospital Colorado

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A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS

Protocol #: 18-2047

Location: University of Colorado Hospital

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A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula Repair

Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure.

Protocol #: 18-1823

Location: Childrens Hospital Colorado

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors

The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments

Protocol #: 18-2021

Location: University of Colorado Hospital

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Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (DELIVERMS)

Protocol #: 18-1633

Location: University of Colorado Hospital

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A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red blood cells in Subjects undergoing Complex Cardiac Surgery Procedures (the ReCePI study)

Protocol #: 18-2032

Location: University of Colorado Hospital

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Identifying Predictors of Poor Health-Related Quality-of-Life among Pediatric Hematopoietic Stem Cell Donors

Protocol #: 18-1997

Location: Childrens Hospital Colorado

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Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen

Protocol #: 18-6061

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies

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COG AGCT1532 - Phase 3 Accelerated BEP Trial: A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours

Protocol #: 18-1674

Location: Childrens Hospital Colorado

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COG AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Protocol #: 18-1527

Location: Childrens Hospital Colorado

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A Phase 3 Study of Eltrombopag vs. Standard First-Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children (ICON3)

To determine if the proportion of patients with a platelet response is significantly greater in patients with newly diagnosed ITP treated with eltrombopag than those treated with standard first-line treatments

Protocol #: 18-1963

Location: Childrens Hospital Colorado

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PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High-Dose Inhaled Corticosteroid plus Long-acting 946;2 Agonist and Chronic Oral Corticosteroid Therapy

This is an open-label, multicenter study designed to evaluate the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of a 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks (Q4W) up until the third dose of benralizumab and then every 8 weeks (Q8W) thereafter in patients with severe eosinophilic asthma who are receiving high-dose inhaled corticosteroids (ICS)/long-acting β2 agonists (LABAs) and OCS with or without additional asthma controller(s). After they sign the informed consent form, patients will undergo a screening visit (Visit 1) to assess eligibility criteria and laboratory tests. All patients who are not already taking prednisone/prednisolone as their OCS treatment will be switched to prednisone/prednisolone, and the laboratory tests will be delayed 3 to 7 days. Patients still fulfilling inclusion/ sion criteria at Visit 2 (Week 0) will enter the study and receive open-label benralizumab.

Protocol #: 18-1978

Location: University of Colorado Hospital

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Clinical Outcome Measures in Friedreich's Ataxia

Protocol #: 18-1641

Location: University of Colorado Hospital

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An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Protocol #: 18-1672

Location: University of Colorado Hospital

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A multicenter, randomized, double-blinded, placebo-controlled, Phase 3 trial of adjuvant Avelumab (anti-PDL-1 antibody) in Merkel cell carcinoma patients with lymph node metastases

Protocol #: 18-1734

Location: University of Colorado Hospital

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Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer

Protocol #: 18-1728

Location: University of Colorado Hospital

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Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years.

Protocol #: 18-1842

Location: University of Colorado Hospital

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A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects with acute coronary syndrome.

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)

Protocol #: 18-6081

Locations: Harmony Campus; Medical Center of the Rockies

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A study to investigate biomarkers in rheumatoid arthritis associated interstitial lung disease

Protocol #: 18-1808

Location: University of Colorado Hospital

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Square wave testosterone therapy in castration resistant prostate cancer

Feasibility of the administration of transdermal testosterone alternating with enzalutamide and the effects it has in the treatment of prostate cancer

Protocol #: 18-0821

Location: University of Colorado Hospital

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A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

Protocol #: 18-1599

Location: University of Colorado Hospital

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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis

This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years.

Protocol #: 18-1795

Locations: Colorado Research Center; Renal Research Center

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My Transgender Brain Study (MyT "Mighty" Brain) - Colorado

Protocol #: 18-1740

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

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A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018

Protocol #: 18-1493

Location: University of Colorado Hospital

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An Investigator-Sponsored, Phase 1/2 trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC)

Protocol #: 18-0554

Location: University of Colorado Hospital

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A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - Sponsor Protocol No. CA045-001

Protocol #: 18-1343

Location: University of Colorado Hospital

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Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma

Protocol #: 18-1654

Location: University of Colorado Hospital

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A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint Blockade

Protocol #: 18-1526

Location: University of Colorado Hospital

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COG ACCL1633 - The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Protocol #: 18-1349

Location: Childrens Hospital Colorado

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A MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS FROM BIRTH TO < 1 YEAR WITH INFLUENZA-LIKE SYMPTOMS

Protocol #: 18-1429

Location: Childrens Hospital Colorado

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A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study

Protocol #: 18-1336

Location: University of Colorado Hospital

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EA2165 A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal Cancer

Protocol #: 18-1216

Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital

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A 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 ig Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase

Protocol #: 18-1445

Location: Childrens Hospital Colorado

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An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects 1 and 30 Years of Age with Relapsed/Refractory Precursor B-cell or T-cell Acute Lympholastic Leukemia or Lymphoblastic Lymphoma

Protocol #: 18-0867

Location: Childrens Hospital Colorado

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AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA

This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in patients with B-cell Non-Hodgkin lymphoma.

Protocol #: 18-1439

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Molecular Characterization of Idiopathic Interstitial Pneumonias

Protocol #: 18-1490

Location: University of Colorado Hospital

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Peripheral Inflammatory Cytokine Levels in Parkinson Disease

Protocol #: 18-1356

Location: University of Colorado Hospital

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Gut microbiome alterations by ketogenic diet treatment V: 2; July 31, 2018

Protocol #: 18-1391

Location: Childrens Hospital Colorado

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Conversational Speech in the Diagnosis of Neurocognitive Disorders

Protocol #: 18-0456

Location: University of Colorado Hospital

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A comparison of the immunogenicity and descriptive safety of a live attenuated herpes zoster vaccine and the GSK herpes zoster recombinant HZ/su candidate vaccine in 50-59 year old and 70-85 year old vaccine recipients.

Protocol #: 13-3192

Location: Adult Infectious Disease Clinical Trials Center

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A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

Protocol #: 18-1347

Location: University of Colorado Hospital

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Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors

Protocol #: 18-1263

Location: University of Colorado Hospital

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A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE'S DISEASE

Participants will come into the clinic for 5 visits which will last 1.5-3.5 hours long. Each visit has an Audiologist and an Otologist component in it. Each participant will need to complete daily diary entries by calling into phone number and answering some questions.

Protocol #: 18-1269

Location: University of Colorado Hospital

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More than a Movement Disorder: Applying Palliative Care to Parkinson?s Disease v: 12/06/2017

Protocol #: 16-1400

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study

The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension.

Protocol #: 18-1297

Location: University of Colorado Hospital

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Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High Risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716) Sponsor Protocol No. MK-3475-716

Protocol #: 18-1199

Location: University of Colorado Hospital

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The Effects of Resistance Training on Appetite Regulation

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

Protocol #: 18-1298

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

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A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs]) in Adolescents with Recent Onset Type 1 Diabetes Mellitus (T1DM) v: 7.0; 17-Jan-2017

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

Protocol #: 16-0905

Locations: Barbara Davis Center; UCD Barbara Davis Center

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A Multicenter, Observational, Prospective, Natural History Study of Homocystinuria Due to Cystathionine Beta-synthase Deficiency in Pediatric and Adult Patients

Protocol #: 18-0910

Location: Childrens Hospital Colorado

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Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Protocol #: 18-6055

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

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Study evaluating feasibility of isolating circulating tumor DNA from blood, cerebrospinal fluid, and urine in Pediatric Solid Tumor patients

Protocol #: 18-1281

Location: Childrens Hospital Colorado

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A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis 14DEC2016

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

Protocol #: 17-0051

Location: University of Colorado Hospital

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Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA)

Protocol #: 15-1868

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

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Obalon? Balloon System, The Post Approval Study

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

Protocol #: 18-1209

Location: University of Colorado Hospital

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Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy

Protocol #: 18-0995

Location: University of Colorado Hospital

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Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults with Advanced Heart Failure

Protocol #: 18-0973

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

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A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3

Protocol #: 18-1150

Location: University of Colorado Hospital

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A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota? (CP101) in Subjects with Recurrence of Clostridium difficile Infection (2/22/2018 version 3)

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

Protocol #: 18-1166

Location: University of Colorado Hospital

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FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study

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

Protocol #: 18-1148

Location: University of Colorado Hospital

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Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)

Protocol #: 18-1137

Location: University of Colorado Hospital

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Neurologic Music Therapy for enhancing fine motor control in Parkinson's Disease 16Apr2018

Protocol #: 16-2308

Location: University of Colorado Hospital

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Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (aged 18-59) with Acute Myeloid Leukemia

Protocol #: 18-0709

Location: University of Colorado Hospital

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Phase I/Ib trial of radiotherapy in combination with Durvalumab (MEDI4736) prior to surgical resection for HPV negative squamous cell carcinoma of the head and neck (HNSCC)

Protocol #: 18-0606

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

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Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients with Previously Untreated High Grade Myelodysplastic Syndromes

Protocol #: 17-2215

Location: University of Colorado Hospital

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A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX Study)

Protocol #: 17-2378

Location: Childrens Hospital Colorado

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A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin in Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection V: 3.0; 22Feb2019

Protocol #: 18-0857

Location: Childrens Hospital Colorado

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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

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

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

Protocol #: 18-1003

Location: University of Colorado Hospital

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EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)

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

Protocol #: 18-0926

Location: University of Colorado Hospital

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EMPERIAL-preserved: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)

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

Protocol #: 18-0925

Location: University of Colorado Hospital

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COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Protocol #: 18-0971

Location: Childrens Hospital Colorado

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Ruptured Aneurysms Treated with Hydrogel Coils

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

Protocol #: 18-6052

Location: Memorial Hospital Central

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A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

Protocol #: 18-0685

Location: University of Colorado Hospital

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RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION

Protocol #: 18-0627

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

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A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin Receptor

Protocol #: 18-0756

Location: University of Colorado Hospital

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A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

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

Protocol #: 16-0701

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

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A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGard

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

To measure contraceptive efficacy of the test product

Protocol #: 17-0225

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

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A study of the genetics of pulmonary fibrosis

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

Protocol #: 15-1147

Location: University of Colorado Hospital

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A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease with Motor Fluctuations

Study is double blind and placebo controlled.

Protocol #: 18-0829

Location: University of Colorado Hospital

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PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)

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

Protocol #: 18-0761

Location: University of Colorado Hospital

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AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

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Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701

Protocol #: 18-0834

Location: Childrens Hospital Colorado

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Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Protocol #: 18-0803

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Molecular Endotypes of Chronic Spontaneous Urticaria

Protocol #: 18-0850

Location: University of Colorado Hospital

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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")

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

Protocol #: 18-0505

Location: University of Colorado Hospital

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Effects of Cannabis Use in Cancer Patients: A Feasibility Study

Protocol #: 18-0836

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

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PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

Protocol #: 18-0498

Location: Childrens Hospital Colorado

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NANT 2013-01 A Phase I Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed Neuroblastoma with Dinutuximab +/- Lenalidomide. A New Approaches To Neuroblastoma Therapy (NANT) Treatment Protocol

Protocol #: 18-0686

Location: Childrens Hospital Colorado

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Automatic measurement of hand movements toward development of an objective assessment of primary motor symptoms in Parkinson?s disease

Protocol #: 15-1041

Location: University of Colorado Hospital

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A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer

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

Protocol #: 18-0567

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

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Education Efficacy in Patient Interventions

Protocol #: 18-6020

Location: Medical Center of the Rockies

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NANT 2017-01: A PHASE I STUDY OF 131I-MIBG WITH DINUTUXIMAB +/- VORINOSTAT FOR RELAPSED/REFRACTORY NEUROBLASTOMA (IND# 137554)

Protocol #: 18-0501

Location: Childrens Hospital Colorado

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Identifying Environmental Triggers of Smoking Behaviors in Low-income Communities

Protocol #: 18-0052

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

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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy

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

Protocol #: 17-2349

Location: University of Colorado Hospital

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Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherence

Protocol #: 18-0715

Location: University of Colorado Hospital

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Narcotic consumption in discectomies: microscopic versus endoscopic

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

Protocol #: 18-0830

Location: University of Colorado Hospital

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Acute Kidney Injury and Vascular Function

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

Protocol #: 18-0654

Location: University of Colorado Hospital

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PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)

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

Protocol #: 18-0637

Location: University of Colorado Hospital

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Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)

Protocol #: 18-0461

Location: Childrens Hospital Colorado

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Intermuscular adipose tissue (IMAT) - protagonist in sarcopenia and insulin resistance in humans

Protocol #: 18-0582

Location: University of Colorado Hospital

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Title: PRO-ACT: Prevention of De Novo HCV with Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

Protocol #: 18-0559

Location: University of Colorado Hospital

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Impact of Fever Prevention in Brain Injured Patients (INTREPID)

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

Protocol #: 18-0548

Location: University of Colorado Hospital

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Precision Approach to PPI Therapy in Gastroesophageal reflux disease

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

Protocol #: 18-0205

Location: University of Colorado Hospital

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An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical Procedure

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

Protocol #: 18-0546

Location: University of Colorado Hospital

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Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Protocol #: 17-2186

Location: University of Colorado Hospital

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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

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

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

Protocol #: 18-0392

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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A PHASE 1 MULTI-CENTER DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY AND EARLY EFFICACY OF TBX-3400 IN PATIENTS WITH STAGE III AND IV MELANOMA RESISTANT OR REFRACTORY TO IMMUNE CHECKPOINT INHIBITORS

Protocol #: 18-0385

Location: University of Colorado Hospital

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Pulse Reduction on Beta Blocker and Ivabradine Therapy (PROBE-IT)

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

Protocol #: 16-1363

Location: University of Colorado Hospital

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A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naive Children with Unresectable or Progressive Low Grade Glioma (LGG)

Protocol #: 16-2322

Location: Childrens Hospital Colorado

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A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal Stents

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

Protocol #: 18-0442

Location: University of Colorado Hospital

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A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF NEFECON IN PATIENTS WITH PRIMARY IGA NEPHROPATHY AT RISK OF PROGRESSING TO END-STAGE RENAL DISEASE (NefIgArd)

Protocol #: 18-0374

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

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Training and testing machine-learning algorithms using a Limited Dataset from the Health Data Compass database: A Pilot Study

Protocol #: 18-0251

Location: University of Colorado Hospital

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Geri-TBI A prospective multi-center evaluation of geriatric patients with traumatic brain injury

Protocol #: 17-6205

Location: Memorial Hospital Central

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Prospective, Observational Trial of Blunt Cerebrovascular Injury Management and Stroke Formation

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

Protocol #: 18-6029

Location: Medical Center of the Rockies

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Diet and Relapses in Pediatric Multiple Sclerosis

Protocol #: 18-0393

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Application of transcranial alternating current stimulation for modulation of sleep and cognitive performance

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

Protocol #: 16-1875

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

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ADVL1615: A Phase I Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors

Protocol #: 18-0017

Location: Childrens Hospital Colorado

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A PHASE Ia/Ib, MULTICENTER, OPEN-LABEL, DOSE ESCALATION, DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-9545 ALONE OR IN COMBINATION WITH PALBOCICLIB AND/OR LHRH AGONIST IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER

Protocol #: 17-2208

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Perceived palliative care needs of Huntington's disease patients

Protocol #: 18-0216

Location: University of Colorado Hospital

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A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with Avelumab

Protocol #: 18-0187

Location: University of Colorado Hospital

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Clinical Trial Readiness for SCA1 and SCA3

Protocol #: 18-0020

Location: University of Colorado Hospital

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A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (!Y10 to <18 years) with Type 2 Diabetes Mellitus

Protocol #: 17-1809

Location: Childrens Hospital Colorado

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PCRC 17-11:Comparative Effectiveness of Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer (Short Name: REACH PC)

Protocol #: 18-0183

Location: University of Colorado Hospital

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EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)

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

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

Protocol #: 17-2267

Location: University of Colorado Hospital

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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure

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

Protocol #: 18-0158

Location: University of Colorado Hospital

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

Protocol #: 18-0153

Location: University of Colorado Hospital

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ARROW study: Weight loss study

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

Our study will find out why people have trouble losing weight

Protocol #: 18-0091

Location: University of Colorado Hospital

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Validation of a performance-based assessment of functional ability related to cognition in Parkinson's disease

Protocol #: 15-0170

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

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A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)

Protocol #: 17-2216

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

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A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Protocol #: 18-0031

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Improving recovery and quality of life with an aerobic exercise intervention soon after concussion

Protocol #: 17-2020

Location: Childrens Hospital Colorado

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Effect of warmed irrigation fluid on immediate post-operative pain scores in patients undergoing hip arthroscopy

Protocol #: 17-2399

Location: University of Colorado Hospital

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Effects of pubertal blockade and hormone therapy on cardiometabolic risk markers in transgender adolescents

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

Protocol #: 17-2328

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017

This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (surgery + post-op physical therapy) and non-operative treatment (physical therapy only without surgery).

Protocol #: 17-0628

Locations: Boulder Sports Clinic; University of Colorado Hospital

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Assisting in Informing Decisions in Emergency Departments (ED-AID) Study

Protocol #: 17-2299

Location: University of Colorado Hospital

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A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors

Protocol #: 17-2431

Location: University of Colorado Hospital

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Bariatric Surgery in Adolescents (BSA) Biobank: Collection and Banking of Biological Specimens and Data from Patients with Obesity, Diabetes and Controls

Protocol #: 17-2355

Locations: Childrens Hospital Colorado; Colorado Research Center

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Barriers and facilitators to maternal visits in the NICU and impact of visiting on infant development

Protocol #: 16-0179

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

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PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma

1.1 Primary Objectives 1.1.1 To evaluate the safety of APX005M administered intravenously every 3 weeks to children with central nervous system tumors. 1.1.2 To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. 1.1.3 To determine the pharmacokinetics of APX005M. 1.2 Secondary Objective 1.2.1 To make a preliminary assessment of efficacy via overall response rate, duration of response, progression-free survival and overall survival for DIPG patients. 1.3 Exploratory Objectives 1.3.1 To assess the incidence of anti-drug antibodies. 1.3.2 To determine the immune pharmacodynamics of APX005M. 1.3.3 To identify tumor and blood efficacy and/or resistance biomarkers.

Protocol #: 17-2394

Location: Childrens Hospital Colorado

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Determining the Optimal Treatment Strategy for Patients who have Chronic Migraine with Medication Overuse

Protocol #: 16-2179

Location: University of Colorado Hospital

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PULSE-PHPF-001: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDCLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACYOF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2)

This is a 16 week study of iNO vs placebo. Once the subject meets criteria, the subject will be required to visit the clinic once a month for 16 weeks. There is an open label extension available for this study in which the subject will be guaranteed to get the actual study drug. The subject must complete the main study to qualify for the open label extension. Study procedures that will be completed during the study are the completion of quality of life questionnaires, 6 minute walk tests, pulmonary function tests, echocardiograms and laboratory assessments. Study required testing will be paid for but the Sponsor. Most visits will take approximately 2 hours.

Protocol #: 17-1863

Location: University of Colorado Hospital

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Prospective Data Collection Study of Intra-operative Radiation Therapy (IORT) For Lumpectomy Cavity Boost Treatment Immediately Following Resection In Patients Receiving Radiation Therapy In The Setting of Breast Conserving Therapy v: 7.1; 12/15/2017

Protocol #: UCH11-1101

Location: Harmony Campus

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A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer

Protocol #: UCH06-778

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

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Risk factors in Early Multiple Sclerosis (RisE-MS)

among asymptomatic first degree relatives (FDRs), aged 18-30, of multiple sclerosis (MS) patients: 1: Determine the prevalence of brain/spine MRI lesions disseminated in space (DIS), consistent with MS 2: Gather data on potential risk factors or early signs related to MS development, including markers for: genes, immunological function, environmental factors, neuroaxonal damage, Vitamin D levels, lipid metabolism, activity levels, mood abnormalities, and cognitive function. From this, develop a risk factor score, incorporating all relevant potential markers of increased risk of DIS. 3: To use this pilot, cross-sectional study as a base for development of a long-term, longitudinal, multi-center study to determine genetic and environmental risks for pre-symptomatic MS 4: To create and maintain a biobank of specimens for future analysis as other potential biomarkers become available.

Protocol #: 17-1884

Location: University of Colorado Hospital

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Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study V:12/18/2018

Protocol #: 16-1752

Location: Childrens Hospital Colorado

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A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutations

This multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in at least 120 patients with NYHA functional Class II and III DCM secondary to LMNA mutations. NYHA functional Class IV patients (up to approximately 40) will ARRY-371797 (p38 MAP Kinase Inhibitor) Array BioPharma Inc. Clinical Study ARRAY-797-301 Protocol Version 2 7 Confidential 23 October 2017 also be enrolled (1:1 randomization) and will be assessed for overall safety and time from randomization to HF-related hospitalization or death due to any cause, in addition to PK and efficacy, if feasible. For the Class IV patients, some assessments (i.e., 6MWT, triplicate ECGs, echocardiograms (ECHO), arrhythmia, PK assessment and PD assessment) are considered optional based on whether the patient is ambulatory or not.

Protocol #: 17-2345

Locations: CTRC-adult; University of Colorado Hospital

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Evaluation of commercial pharmacogenomic testing in psychiatry medicine.

Protocol #: 17-2347

Location: University of Colorado Hospital

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The ANDES study: Antenatal exposures and non-communicable disease in Bolivia

Protocol #: 17-1529

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION

To assess the safety of infusing AB-110, cord blood (CB) hematopoietic stem and progenitor cells (HSPCs) with engineered human umbilical vein endothelial cells.

Protocol #: 17-2078

Location: University of Colorado Hospital

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The Use of Acthar (ACTH) in Patients with Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and are Undergoing Renal Transplant

Protocol #: 17-2336

Location: University of Colorado Hospital

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APEC1621-MASTER, NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)

Protocol #: 17-2168

Location: Childrens Hospital Colorado

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A randomized, double blind, placebo-controlled parallel study of tolerability and efficacy of Cannabidiol (CBD) on tremor in Parkinson's disease

Protocol #: 17-2318

Location: University of Colorado Hospital

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SUNRISE: Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents

I. Hypotheses and Specific Aims: Aim 1: Examine the effect of experimental sleep extension on insulin sensitivity and secretion in typically short-sleeping adolescents. Hypothesis 1: Insulin sensitivity will improve following sleep extension compared to typical short sleep. Aim 2: Examine the effect of experimental sleep extension on dietary intake in typically short-sleeping adolescents. Hypothesis 2: Overall caloric intake, fat, carbohydrate, and sugar intake will decrease following sleep extension.

Protocol #: 17-2095

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in Cardiomyocytes

Protocol #: 17-2296

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Pilot Study: A Strategy for High-Frequency Comprehensive Home Toxicology Screening

Protocol #: 17-1597

Locations: ARTS Synergy Outpatient Treatment; Colorado Research Center

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Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic Prophylaxis

This study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started.

Protocol #: 17-2177

Location: University of Colorado Hospital

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Integrating Palliative Care Social Workers into Sub-Acute Settings: A Feasibility Trial

Protocol #: 17-2263

Location: Kaiser Permanente of Colorado

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EARLY-TAVR Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis

Protocol #: 17-6134

Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies

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COG AALL1631 - International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

Protocol #: 17-2213

Location: Childrens Hospital Colorado

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A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

Determine the safety and tolerability of VRx-3996/valganciclovir. Evaluate the impact of parameters of HIV infection (e.g., CD4 cell counts, HIVqPCR) on safety and efficacy. And Evaluate the impact of VRx-3996/valganciclovir on replication of non-Alpha herpesviruses.

Protocol #: 17-2074

Locations: Lone Tree Medical Center; University of Colorado Hospital

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A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)

Protocol #: 17-2178

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558)in Advanced Solid Tumors.

Protocol #: 17-2164

Location: University of Colorado Hospital

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Mitochondria in HIV and Aging (MITO+)

The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI).

Protocol #: 17-2161

Location: University of Colorado Hospital

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Nutrition in Older HIV-Infected Adults Receiving ART: Impacts of Food Insecurity on Frailty and Disease Progression

Protocol #: 17-2145

Location: University of Colorado Hospital

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American Registry for Migraine Research

Protocol #: 17-2165

Locations: Lone Tree Medical Center; UCHealth Internal Medical Clinic - Lowry; University of Colorado Hospital

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Mitochondrial targeted antioxidant supplementation and diastolic function in healthy men and women

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

Protocol #: 17-1782

Location: University of Colorado Hospital

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Positive Aging Consultations

Protocol #: 17-2160

Location: University of Colorado Hospital

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A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression

Protocol #: 17-1778

Location: University of Colorado Hospital

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S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATION

Protocol #: 17-2125

Locations: Greeley 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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Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - CoBIS 2

The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows: 1.To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke 2.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke 3.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke

Protocol #: 17-2136

Location: University of Colorado Hospital

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ACNS1422 - A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Protocol #: 17-1993

Location: Childrens Hospital Colorado

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ARST1431 - A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Protocol #: 17-1992

Location: Childrens Hospital Colorado

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A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

Protocol #: 17-2036

Locations: Greeley 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 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Protocol #: 17-1808

Location: University of Colorado Hospital

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A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Protocol #: 17-1756

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

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Electronic Cigarette Use During Pregnancy

Protocol #: 17-2033

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

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A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

GSK is currently developing a once-daily ?closed? triple therapy of an ICS/LAMA/LABA combination [FF/UMEC/Vilanterol (VI)] in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. Through the comparison of a closed triple therapy to a standard of care ICS/LABA combination therapy this study will provide important information to prescribers regarding the benefit of step-up to closed triple therapy to patients uncontrolled on ICS/LABA.

Protocol #: 17-2041

Location: University of Colorado Hospital

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PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung Cancer

Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose.

Protocol #: 17-1492

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

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PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory diffuse intrinsic pontine glioma (DIPG), non-brainstem high-grade gliomas (NB-HGG), ependymoma, medulloblastoma or hypermutated brain tumors

Protocol #: 17-1991

Location: Childrens Hospital Colorado

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MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?

Protocol #: 16-2506

Location: University of Colorado Hospital

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Retinal Optical Coherence Tomography in Pre-Dementia Alzheimer's Disease: The Relationship to Amyloid, Cortical Volumes, Cognition, and Visual Fields. (OCT_AD Study)

Protocol #: 17-1956

Location: University of Colorado Hospital

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A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-Matched, Living Donor Kidney Transplants (the "Study")

MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with IS drugs.

Primary Objectives: To evaluate achievement of induction of functional immune tolerance by cellular immunotherapy with MDR-101 in recipients of human leukocyte an tigen (HLA)-matched, living donor kidney transplants. Functional immune tolerance is defined as remaining off of all immunosuppression (IS) drugs for 24 months or more after completion of anti-rejection, IS drug therapy withdrawal with no episodes of biopsy-proven acute rejection (BPAR), de novo donor-specific anti-HLA antibody (dnDSA) development, transplant kidney loss, or subject death. To compare the safety and tolerability of cellular immunotherapy with MDR-101 compared to conventional, standard-of-care (SOC) IS therapy in recipients of HLA-matched, living donor kidney transplants.

Protocol #: 17-1730

Location: University of Colorado Hospital

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Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

Protocol #: 17-6209

Locations: Medical Center of the Rockies; Memorial Hospital Central

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Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Protocol #: 16-0696

Location: University of Colorado Hospital

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The influence of gonadal hormone suppression on adipocyte lineage and the microbiome

Six month intervention of ovarian hormone supression

This research study plans to learn more about the role of female sex hormones on fat and the gut microbiome (or the organisms that are in your digestive tract).

Protocol #: 17-1869

Location: University of Colorado Hospital

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's Disease

Protocol #: 17-1532

Location: University of Colorado Hospital

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GORE? HELEX? Septal Occluder / GORE? Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging- Confirmed TIA in Patients with Patent Foramen Ovale (PFO)

Protocol #: 13-3034

Location: University of Colorado Hospital

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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)

This study is inviting people who have RA into a study to have an HRCT scan and PFT testing done for the study to learn more about lung disease in RA

Protocol #: 16-1097

Location: University of Colorado Hospital

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A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Structure: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Duration: Patients will be enrolled in the study for up to 16 weeks, with up to a 4-week screening period and a 12-week treatment period. Study Treatment: The investigational product is AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]), which is titrated over a 2-week period to d6-DM 42.63 mg/Q 4.9 mg (AVP-786-42.63/4.9) twice daily (BID). Control: Placebo capsules appearing identical to study medication will be used as control. Randomization: Eligible patients will be randomized into the study to receive AVP-786 or placebo. Dose Regimen:

Protocol #: 17-6198

Location: Medical Center of the Rockies

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Duration of Marijuana (THC) Concentration in Breast Milk- a Pilot Study

Protocol #: 15-1639

Location: University of Colorado Hospital

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Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Protocol #: 17-1406

Location: Childrens Hospital Colorado

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Optimizing Physical Activity Outcomes after Total Knee Arthroplasty

Protocol #: 17-0079

Location: University of Colorado Hospital

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A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (BAY 80-6946 /19176)

Protocol #: 17-1495

Location: Childrens Hospital Colorado

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Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)

Protocol #: 17-1751

Location: University of Colorado Hospital

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Transcranial electrical stimulation for the treatment of cervical dystonia

Protocol #: 17-1322

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Protocol #: UCH09-0815

Location: Memorial Hospital North

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Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/Obesity

In this study, we will be evaluating the effects of a reverse-diet compared to standard weight loss maintenance advice.

Protocol #: 17-1726

Location: University of Colorado Hospital

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Ion Channel Genetic Biomarkers: Diagnostic Capability in the Assessment of Mood Disorders

Protocol #: 17-1578

Locations: Colorado Research Center; Sheridan Health Services

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A PHASE III RANDOMIZED TRIAL OF LOBECTOMY VERSUS SUBLOBAR RESECTION FOR SMALL (!U 2 CM) PERIPHERAL NON-SMALL CELL LUNG CANCER

Protocol #: UCH13-0619

Location: Memorial Hospital Central

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Emergency Medicine Specimen Bank

Protocol #: 17-1642

Location: University of Colorado Hospital

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A Phase I/Ib Study of sEphB4-HSA in Combination with Chemotherapy or Cetuximab and Radiation Therapy in Patients with Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck

Protocol #: 16-2575

Location: University of Colorado Hospital

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PRENATAL DEPRESSION AND ANXIETY HAVE AN IMPACT ON PSYCHOLOGICALLY RELATED EARLY INFANT PHYSIOLOGY: TIMING, MEDIATORS AND MODERATORS

Protocol #: 11-0548

Location: University of Colorado Hospital

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Virtual and Augmented Reality Study

Protocol #: 17-6191

Location: Medical Center of the Rockies

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Identification of patients at high risk for readmission after a COPD exacerbation

Protocol #: 17-0245

Location: University of Colorado Hospital

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A cluster randomized trial of a home-based intervention to increase uptake of postpartum contraceptives and its effect on short-interval pregnancy rates in a postpartum population of rural Guatemalan women

Protocol #: 17-1314

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The relationship between the gut microbiome composition and pulmonary immune function in HIV infection

Protocol #: 17-1512

Location: University of Colorado Hospital

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TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017

Protocol #: 17-1317

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic

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Pilot Study to Evaluate Safety and Tolerability of Inhaled N-Acetylcysteine in Pulmonary Fibrosis

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. We will also create a bank of data, blood, and sputum from IPF patients for future research. NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Protocol #: 17-1477

Location: University of Colorado Hospital

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A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma

Protocol #: 17-1474

Locations: Lone Tree Medical Center; University of Colorado Hospital

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Copeptin and Nonalcoholic Fatty Liver Disease

See above

Protocol #: 17-1160

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

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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 movement the person does. This is done with equations that use the data collected by the activity monitors. However, these equations are usually developed using measurements on healthy people. People who have movement disorders related to diseases such as Parkinson?s and Multiple Sclerosis, or conditions such as knee replacement, stroke, or arthritis have very different movement patterns than people without these diseases. Thus, the equations used to convert activity monitor data will not work well in people with these diseases or conditions. The purpose of this study is to develop equations to measure physical activity using activity monitors in people with movement limitations. Rather than creating specific equations for each individual disease and condition, we will perform simple tests to measure upper and lower body function, and then group people into different clusters based on these tests. Our preliminary studies show that these equations are more accurate than equations based on specific diseases or conditions.

Protocol #: 16-2706

Locations: CTRC-adult; University of Colorado Hospital

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Growing up with X and Y chromosome trisomy: the TRIXY study

Protocol #: 16-1710

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The Assessment of Long Term Durability, Safety and Effectiveness of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valve and Surgical Aortic Valve Replacement in Intermediate Risk Patients Suffering from Severe Symptomatic Aortic Stenosis

he PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery. To assure that patients with an STS score ≥ 4% have been selected.

The purpose of this trial is to establish the safety and effectiveness of the Edwards SAPIEN XT? device and delivery systems (transfemoral, transapical and transaortic), which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Protocol #: 12-0660

Location: University of Colorado Hospital

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Ethnography of Synthetic Cannabinoid Abusers to Target Substance Abuse Intervention

Protocol #: 17-1326

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Effect of Bovine Arteriovenous Grafts on Patient Sensitization Prior to Kidney Transplant

Protocol #: 17-1524

Location: University of Colorado Hospital

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Fragile X Biobank

Protocol #: 16-1707

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ADVL1514: A Phase I Study of ABI-009 (Nab-Rapamycin) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan

Protocol #: 17-1376

Location: Childrens Hospital Colorado

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A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

To evaluate the use of Enfortumab vedotin plus CPI in treatment of advanced bladder cancer

Protocol #: 17-1410

Location: University of Colorado Hospital

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Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

Protocol #: 17-6161

Location: Poudre Valley Hospital

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The modified Atkins diet in patients with drug resistant epilepsy and the responsive neurostimulator 09Aug2017

Protocol #: 17-0888

Location: University of Colorado Hospital

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Study of Placental Function in Healthy and Pathological Pregnancies

Protocol #: 14-1073

Location: University of Colorado Hospital

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PROSPECTIVE, LONGITUDINAL, NON-INTERVENTIONAL STUDY OF DISEASE BURDEN AND TREATMENT OF PATIENTS WITH LOW-RISK MYELOFIBROSIS (MF) OR HIGH-RISK ESSENTIAL THROMBOCYTHEMIA (ET) OR ET PATIENTS RECEIVING ET-DIRECTED THERAPY

Protocol #: 17-6155

Location: Memorial Hospital Central

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BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU Study

Protocol #: 15-2114

Locations: Memorial Hospital Central; University of Colorado Hospital

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FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENE

Protocol #: 06-0501

Location: University of Colorado Hospital

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Real-Time Sleep Stage Classification with Unobstrustive Bio-potential Recording System

Protocol #: 16-0328

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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Subthalamic nucleus activity during habitual versus controlled movement

Protocol #: 17-1291

Location: University of Colorado Hospital

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The Risk of Long-Term Vascular Dysfunction in Women with a History of Pregnancy-Induced Hypertension

Protocol #: 16-2581

Location: University of Colorado Hospital

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Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)

The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthritis and study these individuals in a longitudinal manner in order to better understand the development of spondyloarthritis. Results from this study may provide information that contributes to our understanding of the complex relationships among immune dysregulation, genetic risk, subclinical phenotypes, and established spondyloarthritis phenotypes.

Protocol #: 17-0977

Location: University of Colorado Hospital

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Anal Cancer/HSIL Outcomes Research (ANCHOR) Study

Protocol #: 15-1466

Locations: Denver Health Medical Center; University of Colorado Hospital

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Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults with Autosomal Dominant Polycystic Kidney Disease

Protocol #: 17-1327

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

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Rapid measurements of water isotopes in human breath and saliva for doubly labeled water analysis V: 04/03/18

Protocol #: 16-2203

Location: University of Colorado Hospital

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DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women

If you join the study, you will be placed by chance into one of two research groups: 1) exercise and a study pill or 2) no exercise and a study pill. The study pill could be DHEA (50 mg/day) or a placebo. A placebo is a pill that looks like medicine but is not real. DHEA is a naturally occurring hormone that declines with age. In postmenopausal women, nearly all estrogen and most testosterone comes from DHEA. DHEA is considered a food supplement.

Protocol #: 16-2427

Location: University of Colorado Hospital

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Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease

Protocol #: 17-1363

Location: Childrens Hospital Colorado

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AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Protocol #: 17-1043

Location: Childrens Hospital Colorado

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E7080-A001-216: A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Protocol #: 17-1165

Location: Childrens Hospital Colorado

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A Phase I Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies (M13-833)

Protocol #: 17-0564

Location: Childrens Hospital Colorado

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AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#TBD) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Protocol #: 17-1086

Location: Childrens Hospital Colorado

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Team V: Teaching Learners to Improve Healthcare Value at the Bedside

Protocol #: 17-1332

Location: University of Colorado Hospital

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The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Protocol #: 17-1047

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

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Targeted fresh autologous whole blood transfusion after cardiopulmonary bypass: a prospective randomized controlled trial

Protocol #: 16-2647

Location: University of Colorado Hospital

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Genetic Predictors of QT Prolongation with Anti-arrhythmic Medication (AADGEN)

Protocol #: 16-2675

Location: University of Colorado Hospital

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A comparison of intranasal midazolam and Nitrous Oxide (N2O) minimal sedation for minor procedures in a pediatric emergency department

Protocol #: 16-1909

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A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options checklist

Protocol #: 17-1249

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

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T Cell Epitopes in Sarcoidosis

Protocol #: 17-1244

Location: University of Colorado Hospital

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The Feasibility, Safety, and Value of a Virtual Cardiac Implantable Electronic Device Wound Check

Protocol #: 17-1179

Location: University of Colorado Hospital

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A Phase 3, Randomized, Double--Blind, Placebo--Controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Previously Tolerated and Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Protocol #: 17-0399

Location: University of Colorado Hospital

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Assessment of Stakeholder Perspectives of the Clinical Utility of Pharmacogenomics in Solid Organ Transplantation

Protocol #: 17-1173

Location: University of Colorado Hospital

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Using Next Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM) - The International IBM Consortium Genetic Study

Protocol #: 17-1132

Location: University of Colorado Hospital

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