Your search for "All Studies" found 932 studies:
eIND for Trametinib, IND#152589, Patient W.R.

Protocol #: 20-1906

Location: Childrens Hospital Colorado

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

Protocol #: 20-1988

Location: University of Colorado Hospital

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

Protocol #: 20-1864

Location: Childrens Hospital Colorado

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

To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age

Protocol #: 20-9990

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

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (mRNA-1273-P301)

Protocol #: 20-1619

Location: University of Colorado Hospital

The role of biological sex in perceived stress and negative affect in the context of 2 systemic societal stressors

This study is completed online at your convenience. Participants will complete online surveys (the study takes about 25 minutes to complete).

Protocol #: 20-1583

Location: Department Specific Free Standing Clinic

A Phase I study of the ADAM-10 inhibitor, INCB7839 in children with recurrent/progressive high-grade gliomas to target microenvironmental neuroligin-3

Protocol #: 20-1487

Location: Childrens Hospital Colorado

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

Protocol #: 20-1453

Location: University of Colorado Hospital

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

Protocol #: 20-1106

Location: Childrens Hospital Colorado

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

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

Protocol #: 20-6506

Locations: Memorial Hospital Central; Memorial Hospital North

Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

Protocol #: 20-6034

Location: Medical Center of the Rockies

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

Protocol #: 19-2469

Location: Childrens Hospital Colorado

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

Protocol #: 20-0246

Location: University of Colorado Hospital

Colorado Nurses Experience with COVID-19

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

Protocol #: 20-6039

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

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

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

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

Protocol #: 20-6019

Location: Memorial Hospital Central

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

Protocol #: 20-1197

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

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

Protocol #: 20-1219

Location: University of Colorado Hospital

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

Protocol #: 20-1055

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 20-6037

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

S1900C, A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

Protocol #: 20-0564

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

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

Protocol #: 20-0563

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

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

Protocol #: 20-0880

Location: University of Colorado Hospital

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

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

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

Protocol #: 20-0751

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 20-0889

Location: Childrens Hospital Colorado

OPTION

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

Protocol #: 20-6502

Location: Medical Center of the Rockies

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

Protocol #: 20-6031

Location: Poudre Valley Hospital

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

Protocol #: 20-0781

Location: University of Colorado Hospital

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

Protocol #: 20-0820

Location: Childrens Hospital Colorado

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

Protocol #: 20-0584

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

COVID-19: Surgical Implications Study

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

Protocol #: 20-0614

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

COVID-19 Biobank

Protocol #: 20-0685

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

Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI

Protocol #: 20-0537

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 20-0571

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

COVID-19 Preparedness Survey

Protocol #: 20-0620

Location: University of Colorado Hospital

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

Protocol #: 20-0596

Location: Childrens Hospital Colorado

Virtual reality in cancer patient imaging review

Protocol #: 20-0560

Location: University of Colorado Hospital

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

Protocol #: 20-0580

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

CD80 as a biomarker for kidney disease

Protocol #: 13-2700

Location: Childrens Hospital Colorado

Use of accelerometers to improve estimation of the thermic effect of feeding in whole room calorimetry studies

What you receive for participating: -Personalized information about your energy expenditure ("metabolism") -Five total days of food -Monetary compensation

Test whether accelerometer-based measures of physical activity from Actigraph and ActivPAL accelerometers can be used to improve the calculation of TEF in whole room calorimeter studies.

Protocol #: 20-0191

Location: University of Colorado Hospital

The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)

While you are taking part in in the study, you will see your doctor as usual. Your doctor will make notes (medical records) about your disease and its treatment as he/she normally would. For the next 5 years, a study coordinator at your doctor’s office will collect information from your doctor’s notes about your medical condition and treatments, including any medication changes.

Protocol #: 19-6518

Locations: Memorial Hospital Central; Memorial Hospital North

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

Protocol #: 20-0535

Location: Childrens Hospital Colorado

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

Protocol #: 20-0404

Location: University of Colorado Hospital

Immune Profiles in CF Fungal Infections

Protocol #: 20-0099

Location: Childrens Hospital Colorado

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

Protocol #: 20-6027

Locations: Long's Peak Hospital; Longs Peak Hospital

Identifying Fibrinolysis Sensitivity in Liver Transplant to Improve Perioperative Transfusion

Protocol #: 15-0813

Location: University of Colorado Hospital

International CDKL5 Clinical Research Network

Protocol #: 19-2756

Location: Childrens Hospital Colorado

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

Protocol #: 20-0346

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

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

Protocol #: 20-0347

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

Validation of the Apollo EE Device, Indirect Calorimetry

Protocol #: 20-0317

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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

Protocol #: 20-0357

Location: University of Colorado Hospital

S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"

Protocol #: 20-0359

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

NRG-GI005: Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Protocol #: 20-0365

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

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

Protocol #: 20-0360

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

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

Protocol #: 19-2236

Locations: Denver Health Medical Center; University of Colorado Hospital

OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Protocol #: 20-0288

Location: University of Colorado Hospital

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

Protocol #: 20-0226

Location: Childrens Hospital Colorado

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

Protocol #: 20-0104

Location: University of Colorado Hospital

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

Protocol #: 20-0189

Location: Childrens Hospital Colorado

Relationship of hair cortisol to diurnal salivary cortisol and psychological distress measures

The purpose of this research is to demonstrate a relationship between cortisol measured in hair, cortisol measured in saliva, and the results of self-reported psychological measures (questionnaires).

Protocol #: 20-0025

Location: Department Specific Free Standing Clinic

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Protocol #: 20-0052

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-3032

Location: University of Colorado Hospital

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

Protocol #: 20-0007

Location: University of Colorado Hospital

ALS toolkit project

Protocol #: 20-0127

Location: University of Colorado Hospital

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

Protocol #: 20-0124

Location: University of Colorado Hospital

NATURAL HISTORY STUDY OF MITOCHONDRIAL NEUROGASTROINTESTINAL ENCEPHALOMYOPATHY

Protocol #: 20-0091

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-2839

Location: University of Colorado Hospital

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

Protocol #: 19-3061

Location: University of Colorado Hospital

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

Protocol #: 20-0035

Location: University of Colorado Hospital

Tissue Bank and Clinical Database for the Analysis of arterial thrombosis

Protocol #: 19-2998

Location: University of Colorado Hospital

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

Protocol #: 19-3118

Location: University of Colorado Hospital

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

Protocol #: 19-2514

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

North American Pediatric Renal Trials Collaborative Studies (NAPRTCS)

Protocol #: 19-3007

Location: Childrens Hospital Colorado

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

Protocol #: 19-2323

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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

Protocol #: 19-2999

Location: University of Colorado Hospital

MRI for Cardiotoxicity in Kids (MOCK)

Protocol #: 19-3023

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Biomarker Development in LGMD 2i

Protocol #: 19-2943

Location: University of Colorado Hospital

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

Protocol #: 19-2758

Location: University of Colorado Hospital

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

Protocol #: 19-2833

Locations: Memorial Hospital Central; University of Colorado Hospital

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

Protocol #: 19-2987

Location: University of Colorado Hospital

North American Mitrochondrial Disease Consortium Patient Registry and Biorepository

Protocol #: 13-2246

Location: Childrens Hospital Colorado

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

Protocol #: 19-2163

Location: Childrens Hospital Colorado

A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant

Protocol #: 19-2946

Location: University of Colorado Hospital

Pediatric Bone Marrow Failure Tissue Repository

Protocol #: 19-2913

Location: Childrens Hospital Colorado

Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes

Protocol #: 19-2760

Location: University of Colorado Hospital

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

Protocol #: 19-2960

Location: University of Colorado Hospital

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

Protocol #: 19-6517

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

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

Protocol #: 19-2897

Location: University of Colorado Hospital

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

Protocol #: 19-2898

Location: University of Colorado Hospital

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

Protocol #: 19-2940

Location: Childrens Hospital Colorado

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

Protocol #: 19-2893

Location: Steadman Hawkins Clinic - Denver

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

Protocol #: 19-2950

Location: Childrens Hospital Colorado

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

Protocol #: 19-2838

Location: Steadman Hawkins Clinic - Denver

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

Protocol #: 19-2888

Location: University of Colorado Hospital

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

Protocol #: 19-2910

Locations: Barbara Davis Center; University of Colorado Hospital

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

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

Protocol #: 19-2904

Locations: Renal Research Center; University of Colorado Hospital

Valence and Arousal Ratings of Affective Images in Reproductive Aged Women (Females' Affective Image Ratings - FAIR Study)

If you join the study, you will participate in two study sessions, which can be completed either in-person (at Anschutz Medical Campus, in Aurora, CO) or remotely - over the internet, over the course of 2 months. The first part of the study is the screening session. During this session, the research staff will conduct an interview with you and complete questionnaires about your medical and mental health history, and your mood. The second and last part of the study is the test session. During this session, you will complete surveys about your mood, and you will rate 160 digital images. Forty of those images will be pleasant, 40 will be unpleasant, 40 will be neutral, and 40 will be erotic. You will rate these images on scales of how pleasant/unpleasant and of how arousing/non-arousing you find these images.

To investigate ratings of digital images across the female menstrual cycle

Protocol #: 19-2872

Locations: Department Specific Free Standing Clinic; University of Colorado, Boulder

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

Protocol #: 19-2797

Location: University of Colorado Hospital

Protocol I5B-MC-Y001(a) An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

Protocol #: 19-6133

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

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

Protocol #: 19-2818

Location: University of Colorado Hospital

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

Protocol #: 19-2761

Location: University of Colorado Hospital

NRG-GY021: A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer

Protocol #: 19-2780

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

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

Protocol #: 19-2721

Location: University of Colorado Hospital

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

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

Protocol #: 19-2854

Location: University of Colorado Hospital

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

Protocol #: 19-2645

Location: University of Colorado Hospital

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

Protocol #: 19-2788

Location: University of Colorado Hospital

GS-US-200-4334: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIV

This study will test an experimental drug named GS-6207 (long acting capsid inhibitor) in combination with other HIV medications for the treatment of human immunodeficiency virus (HIV) infection. An experimental drug means that it is not yet approved for the treatment of HIV-1 Infection by the United States Food and Drug Administration (FDA) and your country’s regulatory agency. Other HIV medications included in this study are B/F/TAF (Biktarvy?) and, F/TAF (Descovy?), which are currently approved by the U.S. FDA for the treatment of HIV infection and TAF (VEMLIDY?) and Bictegravir (BIC) which are part of the medication Biktarvy but are not currently approved as a single agent HIV medication by the U.S. FDA. This is a randomized, open label study. Open-label means you and your study doctor will know what study drugs you will be taking. Randomized means the study treatment you take will be chosen by chance (like flipping a coin) to receive one of four study treatments. The randomization for this study is in a 2:2:2:1 ratio. You will have 6 out of 7 chances to receive GS-6207 in combination with other HIV medications and a 1 out of 7 chance to receive B/F/TAF.

Protocol #: 19-2810

Location: University of Colorado Hospital

NRG-HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Protocol #: 19-2326

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

An adaptive seamless randomized, double-blind, placebocontrolled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Each study subject will be randomized to receive either study drug or a placebo for 6 months. Neither the subject nor the study staff will know which treatment was given until after the study has finished. Study subjects will be monitored every 2 weeks for the first month, then less frequently as the study progresses. The total length of the study is about 8 months.

Protocol #: 19-2819

Locations: Renal Research Center; University of Colorado Hospital

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

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

Protocol #: 19-2824

Location: University of Colorado Hospital

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

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

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

Protocol #: 19-2820

Location: Comprehensive Women's Health Center

Lipoic acid for Treatment of Progressive Multiple Sclerosis

Protocol #: 19-2525

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

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

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

Protocol #: 19-2782

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

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

Protocol #: 19-2554

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

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

Protocol #: 19-2676

Locations: Anschutz Health and Wellness; University of Colorado Hospital

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

Protocol #: 19-2744

Location: Childrens Hospital Colorado

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

Protocol #: 19-0795

Location: University of Colorado Hospital

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

Protocol #: 19-2471

Location: University of Colorado Hospital

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

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

Protocol #: 19-6129

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 19-2707

Location: University of Colorado Hospital

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

Protocol #: 19-2532

Location: University of Colorado Hospital

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

Protocol #: 19-2564

Location: University of Colorado Hospital

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

Protocol #: 19-2377

Location: University of Colorado Hospital

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

Protocol #: 19-2631

Location: Childrens Hospital Colorado

Microfluidic models of bleeding and thrombosis

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

Protocol #: 19-2408

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

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

Protocol #: 19-2378

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

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

Protocol #: 19-2333

Location: Childrens Hospital Colorado

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

Protocol #: 19-2520

Location: University of Colorado Hospital

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

Protocol #: 19-2445

Locations: Highlands Ranch Hospital; University of Colorado Hospital

In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study

NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee injection (i.e. steroid injection).

Protocol #: 19-2499

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

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

Protocol #: 19-2521

Location: University of Colorado Hospital

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

Protocol #: 19-2524

Location: University of Colorado Hospital

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

Protocol #: 19-1896

Location: Childrens Hospital Colorado

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

Protocol #: 19-2438

Location: Childrens Hospital Colorado

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

Protocol #: 19-2475

Location: Childrens Hospital Colorado

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

Protocol #: 19-2420

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

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

Protocol #: 19-2390

Location: University of Colorado Hospital

Effects of prenatal antibiotics on the infant gut microbiome

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

Protocol #: 19-2288

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-0821

Location: University of Colorado Hospital

Adenosinergic immune suppression pathway in glioblastoma multiforme tumors

Protocol #: 19-2344

Location: University of Colorado Hospital

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

Protocol #: 19-2311

Location: University of Colorado Hospital

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

Protocol #: 19-1929

Location: University of Colorado Hospital

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

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

Protocol #: 19-2401

Location: University of Colorado Hospital

A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Protocol #: 19-2363

Location: University of Colorado Hospital

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

Protocol #: 19-1598

Location: University of Colorado Hospital

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

Protocol #: 19-1980

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

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

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

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

Protocol #: 19-2362

Locations: Pathology - SOM; University of Colorado Hospital

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

Protocol #: 19-2357

Location: Childrens Hospital Colorado

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

Protocol #: 19-2038

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

Perceived Palliative Care Needs in Early-Onset Dementia

Protocol #: 19-2134

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

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

Protocol #: 19-2295

Location: Childrens Hospital Colorado

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

Protocol #: 19-2255

Location: University of Colorado Hospital

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

Protocol #: 19-2242

Location: University of Colorado Hospital

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

Protocol #: 19-1913

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

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

Protocol #: 19-1613

Location: Childrens Hospital Colorado

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

Protocol #: 19-2270

Location: Childrens Hospital Colorado

RADIANT:Rare and Atypical Diabetes Network

Protocol #: 19-2285

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

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

Protocol #: 19-6114

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

Improving Renal Outcomes Collaborative

Protocol #: 16-2190

Location: Childrens Hospital Colorado

Pre-Clinical Evaluation of Xpert Xpress GBS Test

Protocol #: 19-2095

Location: University of Colorado Hospital

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

Protocol #: 16-0927

Location: Childrens Hospital Colorado

Prospective Analysis of Gait Following Hemispherectomy

Protocol #: 17-0230

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.

Protocol #: 16-1934

Location: Childrens Hospital Colorado

International Fetal Cardiac Intervention Registry

Protocol #: 14-0343

Location: Childrens Hospital Colorado

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

Protocol #: 14-1413

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #: 18-1076

Location: Childrens Hospital Colorado

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

Protocol #: 19-1621

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

MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME

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

Protocol #: 19-2092

Location: Childrens Hospital Colorado

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

Protocol #: 19-1840

Location: University of Colorado Hospital

Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability

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

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

Protocol #: 17-0464

Location: Childrens Hospital Colorado

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.

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

Protocol #: 19-1978

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-1977

Location: University of Colorado Hospital

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

Protocol #: 19-1809

Location: University of Colorado Hospital

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

Protocol #: 15-1434

Location: Childrens Hospital Colorado

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

Protocol #: 16-0145

Location: Childrens Hospital Colorado

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

Protocol #: 19-1925

Location: University of Colorado Hospital

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

Protocol #: 19-6100

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

Protocol #: 19-1839

Location: Childrens Hospital Colorado

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

Protocol #: 19-1481

Location: Childrens Hospital Colorado

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

Protocol #: 18-1380

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1874

Location: University of Colorado Hospital

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

Protocol #: 19-6513

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

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

Protocol #: 19-2412

Location: Childrens Hospital Colorado

Colorado Oral Strengthening Device

A new study is looking at a device that would strengthen the muscles of the mouth to make eating and drinking easier for those who have trouble swallowing. Participants will be randomized to either the group using the investigational device for tongue exercise or the group using standard of care tongue depressors. All participants will receive compensation for participating.

To develop a low-cost device that improves patient outcomes by eliciting the same methods of action of existing higher cost devices. To assess if exercising the tongue with this novel device can achieve increased tongue strength among individuals with Parkinson's disease.

Protocol #: 19-1850

Location: University of Colorado Hospital

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

Protocol #: 19-1633

Location: Childrens Hospital Colorado

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

Protocol #: 19-1727

Location: University of Colorado Hospital

INVESTIGATIONAL PULSE SEQUENCES FOR DATA ACQUISITION ON MAGNETIC RESONANCE IMAGING SCANNERS

Protocol #: 02-729

Location: Department Specific Free Standing Clinic

A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients with Advanced Basal Cell Carcinoma

Protocol #: 19-1711

Location: University of Colorado Hospital

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

Protocol #: 19-1597

Location: University of Colorado Hospital

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

The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery.

Protocol #: 19-1823

Location: University of Colorado Hospital

Rare CFTR Mutation Cell Collection Protocol (RARE)

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

Protocol #: 16-2412

Location: Childrens Hospital Colorado

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

Protocol #: 19-6102

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

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

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

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

Protocol #: 19-6101

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 19-1600

Location: University of Colorado Hospital

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

Protocol #: 15-0140

Location: Childrens Hospital Colorado

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

Protocol #: 19-1787

Location: Childrens Hospital Colorado

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

Protocol #: 19-1634

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-1679

Location: University of Colorado Hospital

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

Protocol #: 19-1467

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-6511

Location: Memorial Hospital Central

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

Protocol #: 19-6510

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

ECG Belt for CRT Response

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

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

Protocol #: 19-1703

Location: University of Colorado Hospital

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

Protocol #: 19-1503

Location: University of Colorado Hospital

A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use Disorder

Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.

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

Protocol #: 19-1658

Location: University of Colorado Hospital

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

Protocol #: 19-1620

Location: University of Colorado Hospital

Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome

This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receive tofacitinib. Tofacitinib is an FDA-approved drug currently used to treat arthritis and ulcerative colitis. Participants must attend eight study visits at the University of Colorado Anschutz Medical Campus during the 18-week trial and have a study partner available to attend the visits with them. A blood draw for safety monitoring is required at each visit. Participants will be given tofacitinib at no cost for the duration of the study.

Protocol #: 19-1362

Location: University of Colorado Hospital

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

Protocol #: 14-1720

Location: Childrens Hospital Colorado

TRAVERSE

Protocol #: 19-1644

Location: University of Colorado Hospital

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

Protocol #: 15-0902

Locations: Childrens Hospital Colorado; Colorado Research Center

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

Protocol #: 19-1461

Location: University of Colorado Hospital

S1800A, A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP NON-MATCHED SUB-STUDY)

Protocol #: 19-1318

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

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

Protocol #: 19-1458

Location: University of Colorado Hospital

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

Protocol #: 19-1455

Location: University of Colorado Hospital

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

Protocol #: 19-6509

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

Regression in Down Syndrome

Protocol #: 19-1418

Location: Childrens Hospital Colorado

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

Protocol #: 19-1337

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-1150

Locations: Barbara Davis Center; University of Colorado Hospital

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

Protocol #: 16-1270

Locations: Denver Health Medical Center; University of Colorado Hospital

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

Protocol #: 19-1230

Location: Childrens Hospital Colorado

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

Protocol #: 19-1282

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-1342

Location: University of Colorado Hospital

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

Protocol #: 19-1302

Location: University of Colorado Hospital

An investigation of immune biology and Alzheimers Disease-related biomarkers in asymptomatic, late life mild TBI

Protocol #: 19-1423

Location: University of Colorado Hospital

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

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

Protocol #: 19-1403

Location: Childrens Hospital Colorado

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

Protocol #: 19-1399

Location: University of Colorado Hospital

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

Protocol #: 19-1387

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-0744

Location: University of Colorado Hospital

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

Protocol #: 18-2793

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-1192

Location: University of Colorado Hospital

reST Registry

remede System Therapy in patients with central sleep apnea

Protocol #: 19-6087

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 19-1259

Location: Childrens Hospital Colorado

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

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

Protocol #: 19-6506

Location: Memorial Hospital Central

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

Protocol #: 19-1081

Locations: Lone Tree Medical Center; University of Colorado Hospital

The PISCES Study: A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment

Protocol #: 19-1297

Location: University of Colorado Hospital

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

Protocol #: 19-1111

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 19-1121

Locations: Greeley Campus; 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

Protocol #: 19-1152

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

S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)

Protocol #: 19-1154

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

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

Protocol #: 19-1132

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-1145

Location: University of Colorado Hospital

Comparative Effectiveness Research for Infantile Spasms V: 12Jan2017

Protocol #: 16-2408

Location: Childrens Hospital Colorado

Multi-Institutional Validation of Trauma Specific Frailty Index

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

Protocol #: 19-6084

Location: Medical Center of the Rockies

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

Protocol #: 19-1277

Location: Childrens Hospital Colorado

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

Protocol #: 19-6076

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

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

Protocol #: 19-1272

Location: University of Colorado Hospital

Neurophysiological Correlates V: 31Jan18

Protocol #: 16-1480

Location: Childrens Hospital Colorado

Natural History of Rett Syndrome and Related Disorders

Protocol #: 15-2332

Location: Childrens Hospital Colorado

Gamma band neural stimulation and its effects on resting state networks

Protocol #: 19-1251

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

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

Protocol #: 19-1146

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

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

Protocol #: 19-0889

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

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

Protocol #: 16-1998

Location: Childrens Hospital Colorado

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

Protocol #: 19-0675

Location: University of Colorado Hospital

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

Protocol #: 19-0865

Location: University of Colorado Hospital

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

Protocol #: 19-1171

Location: University of Colorado Hospital

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

Protocol #: 19-1113

Location: University of Colorado Hospital

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

Protocol #: 19-0554

Location: University of Colorado Hospital

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

Protocol #: 19-1199

Location: University of Colorado Hospital

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

Protocol #: 19-1118

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

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

Protocol #: 19-1040

Location: University of Colorado Hospital

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

Protocol #: 19-1074

Location: University of Colorado Hospital

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

Protocol #: 19-1147

Location: University of Colorado Hospital

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

Protocol #: 19-1069

Location: University of Colorado Hospital

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

Protocol #: 15-0693

Location: Childrens Hospital Colorado

Cardiopulmonary and Right Ventricular Function in Health and Disease

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

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

Protocol #: 19-1141

Location: University of Colorado Hospital

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

Protocol #: 19-0561

Location: University of Colorado Hospital

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

Protocol #: 19-0967

Location: University of Colorado Hospital

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

Protocol #: 19-0604

Location: University of Colorado Hospital

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

Protocol #: 19-6065

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

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

Protocol #: 19-0642

Location: University of Colorado Hospital

Prevention of enamel demineralization in fixed appliance orthodontic patients using CPP-ACP-NaF varnish compared to blank varnish base. A randomized split mouth controlled clinical trial

The hypothesis is that casein phosphopeptide stabilized amorphous calcium phosphate fluoride releasing (CPP-ACP-NaF) dental varnish will be more effective at reducing enamel demineralization than the control varnish base that does not contain CPP-ACP-NaF.

Protocol #: 19-0968

Locations: Dental Clinic; UCD Dental Clinic

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Protocol #: 18-0220

Location: University of Colorado Hospital

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

Protocol #: 19-0820

Location: University of Colorado Hospital

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

Protocol #: 19-0905

Locations: Lone Tree Medical Center; University of Colorado Hospital

Understanding the Barriers to Epilepsy Surgery: A North American Survey

Protocol #: 19-0269

Location: University of Colorado Hospital

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

Protocol #: 19-6060

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

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

Protocol #: 19-0900

Location: University of Colorado Hospital

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

Protocol #: 19-0852

Location: University of Colorado Hospital

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

Protocol #: 19-0376

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

Outcomes after Standardized Testicular Torsion Management and Follow-up

Protocol #: 19-0849

Location: Childrens Hospital Colorado

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

Protocol #: 19-0772

Location: University of Colorado Hospital

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

Protocol #: 19-0150

Location: University of Colorado Hospital

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

Protocol #: 19-0814

Location: Childrens Hospital Colorado

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

Protocol #: 19-0858

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-0636

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Meat intake during early complementary feeding on growth, neurodevelopment and gut health

This is a 6 month long study with visits occurring once every month. The baseline (5-6 month) and end of study (12 month) visit will be conducted at Children's Hospital Colorado and the other 5 visits will be home visits. Compensation will be provided.

Protocol #: 19-0546

Location: Childrens Hospital Colorado

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

Protocol #: 14-1072

Location: Childrens Hospital Colorado

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

Protocol #: 19-0556

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-0632

Locations: Lone Tree Medical Center; University of Colorado Hospital

Prognostic factors associated with outcomes in colorectal cancer liver metastases

Protocol #: 19-0770

Location: University of Colorado Hospital

CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY

Protocol #: 19-0519

Location: University of Colorado Hospital

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

Protocol #: 19-0520

Location: University of Colorado Hospital

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

Protocol #: 19-0507

Location: University of Colorado Hospital

The Perelman Study of IntraUterine Growth Restriction

Protocol #: 14-1360

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

Protocol #: 19-0536

Location: Childrens Hospital Colorado

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

Protocol #: 16-0994

Location: Childrens Hospital Colorado

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

Compare Whole Blood vs Component Therapy

Protocol #: 19-6047

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous cell carcinoma (SCC) will be identified and enrolled to undergo serial bronchoscopies at 12 month intervals over a 2-3 year period. A variety of specimen types will be collected to support analyses of the genomic and microenvironmental features of these PMLs.

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

Protocol #: 19-0400

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

EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

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

Protocol #: 19-0422

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Evaluation and Demonstration of Investigational MRI Software and Hardware

Test new MRI scanner sequences in diverse patient population

Protocol #: 19-0518

Location: Childrens Hospital Colorado

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

Protocol #: 19-0457

Location: University of Colorado Hospital

Incidence and Effect of HLA Antibodies in Liver Transplant Recipients

Protocol #: 18-2594

Location: University of Colorado Hospital

Instrumentation of Huntington's Disease Motor Function Assessment

Protocol #: 19-0212

Location: University of Colorado Hospital

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

Protocol #: 19-0414

Location: University of Colorado Hospital

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

Protocol #: 19-0489

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

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

Protocol #: 19-0539

Location: University of Colorado Hospital

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

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

Protocol #: 19-0493

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

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

Protocol #: 19-0473

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 19-0549

Location: Childrens Hospital Colorado

Blunt bowel and mesenteric injury: A WTA Multicenter Prospective Observational Study

Protocol #: 18-6062

Locations: Memorial Hospital Central; Memorial Hospital North

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

Protocol #: 19-0325

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-0476

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

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

Protocol #: 19-0423

Location: University of Colorado Hospital

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

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

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

Protocol #: 19-0510

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

AMPLATZERTM PFO Occluder Post Approval Study

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

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

Protocol #: 19-6502

Location: Memorial Hospital Central

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

Protocol #: 18-2798

Location: University of Colorado Hospital

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

Protocol #: 19-0327

Location: University of Colorado Hospital

Detection and Risk in Early MS

Protocol #: 19-0393

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

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

Protocol #: 18-1695

Location: Childrens Hospital Colorado

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

Protocol #: 19-0172

Location: University of Colorado Hospital

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

Protocol #: 19-0444

Location: University of Colorado Hospital

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

Protocol #: 19-0232

Location: University of Colorado Hospital

Total Joint Arthroplasty in a Pediatric Population

Involves two surveys for approximately 10 mintues

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

Protocol #: 19-0306

Location: Childrens Hospital Colorado

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

Protocol #: 18-2444

Location: University of Colorado Hospital

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

Protocol #: 19-0105

Location: Childrens Hospital Colorado

Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer

Protocol #: 18-2742

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

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

Protocol #: 19-0396

Location: Childrens Hospital Colorado

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

Protocol #: 18-2537

Location: University of Colorado Hospital

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

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

Protocol #: 19-0347

Location: University of Colorado Hospital

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

Protocol #: 19-0267

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

Improving physical activity maintenance following an exercise program for cancer survivors

Protocol #: 19-0323

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

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

Protocol #: 19-0239

Location: University of Colorado Hospital

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

Protocol #: 19-0299

Location: Childrens Hospital Colorado

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

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

Protocol #: 19-0206

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 18-2740

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

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

Protocol #: 19-0207

Location: University of Colorado Hospital

APOGEE

LVAD registry

Protocol #: 18-2576B

Location: University of Colorado Hospital

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

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

Protocol #: 19-6030

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 18-2513

Location: Childrens Hospital Colorado

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

Protocol #: 19-0127

Location: University of Colorado Hospital

Investigating cortical networks disruption and rehabilitation after traumatic brain injury

Protocol #: 19-0049

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

Protocol #: 19-0250

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

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

Protocol #: 18-6102

Location: Medical Center of the Rockies

Surgery Database Project

Protocol #: 18-2839

Location: University of Colorado Hospital

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

Protocol #: 16-0692

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

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

Protocol #: 19-0225

Location: University of Colorado Hospital

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

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

Protocol #: 19-0144

Location: University of Colorado Hospital

Gene Expression of Cerebral Aneurysms

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

Protocol #: 19-0182

Location: University of Colorado Hospital

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

This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily doses of the study drug. During the 3 month study period there are every 2 week visits to evaluate blood pressure. Optional testing includes cerebral artery testing and cognitive testing before after daily doses of nicotinamide riboside.

Protocol #: 19-0149

Locations: Renal Research Center; University of Colorado Hospital

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

Protocol #: 19-0123

Location: University of Colorado Hospital

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

Protocol #: 19-0120

Location: University of Colorado Hospital

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

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

Protocol #: 19-0048

Location: University of Colorado Hospital

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

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

Protocol #: 18-2881

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 18-2607

Location: University of Colorado Hospital

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

Protocol #: 19-0041

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

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

Protocol #: 19-0079

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-2604

Location: University of Colorado Hospital

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

Protocol #: 18-2874

Location: University of Colorado Hospital

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

Protocol #: 18-6515

Location: Memorial Hospital Central

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

Protocol #: 19-0011

Location: University of Colorado Hospital

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

Protocol #: 19-0027

Location: Barbara Davis Center

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

Protocol #: 18-2435

Location: University of Colorado Hospital

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

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

Protocol #: 19-0003

Location: University of Colorado Hospital

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

Protocol #: 18-6119

Locations: Medical Center of the Rockies; Poudre Valley Hospital

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

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

Protocol #: 18-2823

Location: University of Colorado Hospital

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

Protocol #: 18-2654

Location: University of Colorado Hospital

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

Protocol #: 18-2806

Location: University of Colorado Hospital

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

Protocol #: 18-2520

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

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

Protocol #: 18-2679

Location: University of Colorado Hospital

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

Protocol #: 18-2569

Location: University of Colorado Hospital

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

Protocol #: 18-2692

Location: University of Colorado Hospital

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

Protocol #: 18-2772

Location: University of Colorado Hospital

Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System

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

Protocol #: 18-2765

Location: University of Colorado Hospital

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

Protocol #: 18-2089

Location: University of Colorado Hospital

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

Protocol #: 18-2529

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 18-2714

Location: Childrens Hospital Colorado

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

Protocol #: 11-0674

Locations: Memorial Hospital Central; Memorial Hospital North

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

Protocol #: 18-2646

Location: University of Colorado Hospital

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

Protocol #: 18-2684

Location: University of Colorado Hospital

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

Protocol #: 18-2562

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

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

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

Protocol #: 18-6511

Location: Memorial Hospital Central

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

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

Protocol #: 18-2672

Location: University of Colorado Hospital

Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab

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

Protocol #: 18-2286

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-2483

Location: University of Colorado Hospital

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

Protocol #: 18-2346

Location: University of Colorado Hospital

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

Protocol #: 16-2621

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

CLASP IID/IIF

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

Protocol #: 18-6126

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 18-2404

Location: University of Colorado Hospital

Destination Therapy Post Approval Study - Medtronic HVAD System

LVAD registry

Protocol #: 18-2576A

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.

Protocol #: 18-2436

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

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

Protocol #: 18-2488

Location: University of Colorado Hospital

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

Protocol #: 16-0086

Location: University of Colorado Hospital

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

Protocol #: 18-2534

Location: University of Colorado Hospital

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

Protocol #: 18-2482

Location: University of Colorado Hospital

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

Protocol #: 18-2258

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

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

Protocol #: 18-1223

Location: Childrens Hospital Colorado

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

Protocol #: 17-2424

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

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

Protocol #: 18-2209

Location: University of Colorado Hospital

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

Protocol #: 18-2382

Location: University of Colorado Hospital

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

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

Protocol #: 18-2432

Location: Childrens Hospital Colorado

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

Protocol #: 18-2284

Location: University of Colorado Hospital

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

Protocol #: 18-2198

Location: University of Colorado Hospital

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

Protocol #: 18-1816

Location: University of Colorado Hospital

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

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

Protocol #: 18-2252

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

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

Protocol #: 18-2354

Location: University of Colorado Hospital

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

Protocol #: 18-2337

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 18-2012

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 18-2117

Location: University of Colorado Hospital

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

Protocol #: 18-1558

Location: Childrens Hospital Colorado

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

Protocol #: 18-1683

Location: Childrens Hospital Colorado

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

Protocol #: 18-2315

Location: University of Colorado Hospital

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

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

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

Protocol #: 18-2249

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

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

Protocol #: 18-2309

Location: Childrens Hospital Colorado

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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

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

Protocol #: 18-2298

Location: University of Colorado Hospital

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

Protocol #: 18-2230

Location: Childrens Hospital Colorado

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

Protocol #: 18-0369

Location: University of Colorado Hospital

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

Protocol #: 18-6510

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

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

Protocol #: 18-2130

Location: Childrens Hospital Colorado

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

Protocol #: 18-1919

Location: University of Colorado Hospital

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

Protocol #: 18-1856

Location: University of Colorado Hospital

Genomic Translation for ALS Care

Protocol #: 18-1768

Location: University of Colorado Hospital

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

Protocol #: 18-2051

Location: University of Colorado Hospital

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

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

Protocol #: 18-1916

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-2129

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

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

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

Protocol #: 18-1843

Location: Childrens Hospital Colorado

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

Protocol #: 18-2047

Location: University of Colorado Hospital

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

Protocol #: 18-1875

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.

Protocol #: 18-1823

Location: Childrens Hospital Colorado

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

Protocol #: 18-1933

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 18-2021

Location: University of Colorado Hospital

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

Protocol #: 18-1633

Location: University of Colorado Hospital

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

Protocol #: 18-2032

Location: University of Colorado Hospital

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

Protocol #: 18-1997

Location: Childrens Hospital Colorado

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

Protocol #: 18-6061

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

COG ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Protocol #: 18-2000

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-1978

Location: University of Colorado Hospital

Clinical Outcome Measures in Friedreich's Ataxia

Protocol #: 18-1641

Location: University of Colorado Hospital

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Central Precocious Puberty (CPP)

Protocol #: 18-1716

Location: Childrens Hospital Colorado

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

Protocol #: 18-1672

Location: University of Colorado Hospital

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

Protocol #: 18-1706

Location: University of Colorado Hospital

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

Protocol #: 18-1734

Location: University of Colorado Hospital

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

Protocol #: 18-1728

Location: University of Colorado Hospital

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

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

Protocol #: 18-1842

Location: University of Colorado Hospital

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

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

Protocol #: 18-6081

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 18-1808

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

Protocol #: 18-0821

Location: University of Colorado Hospital

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

Protocol #: 18-1599

Location: University of Colorado Hospital

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

Protocol #: 18-1721

Locations: Greeley Campus; Highlands Ranch 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.

Protocol #: 18-1795

Locations: Colorado Research Center; Renal Research Center

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

Protocol #: 18-1740

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

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

Protocol #: 18-1493

Location: University of Colorado Hospital

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

Protocol #: 18-1461

Location: University of Colorado Hospital

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

Protocol #: 18-0554

Location: University of Colorado Hospital

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

Protocol #: 18-1343

Location: University of Colorado Hospital

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

Protocol #: 18-1654

Location: University of Colorado Hospital

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

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

Protocol #: 18-1624

Location: University of Colorado Hospital

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

Protocol #: 18-1526

Location: University of Colorado Hospital

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

Protocol #: 18-1349

Location: Childrens Hospital Colorado

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

Protocol #: 18-1429

Location: Childrens Hospital Colorado

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

Protocol #: 18-1336

Location: University of Colorado Hospital

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

Protocol #: 18-1216

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

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

Protocol #: 18-1445

Location: Childrens Hospital Colorado

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

Protocol #: 18-0867

Location: Childrens Hospital Colorado

AN OPEN-LABEL, 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

Protocol #: 18-1439

Locations: Lone Tree Medical Center; University of Colorado Hospital

Molecular Characterization of Idiopathic Interstitial Pneumonias

Protocol #: 18-1490

Location: University of Colorado Hospital

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.

Protocol #: 18-1102

Location: University of Colorado Hospital

Peripheral Inflammatory Cytokine Levels in Parkinson Disease

Protocol #: 18-1356

Location: University of Colorado Hospital

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

Protocol #: 18-1391

Location: Childrens Hospital Colorado

Conversational Speech in the Diagnosis of Neurocognitive Disorders

Protocol #: 18-0456

Location: University of Colorado Hospital

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

Protocol #: 13-3192

Location: Adult Infectious Disease Clinical Trials Center

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

Protocol #: 18-1347

Location: University of Colorado Hospital

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

Protocol #: 18-1263

Location: University of Colorado Hospital

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

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

Protocol #: 18-1269

Location: University of Colorado Hospital

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

Protocol #: 18-1100

Location: University of Colorado Hospital

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

Protocol #: 16-1400

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

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

Protocol #: 18-1297

Location: University of Colorado Hospital

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

Protocol #: 18-1199

Location: University of Colorado Hospital

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

Protocol #: 18-1344

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.

Protocol #: 18-1298

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

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

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

Protocol #: 16-0905

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

Protocol #: 18-0910

Location: Childrens Hospital Colorado

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

Protocol #: 18-6055

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

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

Protocol #: 18-0708

Locations: City of Hope Cancer Center; Lone Tree Medical 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

Protocol #: 18-1281

Location: Childrens Hospital Colorado

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

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

Protocol #: 17-0051

Location: University of Colorado Hospital

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

Protocol #: 15-1868

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

Obalon? Balloon System, The Post Approval Study

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

Protocol #: 18-1209

Location: University of Colorado Hospital

Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy

Protocol #: 18-0995

Location: University of Colorado Hospital

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

Protocol #: 18-0973

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

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)

Protocol #: 18-0015

Location: University of Colorado Hospital

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

Protocol #: 18-1150

Location: University of Colorado Hospital

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Protocol #: 18-1049

Location: University of Colorado Hospital

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

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

Protocol #: 18-1166

Location: University of Colorado Hospital

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

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

Protocol #: 18-1148

Location: University of Colorado Hospital

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.

Protocol #: 18-1121

Location: University of Colorado Hospital

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

Protocol #: 18-1144

Location: University of Colorado Hospital

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

Protocol #: 18-1137

Location: University of Colorado Hospital

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

Protocol #: 16-2308

Location: University of Colorado Hospital

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

Protocol #: 18-0709

Location: University of Colorado Hospital

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

Protocol #: 18-0606

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

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

Protocol #: 17-2215

Location: University of Colorado Hospital

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

Protocol #: 17-2378

Location: Childrens Hospital Colorado

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

Protocol #: 18-0857

Location: Childrens Hospital Colorado

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

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

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

Protocol #: 18-1003

Location: University of Colorado Hospital

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

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

Protocol #: 18-0926

Location: University of Colorado Hospital

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

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

Protocol #: 18-0925

Location: University of Colorado Hospital

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

Protocol #: 18-0971

Location: Childrens Hospital Colorado

Ruptured Aneurysms Treated with Hydrogel Coils

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

Protocol #: 18-6052

Location: Memorial Hospital Central

A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3021 IN PATIENTS WITH ADVANCED SOLID TUMORS

Protocol #: 18-0685

Location: University of Colorado Hospital

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

Protocol #: 18-0627

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

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

Protocol #: 18-0756

Location: University of Colorado Hospital

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

Protocol #: 16-1038

Location: University of Colorado Hospital

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

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

Protocol #: 16-0701

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

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

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

To measure contraceptive efficacy of the test product

Protocol #: 17-0225

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

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

Protocol #: 16-0121

Location: University of Colorado Hospital

A study of the genetics of pulmonary fibrosis

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

Protocol #: 15-1147

Location: University of Colorado Hospital

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

Study is double blind and placebo controlled.

Protocol #: 18-0829

Location: University of Colorado Hospital

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

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

Protocol #: 18-0761

Location: University of Colorado Hospital

AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

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

Protocol #: 18-0834

Location: Childrens Hospital Colorado

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Protocol #: 18-0803

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Molecular Endotypes of Chronic Spontaneous Urticaria

Protocol #: 18-0850

Location: University of Colorado Hospital

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

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

Protocol #: 18-0505

Location: University of Colorado Hospital

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

Protocol #: 18-0836

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

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

Protocol #: 18-0498

Location: Childrens Hospital Colorado

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

Protocol #: 18-0686

Location: Childrens Hospital Colorado

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

Protocol #: 15-1041

Location: University of Colorado Hospital

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

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

Protocol #: 18-0567

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

Education Efficacy in Patient Interventions

Protocol #: 18-6020

Location: Medical Center of the Rockies

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

Protocol #: 18-0501

Location: Childrens Hospital Colorado

Identifying Environmental Triggers of Smoking Behaviors in Low-income Communities

Protocol #: 18-0052

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

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

Protocol #: 18-0524

Location: Childrens Hospital Colorado

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

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

Protocol #: 17-2349

Location: University of Colorado Hospital

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

Protocol #: 18-0715

Location: University of Colorado Hospital

Narcotic consumption in discectomies: microscopic versus endoscopic

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

Protocol #: 18-0830

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.

Protocol #: 18-0654

Location: University of Colorado Hospital

PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)

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

Protocol #: 18-0637

Location: University of Colorado Hospital

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

Protocol #: 18-0461

Location: Childrens Hospital Colorado

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

Protocol #: 18-0582

Location: University of Colorado Hospital

NRG GU-005:PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER

Protocol #: 18-0285

Locations: Lone Tree Medical Center; 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

Protocol #: 18-0559

Location: University of Colorado Hospital

Impact of Fever Prevention in Brain Injured Patients (INTREPID)

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

Protocol #: 18-0548

Location: University of Colorado Hospital

Precision Approach to PPI Therapy in Gastroesophageal reflux disease

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

Protocol #: 18-0205

Location: University of Colorado Hospital

Impact of Oral mCRPC Therapies Stewardship Pilot Program for Veterans

Protocol #: 18-0167

Location: Rocky Mountain Regional VA Medical Center

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

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

Protocol #: 18-0546

Location: University of Colorado Hospital

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Protocol #: 17-2186

Location: University of Colorado Hospital

COG ANHL1522 - A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-specific Cytotoxic T-Lymphocytes (LMP-TC, IND # 17068) in Pediatric Solid Organ Recipients (SOT) with EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)

Protocol #: 18-0198

Location: Childrens Hospital Colorado

EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

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

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

Protocol #: 18-0392

Locations: Highlands Ranch Hospital; University of Colorado Hospital

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

Protocol #: 18-0385

Location: University of Colorado Hospital

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

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

Protocol #: 16-1363

Location: University of Colorado Hospital

AMPLATZERTM PFO Occluder Post Approval Study

Protocol #: 17-2334

Location: University of Colorado Hospital

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

Protocol #: 16-2322

Location: Childrens Hospital Colorado

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

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

Protocol #: 18-0442

Location: University of Colorado Hospital

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

Protocol #: 18-0374

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

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

Protocol #: 18-0251

Location: University of Colorado Hospital

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

Protocol #: 17-6205

Location: Memorial Hospital Central

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

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

Protocol #: 18-6029

Location: Medical Center of the Rockies

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

Protocol #: 17-0466

Location: University of Colorado Hospital

Diet and Relapses in Pediatric Multiple Sclerosis

Protocol #: 18-0393

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.

Protocol #: 18-6002

Locations: Harmony Campus; Medical Center of the Rockies

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

Protocol #: 15-2388

Location: University of Colorado Hospital

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

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

Protocol #: 16-1875

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

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

Protocol #: 18-0226

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

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

Protocol #: 18-0017

Location: Childrens Hospital Colorado

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

Protocol #: 17-2208

Locations: Lone Tree Medical Center; University of Colorado Hospital

Perceived palliative care needs of Huntington's disease patients

Protocol #: 18-0216

Location: University of Colorado Hospital

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

Protocol #: 18-0187

Location: University of Colorado Hospital

Clinical Trial Readiness for SCA1 and SCA3

Protocol #: 18-0020

Location: University of Colorado Hospital

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

Protocol #: 17-1809

Location: Childrens Hospital Colorado

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

Protocol #: 18-0183

Location: University of Colorado Hospital

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

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

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

Protocol #: 17-2267

Location: University of Colorado Hospital

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

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

Protocol #: 18-0158

Location: University of Colorado Hospital

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

Protocol #: 18-0153

Location: University of Colorado Hospital

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

DUR-928 (investigational drug)

Protocol #: 18-0123

Location: University of Colorado Hospital

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

Protocol #: 15-0170

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

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

Protocol #: 17-2216

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

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

Protocol #: 18-0031

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 17-2020

Location: Childrens Hospital Colorado

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

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

Protocol #: 17-2328

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

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

Protocol #: 17-0628

Locations: Boulder Sports Clinic; University of Colorado Hospital

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

Protocol #: 17-2299

Location: University of Colorado Hospital

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

Protocol #: 17-2431

Location: University of Colorado Hospital

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

Protocol #: 17-2472

Location: Childrens Hospital Colorado

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

Protocol #: 17-2355

Locations: Childrens Hospital Colorado; Colorado Research Center

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

Protocol #: 16-0179

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

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

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

Protocol #: 17-2394

Location: Childrens Hospital Colorado

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

Protocol #: 17-2381

Location: University of Colorado Hospital

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

Protocol #: 16-2179

Location: University of Colorado Hospital

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

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

Protocol #: 17-1863

Location: University of Colorado Hospital

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

Protocol #: UCH11-1101

Location: Harmony Campus

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

Protocol #: UCH06-778

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

Risk factors in Early Multiple Sclerosis (RisE-MS)

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

Protocol #: 17-1884

Location: University of Colorado Hospital

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

Protocol #: 16-1752

Location: Childrens Hospital Colorado

Influence of PTSD Symptoms on Chronic Pain Development After Sexual Assault

Protocol #: 15-6021

Location: Memorial Hospital Central

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

Protocol #: 17-2367

Location: University of Colorado Hospital

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

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

Protocol #: 17-2345

Locations: CTRC-adult; University of Colorado Hospital

Evaluation of commercial pharmacogenomic testing in psychiatry medicine.

Protocol #: 17-2347

Location: University of Colorado Hospital

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

Protocol #: 17-1529

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

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

Protocol #: 17-2078

Location: University of Colorado Hospital

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

Protocol #: 17-2336

Location: University of Colorado Hospital

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

Protocol #: 17-2168

Location: Childrens Hospital Colorado

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

Protocol #: 17-2318

Location: University of Colorado Hospital

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

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

Protocol #: 17-2095

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in Cardiomyocytes

Protocol #: 17-2296

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Kidney Immunosuppression Dosed Daily Only (KIDDO)

Protocol #: 17-2311

Location: Childrens Hospital Colorado

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

Protocol #: 17-2257

Location: Childrens Hospital Colorado

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

Protocol #: 17-1597

Locations: ARTS Synergy Outpatient Treatment; Colorado Research Center

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

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

Protocol #: 17-2177

Location: University of Colorado Hospital

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

Protocol #: 17-2263

Location: Kaiser Permanente of Colorado

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

Protocol #: 17-6134

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

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

Protocol #: 17-2213

Location: Childrens Hospital Colorado

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

Protocol #: 17-2074

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

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

Protocol #: 17-2178

Locations: Childrens Hospital Colorado; University of Colorado Hospital

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

Protocol #: 17-2164

Location: University of Colorado Hospital

Mitochondria in HIV and Aging (MITO+)

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

Protocol #: 17-2161

Location: University of Colorado Hospital

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

Protocol #: 17-2145

Location: University of Colorado Hospital

American Registry for Migraine Research

Protocol #: 17-2165

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

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

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

Protocol #: 17-1782

Location: University of Colorado Hospital

Positive Aging Consultations

Protocol #: 17-2160

Location: University of Colorado Hospital

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

Protocol #: 17-1778

Location: University of Colorado Hospital

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

Protocol #: 17-2125

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

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

Protocol #: 17-2118

Location: University of Colorado Hospital

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

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

Protocol #: 17-2136

Location: University of Colorado Hospital

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

Protocol #: 17-1993

Location: Childrens Hospital Colorado

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

Protocol #: 17-1992

Location: Childrens Hospital Colorado

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

Protocol #: 17-2036

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

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

Protocol #: 17-1808

Location: University of Colorado Hospital

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Protocol #: 17-1756

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

Electronic Cigarette Use During Pregnancy

Protocol #: 17-2033

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

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

GSK is currently developing a once-daily ?closed? triple therapy of an ICS/LAMA/LABA combination [FF/UMEC/Vilanterol (VI)] in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. Through the comparison of a closed triple therapy to a standard of care ICS/LABA combination therapy this study will provide important information to prescribers regarding the benefit of step-up to closed triple therapy to patients uncontrolled on ICS/LABA.

Protocol #: 17-2041

Location: University of Colorado Hospital

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

Protocol #: 17-2000

Location: University of Colorado Hospital

PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung Cancer

Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose.

Protocol #: 17-1492

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

PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory diffuse intrinsic pontine glioma (DIPG), non-brainstem high-grade gliomas (NB-HGG), ependymoma, medulloblastoma or hypermutated brain tumors

Protocol #: 17-1991

Location: Childrens Hospital Colorado

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

Protocol #: 16-2506

Location: University of Colorado Hospital

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

Protocol #: 17-1956

Location: University of Colorado Hospital

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

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

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

Protocol #: 17-1730

Location: University of Colorado Hospital

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

Protocol #: 17-6209

Locations: Medical Center of the Rockies; Memorial Hospital Central

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

Protocol #: 16-0696

Location: University of Colorado Hospital

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

Six month intervention of ovarian hormone supression

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

Protocol #: 17-1869

Location: University of Colorado Hospital

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

Protocol #: 17-1532

Location: University of Colorado Hospital

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

Protocol #: 13-3034

Location: University of Colorado Hospital

Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)

This study is inviting people who have RA into a study to have an HRCT scan and PFT testing done for the study to learn more about lung disease in RA

Protocol #: 16-1097

Location: University of Colorado Hospital

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

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

Protocol #: 17-6198

Location: Medical Center of the Rockies

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

Protocol #: 15-1639

Location: University of Colorado Hospital

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

Protocol #: 17-1406

Location: Childrens Hospital Colorado

Optimizing Physical Activity Outcomes after Total Knee Arthroplasty

Protocol #: 17-0079

Location: University of Colorado Hospital

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

Protocol #: 17-1790

Location: Childrens Hospital Colorado

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

Protocol #: 17-1495

Location: Childrens Hospital Colorado

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

Protocol #: 17-1751

Location: University of Colorado Hospital

Transcranial electrical stimulation for the treatment of cervical dystonia

Protocol #: 17-1322

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

Protocol #: UCH09-0815

Location: Memorial Hospital North

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

In this study, we will be evaluating the effects of a reverse-diet compared to standard weight loss maintenance advice.

Protocol #: 17-1726

Location: University of Colorado Hospital

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

Protocol #: 17-1578

Locations: Colorado Research Center; Sheridan Health Services

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

Protocol #: UCH13-0619

Location: Memorial Hospital Central

Emergency Medicine Specimen Bank

Protocol #: 17-1642

Location: University of Colorado Hospital

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

Protocol #: 16-2575

Location: University of Colorado Hospital

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

Protocol #: 11-0548

Location: University of Colorado Hospital

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.

Protocol #: UCH14-1326

Location: Medical Center of the Rockies

Virtual and Augmented Reality Study

Protocol #: 17-6191

Location: Medical Center of the Rockies

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

Protocol #: 17-0245

Location: University of Colorado Hospital

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

Protocol #: 17-1314

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

Protocol #: 17-1512

Location: University of Colorado Hospital

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

Protocol #: 17-1317

Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic

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

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

Protocol #: 17-1477

Location: University of Colorado Hospital

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

Protocol #: 17-1474

Locations: Lone Tree Medical Center; University of Colorado Hospital

Copeptin and Nonalcoholic Fatty Liver Disease

See above

Protocol #: 17-1160

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

Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches

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

Protocol #: 16-2706

Locations: CTRC-adult; University of Colorado Hospital

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

Protocol #: 16-1710

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

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

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

Protocol #: 12-0660

Location: University of Colorado Hospital

Ethnography of Synthetic Cannabinoid Abusers to Target Substance Abuse Intervention

Protocol #: 17-1326

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

Protocol #: 17-1524

Location: University of Colorado Hospital

Fragile X Biobank

Protocol #: 16-1707

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

Protocol #: 17-1376

Location: Childrens Hospital Colorado

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

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

Protocol #: 17-1410

Location: University of Colorado Hospital

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

Protocol #: 17-6161

Location: Poudre Valley Hospital

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

Protocol #: 17-1010

Location: University of Colorado Hospital

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

Protocol #: 17-0888

Location: University of Colorado Hospital

Study of Placental Function in Healthy and Pathological Pregnancies

Protocol #: 14-1073

Location: University of Colorado Hospital

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

Protocol #: 17-6155

Location: Memorial Hospital Central

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

Protocol #: 15-2114

Locations: Memorial Hospital Central; University of Colorado Hospital

FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENE

Protocol #: 06-0501

Location: University of Colorado Hospital

Lipoprotein lipase enzyme activity assay validation and clinical assessment

Protocol #: 15-1412

Location: University of Colorado Hospital

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

Protocol #: 16-0328

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Subthalamic nucleus activity during habitual versus controlled movement

Protocol #: 17-1291

Location: University of Colorado Hospital

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

Protocol #: 16-2581

Location: University of Colorado Hospital

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

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

Protocol #: 17-0977

Location: University of Colorado Hospital

Anal Cancer/HSIL Outcomes Research (ANCHOR) Study

Protocol #: 15-1466

Locations: Denver Health Medical Center; University of Colorado Hospital

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

Protocol #: 17-1327

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

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

Protocol #: 16-2203

Location: University of Colorado Hospital

DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women

If you join the study, you will be placed by chance into one of two research groups: 1) exercise and a study pill or 2) no exercise and a study pill. The study pill could be DHEA (50 mg/day) or a placebo. A placebo is a pill that looks like medicine but is not real. DHEA is a naturally occurring hormone that declines with age. In postmenopausal women, nearly all estrogen and most testosterone comes from DHEA. DHEA is considered a food supplement.

Protocol #: 16-2427

Location: University of Colorado Hospital

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

Protocol #: 17-1363

Location: Childrens Hospital Colorado

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

Protocol #: 17-1043

Location: Childrens Hospital Colorado

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

Protocol #: 17-1333

Locations: Lone Tree Medical Center; 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

Protocol #: 17-1343

Location: University of Colorado Hospital

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

Protocol #: 17-1165

Location: Childrens Hospital Colorado

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

Protocol #: 17-0564

Location: Childrens Hospital Colorado

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

Protocol #: 17-1086

Location: Childrens Hospital Colorado

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

Protocol #: 17-1332

Location: University of Colorado Hospital

The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Protocol #: 17-1047

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

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

Protocol #: 16-2647

Location: University of Colorado Hospital

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

Protocol #: 16-2675

Location: University of Colorado Hospital

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

Protocol #: 16-1909

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

Protocol #: 17-1249

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

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.

Protocol #: 15-1608

Location: University of Colorado Hospital

T Cell Epitopes in Sarcoidosis

Protocol #: 17-1244

Location: University of Colorado Hospital

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

Protocol #: 17-1179

Location: University of Colorado Hospital

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

Protocol #: 17-0399

Location: University of Colorado Hospital

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

Protocol #: 17-1173

Location: University of Colorado Hospital

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

Protocol #: 17-1132

Location: University of Colorado Hospital

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

Protocol #: 17-1158

Locations: Colorado Research Center; Department Specific Free Standing Clinic

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

Protocol #: 17-1226

Location: University of Colorado Hospital

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

Protocol #: 16-0031

Locations: Denver Health Medical Center; 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

Protocol #: 17-1045

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.

Protocol #: 14-1507

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

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

Protocol #: 17-0991

Locations: Lone Tree Medical Center; University of Colorado Hospital

Dialysis Access Data Repository

This study is designed to collect data for future investigation under the topic of perioperative care and variables affecting outcomes of dialysis access patients at UCHealth.

Protocol #: 17-1073

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

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Protocol #: 17-0092

Location: University of Colorado Hospital

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

Protocol #: 17-0045

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

Pilot work to identify biomarkers of Moral Elevation in typically developing adolescents

Protocol #: 17-0129

Location: University of Colorado Hospital

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

Protocol #: 16-2739

Location: University of Colorado Hospital

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

Protocol #: 16-2399

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.

Protocol #: 14-1957

Location: University of Colorado Hospital

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

Protocol #: 16-1954

Location: University of Colorado Hospital

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

Protocol #: 17-0835

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) Study

Protocol #: 17-0873

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 17-0954

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

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

Protocol #: 17-0004

Locations: Barbara Davis Center; UCD Barbara Davis Center

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

Protocol #: 17-1042

Location: University of Colorado Hospital

Understanding the role of subcortical oscillations in human sleep dysregulation

Protocol #: 17-0868

Location: University of Colorado Hospital

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

Protocol #: 17-0996

Location: University of Colorado Hospital

Imaging for uncomplicated headache: ordering patterns and provider perspective

Protocol #: 17-0622

Locations: Colorado Research Center; University of Colorado Hospital

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

Protocol #: 17-0948

Location: University of Colorado Hospital

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

Protocol #: 17-0914

Locations: Denver Health Medical Center; University of Colorado Hospital

Assessment of hepatic glucose and fat regulation in overweight adolescent girls

Protocol #: 14-0542

Locations: Childrens Hospital Colorado; Colorado Research Center

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

Protocol #: 16-2568

Location: University of Colorado Hospital

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

Protocol #: 16-0248

Location: University of Colorado Hospital

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

Protocol #: 16-2491

Location: University of Colorado Hospital

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

Protocol #: 17-0500

Locations: Lone Tree Medical Center; 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.

Protocol #: 14-2178

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

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

Protocol #: 17-0791

Location: Childrens Hospital Colorado