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A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
Each patient will go through a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period. ...more > Protocol #: 20-3010 Locations: Renal Research Center; University of Colorado Hospital |
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NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
Protocol #: 20-2079 Locations: Highlands Ranch Hospital; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
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A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients with Advanced Solid Tumors
This is a Phase I/II trial with at least 17 patients in the dose escalation phase and 26-45 patients in the Phase II portion of the trial. In the Phase I portion of the trial, patients will receive EMB-02 at doses escalating from 6 to 900 mg IV once weekly. Following the evaluation of i...more > Protocol #: 20-2545 Locations: Memorial Hospital Central; Memorial Hospital North |
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The use of Libre to educate, motivate and activate adults with newly diagnosed type 2 diabetes to improve metabolic control and reduce their reliance on medication: A pilot study.
What will be asked of you: Eligible participants will be asked to follow a lifestyle program for a total of 4 months, complete one (virtual) assessment, and complete questionnaires at the beginning and end of the study. All participants will receive: - A Freestyle Libre 2 continuous b...more > Protocol #: 20-2470 Location: Department Specific Free Standing Clinic |
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eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.
Caregivers and their patients must agree to participate. The interventions will last 8-10 weeks and study participation will 12 months. Caregivers in all 3 groups (TAU, Virtual-PEPRR, or Pep-Pal) will provide biomarker samples (hair and saliva) that they will collect themselves at home, to...more > Protocol #: 20-2458 Location: University of Colorado Hospital |
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The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study
This is a non-treatment study that uses a blood test ("Prospera") to measure kidney function following transplant. This study will look at the usefulness of the Prospera testing compared to the usual serum creatinine testing done at regular intervals in kidney transplant recipients. ...more > Protocol #: 19-2394 Location: University of Colorado Hospital |
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S1823 - A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS
Protocol #: 20-2392 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
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A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer
Protocol #: 20-2279 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....more > Protocol #: 20-0593 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab(NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
Protocol #: 20-2083 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT)
Protocol #: 20-2150 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
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Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls
Patients will complete two visits- a screening visit and a testing visit. Both visits include blood draws and the testing visit includes blood draws and frequent urine samples. Patients will also be asked to provide a stool sample after screening. ...more > Protocol #: 20-2179 Locations: Outpatient CTRC; University of Colorado Hospital |
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Evaluation of Compensatory Reserve in Obstetrical Patients
A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....more > Protocol #: 14-1996 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX)
Protocol #: 20-1907 Location: University of Colorado Hospital |
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Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes
Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. ...more > Protocol #: 20-1681 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)
While in this study you will be asked You will be asked to participate (if eligible) in three STEPS: STEP 1 – a screening step to evaluate the level of antibodies to Ro52 and Ro60 (proteins in your blood); STEP 2 – This step occurs if you are found to have high amounts of anti-Ro60 or...more > Protocol #: 20-1310 Location: Childrens Hospital Colorado |
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A Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring below the Distal Border of the Brachial Plexus Requiring Surgical Repair
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of a severed nerves in patients between 16 and 65 years of age....more > Protocol #: 20-1997 Locations: Denver Health and Hospital Authority; University of Colorado Hospital |
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3
Aerobic exercise is a vital treatment for people living with Parkinson's disease. Although anti-parkinsonian medication helps alleviate Parkinson's symptoms, it is not known to slow the rate of disease progression. Aerobic exercise is a treatment with the most compelling evidence for its p...more > Protocol #: 20-1854 Location: University of Colorado Hospital |
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A221805: Duloxetine To Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IITo Phase III Study
Protocol #: 20-1705 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)
This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints ...more > Protocol #: 19-1226 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations
Protocol #: 20-1757 Location: Childrens Hospital Colorado |
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A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)
Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable...more > Protocol #: 20-1690 Location: University of Colorado Hospital |
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Se status, absorption and outcomes in infants born between 22-28 weeks gestation
Neonates born between 22-28 weeks completed gestational age (cGA) are at high risk for complications of prematurity that impair long term health. Optimizing nutrition in extremely preterm infants can provide an effective and inexpensive modification to neonatal care with potential lifelong...more > Protocol #: 20-1260 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD
This study is a 52 week intervention with visits at the CU Med Building on the Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment of physical function via a q...more > Protocol #: 20-1672 Location: Renal Research Center |
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A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus
Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be ...more > Protocol #: 20-1641 Location: University of Colorado Hospital |
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In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers
This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. ...more > Protocol #: 20-1399 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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Embolization of the Middle Meningeal Artery with ONYX(TM) Liquid Embolic System in the Treatment of Subactue and Chronic Subdural Hematoma (EMBOLISE)
The purpose of this study is to evaluate the safety (short and long term side effects) and effectiveness (how well it helps) of Onyx Liquid Embolic System(LES) (study device) embolization of the middle meningeal artery when used in addition to the standard treatment that is used to treat a...more > Protocol #: 20-1390 Location: University of Colorado Hospital |
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A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Protocol #: 20-0746 Location: University of Colorado Hospital |
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A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy...more > Protocol #: 20-1420 Locations: Memorial Hospital Central; Memorial Hospital North |
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ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection
The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19. ...more > Protocol #: 20-6506 Locations: Memorial Hospital Central; Memorial Hospital North |
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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and
Clinical Activity Study of Intravenously Administered IO-202 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients
with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients
Protocol #: 20-1388 Locations: Pathology - SOM; University of Colorado Hospital |
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EA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response
Protocol #: 20-1318 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
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A prospective randomized trial of antibiotic duration in post-appendectomy abscess
Evaluating 8-day course and 4-day course of antibiotics at drainage for patients who develop a post-appendectomy abscess...more > Protocol #: 20-1008 Location: Childrens Hospital Colorado |
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A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcome (OLIE)
Protocol #: 20-1210 Location: Childrens Hospital Colorado |
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A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the ...more > Protocol #: 20-1341 Location: University of Colorado Hospital |
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AN OPEN-LABEL, SAFETY AND TOLERABILITY PHASE 1b TRIAL OF CAN04, A FULLY HUMANIZED ANTI-IL1RAP MONOCLONAL ANTIBODY, IN COMBINATION WITH PEMBROLIZUMAB IN SUBJECTS WITH SOLID TUMORS PROGRESSING ON PD-1/PD-L1 INHIBITOR-CONTAINING REGIMENS
Protocol #: 20-0605 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn...more > Protocol #: 20-1262 Locations: Anschutz Health and Wellness; Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital |
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Colorado Nurses Experience with COVID-19
The purpose of the study is to find out the experiences of nurses who cared or prepared to care for COVID-19 patients. If you join the study you will help us learn about what nurses are going through during this pandemic time. You will provide insight to how nurses can improve or change th...more > Protocol #: 20-6039 Locations: Boulder Health Center; Broomfield Hospital; Cherry Creek Medical Center; Grandview Hospital; Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Long's Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; Steadman Hawkins Clinic - Denver (Iverness); UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital; Yampa Valley Medical Center |
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Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event
The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). ...more > Protocol #: 20-6019 Location: Memorial Hospital Central |
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Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
This study is designed to collect a repository of resting phase signals from eligible subjects prior to right heart catheterization using the Phase Signal Recorder (PSR) for the purpose of development, testing and optimization of algorithms in the general population. ...more > Protocol #: 20-6505 Location: Memorial Hospital Central |
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A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Protocol #: 20-0884 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
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ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection
Protocol #: 20-6037 Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital |
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S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
Protocol #: 20-0563 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT
Protocol #: 20-0881 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
After a screening period of up to 28 days, eligible subjects will be randomized to receive blinded infusions of obinutuzumab 1000 mg or placebo on Day 1, and weeks 2,24,26,50,52 in three treatment groups. and will be assessed at week 76. Neither the subject or study staff will know which t...more > Protocol #: 20-0941 Location: University of Colorado Hospital |
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Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB Suture Anchor, MICRORAPTOR Knotless REGENESORB Suture Anchor and MICRORAPTOR Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
Protocol #: 20-0923 Locations: Highlands Ranch Hospital; Steadman Hawkins Clinic - Denver (Iverness); University of Colorado Hospital |
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A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patientreported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy (COMB157G23101)
Protocol #: 20-0705 Locations: Brain Imaging Center (BIC); University of Colorado Hospital |
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The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation
This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections....more > Protocol #: 20-0751 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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OPTION
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation....more > Protocol #: 20-6502 Location: Medical Center of the Rockies |
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A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188-MS-101
Protocol #: 20-0454 Locations: Brain Imaging Center (BIC); University of Colorado Hospital |
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A PHASE 3, RANDOMIZED, DOUBLE- OR OBSERVER-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
Protocol #: 20-0481 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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The effects of hormone therapy on renal hemodynamic function in transgender youth
One screening visit to see if you are eligible to participate, then one study visit prior to starting testosterone or estradiol and one study visit 3 months later. ...more > Protocol #: 20-0572 Locations: Childrens Hospital Colorado; Outpatient CTRC |
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A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)
Protocol #: 20-0589 Location: University of Colorado Hospital |
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A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)
Protocol #: 20-0580 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene
Protocol #: 20-0346 Locations: Brain Imaging Center (BIC); University of Colorado Hospital |
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S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"
Protocol #: 20-0359 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin
Protocol #: 20-0360 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c...more > Protocol #: 20-0288 Location: University of Colorado Hospital |
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Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study
The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp...more > Protocol #: 19-1526 Locations: Barbara Davis Center; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective o...more > Protocol #: 20-0254 Location: University of Colorado Hospital |
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The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis
We are enrolling transgender women who are starting feminizing Gender Affirming Hormone Therapy (e.g., estrogen plus spironolactone). They are adults who were assigned male at birth but whose gender identity is female. ...more > Protocol #: 20-0104 Location: University of Colorado Hospital |
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ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Protocol #: 20-0052 Location: Childrens Hospital Colorado |
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Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE study)
This is a 12-week combined aerobic and resistance exercise intervention in breast cancer survivors. Before and after the intervention, women will undergo measures of appetite, energy intake, body composition, and resting metabolic rate....more > Protocol #: 19-3032 Location: University of Colorado Hospital |
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Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations
Protocol #: 19-3063 Locations: Boulder Health Center; Broomfield Hospital; Grandview Hospital; Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Long's Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; Steadman Hawkins Clinic - Denver (Iverness); UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital |
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A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination with Intravesical BCG versus Standard of Care BCG Alone in Participants with High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment with BCG
Protocol #: 20-0003 Location: University of Colorado Hospital |
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NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Protocol #: 19-2514 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopaedic Hardware
Screened patients will be briefed of the study protocol and if interested in participating in the study, will complete informed consent. During their regular follow-up visits, patients will have an antenna attached to their affected limb using velcro straps and stand on a flat platform tha...more > Protocol #: 19-3107 Location: Medical Center of the Rockies |
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A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (TRANSCEND FL)
Protocol #: 19-3011 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart d...more > Protocol #: 19-2323 Locations: Anschutz Health and Wellness; University of Colorado Hospital |
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A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and clinical benefit of AK002 in adult and adolescent patients with active and biopsy-proven EoE. Patients enrolled in the study will receive 6 infusions of placebo or...more > Protocol #: 19-3097 Location: University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AK002 in patients with EG and/or EoD who have an inadequate response with, lost response to, or were intolerant to standard therapies. Patients enrolled in the study...more > Protocol #: 19-3096 Location: University of Colorado Hospital |
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ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Protocol #: 19-2163 Location: Childrens Hospital Colorado |
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An open-label, randomised, multicentre, phase III study of irinotecan
liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas
Protocol #: 19-6517 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
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A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the v...more > Protocol #: 19-2935 Locations: Outpatient CTRC; University of Colorado Hospital |
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A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and
Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 wee...more > Protocol #: 19-2904 Locations: Renal Research Center; University of Colorado Hospital |
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A Multicenter, Comparative Safety and Efficacy Study of ACTHar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy
Each patient will undergo 12 months of treatment with 17 patients randomized to ACTHar gel alone (17 patients) or to ACTHar gel plus oral Tacrolimus (17 patients) Year 2: Follow up and observation for 12 months OFF ACTHar gel or ACTHar gel and Tacrolimus...more > Protocol #: 19-2902 Locations: Renal Research Center; University of Colorado Hospital |
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A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
Protocol #: 19-2721 Location: University of Colorado Hospital |
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A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)
Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs....more > Protocol #: 19-2854 Location: University of Colorado Hospital |
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A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)
Protocol #: 19-2788 Location: University of Colorado Hospital |
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A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabete...more > Protocol #: 19-2824 Location: University of Colorado Hospital |
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A Phase I study to evaluate the pharmacokinetic and pharmacodynamic profile of intramuscular or subcutaneous injections of levonorgestrel butanoate (LB) for female contraception
Your participation in the study would include up to 36 clinic visits over a 9-month period. During your time in the study, you will have physical exams, pelvic exams, breast exams, vital sign assessments, blood tests, pregnancy tests, and possibly a PAP smear. You will also have transvagin...more > Protocol #: 19-2820 Location: Comprehensive Women's Health Center |
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A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the st...more > Protocol #: 19-2782 Locations: Brain Imaging Center (BIC); Renal Research Center; University of Colorado Hospital |
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EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC
Protocol #: 19-2554 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid reg...more > Protocol #: 19-6129 Locations: Harmony Campus; Medical Center of the Rockies |
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Microfluidic models of bleeding and thrombosis
This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. ...more > Protocol #: 19-2408 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital |
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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy
Protocol #: 19-2520 Location: University of Colorado Hospital |
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In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study
NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee inject...more > Protocol #: 19-2499 Locations: Boulder Sports Clinic; CU Sports Medicine - Denver; University of Colorado Hospital |
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
Protocol #: 19-2534 Locations: Barbara Davis Center; University of Colorado Hospital |
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Pharmacology of Marijuana During Pregnancy
This study will enroll pregnant women who use marijuana during their pregnancy and ask them to provide urine and blood samples at two prenatal visits. At delivery they will again be asked to provide blood and urine samples, the placenta, as well as blood from the baby's umbilical cord. Sur...more > Protocol #: 19-1757 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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Effects of prenatal antibiotics on the infant gut microbiome
Three different bacteria of the infant gut microbiome will be obtained through collection of infant stool samples at birth and at 6 weeks of age. These bacteria will be measured and comparisons made between infants whose mothers took antibiotics during pregnancy and infants whose mothers d...more > Protocol #: 19-2288 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)
This study assesses whether Lungpacer therapy plus usual medical care can safely improve the chances of patients on a breathing machine to regain the ability to breathe on their own as compared to usual medical care alone. ...more > Protocol #: 19-2401 Location: University of Colorado Hospital |
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Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)
CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard...more > Protocol #: 19-2362 Locations: Pathology - SOM; University of Colorado Hospital |
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RADIANT:Rare and Atypical Diabetes Network
Protocol #: 19-2285 Locations: Boulder Health Center; Broomfield Hospital; Cherry Creek Medical Center; Highlands Ranch Hospital; Lone Tree Medical Center; Steadman Hawkins Clinic - Denver; UCHealth Central Park Medical Center; UCHealth Internal Medical Clinic - Lowry; UCHealth Inverness; University of Colorado Hospital |
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A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)
Protocol #: 19-6114 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health
This study will involve 4-5 in person visits. There will be screening visit for some patients and then a baseline visit over two days. The first day will involve an IV and drinking a sugary drink with blood draws as well as measuring the resting metabolic rate and answering questionnaires....more > Protocol #: 19-2109 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS,
PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION
CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS
AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS
Protocol #: 19-2157 Location: Childrens Hospital Colorado |
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Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts th...more > Protocol #: 17-0464 Location: Childrens Hospital Colorado |
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S1803: PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY)
Protocol #: 19-1589 Location: Rocky Mountain Regional VA Medical Center |
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Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D)...more > Protocol #: 19-1978 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors
Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compen...more > Protocol #: 19-1974 Location: University of Colorado Hospital |
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COG AHOD1822 / Merck MK-3475-667:
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)
Protocol #: 19-1481 Location: Childrens Hospital Colorado |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa...more > Protocol #: 19-1874 Location: University of Colorado Hospital |
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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)
Protocol #: 19-6513 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Protocol #: 19-1727 Location: University of Colorado Hospital |
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Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with t...more > Protocol #: 19-1823 Location: University of Colorado Hospital |
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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination with Bevacizumab Compared to Bevacizumab with 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX wit Bevacizumab (LYNK-003)
Protocol #: 19-6102 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation...more > Protocol #: 19-6101 Locations: Harmony Campus; Medical Center of the Rockies |
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
Protocol #: 19-1634 Location: Childrens Hospital Colorado |
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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fat...more > Protocol #: 19-6511 Location: Memorial Hospital Central |
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ECG Belt for CRT Response
Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A c...more > Protocol #: 19-1703 Location: University of Colorado Hospital |
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A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder
Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may...more > Protocol #: 19-1658 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital |
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Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome
This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receiv...more > Protocol #: 19-1362 Location: University of Colorado Hospital |
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APOL1 Long-term Kidney Transplantation Outcomes Network
APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a pros...more > Protocol #: 19-0461 Location: University of Colorado Hospital |
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A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Protocol #: 19-1455 Location: University of Colorado Hospital |
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Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer
Protocol #: 19-6509 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
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A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.
Protocol #: 19-1337 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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Sex effects on the neurobiology of eating behaviors in Veterans with overweight/obesity
Participants will complete: - 2 to 4 MRI scans - Food, attention, and mood questionnaires - Blood draws for measuring hormones Participants will be compensated for their time...more > Protocol #: 19-0940 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors
Protocol #: 19-1302 Location: University of Colorado Hospital |
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ImTAB
Immunity, mTBI, and Alzheimer's Biomarkers
You may qualify if you are: - 65 years or older - Have had a concussion within the past 5 years - Saw a doctor within 1 week of your concussion - Have not been diagnosed with a memory disorder Participants will receive: -Snacks and refreshments -Medical screening (neurological e...more > Protocol #: 19-1423 Location: University of Colorado Hospital |
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A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV....more > Protocol #: 19-1403 Location: Childrens Hospital Colorado |
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PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)
PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a...more > Protocol #: 19-0619 Location: Childrens Hospital Colorado |
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reST Registry
remede System Therapy in patients with central sleep apnea...more > Protocol #: 19-6087 Locations: Harmony Campus; Medical Center of the Rockies |
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Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation
This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which...more > Protocol #: 19-6506 Location: Memorial Hospital Central |
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NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Protocol #: 19-1152 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)
Protocol #: 19-1154 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Protocol #: 19-1132 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer
Protocol #: 19-6076 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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A Two-year Prospective Natural History Study Examining the Use of Neuronal Injury Biomarkers in Autoimmune Encephalitis as a Potential Biomarker for Disease Activity and Severity
Protocol #: 19-0889 Locations: Brain Imaging Center (BIC); Childrens Hospital Colorado; Colorado Research Center; University of Colorado Hospital |
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The contributions of age related changes in the sound localization pathway to central hearing loss
This study plans to learn more about how age affects the way we process sounds we hear. If you join the study, you will come into our Auditory Lab on the Anschutz Medical Campus 4-6 times and complete hearing assessments and questionnaires. ...more > Protocol #: 19-1213 Location: Department Specific Free Standing Clinic |
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A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS
This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimm...more > Protocol #: 19-0460 Locations: Pathology - SOM; University of Colorado Hospital |
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Cardiopulmonary and Right Ventricular Function in Health and Disease
The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as...more > Protocol #: 19-1141 Location: University of Colorado Hospital |
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A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer
Protocol #: 19-6065 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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Prevention of enamel demineralization in fixed appliance orthodontic patients using CPP-ACP-NaF varnish compared to blank varnish base. A randomized split mouth controlled clinical trial
The hypothesis is that casein phosphopeptide stabilized amorphous calcium phosphate fluoride releasing (CPP-ACP-NaF) dental varnish will be more effective at reducing enamel demineralization than the control varnish base that does not contain CPP-ACP-NaF. ...more > Protocol #: 19-0968 Locations: Dental Clinic; UCD Dental Clinic |
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A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Protocol #: 19-0905 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Protocol #: 19-0376 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)
The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study....more > Protocol #: 19-0636 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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Solid foods and infant growth
This is a 6 month long study with visits occurring once every month. The first and last visit will be conducted at Children's Hospital Colorado and the other 5 visits will be home visits. Compensation will be provided. ...more > Protocol #: 19-0546 Location: Childrens Hospital Colorado |
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A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors
Protocol #: 19-0556 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and,
harmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from 1 month to < 18 years of age with
heart failure due to systemic left ventricle systolic dysfunction
Protocol #: 16-0994 Location: Childrens Hospital Colorado |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...more > Protocol #: 19-0400 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis
The purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, an...more > Protocol #: 19-0422 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D)
Protocol #: 19-0489 Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital |
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A 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)
Protocol #: 19-0473 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
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CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
Protocol #: 19-0476 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics
The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cy...more > Protocol #: 19-0510 Locations: Outpatient CTRC; University of Colorado Hospital; University of Pittsburgh Cancer Institute |
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AMPLATZERTM PFO Occluder Post
Approval Study
This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting...more > Protocol #: 19-6502 Location: Memorial Hospital Central |
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Total Joint Arthroplasty in a Pediatric Population
Involves two surveys for approximately 10 mintues...more > Protocol #: 19-0306 Location: Childrens Hospital Colorado |
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An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis
Protocol #: 19-0105 Location: Childrens Hospital Colorado |
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A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale
Protocol #: 19-0396 Location: Childrens Hospital Colorado |
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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. ...more > Protocol #: 19-0347 Location: University of Colorado Hospital |
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LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Protocol #: 19-0267 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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Multiomics Investigation of Marijuana Use
This research study seeks to learn more about biomarkers and biological pathways associated with marijuana use. We are enrolling adults who are marijuana users or non-users. The study involves filling out online surveys and one on-campus visit to give a blood, urine, and hair sample. If yo...more > Protocol #: 18-0853 Location: University of Colorado Hospital |
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PHASE 1 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE?) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS (Pfizer Protocol A5481092/ ADVL1921)
Protocol #: 19-0299 Location: Childrens Hospital Colorado |
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A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER
A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER...more > Protocol #: 19-0206 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting....more > Protocol #: 19-6030 Locations: Harmony Campus; Medical Center of the Rockies |
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A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCER
Protocol #: 19-0127 Location: University of Colorado Hospital |
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Gene Expression of Cerebral Aneurysms
In this study, we will collect tissue and blood from participants during their epilepsy surgery. ...more > Protocol #: 19-0182 Location: University of Colorado Hospital |
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Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ...more > Protocol #: 19-0149 Locations: Renal Research Center; University of Colorado Hospital |
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How Does Inflammation Affect the Aging Brain? Research Study Investigates Aging, Memory, and Immune Function.
The University of Colorado Anschutz Medical Campus is looking for interested adults 60 and over to participate in a research study examining how inflammation influences brain health. Data gathered from this study will be used to better understand how inflammation may or may not disrupt thi...more > Protocol #: 18-2607 Location: University of Colorado Hospital |
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The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER
Protocol #: 18-2604 Location: University of Colorado Hospital |
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Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI)
The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subj...more > Protocol #: 19-0003 Location: University of Colorado Hospital |
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A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps
OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis....more > Protocol #: 18-2823 Location: University of Colorado Hospital |
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CLINICAL TRIALS IN ORGAN TRANSPLANTATION
CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation
This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the ...more > Protocol #: 18-2679 Location: University of Colorado Hospital |
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PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY
Protocol #: 18-2569 Location: University of Colorado Hospital |
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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Protocol #: 18-2692 Location: University of Colorado Hospital |
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Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System
Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT)....more > Protocol #: 18-2765 Location: University of Colorado Hospital |
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A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study dru...more > Protocol #: 18-6511 Location: Memorial Hospital Central |
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GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)
This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patie...more > Protocol #: 18-2672 Location: University of Colorado Hospital |
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Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab
Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase ...more > Protocol #: 18-2286 Location: Childrens Hospital Colorado |
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Bioenergetic and Metabolic Consequences of the Loss of Gonadal Function- 2018
This research study is investigating the roles of estrogen (female sex hormone) and FSH, or follicle-stimulating hormone, on cortisol (a stress hormone), fat gain, and disease risk....more > Protocol #: 18-2483 Location: University of Colorado Hospital |
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Destination Therapy Post Approval Study - Medtronic HVAD System
LVAD registry...more > Protocol #: 18-2576A Location: University of Colorado Hospital |
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Predictors of physical activity maintenance in colorectal cancer survivors
Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions....more > Protocol #: 18-2436 Locations: Anschutz Health and Wellness; Colorado State University; Harmony Campus; Poudre Valley Hospital; UCD Anschutz Health & Wellness Center |
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A Phase 3, randomized, double-blind, parallel group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.
Protocol #: 18-2534 Location: University of Colorado Hospital |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o...more > Protocol #: 18-2258 Locations: Anschutz Health and Wellness; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.
Protocol #: 18-1223 Location: Childrens Hospital Colorado |
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Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer
Protocol #: 18-2209 Location: University of Colorado Hospital |
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PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations
This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dos...more > Protocol #: 18-2432 Location: Childrens Hospital Colorado |
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Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naive
Protocol #: 18-2284 Location: University of Colorado Hospital |
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A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)
Protocol #: 18-2198 Location: University of Colorado Hospital |
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PHASE 1/2 DOSE ESCALATION AND PRELIMINARY EFFICACY OF CD19 DIRECTED CAR T CELLS GENERATED USING THE MILTENYI CLINIMACS PRODIGY SYSTEM (UCD19 CART) IN PEDIATRIC PATIENTS WITH REPLASED AND/OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) AND B-CELL NON-HODGKIN'S LYMPHOMA (B-NHL)
Protocol #: 18-2424 Location: Childrens Hospital Colorado |
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S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER
Protocol #: 18-2252 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Protocol #: 18-2337 Location: Childrens Hospital Colorado |
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Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)
Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery. ...more > Protocol #: 18-2012 Location: Childrens Hospital Colorado |
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A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I)
Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with ...more > Protocol #: 18-2117 Location: University of Colorado Hospital |
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A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding....more > Protocol #: 18-2249 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who...more > Protocol #: 18-2298 Location: University of Colorado Hospital |
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CU Faces of Hope-Genetics of Craniofacial and Dental Development Research Study
This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors ...more > Protocol #: 18-1916 Location: Childrens Hospital Colorado |
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Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)
The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determin...more > Protocol #: 18-2129 Locations: Medical Center of the Rockies; Memorial Hospital Central; University of Colorado Hospital |
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A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula Repair
Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure....more > Protocol #: 18-1823 Location: Childrens Hospital Colorado |
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors
The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days ...more > Protocol #: 18-2021 Location: University of Colorado Hospital |
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A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red blood cells in Subjects undergoing Complex Cardiac Surgery Procedures (the ReCePI study)
Protocol #: 18-2032 Location: University of Colorado Hospital |
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PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High-Dose Inhaled Corticosteroid plus Long-acting 946;2 Agonist and Chronic Oral Corticosteroid Therapy
This is an open-label, multicenter study designed to evaluate the efficacy and safety of reducing oral corticosteroid (OCS) use after initiation of a 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks (Q4W) up until the third dose of benralizumab and then every 8...more > Protocol #: 18-1978 Location: University of Colorado Hospital |
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Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years. ...more > Protocol #: 18-1842 Location: University of Colorado Hospital |
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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years. ...more > Protocol #: 18-1795 Locations: Colorado Research Center; Renal Research Center |
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A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study
Protocol #: 18-1336 Location: University of Colorado Hospital |
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EA2165 A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal Cancer
Protocol #: 18-1216 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
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A 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group,
Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 ig Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase
Protocol #: 18-1445 Location: Childrens Hospital Colorado |
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An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects 1 and 30 Years of Age with Relapsed/Refractory Precursor B-cell or T-cell Acute Lympholastic Leukemia or Lymphoblastic Lymphoma
Protocol #: 18-0867 Location: Childrens Hospital Colorado |
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AN OPEN-LABEL, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON HODGKIN LYMPHOMA
Protocol #: 18-1439 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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VA Protocol: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Adults diagnosed with schizophrenia are needed for a clinical trial to learn more about how a new medication may affect the brain. Study participants will complete MRI scans, clinical interviews, and cognitive tests. Duration of participation: 14 weeks. Participants will be compensated for...more > Protocol #: 16-1831 Location: University of Colorado Hospital |
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A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women
Protocol #: 18-1254 Location: Outpatient CTRC |
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The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compa...more > Protocol #: 18-1297 Location: University of Colorado Hospital |
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The Effects of Resistance Training on Appetite Regulation
In this study we will be evaluating how your brain responds to food images, as well as how your behaviors and hormones change with a 12-week resistance training intervention....more > Protocol #: 18-1298 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
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A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs]) in Adolescents with Recent Onset Type 1 Diabetes Mellitus (T1DM) v: 7.0; 17-Jan-2017
Protocol #: 16-0905 Locations: Barbara Davis Center; UCD Barbara Davis Center |
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A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota? (CP101) in Subjects with Recurrence of Clostridium difficile Infection (2/22/2018 version 3)
This is a double-blind, placebo-controlled, parallel-arm, multicenter study comparing the safety, tolerability, and efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent CDI. Subjects who are experiencing recurrent CDI will undergo screening procedures...more > Protocol #: 18-1166 Location: University of Colorado Hospital |
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Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
Protocol #: 18-1137 Location: University of Colorado Hospital |
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A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin in Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection V: 3.0; 22Feb2019
Protocol #: 18-0857 Location: Childrens Hospital Colorado |
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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)
This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting...more > Protocol #: 18-1003 Location: University of Colorado Hospital |
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EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)
Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks....more > Protocol #: 18-0926 Location: University of Colorado Hospital |
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EMPERIAL-preserved: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)
Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks. ...more > Protocol #: 18-0925 Location: University of Colorado Hospital |
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A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGard
A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini. ...more > Protocol #: 17-0225 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
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A study of the genetics of pulmonary fibrosis
This study plans to learn more about pulmonary fibrosis and determine if some diseases that cause scarring in the lung might be inherited diseases. We are especially interested in the genetics of pulmonary fibrosis and cases where it might run in families. What we learn may be helpful in...more > Protocol #: 15-1147 Location: University of Colorado Hospital |
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A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease with Motor Fluctuations
Study is double blind and placebo controlled....more > Protocol #: 18-0829 Location: University of Colorado Hospital |
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PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another ...more > Protocol #: 18-0761 Location: University of Colorado Hospital |
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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")
Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site hea...more > Protocol #: 18-0505 Location: University of Colorado Hospital |
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A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer
This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. ...more > Protocol #: 18-0567 Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania |
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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at we...more > Protocol #: 17-2349 Location: University of Colorado Hospital |
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Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherence
Protocol #: 18-0715 Location: University of Colorado Hospital |
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Narcotic consumption in discectomies: microscopic versus endoscopic
In this study a member of the study team will review consenting patient's medical records at pre-op, spine surgery, recovery, follow up visits at 3 months and 12 months...more > Protocol #: 18-0830 Location: University of Colorado Hospital |
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PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)
This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function....more > Protocol #: 18-0637 Location: University of Colorado Hospital |
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Defining Molecular Phenotypes of Exacerbation-Prone Asthmatics
We want to learn more about asthma and how stuff in the air, like pollution and allergens, can make asthma worse in children. To do this we want to look at kids with and without asthma. If you join the study, you will participate in a remote consent visit, a clinic visit and a remote home...more > Protocol #: 17-1416 Location: Childrens Hospital Colorado |
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Impact of Fever Prevention in Brain Injured Patients (INTREPID)
Patients randomized to the fever prevention group will have ArcticGel Pads placed on their body. These will be connected to the Arctic Sun System. The system will be programmed to keep the patient's body temperature at 98.6. Treatment will last for 14 days or until ready to be discharge...more > Protocol #: 18-0548 Location: University of Colorado Hospital |
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Precision Approach to PPI Therapy in Gastroesophageal reflux disease
Over the past 25 years, RALS has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion. Despite the limitations of current diagnostic tests and therapeutic strategies, recent advances in gastoresophageal reflux disease offer tremendous...more > Protocol #: 18-0205 Location: University of Colorado Hospital |
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An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical Procedure
The purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery...more > Protocol #: 18-0546 Location: University of Colorado Hospital |
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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ...more > Protocol #: 18-0392 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
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Pulse Reduction on Beta Blocker and Ivabradine Therapy (PROBE-IT)
The goals of this study are (1) to test the hypothesis that HR reduction is an important underlying antecedent for reverse remodeling, and (2) to identify components of the beta1-GSN responsible for reverse remodeling caused by HR reduction using ivabradine, which could allow for better dr...more > Protocol #: 16-1363 Location: University of Colorado Hospital |
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A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal Stents
The purpose of this study is to determine if a newer type of metal stent with a plastic covering, called the AXIOSTM stent, is safe and effective in draining your WON. ...more > Protocol #: 18-0442 Location: University of Colorado Hospital |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF NEFECON IN PATIENTS WITH PRIMARY IGA NEPHROPATHY AT RISK OF PROGRESSING TO END-STAGE RENAL DISEASE (NefIgArd)
Protocol #: 18-0374 Locations: Colorado Research Center; Renal Research Center; University of Colorado Hospital |
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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 th...more > Protocol #: 17-2267 Location: University of Colorado Hospital |
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure
This study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 1...more > Protocol #: 18-0158 Location: University of Colorado Hospital |
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ARROW study: Weight loss study
Research study looking at your body's response to dietary changes after completing a free weight loss program....more > Protocol #: 18-0091 Location: University of Colorado Hospital |
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Effects of pubertal blockade and hormone therapy on cardiometabolic risk markers in transgender adolescents
There will be 6 study visits over about a year. They will take place over 2 days before starting testosterone and then 1 month and 12 months after starting testosterone. The first study visit will involve a blood draw, an oral glucose tolerance test (sugar drink) and answering questionnair...more > Protocol #: 17-2328 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017
This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (...more > Protocol #: 17-0628 Locations: Boulder Sports Clinic; University of Colorado Hospital |
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PULSE-PHPF-001: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDCLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACYOF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2)
This is a 16 week study of iNO vs placebo. Once the subject meets criteria, the subject will be required to visit the clinic once a month for 16 weeks. There is an open label extension available for this study in which the subject will be guaranteed to get the actual study drug. The subjec...more > Protocol #: 17-1863 Location: University of Colorado Hospital |
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A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer
Protocol #: UCH06-778 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutations
This multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in at least 120 patients with NYHA functional Class II and III DCM secondary to LMNA mutations. NYHA functional Class IV patients (u...more > Protocol #: 17-2345 Locations: CTRC-adult; University of Colorado Hospital |
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A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION
A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION...more > Protocol #: 17-2078 Location: University of Colorado Hospital |
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Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic Prophylaxis
This study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started. ...more > Protocol #: 17-2177 Location: University of Colorado Hospital |
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EARLY-TAVR Evaluation of Transcatheter Aortic Valve
Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis
Protocol #: 17-6134 Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Yampa Valley Medical Center |
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A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)
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)...more > Protocol #: 17-2178 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558)in Advanced Solid Tumors.
Protocol #: 17-2164 Location: University of Colorado Hospital |
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Mitochondria in HIV and Aging (MITO+)
The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment,...more > Protocol #: 17-2161 Location: University of Colorado Hospital |
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Mitochondrial targeted antioxidant supplementation and diastolic function in healthy men and women
As we get older, our cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men and women. Also we want to find out what happens to the cardiovascular system when we take ...more > Protocol #: 17-1782 Location: University of Colorado Hospital |
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S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATION
Protocol #: 17-2125 Locations: Greeley Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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ARST1431 - A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
Protocol #: 17-1992 Location: Childrens Hospital Colorado |
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A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Protocol #: 17-2036 Locations: Greeley Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma
GSK is currently developing a once-daily ?closed? triple therapy of an ICS/LAMA/LABA combination [FF/UMEC/Vilanterol (VI)] in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL)...more > Protocol #: 17-2041 Location: University of Colorado Hospital |
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PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung Cancer
Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects...more > Protocol #: 17-1492 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
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PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory diffuse intrinsic pontine glioma (DIPG), non-brainstem high-grade gliomas (NB-HGG), ependymoma, medulloblastoma or hypermutated brain tumors
Protocol #: 17-1991 Location: Childrens Hospital Colorado |
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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....more > Protocol #: 17-1730 Location: University of Colorado Hospital |
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The influence of gonadal hormone suppression on adipocyte lineage and the microbiome
Six month intervention of ovarian hormone supression...more > Protocol #: 17-1869 Location: University of Colorado Hospital |
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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)
This study is inviting people who have RA into a study to have an HRCT scan and PFT testing done for the study to learn more about lung disease in RA...more > Protocol #: 16-1097 Location: University of Colorado Hospital |
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Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)
Protocol #: 17-1406 Location: Childrens Hospital Colorado |
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Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/Obesity
In this study, we will be evaluating the effects of a reverse-diet compared to standard weight loss maintenance advice....more > Protocol #: 17-1726 Location: University of Colorado Hospital |
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Pilot Study to Evaluate Safety and Tolerability of Inhaled N-Acetylcysteine in Pulmonary Fibrosis
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. We will also create a bank of data, blood, and sputum from IPF patients for future research. NAC is a medication used to loosen thick mucus. NAC was in...more > Protocol #: 17-1477 Location: University of Colorado Hospital |
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Copeptin and Nonalcoholic Fatty Liver Disease
See above...more > Protocol #: 17-1160 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
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Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches
Regular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movemen...more > Protocol #: 16-2706 Locations: CTRC-adult; University of Colorado Hospital |
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The Assessment of Long Term Durability, Safety and Effectiveness of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valve and Surgical Aortic
Valve Replacement in Intermediate Risk Patients Suffering from Severe
Symptomatic Aortic Stenosis
he PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control ar...more > Protocol #: 12-0660 Location: University of Colorado Hospital |
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Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)
The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri...more > Protocol #: 17-0977 Location: University of Colorado Hospital |
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DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
If you join the study, you will be placed by chance into one of two research groups: 1) exercise and a study pill or 2) no exercise and a study pill. The study pill could be DHEA (50 mg/day) or a placebo. A placebo is a pill that looks like medicine but is not real. DHEA is a naturally oc...more > Protocol #: 16-2427 Location: University of Colorado Hospital |
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A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options checklist
Protocol #: 17-1249 Locations: Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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