North American Mitrochondrial Disease Consortium Patient Registry and BiorepositoryProtocol #: 13-2246 Location: Childrens Hospital Colorado |
Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomesProtocol #: 19-2760 Location: University of Colorado Hospital |
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 LYMPHOMAProtocol #: 19-2950 Location: Childrens Hospital Colorado |
NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial CancerProtocol #: 19-2828 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
Valence and Arousal Ratings of Affective Images in Reproductive Aged Women (Females' Affective Image Ratings - FAIR Study)If you join the study, you will participate in two study sessions, which can be completed either in-person (at Anschutz Medical Campus, in Aurora, CO) or remotely - over the internet, over the course of 2 months. The first part of the study is the screening session. During this session, the research staff will conduct an interview with you and complete questionnaires about your medical and mental health history, and your mood. The second and last part of the study is the test session. During this session, you will complete surveys about your mood, and you will rate 160 digital images. Forty of those images will be pleasant, 40 will be unpleasant, 40 will be neutral, and 40 will be erotic. You will rate these images on scales of how pleasant/unpleasant and of how arousing/non-arousing you find these images. To investigate ratings of digital images across the female menstrual cycle Protocol #: 19-2872 Locations: Department Specific Free Standing Clinic; University of Colorado, Boulder |
Protocol I5B-MC-Y001(a) An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue SarcomaProtocol #: 19-6133 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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 |
Single Patient IND for Binimetinib, IND# 146690, Patient BLGProtocol #: 19-2744 Location: Childrens Hospital Colorado |
PREcision Event Monitoring of PatienTs with Heart Failure using HeartLogicYou are being asked to participate in this research study because you have been diagnosed with heart failure and you are implanted with a commercially approved Boston Scientific Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. Inside your device are sensors that monitor your heart failure condition. The purpose of this study is to better understand how sensor readings from your device relate to specific clinical events that you may experience during the time you are in the study. This information may be able to detect when your heart failure is getting worse earlier and with more accuracy. This could help your doctor treat your heart failure timely and with the appropriate treatments. Protocol #: 19-6516 Location: Memorial Hospital Central |
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-LLyProtocol #: 19-2631 Location: Childrens Hospital Colorado |
An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue SarcomaProtocol #: 19-2529 Location: University of Colorado Hospital |
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 |
Adenosinergic immune suppression pathway in glioblastoma multiforme tumorsProtocol #: 19-2344 Location: University of Colorado Hospital |
A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVISProtocol #: 19-1929 Location: University of Colorado Hospital |
A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONSProtocol #: 19-2255 Location: University of Colorado Hospital |
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 Hospital; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic SclerosisProtocol #: 19-1613 Location: Childrens Hospital Colorado |
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 Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
This is our 15.4 Health Affairs testing protocolProtocol #: X19-9999 Locations: Department Specific Free Standing Clinic; Highlands Ranch Hospital; University of Colorado Hospital |
Improving Renal Outcomes CollaborativeProtocol #: 16-2190 Location: Childrens Hospital Colorado |
Pre-Clinical Evaluation of Xpert Xpress GBS TestProtocol #: 19-2095 Location: University of Colorado Hospital |
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 DeficiencyProtocol #: 16-0927 Location: Childrens Hospital Colorado |
Prospective Analysis of Gait Following HemispherectomyProtocol #: 17-0230 Location: Childrens Hospital Colorado |
Gait Analysis of Femoroacetabular Impingement Patientsi. 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 |
International Fetal Cardiac Intervention RegistryProtocol #: 14-0343 Location: Childrens Hospital Colorado |
Defining the Genetic and Cellular Causes of Human Spina BifidaProtocol #: 15-1141 Location: Childrens Hospital Colorado |
Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)Protocol #: 14-1413 Location: Childrens Hospital Colorado |
NAFTNet Prenatal Diagnosis of Isolated Aqueductal StenosisProtocol #: 18-1076 Location: Childrens Hospital Colorado |
MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROMEAim 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 |
Neurocognitive Targets of Hostile Interpretation Bias Training to Treat IrritabilityThis 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 |
Surgical or Medical Treatment for Pediatric Type 2 DiabetesSurgical 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 |
Investigation of the efficacy of chemotherapy induced nausea/vomiting (CINV) prophylaxis with FOLFOX/FOLFIRI/FOLFIRINOXProtocol #: 19-1809 Location: University of Colorado Hospital |
A Phase II Study of the PARP Inhibitor Olaparib in Combination with the DNA Damaging Agent Temozolomide for the Treatment of Advanced Uterine LeiomyosarcomaProtocol #: 19-2018 Location: University of Colorado Hospital |
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENTProtocol #: 15-1434 Location: Childrens Hospital Colorado |
An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral CataractsProtocol #: 16-0145 Location: Childrens Hospital Colorado |
Neurological Screening of Controls in an Age-Related Macular Degeneration RegistryProtocol #: 19-1925 Location: University of Colorado Hospital |
Impact of Novel Therapeutic Music Delivery Device on Drug Use and Recovery in Surgical PatientsProtocol #: 19-6100 Locations: Medical Center of the Rockies; Poudre Valley Hospital |
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 |
Personalized experiences to inform improved communication for patients with Life Limiting IllnessFor 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 |
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 MutationsProtocol #: 19-1633 Location: Childrens Hospital Colorado |
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 TumorsProtocol #: 19-1727 Location: University of Colorado Hospital |
INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERSProtocol #: 02-729 Location: Department Specific Free Standing Clinic |
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVISProtocol #: 19-1597 Location: University of Colorado Hospital |
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 |
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 |
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 |
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 |
COG 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 GroupsProtocol #: 19-1467 Location: Childrens Hospital Colorado |
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa (pegloticase)(MIRROR Randomized Controlled Trial [RCT])Protocol #: 19-1717 Locations: Barbara Davis Center; University of Colorado Hospital |
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 StrokeThis 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 |
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 |
ECG Belt for CRT ResponseDemonstrate 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 |
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 CarcinomaProtocol #: 19-1503 Location: University of Colorado Hospital |
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset EpilepsyProtocol #: 19-1620 Location: University of Colorado Hospital |
Body Composition in Infants with Klinefelter Syndrome and Effects of Testosterone TreatmentProtocol #: 14-1720 Location: Childrens Hospital Colorado |
TRAVERSEProtocol #: 19-1644 Location: University of Colorado Hospital |
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKDProtocol #: 15-0902 Locations: Childrens Hospital Colorado; Colorado Research Center |
A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)Protocol #: 19-1599 Locations: Brain Imaging Center (BIC); University of Colorado Hospital |
S1900A, A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA1/2 MUTATION STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (Lung-MAP SUB-STUDY)Protocol #: 19-1317 Locations: Greeley Hospital; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase 1a/b Dose-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 TherapyProtocol #: 19-1458 Location: University of Colorado Hospital |
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 |
YSI Feasibility Session Study of the Dexcom? Continuous Glucose Monitoring (CGM) System in Adults and Pediatrics with Diabetes MellitusProtocol #: 19-1533 Locations: Barbara Davis Center; UCD Barbara Davis Center |
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 cancerProtocol #: 19-6509 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
Allen CU-UCSD Transition to RA Project: Blood and FluProtocol #: 19-1150 Locations: Barbara Davis Center; University of Colorado Hospital |
Apoyo con Cari?o (Support through Caring): Improving Palliative Care Outcomes for Latinos with Advanced Medical Illness V: 03/20/19Protocol #: 16-1270 Locations: Denver Health Medical Center; University of Colorado Hospital |
CROCODILE Study: Control of Renal Oxygenation, COnsumption, mitochondrial Dysfunction, and InsuLin rEsistanceProtocol #: 19-1282 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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 TumorsProtocol #: 19-1302 Location: University of Colorado Hospital |
An investigation of immune biology and Alzheimers Disease-related biomarkers in asymptomatic, late life mild TBIProtocol #: 19-1423 Location: University of Colorado Hospital |
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 |
Using point of care ultrasound to measure perioperative edema in infants with congenital heart diseaseProtocol #: 19-1387 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Feasibility of the Multiple Sclerosis Performance Test for assessment of functional performance measures in patients with Multiple SclerosisProtocol #: 19-1192 Location: University of Colorado Hospital |
reST Registryremede System Therapy in patients with central sleep apnea Protocol #: 19-6087 Locations: Harmony Campus; Medical Center of the Rockies |
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive NeuroblastomaProtocol #: 19-1259 Location: Childrens Hospital Colorado |
Comparison of Anticoagulation with Left Atrial Appendage Closure after AF AblationThis 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 |
Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCCProtocol #: 19-1081 Location: University of Colorado Hospital |
Assessing patient preferences and a clinical tool for evaluating for sexual function in adolescent and young adult survivors of childhood cancerProtocol #: 19-1111 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven AnalysisProtocol #: 19-1121 Locations: Greeley Hospital; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast CancerProtocol #: 19-1152 Locations: Greeley Hospital; 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 |
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 Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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 with Specific Genomic AberrationsProtocol #: 19-1132 Location: University of Colorado Hospital |
An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 in Patients with Locally Advanced or Metastatic Solid Tumors, Hodgkin or Non-Hodgkin LymphomaProtocol #: 19-1145 Location: University of Colorado Hospital |
Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017Protocol #: 16-2408 Location: Childrens Hospital Colorado |
Multi-Institutional Validation of Trauma Specific Frailty IndexTo test the predictive ability of the Trauma Sepcific Frailty Index. Protocol #: 19-6084 Location: Medical Center of the Rockies |
NRG GY017: Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical CancerProtocol #: 19-1151 Location: University of Colorado Hospital |
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 cancerProtocol #: 19-6076 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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 |
Neurophysiological Correlates V: 31Jan18Protocol #: 16-1480 Location: Childrens Hospital Colorado |
Natural History of Rett Syndrome and Related DisordersProtocol #: 15-2332 Location: Childrens Hospital Colorado |
Gamma band neural stimulation and its effects on resting state networksProtocol #: 19-1251 Locations: Brain Imaging Center (BIC); Department Specific Free Standing Clinic |
NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK MASTER PROTOCOLProtocol #: 19-1146 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
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 SeverityProtocol #: 19-0889 Locations: Brain Imaging Center (BIC); Childrens Hospital Colorado; Colorado Research Center; University of Colorado Hospital |
Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia V: 5; March 20, 2018Protocol #: 16-1998 Location: Childrens Hospital Colorado |
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 InfarctionProtocol #: 19-0675 Location: University of Colorado Hospital |
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 |
The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents with and without ObesityProtocol #: 19-1171 Location: University of Colorado Hospital |
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE?) TO HEAL CHRONIC DIABETIC FOOT ULCERSProtocol #: 19-1113 Location: University of Colorado Hospital |
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 SarcomasProtocol #: 19-0554 Location: University of Colorado Hospital |
Prognostic significance of variants in the CTNNB1 gene and the B-catenin pathway in recurrent high-intermediate risk endometrial cancerProtocol #: 19-1199 Location: University of Colorado Hospital |
A Phase 1, Open Label, Dose-Escalation and Expansion Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid TumorsProtocol #: 19-1118 Location: University of Colorado Hospital |
A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SUBCUTANEOUS OCRELIZUMAB ADMINISTRATION IN PATIENTS WITH MULTIPLE SCLEROSISProtocol #: 19-1040 Location: University of Colorado Hospital |
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 |
TOPP-2 registry Tacking Outcomes and Practice in Pediatric Pulmonary Hypertension V: 27 July 2018Protocol #: 15-0693 Location: Childrens Hospital Colorado |
Cardiopulmonary and Right Ventricular Function in Health and DiseaseThe 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 |
A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid TumorsProtocol #: 19-0946 Location: University of Colorado Hospital |
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)Protocol #: 19-0967 Location: University of Colorado Hospital |
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 19-0604 Location: University of Colorado Hospital |
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 MelanomaProtocol #: 19-0642 Location: University of Colorado Hospital |
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 trialThe 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 |
Molecular Transducers of Physical Activity Consortium (MoTrPAC) - AdultProtocol #: 18-0220 Location: University of Colorado Hospital |
Effect of freestyle skiing on bone mineral densityProtocol #: 19-0802 Locations: Barbara Davis Center; UCD Barbara Davis Center |
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or AblationProtocol #: 19-0820 Location: University of Colorado Hospital |
A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of RelapseProtocol #: 19-0905 Location: University of Colorado Hospital |
Understanding the Barriers to Epilepsy Surgery: A North American SurveyProtocol #: 19-0269 Location: University of Colorado Hospital |
A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVDProtocol #: 19-6060 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Outcomes and Prognostic Factors of Patients with Newly Diagnosed Burkitt Lymphoma (HRP-503c)Protocol #: 19-0900 Location: University of Colorado Hospital |
Ablation versus Stereotactic Body Radiotherapy for Early Stage Hepatocellular Carcinoma Not Amenable to Surgical TreatmentProtocol #: 19-0852 Location: University of Colorado Hospital |
Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal JunctionProtocol #: 19-0376 Locations: Greeley Hospital; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Outcomes after Standardized Testicular Torsion Management and Follow-upProtocol #: 19-0849 Location: Childrens Hospital Colorado |
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 GravisProtocol #: 19-0772 Location: University of Colorado Hospital |
An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia GravisProtocol #: 19-0150 Location: University of Colorado Hospital |
Inception Cohort for Juvenile Systemic Sclerosis: A Follow-Up Study Over 3 Years for Children and Young People with Systemic SclerosisProtocol #: 19-0814 Location: Childrens Hospital Colorado |
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 579Protocol #: 19-0858 Location: Childrens Hospital Colorado |
Treating PCOS with Exenatide 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 |
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 tumorsProtocol #: 19-0556 Location: University of Colorado Hospital |
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: Lone Tree Medical Center; University of Colorado Hospital |
Prognostic factors associated with outcomes in colorectal cancer liver metastasesProtocol #: 19-0770 Location: University of Colorado Hospital |
CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDYProtocol #: 19-0519 Location: University of Colorado Hospital |
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic FailureProtocol #: 19-0520 Location: University of Colorado Hospital |
A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal CancerProtocol #: 19-0591 Location: University of Colorado Hospital |
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 |
The Perelman Study of IntraUterine Growth RestrictionProtocol #: 14-1360 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)Protocol #: 19-0536 Location: Childrens Hospital Colorado |
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 dysfunctionProtocol #: 16-0994 Location: Childrens Hospital Colorado |
A Comprehensive and Collaborative Review of the Use of Whole Blood at Trauma Centers in the United StatesCompare Whole Blood vs Component Therapy Protocol #: 19-6047 Locations: Medical Center of the Rockies; Poudre Valley Hospital |
The Lung PCA: A Multi-Dimensional Atlas of Pulmonary PremalignancyThis 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 |
EnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisThe 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 |
Evaluation and Demonstration of Investigational MRI Software and HardwareTest new MRI scanner sequences in diverse patient population Protocol #: 19-0518 Location: Childrens Hospital Colorado |
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 CancerProtocol #: 19-0457 Location: University of Colorado Hospital |
The Role of the Autism Diagnostic Observation Schedule in the Diagnosis of Autism by a Developmental-Behavioral Pediatrician: A DBPNet StudyProtocol #: 19-0382 Location: Childrens Hospital Colorado |
Incidence and Effect of HLA Antibodies in Liver Transplant RecipientsProtocol #: 18-2594 Location: University of Colorado Hospital |
Instrumentation of Huntington's Disease Motor Function AssessmentProtocol #: 19-0212 Location: University of Colorado Hospital |
A PROSPECTIVE, MULTI-CENTER, SINGLE ARM STUDY TO OBTAIN "REAL WORLD" CLINICAL DATA AND CHARACTERIZE THE ACUTE AND LONG-TERM PERFORMANCE OF THE MICRUSFRAME AND GALAXY COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMSA Prospective, Multi-Center, Single Arm Study to obtain “Real World” Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils for the Endovascular Treatment of Intracranial Aneurysms Protocol #: 19-6503 Location: Memorial Hospital Central |
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 FailureProtocol #: 19-0414 Location: University of Colorado Hospital |
A 14-Week, Double-Blind, Randomized, Three-Arm, Parallel Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease (gLIDe)Protocol #: 19-0478 Location: University of Colorado Hospital |
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 |
A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors of any Type, and in Patients with Refractory Metastatic Colorectal CancerProtocol #: 19-0539 Location: University of Colorado Hospital |
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 |
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 |
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 |
Blunt bowel and mesenteric injury: A WTA Multicenter Prospective Observational StudyProtocol #: 18-6062 Locations: Memorial Hospital Central; Memorial Hospital North |
A phase II study to evaluate neoadjuvant osimertinib therapy in patients with surgically resectable, EGFRmutant non-small cell lung cancerProtocol #: 19-0325 Location: University of Colorado Hospital |
CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCERProtocol #: 19-0476 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed MeningiomaProtocol #: 19-0423 Location: University of Colorado Hospital |
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter TrialProtocol #: 19-6041 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
AMPLATZERTM PFO Occluder Post Approval StudyThis 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 |
Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous InfusionProtocol #: 19-0025 Location: University of Colorado Hospital |
ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)Protocol #: 19-0327 Location: University of Colorado Hospital |
A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain MetastasisProtocol #: 19-0161 Location: University of Colorado Hospital |
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 ExtensionProtocol #: 18-1695 Location: Childrens Hospital Colorado |
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 MELANOMAProtocol #: 19-0172 Location: University of Colorado Hospital |
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 CholangitisProtocol #: 19-0444 Location: University of Colorado Hospital |
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-MetProtocol #: 19-0232 Location: University of Colorado Hospital |
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimensProtocol #: 19-0326 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
Total Joint Arthroplasty in a Pediatric PopulationInvolves 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 |
Impact of Air Pollution on Immunotherapy Outcomes in Bladder CancerProtocol #: 18-2742 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital |
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 ScaleProtocol #: 19-0396 Location: Childrens Hospital Colorado |
A Natural History Study of CMT1B, CMT2A, CMT4A and CMT4CProtocol #: 18-2537 Location: University of Colorado Hospital |
A MULTICENTER, OPEN-LABEL SAFETY AND EFFICACY STUDY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN PATIENTS WITH MULTIPLE SCLEROSIS AND WALKING IMPAIRMENTProtocol #: 19-0363 Location: University of Colorado Hospital |
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 |
Prospective, multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellis SystemPatients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study Protocol #: 19-6501 Location: Memorial Hospital Central |
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 Hospital; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Improving physical activity maintenance following an exercise program for cancer survivorsProtocol #: 19-0323 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center |
Impact of surgical intervention on sleep dysfunction in patients with refractory epilepsyProtocol #: 19-0239 Location: University of Colorado Hospital |
PHASE I STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS (Pfizer Protocol A5481092/ ADVL1921)Protocol #: 19-0299 Location: Childrens Hospital Colorado |
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 CANCERA PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER Protocol #: 19-0206 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory OsteosarcomaPrimary 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: Children?s Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital |
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 TumorsProtocol #: 19-0207 Location: University of Colorado Hospital |
A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTSProtocol #: 19-0233 Location: University of Colorado Hospital |
APOGEELVAD registry Protocol #: 18-2576B Location: University of Colorado Hospital |
GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyThis 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 |
Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating RoomProtocol #: 18-2513 Location: Childrens Hospital Colorado |
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 CANCERProtocol #: 19-0127 Location: University of Colorado Hospital |
Investigating cortical networks disruption and rehabilitation after traumatic brain injuryProtocol #: 19-0049 Locations: Colorado Research Center; Department Specific Free Standing Clinic |
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 GlargineProtocol #: 19-0250 Locations: Barbara Davis Center; UCD Barbara Davis Center |
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 RecordingsTo test wireless vital sign monitor in the field and determine feasibility. Protocol #: 18-6102 Location: Medical Center of the Rockies |
Surgery Database ProjectProtocol #: 18-2839 Location: University of Colorado Hospital |
Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell)Protocol #: 16-0692 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid CardiomyopathyProtocol #: 19-0225 Location: University of Colorado Hospital |
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 |
Gene Expression of Cerebral AneurysmsIn this study, we will collect tissue and blood from participants during their epilepsy surgery. Protocol #: 19-0182 Location: University of Colorado Hospital |
Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKDThis 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 |
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II HypertensionProtocol #: 19-0159 Location: University of Colorado Hospital |
A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASISThis study is designed to test the effectiveness of the oral drug Apremilast in patients with mild to moderate Plaque Psoriasis. The study lasts ~36 weeks (around 9 months) from start to finish for each participant. There are around 11 scheduled visits throughout the 36 weeks that participants are asked to come to the clinic to see the research team. There are treatment groups and a placebo group in this study. After the first 16 weeks of the study, everyone from the placebo group will be placed into one of the treatment groups. Please direct any further questions or inquries to the Dermatology Clinical Research Team @ 720-848-0556 or diane.ladell@cuanschutz.edu OR daniel.uy@cuanschutz.edu Protocol #: 18-2578 Location: University of Colorado Hospital |
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 trialProtocol #: 19-0120 Location: University of Colorado Hospital |
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 GroupsA comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer Protocol #: 19-0048 Location: University of Colorado Hospital |
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 DysplasiaA 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 |
Investigating the Contribution of Peripheral versus Central Nervous System Immune Dysfunction to Cognitive AgingProtocol #: 18-2607 Location: University of Colorado Hospital |
Moderating effects of sleep on quality of life and fatigue following an exercise program for cancer survivorsProtocol #: 19-0041 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center |
An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi SyndromeProtocol #: 19-0079 Location: Childrens Hospital Colorado |
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 CANCERA double blind comparison of MPX versus placebo in men with prostate cancer. Protocol #: 18-2604 Location: University of Colorado Hospital |
Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patientsProtocol #: 18-2874 Location: University of Colorado Hospital |
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 cancerProtocol #: 18-6515 Location: Memorial Hospital Central |
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 FusionsProtocol #: 19-0011 Location: University of Colorado Hospital |
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 ErythematosusProtocol #: 19-0027 Location: Barbara Davis Center |
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic GastroparesisProtocol #: 18-2435 Location: University of Colorado Hospital |
New Graduate Nurse Orientation Using a Staged, Task-Layered Strategy: Implications for Length of Orientation and Self-Reported ConfidenceProtocol #: 18-6119 Locations: Medical Center of the Rockies; Poudre Valley Hospital |
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 PolypsOptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis. Protocol #: 18-2823 Location: University of Colorado Hospital |
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast CancerProtocol #: 18-2654 Location: University of Colorado Hospital |
Association of depth recordings from the temporal cortex with sleep pattern detection and characterization of sleep dysfunction in patients with refractory epilepsy.Protocol #: 18-2806 Location: University of Colorado Hospital |
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid TumorsProtocol #: 18-2520 Location: University of Colorado Hospital |
CLINICAL TRIALS IN ORGAN TRANSPLANTATION CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney TransplantationThis 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 |
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 THERAPYProtocol #: 18-2569 Location: University of Colorado Hospital |
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 |
Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in left ventricular outflow tract arrhythmias ablationProtocol #: 18-2772 Location: University of Colorado Hospital |
Early Feasibility Study of the Edwards Transcatheter Atrial Shunt SystemAdult 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 |
Use of a Pharmacy Managed Empiric Continuous Infusion Vancomycin Protocol in PediatricsProtocol #: 18-6128 Location: Memorial Hospital Central |
Identifying relevant seizure biomarkers from RNS? System recorded electrocorticography for the development of optimized seizure detection algorithmsProtocol #: 18-2089 Location: University of Colorado Hospital |
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C MutationProtocol #: 18-2529 Location: University of Colorado Hospital |
An Exploratory Investigation of the Impact of the Assistive Technology Partners Product Testing LaboratoryProtocol #: 11-0674 Locations: Memorial Hospital Central; Memorial Hospital North |
A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial SarcomaProtocol #: 18-2646 Location: University of Colorado Hospital |
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]:NATALEE).Protocol #: 18-2357 Locations: Lone Tree Medical Center; University of Colorado Hospital |
Understanding Barriers to Enrollment in Clinical Trials at the University of Colorado Cancer CenterProtocol #: 18-2684 Location: University of Colorado Hospital |
A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey ResultsProtocol #: 18-2562 Locations: Cherry Creek Medical Center; Lone Tree Medical Center; University of Colorado Hospital |
A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular diseaseAbout 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 |
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 |
A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL201 IN SUBJECTS WITH PARKINSON'S DISEASEProtocol #: 18-2423 Location: University of Colorado Hospital |
Controlling and Preventing Asthma Progression and Severity in Kids with OmalizumabRandomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase Protocol #: 18-2286 Location: Childrens Hospital Colorado |
Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018This 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 |
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 |
A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers.Protocol #: 16-2621 Locations: Denver Health Medical Center; National Jewish Health; University of Colorado Hospital |
CLASP IID/IIFPASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation Protocol #: 18-6126 Locations: Harmony Campus; Medical Center of the Rockies |
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 |
Destination Therapy Post Approval Study - Medtronic HVAD SystemLVAD registry Protocol #: 18-2576A Location: University of Colorado Hospital |
Predictors of physical activity maintenance in colorectal cancer survivorsSupervised 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 |
A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)Protocol #: 18-2487 Location: University of Colorado Hospital |
A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)Protocol #: 18-2466 Location: University of Colorado Hospital |
A Phase 2, multicenter, open-label, 2-cohort study of trastuzumab deruxtecan (DS-8201a), an anti-HER2 antibody drug conjugate (ADC), for HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer (NSCLC)Protocol #: 18-2488 Location: University of Colorado Hospital |
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 2017Protocol #: 16-0086 Location: University of Colorado Hospital |
A Phase 2 Study of M6620 in Combination with Carboplatin compared with Docetaxel in Combination with Carboplatin in Metastatic Castration-Resistant Prostate CancerA comparison of M6620 + Carboplatin versus Docetaxel + Carboplatin in metastatic castrate-resistant prostate cancer Protocol #: 18-2398 Location: University of Colorado Hospital |
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 |
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia GravisProtocol #: 18-2341 Location: University of Colorado Hospital |
Study of Pulmonary Rehabilitation In Nintedanib Treated Patients with IPF: Improvements in Activity, Exercise Endurance Time, and QoLProtocol #: 18-2482 Location: University of Colorado Hospital |
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 AdultsProtocol #: 18-2258 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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 |
Evaluation of Sun Protection Education using the Reveal Imager Photo-aging and the SPA QuestionnaireProtocol #: 17-2424 Locations: University of Colorado Cancer Center; University of Colorado Hospital |
A PHASE 2 STUDY OF AZD1775, A WEE1 INHIBITOR, IN PATIENTS WITH CCNE1 AMPLIFICATIONProtocol #: 18-2334 Location: University of Colorado Hospital |
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 cancerProtocol #: 18-2209 Location: University of Colorado Hospital |
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 |
PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, or Diffuse Intrinsic Pontine GliomaThis 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 |
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 MutationProtocol #: 18-2219 Location: University of Colorado Hospital |
A Phase 2, Open-Label Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 ImmunotherapyProtocol #: 18-2284 Location: University of Colorado Hospital |
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 |
A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 18-1816 Location: University of Colorado Hospital |
Safety and Efficacy Study of Elezanumab (ABT-555) in Relapsing Forms of Multiple SclerosisProtocol #: 18-2451 Location: University of Colorado Hospital |
Safety and Efficacy Study of Elezanumab (ABT-555) in Progressive Forms of Multiple SclerosisProtocol #: 18-2152 Location: University of Colorado Hospital |
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 CANCERA comparison of standard systemic therapy versus standard systemic therapy plus surgery or radiation therpy Protocol #: 18-2252 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)Protocol #: 18-2354 Location: University of Colorado Hospital |
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 HemodialysisProtocol #: 18-2337 Location: Childrens Hospital Colorado |
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 |
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 |
Metabolic and Renal Effects of Automated Insulin Delivery Systems in Youth with Type 1 Diabetes MellitusProtocol #: 18-1558 Location: Childrens Hospital Colorado |
A prospective, long term registry of patients with a diagnosis of spinal muscular atrophy V: 1.0; 20March2018Protocol #: 18-1683 Location: Childrens Hospital Colorado |
A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1Protocol #: 18-2315 Location: University of Colorado Hospital |
A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual BleedingThe 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 |
Phase I trial of indoximod in combination with temozolomide-based therapy for children with progressive primary brain tumors (NLG2105)Protocol #: 18-2309 Location: Childrens Hospital Colorado |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialA 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 |
A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYProtocol #: 18-2230 Location: Childrens Hospital Colorado |
The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic SyndromeProtocol #: 18-0369 Location: University of Colorado Hospital |
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin LymphomaProtocol #: 18-6510 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital HyperinsulinismProtocol #: 18-2130 Location: Childrens Hospital Colorado |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted TherapyProtocol #: 18-1919 Location: University of Colorado Hospital |
A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with ImatinibProtocol #: 18-1856 Location: University of Colorado Hospital |
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF).Protocol #: 18-1858 Location: University of Colorado Hospital |
Genomic Translation for ALS CareProtocol #: 18-1768 Location: University of Colorado Hospital |
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 |
CU Faces of Hope-Genetics of Craniofacial and Dental Development Research StudyThis 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 |
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 |
The Associations between EIT and Clinical Measures during Standard of Care Procedures in Patients with Respiratory Disease: A Preliminary StudyPrimary 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 |
A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONSProtocol #: 18-2047 Location: University of Colorado Hospital |
A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar AtaxiaProtocol #: 18-1875 Location: University of Colorado Hospital |
A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 in Pediatric and Adult Subjects with Distal Renal Tubular AcidosisProtocol #: 18-2100 Location: Childrens Hospital Colorado |
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula RepairComparing 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 |
A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related GenesProtocol #: 18-1933 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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 InhibitorsThe 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 |
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 |
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 |
A PHASE 3, MULTICENTER, RANDOMIZED, OPENLABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF BB2121 VERSUS STANDARD TRIPLET REGIMENS IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (KarMMa-3)Protocol #: 18-1983 Location: University of Colorado Hospital |
Identifying Predictors of Poor Health-Related Quality-of-Life among Pediatric Hematopoietic Stem Cell DonorsProtocol #: 18-1997 Location: Childrens Hospital Colorado |
Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense RegimenProtocol #: 18-6061 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies |
COG ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot StudyProtocol #: 18-2000 Location: Childrens Hospital Colorado |
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 TherapyThis 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 |
Clinical Outcome Measures in Friedreich's AtaxiaProtocol #: 18-1641 Location: University of Colorado Hospital |
A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Central Precocious Puberty (CPP)Protocol #: 18-1716 Location: Childrens Hospital Colorado |
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 SarcomasProtocol #: 18-1672 Location: University of Colorado Hospital |
An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical VentilationThe study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug. Protocol #: 18-1706 Location: University of Colorado Hospital |
A multicenter, randomized, double-blinded, placebo-controlled, Phase 3 trial of adjuvant Avelumab (anti-PDL-1 antibody) in Merkel cell carcinoma patients with clinically detected lymph node metastasesProtocol #: 18-1734 Location: University of Colorado Hospital |
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung CancerProtocol #: 18-1728 Location: University of Colorado Hospital |
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 |
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 |
A study to investigate biomarkers in rheumatoid arthritis associated interstitial lung diseaseProtocol #: 18-1808 Location: University of Colorado Hospital |
Square wave testosterone therapy in castration resistant prostate cancerFeasibility 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 |
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell CarcinomaProtocol #: 18-1599 Location: University of Colorado Hospital |
Phase 1, two-part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumorsProtocol #: 18-1721 Location: University of Colorado Hospital |
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 AcidosisThis 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 |
My Transgender Brain Study (MyT "Mighty" Brain) - ColoradoProtocol #: 18-1740 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018Protocol #: 18-1493 Location: University of Colorado Hospital |
Prospective, observational, multi-center cohort study of venous thromboembolism outcomes in thrombocytopenic cancer patients (TROVE Study)Protocol #: 18-1461 Location: University of Colorado Hospital |
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. CA045-001Protocol #: 18-1343 Location: University of Colorado Hospital |
A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid TumorsProtocol #: 18-1659 Location: University of Colorado Hospital |
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 MesotheliomaProtocol #: 18-1654 Location: University of Colorado Hospital |
Moderate to Severe Atopic Dermatitis: Evaluation of Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects.A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis Protocol #: 18-1624 Location: University of Colorado Hospital |
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 BlockadeProtocol #: 18-1526 Location: University of Colorado Hospital |
ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)Protocol #: 18-1337 Location: University of Colorado Hospital |
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 |
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 SYMPTOMSProtocol #: 18-1429 Location: Childrens Hospital Colorado |
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 StudyProtocol #: 18-1336 Location: University of Colorado Hospital |
EA2165 A Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal CancerProtocol #: 18-1216 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
NRG-DT001: A PHASE IB TRIAL OF NEOADJUVANT AMG 232 CONCURRENT WITH PREOPERATIVE RADIOTHERAPY IN WILD-TYPE P53 SOFT TISSUE SARCOMA (STS)Protocol #: 18-1477 Locations: Greeley Hospital; Harmony Campus; Longs Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination with Pembrolizumab in Patients with Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)Protocol #: 18-1431 Location: University of Colorado Hospital |
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 LymphomaProtocol #: 18-0867 Location: Childrens Hospital Colorado |
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 LYMPHOMAProtocol #: 18-1439 Location: University of Colorado Hospital |
Acceptance and Commitment Therapy for Chronic Pain in Cancer SurvivorsPrimary Objective: To evaluate the effectiveness of an 8-week, group-based, Acceptance and Commitment Therapy (ACT) intervention for chronic pain management in cancer survivors who have completed active treatment. Secondary Objective: To evaluate the implementation of an 8-week, group-based, ACT intervention for chronic pain management in cancer survivors who have completed active treatment. Protocol #: 18-1102 Location: University of Colorado Hospital |
Peripheral Inflammatory Cytokine Levels in Parkinson DiseaseProtocol #: 18-1356 Location: University of Colorado Hospital |
Gut microbiome alterations by ketogenic diet treatment V: 2; July 31, 2018Protocol #: 18-1391 Location: Childrens Hospital Colorado |
A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-a-cyclodextrin) in Subjects with Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) DiseaseProtocol #: 18-0997 Location: University of Colorado Hospital |
Conversational Speech in the Diagnosis of Neurocognitive DisordersProtocol #: 18-0456 Location: University of Colorado Hospital |
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 |
A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic CancerProtocol #: 18-1347 Location: University of Colorado Hospital |
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 TumorsProtocol #: 18-1263 Location: University of Colorado Hospital |
A221504 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF AN ORAL, SELECTIVE PERIPHERAL OPIOID RECEPTOR ANTAGONIST IN ADVANCED NON-SMALL CELL LUNG CANCERProtocol #: 18-1203 Locations: Memorial Hospital Central; Memorial Hospital North |
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 DISEASEParticipants 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 |
Effect of guided imagery for radiotherapy-related distress: A randomized controlled trial for patients with head and neck cancerProtocol #: 18-1100 Location: University of Colorado Hospital |
More than a Movement Disorder: Applying Palliative Care to Parkinson?s Disease v: 12/06/2017Protocol #: 16-1400 Locations: Colorado Research Center; Department Specific Free Standing Clinic |
The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot StudyThe 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 |
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-3475-716Protocol #: 18-1199 Location: University of Colorado Hospital |
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile InfectionPrimary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment. Protocol #: 18-1344 Location: University of Colorado Hospital |
The Effects of Resistance Training on Appetite RegulationIn 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 |
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-2017Assess 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 |
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid TumorsProtocol #: 18-6055 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Nivolumab with standard of care chemotherapy for the first line treatment of peripheral T cell lymphomaProtocol #: 18-0708 Locations: City of Hope Cancer Center; Thomas Jefferson University Hospital Cancer Center; University of Colorado Hospital |
Study evaluating feasibility of isolating circulating tumor DNA from blood, cerebrospinal fluid, and urine in Pediatric Solid Tumor patientsProtocol #: 18-1281 Location: Childrens Hospital Colorado |
A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis 14DEC2016TARGET-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 |
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 |
Obalon? Balloon System, The Post Approval StudyThe 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 |
Microburst VNS Therapy Feasibility Study in Patients with Refractory EpilepsyProtocol #: 18-0995 Location: University of Colorado Hospital |
An open-label, Phase I study to assess the safety of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.Protocol #: 18-1093 Location: University of Colorado Hospital |
Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults with Advanced Heart FailureProtocol #: 18-0973 Locations: Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone FormationWe are looking for healthy men to participate in a research study on the effects of sleep restriction on bone. The purpose of this research is to understand how shortened sleep affects bone metabolism. The study includes an intervention phase consisting of a 1-week outpatient and 8-night inpatient stay. Participants will be observed after discharge from the intervention phase for 3 weeks. Principal Investigator, Christine Swanson, MD, MCR (COMIRB #18-0015) Protocol #: 18-0015 Location: University of Colorado Hospital |
A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3Protocol #: 18-1150 Location: University of Colorado Hospital |
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and NeckProtocol #: 18-1049 Location: University of Colorado Hospital |
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 |
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) StudyThe 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 |
A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTSThe primary objective of this study is: To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life. Protocol #: 18-1121 Location: University of Colorado Hospital |
An Observational Cohort Study of the Use of Avatrombopag in Patients with Thrombocytopenia Associated with Chronic Liver Disease Undergoing a ProcedureProtocol #: 18-1144 Location: University of Colorado Hospital |
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 |
Neurologic Music Therapy for enhancing fine motor control in Parkinson's Disease 16Apr2018Protocol #: 16-2308 Location: University of Colorado Hospital |
PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI). 10DEC2017Protocol #: 18-1095 Locations: Memorial Hospital Central; University of Colorado Hospital |
Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (aged 18-59) with Acute Myeloid LeukemiaProtocol #: 18-0709 Location: University of Colorado Hospital |
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 Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
ProSTAR: A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer.A comparison of enzalutamide with and without CPI1205 in patients with metastatic prostate cancer Protocol #: 18-0990 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORSProtocol #: 18-0965 Location: University of Colorado Hospital |
Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients with Previously Untreated High Grade Myelodysplastic SyndromesProtocol #: 17-2215 Location: University of Colorado Hospital |
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 |
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; 22Feb2019Protocol #: 18-0857 Location: Childrens Hospital Colorado |
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 |
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 |
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 |
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 |
Ruptured Aneurysms Treated with Hydrogel CoilsTo determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms. Protocol #: 18-6052 Location: Memorial Hospital Central |
A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3021 IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 18-0685 Location: University of Colorado Hospital |
RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTIONProtocol #: 18-0627 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCERA comparison of Talazoparib plus enzalutamide vs placebo plus enzalutamide Protocol #: 18-0884 Location: University of Colorado Hospital |
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 SyndromeIf you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period. Protocol #: 18-6051 Location: Memorial Hospital Central |
PBTC-050: A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children with Recurrent or Refractory Malignant Brain TumorsProtocol #: 18-0947 Location: Childrens Hospital Colorado |
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 ReceptorProtocol #: 18-0756 Location: University of Colorado Hospital |
A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor KidneyThe study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg ANG-3777 or placebo (normal saline). Primary Objective: ? To demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft with DGF Secondary Objectives: ? To demonstrate the efficacy of ANG-3777 in optimizing renal function in recipients of a deceased donor renal allograft with DGF ? To demonstrate the efficacy of ANG-3777 in reducing length of hospital stay in recipients of a deceased donor renal allograft with DGF Protocol #: 16-1038 Location: University of Colorado Hospital |
A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial NeoplasiaThe 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 |
A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGardA 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 |
Multi-center, randomized, double-blinded assessment of Tecfidera? in extending the time to a first attack in radiologically isolated syndrome (RIS) (ARISE)Protocol #: 16-0121 Location: University of Colorado Hospital |
A study of the genetics of pulmonary fibrosisThis 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 |
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 FluctuationsStudy is double blind and placebo controlled. Protocol #: 18-0829 Location: University of Colorado Hospital |
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 |
AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled TrialProtocol #: 16-6109-2N Location: Medical Center of the Rockies |
Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Cisplatin-Ineligble or Chemotherapy-refusing Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the BladderA comparison of Neoadjuvant Nivolumab with versus without Urelumab in patients with cisplatin-ineligible bladder cancer Protocol #: 18-0760 Location: University of Colorado Hospital |
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701Protocol #: 18-0834 Location: Childrens Hospital Colorado |
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOSProtocol #: 18-0803 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Molecular Endotypes of Chronic Spontaneous UrticariaProtocol #: 18-0850 Location: University of Colorado Hospital |
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 |
Effects of Cannabis Use in Cancer Patients: A Feasibility StudyProtocol #: 18-0836 Locations: University of Colorado Hospital; University of Colorado, Boulder |
A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)Protocol #: 18-0818 Location: University of Colorado Hospital |
PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and EpendymomaProtocol #: 18-0498 Location: Childrens Hospital Colorado |
NANT 2013-01: Immunotherapy of relapsed refractory neuroblastoma with expanded NK cells, dinutuximab and lenalidomideProtocol #: 18-0686 Location: Childrens Hospital Colorado |
The Longitudinal Surveillance Study of the 4-SITE Lead/Header SystemProtocol #: 13-2415 |
Automatic measurement of hand movements toward development of an objective assessment of primary motor symptoms in Parkinson?s diseaseProtocol #: 15-1041 Location: University of Colorado Hospital |
A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancerThis 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 |
Education Efficacy in Patient InterventionsProtocol #: 18-6020 Location: Medical Center of the Rockies |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying TherapiesProtocol #: 18-0482 Location: University of Colorado Hospital |
A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)Protocol #: 18-0541 Location: University of Colorado Hospital |
NANT 2017-01: A Phase I Study of 131I-MIBG with Dinutuximab for Relapsed/Refractory NeuroblastomaProtocol #: 18-0501 Location: Childrens Hospital Colorado |
Identifying Environmental Triggers of Smoking Behaviors in Low-income CommunitiesProtocol #: 18-0052 Locations: Department Specific Free Standing Clinic; University of Colorado Cancer Center; University of Colorado Hospital |
Unrelated Donor Transplant versus Immune Therapy in Pediatric Severe Aplastic Anemia (TransIT)Protocol #: 18-0524 Location: Childrens Hospital Colorado |
Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary ThromboendoarterectomyThis 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 |
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 adherenceProtocol #: 18-0715 Location: University of Colorado Hospital |
X-linked Hypophosphatemia Disease Monitoring Program (XLH-DMP)Protocol #: 18-0225 Location: Childrens Hospital Colorado |
Narcotic consumption in discectomies: microscopic versus endoscopicIn 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 |
Acute Kidney Injury and Vascular FunctionThis 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 |
Trauma ICU Prevelance Project (TRIPP study) - an American Association for the Surgery of Trauma Multi-institutional StudyProtocol #: 18-6038 Location: Memorial Hospital Central |
Pilot study of time restricted feeding as a weight loss intervention in overweight and obese adultsProtocol #: 18-0487 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
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 |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)Protocol #: 18-0461 Location: Childrens Hospital Colorado |
Intermuscular adipose tissue (IMAT) - protagonist in sarcopenia and insulin resistance in humansProtocol #: 18-0582 Location: University of Colorado Hospital |
PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCERProtocol #: 18-0285 Locations: Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Title: PRO-ACT: Prevention of De Novo HCV with Antiviral HCV Therapy Post-Liver and Post-Kidney TransplantProtocol #: 18-0559 Location: University of Colorado Hospital |
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 |
Precision Approach to PPI Therapy in Gastroesophageal reflux diseaseOver 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 |
Impact of Oral mCRPC Therapies Stewardship Pilot Program for VeteransProtocol #: 18-0167 Location: Rocky Mountain Regional VA Medical Center |
An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical ProcedureThe 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 |
Combining Testosterone Therapy and Exercise to Improve Function Post Hip FractureProtocol #: 17-2186 Location: University of Colorado Hospital |
A Multi-Site Randomized Phase I/II Study of Stereotactic Ablative Body Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early- Stage Non-Small Cell Lung CancerProtocol #: 18-0504 Location: University of Colorado Hospital |
COG ANHL1522 - A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-specific Cytotoxic T-Lymphocytes (LMP-TC, IND # 17068) in Pediatric Solid Organ Recipients (SOT) with EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)Protocol #: 18-0198 Location: Childrens Hospital Colorado |
Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to CisplatinProtocol #: 18-0286 Locations: Greeley Hospital; Harmony Campus; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Poudre Valley Hospital; University of Colorado Hospital |
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 |
A PHASE 1 SINGLE-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 INHIBITORSProtocol #: 18-0385 Location: University of Colorado Hospital |
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 |
AMPLATZERTM PFO Occluder Post Approval StudyProtocol #: 17-2334 Location: University of Colorado Hospital |
Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF)The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial. Phase I will be non-randomized. Phase II will be randomized. 1) To evaluate and optimize HeartLogic? Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II) Protocol #: 18-6028 Locations: Memorial Hospital Central; Memorial Hospital North |
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 |
A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal StentsThe 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 |
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 |
Training and testing machine-learning algorithms using a Limited Dataset from the Health Data Compass database: A Pilot StudyProtocol #: 18-0251 Location: University of Colorado Hospital |
Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid TumorsProtocol #: 18-0247 Location: University of Colorado Hospital |
Can the cervical spine be clinically cleared in awake and alert blunt trauma patients with "distracting injuries"?Protocol #: 17-6220 Location: Memorial Hospital Central |
Geri-TBI A prospective multi-center evaluation of geriatric patients with traumatic brain injuryProtocol #: 17-6205 Location: Memorial Hospital Central |
Prospective, Observational Trial of Blunt Cerebrovascular Injury Management and Stroke FormationThe 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 |
A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant TumorsProtocol #: 18-0154 Location: University of Colorado Hospital |
Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancerProtocol #: 17-0466 Location: University of Colorado Hospital |
Diet and Relapses in Pediatric Multiple SclerosisProtocol #: 18-0393 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Watchman for patients with atrial fibrillation undergoing transcatheter aortic valve replacementWATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial. Protocol #: 18-6002 Locations: Harmony Campus; Medical Center of the Rockies |
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Protocol #: 15-2388 Location: University of Colorado Hospital |
Application of transcranial alternating current stimulation for modulation of sleep and cognitive performance1).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 |
A multicenter, open-label randomized study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of Nestorone? and estradiol (NES-E2 CVR)Protocol #: 18-0226 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
ADVL1614: A Phase I/II Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid TumorsProtocol #: 18-0320 Location: Childrens Hospital Colorado |
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 TumorsProtocol #: 18-0017 Location: Childrens Hospital Colorado |
Multiple-Biopsy of Infiltrative Glioma (M-BIG) StudyProtocol #: 17-2111 Location: Childrens Hospital Colorado |
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 CANCERProtocol #: 17-2208 Location: University of Colorado Hospital |
Perceived palliative care needs of Huntington's disease patientsProtocol #: 18-0216 Location: University of Colorado Hospital |
A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with AvelumabProtocol #: 18-0187 Location: University of Colorado Hospital |
An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab TherapeuticallyThe safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk. Protocol #: 16-0066 Location: University of Colorado Hospital |
Clinical Trial Readiness for SCA1 and SCA3Protocol #: 18-0020 Location: University of Colorado Hospital |
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 MellitusProtocol #: 17-1809 Location: Childrens Hospital Colorado |
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 |
A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients with Parkinson's DiseaseProtocol #: 18-0113 Locations: Anschutz Health and Wellness; University of Colorado Hospital |
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid TumorsProtocol #: 18-0033 Location: University of Colorado Hospital |
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 |
A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects with Congenital Adrenal Hyperplasia V: 2Feb2018Protocol #: 17-1543 Location: Childrens Hospital Colorado |
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart FailureThis 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 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) CirrhosisProtocol #: 18-0153 Location: University of Colorado Hospital |
A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Primary Sclerosing Cholangitis (PSC)DUR-928 (investigational drug) Protocol #: 18-0123 Location: University of Colorado Hospital |
Validation of a performance-based assessment of functional ability related to cognition in Parkinson's diseaseProtocol #: 15-0170 Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
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 |
A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 18-0031 Location: University of Colorado Hospital |
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax-AXL-ADC) in patients with solid tumorsProtocol #: 17-2451 Location: University of Colorado Hospital |
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase CProtocol #: 17-2226 Location: University of Colorado Hospital |
Effects of pubertal blockade and hormone therapy on cardiometabolic risk markers in transgender adolescentsThere 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 |
Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017This 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 |
Assisting in Informing Decisions in Emergency Departments (ED-AID) StudyProtocol #: 17-2299 Location: University of Colorado Hospital |
A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase InhibitorsProtocol #: 17-2431 Location: University of Colorado Hospital |
ALTE16C1: Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of OsteosarcomaProtocol #: 17-2472 Location: Childrens Hospital Colorado |
Bariatric Surgery in Adolescents (BSA) Biobank: Collection and Banking of Biological Specimens and Data from Patients with Obesity, Diabetes and ControlsProtocol #: 17-2355 Locations: Childrens Hospital Colorado; Colorado Research Center |
Barriers and facilitators to maternal visits in the NICU and impact of visiting on infant developmentProtocol #: 16-0179 Locations: Childrens Hospital Colorado; Denver Health Medical Center; University of Colorado Hospital |
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 Glioma1.1 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 |
A Phase I Trial of AZD9291 and Necitumumab in EGFR-Mutant Non-Small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase InhibitorProtocol #: 17-2381 Location: University of Colorado Hospital |
Determining the Optimal Treatment Strategy for Patients who have Chronic Migraine with Medication OveruseProtocol #: 16-2179 Location: University of Colorado Hospital |
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; 12/15/2017Protocol #: UCH11-1101 Location: Harmony Campus |
A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)Protocol #: UCH04-680 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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 CancerProtocol #: UCH06-778 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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 |
Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study V:12/18/2018Protocol #: 16-1752 Location: Childrens Hospital Colorado |
Influence of PTSD Symptoms on Chronic Pain Development After Sexual AssaultProtocol #: 15-6021 Location: Memorial Hospital Central |
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects with Primary Sclerosing Cholangitis (PSC)Protocol #: 17-2367 Location: University of Colorado Hospital |
A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene MutationsThis 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 |
Evaluation of commercial pharmacogenomic testing in psychiatry medicine.Protocol #: 17-2347 Location: University of Colorado Hospital |
The ANDES study: Antenatal exposures and non-communicable disease in BoliviaProtocol #: 17-1529 Locations: Colorado Research Center; Department Specific Free Standing Clinic |
A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATIONA PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION Protocol #: 17-2078 Location: University of Colorado Hospital |
Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapyProtocol #: 15-0657 Location: University of Colorado Hospital |
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 TransplantProtocol #: 17-2336 Location: University of Colorado Hospital |
APEC1621-MASTER, NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)Protocol #: 17-2168 Location: Childrens Hospital Colorado |
A randomized, double blind, placebo-controlled parallel study of tolerability and efficacy of Cannabidiol (CBD) on tremor in Parkinson's diseaseProtocol #: 17-2318 Location: University of Colorado Hospital |
SUNRISE: Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in AdolescentsI. 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 |
Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in CardiomyocytesProtocol #: 17-2296 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3011 IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 17-2450 Location: University of Colorado Hospital |
Kidney Immunosuppression Dosed Daily Only (KIDDO)Protocol #: 17-2311 Location: Childrens Hospital Colorado |
PBTC-039: Phase II study of Peginterferon alfa-2b (SYLATRON) for pediatric patients with unresectable or recurrent craniopharyngiomaProtocol #: 17-2257 Location: Childrens Hospital Colorado |
A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic CancerProtocol #: 17-2189 Location: University of Colorado Hospital |
Pilot Study: A Strategy for High-Frequency Comprehensive Home Toxicology ScreeningProtocol #: 17-1597 Locations: ARTS Synergy Outpatient Treatment; Colorado Research Center |
Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic ProphylaxisThis 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 |
Integrating Palliative Care Social Workers into Sub-Acute Settings: A Feasibility TrialProtocol #: 17-2263 Location: Kaiser Permanente of Colorado |
Prospective, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel Paclitaxel-CoatEd Percutaneous Angioplasty BalloonProtocol #: UCH13-1272 |
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal ArteriesProtocol #: UCH12-1142 |
EARLY-TAVR Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic StenosisProtocol #: 17-6134 Locations: Greeley Hospital; Harmony Campus; Longs Peak Hospital; Medical Center of the Rockies |
COG AALL1631 - International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbonesProtocol #: 17-2213 Location: Childrens Hospital Colorado |
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 MalignanciesProtocol #: 17-2074 Location: University of Colorado Hospital |
A Phase I Study of the Wee 1 kinase (Wee 1) inhibitor AZD1775 in combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)Protocol #: 17-2198 Location: University of Colorado Hospital |
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)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 |
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 |
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 |
Open label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma (Merck-Serono Protocol MS100070-0306Protocol #: 17-1845 Location: Childrens Hospital Colorado |
Nutrition in Older HIV-Infected Adults Receiving ART: Impacts of Food Insecurity on Frailty and Disease ProgressionProtocol #: 17-2145 Location: University of Colorado Hospital |
American Registry for Migraine ResearchProtocol #: 17-2165 Locations: Lone Tree Medical Center; UCHealth Internal Medical Clinic - Lowry; University of Colorado Hospital |
Mitochondrial targeted antioxidant supplementation and diastolic function in healthy men and womenAs 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 |
Positive Aging ConsultationsProtocol #: 17-2160 Location: University of Colorado Hospital |
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 ExpressionProtocol #: 17-1778 Location: University of Colorado Hospital |
SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL? SystemThis is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart, Penumbra Coil 400, and the Penumbra Occlusion Device. Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Protocol #: 17-2122 Location: University of Colorado Hospital |
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 AMPLIFICATIONProtocol #: 17-2125 Locations: Greeley Hospital; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)Protocol #: 17-2118 Location: University of Colorado Hospital |
Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - CoBIS 2The 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 |
A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients with Postbariatric HypoglycemiaProtocol #: 17-0366 Location: University of Colorado Hospital |
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 |
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY OF CK-2127107 IN TWO ASCENDING DOSE COHORTS OF PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA)Protocol #: 17-1816 Location: University of Colorado Hospital |
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 RepairProtocol #: 17-2036 Locations: Greeley Hospital; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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 TumorsProtocol #: 17-1808 Location: University of Colorado Hospital |
Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn's Disease v:5.0; March 20, 2018Protocol #: 17-0019 Location: University of Colorado Hospital |
An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With MyelofibrosisProtocol #: 17-2086 Location: University of Colorado Hospital |
TACL 2016-001: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin LymphomaProtocol #: 17-1481 Location: Childrens Hospital Colorado |
A Multi-Center, Open-Label, Prospective Study of CervicalStim device as Adjunctive Care following Cervical FusionProtocol #: 17-1013 Location: University of Colorado Hospital |
Electronic Cigarette Use During PregnancyProtocol #: 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 |
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 asthmaGSK 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 |
A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndromeProtocol #: 17-2000 Location: University of Colorado Hospital |
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 CancerSubjects 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 |
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 tumorsProtocol #: 17-1991 Location: Childrens Hospital Colorado |
An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following A Single Oral Dose in Patients with Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic ImpairmentProtocol #: 17-1943 Location: University of Colorado Hospital |
A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLCProtocol #: 17-1757 Location: University of Colorado Hospital |
MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?Protocol #: 16-2506 Location: University of Colorado Hospital |
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 |
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 |
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 |
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve ReplacementProtocol #: 16-0696 Location: University of Colorado Hospital |
S1616, A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 AgentProtocol #: 17-1834 Locations: Greeley Hospital; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
The influence of gonadal hormone suppression on adipocyte lineage and the microbiomeSix 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 |
COG AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene RearrangementProtocol #: 17-0619 Location: Childrens Hospital Colorado |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's DiseaseProtocol #: 17-1532 Location: University of Colorado Hospital |
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 |
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).Protocol #: 17-6199 Location: Memorial Hospital Central |
A Multi-Center, Open-Label, Prospective Study of SpinalStim (MOP-SS) as adjunctive Care following Lumbar Fusion SurgeryThe study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim. Protocol #: 17-1037 Location: University of Colorado Hospital |
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 |
Protocol I7S-MC-HBEH Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD) (The PRESENCE Study)Protocol #: 17-1825 Location: University of Colorado Hospital |
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 |
Duration of Marijuana (THC) Concentration in Breast Milk- a Pilot StudyProtocol #: 15-1639 Location: University of Colorado Hospital |
TACL 2016-003: Epigenetic Reprogramming in Relapse AML: A Phase I Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults with Relapsed/Refractory AMLProtocol #: 17-1777 Location: Childrens Hospital Colorado |
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 |
Optimizing Physical Activity Outcomes after Total Knee ArthroplastyProtocol #: 17-0079 Location: University of Colorado Hospital |
PBTC-029: A Phase I and Phase II Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade GliomaProtocol #: 17-1790 Location: Childrens Hospital Colorado |
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 |
Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection FractionThe objective of this study is to understand real-world treatment patterns, as well as the reasons and barriers for treatment changes in heart failure patients with reduced ejection fraction. Protocol #: 16-6062 Location: Memorial Hospital Central |
Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)Protocol #: 17-1751 Location: University of Colorado Hospital |
Transcranial electrical stimulation for the treatment of cervical dystoniaProtocol #: 17-1322 Locations: Colorado Research Center; Department Specific Free Standing Clinic |
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 LumpectomyProtocol #: UCH09-0815 Location: Memorial Hospital North |
Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/ObesityIn 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 |
Ion Channel Genetic Biomarkers: Diagnostic Capability in the Assessment of Mood DisordersProtocol #: 17-1578 Locations: Colorado Research Center; Sheridan Health Services |
A PHASE III RANDOMIZED TRIAL OF LOBECTOMY VERSUS SUBLOBAR RESECTION FOR SMALL (!U 2 CM) PERIPHERAL NON-SMALL CELL LUNG CANCERProtocol #: UCH13-0619 Location: Memorial Hospital Central |
Emergency Medicine Specimen BankProtocol #: 17-1642 Location: University of Colorado Hospital |
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)Protocol #: UCH14-0104 Location: Memorial Hospital Central |
A Phase I/Ib Study of sEphB4-HSA in Combination with Cetuximab and Radiation Therapy in Patients with High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and NeckProtocol #: 16-2575 Location: University of Colorado Hospital |
A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)Protocol #: 17-1021 Location: University of Colorado Hospital |
A Pilot Study to Investigate the Efficacy and Safety of ARRY-371797 in Patients with Symptomatic Genetic Dilated Cardiomyyopathy Due to a Lamin A/C Gene MutationProtocol #: 16-0133 Location: University of Colorado Hospital |
PRENATAL DEPRESSION AND ANXIETY HAVE AN IMPACT ON PSYCHOLOGICALLY RELATED EARLY INFANT PHYSIOLOGY: TIMING, MEDIATORS AND MODERATORSProtocol #: 11-0548 Location: University of Colorado Hospital |
Lifeboard Software Functionality StudyAccuracy of the software will be evaluated through case review. The cases entered into the Lifeboard software will be compared to the paper trauma flow sheet. Research staff will be comparing what is entered into the software on the tablet against the trauma flow sheet for each case. Protocol #: UCH14-1326 Location: Medical Center of the Rockies |
Virtual and Augmented Reality StudyProtocol #: 17-6191 Location: Medical Center of the Rockies |
Identification of patients at high risk for readmission after a COPD exacerbationProtocol #: 17-0245 Location: University of Colorado Hospital |
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 womenProtocol #: 17-1314 |
The relationship between the gut microbiome composition and pulmonary immune function in HIV infectionProtocol #: 17-1512 Location: University of Colorado Hospital |
TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017Protocol #: 17-1317 Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic |
Pilot Study to Evaluate Safety and Tolerability of Inhaled N-Acetylcysteine in Pulmonary FibrosisThis 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 |
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic MelanomaProtocol #: 17-1474 Location: University of Colorado Hospital |
Copeptin and Nonalcoholic Fatty Liver DiseaseSee above Protocol #: 17-1160 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approachesRegular 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 |
Growing up with X and Y chromosome trisomy: the TRIXY studyProtocol #: 16-1710 |
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 Stenosishe 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 |
Ethnography of Synthetic Cannabinoid Abusers to Target Substance Abuse InterventionProtocol #: 17-1326 |
Effect of Bovine Arteriovenous Grafts on Patient Sensitization Prior to Kidney TransplantProtocol #: 17-1524 Location: University of Colorado Hospital |
Fragile X BiobankProtocol #: 16-1707 |
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 IrinotecanProtocol #: 17-1376 Location: Childrens Hospital Colorado |
A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancerTo evaluate the use of Enfortumab vedotin plus CPI in treatment of advanced bladder cancer Protocol #: 17-1410 Location: University of Colorado Hospital |
Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee ArthroplastyProtocol #: 17-6161 Location: Poudre Valley Hospital |
A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant RecipientsThis is a Phase 2a, randomized, open-label, active control, multi-center study to assess the efficacy and safety of bleselumab in preventing the rFSGS in de novo kidney transplant subjects. Primary Objective: - To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the SOC regimen (basiliximab induction, tacrolimus, steroids and MMF) in the prevention of the recurrence of focal segmental glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with proteincreatinine ratio (> or equal to 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. Secondary Objectives: - To assess the incidence of nephrotic range proteinuria with protein-creatinine ratio (> or equal to 3.0 g/g) through 6 and 12 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. - To assess the incidence of biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1; local read) through 3, 6 and 12 months post-transplant. - To assess the incidence of efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss or lost to follow-up through 12 months post-transplant. - To assess the incidence of biopsy-proven (blinded, central read) rFSGS through 3, 6 and 12 months post-transplant. - To assess the safety of the bleselumab regimen compared with the SOC regimen. Protocol #: 17-1010 Location: University of Colorado Hospital |
The modified Atkins diet in patients with drug resistant epilepsy and the responsive neurostimulator 09Aug2017Protocol #: 17-0888 Location: University of Colorado Hospital |
Study of Placental Function in Healthy and Pathological PregnanciesProtocol #: 14-1073 Location: University of Colorado Hospital |
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 THERAPYProtocol #: 17-6155 Location: Memorial Hospital Central |
BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU StudyProtocol #: 15-2114 Locations: Memorial Hospital Central; University of Colorado Hospital |
FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENEProtocol #: 06-0501 Location: University of Colorado Hospital |
Lipoprotein lipase enzyme activity assay validation and clinical assessmentProtocol #: 15-1412 Location: University of Colorado Hospital |
Real-Time Sleep Stage Classification with Unobstrustive Bio-potential Recording SystemProtocol #: 16-0328 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Subthalamic nucleus activity during habitual versus controlled movementProtocol #: 17-1291 Location: University of Colorado Hospital |
The Risk of Long-Term Vascular Dysfunction in Women with a History of Pregnancy-Induced HypertensionProtocol #: 16-2581 Location: University of Colorado Hospital |
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 |
Anal Cancer/HSIL Outcomes Research (ANCHOR) StudyProtocol #: 15-1466 Locations: Denver Health Medical Center; University of Colorado Hospital |
Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults with Autosomal Dominant Polycystic Kidney DiseaseProtocol #: 17-1327 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Rapid measurements of water isotopes in human breath and saliva for doubly labeled water analysis V: 04/03/18Protocol #: 16-2203 Location: University of Colorado Hospital |
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older WomenIf 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 |
Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell DiseaseProtocol #: 17-1363 Location: Childrens Hospital Colorado |
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 TumorsProtocol #: 17-1043 Location: Childrens Hospital Colorado |
A Phase I Study of Stereotactic Body Radiation Therapy for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous CarcinomaProtocol #: 17-1333 Location: University of Colorado Hospital |
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection FractionProtocol #: 17-1343 Location: University of Colorado Hospital |
E7080-A001-216: A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS TumorsProtocol #: 17-1165 Location: Childrens Hospital Colorado |
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 |
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 |
Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)Protocol #: 17-1170 Location: University of Colorado Hospital |
A PHASE 1B/2, MULTI-CENTER, DOUBLE-BLIND (PRINCIPAL INVESTIGATORS AND STUDY SUBJECTS BLINDED, SPONSOR UNBLINDED), PLACEBO-CONTROLLED, RANDOMIZED, SINGLE-ASCENDING DOSE STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DS-1040B IN SUBJECTS WITH ACUTE ISCHEMIC STROKEProtocol #: 17-6183 Location: Memorial Hospital Central |
Team V: Teaching Learners to Improve Healthcare Value at the BedsideProtocol #: 17-1332 Location: University of Colorado Hospital |
The effect of topiramate on etonogestrel concentrations in contraceptive implant usersProtocol #: 17-1047 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
Cesarean Wound Closure in Women with BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples C: 4.0; 04/24/2017Protocol #: 16-1748 Location: University of Colorado Hospital |
Targeted fresh autologous whole blood transfusion after cardiopulmonary bypass: a prospective randomized controlled trialProtocol #: 16-2647 Location: University of Colorado Hospital |
Genetic Predictors of QT Prolongation with Anti-arrhythmic Medication (AADGEN)Protocol #: 16-2675 Location: University of Colorado Hospital |
A comparison of intranasal midazolam and Nitrous Oxide (N2O) minimal sedation for minor procedures in a pediatric emergency departmentProtocol #: 16-1909 |
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 checklistProtocol #: 17-1249 Locations: Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Registry of Angiovac Procedures In Detail Outcomes DatabaseThe primary objective of this registry is to determine the procedure related mortality associated with the use of the Angiovac device. This is a FDA approved device, being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. Protocol #: 15-1608 Location: University of Colorado Hospital |
T Cell Epitopes in SarcoidosisProtocol #: 17-1244 Location: University of Colorado Hospital |
The Feasibility, Safety, and Value of a Virtual Cardiac Implantable Electronic Device Wound CheckProtocol #: 17-1179 Location: University of Colorado Hospital |
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) TreatmentProtocol #: 17-0399 Location: University of Colorado Hospital |
Assessment of Stakeholder Perspectives of the Clinical Utility of Pharmacogenomics in Solid Organ TransplantationProtocol #: 17-1173 Location: University of Colorado Hospital |
Using Next Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM) - The International IBM Consortium Genetic StudyProtocol #: 17-1132 Location: University of Colorado Hospital |
A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination with Venetoclax in Subjects with Relapsed or Refractory Haematologic MalignanciesProtocol #: 17-0900 Location: University of Colorado Hospital |
The role of innate immunity in the acquisition of sterile protection against tuberculosis infectionProtocol #: 17-1158 Locations: Colorado Research Center; Department Specific Free Standing Clinic |
Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung diseaseProtocol #: 17-1226 Location: University of Colorado Hospital |
Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic TumorsThis study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen. To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure Protocol #: 16-0031 Location: University of Colorado Hospital |
ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare TumorsProtocol #: 17-1045 Location: Childrens Hospital Colorado |
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing SpondylitisThis study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls. To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls. Protocol #: 14-1507 Locations: Colorado Research Center; Denver Health Medical Center; University of Colorado Hospital |
A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic TumorsProtocol #: 17-0991 Location: University of Colorado Hospital |
Dialysis Access Data RepositoryThis study is designed to collect data for future investigation under the topic of perioperative care and variables affecting outcomes of dialysis access patients at UCHealth. Protocol #: 17-1073 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital |
Effects of Ovarian Hormone Suppression on Vascular and Cognitive FunctionProtocol #: 17-0092 Location: University of Colorado Hospital |
Randomized controlled trial of a mobile health intervention to increase postpartum weight loss in women at increased risk for cardiometabolic disease V:11.28.17Protocol #: 17-0045 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Pilot work to identify biomarkers of Moral Elevation in typically developing adolescentsProtocol #: 17-0129 Location: University of Colorado Hospital |
Validation of a method for isotopic analysis in human plasma samples V:04/20/2018Protocol #: 16-2739 Location: University of Colorado Hospital |
Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and understanding Standard of Care MedicationsProtocol #: 16-2399 Location: University of Colorado Hospital |
Inhaled Cannabis, Oxidative Stress and the Pulmonary Innate Immune ResponseThis study evaluates the effect of long term cannabis/marijuana smoking on lung health. This study evaluates the effect of long term cannabis/marijuana smoking on lung health. Protocol #: 14-1957 Location: University of Colorado Hospital |
Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's DiseaseProtocol #: 16-1954 Location: University of Colorado Hospital |
Consent 2.0 (ATN 150) Study: Innovative Approaches to Minor Consent to Biomedical HIV Prevention ResearchProtocol #: 17-0835 |
Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) StudyProtocol #: 17-0873 Location: University of Colorado Hospital |
A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease (KD019-211)Protocol #: 17-0954 Locations: Colorado Research Center; Renal Research Center; University of Colorado Hospital |
Home Telemedicine to Optimize Health Outcomes in High-Risk Youth with Type 1 DiabetesProtocol #: 17-0004 Locations: Barbara Davis Center; UCD Barbara Davis Center |
Randomized Observation of Biventricular pacemakers on ventrIcular function among patients with mechaNical circulatory support devices: "ROBIN"Protocol #: 17-1042 Location: University of Colorado Hospital |
Understanding the role of subcortical oscillations in human sleep dysregulationProtocol #: 17-0868 Location: University of Colorado Hospital |
A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal MelanomaProtocol #: 17-0996 Location: University of Colorado Hospital |
Imaging for uncomplicated headache: ordering patterns and provider perspectiveProtocol #: 17-0622 Locations: Colorado Research Center; University of Colorado Hospital |
A Phase I Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid TumorsProtocol #: 17-0948 Location: University of Colorado Hospital |
A Pragmatic Multicenter Randomized Trial: Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy (CHAP Project)Protocol #: 17-0914 Locations: Denver Health Medical Center; University of Colorado Hospital |
A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's diseaseThis study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease. Protocol #: 17-0483 Location: University of Colorado Hospital |
Assessment of hepatic glucose and fat regulation in overweight adolescent girlsProtocol #: 14-0542 Locations: Childrens Hospital Colorado; Colorado Research Center |
Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) StudyProtocol #: 16-2568 Location: University of Colorado Hospital |
Cardiometabolic profiles of pubertal boys with Klinefelter syndrome with or without one year of exogenous testosterone treatmentProtocol #: 16-0248 Location: University of Colorado Hospital |
A Prospective, Multicenter Registry for Premature Newborns with Severe Pulmonary HypertensionProtocol #: 16-2491 Location: University of Colorado Hospital |
Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (nivolumab) in Participants with Severe Sepsis or Septic Shock.Protocol #: 17-6150 Location: Memorial Hospital Central |
Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart FailureAssess your medical care Help researchers better understand your medical treatment and health outcomes Provide an understanding on how diseases impact your daily life Provide you with more information about heart disease Protocol #: 17-6148 Location: Memorial Hospital Central |
A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced MalignanciesProtocol #: 17-0500 Location: University of Colorado Hospital |
Effects of high altitude on AMPK activationThis study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery. Protocol #: 14-2178 Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital |
Home or Away From Home: Comparing patient and caregiver reported quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapyProtocol #: 17-0812 Location: Childrens Hospital Colorado |
Home or away from home: comparing clinical outcomes relevant to the care of pediatric acute myeloid leukemia during periods of neutropenia (Aim 1)Protocol #: 17-0791 Location: Childrens Hospital Colorado |
Motivational Enhancement System for Adherence (MESA) for Youth Starting ARTProtocol #: 17-0885 |
Signaling and epigenetic mechanism of immune cell activation in healthy and asthmatic childrenProtocol #: 17-0699 |
Diagnostic and Rating Tools for BlepharospasmProtocol #: 16-0017 Location: University of Colorado Hospital |
Clinical trial to validate the 2015 ATA thyroid nodule management guidelines, assess diagnostic performance of a thyroid nodule management algorithm based upon a published malignancy risk estimation model relative to TI-RADS and ATA categories, and to evaluate inter-observer variability of assessment of sonographic features and risk patterns of thyroid nodulesProtocol #: 17-0534 Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
MULTICENTER 1-YEAR OBSERVATIONAL STUDY OF PATIENTS WHO ARE INITIATING BRIVARACETAMProtocol #: 17-0679 Location: University of Colorado Hospital |
Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollmentProtocol #: 17-0585 Location: University of Colorado Hospital |
Targeted strength training to improve gait in people with multiple sclerosis: a feasibility studyProtocol #: 16-2610 Locations: Colorado Research Center; University of Colorado Hospital |
Therapeutic modulation of the intestinal creatine kinase system in inflammatory bowel disease (IBD)Specific Aim 1: Determine whether creatine supplementation induces improvement in the endoscopic assessment of mucosal inflammation in ulcerative colitis (UC). Specific Aim 2: Evaluate the feasibility of the current study protocol. Specific Aim 3: Assess the impact of creatine supplementation on intestinal epithelial barrier function and the intestinal microbiome. Protocol #: 13-3054 Location: University of Colorado Hospital |
NRG-LU002: Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III TrialProtocol #: 17-0828 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Longitudinal Coverage with Evidence Development Study on MicraTM Leadless PacemakersProtocol #: 17-6131 |
PARTNER 3: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a FailingTo assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve. Protocol #: 17-6104 Locations: Harmony Campus; Medical Center of the Rockies |
High Dose Oral Steroids in Sudden Sensorineural Hearing lossProtocol #: 16-2342 Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
Bone and Vascular Health in Postmenopausal Women with Type 1 diabetesProtocol #: 15-1854 Location: University of Colorado Hospital |
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetcs and Renal Safety of TenofovirProtocol #: 15-0123 Location: University of Colorado Hospital |
Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure-Connect-HFProtocol #: 17-0423 Location: University of Colorado Hospital |
HepQuant (HQ)-SHUNT Correlates of Hepatic Venous Pressure Gradient (HVPG) TestingProtocol #: 15-0520 Location: University of Colorado Hospital |
A Patient Decision Aid to Augment Lethal Means Counseling for Suicidal PatientsProtocol #: 17-0670 Location: University of Colorado Hospital |
Analysis of Discarded Spinal Tissues from Individuals with Spinal ConditionsProtocol #: 17-0687 Location: University of Colorado Hospital |
Human Trisome ProjectAdditional information about this study can be found at www.trisome.org. Designed to be the largest and most comprehensive study of its kind, The Human Trisome Project will help us understand why individuals with Down syndrome (caused by trisomy of chromosome 21) are protected from some medical conditions, such as cancer, while highly predisposed to others, such as Alzheimer's disease and autoimmune disorders. Protocol #: 15-2170 Location: University of Colorado Hospital |
CORONARY ARTERY CALCIFICATION IN TYPE I DIABETESProtocol #: 97-661 Location: University of Colorado Hospital |
Comparative Effectiveness Between Long Term Fingolimod versus Glatiramer Acetate On Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients with Multiple SclerosisProtocol #: 14-0774 Location: University of Colorado Hospital |
Effects of acetate, alcohol, and gut microbiome on brain functionProtocol #: 15-0933 Location: University of Colorado Hospital |
Effects of low-dose levetiracetam on clinical symptoms, cognition and hippocampal hyperactivity in patients with schizophreniaProtocol #: 13-1495 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Dystonia Coalition Project 1: Natural History and Biospecimen Repository for DystoniaProtocol #: 11-0647 Location: University of Colorado Hospital |
Vascular mechanisms for the effects of loss of ovarian hormone function on cognition in womenProtocol #: 14-0193 Location: University of Colorado Hospital |
Appetite Regulation in Older-Aged Obese IndividualsParticipants needed for a research study that plans to examine the effects of age and body weight on food intake, appetite regulation, and brain responses to food. Protocol #: 15-1511 Location: University of Colorado Hospital |
10-1311 DoneSave Functional connectivity of the motor network in two major subtypes of Parkinson Disease December 24,2015Protocol #: 10-1311 Location: University of Colorado Hospital |
Genotype Phenotype Discordance in Polypharmacy PatientsProtocol #: 14-0381 Location: University of Colorado Hospital |
Tissue-specific effects of insufficient sleepThe proposed project is a within-subject consecutive design examining 14 healthy individuals after baseline and after 4 nights of insufficient sleep. Following 7 days of at-home habitual sleep of 9 hours/night and a 3-day lead-in energy balanced diet, participants will be admitted for a 6-night inpatient stay at the UC Denver. Sleep schedules will be verified via sleep logs, time-stamped voice-recorder of bed and wake times, and wrist actigraphy recordings. On the morning after the 1st night in the lab, subjects will undergo including saliva sampling, endothelial function testing, muscle biopsy, fat biopsy, hyperinsulinemic euglycemic clamp. Protocol #: 17-0533 Locations: CTRC-UC Boulder; University of Colorado Hospital |
The University of Colorado Denver PerinAtal RegisTrY (PARITY)Protocol #: 17-0209 Location: University of Colorado Hospital |
Statin Therapy in Patients with Early Stage Autosomal dominant polycystic kidney diseaseProtocol #: 17-0678 Locations: Colorado Research Center; Renal Research Center; University of Colorado Hospital |
Procurement of Blood Samples from Subjects with Diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for Use in the Development of a Liver Fibrosis Test V: Jan 20 2017Protocol #: 17-0571 Location: University of Colorado Hospital |
CA209744: Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.Protocol #: 17-0401 Location: Childrens Hospital Colorado |
A NOVEL APPROACH TO INFANTILE SPASMS: COMBINED COSYNTROPIN INJECTABLE SUSPENSION, 1 MG/ML AND VIGABATRIN INDUCTION THERAPY V: 2.4; 11.20.2018Protocol #: 17-0222 Location: Childrens Hospital Colorado |
Prospective evaluation of the efficacy and safety of endoscopic anti-reflux proceduresProtocol #: 17-0567 Location: University of Colorado Hospital |
Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Stereotactic Targeting and Clinical EfficacyProtocol #: 16-1443 Location: University of Colorado Hospital |
Mechanisms of Local Anesthetic ResistanceProtocol #: 17-0053 Location: University of Colorado Hospital |
PHANTOM: Anastrozole in Patients with Pulmonary Arterial HypertensionProtocol #: 17-0536 Location: University of Colorado Hospital |
The Care Project: Helping Pregnant Moms and BabiesProtocol #: 16-2040 Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
Use of systematic stimulation mapping and functional/structural imaging to improve localization of seizure-onset zone, determination of seizure spread patterns, and elucidation of impact on neurological function in focal epilepsy patients undergoing Phase II monitoringProtocol #: 16-2543 Location: University of Colorado Hospital |
Anterior knee pain after ACL reconstruction: improvement after anterior interval scar releaseProtocol #: 17-0413 Location: University of Colorado Hospital |
NANT 2015-02: PHASE 1 STUDY OF LORLATINIB (PF-06463922), AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH ALK-DRIVEN RELAPSED OR REFRACTORY NEUROBLASTOMAProtocol #: 17-0511 Location: Childrens Hospital Colorado |
Phase 1 trial of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancersProtocol #: 17-0512 Location: University of Colorado Hospital |
ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) TrialProtocol #: 17-0486 Location: Childrens Hospital Colorado |
Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesityProtocol #: 17-0373 Location: University of Colorado Hospital |
Aortic Trauma Foundation Prospective Blunt Thoracic Aortic Injury RegistryProtocol #: 17-0537 Location: University of Colorado Hospital |
Inotuzumab Ozogamicin Compassionate Access Single INDProtocol #: 16-2747 Location: Childrens Hospital Colorado |
Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of SexThis study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise. This study will evaluate & compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects). Protocol #: 17-0356 Location: University of Colorado Hospital |
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohns Disease V: 05 March 2018Protocol #: 16-2456 Location: University of Colorado Hospital |
Using chronic epilepsy monitoring to study the role of parietal and occipital cortex in movement initiation and perceptionProtocol #: 17-0321 Location: University of Colorado Hospital |
Cath Lab Data Collection StudyProtocol #: 16-1481 Location: University of Colorado Hospital |
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced MalignanciesProtocol #: 17-0402 Location: University of Colorado Hospital |
Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized TrialThis study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study. Protocol #: 17-0369 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)A comparison of Nivolumab vs no Nivolumab prior to nephrectomy. Protocol #: 17-0406 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Retrospective Study of Local Tissue Reaction to the Release of Metal Ions in Spinal ImplantsProtocol #: 16-2465 Location: University of Colorado Hospital |
EVALUATION OF THE DREAMED ADVISOR PRO FOR AUTOMATED INSULIN PUMP SETTINGS ADJUSTMENTS IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES - THE ADVICE4U PRO STUDYProtocol #: 17-0013 Locations: Barbara Davis Center; UCD Barbara Davis Center |
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDERProtocol #: 16-2718 Location: University of Colorado Hospital |
Mechanisms of Vascular Dysfunction in CKD and ADPKD: A Cross-Sectional StudyThis research study will compare blood vessel function in healthy adults to adults with two different types of kidney disease. The testing visit will include non-invasive testing of blood vessel function and collection of blood and cells from an IV. Protocol #: 15-0869 |
Phosphate Lowering to Treat Vascular Dysfunction in Chronic Kidney DiseaseProtocol #: 13-0328 |
Effectiveness of Therapy via Telemedicine following Cochlear ImplantsThis research plans to learn more about the use of telemedicine as a means of providing therapy to children who have a cochlear implant(s). While Auditory-Verbal Therapy has typically been delivered in person, many people are starting to access therapy over the internet. We are conducting this research to determine if the outcomes of therapy are the same when AVT is delivered in person and via telemedicine. Protocol #: 12-1103 |
Measurement of Hematopoietic Stem Cell Derived AdipocytesThe purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML). To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat. Protocol #: 13-0026 Location: University of Colorado Hospital |
Pharmacogenetic Prediction of Metoprolol EffectivenessProtocol #: 13-3174 |
Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate MonitorThe purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjogren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born. Protocol #: 13-1879 |
IMove: Instrumented Movement Analysis to Quantify Gait in Cerebral PalsyThe first aim of this study is to develop IMove to detect the stance and swing phase of gait cycles and to characterize pelvic, hip, knee and ankle joint angles during these phases. The second aim is to then validate measures obtained from IMove with those obtained from a motion capture system. The central hypothesis of this proposal is that IMove can accurately measure kinematics of the lower limb joints in the sagittal, frontal and horizontal planes, and characterize their coordination during gait, using inertial sensors attached to the pelvis, femur, tibia and foot using strap bands. Protocol #: 14-1303 |
Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in SmokersThe goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. Protocol #: 15-1016 |
Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical TrialThe primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation. Protocol #: 15-0983 |
Improving Rehabilitation Outcomes after Total Hip ArthroplastyThe purpose of this study is to compare standard of care PT after THA with a physical therapy program specifically designed to integrate targeted core and hip muscle strength and functional training. Protocol #: 16-0956 |
Qualitative Needs Assessment for a Hospice Care Decision AidProtocol #: 16-0479 Locations: Denver Health Medical Center; University of Colorado Hospital |
Examining the Effectiveness of a Telehealth Adherence Support Group Intervention for Adolescent Transplant Recipients At-Risk for Non-adherenceProtocol #: 13-2997 |
A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS SystemProtocol #: 17-0054 Location: University of Colorado Hospital |
Effectiveness Analysis of Natalizumab versus Fingolimod using Patient-Reported Outcomes in Patients with Multiple SclerosisThe purpose of this study is to compare two medications, natalizumab and fingolimod, used in the treatment of multiple sclerosis (MS) through a variety of previously validated patient reported outcomes (PROs). Protocol #: 13-2767 Location: University of Colorado Hospital |
EFFECTS OF SERUM FATTY ACID LOWERING ON INSULIN SENSITIVITY, CARDIOVASCULAR FUNCTION, AND EXERCISE CAPACITY IN NON-INSULIN DEPENDENT DIABETESTo research the effects of an investigational drug on exercise capacity and blood vessel function. Protocol #: 10-1393 Location: University of Colorado Hospital |
Feasibility Study of Metformin Therapy in ADPKD V: 6.20.2017The primary purpose of the research study is to determine the safety and tolerability of the study drug (Metformin or placebo) when given to subjects with ADPKD (Autosomal Dominant Polycystic Kidney Disease). Protocol #: 16-0802 Location: University of Colorado Hospital |
Periodontal inflammation and immunity in preclinical RAThe purpose of this study is to learn more about rheumatoid arthritis by studying people who do not have rheumatoid arthritis. Your participation in this study will help us determine if gum disease affects the chances of developing protein markers associated with rheumatoid arthritis. Protocol #: 15-2288 |
Nicotinic agonist effects on BMI and neuronal response in overweight/obese adultsThis study plans to learn more about the effects of an investigational new drug (DMXB-A) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to effect appetite, we are interested in studying the effects of the study drug, which has similarities to nicotine, on how your brain responds to such things as pictures of food. This study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental. This research study plans to examine the effects of an investigational new drug on neuronal, physiological, and behavioral mechanisms of obesity in the general population. Protocol #: 15-0650 Location: University of Colorado Hospital |
Myeloid to Adipocyte Transdifferentiation in Human cellsIf you join the study, you will complete the following research procedures over the course of 2 study visits: Informed consent, physical exam and medical history, body composition test, blood draw and fat biopsy. This research study plans to learn more about where the fat cells in your body come from. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more "unhealthy" than other fat. Protocol #: 15-1779 Location: University of Colorado Hospital |
Prospective, Inceptional Cohort Study of Individuals with Bleeding DisordersProtocol #: 09-0816 |
An investigation of the neural and executive function underpinnings of severe worry among adolescentsThis study seeks to improve our understanding of worry among adolescents. Protocol #: 15-1593 |
Neuronal and Behavioral Effects of Implicit Priming in Obese IndividualsThe overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. Protocol #: 13-1786 |
PTH And Calcium Responses to Exercise (PACE) in Older AdultsThe primary goal of this research is to find out if exercise that causes the loss of calcium from the blood, possibly through the sweat, also causes the release of calcium from the bones. Protocol #: 15-0250 Location: University of Colorado Hospital |
Effects of dietary protein from meat vs. dairy on infant growth, body composition and gut healthThis longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time. Protocol #: 14-0139 |
CD8+ T-cell Responses to a Conserved Herpesvirus Epitope After Natural Infection, Vaccination, or Reactivation with Human HerpesvirusesProtocol #: 13-2122 Location: University of Colorado Hospital |
Dysregulation of FSH in Obesity: Functional and Statistical AnalysisThis study plans to learn more about the relationship between fertility and obesity. Protocol #: 15-0474 Location: University of Colorado Hospital |
Parent Perspectives on Transitioning Premature Infants from Tube Feeding to Oral FeedingThis project will conduct focus groups with parents and caregivers who have a child that was born prematurely and required tube feeding for over 3 months. The purpose of the focus groups is to understand challenges related to eating orally for these children, discuss current guidance the family has received, explore what could be done to improve the process of transitioning to oral feeding, as well as what resources and support would be helpful to families. Results will be used to identify methods to improve feeding support for families and caregivers of premature infants, as well as preliminary data to obtain additional funding. Protocol #: 16-0864 |
Reprometabolic Syndrome Mediates Subfertility in ObesityProtocol #: 15-1052 Location: University of Colorado Hospital |
NRG-GU002, PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXELA comparison of adjuvant radiotherapy + androgen therapy after a radical prostatectomy with and without Docetaxel. Protocol #: 17-0266 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare TumorsProtocol #: 17-0280 Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
The effect of isotretinoin on the etonogestrel contraceptive implantProtocol #: 16-0614 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center |
The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CTThe physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. However, whether E2 status affects BAT activity in women has not been studied. In this research, we will study 1) the contribution of BAT to REE under basal (room temperature) and stimulated conditions (mild cold-exposure); and 2) whether these responses are modulated by E2 status. Protocol #: 16-1479 Locations: CTRC-adult; University of Colorado Hospital |
Effect of Mechanical Circulatory Support on Exercise Capacity in Heart FailureProtocol #: 16-1635 Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital |
Obesity, Metabolic Dysregulation and the Airway Epithelium in AsthmaticsThis is a pilot study looking at asthmatics and non-asthmatics with different BMIs. Participants will undergo a baseline evaluation, lung function testing, and a subsequent bronchoscopy and nasal epithelial brush smapling in those that meet study enrollment. Protocol #: 16-2522 Location: University of Colorado Hospital |
a retrospective review of regional variation in pediatric musculoskeletal infectionProtocol #: 15-2466 |
a characterization of the effect of total knee arthroplasty on glycemic control in the VA populationProtocol #: 15-2242 |
A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced MalignanciesProtocol #: 17-0074 Location: University of Colorado Hospital |
A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced TumorsProtocol #: 16-2407 Location: University of Colorado Hospital |
A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPYProtocol #: 16-2696 Location: University of Colorado Hospital |
A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMAProtocol #: 16-2248 Location: University of Colorado Hospital |
CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)Protocol #: 16-2449 Location: University of Colorado Hospital |
S1418/BR006, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with greater than 1 cm Residual Invasive Cancer or Positive Lymph Nodes (greater than pN1mic) After Neoadjuvant Chemotherapy.Protocol #: 16-2594 Locations: Greeley Hospital; 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 |
CRIZOTINIB (XALKORI) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULESProtocol #: 16-2544 Location: Childrens Hospital Colorado |
Cardiovascular consequences of hypogonadism in menProtocol #: 15-1162 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
Phase I/II Study of Pembrolizumab and Cabozantinib in Patients with Metastatic Renal Cell CarcinomaTo assess the efficacy of Prmbrolizumab plus Cabozantinib in patients with metastatic renal cell carcinoma Protocol #: 16-2300 Locations: Greeley Hospital; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study)Protocol #: 16-2448 Location: Childrens Hospital Colorado |
A011502: A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIALProtocol #: 16-2437 Locations: Greeley Hospital; 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 |
Amyloid Imaging with 11C-PiB in Healthy Aging and Mild Cognitive ImpairmentProtocol #: 16-2064 Location: University of Colorado Hospital |
Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II StudyProtocol #: 16-2230 Locations: Dana Farber Cancer Institute; MD Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; The Ohio State University Comprehensive Cancer Center; UCLA, Jonsson Cancer Center; University of Colorado Hospital; University of Michigan Comprehensive Cancer Center |
ARM Study: A phase II trial to evaluate crizotinib in the neoadjuvant setting in non-small cell lung cancer patients with surgically resectable, ALK, ROS1, or MET-oncogene positive non-small cell lung cancerProtocol #: 16-2025 Locations: University of California San Francisco; University of Colorado Hospital |
An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin LymphomaProtocol #: 16-2269 Location: Childrens Hospital Colorado |
Is disruption of the human gut microbial environment associated with cognitive impairment following chemotherapy for breast cancer?Protocol #: 16-2138 Location: University of Colorado Hospital |
ADVL1414: A PHASE 1 STUDY OF SELINEXOR (KPT-330, IND #125052), A SELECTIVE XPO1 INHIBITOR, IN RECURRENT AND REFRACTORY PEDIATRIC SOLID TUMORS, INCLUDING CNS TUMORSProtocol #: 15-1936 Location: Childrens Hospital Colorado |
NEWLY DIAGNOSED CHILDREN (LESS THAN 10 YEARS OLD) WITH MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS: CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO EITHER SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR CELL RESCUEProtocol #: 16-1804 Location: Childrens Hospital Colorado |
A Phase 2 Study of the JAK1/JAK2 Inhi |