Your search for "All Studies" found 897 studies:
Adenosinergic immune suppression pathway in glioblastoma multiforme tumors

Location: University of Colorado Hospital

This is our 15.4 Health Affairs testing protocol

Locations: Highlands Ranch Hospital; University of Colorado Hospital

Improving Renal Outcomes Collaborative

Location: Childrens Hospital Colorado

Prospective Analysis of Gait Following Hemispherectomy

Location: Childrens Hospital Colorado

Gait Analysis of Femoroacetabular Impingement Patients

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

Location: Childrens Hospital Colorado

International Fetal Cardiac Intervention Registry

Location: Childrens Hospital Colorado

Defining the Genetic and Cellular Causes of Human Spina Bifida

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Personalized experiences to inform improved communication for patients with Life Limiting Illness

For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses.

Location: University of Colorado Hospital

Immunohistochemical characterization of archival surgical lung pathology specimens

Location: University of Colorado Hospital

INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

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

Location: University of Colorado Hospital

Rare CFTR Mutation Cell Collection Protocol (RARE)

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

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects with Epilepsy with a Predictable Seizure Pattern

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

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

Locations: Childrens Hospital Colorado; Colorado Research Center

A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)

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

S1900A, A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA1/2 MUTATION STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (Lung-MAP SUB-STUDY)

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

YSI Feasibility Session Study of the Dexcom? Continuous Glucose Monitoring (CGM) System in Adults and Pediatrics with Diabetes Mellitus

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

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

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

Locations: Barbara Davis Center; University of Colorado Hospital

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

Locations: Denver Health Medical Center; University of Colorado Hospital

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

Location: University of Colorado Hospital

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

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

Location: Childrens Hospital Colorado

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

reST Registry

remede System Therapy in patients with central sleep apnea

Locations: Harmony Campus; Medical Center of the Rockies

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

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

Location: Memorial Hospital Central

Assessing patient preferences and a clinical tool for evaluating for sexual function in adolescent and young adult survivors of childhood cancer

Locations: Childrens Hospital Colorado; University of Colorado Hospital

EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

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

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

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

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors with Specific Genomic Aberrations

Location: University of Colorado Hospital

Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Location: Childrens Hospital Colorado

Multi-Institutional Validation of Trauma Specific Frailty Index

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

Location: Medical Center of the Rockies

NRG GY017: Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer

Location: University of Colorado Hospital

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

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

Gamma band neural stimulation and its effects on resting state networks

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

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

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

A Two-year Prospective Natural History Study Examining the Use of Neuronal Injury Biomarkers in Autoimmune Encephalitis as a Potential Biomarker for Disease Activity and Severity

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

Location: Childrens Hospital Colorado

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

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

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

Location: University of Colorado Hospital

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

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 well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.

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

Location: University of Colorado Hospital

A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors

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

Location: University of Colorado Hospital

Reliability of Fluorescein-assisted Stereotactic Brain Biopsies in Predicting Conclusive Tissue Diagnosis

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.

Location: UCD Dental Clinic

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Location: University of Colorado Hospital

Effect of freestyle skiing on bone mineral density

Locations: Barbara Davis Center; UCD Barbara Davis Center

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation

Location: University of Colorado Hospital

A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Location: University of Colorado Hospital

Understanding the Barriers to Epilepsy Surgery: A North American Survey

Location: University of Colorado Hospital

Outcomes Research for Patients Undergoing Treatment for Cutaneous Squamous Cell Carcinoma at the University of Colorado

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Outcomes after Standardized Testicular Torsion Management and Follow-up

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

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

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

Treating PCOS with Exenatide vs Active Lifestyle Intervention (TEAL Study)

The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study.

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Treatment Patterns, Mechanisms of Resistance and Outcomes among patients with EGFR, ALK and ROS1 Translocated Non-Small Cell Lung Cancer: An ATOMIC Consortium Analysis

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Prognostic factors associated with outcomes in colorectal cancer liver metastases

Location: University of Colorado Hospital

CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY

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

Location: University of Colorado Hospital

A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Location: University of Colorado Hospital

The Perelman Study of IntraUterine Growth Restriction

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

Location: Childrens Hospital Colorado

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

Compare Whole Blood vs Component Therapy

Locations: Medical Center of the Rockies; Poudre Valley 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, and get a DXA scan.

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Evaluation and Demonstration of Investigational MRI Software and Hardware

Test new MRI scanner sequences in diverse patient population

Location: Childrens Hospital Colorado

The Role of the Autism Diagnostic Observation Schedule in the Diagnosis of Autism by a Developmental-Behavioral Pediatrician: A DBPNet Study

Location: Childrens Hospital Colorado

Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Location: University of Colorado Hospital

Instrumentation of Huntington's Disease Motor Function Assessment

Location: University of Colorado Hospital

A PROSPECTIVE, MULTI-CENTER, SINGLE ARM STUDY TO OBTAIN "REAL WORLD" CLINICAL DATA AND CHARACTERIZE THE ACUTE AND LONG-TERM PERFORMANCE OF THE MICRUSFRAME AND GALAXY COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS

A Prospective, Multi-Center, Single Arm Study to obtain “Real World” Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils for the Endovascular Treatment of Intracranial Aneurysms

Location: Memorial Hospital Central

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

Location: University of Colorado Hospital

A 14-Week, Double-Blind, Randomized, Three-Arm, Parallel Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease (gLIDe)

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)

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

An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays containing Doxorubicin (D-MNA) in Participants with Basal Cell Carcinoma (BCC)

The participant will be treated with microneedle arrays containing doxorubicin (D-MNA) or microneedle arrays containing placebo. The D-MNA or MNA-placebo is applied to the BCC lesion and secured to the skin with a self-adhesive bandage. The D-MNA is removed from the skin after 30 minutes. Each participant will receive three (3) weekly applications of the D-MNA unless a dose limiting toxicity (DLT) requires skipping or postponement of an application. The investigational product is chemotherapeutic agent doxorubicin (25 ug, 50 ug, 100 ug, or 200 ug) delivered to specific skin strata by a novel delivery system, MNA or placebo delivered to specific skin strata by MNA.

Location: University of Colorado Hospital

A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors of any Type, and in Patients with Refractory Metastatic Colorectal Cancer

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

Locations: Highlands Ranch Hospital; University of Colorado Hospital

CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

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

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

Location: University of Colorado Hospital

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial

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

AMPLATZERTM PFO Occluder Post Approval Study

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

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

Location: Memorial Hospital Central

Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion

Location: University of Colorado Hospital

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)

Location: University of Colorado Hospital

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

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

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

Location: University of Colorado Hospital

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Locations: Lone Tree Medical Center; University of Colorado Hospital

Total Joint Arthroplasty in a Pediatric Population

Involves two surveys for approximately 10 mintues

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

Location: Childrens Hospital Colorado

Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer

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

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

Location: University of Colorado Hospital

A MULTICENTER, OPEN-LABEL SAFETY AND EFFICACY STUDY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN PATIENTS WITH MULTIPLE SCLEROSIS AND WALKING IMPAIRMENT

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.

Location: University of Colorado Hospital

Prospective, multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellis System

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study

Location: Memorial Hospital Central

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

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

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

Location: University of Colorado Hospital

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

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

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

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

Locations: Children?s Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital

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

Location: University of Colorado Hospital

A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS

Location: University of Colorado Hospital

APOGEE

LVAD registry

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.

Locations: Harmony Campus; Medical Center of the Rockies

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

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

Location: University of Colorado Hospital

Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

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

Location: Medical Center of the Rockies

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

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

Surgery Database Project

Location: University of Colorado Hospital

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

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

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

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

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.

Location: University of Colorado Hospital

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Location: University of Colorado Hospital

A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS

This study is designed to test the effectiveness of the oral drug Apremilast in patients with mild to moderate Plaque Psoriasis. The study lasts ~36 weeks (around 9 months) from start to finish for each participant. There are around 11 scheduled visits throughout the 36 weeks that participants are asked to come to the clinic to see the research team. There are treatment groups and a placebo group in this study. After the first 16 weeks of the study, everyone from the placebo group will be placed into one of the treatment groups. Please direct any further questions or inquries to the Dermatology Clinical Research Team @ 720-848-0556 or diane.ladell@cuanschutz.edu OR daniel.uy@cuanschutz.edu

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

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Investigating the Contribution of Peripheral versus Central Nervous System Immune Dysfunction to Cognitive Aging

Location: University of Colorado Hospital

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

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

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

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

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

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

Location: Memorial Hospital Central

A PHASE 2 STUDY TO EVALUATE THE OBJECTIVE RESPONSE TO TARLOXOTINIB ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH NON-SMALL CELL LUNG CANCER THAT HARBORS EITHER EGFR EXON 20 INSERTION OR A HER2-ACTIVATING MUTATION

Location: University of Colorado Hospital

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

Location: Barbara Davis Center

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Location: University of Colorado Hospital

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

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.

Location: University of Colorado Hospital

NCCN Best Practices Psychologist Staffing Metrics Survey

Location: University of Colorado Hospital

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast Cancer

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.

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Analyzing variations in pre-operative imaging for patients with newly diagnosed breast cancer using the SEER-Medicare database

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

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)

Location: University of Colorado Hospital

Use of a Pharmacy Managed Empiric Continuous Infusion Vancomycin Protocol in Pediatrics

Location: Memorial Hospital Central

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

Location: University of Colorado Hospital

HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

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

Location: University of Colorado Hospital

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

Locations: Memorial Hospital Central; Memorial Hospital North

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]:NATALEE).

Locations: Lone Tree Medical Center; University of Colorado Hospital

Evaluation of the treatment of coagulase negative staphylococci identified in blood cultures of outpatient stem cell transplant patients

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Nervus intermedius outcomes after vestibular schwannoma surgery

Location: University of Colorado Hospital

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

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

Dissecting the Role of Inflammation in Smoking and Aging Associated Lung Cancers

Location: Rocky Mountain Regional VA Medical Center

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

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

Location: Memorial Hospital Central

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

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

Location: University of Colorado Hospital

A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL201 IN SUBJECTS WITH PARKINSON'S DISEASE

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

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.

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)

Location: University of Colorado Hospital

A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers.

Locations: Denver Health Medical Center; National Jewish Health; University of Colorado Hospital

CLASP IID

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

Locations: Harmony Campus; Medical Center of the Rockies

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

Location: University of Colorado Hospital

Destination Therapy Post Approval Study - Medtronic HVAD System

LVAD registry

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.

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

A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)

Location: University of Colorado Hospital

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

Location: University of Colorado Hospital

A Phase 2, multicenter, open-label, 2-cohort study of trastuzumab deruxtecan (DS-8201a), an anti-HER2 antibody drug conjugate (ADC), for HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer (NSCLC)

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

A Phase 2 Study of M6620 in Combination with Carboplatin compared with Docetaxel in Combination with Carboplatin in Metastatic Castration-Resistant Prostate Cancer

A comparison of M6620 + Carboplatin versus Docetaxel + Carboplatin in metastatic castrate-resistant prostate cancer

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.

Location: University of Colorado Hospital

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis

Location: University of Colorado Hospital

Study of Pulmonary Rehabilitation In Nintedanib Treated Patients with IPF: Improvements in Activity, Exercise Endurance Time, and QoL

Location: University of Colorado Hospital

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

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

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

Location: Childrens Hospital Colorado

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the Hematologic Tissue Bank

Location: University of Colorado Hospital

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

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

A PHASE 2 STUDY OF AZD1775, A WEE1 INHIBITOR, IN PATIENTS WITH CCNE1 AMPLIFICATION

Location: University of Colorado Hospital

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

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).

Location: University of Colorado Hospital

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

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

Location: Childrens Hospital Colorado

A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation

Location: University of Colorado Hospital

Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer

Location: University of Colorado Hospital

Addressing Urban Rural Disparities in Cancer: The Case for Registry Expansion

Location: University of Colorado Cancer Center

Harnessing the Principles of Visual Perceptual Learning for Training Observers to Interpret Mammography

Location: University of Colorado Hospital

A Phase 2, Open-Label Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy

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)

Location: University of Colorado Hospital

EsVan Infection Risk Prediction Model in Non-Neutropenic Pediatric Oncology Patients

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

Safety and Efficacy Study of Elezanumab (ABT-555) in Relapsing Forms of Multiple Sclerosis

Location: University of Colorado Hospital

Safety and Efficacy Study of Elezanumab (ABT-555) in Progressive Forms of Multiple Sclerosis

Location: University of Colorado Hospital

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

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

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

"A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of oncastuximab Tesirine and Durvalumab in Patients with advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma"

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

Precision treatment of acute myeloid leukemia

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

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

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

Location: Childrens Hospital Colorado

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Location: University of Colorado Hospital

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

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

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

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

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

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.

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

Locations: Comprehensive Womens Health Center; University of Colorado Hospital

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Location: University of Colorado Hospital

Phase I trial of indoximod in combination with temozolomide-based therapy for children with progressive primary brain tumors (NLG2105)

Location: Childrens Hospital Colorado

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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

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

Location: University of Colorado Hospital

Assessment of potential predicative and prognostic factors in patients with solid tumors receiving single agent check point inhibitor

Location: University of Colorado Hospital

Efficacy of clofarabine with cytarabine and granulocyte colony-stimulating factor for relapsed and refractory acute myeloid leukemia: a single-center experience

Location: University of Colorado Hospital

Identifying cancer biomarkers using natural-language processing methods

Location: University of Colorado Hospital

A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Location: Childrens Hospital Colorado

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

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

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

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

The Agili-C™ scaffold is indicated for the treatment of an ICRS grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2 and without severe osteoarthritis (Kellgren-Lawrence grade 0-3)

Locations: Boulder Sports Clinic; University of Colorado Hospital

A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

Location: Childrens Hospital Colorado

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Location: University of Colorado Hospital

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib

Location: University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF).

Location: University of Colorado Hospital

Genomic Translation for ALS Care

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)

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 who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not.

Location: Childrens Hospital Colorado

Evaluation of breast asymmetries with 3D mammography; can biopsy be avoided?

Location: University of Colorado Hospital

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

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

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

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

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

Location: University of Colorado Hospital

A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia

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.

Location: Childrens Hospital Colorado

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

A PHASE 3, MULTICENTER, RANDOMIZED, OPENLABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF BB2121 VERSUS STANDARD TRIPLET REGIMENS IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (KarMMa-3)

Location: University of Colorado Hospital

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

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

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

Patient derived cell lines and ex vivo slice cultures for evaluation of autophagy inhibition in central nervous system tumors

Location: Childrens Hospital Colorado

Molecular Genomic Profiling of Glassy Cell Cervical Carcinoma

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

Clinical Outcome Measures in Friedreich's Ataxia

Location: University of Colorado Hospital

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Location: Childrens Hospital Colorado

Surgically Treated Biphenotypic (Hepatobilliary) Primary Liver Carcinomas A Multicenter Review

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

Location: University of Colorado Hospital

An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical Ventilation

The study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug.

Location: University of Colorado Hospital

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

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

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.

Location: University of Colorado Hospital

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

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

Locations: Harmony Campus; Medical Center of the Rockies

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

Location: University of Colorado Hospital

A211401: REDUCING SURGICAL COMPLICATIONS IN NEWLY DIAGNOSED LUNG CANCER PATIENTS WHO SMOKE CIGARETTES

Locations: Memorial Hospital Central; Memorial Hospital North

Liposomal Doxorubicin MUE: An evaluation of ejection fraction assessment in breast and ovarian cancer patients receiving liposomal doxorubicin at the University of Colorado Hospital and Cancer Center

Location: University of Colorado Hospital

Square wave testosterone therapy in castration resistant prostate cancer

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Phase 1, two-part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors

Location: University of Colorado Hospital

An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab with Nivolumab in Patients with Advianced or Metastatic Melanoma - Sponsor Protocol No. NT-003

Location: University of Colorado Hospital

NRG-GU006: A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER (BALANCE)

Evaluating the addition of apalutamide to radiotherapy for men with recurrent prostate cancer

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

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.

Locations: Colorado Research Center; Renal Research Center

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

Locations: 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

Location: University of Colorado Hospital

Prospective, observational, multi-center cohort study of venous thromboembolism outcomes in thrombocytopenic cancer patients (TROVE Study)

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

Location: University of Colorado Hospital

A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors

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

Location: University of Colorado Hospital

Moderate to Severe Atopic Dermatitis: Evaluation of Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects.

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

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

Location: University of Colorado Hospital

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

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

Laryngeal Chemosensation: A Pilot Study

Location: University of Colorado Hospital

NRG-DT001: A PHASE IB TRIAL OF NEOADJUVANT AMG 232 CONCURRENT WITH PREOPERATIVE RADIOTHERAPY IN WILD-TYPE P53 SOFT TISSUE SARCOMA (STS)

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

An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination with Pembrolizumab in Patients with Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Primary Objective: To evaluate the effectiveness of an 8-week, group-based, Acceptance and Commitment Therapy (ACT) intervention for chronic pain management in cancer survivors who have completed active treatment. Secondary Objective: To evaluate the implementation of an 8-week, group-based, ACT intervention for chronic pain management in cancer survivors who have completed active treatment.

Location: University of Colorado Hospital

Practice patterns and incidence of adenovirus infections in hematopoietic cell transplant in the United States: AdVance US

Location: Childrens Hospital Colorado

Computational Phenotyping of Cancer Antecedents and Outcomes

Location: University of Colorado Hospital

Peripheral Inflammatory Cytokine Levels in Parkinson Disease

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-a-cyclodextrin) in Subjects with Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

Location: University of Colorado Hospital

Conversational Speech in the Diagnosis of Neurocognitive Disorders

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.

Location: Adult Infectious Disease Clinical Trials Center

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

Location: University of Colorado Hospital

Optimizing delivery of tumor molecular profile information

Location: University of Colorado Hospital

Targeted therapy for pediatric low-grade glioma and plexiform neurofibromas with trametinib

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

A221504 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF AN ORAL, SELECTIVE PERIPHERAL OPIOID RECEPTOR ANTAGONIST IN ADVANCED NON-SMALL CELL LUNG CANCER

Locations: Memorial Hospital Central; Memorial Hospital North

Second opinion review of outside breast imaging: an analysis of the frequency that additional testing is recommended and radiology/pathology outcomes

Location: University of Colorado Hospital

Screening and Surveillance in PCC/PGL Susceptibility Gene Mutation Carriers

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

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

Location: University of Colorado Hospital

Effect of guided imagery for radiotherapy-related distress: A randomized controlled trial for patients with head and neck cancer

Location: University of Colorado Hospital

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

Location: Colorado Research Center

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

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

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

Location: University of Colorado Hospital

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection

Primary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment.

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.

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

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

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

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

Nivolumab with standard of care chemotherapy for the first line treatment of peripheral T cell lymphoma

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

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

Location: Childrens Hospital Colorado

Targeting MCJ/DNAJC15 and the mitochondrial electron transport chain in acute myeloid leukemia

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

Obalon? Balloon System, The Post Approval Study

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

Location: University of Colorado Hospital

Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy

Location: University of Colorado Hospital

An open-label, Phase I study to assess the safety of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.

Location: University of Colorado Hospital

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

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

Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation

We are looking for healthy men to participate in a research study on the effects of sleep restriction on bone. The purpose of this research is to understand how shortened sleep affects bone metabolism. The study includes an intervention phase consisting of a 1-week outpatient and 8-night inpatient stay. Participants will be observed after discharge from the intervention phase for 3 weeks. Principal Investigator, Christine Swanson, MD, MCR (COMIRB #18-0015)

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTS

The primary objective of this study is:  To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.

Location: University of Colorado Hospital

An Observational Cohort Study of the Use of Avatrombopag in Patients with Thrombocytopenia Associated with Chronic Liver Disease Undergoing a Procedure

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI). 10DEC2017

Locations: Memorial Hospital Central; University of Colorado Hospital

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

Location: University of Colorado Hospital

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

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

ProSTAR: A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer.

A comparison of enzalutamide with and without CPI1205 in patients with metastatic prostate cancer

Locations: Lone Tree Medical Center; University of Colorado Hospital

A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS

Location: University of Colorado Hospital

Assessment of the Current Status and Needs for Residency Training on Physics Plan Reviews

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Lynch Syndrome: Further Defining the Pediatric Spectrum

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

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

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

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

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.

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.

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)

Location: Childrens Hospital Colorado

Ruptured Aneurysms Treated with Hydrogel Coils

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

Location: Memorial Hospital Central

A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF A3021 IN PATIENTS WITH ADVANCED SOLID TUMORS

Location: University of Colorado Hospital

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

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH BACKGROUND ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

A comparison of Talazoparib plus enzalutamide vs placebo plus enzalutamide

Location: University of Colorado Hospital

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

If you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.

Location: Memorial Hospital Central

PBTC-050: A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children with Recurrent or Refractory Malignant Brain Tumors

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

Effect of Rotational Angiography on Radiation Exposure During Percutaneous Liver Directed Therapy in Interventional Radiology

Location: University of Colorado Hospital

Comparison of Tomosynthesis and Digital Mammography for Breast Cancer Screening

Location: University of Colorado Hospital

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney

The study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg ANG-3777 or placebo (normal saline).

Primary Objective: ? To demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft with DGF Secondary Objectives: ? To demonstrate the efficacy of ANG-3777 in optimizing renal function in recipients of a deceased donor renal allograft with DGF ? To demonstrate the efficacy of ANG-3777 in reducing length of hospital stay in recipients of a deceased donor renal allograft with DGF

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

To measure contraceptive efficacy of the test product

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

Multi-center, randomized, double-blinded assessment of Tecfidera? in extending the time to a first attack in radiologically isolated syndrome (RIS) (ARISE)

Location: 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 the future to people with pulmonary fibrosis and their family members.

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.

Location: University of Colorado Hospital

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Location: Medical Center of the Rockies

Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Cisplatin-Ineligble or Chemotherapy-refusing Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder

A comparison of Neoadjuvant Nivolumab with versus without Urelumab in patients with cisplatin-ineligible bladder cancer

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Molecular Endotypes of Chronic Spontaneous Urticaria

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

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

Predictors of childhood obesity in cancer survivors

Location: University of Colorado Hospital

Risk Factors for Acquired Immune Deficiency Syndrome-Associated Kaposi sarcoma AIDS-KS) Mortality among Zimbabwean Adults (A sub-study of Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO))

Location:

Koebnerizing squamous cell carcinoma treated with intralesional 5-fluouracil

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

NANT 2013-01: Immunotherapy of relapsed refractory neuroblastoma with expanded NK cells, dinutuximab and lenalidomide

Location: Childrens Hospital Colorado

The Longitudinal Surveillance Study of the 4-SITE Lead/Header System

Location:

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

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.

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

Education Efficacy in Patient Interventions

Location: Medical Center of the Rockies

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

Location: University of Colorado Hospital

A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)

Location: University of Colorado Hospital

NANT 2017-01: A Phase I Study of 131I-MIBG with Dinutuximab for Relapsed/Refractory Neuroblastoma

Location: Childrens Hospital Colorado

Identifying Environmental Triggers of Smoking Behaviors in Low-income Communities

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

Unrelated Donor Transplant versus Immune Therapy in Pediatric Severe Aplastic Anemia (TransIT)

Location: Childrens Hospital Colorado

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

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

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

Location: University of Colorado Hospital

A 3-ARM, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN MULTIPLE SCLEROSIS PATIENTS WITH WALKING IMPAIRMENT

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

Location: University of Colorado Hospital

Acute Kidney Injury and Vascular Function

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

Location: University of Colorado Hospital

Trauma ICU Prevelance Project (TRIPP study) - an American Association for the Surgery of Trauma Multi-institutional Study

Location: Memorial Hospital Central

Pilot study of time restricted feeding as a weight loss intervention in overweight and obese adults

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

PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)

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

Location: University of Colorado Hospital

The Effect of Cervical Cancer Screening on the Incidence Rate of Invasive Cervical Carcinoma in HIV-positive Women in Lusaka, Zambia

Location: University of Colorado Hospital

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

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

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

PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER

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

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

Location: University of Colorado Hospital

Impact of Fever Prevention in Brain Injured Patients (INTREPID)

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

Location: University of Colorado Hospital

Time to Teach: A Time-banking Initiative to Promote Resident Led Patient Education

Locations: Childrens Hospital Colorado; 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 potential for RALS diagnosis and treatment. Newer diagnostic tools are able to assess physiologic properties of RALS. Thus, this study will address three crucial gaps impacting the clinical approach to RALS: 1) Paucity of diagnostic tests that predict clinically relevant outcomes, 2) undefined clinical role of UES augmentation, and 3) deficiency or cost-effective and personalized approaches.

Location: University of Colorado Hospital

Impact of Oral mCRPC Therapies Stewardship Pilot Program for Veterans

Location: Rocky Mountain Regional VA Medical Center

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

Location: University of Colorado Hospital

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Location: University of Colorado Hospital

A Multi-Site Randomized Phase I/II Study of Stereotactic Ablative Body Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early- Stage Non-Small Cell Lung Cancer

Location: University of Colorado Hospital

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

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

The impact of utilizing radiation therapy planning CT on FDG PET/CT interpretation

Location: University of Colorado Hospital

Ovarian Cancer: An interdisciplinary approach for the identification of novel diagnostic biomarkers and therapeutic targets

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.

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

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Location: University of Colorado Hospital

Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation

This study is a prospective, randomized, multi-center, global investigation to determine the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anticoagulation therapy to reduce the risk of stroke.

Location: Memorial Hospital Central

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

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

Location: University of Colorado Hospital

A Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children with Osteogenesis Imperfecta V: 24 March 2016

Location: Childrens Hospital Colorado

AMPLATZERTM PFO Occluder Post Approval Study

Location: University of Colorado Hospital

Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF)

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial. Phase I will be non-randomized. Phase II will be randomized.

1) To evaluate and optimize HeartLogic? Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II)

Locations: Memorial Hospital Central; Memorial Hospital North

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

Location: Childrens Hospital Colorado

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.

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)

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

Location: University of Colorado Hospital

Intraoperative sodium fluorescein for tissue biopsy and resection of spinal cord lesions

Location: University of Colorado Hospital

Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

Location: University of Colorado Hospital

Can the cervical spine be clinically cleared in awake and alert blunt trauma patients with "distracting injuries"?

Location: Memorial Hospital Central

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

Location: Memorial Hospital Central

Avascular Necrosis Secondary to the Treatment of Leukemia in the Pediatric Population

Location: Childrens Hospital Colorado

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

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

Location: Medical Center of the Rockies

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Location: University of Colorado Hospital

Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancer

Location: University of Colorado Hospital

Diet and Relapses in Pediatric Multiple Sclerosis

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Watchman for patients with atrial fibrillation undergoing transcatheter aortic valve replacement

WATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial.

Locations: Harmony Campus; Medical Center of the Rockies

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)

Location: University of Colorado Hospital

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

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

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

A multicenter, open-label randomized study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of Nestorone? and estradiol (NES-E2 CVR)

Locations: Comprehensive Womens Health Center; University of Colorado Hospital

ADVL1614: A Phase I/II Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

Perceived palliative care needs of Huntington's disease patients

Location: University of Colorado Hospital

Harnessing principles of visual perceptual learning to improve breast cancer detection by developing evidence based training techniques

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

Location: University of Colorado Hospital

An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk.

Location: University of Colorado Hospital

Analyzing differences in treatment regimens and outcomes in elderly breast, lung, and colorectal cancer patients using the SEER-Medicare database

Location:

Clinical Trial Readiness for SCA1 and SCA3

Location: University of Colorado Hospital

Machine Learning Technology as a Diagnostic Tool in Medulloblastoma and Ependymoma

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Location: University of Colorado Hospital

A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients with Parkinson's Disease

Locations: Anschutz Health and Wellness; University of Colorado Hospital

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Location: University of Colorado Hospital

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

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

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

Location: University of Colorado Hospital

A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects with Congenital Adrenal Hyperplasia V: 2Feb2018

Location: Childrens Hospital Colorado

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

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Primary Sclerosing Cholangitis (PSC)

DUR-928 (investigational drug)

Location: University of Colorado Hospital

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

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)

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

Location: University of Colorado Hospital

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax-AXL-ADC) in patients with solid tumors

Location: University of Colorado Hospital

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C

Location: University of Colorado Hospital

Disorders of Sex Development and Malignant Germ Cell Tumors

Location: Childrens Hospital Colorado

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

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

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 (surgery + post-op physical therapy) and non-operative treatment (physical therapy only without surgery).

Locations: Boulder Sports Clinic; University of Colorado Hospital

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

ALTE16C1: Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Location: Childrens Hospital Colorado

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

Locations: Childrens Hospital Colorado; Colorado Research Center

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

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

A Phase I Trial of AZD9291 and Necitumumab in EGFR-Mutant Non-Small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase Inhibitor

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Ovarian Cancer: An interdisciplinary approach for the identification of novel therapeutic targets.

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

Location: Harmony Campus

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)

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

Bicarbonate Administration in Kidney Transplant Recipients

Assess impact of sodium bicarbonate vs. placebo on brachial artery flow-mediated dilation in kidney transplant recipients

Location: University of Colorado Hospital

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

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

Risk factors in Early Multiple Sclerosis (RisE-MS)

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

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

Location: Childrens Hospital Colorado

Influence of PTSD Symptoms on Chronic Pain Development After Sexual Assault

Location: Memorial Hospital Central

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects with Primary Sclerosing Cholangitis (PSC)

Location: University of Colorado Hospital

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

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

Locations: CTRC-adult; University of Colorado Hospital

Evaluation of commercial pharmacogenomic testing in psychiatry medicine.

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy

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

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

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

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Development and Dissemination of KiNet: An Imaging Informatics Tool for Ki67 Counting in Neuroendocrine Tumor

Location: University of Colorado Hospital

Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in Cardiomyocytes

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3011 IN PATIENTS WITH ADVANCED SOLID TUMORS

Location: University of Colorado Hospital

SouthPaw: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)

This is a 24 week study to evaluate the safety of using oral treprostinil to treat PH associated with HFpEF

Location: University of Colorado Hospital

PBTC-039: Phase II study of Peginterferon alfa-2b (SYLATRON) for pediatric patients with unresectable or recurrent craniopharyngioma

Location: Childrens Hospital Colorado

A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic Cancer

Location: University of Colorado Hospital

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

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.

Location: University of Colorado Hospital

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

Location: Kaiser Permanente of Colorado

Prospective, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel Paclitaxel-CoatEd Percutaneous Angioplasty Balloon

Location:

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Location:

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

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

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

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

Location: University of Colorado Hospital

A Phase I Study of the Wee 1 kinase (Wee 1) inhibitor AZD1775 in combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)

Location: University of Colorado Hospital

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

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

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.

Location: University of Colorado Hospital

Mitochondria in HIV and Aging (MITO+)

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

Location: University of Colorado Hospital

Open label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma (Merck-Serono Protocol MS100070-0306

Location: Childrens Hospital Colorado

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

Location: University of Colorado Hospital

American Registry for Migraine Research

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 a dietary antioxidant supplement for a short period of time. Specifically, we want to see if the antioxidant supplement will improve cardiovascular health in older men and women because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand whether improvements in mitochondrial function will also improve cardiovascular health in older men and women.

Location: University of Colorado Hospital

Positive Aging Consultations

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

Location: University of Colorado Hospital

SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL? System

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart, Penumbra Coil 400, and the Penumbra Occlusion Device. Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up.

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

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

A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients with Postbariatric Hypoglycemia

Location: University of Colorado Hospital

Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated with Immune Checkpoint Inhibitors; A Pilot Project

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

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

Location: Childrens Hospital Colorado

MONALEESA-3: A randomized double-blind, placebocontrolledstudy of ribociclib in combination withfulvestrant for the treatment of postmenopausal womenwith hormone receptor positive, HER2-negative, advancedbreast cancer who have received no or only one line ofprior endocrine treatment

To compare PFS between ribociclib in combination with fulvestrant to placebo in combination with fulvestrant among postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for advanced disease

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

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY OF CK-2127107 IN TWO ASCENDING DOSE COHORTS OF PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA)

Location: University of Colorado Hospital

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

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

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

Location: University of Colorado Hospital

Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn's Disease v:5.0; March 20, 2018

Location: University of Colorado Hospital

An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Location: University of Colorado Hospital

TACL 2016-001: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma

Location: Childrens Hospital Colorado

A Multi-Center, Open-Label, Prospective Study of CervicalStim device as Adjunctive Care following Cervical Fusion

Location: University of Colorado Hospital

Electronic Cigarette Use During Pregnancy

Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health Medical Center; University of Colorado Hospital

Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Realworld Anticoagulant Management Issues in Stroke (ARAMIS) Registry

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulant in community practice

Locations: Medical Center of the Rockies; Poudre Valley 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) and symptom control over established combination therapies. Through the comparison of a closed triple therapy to a standard of care ICS/LABA combination therapy this study will provide important information to prescribers regarding the benefit of step-up to closed triple therapy to patients uncontrolled on ICS/LABA.

Location: University of Colorado Hospital

A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome

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 may be dosed no less than 12 days from the previous dose.

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

Bone Morphogenetic Proteins in Bone Metastases

Location: 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

Location: Childrens Hospital Colorado

An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following A Single Oral Dose in Patients with Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment

Location: University of Colorado Hospital

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC

Location: University of Colorado Hospital

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

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)

Location: University of Colorado Hospital

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

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

Primary Objectives: ? To evaluate achievement of induction of functional immune tolerance by cellular immunotherapy with MDR-101 in recipients of human leukocyte an tigen (HLA)-matched, living donor kidney transplants. Functional immune tolerance is defined as remaining off of all immunosuppression (IS) drugs for 24 months or more after completion of anti-rejection, IS drug therapy withdrawal with no episodes of biopsy-proven acute rejection (BPAR), de novo donor-specific anti-HLA antibody (dnDSA) development, transplant kidney loss, or subject death. ? To compare the safety and tolerability of cellular immunotherapy with MDR-101 compared to conventional, standard-of-care (SOC) IS therapy in recipients of HLA-matched, living donor kidney transplants.

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)

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

Location: University of Colorado Hospital

S1616, A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent

Locations: Greeley Hospital; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital

The influence of gonadal hormone suppression on adipocyte lineage and the microbiome

Six month intervention of ovarian hormone supression

This research study plans to learn more about the role of female sex hormones on fat and the gut microbiome (or the organisms that are in your digestive tract).

Location: University of Colorado Hospital

COG AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Location: Childrens Hospital Colorado

A Phase II Study of TAK-228 in patients with previously treated metastatic renal cell carcinoma

Assessment of TAK 228 in metastatic kidney cancer

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

Location: University of Colorado Hospital

GORE? HELEX? Septal Occluder / GORE? Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging- Confirmed TIA in Patients with Patent Foramen Ovale (PFO)

Location: University of Colorado Hospital

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Location: Memorial Hospital Central

A Multi-Center, Open-Label, Prospective Study of SpinalStim (MOP-SS) as adjunctive Care following Lumbar Fusion Surgery

The study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim.

Location: University of Colorado Hospital

Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)

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

Location: University of Colorado Hospital

Protocol I7S-MC-HBEH Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD) (The PRESENCE Study)

Location: University of Colorado Hospital

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Structure: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Duration: Patients will be enrolled in the study for up to 16 weeks, with up to a 4-week screening period and a 12-week treatment period. Study Treatment: The investigational product is AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]), which is titrated over a 2-week period to d6-DM 42.63 mg/Q 4.9 mg (AVP-786-42.63/4.9) twice daily (BID). Control: Placebo capsules appearing identical to study medication will be used as control. Randomization: Eligible patients will be randomized into the study to receive AVP-786 or placebo. Dose Regimen:

Location: Medical Center of the Rockies

External Reproducibility Study of SK005 PD-L1 IHC 28-8 pharmDx on Gastric Gastroesophageal Junction Specimens

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

TACL 2016-003: Epigenetic Reprogramming in Relapse AML: A Phase I Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults with Relapsed/Refractory AML

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

PBTC-029: A Phase I and Phase II Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Location: Childrens Hospital Colorado

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

Location: Childrens Hospital Colorado

Extracolonic Cancer Risks in Monoallelic and Biallelic MutYH Carriers

Location: University of Colorado Hospital

Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction

The objective of this study is to understand real-world treatment patterns, as well as the reasons and barriers for treatment changes in heart failure patients with reduced ejection fraction.

Location: Memorial Hospital Central

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

Location: University of Colorado Hospital

Transcranial electrical stimulation for the treatment of cervical dystonia

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

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.

Location: University of Colorado Hospital

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

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

Location: Memorial Hospital Central

Emergency Medicine Specimen Bank

Location: University of Colorado Hospital

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Location: Memorial Hospital Central

A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)

Location: University of Colorado Hospital

Investigating alterations in molecular pathways in human epithelial ovarian cancer tumors

Location: University of Colorado Hospital

A Pilot Study to Investigate the Efficacy and Safety of ARRY-371797 in Patients with Symptomatic Genetic Dilated Cardiomyyopathy Due to a Lamin A/C Gene Mutation

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Lifeboard Software Functionality Study

Accuracy of the software will be evaluated through case review. The cases entered into the Lifeboard software will be compared to the paper trauma flow sheet. Research staff will be comparing what is entered into the software on the tablet against the trauma flow sheet for each case.

Location: Medical Center of the Rockies

Virtual and Augmented Reality Study

Location: Medical Center of the Rockies

A Randomized, Single-Blinded, Phase 3 Study of Second- or Third-Line Chemotherapy with Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients with Advanced Non-Small Cell Lung Cancer with at Least One Measurable Lung Lesion (DUBLIN-3)

Location: Memorial Hospital Central

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

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

Location:

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

Location: University of Colorado Hospital

Pilot Study to Evaluate Safety and Tolerability of Inhaled N-Acetylcysteine in Pulmonary Fibrosis

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. We will also create a bank of data, blood, and sputum from IPF patients for future research. NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Location: University of Colorado Hospital

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma

Location: University of Colorado Hospital

Copeptin and Nonalcoholic Fatty Liver Disease

See above

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 movement the person does. This is done with equations that use the data collected by the activity monitors. However, these equations are usually developed using measurements on healthy people. People who have movement disorders related to diseases such as Parkinson?s and Multiple Sclerosis, or conditions such as knee replacement, stroke, or arthritis have very different movement patterns than people without these diseases. Thus, the equations used to convert activity monitor data will not work well in people with these diseases or conditions. The purpose of this study is to develop equations to measure physical activity using activity monitors in people with movement limitations. Rather than creating specific equations for each individual disease and condition, we will perform simple tests to measure upper and lower body function, and then group people into different clusters based on these tests. Our preliminary studies show that these equations are more accurate than equations based on specific diseases or conditions.

Locations: CTRC-adult; University of Colorado Hospital

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

Location:

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

he PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery. To assure that patients with an STS score ≥ 4% have been selected.

The purpose of this trial is to establish the safety and effectiveness of the Edwards SAPIEN XT? device and delivery systems (transfemoral, transapical and transaortic), which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Location: University of Colorado Hospital

Ethnography of Synthetic Cannabinoid Abusers to Target Substance Abuse Intervention

Location:

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

Location: University of Colorado Hospital

Fragile X Biobank

Location:

A Phase I, Open-Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients with Advanced/Metastatic Solid Tumors or Lymphomas

Location: University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson's Disease (PD)

Location: University of Colorado Hospital

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

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

To evaluate the use of Enfortumab vedotin plus CPI in treatment of advanced bladder cancer

Location: University of Colorado Hospital

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

Location: Poudre Valley Hospital

A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients

This is a Phase 2a, randomized, open-label, active control, multi-center study to assess the efficacy and safety of bleselumab in preventing the rFSGS in de novo kidney transplant subjects.

Primary Objective: - To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the SOC regimen (basiliximab induction, tacrolimus, steroids and MMF) in the prevention of the recurrence of focal segmental glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with proteincreatinine ratio (> or equal to 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. Secondary Objectives: - To assess the incidence of nephrotic range proteinuria with protein-creatinine ratio (> or equal to 3.0 g/g) through 6 and 12 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. - To assess the incidence of biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1; local read) through 3, 6 and 12 months post-transplant. - To assess the incidence of efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss or lost to follow-up through 12 months post-transplant. - To assess the incidence of biopsy-proven (blinded, central read) rFSGS through 3, 6 and 12 months post-transplant. - To assess the safety of the bleselumab regimen compared with the SOC regimen.

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Study of Placental Function in Healthy and Pathological Pregnancies

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

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

Locations: Memorial Hospital Central; University of Colorado Hospital

FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENE

Location: University of Colorado Hospital

Lipoprotein lipase enzyme activity assay validation and clinical assessment

Location: University of Colorado Hospital

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

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Subthalamic nucleus activity during habitual versus controlled movement

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthritis and study these individuals in a longitudinal manner in order to better understand the development of spondyloarthritis. Results from this study may provide information that contributes to our understanding of the complex relationships among immune dysregulation, genetic risk, subclinical phenotypes, and established spondyloarthritis phenotypes.

Location: University of Colorado Hospital

Anal Cancer/HSIL Outcomes Research (ANCHOR) Study

Locations: Denver Health Medical Center; University of Colorado Hospital

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

Locations: 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

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 occurring hormone that declines with age. In postmenopausal women, nearly all estrogen and most testosterone comes from DHEA. DHEA is considered a food supplement.

Location: University of Colorado Hospital

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

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

Location: Childrens Hospital Colorado

A Phase I Study of Stereotactic Body Radiation Therapy for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma

Location: University of Colorado Hospital

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction

Location: University of Colorado Hospital

A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RSLV-132 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

- assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity using the CLASI activity score. -assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; - evaluate the immunogenicity of RSLV-132 in subjects with SLE; - assess improvement in tender or swollen joint count; - assess improvement in patient reported outcomes using the FACIT-Fatigue scale; - assess the ability of subjects to reduce oral steroids at Day 169; ? evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; - assess the proportion of subjects achieving a 50% improvement in CLASI activity score - assess the following exploratory endpoints -- evaluate the impact of RSLV-132 treatment on gene expression profile; -- evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; -- evaluate the impact of RSLV-132 on serum protein levels; -- assess the impact of RSLV-132 on the CLASI damage score

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

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

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)

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)

Location: Childrens Hospital Colorado

The Incidence and Risk of Thrombocytopenia Following Peripheral Blood Stem Cell Donation in Adult, Related Allogeneic Donors.

Location: University of Colorado Hospital

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)

Location: University of Colorado Hospital

A PHASE 1B/2, MULTI-CENTER, DOUBLE-BLIND (PRINCIPAL INVESTIGATORS AND STUDY SUBJECTS BLINDED, SPONSOR UNBLINDED), PLACEBO-CONTROLLED, RANDOMIZED, SINGLE-ASCENDING DOSE STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DS-1040B IN SUBJECTS WITH ACUTE ISCHEMIC STROKE

Location: Memorial Hospital Central

The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Locations: Comprehensive Womens Health Center; University of Colorado Hospital

Cesarean Wound Closure in Women with BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples C: 4.0; 04/24/2017

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

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

Location:

Damage to the temporal and marginal mandibular branches of the facial nerve in Mohs Micrographic Surgery

Location: University of Colorado Hospital

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

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

Brain metastases from endometrial cancer: a case series and literature review

Location: University of Colorado Hospital

Registry of Angiovac Procedures In Detail Outcomes Database

The primary objective of this registry is to determine the procedure related mortality associated with the use of the Angiovac device. This is a FDA approved device, being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Location: University of Colorado Hospital

T Cell Epitopes in Sarcoidosis

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

A Phase 3, Randomized, Double--Blind, Placebo--Controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Previously Tolerated and Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Location: University of Colorado Hospital

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

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

Location: University of Colorado Hospital

A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination with Venetoclax in Subjects with Relapsed or Refractory Haematologic Malignancies

Location: University of Colorado Hospital

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

Locations: Colorado Research Center; Department Specific Free Standing Clinic

Azacitidine and Venetoclax (ABT-199) as Induction Therapy with Venetoclax Maintenance in Previously Untreated Elderly Patients with Acute Myeloid Leukemia

Location: University of Colorado Hospital

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

Location: University of Colorado Hospital

Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic Tumors

This study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen.

To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure

Location: University of Colorado Hospital

ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

Location: Childrens Hospital Colorado

The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

This study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls.

To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls.

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

A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors

Location: University of Colorado Hospital

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors

Location: University of Colorado Hospital

Phase I Trial of Arsenic Trioxide with Cyclophosphamide in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Location: University of Colorado Hospital

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Location: University of Colorado Hospital

Randomized controlled trial of a mobile health intervention to increase postpartum weight loss in women at increased risk for cardiometabolic disease V:11.28.17

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

Validation of a method for isotopic analysis in human plasma samples V:04/20/2018

Location: University of Colorado Hospital

Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and understanding Standard of Care Medications

Location: University of Colorado Hospital

Evaluating the Tolerability and Safety Profile of Switching from Rituximab to Ocrelizumab: A Real World Evaluation of Patients with Relapsing Forms of Multiple Sclerosis

Location: University of Colorado Hospital

Inhaled Cannabis, Oxidative Stress and the Pulmonary Innate Immune Response

This study evaluates the effect of long term cannabis/marijuana smoking on lung health.

This study evaluates the effect of long term cannabis/marijuana smoking on lung health.

Location: University of Colorado Hospital

Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease

Location: University of Colorado Hospital

Consent 2.0 (ATN 150) Study: Innovative Approaches to Minor Consent to Biomedical HIV Prevention Research

Location:

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) Study

Location: University of Colorado Hospital

A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease (KD019-211)

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

Home Telemedicine to Optimize Health Outcomes in High-Risk Youth with Type 1 Diabetes

Location: UCD Barbara Davis Center

Randomized Observation of Biventricular pacemakers on ventrIcular function among patients with mechaNical circulatory support devices: "ROBIN"

Location: University of Colorado Hospital

Understanding the role of subcortical oscillations in human sleep dysregulation

Location: University of Colorado Hospital

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

Location: University of Colorado Hospital

Study of bone growth in the Sacroiliac Joint after minimally invasive surgery with titanium implants

Location: University of Colorado Hospital

Imaging for uncomplicated headache: ordering patterns and provider perspective

Locations: Colorado Research Center; University of Colorado Hospital

A Phase I Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Location: University of Colorado Hospital

A Pragmatic Multicenter Randomized Trial: Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy (CHAP Project)

Locations: Denver Health Medical Center; University of Colorado Hospital

A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease

This study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease.

Location: University of Colorado Hospital

Assessment of hepatic glucose and fat regulation in overweight adolescent girls

Locations: Childrens Hospital Colorado; Colorado Research Center

Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study

Location: University of Colorado Hospital

Cardiometabolic profiles of pubertal boys with Klinefelter syndrome with or without one year of exogenous testosterone treatment

Location: University of Colorado Hospital

A Prospective, Multicenter Registry for Premature Newborns with Severe Pulmonary Hypertension

Location: University of Colorado Hospital

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

Locations: CTRC-adult; University of Colorado Hospital

Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (nivolumab) in Participants with Severe Sepsis or Septic Shock.

Location: Memorial Hospital Central

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

Assess your medical care Help researchers better understand your medical treatment and health outcomes Provide an understanding on how diseases impact your daily life Provide you with more information about heart disease

Location: Memorial Hospital Central

Comparison of Kidney Function Equations for Drug Dosing Adjustments

Locations: Colorado Research Center; Department Specific Free Standing Clinic

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies

Location: University of Colorado Hospital

Effects of high altitude on AMPK activation

This study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery.

Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital

Home or Away From Home: Comparing patient and caregiver reported quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapy

Location: Childrens Hospital Colorado

Home or away from home: comparing clinical outcomes relevant to the care of pediatric acute myeloid leukemia during periods of neutropenia (Aim 1)

Location: Childrens Hospital Colorado

Motivational Enhancement System for Adherence (MESA) for Youth Starting ART

Location:

Signaling and epigenetic mechanism of immune cell activation in healthy and asthmatic children

Location:

Diagnostic and Rating Tools for Blepharospasm

Location: University of Colorado Hospital

Clinical trial to validate the 2015 ATA thyroid nodule management guidelines, assess diagnostic performance of a thyroid nodule management algorithm based upon a published malignancy risk estimation model relative to TI-RADS and ATA categories, and to evaluate inter-observer variability of assessment of sonographic features and risk patterns of thyroid nodules

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

MULTICENTER 1-YEAR OBSERVATIONAL STUDY OF PATIENTS WHO ARE INITIATING BRIVARACETAM

Location: University of Colorado Hospital

Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment

Location: University of Colorado Hospital

Targeted strength training to improve gait in people with multiple sclerosis: a feasibility study

Locations: Colorado Research Center; University of Colorado Hospital

Therapeutic modulation of the intestinal creatine kinase system in inflammatory bowel disease (IBD)

Specific Aim 1: Determine whether creatine supplementation induces improvement in the endoscopic assessment of mucosal inflammation in ulcerative colitis (UC). Specific Aim 2: Evaluate the feasibility of the current study protocol. Specific Aim 3: Assess the impact of creatine supplementation on intestinal epithelial barrier function and the intestinal microbiome.

Location: University of Colorado Hospital

NRG-LU002: MAINTENANCE SYSTEMIC THERAPY VERSUS CONSOLIDATIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL

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

Longitudinal Coverage with Evidence Development Study on MicraTM Leadless Pacemakers

Location:

PARTNER 3: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

Locations: Harmony Campus; Medical Center of the Rockies

High Dose Oral Steroids in Sudden Sensorineural Hearing loss

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

Bone and Vascular Health in Postmenopausal Women with Type 1 diabetes

Location: University of Colorado Hospital

Observational study of obstructive lung disease (NOVELTY): A NOVEL observational longiTudinal studY on patients with a diagnosis or suspected diagnosis of asthma and/or COPD to describe patient characteristics, treatment patterns and the burden of illness over time and to identify phenotypes and endotypes associated with differential outcomes that may support future development of personalised treatment strategies

This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.

Location: University of Colorado Hospital

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetcs and Renal Safety of Tenofovir

Location: University of Colorado Hospital

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure-Connect-HF

Location: University of Colorado Hospital

HepQuant (HQ)-SHUNT Correlates of Hepatic Venous Pressure Gradient (HVPG) Testing

Location: University of Colorado Hospital

A Patient Decision Aid to Augment Lethal Means Counseling for Suicidal Patients

Location: University of Colorado Hospital

Analysis of Discarded Spinal Tissues from Individuals with Spinal Conditions

Location: University of Colorado Hospital

The Human Trisome Project Biobank V: Sept 26 2018

Additional information about this study can be found at www.trisome.org.

Location: University of Colorado Hospital

Comparative Effectiveness Between Long Term Fingolimod versus Glatiramer Acetate On Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients with Multiple Sclerosis

Location: University of Colorado Hospital

Effects of acetate, alcohol, and gut microbiome on brain function

Location: University of Colorado Hospital

Effects of low-dose levetiracetam on clinical symptoms, cognition and hippocampal hyperactivity in patients with schizophrenia

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

Dystonia Coalition Project 1: Natural History and Biospecimen Repository for Dystonia

Location: University of Colorado Hospital

Vascular mechanisms for the effects of loss of ovarian hormone function on cognition in women

Location: University of Colorado Hospital

Appetite Regulation in Older-Aged Obese Individuals

Participants needed for a research study that plans to examine the effects of age and body weight on food intake, appetite regulation, and brain responses to food.

Location: University of Colorado Hospital

10-1311 DoneSave Functional connectivity of the motor network in two major subtypes of Parkinson Disease December 24,2015

Location: University of Colorado Hospital

Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults with Type 1 Diabetes

Locations: CTRC-adult; University of Colorado Hospital

Developing biomarkers of acute alcohol exposure

Locations: CTRC-adult; University of Colorado Hospital

Genotype Phenotype Discordance in Polypharmacy Patients

Location: University of Colorado Hospital

Tissue-specific effects of insufficient sleep

The proposed project is a within-subject consecutive design examining 14 healthy individuals after baseline and after 4 nights of insufficient sleep. Following 7 days of at-home habitual sleep of 9 hours/night and a 3-day lead-in energy balanced diet, participants will be admitted for a 6-night inpatient stay at the UC Denver. Sleep schedules will be verified via sleep logs, time-stamped voice-recorder of bed and wake times, and wrist actigraphy recordings. On the morning after the 1st night in the lab, subjects will undergo including saliva sampling, endothelial function testing, muscle biopsy, fat biopsy, hyperinsulinemic euglycemic clamp.

Locations: CTRC-UC Boulder; University of Colorado Hospital

The University of Colorado Denver PerinAtal RegisTrY (PARITY)

Location: University of Colorado Hospital

Statin Therapy in Patients with Early Stage Autosomal dominant polycystic kidney disease

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

Procurement of Blood Samples from Subjects with Diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for Use in the Development of a Liver Fibrosis Test V: Jan 20 2017

Location: University of Colorado Hospital

Cognition and Neurodevelopmental Influence (CANDI)

Location: University of Colorado Hospital

CA209744: Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.

Location: Childrens Hospital Colorado

Twenty-One-Gene Recurrence Score Assay in CHEK2-Associated Versus Sporadic Breast Cancers: A Case-Control Study

Location: University of Colorado Hospital

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF THE COMBINATION OF NKTR-214 AND NIVOLUMAB OR THE COMBINATION OF NKTR-214, NIVOLUMAB, AND OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH SELECT LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Location: University of Colorado Hospital

A NOVEL APPROACH TO INFANTILE SPASMS: COMBINED COSYNTROPIN INJECTABLE SUSPENSION, 1 MG/ML AND VIGABATRIN INDUCTION THERAPY V: 2.4; 11.20.2018

Location: Childrens Hospital Colorado

Prospective evaluation of the efficacy and safety of endoscopic anti-reflux procedures

Location: University of Colorado Hospital

Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Stereotactic Targeting and Clinical Efficacy

Location: University of Colorado Hospital

Mechanisms of Local Anesthetic Resistance

Location: University of Colorado Hospital

PHANTOM: Anastrozole in Patients with Pulmonary Arterial Hypertension

Location: University of Colorado Hospital

The Care Project: Helping Pregnant Moms and Babies

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

Use of systematic stimulation mapping and functional/structural imaging to improve localization of seizure-onset zone, determination of seizure spread patterns, and elucidation of impact on neurological function in focal epilepsy patients undergoing Phase II monitoring

Location: University of Colorado Hospital

Anterior knee pain after ACL reconstruction: improvement after anterior interval scar release

Location: University of Colorado Hospital

NANT 2015-02: PHASE 1 STUDY OF LORLATINIB (PF-06463922), AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH ALK-DRIVEN RELAPSED OR REFRACTORY NEUROBLASTOMA

Location: Childrens Hospital Colorado

Phase 1 trial of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers

Location: University of Colorado Hospital

ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

Location: Childrens Hospital Colorado

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Location: University of Colorado Hospital

Aortic Trauma Foundation Prospective Blunt Thoracic Aortic Injury Registry

Location: University of Colorado Hospital

Inotuzumab Ozogamicin Compassionate Access Single IND

Location: Childrens Hospital Colorado

Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex

This study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise. This study will evaluate & compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects).

Location: University of Colorado Hospital

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohns Disease V: 05 March 2018

Location: University of Colorado Hospital

Cath Lab Data Collection Study

Location: University of Colorado Hospital

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced Malignancies

Location: University of Colorado Hospital

Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized Trial

This study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study.

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

EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

A comparison of Nivolumab vs no Nivolumab prior to nephrectomy.

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

Retrospective Study of Local Tissue Reaction to the Release of Metal Ions in Spinal Implants

Location: University of Colorado Hospital

EVALUATION OF THE DREAMED ADVISOR PRO FOR AUTOMATED INSULIN PUMP SETTINGS ADJUSTMENTS IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES - THE ADVICE4U PRO STUDY

Locations: Barbara Davis Center; UCD Barbara Davis Center

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

Location: University of Colorado Hospital

Mechanisms of Vascular Dysfunction in CKD and ADPKD: A Cross-Sectional Study

This research study will compare blood vessel function in healthy adults to adults with two different types of kidney disease. The testing visit will include non-invasive testing of blood vessel function and collection of blood and cells from an IV.

Location:

Phosphate Lowering to Treat Vascular Dysfunction in Chronic Kidney Disease

Location:

Effectiveness of Therapy via Telemedicine following Cochlear Implants

This research plans to learn more about the use of telemedicine as a means of providing therapy to children who have a cochlear implant(s). While Auditory-Verbal Therapy has typically been delivered in person, many people are starting to access therapy over the internet. We are conducting this research to determine if the outcomes of therapy are the same when AVT is delivered in person and via telemedicine.

Location:

Measurement of Hematopoietic Stem Cell Derived Adipocytes

The purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML).

To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat.

Location: University of Colorado Hospital

Pharmacogenetic Prediction of Metoprolol Effectiveness

Location:

Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjogren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

Location:

IMove: Instrumented Movement Analysis to Quantify Gait in Cerebral Palsy

The first aim of this study is to develop IMove to detect the stance and swing phase of gait cycles and to characterize pelvic, hip, knee and ankle joint angles during these phases. The second aim is to then validate measures obtained from IMove with those obtained from a motion capture system. The central hypothesis of this proposal is that IMove can accurately measure kinematics of the lower limb joints in the sagittal, frontal and horizontal planes, and characterize their coordination during gait, using inertial sensors attached to the pelvis, femur, tibia and foot using strap bands.

Location:

Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers.

Location:

Thoracic Spine Thrust Manipulation for Cervicogenic Headaches: A Randomized Clinical Trial

The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation.

Location:

Improving Rehabilitation Outcomes after Total Hip Arthroplasty

The purpose of this study is to compare standard of care PT after THA with a physical therapy program specifically designed to integrate targeted core and hip muscle strength and functional training.

Location:

Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans

The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues.

Locations: CTRC-adult; Denver Health Medical Center; University of Colorado Hospital

Qualitative Needs Assessment for a Hospice Care Decision Aid

Locations: Denver Health Medical Center; University of Colorado Hospital

Examining the Effectiveness of a Telehealth Adherence Support Group Intervention for Adolescent Transplant Recipients At-Risk for Non-adherence

Location:

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS System

Location: University of Colorado Hospital

Effectiveness Analysis of Natalizumab versus Fingolimod using Patient-Reported Outcomes in Patients with Multiple Sclerosis

The purpose of this study is to compare two medications, natalizumab and fingolimod, used in the treatment of multiple sclerosis (MS) through a variety of previously validated patient reported outcomes (PROs).

Location: University of Colorado Hospital

EFFECTS OF SERUM FATTY ACID LOWERING ON INSULIN SENSITIVITY, CARDIOVASCULAR FUNCTION, AND EXERCISE CAPACITY IN NON-INSULIN DEPENDENT DIABETES

To research the effects of an investigational drug on exercise capacity and blood vessel function​.​

Location: University of Colorado Hospital

Feasibility Study of Metformin Therapy in ADPKD V: 6.20.2017

The primary purpose of the research study is to determine the safety and tolerability of the study drug (Metformin or placebo) when given to subjects with ADPKD (Autosomal Dominant Polycystic Kidney Disease).

Location: University of Colorado Hospital

Periodontal inflammation and immunity in preclinical RA

The purpose of this study is to learn more about rheumatoid arthritis by studying people who do not have rheumatoid arthritis. Your participation in this study will help us determine if gum disease affects the chances of developing protein markers associated with rheumatoid arthritis.

Location:

Nicotinic agonist effects on BMI and neuronal response in overweight/obese adults

This study plans to learn more about the effects of an investigational new drug (DMXB-A) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to effect appetite, we are interested in studying the effects of the study drug, which has similarities to nicotine, on how your brain responds to such things as pictures of food. This study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.

This research study plans to examine the effects of an investigational new drug on neuronal, physiological, and behavioral mechanisms of obesity in the general population.

Location: University of Colorado Hospital

Myeloid to Adipocyte Transdifferentiation in Human cells

If you join the study, you will complete the following research procedures over the course of 2 study visits: Informed consent, physical exam and medical history, body composition test, blood draw and fat biopsy.

This research study plans to learn more about where the fat cells in your body come from. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more "unhealthy" than other fat.

Location: University of Colorado Hospital

Prospective, Inceptional Cohort Study of Individuals with Bleeding Disorders

Location:

An investigation of the neural and executive function underpinnings of severe worry among adolescents

This study seeks to improve our understanding of worry among adolescents.

Location:

Lenalidomide and Dexamethasone (Rd) versus Clarithromycin (Biaxin) /Lenalidomide (Revlimid) / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma

Location: University of Colorado Hospital

Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

The overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals.

Location:

PTH And Calcium Responses to Exercise (PACE) in Older Adults

The primary goal of this research is to find out if exercise that causes the loss of calcium from the blood, possibly through the sweat, also causes the release of calcium from the bones.

Location: University of Colorado Hospital

IMPAACT 2012: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID cp AM2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age, Version 1.0

Location:

Effects of dietary protein from meat vs. dairy on infant growth, body composition and gut health

This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.

Location:

CD8+ T-cell Responses to a Conserved Herpesvirus Epitope After Natural Infection, Vaccination, or Reactivation with Human Herpesviruses

Location: University of Colorado Hospital

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

This study plans to learn more about the relationship between fertility and obesity.

Location: University of Colorado Hospital

Parent Perspectives on Transitioning Premature Infants from Tube Feeding to Oral Feeding

This project will conduct focus groups with parents and caregivers who have a child that was born prematurely and required tube feeding for over 3 months. The purpose of the focus groups is to understand challenges related to eating orally for these children, discuss current guidance the family has received, explore what could be done to improve the process of transitioning to oral feeding, as well as what resources and support would be helpful to families. Results will be used to identify methods to improve feeding support for families and caregivers of premature infants, as well as preliminary data to obtain additional funding.

Location:

Reprometabolic Syndrome Mediates Subfertility in Obesity

Location: University of Colorado Hospital

NRG-GU002, PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

A comparison of adjuvant radiotherapy + androgen therapy after a radical prostatectomy with and without Docetaxel.

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

S1609, DART: Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

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

The effect of isotretinoin on the etonogestrel contraceptive implant

Location: Comprehensive Womens Health Center

The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT

The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. However, whether E2 status affects BAT activity in women has not been studied. In this research, we will study 1) the contribution of BAT to REE under basal (room temperature) and stimulated conditions (mild cold-exposure); and 2) whether these responses are modulated by E2 status.

Locations: CTRC-adult; University of Colorado Hospital

Effect of Mechanical Circulatory Support on Exercise Capacity in Heart Failure

Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital

Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

This is a pilot study looking at asthmatics and non-asthmatics with different BMIs. Participants will undergo a baseline evaluation, lung function testing, and a subsequent bronchoscopy and nasal epithelial brush smapling in those that meet study enrollment.

Location: University of Colorado Hospital

BIOMARKERS IN BARRETT'S ESOPHAGUS AND ESOPHAGEAL ADENOCARCINOMA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM BIOBANK

Location: University of Colorado Hospital

a retrospective review of regional variation in pediatric musculoskeletal infection

Location:

a characterization of the effect of total knee arthroplasty on glycemic control in the VA population

Location:

A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced Malignancies

Location: University of Colorado Hospital

A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors

Location: University of Colorado Hospital

A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPY Version Amendment 3, 7/17/2017

Location: University of Colorado Hospital

A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA

Location: University of Colorado Hospital

Automated Three Dimensional Morphologic Analysis of Sputum Cells for the Diagnosis of Lung Cancer

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

CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)

Location: University of Colorado Hospital

S1418/BR006, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with greater than 1 cm Residual Invasive Cancer or Positive Lymph Nodes (greater than pN1mic) After Neoadjuvant Chemotherapy.

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

CRIZOTINIB (XALKORI) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES

Location: Childrens Hospital Colorado

Cardiovascular consequences of hypogonadism in men

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

Phase I/II Study of Pembrolizumab and Cabozantinib in Patients with Metastatic Renal Cell Carcinoma

To assess the efficacy of Prmbrolizumab plus Cabozantinib in patients with metastatic renal cell carcinoma

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

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study)

Location: Childrens Hospital Colorado

A011502: A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL

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

Amyloid Imaging with 11C-PiB in Healthy Aging and Mild Cognitive Impairment

Location: University of Colorado Hospital

Molecular Analysis of Drug Sensitivity and Resistance in Advanced Thyroid Cancer

Location: University of Colorado Hospital

Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study

Locations: Dana Farber Cancer Institute; MD Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; The Ohio State University Comprehensive Cancer Center; UCLA, Jonsson Cancer Center; University of Colorado Hospital; University of Michigan Comprehensive Cancer Center

ARM Study: A phase II trial to evaluate crizotinib in the neoadjuvant setting in non-small cell lung cancer patients with surgically resectable, ALK, ROS1, or MET-oncogene positive non-small cell lung cancer

Locations: University of California San Francisco; University of Colorado Hospital

An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Location: Childrens Hospital Colorado

The Oncoshare Project: An integrated informatics approach to understanding breast cancer survival.

Location:

Is disruption of the human gut microbial environment associated with cognitive impairment following chemotherapy for breast cancer?

Location: University of Colorado Hospital

ADVL1414: A PHASE 1 STUDY OF SELINEXOR (KPT-330, IND #125052), A SELECTIVE XPO1 INHIBITOR, IN RECURRENT AND REFRACTORY PEDIATRIC SOLID TUMORS, INCLUDING CNS TUMORS

Location: Childrens Hospital Colorado

Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes

Locations: CTRC-adult; University of Colorado Hospital

NEWLY DIAGNOSED CHILDREN (LESS THAN 10 YEARS OLD) WITH MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS: CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO EITHER SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR CELL RESCUE

Location: Childrens Hospital Colorado

Comparison of Prolaris and Oncotype Dx Genomic Prostate Cancer Tests

Location: University of Colorado Hospital

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway Mutant Acute Lymphoblastic Leukemia

Location: Childrens Hospital Colorado

A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without M6620 (VX-970) in Metastatic Urothelial Carcinoma

A comparison of Gem/Cis +/- VX-970

Location: University of Colorado Hospital

Aflac ST 1501: Abemaciclib in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, and in Children with Recurrent and Refractory Solid Tumors Including Malignant Brain Tumors

Location: Childrens Hospital Colorado

PHASE 2 STUDY OF ALISERTIB AS A SINGLE AGENT IN RECURRENT OR PROGRESSIVE CENTRAL NERVOUS SYSTEM (CNS) ATYPICAL TERATOID RHABDOID TUMORS (AT/RT) AND EXTRA-CNS MALIGNANT RHABDOID TUMORS (MRT) AND IN COMBINATION THERAPY IN NEWLY DIAGNOSED AT/RT (SJATRT)

Location: Childrens Hospital Colorado

Skin cancer prevention in a young adult population - nevus excision

Location: University of Colorado Hospital

Double-blind Trial of Phosphatidylcholine Supplementation during Pregnancy: Impact on Attention and Social Withdrawal at 4 years of Age

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

Identification of the optimal stem cell source for bone and cartilage repair

Location:

Qualitative Outcomes and Operative Experience in Patients with Total Shoulder Arthroplasty: Comparison to Total Hip and Knee Arthroplasty

Location:

Concentrated Bone Marrow Aspirate for the Treatment of Early Osteoarthritis for the Knee and Hip

Location:

A double-blind, placebo-controlled crossover study comparing the analgesic efficacy of cannabis versus oxycodone

PRIMARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on spontaneous chronic spine pain relief, as measured by change in score on the 10-point Numeric Rating Scale (NRS); (2) To compare the effects of cannabis versus oxycodone versus placebo on experimental pain analgesia, as measured by change in Experimental Pain Threshold (EPTh), in both patients with chronic spine pain and healthy controls. SECONDARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on chronic spine pain, as measured by the Patient Global Impression of Change (PGIC) scale; (2) To compare the effects of cannabis versus oxycodone versus placebo on subjective reports of drug effects, psychoactive effects, and mood; (3) To compare the effects of cannabis versus oxycodone versus placebo on tests of neurocognitive functioning (Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test, the Hopkins Verbal Learning Test Revised (HVLT), and the Grooved Pegboard Test); (4) To compare the effects of cannabis versus oxycodone versus placebo on Standardized Field Sobriety Tests (SFST).

Locations: CTRC-adult; University of Colorado Hospital

Bromocriptine QR as adjunct therapy in Type 1 Diabetes

Locations: CTRC-adult; University of Colorado Hospital

Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study

To demonstrate the superiority of MD1003, 300 mg/day, over placebo to clinically improve patients with progressive multiple sclerosis (MS).

Location: University of Colorado Hospital

A Phase 2, Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

A rollover study to continue to document patients previously enrolled to an enzalutamide study

Location: University of Colorado Hospital

When is enough, enough? Investigating end-of-life care provided to HSCT recipients

Location: University of Colorado Hospital

Identification of New Therapeutic Targets in Down Syndrome Acute Lymphoblastic Leukemia

Location: Childrens Hospital Colorado

GRADE: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.

Locations: CTRC-adult; University of Colorado Hospital

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

To establish safety and efficacy of Niraparib in patients with targeted DNA- repair anomalies

Location: University of Colorado Hospital

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Location: Childrens Hospital Colorado

Evaluation of Colorado Oncology Providers on the Use of Medical Marijuana

Location: University of Colorado Hospital

NANT 2015-01: Neuroblastoma Precision Trial

Location:

Effects of Antidepressant Medication Use in Glioblastoma Multiforme

Location: University of Colorado Hospital

Tumor Genetics as Predictors of Response to Stereotactic Radiosurgery (SRS) in Melanoma Brain Metastases

Location: University of Colorado Hospital

Rocky Mountain Multiple Sclerosis Center (RMMSC) Biorepository for the Study of Neuroimmunological Disorders

Location: University of Colorado Hospital

WHOLE BLOOD SPECIMEN COLLECTION FROM PREGNANT SUBJECTS (PRO-101-SAMPLES)

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

To demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed disability progression in patients with SPMS as measured by EDSS.

Location: University of Colorado Hospital

A Phase 3, Open-Label Study of the Safety, Efficacy, and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients with Unsatisfactory Control on Available Therapy.

To assess the long-term safety of apomorphine continuous infusion in advanced Parkinson?s disease (PD) patients who are unable to achieve adequate motor control despite optimal treatment with noninvasive therapy.

Location: University of Colorado Hospital

RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER

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

ADVL1412 A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab

Location: Childrens Hospital Colorado

Phase l-ll Study of MEK 162 for Children with Low-Grade Gliomas and Other Ras/Raf/ERK Pathway Activated Tumors

Location: Childrens Hospital Colorado

Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study

To create a repository of data and samples to be used to answer future research questions

Location: University of Colorado Hospital

A Phase IV Trial of Neuroprotection with ACTH in Acute Optic Neuritis

Location: University of Colorado Hospital

Wireless electroencephalography for continuous monitoring in the EEG LTM unit 12Apr2018

1. To evaluate the device?s ability to record wireless EEG from patients in the long-term EEG monitoring unit 2. To compare wireless EEG in these recordings to standard-of-care wired EEG

Location: University of Colorado Hospital

NAtalizumab for Prevention of Post-partum Relapses in patients with Multiple Sclerosis 09May2016

To assess the efficacy of IV administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period.

Location: University of Colorado Hospital

The Impact of Vocal Folds Augmentation with Injection Laryngoplasty on Quality of Voice in Patients with Parkinson Disease (VoCAL-PD ? Vocal Cords Augmentation Laryngoplasty in PD)

1. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on the quality of voice in PD subjects. 2. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on structural and functional parameters of the larynx measured on videostroboscopic recordings assessing glottic closure time and supraglottic constriction. 3. Assess the duration of the long term treatment effect.

Location: University of Colorado Hospital

A Double-Masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.

Location: University of Colorado Hospital

Collaborative International Research in Clinical and Longitudinal Experience for Neuromyelitis Optica (NMO) Studies

To create a longitudinal collections of samples and data from: 1. Subjects with clinically-defined or highly suspicious for NMO or NMOSD; 2. Affected or unaffected relatives of subjects with clinically defined NMO or NMOSD; 3. Subjects with autoimmune diseases other NMO or NMOSD, such as multiple sclerosis, myasthenia gravis, Graves' disease, lupus, etc. 4. Healthy subjects

Location: University of Colorado Hospital

An Open-Label, Phase 3 Study Examining the Long-Term Safety Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

To evaluate the safety and tolerability of APL-130277 in patients with Parkinson's disease (PD) over a 24 week period

Location: University of Colorado Hospital

A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients with Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Clinical Study with Patisiran

To assess the safety and efficacy of long-term dosing with patisiran in transthyretin-mediated amyloidosis (ATTR) patients with familial amyloidotic polyneuropathy (FAP).

Location: University of Colorado Hospital

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injections(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optin Neuropathy (NAION)

1. To assess the safety and tolerability of QPI-1007 intravitreal (IVT) injections in subjects with recent-onset NAION 2. To determine the effect on visual function of QPI-1007 IVT injections in subjects with recent-onset NAION

Location: University of Colorado Hospital

MAINTENANCE OBINUTUZUMAB FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA COMPLETE RESPONDERS

Location: University of Colorado Hospital

AOST1421 A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC#764038, IND#4308) in Combination with GM-CSF in Patients with Recurrent Osteosarcoma

Location: Childrens Hospital Colorado

AR22.001 Vigilant ObservatIon of G1IadeL Wafer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel Wafer (Carmustine Implant) Used in Usual Medical Practice

Location: University of Colorado Hospital

Patient-Initiated Biobanking of Deceased Lung Cancer Patient Tissues

To collect archival tissues and validated clinical history of deceased Lung cancer patients & deposit them into the NCI SPORE biobank

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

Randomized Phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/Her2- breast cancer

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Sloan Kettering Cancer Center; University of Colorado Hospital; West Cancer Center

A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic or Minimally Symptomatic Non-Metastatic Prostate Cancer Patients with Rising PSA

The objective is to study the effects of GSE (Grape Seed Extract) on patients with Prostate cancer

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

Molecular Profiling-based Assignment of Cancer Therapy for Patients with Advanced Solid Tumors (MPACT)

Location: University of Colorado Hospital

Effect of breaking up prolonged sitting on metabolic flexibility

Our objective is to test the effect of breaking-up prolonged sitting with bouts of physical activity on metabolic flexibility, a recognized core component of metabolic health. Metabolic flexibility is defined as the body's ability to adapt fuel oxidation to changing fuel availability and energy demands.

Locations: CTRC-adult; University of Colorado Hospital

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) V: 6.0; 12Sept2018

Location: University of Colorado Hospital

Successful use of EPOCH-R in two pediatric patients with Burkitts Lymphoma and Acute Kidney Injury: a case report

Location: Childrens Hospital Colorado

051/02 A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Location: Childrens Hospital Colorado

A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN CHILDREN AND ADOLESCENTS WITH NO CURATIVE FIRST-LINE TREATMENT OPTION, RECURRENT OR REFRACTORY SOLID TUMORS AND PRIMARY CNS TUMORS, WITH OR WITHOUT TRK, ROS1, OR ALK FUSIONS

Location: Childrens Hospital Colorado

NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

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

AAML1531 Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Location: Childrens Hospital Colorado

An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease (PROTOCOL No. CMX001-351)

Location:

I3Y-MC-JPCE Phase 1b Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

Location: University of Colorado Hospital

KCP-9274-901 A Phase 1 Open-label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or Non-Hodgkin's Lymphoma

Location: University of Colorado Hospital

LCCC 1523: Phase 2 Trial of Brigatinib after Treatment with Next-Generation ALK inhibitors in Refractory ALK Rearranged NSCLC

Location: University of Colorado Hospital

NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Location: University of Colorado Hospital

Department of Otolaryngology Biobank

Location: University of Colorado Hospital

Developing a biomarker of infant speech perception

Location:

D419NC00001 A Phase I Study of Durvalumab and IPH2201 in Adult Subjects with Select Advanced Solid Tumors

Location: University of Colorado Hospital

INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL GAP4): A Multicenter, Randomised, Controlled Phase III Study

A comparison of exercise versus no exercise in men with Metastatic Castrate-Resistant Prostate Cancer.

Location: University of Colorado Hospital

ANHL12P1 A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710) or Crizotinib (NSC# 749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) IND#117117

Location: Childrens Hospital Colorado

Multicenter Cohort Study To Evaluate Outcomes after Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults with Solid Tumors: The iCat2, GAIN Consortium Study

Location: Childrens Hospital Colorado

AP32788-15-101 A Phase I/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

1. To determine the safety profile of orally administered AP32788 2. To identify the RP2D, dose-limiting toxicities (DLTs), and the maximum tolerated dose (MTD) of AP32788 3 .To determine the pharmacokinetic (PK) profile of AP32788 and its active metabolites, AP32960 and AP32914 4. To evaluate the anti-tumor activity of AP32788 in NSCLC patients with EGFR or HER2 mutations 5. To explore associations between tumor and plasma biomarkers and AP32788 efficacy and safety

Location: University of Colorado Hospital

APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Location: Childrens Hospital Colorado

Functional Connectivity of the Basal Ganglia in Primary Focal Dystonia

In this study we are looking at how the brain works in people who have dystonia compared to those who don't have dystonia. This study will use magnetic resonance imaging (MRI), magnetoencephalography (MEG), and Electroencephalography (EEG) to see how the brain reacts while resting and doing a finger-tapping task.

Aim 1: A second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients at rest and during a tapping motor task Aim 2: the strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores

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

15-2316 Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Targeted Therapy in patients with EGFR, ALK, ROS1 or BRAF mutations

The primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and early treatment tumors b. Measurement of immunohistochemistry biomarkers of pre- and early treatment tumors tumors Secondary Objectives: 2- Identify pre-therapy predictive markers that can be used to determine which tumors will undergo EMT or activation of other bypass pathways following targeted therapy. 3- Determine if there is a correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature. 4- Estimate success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analyses. 5- Determine adverse event rate associated with rapid second biopsy Exploratory Objectives: 6- Determine if there is an association between progression free survival and bypass pathway activation status 7- Determine whether there is evidence of bypass pathway activation in circulating tumor cells. Enrolled subjects will be asked to have one - two research tumor biopsies of predetermined target lesions. If they do not have tissue from the target lesion that was previously collected, they will be asked to allow study investigators to use the tissue as part of this study and will have one biopsy before they begin their targeted therapy, and the second biopsy about two weeks later. The subject may also have a third SOC biopsy if tumor progresses.

Location: University of Colorado Hospital

Review of Outcomes of Bone Marrow Transplant (BMT) Patients

Location:

Tissue Pentosidine Levels of Type I & Type II Diabetic Patients with Carpal Tunnel Syndrome and Trigger Finger V: December 1, 2017

Location:

Review of Distal Radius Fracture Outcomes in a Pediatric Population

Location:

Outcomes of Nonoperative versus Operative Management of Subcapital Phalangeal Fractures in a Pediatric Population: A Retrospective Review

Location:

14-1076 Molecular Biology and Phase I Study of GM-CSF and Intrathecal Trastuzumab in Children with Recurrent Ependymoma

Location: Childrens Hospital Colorado

A221405 POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsive breast cancer)

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

I5B-MC-JGDL A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Location: University of Colorado Hospital

Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim?) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process

Location:

RU2413061 Randomized, Double-Blind, Phase II Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers

Location: University of Colorado Hospital

Post Approval Study: Longitudinal Monitoring of Newly Implanted Subjects with the Nucleus Hybrid L24 Cochlear Implant System

The visit dates for this study are a candidacy evaluation, a baseline evaluation, the Initial Activation, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Most of these visits will be at the same time as your clinical audiologist visits.

To evaluate the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted individuals

Location: University of Colorado Hospital

MLN0128 A Phase Ib Study of the Combination of MLN0128 (Dual TORC I/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Triple-Negative Breast Cancer (TNBC)

Location: University of Colorado Hospital

MER3101: MAS-1 ADJUVANTED ANTIGEN-SPECIFIC IMMUNOTHERAPEUTIC FOR PREVENTION AND TREATMENT OF TYPE 1 DIABETES

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

15-1621 A Phase 0 Trial of Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

Location: Childrens Hospital Colorado

EZH-102 A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Location: Childrens Hospital Colorado

Clinical, Radiographic, and Intraoperative Findings in Young Adults Undergoing Hip Arthroscopy

Location:

Prevalence of Corticosteroid Injections in Collegiate Athletes

Location:

Retrospective Review of Minimally Invasive Placement of Pedicle Screws in Spine Surgery

Location:

Prospective Randomized Trial to Assess PO versus IV Antibiotics for the Treatment of Early Post-op Wound Infection after Extremity Fractures (POvIV Study)

Location:

Failure of ACL Allograft: Does Tendon Type Make a Difference

Location:

AVANTA PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT PROSTHESIS

Location:

RXDX-101-02 An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangement

Location: University of Colorado Hospital

S0820 A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III-Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES). Amendment 3 7.15.18

Locations: Memorial Hospital Central; University of Colorado Hospital

AEWS1221 Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 75008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

Location:

Women with Cancer Survivorship Outcomes Program (WCSOP)

Location: University of Colorado Hospital

EAY131 Molecular Analysis for Therapy Choice (MATCH)

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

Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)

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

ML28897/PRO 02 My Pathway: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib. Vemurafenib, and Vismodegib in Patients Who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

Location: University of Colorado Hospital

Pulmonary Nodule Biomarker Trial

We propose a prospective tissue banking trial of subjects with CT detected lung nodules. Sputum, blood, urine and exhaled breath will be collected and either rapidly analyzed or stored for future use. Subjects will either have diagnosis pursued by biopsy or surgical excision or by serial observation of chest CTs for growth or stability over a period of up to 2 years, as determined by the clinician recommendations and patient preference. Stability of size over a 2 year or greater period of CT monitoring will be considered as evidence of a benign etiology(17).

Locations: Department of Defense (DOD); Greeley Hospital; Harmony Campus; Kaiser Permanente of Colorado; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; National Jewish Health; Poudre Valley Hospital; Rocky Mountain Regional VA Medical Center; University of Colorado Hospital

Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular Correlates

Locations: Dana Farber Cancer Institute; Lone Tree Medical Center; Mayo Clinic, Arizona; New York University; University of Arizona Cancer Center; University of Colorado Hospital; University of Kansas Cancer Center

Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone

Location: University of Colorado Hospital

E4512 A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This is a double-blind clinical trial of Crizotinib(investigational) that will be administered orally.

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

Shoulder Arthroplasty Registry

Location:

Impact of Neck Strengthening Program in Adolescent Athletes

Location:

Cerebral Palsy Adult Transition Longitudinal Study

Location:

Quantification of the variable expression of estrogen receptors in human articular cartilage of healthy versus osteoarthritic females

Location:

Registry of Total Hip and Total Knee Replacements

Location:

CU Sports Medicine Outcomes Registry

Location:

Validation of a New Sacroiliac-joint Specific Disability Questionnaire

Location:

A prospective, post-market, clinical outcomes of the Secur-Fit Advanced Hip Stem by Stryker Orthopedics-Total Hip Arthroplasty

Primary Objective: - 5-year success rate of the Secur-Fit Advanced Hip Stem with an endpoint of revision for aseptic loosening or femoral fracture will be compared with a 99% success rate, with a 2.5% noninferiority margin.

Locations: Colorado Research Center; University of Colorado Hospital

Retrospective Review of Outcomes in Complex Spine Surgery

Location:

MOON Shoulder Instability: Patients Undergoing Operative Treatment of the Shoulder Capsule or Labrum

Location:

Transcriptome Profiling of Progressive Idiopathic Scoliosis via mRNA Sequencing

Location:

Educational Dietetic Intern Protocol

Compare glucose concentration at each time point between the two diet conditions

Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital

Hip and Lower Extremity Outcomes Registry

Location:

An analysis of leg length discrepancies in children with spastic hemiplegic cerebral palsy

Location:

Autograft plus Allograft Hybrid ACL Reconstruction

Location:

REAL Athlete Injury Tracking Database

Location:

Videoconferencing for Rural Pediatric Diabetes Care

To determine if video conferencing among rural pediatric diabetic patients and their family intervention will result in increased accessibility to care, improved diabetes control, and increased adherence to the American Diabetes Association guidelines.

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

Inter-Segmental Coordination and Ankle-foot Orthoses during Gait by Children with Spastic Cerebral Palsy

Location:

PT-112-101 A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-122 Injection in Subjects with Advanced Solid Tumors

This is a clinical trial of PT-112 that will be administered injection which is investigational.

Location: University of Colorado Hospital

Acetabular and Femoral Development Before and After a Varus Derotational Osteotomy in Children with Cerebral Palsy

Location:

RTOG 1304/NSABP B-51/Endorsed Study: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

This is a clinical trial of radiation that will be administered after a lumpectomy, to the breast and lymph nodes or mastectomy, to the area where the breast used to be and lymph nodes. This is done to see if giving radiation as described above will help women live longer.

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

Quantification of Pain Sensitivity to Controlled Objective Pain Stimuli

Location:

A Translational Study of the Interactions between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction

This study examines differences in the immune system of younger women with pregnancy associated breast cancer (those diagnosed within 5 years of a pregnancy) to those who are not diagnosed with a pregnancy associated breast cancer.

Locations: Lone Tree Medical Center; University of Colorado Hospital

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study

This study plans to learn more about breast cancer in young women, including the biology of the disease and young women's experiences with it. We aim to use this information to improve the care and information available for young women with breast cancer.

Location: University of Colorado Hospital

RTOG 1008: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

This is a clinical trial of cisplatin that will be administered by IV which is standard of care and radiation therapy that will be administered standard of care.

Location: University of Colorado Hospital