Your search for "All Studies" found 971 matches:
A retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe PROVE (Retrospective Cefiderocol Chart Review Study)

Protocol #: 21-3197

Location: University of Colorado Hospital

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

Protocol #: 21-2749

Location: Childrens Hospital Colorado

Mind Body Balance for Pediatric Migraine

Protocol #: 21-2568

Location: Childrens Hospital Colorado

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

Protocol #: 21-2481

Location: Childrens Hospital Colorado

Neurocognitive Function in the Pediatric Hematology Oncology Population

Protocol #: 20-2765

Location: Childrens Hospital Colorado

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

Protocol #: 20-2627

Location: University of Colorado Hospital

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)

Protocol #: 20-2995

Location: University of Colorado Hospital

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

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

Protocol #: 20-3010

Locations: Renal Research Center; University of Colorado Hospital

Pediatric Peritoneal Dialysis Telehealth Survey

Protocol #: 20-3009

Location: Childrens Hospital Colorado

The ENCIRCLE high-risk trial: SAPIEN M3 system TransCatheter mitral valve ReplaCement vis TransseptaL AccEss

Protocol #: 20-2889

Location: Medical Center of the Rockies

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

Protocol #: 20-2972

Location: University of Colorado Hospital

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

Protocol #: 20-2971

Location: Medical Center of the Rockies

A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS)

Protocol #: 20-2721

Location: University of Colorado Hospital

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

Protocol #: 17-2168I

Location: Childrens Hospital Colorado

Department of Otolaryngology Inner Ear Biobank

Protocol #: 19-1340

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study

Protocol #: 20-2772

Location: University of Colorado Hospital

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

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

Protocol #: 20-2738

Location: Childrens Hospital Colorado

Pediatric Brain Injury Caregiver Education Program

Protocol #: 20-0272

Location: Childrens Hospital Colorado

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

Protocol #: 18-1270

Location: Childrens Hospital Colorado

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

Protocol #: 19-0741

Location: Dental Clinic

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

Protocol #: 20-2681

Location: Childrens Hospital Colorado

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Protocol #: 20-6512

Locations: Memorial Hospital Central; Memorial Hospital North

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

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

Sleep assessed by actigraphy and direct recordings of the subthalamic nucleus in Parkinson's Disease.

Protocol #: 20-2508

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

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

Protocol #: 20-2584

Location: University of Colorado Hospital

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

Protocol #: 20-2610

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 20-2566

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-2541

Location: University of Colorado Hospital

Biomarker Development for Sepsis in Pediatric Oncology Patients

Protocol #: 20-2374

Location: Childrens Hospital Colorado

A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment

Protocol #: 20-2383

Location: University of Colorado Hospital

PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer

Protocol #: 20-6514

Locations: Memorial Hospital Central; Memorial Hospital North

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Protocol #: 20-1994

Location: University of Colorado Hospital

A Phase 1/2 Study of M3814 (peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

Protocol #: 20-2093

Location: University of Colorado Hospital

Paired Germline/Tumor Genetic Testing Outcomes

Protocol #: 20-2287

Locations: Childrens Hospital Colorado; Childrens Hospital Colorado at Memorial

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

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

Protocol #: 20-2414

Location: Childrens Hospital Colorado

NRG-LU007: Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

Protocol #: 20-2369

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

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

Protocol #: 20-2411

Location: Childrens Hospital Colorado

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

Protocol #: 20-2410

Location: University of Colorado Hospital

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

Protocol #: 20-2407

Location: University of Colorado Hospital

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

Protocol #: 20-2406

Location: University of Colorado Hospital

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

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

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

Protocol #: 20-2139

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-2220

Location: Barbara Davis Center

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

Protocol #: 20-0113

Location: Childrens Hospital Colorado

STUDY OF ANTIMALARIALS IN INCOMPLETE LUPUS ERYTHEMATOSUS (SMILE)

Protocol #: 20-0141

Locations: Barbara Davis Center; University of Colorado Hospital

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

Real World Observational Study using clonoSEQ? Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry

Protocol #: 20-2108

Location: University of Colorado Hospital

A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Protocol #: 20-2042

Location: University of Colorado Hospital

Clinical Survey Study to Evaluate Biomarkers and Clinical Manifestations in Individuals with Glycogen Storage Disease Type III (GSD III)

Protocol #: 20-2123

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-1948

Location: Rocky Mountain Regional VA Medical Center

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

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

Personalized Spine Study Group Registry

Protocol #: 20-2016

Location: University of Colorado Hospital

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

Protocol #: 20-1892

Location: University of Colorado Hospital

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

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS

Protocol #: 20-1787

Location: University of Colorado Hospital

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

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

Protocol #: 20-1988

Location: University of Colorado Hospital

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

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

Protocol #: 20-1938

Location: Childrens Hospital Colorado

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Protocol #: 20-1524

Location: University of Colorado Hospital

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

Protocol #: 20-1845

Location: University of Colorado Hospital

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

Protocol #: 20-1864

Location: Childrens Hospital Colorado

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

Protocol #: 20-1830

Location: University of Colorado Hospital

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

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

Protocol #: 20-1827

Location: Childrens Hospital Colorado

Patient Perpetrated Workplace Violence and the Effects on Patient Outcomes

Protocol #: 20-6057

Location: Memorial Hospital Central

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

Protocol #: 20-1715

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic

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

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

Protocol #: 19-2216

Location: Rocky Mountain Regional VA Medical Center

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

Protocol #: 19-2862

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

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

Protocol #: 20-1667

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 20-1736

Location: University of Colorado Hospital

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

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

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

Protocol #: 20-1721

Location: Childrens Hospital Colorado

Dystonia Coalition Projects-3

Protocol #: 20-0290

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

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

Protocol #: 20-1602

Location: Childrens Hospital Colorado

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

Protocol #: 20-1525

Location: University of Colorado Hospital

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

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

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

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

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

Protocol #: 20-1487

Location: Childrens Hospital Colorado

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

Protocol #: 20-1445

Location: Childrens Hospital Colorado

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

Protocol #: 20-1438

Location: University of Colorado Hospital

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

Protocol #: 20-1453

Location: University of Colorado Hospital

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

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

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

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

Protocol #: 20-1106

Location: Childrens Hospital Colorado

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

Protocol #: 20-1380

Location: Childrens Hospital Colorado

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

Patient Preferences in Deep Brain Stimulation Products

Protocol #: 19-3015

Location: University of Colorado Hospital

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 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

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

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

Protocol #: 20-1204

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

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

Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

Protocol #: 20-6034

Location: Medical Center of the Rockies

Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic Anemia

Protocol #: 20-1333

Location: Childrens Hospital Colorado

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

Protocol #: 19-2469

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 20-0246

Location: University of Colorado Hospital

TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Protocol #: 20-1306

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

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

Protocol #: 20-1289

Location: University of Colorado Hospital

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

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

Protocol #: 20-1227

Location: University of Colorado Hospital

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

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

Protocol #: 20-1262

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

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

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

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

Protocol #: 20-1197

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

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

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

Protocol #: 20-1219

Location: University of Colorado Hospital

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

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

Protocol #: 20-0138

Location: University of Colorado Hospital

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

Protocol #: 20-1055

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Impaired Renal Function

Protocol #: 20-0902

Location: University of Colorado Hospital

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

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

SLEEP-DISORDERED BREATHING IN INFANTS WITH MYELOMENINGOCELE

Protocol #: 20-0996

Location: Childrens Hospital Colorado

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

Protocol #: 20-0880

Location: University of Colorado Hospital

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

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

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

Molecular and Genomic Studies of Bone Marrow Failure and Myelodysplastic Syndromes

Protocol #: 16-1438

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-0978

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

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

Protocol #: 20-0889

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-0781

Location: University of Colorado Hospital

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

Protocol #: 20-0609

Location: University of Colorado Hospital

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

Protocol #: 20-0820

Location: Childrens Hospital Colorado

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

Protocol #: 20-0727

Location: University of Colorado Hospital

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

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

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

Protocol #: 19-1130

Location: University of Colorado Hospital

COVID-19 Biobank

Protocol #: 20-0685

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

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

Protocol #: 20-0579

Location: Childrens Hospital Colorado

Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI

Protocol #: 20-0537

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 20-0590

Location: Department Specific Free Standing Clinic

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

Protocol #: 20-0571

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

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

COVID-19 Preparedness Survey

Protocol #: 20-0620

Location: University of Colorado Hospital

Virtual reality in cancer patient imaging review

Protocol #: 20-0560

Location: University of Colorado Hospital

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

CD80 as a biomarker for kidney disease

Protocol #: 13-2700

Location: Childrens Hospital Colorado

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

Protocol #: 20-0490

Location: Childrens Hospital Colorado

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

Protocol #: 20-0535

Location: Childrens Hospital Colorado

Characterization of cannabinoids, endocannabinoids, and biomarkers in adolescents

Protocol #: 20-0553

Location: University of Colorado Hospital

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

Protocol #: 20-0404

Location: University of Colorado Hospital

Immune Profiles in CF Fungal Infections

Protocol #: 20-0099

Location: Childrens Hospital Colorado

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

Protocol #: 20-6027

Locations: Long's Peak Hospital; Longs Peak Hospital

Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion

Protocol #: 15-0813

Location: University of Colorado Hospital

International CDKL5 Clinical Research Network

Protocol #: 19-2756

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-0347

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

Validation of the Apollo EE Device, Indirect Calorimetry

Protocol #: 20-0317

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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

Protocol #: 20-0357

Location: University of Colorado Hospital

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

Protocol #: 20-0261

Location: University of Colorado Hospital

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

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

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

Protocol #: 20-0262

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-2236

Locations: Denver Health and Hospital Authority; University of Colorado Hospital

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

Protocol #: 20-0303

Location: University of Colorado Hospital

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

Protocol #: 20-0271

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 20-0279

Location: Childrens Hospital Colorado

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS

Protocol #: 19-3082

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

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

Protocol #: 20-0216

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

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

Protocol #: 19-2345

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-0226

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

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

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

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

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

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

Protocol #: 20-0007

Location: University of Colorado Hospital

ALS toolkit project

Protocol #: 20-0127

Location: University of Colorado Hospital

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

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

Protocol #: 20-0124

Location: University of Colorado Hospital

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

Protocol #: 17-2350

Location: University of Colorado Hospital

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

Protocol #: 20-0094

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 19-3061

Location: University of Colorado Hospital

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

Protocol #: 20-0036

Location: University of Colorado Hospital

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

Protocol #: 20-0035

Location: University of Colorado Hospital

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

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

Protocol #: 19-2988

Locations: Lone Tree Medical Center; University of Colorado Hospital

Tissue Bank and Clinical Database for the Analysis of arterial thrombosis

Protocol #: 19-2998

Location: University of Colorado Hospital

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

Protocol #: 19-3118

Location: University of Colorado Hospital

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

North American Pediatric Renal Trials Collaborative Studies (NAPRTCS)

Protocol #: 19-3007

Location: Childrens Hospital Colorado

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

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

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

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

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

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

Protocol #: 19-2999

Location: University of Colorado Hospital

Biomarker Development in LGMD 2i

Protocol #: 19-2943

Location: University of Colorado Hospital

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

Protocol #: 19-3075

Location: University of Colorado Hospital

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

Protocol #: 19-2758

Location: University of Colorado Hospital

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

Protocol #: 19-2833

Locations: Memorial Hospital Central; University of Colorado Hospital

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

Protocol #: 19-2987

Location: University of Colorado Hospital

North American Mitrochondrial Disease Consortium Patient Registry and Biorepository

Protocol #: 13-2246

Location: Childrens Hospital Colorado

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

Pediatric Bone Marrow Failure Tissue Repository

Protocol #: 19-2913

Location: Childrens Hospital Colorado

Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes

Protocol #: 19-2760

Location: University of Colorado Hospital

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

Protocol #: 19-2960

Location: University of Colorado Hospital

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

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

Protocol #: 19-2898

Location: University of Colorado Hospital

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

Protocol #: 19-2940

Location: Childrens Hospital Colorado

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

Protocol #: 19-2893

Location: Steadman Hawkins Clinic - Denver (Iverness)

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

Protocol #: 19-2950

Location: Childrens Hospital Colorado

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

Protocol #: 19-2838

Location: Steadman Hawkins Clinic - Denver (Iverness)

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

Protocol #: 19-2888

Location: University of Colorado Hospital

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

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

Protocol #: 19-2910

Locations: Barbara Davis Center; University of Colorado Hospital

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

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

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

Protocol #: 19-2797

Location: University of Colorado Hospital

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

Protocol #: 19-2818

Location: University of Colorado Hospital

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

Protocol #: 19-2761

Location: University of Colorado Hospital

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

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

Protocol #: 19-2795

Location: University of Colorado Hospital

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

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

Protocol #: 19-2645

Location: University of Colorado Hospital

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

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

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

Lipoic acid for Treatment of Progressive Multiple Sclerosis

Protocol #: 19-2525

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

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

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

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

Protocol #: 19-2676

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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

Protocol #: 19-2744

Location: Childrens Hospital Colorado

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

Protocol #: 19-0795

Location: University of Colorado Hospital

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

Protocol #: 19-2471

Location: University of Colorado Hospital

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

Protocol #: 19-2405

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-2640

Location: Rocky Mountain Regional VA Medical Center

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

Protocol #: 19-2707

Location: University of Colorado Hospital

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

Protocol #: 19-2532

Location: University of Colorado Hospital

A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (DEFI-RDEB)

Protocol #: 19-1972

Location: Childrens Hospital Colorado

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

Protocol #: 19-2377

Location: University of Colorado Hospital

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

Protocol #: 19-2631

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-2378

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

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

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

Protocol #: 19-2445

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

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

Protocol #: 19-2521

Location: University of Colorado Hospital

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

Protocol #: 19-2524

Location: University of Colorado Hospital

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

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

Protocol #: 19-2533

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 19-1896

Location: Childrens Hospital Colorado

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

Protocol #: 19-2438

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-2475

Location: Childrens Hospital Colorado

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

Protocol #: 19-2420

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

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

Adenosinergic immune suppression pathway in glioblastoma multiforme tumors

Protocol #: 19-2344

Location: University of Colorado Hospital

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

Protocol #: 19-2311

Location: University of Colorado Hospital

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

Protocol #: 19-1929

Location: University of Colorado Hospital

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

A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Protocol #: 19-2363

Location: University of Colorado Hospital

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

Protocol #: 19-1598

Location: University of Colorado Hospital

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

Protocol #: 19-1980

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

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

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

Protocol #: 19-2357

Location: Childrens Hospital Colorado

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

Protocol #: 19-2038

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

Perceived Palliative Care Needs in Early-Onset Dementia

Protocol #: 19-2134

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

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

Protocol #: 19-2295

Location: Childrens Hospital Colorado

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

Protocol #: 19-2242

Location: University of Colorado Hospital

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

Protocol #: 19-1613

Location: Childrens Hospital Colorado

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

Protocol #: 19-2270

Location: Childrens Hospital Colorado

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

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

Improving Renal Outcomes Collaborative

Protocol #: 16-2190

Location: Childrens Hospital Colorado

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

Protocol #: 19-1985

Location: University of Colorado Hospital

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

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

Protocol #: 16-0927

Location: Childrens Hospital Colorado

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

Protocol #: 19-2157

Location: Childrens Hospital Colorado

Prospective Analysis of Gait Following Hemispherectomy

Protocol #: 17-0230

Location: Childrens Hospital Colorado

Gait Analysis of Femoroacetabular Impingement Patients

Protocol #: 16-1934

Location: Childrens Hospital Colorado

International Fetal Cardiac Intervention Registry

Protocol #: 14-0343

Location: Childrens Hospital Colorado

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

Protocol #: 14-1413

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #: 18-1076

Location: Childrens Hospital Colorado

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

Protocol #: 19-1621

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

MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME

Protocol #: 19-2092

Location: Childrens Hospital Colorado

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

Protocol #: 19-1840

Location: University of Colorado Hospital

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

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

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

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

Protocol #: 19-1977

Location: University of Colorado Hospital

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

Protocol #: 19-1809

Location: University of Colorado Hospital

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

Protocol #: 15-1434

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1925

Location: University of Colorado Hospital

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

Protocol #: 19-6100

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

Protocol #: 19-1839

Location: Childrens Hospital Colorado

Prospective Analysis of Circulating Tumor Cells in Patients with Metastatic Prostate Cancer.

Protocol #: 19-1687

Location: University of Colorado Hospital

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

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

Protocol #: 18-1380

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 19-2412

Location: Childrens Hospital Colorado

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

Protocol #: 19-1633

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1581

Location: University of Colorado Hospital

INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

Protocol #: 02-729

Location: Department Specific Free Standing Clinic

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

Protocol #: 19-1597

Location: University of Colorado Hospital

Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)

The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with t...more >

Protocol #: 19-1823

Location: University of Colorado Hospital

Rare CFTR Mutation Cell Collection Protocol (RARE)

Protocol #: 16-2412

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 19-1600

Location: University of Colorado Hospital

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

Protocol #: 15-0140

Location: Childrens Hospital Colorado

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

Protocol #: 19-1787

Location: Childrens Hospital Colorado

The National Myelodysplastic Syndromes (MDS) Study

Protocol #: 19-1696

Location: Rocky Mountain Regional VA Medical Center

COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

Protocol #: 19-1634

Location: Childrens Hospital Colorado

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

Protocol #: 19-1748

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 19-1467

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-6510

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

ECG Belt for CRT 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

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

Protocol #: 19-1503

Location: University of Colorado Hospital

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

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

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

Protocol #: 14-1720

Location: Childrens Hospital Colorado

TRAVERSE

Protocol #: 19-1644

Location: University of Colorado Hospital

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

Protocol #: 15-0902

Locations: Childrens Hospital Colorado; Colorado Research Center

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

Protocol #: 19-1566

Location: University of Colorado Hospital

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

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

Protocol #: 19-0506

Location: University of Colorado Hospital

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

Protocol #: 19-1458

Location: University of Colorado Hospital

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

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

Regression in Down Syndrome

Protocol #: 19-1418

Location: Childrens Hospital Colorado

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the University of Colorado's Hematology Tissue Bank Protocol

Protocol #: 19-1498

Location: University of Colorado Hospital

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

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

Protocol #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 18-2128

Location: University of Colorado Hospital

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

Protocol #: 16-1270

Locations: Denver Health and Hospital Authority; University of Colorado Hospital

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

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

Protocol #: 19-1230

Location: Childrens Hospital Colorado

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

Protocol #: 19-1282

Locations: Childrens Hospital Colorado; Outpatient CTRC; University of Colorado Hospital

Informational Meetings for Planning And Coordinating Treatment (IMPACT)

Protocol #: 19-1462

Location: Childrens Hospital Colorado

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

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

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

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

Protocol #: 19-1399

Location: University of Colorado Hospital

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

Protocol #: 19-1387

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

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

Protocol #: 19-0744

Location: University of Colorado Hospital

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

Protocol #: 18-2793

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-1192

Location: University of Colorado Hospital

reST Registry

remede System Therapy in patients with central sleep apnea...more >

Protocol #: 19-6087

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 19-1259

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1081

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

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

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

Protocol #: 19-1145

Location: University of Colorado Hospital

Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Protocol #: 16-2408

Location: Childrens Hospital Colorado

Multi-Institutional Validation of Trauma Specific Frailty Index

Protocol #: 19-6084

Location: Medical Center of the Rockies

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

Protocol #: 19-1277

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1272

Location: University of Colorado Hospital

Neurophysiological Correlates V: 31Jan18

Protocol #: 16-1480

Location: Childrens Hospital Colorado

Natural History of Rett Syndrome and Related Disorders

Protocol #: 15-2332

Location: Childrens Hospital Colorado

Gamma band neural stimulation and its effects on resting state networks

Protocol #: 19-1251

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

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

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

Protocol #: 16-1998

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-0675

Location: University of Colorado Hospital

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

Protocol #: 19-0865

Location: University of Colorado Hospital

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

Protocol #: 19-1171

Location: University of Colorado Hospital

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

Protocol #: 19-1113

Location: University of Colorado Hospital

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

Protocol #: 19-0554

Location: University of Colorado Hospital

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

Protocol #: 19-1199

Location: University of Colorado Hospital

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

Protocol #: 19-1118

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

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

Protocol #: 19-1040

Location: University of Colorado Hospital

Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab

Protocol #: 19-1074

Location: University of Colorado Hospital

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

Protocol #: 18-2625

Location: Rocky Mountain Regional VA Medical Center

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

Protocol #: 19-1147

Location: University of Colorado Hospital

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

Protocol #: 19-1069

Location: University of Colorado Hospital

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

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

Protocol #: 19-1148

Location: University of Colorado Hospital

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

Protocol #: 15-0693

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-0561

Location: University of Colorado Hospital

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

Protocol #: 19-0967

Location: University of Colorado Hospital

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

Protocol #: 19-0604

Location: University of Colorado Hospital

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

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

Protocol #: 19-0642

Location: University of Colorado Hospital

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

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Protocol #: 18-0220

Location: University of Colorado Hospital

The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D

Protocol #: 19-0856

Locations: Barbara Davis Center; University of Colorado Hospital

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

Understanding the Barriers to Epilepsy Surgery: A North American Survey

Protocol #: 19-0269

Location: University of Colorado Hospital

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

Protocol #: 19-6060

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

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

Protocol #: 19-0900

Location: University of Colorado Hospital

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

Protocol #: 19-0852

Location: University of Colorado Hospital

Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal 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

Outcomes after Standardized Testicular Torsion Management and Follow-up

Protocol #: 19-0849

Location: Childrens Hospital Colorado

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

Protocol #: 19-0772

Location: University of Colorado Hospital

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

Protocol #: 19-0150

Location: University of Colorado Hospital

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

Protocol #: 19-0814

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 14-1072

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-0632

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

Prognostic factors associated with outcomes in colorectal cancer liver metastases

Protocol #: 19-0770

Location: University of Colorado Hospital

CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY

Protocol #: 19-0519

Location: University of Colorado Hospital

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

Protocol #: 19-0520

Location: University of Colorado Hospital

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

Protocol #: 19-0507

Location: University of Colorado Hospital

The Perelman Study of IntraUterine Growth Restriction

Protocol #: 14-1360

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

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

Protocol #: 19-6047

Locations: Medical Center of the Rockies; Poudre Valley Hospital

The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...more >

Protocol #: 19-0400

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

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

Evaluation and Demonstration of Investigational MRI Software and Hardware

Protocol #: 19-0518

Location: Childrens Hospital Colorado

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

Protocol #: 19-0457

Location: University of Colorado Hospital

Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Protocol #: 18-2594

Location: University of Colorado Hospital

Instrumentation of Huntington's Disease Motor Function Assessment

Protocol #: 19-0212

Location: University of Colorado Hospital

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

Protocol #: 19-0414

Location: University of Colorado Hospital

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

Protocol #: 19-0489

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

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

Protocol #: 19-0539

Location: University of Colorado Hospital

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

Protocol #: 19-0493

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 19-0473

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 19-0551

Location: Childrens Hospital Colorado

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

Protocol #: 19-0549

Location: Childrens Hospital Colorado

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

Protocol #: 19-0325

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 19-0423

Location: University of Colorado Hospital

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

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

Detection and Risk in Early MS

Protocol #: 19-0393

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

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

Protocol #: 18-1695

Location: Childrens Hospital Colorado

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

Protocol #: 19-0172

Location: University of Colorado Hospital

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

Protocol #: 19-0444

Location: University of Colorado Hospital

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

Protocol #: 19-0232

Location: University of Colorado Hospital

Total Joint Arthroplasty in a Pediatric Population

Involves two surveys for approximately 10 mintues...more >

Protocol #: 19-0306

Location: Childrens Hospital Colorado

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

Protocol #: 18-2444

Location: University of Colorado Hospital

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

Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer

Protocol #: 18-2742

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

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

Protocol #: 19-0396

Location: Childrens Hospital Colorado

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

Protocol #: 18-2537

Location: University of Colorado Hospital

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

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

Protocol #: 19-0347

Location: University of Colorado Hospital

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

Protocol #: 19-0267

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

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

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

Protocol #: 19-0239

Location: University of Colorado Hospital

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

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

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

Protocol #: 19-0206

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 18-2740

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

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

Protocol #: 19-0207

Location: University of Colorado Hospital

APOGEE

LVAD registry...more >

Protocol #: 18-2576B

Location: University of Colorado Hospital

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

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

Protocol #: 18-2513

Location: Childrens Hospital Colorado

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

Protocol #: 19-0127

Location: University of Colorado Hospital

Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Protocol #: 19-0049

Locations: Colorado Research Center; Department Specific Free Standing Clinic

Surgery Database Project

Protocol #: 18-2839

Location: University of Colorado Hospital

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

Protocol #: 16-0692

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

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

Protocol #: 19-0225

Location: University of Colorado Hospital

Randomized phase 2 clinical trial of nab-paclitaxel + durvalumab (MEDI4736) + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) in patients with metastatic triple negative breast cancer

Protocol #: 19-0013

Location: University of Colorado Hospital

Gene Expression of Cerebral Aneurysms

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

Protocol #: 19-0182

Location: University of Colorado Hospital

Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD

This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ...more >

Protocol #: 19-0149

Locations: Renal Research Center; University of Colorado Hospital

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

Protocol #: 19-0123

Location: University of Colorado Hospital

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

Protocol #: 19-0120

Location: University of Colorado Hospital

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

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

Protocol #: 19-0041

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

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

Protocol #: 19-0079

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-2874

Location: University of Colorado Hospital

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

Protocol #: 18-6515

Location: Memorial Hospital Central

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

Protocol #: 19-0027

Location: Barbara Davis Center

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

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

Protocol #: 18-6119

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

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

Protocol #: 18-2654

Location: University of Colorado Hospital

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

Protocol #: 18-2806

Location: University of Colorado Hospital

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

Protocol #: 18-2520

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

Protocol #: 18-2692

Location: University of Colorado Hospital

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

Protocol #: 18-2772

Location: University of Colorado Hospital

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

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

Protocol #: 18-2089

Location: University of Colorado Hospital

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

Protocol #: 18-2529

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

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

Protocol #: 18-2714

Location: Childrens Hospital Colorado

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

Protocol #: 11-0674

Locations: Memorial Hospital Central; Memorial Hospital North

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

Protocol #: 18-2646

Location: University of Colorado Hospital

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

Protocol #: 18-2684

Location: University of Colorado Hospital

A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey Results

Protocol #: 18-2562

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

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

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

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

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

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

Protocol #: 18-2346

Location: University of Colorado Hospital

CLASP IID/IIF

Protocol #: 18-6126

Locations: Harmony Campus; Medical Center of the Rockies

Destination Therapy Post Approval Study - Medtronic HVAD System

LVAD registry...more >

Protocol #: 18-2576A

Location: University of Colorado Hospital

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

Protocol #: 18-2417

Location: University of Colorado Hospital

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

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

Protocol #: 16-0086

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-1223

Location: Childrens Hospital Colorado

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

Protocol #: 17-2424

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

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

Protocol #: 18-2209

Location: University of Colorado Hospital

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

Protocol #: 18-2382

Location: University of Colorado Hospital

PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, 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

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

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

Protocol #: 18-2198

Location: University of Colorado Hospital

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

Protocol #: 18-1816

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-2354

Location: University of Colorado Hospital

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

Protocol #: 18-2337

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-2012

Location: Childrens Hospital Colorado

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

Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with ...more >

Protocol #: 18-2117

Location: University of Colorado Hospital

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

Protocol #: 18-1558

Location: Childrens Hospital Colorado

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

Protocol #: 18-1683

Location: Childrens Hospital Colorado

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

Protocol #: 18-2315

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-0369

Location: University of Colorado Hospital

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

Protocol #: 18-6510

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

Genomic Translation for ALS Care

Protocol #: 18-1768

Location: University of Colorado Hospital

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

Protocol #: 18-2051

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-1843

Location: Childrens Hospital Colorado

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

Protocol #: 18-2047

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-1633

Location: University of Colorado Hospital

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

Protocol #: 18-2032

Location: University of Colorado Hospital

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

Protocol #: 18-1997

Location: Childrens Hospital Colorado

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

Protocol #: 18-6061

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

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

Protocol #: 18-1674

Location: Childrens Hospital Colorado

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

Protocol #: 18-1527

Location: Childrens Hospital Colorado

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

Protocol #: 18-1963

Location: Childrens Hospital Colorado

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

Clinical Outcome Measures in Friedreich's Ataxia

Protocol #: 18-1641

Location: University of Colorado Hospital

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

Protocol #: 18-1672

Location: University of Colorado Hospital

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

Protocol #: 18-1734

Location: University of Colorado Hospital

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

Protocol #: 18-1728

Location: University of Colorado Hospital

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

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

Protocol #: 18-1808

Location: University of Colorado Hospital

Square wave testosterone therapy in castration resistant prostate cancer

Protocol #: 18-0821

Location: University of Colorado Hospital

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

Protocol #: 18-1599

Location: University of Colorado Hospital

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

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

Protocol #: 18-1740

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

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

Protocol #: 18-1493

Location: University of Colorado Hospital

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

Protocol #: 18-0554

Location: University of Colorado Hospital

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

Protocol #: 18-1343

Location: University of Colorado Hospital

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

Protocol #: 18-1654

Location: University of Colorado Hospital

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

Protocol #: 18-1526

Location: University of Colorado Hospital

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

Protocol #: 18-1349

Location: Childrens Hospital Colorado

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

Protocol #: 18-1429

Location: Childrens Hospital Colorado

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

Protocol #: 18-1336

Location: University of Colorado Hospital

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

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

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

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

Molecular Characterization of Idiopathic Interstitial Pneumonias

Protocol #: 18-1490

Location: University of Colorado Hospital

Peripheral Inflammatory Cytokine Levels in Parkinson Disease

Protocol #: 18-1356

Location: University of Colorado Hospital

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

Protocol #: 18-1391

Location: Childrens Hospital Colorado

Conversational Speech in the Diagnosis of Neurocognitive Disorders

Protocol #: 18-0456

Location: University of Colorado Hospital

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

Protocol #: 13-3192

Location: Adult Infectious Disease Clinical Trials Center

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

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

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

Protocol #: 16-1400

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

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

Protocol #: 18-1199

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-0910

Location: Childrens Hospital Colorado

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

Protocol #: 18-6055

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

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

Protocol #: 18-1281

Location: Childrens Hospital Colorado

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

Protocol #: 17-0051

Location: University of Colorado Hospital

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

Protocol #: 15-1868

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

Obalon? Balloon System, The Post Approval Study

Protocol #: 18-1209

Location: University of Colorado Hospital

Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy

Protocol #: 18-0995

Location: University of Colorado Hospital

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

Protocol #: 18-0973

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

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

Protocol #: 18-1150

Location: University of Colorado Hospital

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

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

Protocol #: 18-1148

Location: University of Colorado Hospital

Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain

Protocol #: 16-1063

Location: Childrens Hospital Colorado

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

Protocol #: 18-1137

Location: University of Colorado Hospital

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

Protocol #: 16-2308

Location: University of Colorado Hospital

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

Protocol #: 18-0709

Location: University of Colorado Hospital

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

Protocol #: 17-2215

Location: University of Colorado Hospital

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

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

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

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

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

Protocol #: 18-0971

Location: Childrens Hospital Colorado

Ruptured Aneurysms Treated with Hydrogel Coils

Protocol #: 18-6052

Location: Memorial Hospital Central

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

Protocol #: 18-0685

Location: University of Colorado Hospital

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

Protocol #: 18-0627

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

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

Protocol #: 16-0701

Locations: Denver Health and Hospital Authority; University of Colorado Hospital; University of Oklahoma

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

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

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

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

AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Protocol #: 18-0803

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Molecular Endotypes of Chronic Spontaneous Urticaria

Protocol #: 18-0850

Location: University of Colorado Hospital

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

Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site hea...more >

Protocol #: 18-0505

Location: University of Colorado Hospital

Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction Protocol No.:XEL-CR-03

Protocol #: 18-0444

Location: Childrens Hospital Colorado

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

Protocol #: 18-0836

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

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

Protocol #: 18-0498

Location: Childrens Hospital Colorado

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

Protocol #: 18-0686

Location: Childrens Hospital Colorado

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

Protocol #: 15-1041

Location: University of Colorado Hospital

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

Education Efficacy in Patient Interventions

Protocol #: 18-6020

Location: Medical Center of the Rockies

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

Protocol #: 18-0501

Location: Childrens Hospital Colorado

Identifying Environmental Triggers of Smoking Behaviors in Low-income Communities

Protocol #: 18-0052

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

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

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

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

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

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

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

Protocol #: 18-0461

Location: Childrens Hospital Colorado

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

Protocol #: 18-0582

Location: University of Colorado Hospital

Impact of Fever Prevention in Brain Injured Patients (INTREPID)

Patients randomized to the fever prevention group will have ArcticGel Pads placed on their body. These will be connected to the Arctic Sun System. The system will be programmed to keep the patient's body temperature at 98.6. Treatment will last for 14 days or until ready to be discharge...more >

Protocol #: 18-0548

Location: University of Colorado Hospital

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

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

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Protocol #: 17-2186

Location: University of Colorado Hospital

EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

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

Protocol #: 18-0392

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 18-0385

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-0374

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

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

Protocol #: 18-0251

Location: University of Colorado Hospital

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

Protocol #: 17-6205

Location: Memorial Hospital Central

Diet and Relapses in Pediatric Multiple Sclerosis

Protocol #: 18-0393

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 16-1875

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

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

Protocol #: 18-0017

Location: Childrens Hospital Colorado

Perceived palliative care needs of Huntington's disease patients

Protocol #: 18-0216

Location: University of Colorado Hospital

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

Protocol #: 18-0187

Location: University of Colorado Hospital

Clinical Trial Readiness for SCA1 and SCA3

Protocol #: 18-0020

Location: University of Colorado Hospital

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

Protocol #: 17-1809

Location: Childrens Hospital Colorado

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

Protocol #: 18-0183

Location: University of Colorado Hospital

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

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

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

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

Protocol #: 15-0170

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

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

Protocol #: 17-2216

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

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

Protocol #: 18-0031

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 17-2020

Location: Childrens Hospital Colorado

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

Protocol #: 17-2399

Location: University of Colorado Hospital

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

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

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

Protocol #: 17-2299

Location: University of Colorado Hospital

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

Protocol #: 17-2355

Locations: Childrens Hospital Colorado; Colorado Research Center

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

Protocol #: 16-0179

Locations: Childrens Hospital Colorado; Denver Health and Hospital Authority; University of Colorado Hospital

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

Protocol #: 17-2394

Location: Childrens Hospital Colorado

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

Protocol #: 16-2179

Location: University of Colorado Hospital

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

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

Protocol #: UCH11-1101

Location: Harmony Campus

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

Risk factors in Early Multiple Sclerosis (RisE-MS)

Protocol #: 17-1884

Location: University of Colorado Hospital

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

Protocol #: 16-1752

Location: Childrens Hospital Colorado

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

Evaluation of commercial pharmacogenomic testing in psychiatry medicine.

Protocol #: 17-2347

Location: University of Colorado Hospital

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

Protocol #: 17-1529

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

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

Protocol #: 17-2336

Location: University of Colorado Hospital

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

Protocol #: 17-2168

Location: Childrens Hospital Colorado

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

Protocol #: 17-2318

Location: University of Colorado Hospital

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

Protocol #: 17-2095

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in Cardiomyocytes

Protocol #: 17-2296

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 17-1597

Locations: ARTS Synergy Outpatient Treatment; Colorado Research Center

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

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

Protocol #: 17-2263

Location: Kaiser Permanente of Colorado

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

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

Protocol #: 17-2213

Location: Childrens Hospital Colorado

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

Protocol #: 17-2074

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 17-2178

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 17-2164

Location: University of Colorado Hospital

Mitochondria in HIV and Aging (MITO+)

The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment,...more >

Protocol #: 17-2161

Location: University of Colorado Hospital

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

Protocol #: 17-2145

Location: University of Colorado Hospital

American Registry for Migraine Research

Protocol #: 17-2165

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

Mitochondrial targeted antioxidant supplementation and diastolic function in healthy men and 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

Positive Aging Consultations

Protocol #: 17-2160

Location: University of Colorado Hospital

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

Protocol #: 17-1778

Location: University of Colorado Hospital

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

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

Protocol #: 17-2136

Location: University of Colorado Hospital

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

Protocol #: 17-1993

Location: Childrens Hospital Colorado

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

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

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Protocol #: 17-1808

Location: University of Colorado Hospital

Electronic Cigarette Use During Pregnancy

Protocol #: 17-2033

Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health and Hospital Authority; Department Specific Free Standing Clinic; University of Colorado Hospital

A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled 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

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

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

MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?

Protocol #: 16-2506

Location: University of Colorado Hospital

Retinal Optical Coherence Tomography in Pre-Dementia Alzheimer's Disease: The Relationship to Amyloid, Cortical Volumes, Cognition, and Visual Fields. (OCT_AD Study)

Protocol #: 17-1956

Location: University of Colorado Hospital

A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-Matched, Living Donor Kidney Transplants (the "Study")

MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with IS drugs....more >

Protocol #: 17-1730

Location: University of Colorado Hospital

Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

Protocol #: 17-6209

Locations: Medical Center of the Rockies; Memorial Hospital Central

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Protocol #: 16-0696

Location: University of Colorado Hospital

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's Disease

Protocol #: 17-1532

Location: University of Colorado Hospital

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

Duration of Marijuana (THC) Concentration in Breast Milk- a Pilot Study

Protocol #: 15-1639

Location: University of Colorado Hospital

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Protocol #: 17-1406

Location: Childrens Hospital Colorado

Optimizing Physical Activity Outcomes after Total Knee Arthroplasty

Protocol #: 17-0079

Location: University of Colorado Hospital

A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (BAY 80-6946 /19176)

Protocol #: 17-1495

Location: Childrens Hospital Colorado

Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)

Protocol #: 17-1751

Location: University of Colorado Hospital

Transcranial electrical stimulation for the treatment of cervical dystonia

Protocol #: 17-1322

Locations: Colorado Research Center; Department Specific Free Standing Clinic

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Protocol #: UCH09-0815

Location: Memorial Hospital North

Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/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

Ion Channel Genetic Biomarkers: Diagnostic Capability in the Assessment of Mood Disorders

Protocol #: 17-1578

Locations: Colorado Research Center; Sheridan Health Services

A PHASE III RANDOMIZED TRIAL OF LOBECTOMY VERSUS SUBLOBAR RESECTION FOR SMALL (!U 2 CM) PERIPHERAL NON-SMALL CELL LUNG CANCER

Protocol #: UCH13-0619

Location: Memorial Hospital Central

Emergency Medicine Specimen Bank

Protocol #: 17-1642

Location: University of Colorado Hospital

A Phase I/Ib Study of sEphB4-HSA in Combination with Chemotherapy or Cetuximab and Radiation Therapy in Patients with Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck

Protocol #: 16-2575

Location: University of Colorado Hospital

PRENATAL DEPRESSION AND ANXIETY HAVE AN IMPACT ON PSYCHOLOGICALLY RELATED EARLY INFANT PHYSIOLOGY: TIMING, MEDIATORS AND MODERATORS

Protocol #: 11-0548

Location: University of Colorado Hospital

Identification of patients at high risk for readmission after a COPD exacerbation

Protocol #: 17-0245

Location: University of Colorado Hospital

A cluster randomized trial of a home-based intervention to increase uptake of postpartum contraceptives and its effect on short-interval pregnancy rates in a postpartum population of rural Guatemalan women

Protocol #: 17-1314

The relationship between the gut microbiome composition and pulmonary immune function in HIV infection

Protocol #: 17-1512

Location: University of Colorado Hospital

TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017

Protocol #: 17-1317

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic

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

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

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

Growing up with X and Y chromosome trisomy: the TRIXY study

Protocol #: 16-1710

The Assessment of Long Term Durability, Safety and Effectiveness of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valve and Surgical Aortic Valve Replacement in Intermediate Risk Patients Suffering from Severe Symptomatic Aortic 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

Ethnography of Synthetic Cannabinoid Abusers to Target Substance Abuse Intervention

Protocol #: 17-1326

Effect of Bovine Arteriovenous Grafts on Patient Sensitization Prior to Kidney Transplant

Protocol #: 17-1524

Location: University of Colorado Hospital

Fragile X Biobank

Protocol #: 16-1707

ADVL1514: A Phase I Study of ABI-009 (Nab-Rapamycin) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan

Protocol #: 17-1376

Location: Childrens Hospital Colorado

A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

Protocol #: 17-1410

Location: University of Colorado Hospital

Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

Protocol #: 17-6161

Location: Poudre Valley Hospital

The modified Atkins diet in patients with drug resistant epilepsy and the responsive neurostimulator 09Aug2017

Protocol #: 17-0888

Location: University of Colorado Hospital

Study of Placental Function in Healthy and Pathological Pregnancies

Protocol #: 14-1073

Location: University of Colorado Hospital

PROSPECTIVE, LONGITUDINAL, NON-INTERVENTIONAL STUDY OF DISEASE BURDEN AND TREATMENT OF PATIENTS WITH LOW-RISK MYELOFIBROSIS (MF) OR HIGH-RISK ESSENTIAL THROMBOCYTHEMIA (ET) OR ET PATIENTS RECEIVING ET-DIRECTED THERAPY

Protocol #: 17-6155

Location: Memorial Hospital Central

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU Study

Protocol #: 15-2114

Locations: Memorial Hospital Central; University of Colorado Hospital

FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENE

Protocol #: 06-0501

Location: University of Colorado Hospital

Real-Time Sleep Stage Classification with Unobstrustive Bio-potential Recording System

Protocol #: 16-0328

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Subthalamic nucleus activity during habitual versus controlled movement

Protocol #: 17-1291

Location: University of Colorado Hospital

The Risk of Long-Term Vascular Dysfunction in Women with a History of Pregnancy-Induced Hypertension

Protocol #: 16-2581

Location: University of Colorado Hospital

Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)

The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri...more >

Protocol #: 17-0977

Location: University of Colorado Hospital

Anal Cancer/HSIL Outcomes Research (ANCHOR) Study

Protocol #: 15-1466

Locations: Denver Health and Hospital Authority; University of Colorado Hospital

Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults with Autosomal Dominant Polycystic Kidney Disease

Protocol #: 17-1327

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

Rapid measurements of water isotopes in human breath and saliva for doubly labeled water analysis V: 04/03/18

Protocol #: 16-2203

Location: University of Colorado Hospital

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

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection (PBMTC SUP1601)

Protocol #: 17-1337

Location: Childrens Hospital Colorado

Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease

Protocol #: 17-1363

Location: Childrens Hospital Colorado

AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Protocol #: 17-1043

Location: Childrens Hospital Colorado

E7080-A001-216: A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Protocol #: 17-1165

Location: Childrens Hospital Colorado

A Phase I Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies (M13-833)

Protocol #: 17-0564

Location: Childrens Hospital Colorado

AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#TBD) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Protocol #: 17-1086

Location: Childrens Hospital Colorado

Time Restricted Feeding and Metabolic Rhythms in Humans

Protocol #: 16-2754

Location: University of Colorado Hospital

Team V: Teaching Learners to Improve Healthcare Value at the Bedside

Protocol #: 17-1332

Location: University of Colorado Hospital

The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Protocol #: 17-1047

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

Targeted fresh autologous whole blood transfusion after cardiopulmonary bypass: a prospective randomized controlled trial

Protocol #: 16-2647

Location: University of Colorado Hospital

Genetic Predictors of QT Prolongation with Anti-arrhythmic Medication (AADGEN)

Protocol #: 16-2675

Location: University of Colorado Hospital

A comparison of intranasal midazolam and Nitrous Oxide (N2O) minimal sedation for minor procedures in a pediatric emergency department

Protocol #: 16-1909

A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options 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

T Cell Epitopes in Sarcoidosis

Protocol #: 17-1244

Location: University of Colorado Hospital

The Feasibility, Safety, and Value of a Virtual Cardiac Implantable Electronic Device Wound Check

Protocol #: 17-1179

Location: University of Colorado Hospital

Assessment of Stakeholder Perspectives of the Clinical Utility of Pharmacogenomics in Solid Organ Transplantation

Protocol #: 17-1173

Location: University of Colorado Hospital

Using Next Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM) - The International IBM Consortium Genetic Study

Protocol #: 17-1132

Location: University of Colorado Hospital

The role of innate immunity in the acquisition of sterile protection against tuberculosis infection

Protocol #: 17-1158

Locations: Colorado Research Center; Department Specific Free Standing Clinic

Denver Zoo Antivenin Project

Protocol #: 93-217

Location: Denver Health and Hospital Authority

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease

Protocol #: 17-1226

Location: University of Colorado Hospital

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)

Protocol #: 17-0396

Location: Childrens Hospital Colorado

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