Your search for "All Studies" found 430 matches:
An Open_label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV

Outpatient CTRC, University of Colorado Hospital

The purpose of this research study is to evaluate the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and mild neurocognitive disorder (MND) in people living with HIV (PWH)....

A PILOT STUDY OF PROSPECTIVE PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ADULT AND PEDIATRIC PATIENTS WITH NODULAR LYMPHOCYTE-PREDOMINANT HODGKIN LYMPHOMA (NLPHL)

University of Colorado Hospital

CONtiNuous glucosE monitoring (CGM) in people wiTh type 2 diabetes not on insulin: The CONNECT Study

Anschutz Health and Wellness, Boulder Health Center, Lone Tree Medical Center, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Family Practice - Westminster

This multi-center study is a 26-week randomized controlled trial (RCT) in which adults (>17 years) with type 2 diabetes (T2D) not using insulin and managed in a primary-care setting will be randomly assigned 1:1 to either use of real-time continuous glucose monitoring (CGM) or routine care...

A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Perioperative Informatics of Colorado (PICO) Database

University of Colorado Hospital

The development of this database will allow us to study various aspects of care provided by members of the Department of Anesthesiology at the University of Colorado School of Medicine (CU-DOA) and their association with perioperative outcomes or hospital resource utilization. The informat...

An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19

CTRC Inpatient, University of Colorado Hospital

This outpatient study involves recently diagnosed COVID-19 patients to determine if a single infusion of antibodies can help prevent disease progression. In this placebo-controlled trial, 50% of participants will receive the antibodies, while the other half will receive saline. Neither the...

ANBL2131 - A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

Childrens Hospital Colorado

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabin...

Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development

Outpatient CTRC, University of Colorado Hospital

Have an in-person appointment every six weeks and a telephone call every two weeks starting around 16-weeks gestation up until birth. Take the study supplement by mouth every morning and evening until birth. Have 5 in-person appointments and once monthly telephone calls about your chil...

Lynch syndrome INtegrative Epidemiology And GEnetics (LINEAGE) Consortium

University of Colorado Hospital

The purpose of this consortium is to establish a cohort of LS patients with systematic collection of cancer risk factors, adherence to risk reduction care, and quality of colonoscopic surveillance to estimate the rates of prevalent and incident cancers in LS, and patient-, provider- and sy...

Stress Response to Glaucoma Visual Field Testing

Outpatient CTRC, University of Colorado Hospital

The primary outcome measures will be change in heart rate, blood pressure, salivary cortisol levels, and state anxiety pre- and post-visual field testing and the difference in these responses between HVF and VRVF...

Protocol A032103, "MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer"

Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVES: I. To compare the ctDNA clearance proportion (i.e., ctDNA positive [+] --> ctDNA negative [-]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion). II. To compare overall survival in patients...

A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma

CTRC Inpatient, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about and identify the highest safe dose (called the maximum tolerated dose and/ or recommended dose) of the study drug HC-7366 and Belzutifan (also known as MK-6482) for the next phase of testing (called the recommended Phase 2 dose). The study aims to under...

A Study Evaluating the Safety and Effectiveness of RE104, a Psilocybin-like substance, in the Treatment of Patients with Postpartum Depression (PPD)

Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital

After having a baby, some women get the "baby blues" or feel sad, worried or tired within a few days of giving birth. For many women, the baby blues go away in a few days. However, if any of the following symptoms persist for more than two weeks, this may be a sign of postpartum depressi...

Rehabbing with Peloton: Commercially Available Fitness mHealth for Cardiac Rehabilitation among Individuals Recovering from Transcatheter Aortic Valve Replacement

University of Colorado Hospital

Rehabbing with Peloton (RWP) is an 8-week intervention beginning immediately upon referral to cardiac rehabilitation (CR), designed to be initiated while patients are placed on CR waitlists. Transcatheter aortic valve replacement (TAVR) recipients engage with Peloton walking, strength, and...

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Feasibility Pilot Study: Adding a Sleep Health Intervention to a Behavioral Weight Loss Intervention

Anschutz Health and Wellness, Outpatient CTRC, University of Colorado Hospital

A 6-month behavioral weight loss (BWL) + sleep health (SLEEP) intervention . This will use a skills-based approach and cognitive behavioral strategies for lifestyle modification with a dietary focus on daily caloric restriction and increased physical activity. Group classes will be taugh...

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

CTRC Inpatient, University of Colorado Hospital

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommen...

Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Protocol 10608, "A phase II trial of durvalumab with gemcitabine and cisplatin as neoadjuvant therapy for high-risk resectable intrahepatic cholangiocarcinoma" (NCT TBD)

University of Colorado Hospital

PRIMARY OBJECTIVE: I. To examine the proportion of patients who complete neoadjuvant therapy followed by curative intent surgical resection. SECONDARY OBJECTIVES: I. To determine the major pathologic response (MPR) rate. (Efficacy) II. To determine the proportion of patients who a...

Protocol S1900K, "A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"

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

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a...

Cancer Care Delivery for Undocumented Individuals across the United States: Perspectives of Frontline Healthcare Providers

Department Specific Free Standing Clinic, University of Colorado Hospital

CLEAN-PE: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism

Outpatient CTRC, University of Colorado Hospital

Prospective, single-arm, multicenter study. Approximately 125 subjects will be screened for 105 enrolled at up to 15 investigational sites in the United States....

A Phase 1b study of Psilocybin Assisted Psychotherapy to address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission

Outpatient CTRC, University of Colorado Hospital

A study conducted to determine if a single dose of 25 mg. of psilocybin, in combination with therapy, will address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission...

S2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer,

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Outpatient CTRC, University of Colorado Hospital

Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Ni...

Prospective Clinical Assessment Study in Children with Hypochondroplasia: ACCEL

Childrens Hospital Colorado

This is a prospective, non-interventional clinical assessment study to collect data on children aged 2.5 to <17 years with HCH, which will contribute to the characterization of the natural history of children with HCH. This study is designed to evaluate study participants over a period of...

An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily A Member 4 (ABCA4) Gene (POLARIS)

University of Colorado Hospital

This is a prospective, observational, non-interventional, multi-center, global clinical study of subjects with early to advanced stage STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene, confirmed genotypically by an accredited genotyping laboratory. T...

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Outpatient CTRC, Renal Research Center, University of Colorado Hospital

Access to the investigational medication (ravulizumab) will be available to participants following the double-blinded portion of the trial. ...

Achondroplasia Biobank

Childrens Hospital Colorado

Collecting a biological sample such as blood, saliva and/or buccal swab from the patients with achondroplasia and their family members...

Molecular Analysis for Combination Therapy Choice (ComboMATCH) Protocol EAY191-A3, A ComboMATCH Treatment Trial: Palbociclib and Binimetinib in RAS-Mutant Cancers (NCT05554367)

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Outpatient CTRC, Poudre Valley Hospital, University of Colorado Hospital

A multicenter, observational study to evaluate corneal neurosensory abnormalities in patients with Sjögren's dry eye

University of Colorado Hospital

This clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who present with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity....

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Childrens Hospital Colorado, Denver Health and Hospital Authority

Longitudinal studies are needed to identify early contributors to insulin resistance and β-cell dysfunction in youth with obesity, and to explore the interrelationships between the transition through puberty and the evolution of dysglycemia, particularly in the context of psychosocial fact...

Lotus Study: Research about bone health with progestin-only birth control pill, Slynd

Comprehensive Women's Health Center, Outpatient CTRC, University of Colorado Hospital

Slynd is an FDA-approved birth control that is 98% effective at preventing pregnancy when taken correctly. Some birth control can affect bone mineral density (the amount of calcium and other minerals in your bones). Because of this, the company that makes Slynd, Exeltis, is researching t...

ACCL1931 - A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Childrens Hospital Colorado

IDE196 (DAROVASERTIB) IN COMBINATION WITH CRIZOTINIB VERSUS INVESTIGATOR'S CHOICE OF TREATMENT AS FIRST-LINE THERAPY IN HLA-A2 NEGATIVE METASTATIC UVEAL MELANOMA (DAR-UM-2)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about if the investigational drug called IDE196 (also called darovasertib) in combination with crizotinib is safe and effective in people who have a cancer in their eye, called uveal melanoma, which has now spread (metastasized) to another part of your body...

Protocol NRG-BR009, A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score less than or equal to 25 (OFSET)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (pegloticase) Administered Every 4 Weeks Compared with KRYSTEXXA Administered Every 2 Weeks with Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants with Uncontrolled Refractory Gout (FORWARD II)

Barbara Davis Center, University of Colorado Hospital

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout...

EA8211: A Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVES: I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy (SABR+ST) versus systemic therapy (ST) only. II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm. SECONDARY OBJECTIVES: I. To compare globa...

A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

University of Colorado Hospital

PRIMARY OBJECTIVES: I. To determine the safety and tolerability and recommended phase 2 dose (RP2D) of peposertib (M3814) in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. (Phase I) II. To determine the efficacy of the combina...

A Phase 1, Safety Lead-In and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination with Pembrolizumab in Subjects with Recurrent or Progressive IDH-1 Mutant Glioma

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be eval...

Point of Care Spirometry - A prospective comparison vs. laboratory spirometry for children with early onset scoliosis

Childrens Hospital Colorado

Spirometry will be performed in the clinic and lab...

Airway Progenitor Dysfunction During Early COPD

Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Northfield Medical Center, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

You may be eligible for the APD Research Study, which is designed to identify objective measurements (known as biomarkers) of COPD at its earliest stages. These biomarkers can help identify individuals most susceptible to COPD and explore new treatments to address the underlying causes of ...

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital

Protocol EA2222 - A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

University of Colorado Hospital

PRIMARY OBJECTIVE: I. To determine if patients with persistently unresectable colorectal liver metastases (CRLM) after treatment with first-line chemotherapy have improved overall survival (OS) with hepatic arterial infusion (HAI) and systemic chemotherapy versus systemic chemotherapy a...

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis

Outpatient CTRC, University of Colorado Hospital

A phase three study to evaluate the safety and tolerability of MK-7240 for patients who have moderate to severely active ulcerative colitis (UC). ...

Postoperative Utilization of Incentive Spirometry with and without Electronic Patient Reminders

University of Colorado Hospital

All eligible patients arriving to the PACU every day will be provided with a Vyaire Medical's AirLife volumetric incentive spirometer and instructions to perform 3 IS breaths every 20 minutes until discharge from PACU. The IS device will be set up with the breath volume considered adequate...

A Phase 1 study evaluating SC291, a hypoimmune, allogeneic CD19-directed CAR T cell therapy, in subjects with severe relapsed or refractory autoimmune diseases (GLEAM)

Outpatient CTRC, Renal Research Center, University of Colorado Hospital

Screening and tapering of current immunosuppression therapy for up to 30 days; treatment with lymphodepleting therapy for 3 days followed by one treatment, via infusion, of SC291. Follow-up will be for at least one year. ...

AALL2121: A Phase 2 Study of Revumenib (SNDX-5613) in Combination with Chemotherapy for Patients with Relapsed or Refractory KMT2A-Rearranged infant Leukemia

Childrens Hospital Colorado

A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia...

Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (tocilizumab) for the treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

Childrens Hospital Colorado

Protocol S2210, "A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Localized Prostate Cancer with Germline BRCA1/2 Mutations," NCT# 05806515

Lone Tree Medical Center, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents. SECONDARY OBJECTIVE...

A PHASE IV OPEN-LABEL STUDY EVALUATING THE EFFECTIVENESS AND SAFETY OF RISDIPLAM ADMINISTERED AS AN EARLY INTERVENTION IN PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY AFTER GENE THERAPY

Childrens Hospital Colorado

This is a Phase IV, open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam (Evrysdi®) administered as an early intervention in pediatric patients with SMA who previously received onasemnogene abeparvovec. Patients to be enrolled are chil...

A PHASE IV OPEN-LABEL STUDY EVALUATING THE EFFECTIVENESS AND SAFETY OF RISDIPLAM ADMINISTERED IN PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY WHO EXPERIENCED A PLATEAU OR DECLINE IN FUNCTION AFTER GENE THERAPY

Childrens Hospital Colorado

This is a Phase IV, open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam (Evrysdi®) administered in pediatric patients with SMA who previously received onasemnogene abeparvovec and experience a plateau or decline in function. Patients t...

AN OPEN-LABEL, NONRANDOMIZED, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PEGCETACOPLAN IN PARTICIPANTS WITH C3 GLOMERULOPATHY OR IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS

Childrens Hospital Colorado

An Open-Label, nonrandomized, extension study to evaluate long-term safety and efficacy of pegcetacoplan in patients with C3G or IC-MPGN...

Debio 4326-301: An open-label, single-arm, multi-center, Phase 3 study on the efficacy, safety, and pharmacokinetics of Debio 4326, a triptorelin 12-month formulation, in pediatric participants who are receiving gonadotropin-releasing hormone agonist therapy for central precocious puberty

Childrens Hospital Colorado

Interventional...

The time course of the therapeutic influence of a single exercise bout on cancer-related fatigue

Harmony Campus

This study plans to learn more about cancer related fatigue changes from before to immediately after a single exercise session. In addition, we want to assess the changes in fatigue levels following a single exercise session at various time intervals over the course of a day. Finally, we w...

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT...

A Study Evaluating an Intermittent Fasting Intervention in Adults with Breast Cancer and Overweight or Obesity

Anschutz Health and Wellness, Outpatient CTRC, University of Colorado Hospital

If you decide to participate in the study, you will be on an intermittent fasting diet three days per week to reduce what you are eating for 6 months. On the intermittent fasting diet days, you will only eat about 500 calories per day. On the other four non-fasting diet days per week, you ...

Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

CTRC Inpatient, University of Colorado Hospital

Part 1 of this study plans to learn more about: To find the recommended dose of the study drug, BI 1831169, that can be used in Part 2 of this study. This will be done by testing different doses of the study drug to see which dose has less unacceptable side effects in subjects with soli...

BEGIN Substudy: Continuous Glucose Monitoring in Healthy Children

Childrens Hospital Colorado

This data is being collected as a sub-study of a larger study, which is looking at blood sugars in children with Cystic Fibrosis (CF). A device called a continuous glucose monitor (CGM) will be used to collect data for this study. The device brand is the Dexcom G6 and it is an FDA-approv...

An open-label phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors

University of Colorado Hospital

This study plans to learn more about the investigational drug PF-0804650 to find out what its side effects are and if it works for solid tumor cancer. A side effect is anything the drug does to your body besides treating your disease. If you have side effects, your study doctor may prescr...

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

CTRC Inpatient, University of Colorado Hospital

You are being asked to be in this research study because you are an adult with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye. This study plans to...

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

CTRC Inpatient, University of Colorado Hospital

A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Patients With Solid Malignancies

CTRC Inpatient, University of Colorado Hospital

BfedBwell: A Nutrition Program for Cancer Survivors with Overweight or Obesity

Anschutz Health and Wellness, Outpatient CTRC

If you decide to be in the study, you will participate in the BfedBwell survivorship nutrition program for 6 months. The BfedBwell program has group education sessions and none, some, or all of the following: group support sessions, cooking demonstrations, and/or 1-on-1 counseling with a d...

Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias

Department Specific Free Standing Clinic, University of Colorado Hospital

CU OB-Gyn providers are committed to addressing racial inequities in healthcare. We invite patients, advocates and members of the community who identify as Black, African American, African, Afro-Latinx or Afro-Caribbean to share your experiences and feedback, especially those that have rec...

Protocol CCTG-NE.1 "NET RETREAT: A phase II study of 177Lutetium-DOTATATE retreatment vs. everolimus in metastatic/unresectable midgut NET"

University of Colorado Hospital

PRIMARY OBJECTIVE: I. To evaluate the effect of lutetium Lu 177 dotatate (177Lu-DOTATATE) versus (vs.) everolimus on progression-free survival (PFS) in patients with metastatic/unresectable midgut neuroendocrine tumour (NET) who have progressed following previous peptide receptor radion...

A Phase 1/2, First in Human, Multiple-dose, 2-part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NS-050/NCNP-03 in Boys with Duchenne Muscular Dystrophy (DMD)

Childrens Hospital Colorado

This is a Phase 1/2, first in human, multicenter, two-part study of MAD levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD mutation amenable to exon 50 sk...

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Memorial Hospital Central, Memorial Hospital North

Prospective, Multicentric Registry of Pulmonary AVM Embolization

University of Colorado Hospital

Patients with hereditary hemorrhagic telangiectasias (both pediatric and adults) will be enrolled in this study. A total of 90 patients will be enrolled across 5 sites and over 60 months. The sample size was calculated based on the number of PAVM embolization performed at Johns Hopkins ty...

The Balanced and Empowered EaTing (BEET) in Diabetes Feasibility Trial

Outpatient CTRC, University of Colorado Hospital

The study is currently recruiting integrated behavioral health providers in clinical settings with patients with type 2 diabetes. Once integrated behavioral health providers are recruited, they will be randomized and trained to deliver and test the implementation of one of two behavior cha...

Study of cladribine+venetoclax after failure of venetoclax+hypomethylating agent in monocytic AML

University of Colorado Hospital

The Effects of Hemp-Derived CBD on the Neural Basis of Cannabis-Cue and Emotion Related Processing

Brain Imaging Center (BIC) - Scan Read, Outpatient CTRC

We will recruit young adults (ages 18-25). Participants will be selected to achieve a diverse gender and ethnic sample, with roughly balanced male/female participation We will enroll up to 75 participants to achieve a sample size of ~52 participants with usable data. ...

A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)

Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults with Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a randomized, open-label, cross-over trial

Childrens Hospital Colorado

This research is being done to better understand Cystic-Fibrosis Related Diabetes (CFRD) and to see the effects of GLP-1 (dulaglutide) in individuals with abnormal glucose tolerance. GLP-1 (dulaglutide) helps the pancreas release insulin, which controls blood sugar levels from getting too...

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

SNDX-5613-0707: Expanded Access Program for SNDX-5613 in Patients with Relapsed/Refractory Acute Leukemias with Genetic Alterations Associated with HOXA Overexpression

Outpatient CTRC, University of Colorado Hospital

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

You are being asked to be in this research study because you have metastatic castration-resistant prostate cancer (mCRPC). This study plans to learn more about whether JNJ-87189401 given in combination with JNJ78278343 in patients with mCRPC can cause side effects, and to find doses of th...

A 52-week randomized, double-blind, placebocontrolled, multi-center Phase 2b study with a 52-week blinded extension assessing safety and efficacy of frexalimab, a CD40Lantagonist monoclonal antibody, for preservation of pancreatic β-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy

Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

DRI17476 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, efficacy, and tolerability of frexalimab in participants with newly diagnosed T1D on insulin therapy: adults (18-35 y.o.)...

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

University of Colorado Hospital

A First-in-Human Phase I Study of ATG-031 in Patients with Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Exploring headaches in pediatric neuro-oncology patients and provider comfort in management

Childrens Hospital Colorado

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

CTRC Inpatient, Highlands Ranch Hospital, University of Colorado Hospital

Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to r...

EMERALD-Y90: Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy

University of Colorado Hospital

A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant. Participants with previous Transarterial Chemoemboliza...

Accelerating Medicines Partnership: Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis

Barbara Davis Center, University of Colorado Hospital

If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove...

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Childrens Hospital Colorado

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)...

A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate long-term safety of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) under normal routine practice (REAL 7)

University of Colorado Hospital

We are doing this study to collect information about how safe and effective Sogroya (somapacitan) is, when used for treatment of people with Adult Growth Hormone Deficiency (AGHD). This study has a special focus on neoplasms and diabetes mellitus type 2. Sogroya (somapacitan), which is p...

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects with Leiomyosarcoma (ARGSARC): A Randomized, Double-Blind, Multi-Center Phase 3 Trial

University of Colorado Hospital

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline....

Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults with Prediabetes

Anschutz Health and Wellness, Outpatient CTRC

Baseline (no exercise) will be performed first with testing done on the fourth day of this condition. Testing will include a full day at the Anschutz Health Science Building Clinical and Translational Research Core clinic and will involve direct measurements of insulin action on the body, ...

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital

Cardiometabolic consequences of the loss of ovarian function (LILAC Study)

Outpatient CTRC, University of Colorado Hospital

We are inviting premenopausal women (women with regular menstrual periods) to participate in a study looking at the effects of estrogen and menopause on body composition and vascular function. ...

Protocol NRG-LU008, "Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer"

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

PRIMARY OBJECTIVES: I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (arm 1) or after image guided, motion-...

TEMPUS SCLC OBSERVATIONAL STUDY: A Tissue and Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients with Small Cell Lung Cancer (SCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays

Lone Tree Medical Center, University of Colorado Hospital

The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance....

A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

Outpatient CTRC

This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl...

A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)

CTRC Inpatient, University of Colorado Hospital

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Protocol EAY191 Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital

The study is looking for 200 adults diagnosed with T2D within the last 12 months. CU will enroll 100 of those participants. Participants will be assigned to one of two groups. The first group will receive individualized routine care. The second group will receive individualized routine car...

Protocol A012103, "OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy"

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

The ROSIE Study

Outpatient CTRC, University of Colorado Hospital

Two, in-person visits between 1-2 hours over approximately a 3-month period....

A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Barbara Davis Center, University of Colorado Hospital

This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec...

Efficacy and mechanisms of dapagliflozin in promoting kidney function and cardiovascular health in kidney transplant recipients

Renal Research Center, University of Colorado Hospital

Main procedures done in the study: - Physical exam and medical history - Blood draw - Blood pressure - Blood vessel function testing - Urine collection - Kidney function measures - Kidney and cardiac MRI You will take study drug daily for 12 months You will have approximately ...

A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients with MGMT Unmethylated Glioblastoma

University of Colorado Hospital

Protocol S1900G, "A Randomized Phase II Study of Capmatinib plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"

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

This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (adv...

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer

CTRC Inpatient, University of Colorado Hospital

Alliance Protocol A212102, "Blinded Reference Set for Multicancer Early Detection Blood Tests

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital, Yampa Valley Medical Center

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Highlands Ranch Hospital, University of Colorado Hospital

This study plans to learn more about if an investigational drug called zanzalintinib (XL092) in combination with nivolumab is effective in treating unresectable, locally advanced, or metastatic non-clear cell renal cell carcinoma compared with sunitinib alone among patients who have neve...

S2302, PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

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

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal an...

Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study

Outpatient CTRC, University of Colorado Hospital

Study participation will include 4 visits over about 5 weeks, with an on-campus screening visit and three home-based visits in our mobile pharmacology lab, a specially equipped van. Participation will involve taking cannabidiol (CBD) or a placebo....

Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

Brain Imaging Center (BIC), Brain Imaging Center (BIC) - Scan Read, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

This study plans to investigate if taking a protein nutrition supplement (EAA) for 8 weeks may reduce fat that is stored in the liver. This will be compared to 8 weeks of placebo (a “fake” supplement that does not contain protein). Participants will be assigned randomly either the protein ...

NRG-BR008, "A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

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

The landmark trials that established breast conservation therapy (BCT) (breast-conserving surgery followed by adjuvant breast irradiation) as a suitable alternative to mastectomy were conducted in an era that predated biological subtyping of breast cancer and the use of HER2-directed thera...

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

Barbara Davis Center, Childrens Hospital Colorado

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype...

Validation of Instruments Measuring Caregiver Experiences (Caregiver VOICE Study)

Lone Tree Medical Center, University of Colorado Hospital

Attention, Dementia Caregiving Dementia caregivers have important roles in supporting someone with Dementia. We are interested in hearing the voices of those caregivers. Participation in this telephone based study will take approx. 30-45 minutes. We are interested in your perspective o...

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN) (G0102598)

Childrens Hospital Colorado, University of Colorado Hospital

Assess efficacy and safety of iptacopan compared to placebo and standard of care in adults and adolescents (12-17) with IC-MPGN in native Kidneys...

A Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover Phase 1/2a Study to Test the Safety and Efficacy of Advair HFA (Salmeterol and Fluticasone) in Resting and Exercising Healthy and High Altitude Pulmonary Edema (HAPE) Predisposed Subjects

CTRC Inpatient, Outpatient CTRC

The study involves two separate study periods of 12 days each, where you will: • Take the study drug or placebo through a puffer for 7 days. You will not know which drug you are taking during which period • Wear a continuous heart monitor for 12 days • Have blood tests drawn during 5 vi...

A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

ASCT2031: A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Childrens Hospital Colorado

Matched Unrelated Donor (MUD) versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)...

A Phase 1A/B Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours

CTRC Inpatient, University of Colorado Hospital

ELACESTRANT in Women and Men with CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)

University of Colorado Hospital

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients with Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Study participants will undergo testing to identify patterns of right ventricular dysfunction. If a study participant decides to participate in exercise training, the participant will complete an optional Part 2 of the study. Optional Part 2 includes an exercise training intervention follo...

Study of the Association between Cellular Processes in the Lung & Blood and Patient Health in Individuals with Rheumatoid Arthritis with and without Evidence of Interstitial Lung Disease

Barbara Davis Center, University of Colorado Hospital

This study involves blood tests, sputum collection, physical exams, and questionnaires; it may also involve pulmonary function tests (PFTs) and a high-resolution computed tomography (HRCT) scan of your lungs. PFTs involve breathing into a tube to determine any lung abnormalities while HRCT...

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of BION-1301 in Adults with IgA Nephropathy

Renal Research Center

The medication is taken by injection every 2 weeks for two years. ...

Protocol 10483: Phase Ib trial of Erdafitinib combined with Enfortumab Vedotin following platinum and PD1/L1 inhibitors for metastatic urothelial carcinoma with FGFR2/3 genetic alterations

University of Colorado Hospital

PRIMARY OBJECTIVES: I. To determine the feasibility and safety of erdafitinib when combined with enfortumab vedotin (EV) for patients with metastatic urothelial carcinoma (mUC) harboring FGFR2/3 activating genomic alterations who are progressing following platinum-based chemotherapy and...

Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ Dysfunction

University of Colorado Hospital

Blood draws will be completed at baseline, 6-24 hours after arrival, and then daily through study day 7 to evaluate fibrinogen levels and response to trauma....

Genetic Engagement, Education, and Screening (CU-GENES) Study

Department Specific Free Standing Clinic, University of Colorado Hospital

This study plans to implement a community-based genetic testing program for hereditary cancer risk in a higher risk population. The study team will partner with the Colorado Ovarian Cancer Alliance (COCA) and the Jewish Community Center (JCC) to provide educational events to the Jewish com...

Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator's Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior s...

A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)

CTRC Inpatient, University of Colorado Hospital

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with associated Inferior vena cava tumor thrombus (NEOPAX)

University of Colorado Hospital

The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can decrease the IVC TT burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patie...

TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes

Barbara Davis Center, University of Colorado Hospital

This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. We are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with docu...

Assessing accuracy and precision of home quantitative urine beta hCG with serum for pregnancy of unknown location (CONNECT).

University of Colorado Hospital

The current management of patients with PUL involves multiple trips to the clinic and/or hospital for blood draws and close monitoring of their pregnancy. Specifically, doctors are monitoring levels of a hormone called human Chorionic Gonadotropin (hCG). The hCG can be detected in blood ...

ACNS1821- A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Childrens Hospital Colorado

Randomized, controlled trial of Rybelsus (semaglutide) among adults with AUD

Outpatient CTRC, University of Colorado Hospital

You will be randomly assigned to one of two groups. You will have a 50% (1 in 2) chance of receiving semaglutide and a 50% chance of receiving placebo. This is a double-blind study, which means neither you nor the study investigator will make the choice to which group you are assigned, an...

A212102: Blinded Reference Set for Multicancer Early Detection Blood Tests

Rocky Mountain Regional VA Medical Center

MEASURE: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events

CTRC Inpatient, University of Colorado Hospital

S2302: PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Rocky Mountain Regional VA Medical Center

Phase 1 study of venetoclax/azacitidine or venetoclax in combination with ziftomenib (KO-539) or standard induction cytarabine/daunorubicin (7+3) chemotherapy in combination with ziftomenib for the treatment of patients with acute myeloid leukemia

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Development and Validation of an Ancillary Diagnostic Test for Mycosis Fungoides (SIGNAL-MF)

Department Specific Free Standing Clinic, University of Colorado Hospital

Castle Biosciences, Incorporated (CSTL) recently developed and validated a 35-GEP test to aid in the diagnosis of difficult- to-diagnose primary cutaneous melanocytic neoplasms and to improve accuracy when used in combination with currently applied diagnostic tools. Ambiguous lesions repre...

First-in-Human Study of STX-478, a Mutant Selective PI3K alpha Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor

CTRC Inpatient, University of Colorado Hospital

Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET)

University of Colorado Hospital

EA8212, "A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)"

University of Colorado Hospital

The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bla...

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma

University of Colorado Hospital

PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER

Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Short-Term Effects of Equol (Soy metabolite) Supplementation on Blood Vessel Function in Postmenopausal Women with and without Chronic Kidney Disease

Renal Research Center, University of Colorado Hospital

-One screening visit (1.5 hours) and two testing visits (each 5 hours) -Testing visits will include a blood draw and non-invasive testing of blood vessel function -All visits will take place at CU Anschutz As a volunteer, you will receive the following information about your health: ...

A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients with Relapsed or Refractory Non-Hodgkin Lymphoma (NHL [APOLLO])

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

A 36-week, single-arm, open-label study to evaluate the safety and tolerability of ferric citrate in children with hyperphosphatemia related to chronic kidney disease.

Childrens Hospital Colorado

A single arm trial evaluating efficacy of ferric citrate over 36 weeks in pediatric patients with hyperphosphatemia related to CKD....

Boomerang Early Feasibility Study: Prospective, multi-center, single-arm early feasibility study (EFS)

Outpatient CTRC, University of Colorado Hospital

Researchers in the BOOM-IBD Clinical Trial are studying whether nerve stimulation can be effective in treating patients with Crohn's disease and ulcerative colitis....

PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life - The PROMISE Study

Barbara Davis Center, University of Colorado Hospital

The environment during pregnancy may contribute to the risk of islet autoimmunity (IA) in the baby. Having IA increases the risk of type 1 diabetes (T1D) in the child. Illnesses such as viruses could contribute to IA and T1D risk. Pregnancy history may also influence IA and T1D risk. Ha...

A Phase 1 / 2, Open Label, Study of Amivantamab (JNJ-61186372) Among Participants with Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination with Tyrosine Kinase Inhibitors

New York University, Outpatient CTRC, University of Colorado Hospital, University of Michigan, University of Michigan Comprehensive Cancer Center

Although non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK), c-ros oncogene 1(ROS1), and ret proto-oncogene (RET) gene fusions initially respond well to tyrosine kinase inhibitor (TKI) therapies, acquired resistance is inevitable. In many of these cases, incr...

Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy

Outpatient CTRC

We are recruiting individuals with or without prostate cancer to participate in a research study to help us understand how androgen deprivation therapy affects cardiovascular health. Men with prostate cancer will be studied at the start and after 2 months of androgen deprivation therapy. H...

Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase

University of Colorado Hospital

This study involves interviews with couples facing metastatic colorectal cancer to learn about their experiences and challenges in coping with this disease.  From what we learn, we will develop a mindfulness program for couples to lower their stress and help them cope better. ...

4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults

Department Specific Free Standing Clinic

A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX®

Rocky Mountain Regional VA Medical Center

S2101: Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Rocky Mountain Regional VA Medical Center

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic

Memorial Hospital Central, Memorial Hospital North

FORTE: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Rocky Mountain Regional VA Medical Center

A 2-part Phase 2 Study of Safety, Pharmacokinetics and Biomarkers in Children with Duchenne Muscular Dystrophy including a Randomized, Double-Blind, Placebo-Controlled Part A, Followed by an Open-Label Part B

Childrens Hospital Colorado

This is a 2-part multi-center, Phase 2 study to evaluate the effect of EDG-5506 on safety, PK and biomarkers of muscle damage in approximately 27 children with DMD treated with oral, once daily EDG-5506 for 12 months. Part A will include a 12-week, randomized, double-blind, placebo-contr...

DEFIANCE: ClotTriever vs. Anticoagulation for DVT

Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservativ...

Phase II Open Label Multicenter Study of Early REinFusion of Tisagenlecleucel to Promote Durable B-CEll ApLasia in Pediatric and Young Adult Patients with Relapsed/Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia (REFUEL)

Childrens Hospital Colorado

The primary objective of this phase 2 trial is to decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-...

Menstrual profiles and cardiovascular disease risk among female adolescent athletes with and without menstrual irregularities

Childrens Hospital Colorado, Department Specific Free Standing Clinic, Outpatient CTRC

Participants will undergo a bone scan, 15 minutes of metabolic testing, and blood draw to assess markers of cardiovascular disease as well as hormone levels. ...

Mothers Optimizing Resources Everyday (MORE)

University of Colorado Hospital

This study plans to learn more about perinatal mood disorders and sources of support for pregnant and postpartum individuals. Personal and social resources can help individuals cope with the demands associated with the transition to motherhood. Interventions that support personal resources...

Effects of psilocybin with psychological support on anhedonia in treatment-resistant depression

Brain Imaging Center (BIC), Outpatient CTRC

Participants will be randomly assigned to receive either active psilocybin or placebo. Participation in the study will last a minimum of 13 weeks, up to a maximum of 26 weeks. The study will involve completion of a physical exam, blood draw, two MRI scans, surveys and psychological assessm...

Urinary Hormones (uHoWL) Research Study

Anschutz Health and Wellness, Outpatient CTRC

Are you interested in a research study on women's reproductive hormones? We are conducting a study among women aged 18-40 years old who have regular menstrual cycles, are not using hormonal birth control, and have a body mass index between 27-45 kg/m2. ...

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

NRG-BN011, A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital

NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IB-III NON-SMALL CELL LUNG CANCER

Outpatient CTRC, University of Colorado Hospital

This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria....

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

CTRC Inpatient, University of Colorado Hospital

The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) an...

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease

Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital

Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ...

A Phase II Study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer

Outpatient CTRC, University of Colorado Hospital

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

NRG-CC005. FORTE: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Cherry Creek Medical Center, University of Colorado Hospital

A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as...

A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

CTRC Inpatient, University of Colorado Hospital

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

CU Sports Medicine - Denver, Department Specific Free Standing Clinic, UCHealth Central Park Medical Center

During this study, we will enroll n=48 total subjects who have recently sustained an mTBI. Subjects will be randomized to one of two study groups, followed throughout the duration of the 8-week vNDT intervention period, returned for post-intervention period testing, and then followed via m...

A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy

Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6- C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopat...

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Effects of THC on Alcohol Consumption and Brain Function

Brain Imaging Center (BIC), Outpatient CTRC

Alcohol and cannabis are often used together such that their effects overlap. Cannabis edibles (which may contain large doses of THC) have not been well-studied in the laboratory, and it is unclear how such products may impact alcohol consumption patterns. This study will test the effects ...

Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***

Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital

This multi-center trial will enroll 200 participants across two sites. During the randomized, controlled phase of the study, participants will receive either a single 25mg oral ‘high’ dose of psilocybin or an active placebo (100mg niacin), alongside psychotherapy. During the open-label ...

A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-Cell Acute Lymphoblastic Leukemia (IDEAL2)

Childrens Hospital Colorado

Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men

Outpatient CTRC, University of Colorado Hospital

The aim of this study is to determine whether intestinal barrier dysfunction is higher in HIV+ MSM with MS compared to without MS and related to deficiency in butyrate-production and/or activity of mucolytic bacteria in the gut microbiome....

The Child Bipolar Disorder Network (CBN): A Collaborative Treatment Study of Youth With or at High Risk for Bipolar Disorder

Department Specific Free Standing Clinic, Johnson Depression Center, Outpatient CTRC

Does your child have symptoms of bipolar disorder? We are looking for children, teens, and young adults (ages 9 to 21 years) who have moods that alternate between depression and periods of excessive energy and activity for this study. Participants will get a full diagnostic evaluation fro...

S2013: IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY

Rocky Mountain Regional VA Medical Center

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Comparison of Methods In Post Operative Knee Arthroscopy Rehabilitation

CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness)

1:1 randomized clinical trial following post-op ACL patients during their recovery...

NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)

Cherry Creek Medical Center, 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

Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with seri...

S1937: A PHASE III RANDOMIZED TRIAL OF ERIBULIN (NSC #707389) WITH OR WITHOUT GEMCITABINE VERSUS STANDARD OF CARE (PHYSICIAN'S CHOICE) FOR TREATMENT OF METASTATIC UROTHELIAL CARCINOMA REFRACTORY TO, OR INELIGIBLE FOR, ANTI PD1/PDL1 THERAPY

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVES: I. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine). SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) ...

Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients with Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Childrens Hospital Colorado

This Phase I trial aims to determine the safety and tolerability of bispecific CD19x22 CAR T cell administration after lymphodepleting chemotherapy in pediatric patients with R/R B-ALL....

GD2-CAR PERSIST: Production and Engineering of GD2-Targeted, Receptor Modified T Cells (GD2CART) for Osteosarcoma or Neuroblastoma to Increase Systemic Tumor Exposure

Childrens Hospital Colorado

The Nephrotic Syndrome Study Network (NEPTUNE)

Childrens Hospital Colorado, Renal Research Center, University of Colorado Hospital

Collection of blood, urine and tissue (optional)...

Cannabis Teens and Choice Study (CATCH Study)

Outpatient CTRC

We are currently seeking participants ages 14-21 for a two visit (one remote, one on campus) study at CU Anschutz. The purpose of this research is to better understand the effects of substance use on decision making and biologic-systems in adolescents. Compensation is provided. ...

Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

Renal Research Center, University of Colorado Hospital

A double-blind, placebo-controlled trial of investigational agent combined with MMF....

A PHASE 1 MULTICENTER STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GCC19CART IN SUBJECTS WITH RELAPSED OR REFRACTORY METASTATIC COLORECTAL CANCER (CARAPIA-1 Study)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about an investigational drug, GCC19CART. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). This research study is a Phase I clinical trial, which tests the safety of an investigational drug an...

Lipids to Energy (LTE) Research Study

Outpatient CTRC

The Lipids to Energy (LTE) study at the University of Colorado – AMC is recruiting males aged 15-30 years old with or without a diagnosis of Klinefelter Syndrome (KS). Research study participation starts with a 2.5-3 hour screening visit that includes a blood draw, physical exam, DXA bo...

A Pilot Study of Safety, Tolerability, and Immunological Effects of SurVaxM in Pediatric Patients with Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Childrens Hospital Colorado

An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

University of Colorado Hospital

The short-chain fatty acid acetate for improving age-associated arterial dysfunction

Anschutz Health and Wellness, Department Specific Free Standing Clinic

If you join this study, you will participate in Screening, Baseline, Study Period, and End of Study visits over a ~4-month period. These visits will take about 14 hours of your time total. The study visits will take place at the Division of Renal Diseases and Hypertension Clinical Resear...

PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER

CTRC Inpatient, Department Specific Free Standing Clinic, LSU Health Sciences Center, Mt. Sinai Comprehensive Cancer Center, University of Colorado Hospital, USD Moores Cancer Center, UW Carbone Cancer Center

(PEAK) A PHASE 3 RANDOMIZED, OPEN-LABEL, MULTICENTER CLINICAL STUDY OF CGT9486+SUNITINIB VS SUNITINIB IN SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC GASTROINTESTINAL STROMAL TUMORS

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about an investigational drug called bezuclastinib (also known as CGT9486) in combination with sunitinib. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). The purpose of this part of the resear...

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

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

PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivatio...

GALAXY: Generating Advancements through Longitudinal Analysis in X and Y Syndromes

Childrens Hospital Colorado, Outpatient CTRC

Participants who join the GALAXY Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. If participants are seen outside of Children’s Colorado, they can sign a Releas...

Understanding How Sleep Health Affects Recovery from Adolescent Concussion

Boulder Health Center, Childrens Hospital Colorado

We will conduct a prospective cohort study, with two groups (concussed and control). They will undergo an initial assessment (within 14 days of concussion) and a follow up ~28 days post-concussion. Controls will follow a similar timeline. During the ~two-week period between Visits 1 & 2, p...

A PHASE I AND EXPANSION COHORT STUDY OF SELINEXOR AND VENETOCLAX IN COMBINATION WITH CHEMOTHERAPY IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

Childrens Hospital Colorado

Feasibility of VR Programs for Anxiety Related Disorders in an Outpatient Care Setting

Department Specific Free Standing Clinic

For this project, semi-structured interviews will be conducted with up to 10 providers specializing in mental health care for adolescents and up to 20 adolescents, ages 14-18, with mild to moderate social anxiety symptoms. Adolescent interviews will focus on using the VR program and provi...

Reducing Pain and Opioid Use with CBD

Outpatient CTRC, Outpatient CTRC

Your participation in the research study will be 16 weeks, with 12 weeks of study medication use....

EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

University of Colorado Hospital

NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

Breast conservation therapy for early stage breast cancer has been an important achievement of oncology practice in the last half century and breast radiotherapy (RT) has been essential in its development. Several seminal randomized clinical trials conducted in the 1980's era demonstrated ...

An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or r...

A Phase II study of induction SBRT and olaparib followed by combination pembrolizumab/olaparib in gastric and gastroesophageal junction (GEJ) cancers

Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

PRIMARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of objective response rate (ORR) SECONDARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of overall survival (OS), progression free survival (PFS), duratio...

A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 as monotherapy and in combination with bevacizumab in adult subjects with advanced solid tumors

CTRC Inpatient, University of Colorado Hospital

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study wil...

EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea catechins (GTCs) or placebo for 6 mon...

A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

CTRC Inpatient, University of Colorado Hospital

Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease B...

Comparison of Methods in Post-Operative Hip Arthroscopy Rehabilitation

UCHealth Steadman Hawkins Clinic - Denver (Inverness)

Inquire within...

Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA

University of Colorado Hospital

In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d...

LIMA: LIPID ANTI-FLAMMATORY MEDIATORS IN ASTHMA TO REDUCE HYPERRESONSIVENESS IN OBESE ASTHMATICS

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

The research plan is designed to test the beneficial metabolic and anti-inflammatory actions of an endogenously present class of modified fats, termed nitro-fatty acids. This project provides a novel precision pharmacology therapy, oral CXA-10, for the treatment of obese asthma, a disease ...

A prospective, randomized, multi-center evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM compared to iStent Inject W® in Patients with Open-Angle Glaucoma

University of Colorado Hospital

The STREAMLINE® Surgical System consists of a surgical grade stainless steel disposable cannula (hollow tube) and a manual handset. The stainless steel cannula (hollow tube) is placed along the drainage duct of the eye (also called the trabecular meshwork) and a button is pressed that acti...

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease

Renal Research Center

Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu...

PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Childrens Hospital Colorado

For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os...

ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

Childrens Hospital Colorado

ANHL1931- A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Childrens Hospital Colorado

A Phase 1/2, dose escalation, dose expansion, and dose optimization study of the safety, tolerability, and anti-tumor activity of SAR444881 administered alone and in combination with pembrolizumab, cetuximab, and/or chemotherapy in participants with advanced solid tumors

University of Colorado Hospital

Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease

Childrens Hospital Colorado

Understanding the impact of gaps in care on healthcare utilization, long-term co-morbidities, and patient reported outcomes are the highest priority topics from patients, families and researchers. Additionally, knowledge about the factors associated with these gaps in care was a key facto...

An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

University of Colorado Hospital

In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts: Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy; Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chem...

EA2182: A Randomized Phase II Study of De-Intensified Chemo Radiation for Early Stage Anal Squamous Cell Carcinoma(DECREASE)

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

PRIMARY OBJECTIVES: I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to s...

Phase I clinical trial utilizing direct peritoneal resuscitation in liver transplant recipient population at increased risk of return to the operating room and early allograft dysfunction.

University of Colorado Hospital

This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreci...

Teen Brain Imaging Study on Irritability and Social Information Processing

Brain Imaging Center (BIC), Brain Imaging Center (BIC) - Scan Read

Interested in how irritability affects how teens interpret social situations? Our goal is to learn more about how teens think and feel about unclear social situations and how irritable mood may relate to negative thoughts and feelings about these social situations....

ACNS2021-A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Childrens Hospital Colorado

PANDEMIC RESPONSE REPOSITORY - MICROBIAL AND IMMUNE SURVEILLANCE AND EPIDEMIOLOGY (PREMISE): ENTEROVIRUS D68 (EV-D68) PILOT STUDY

Childrens Hospital Colorado

What do I have to do if I join the study? Part 1: Provide a blood, saliva and nose samples and information about yourself Part 2: Fill out surveys about yourself and provide respiratory swabs when sick Part 3: Provide another blood, saliva, and nose sample one year later and information...

PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)

Childrens Hospital Colorado, University of Colorado Hospital

The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...

A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling

Childrens Hospital Colorado

There are two parts planned for this study, the Phase 1 that will test different doses of avapritinib to identify the recommended dose of avapritinib for the Phase 2. The Phase 2 will continue to test this recommended dose of avapritinib to determine if it is a tolerable, safe, and effecti...

Pilot Study of suction as a mechanism of IUD Expulsion with Concomitant Menstrual Cup Use.

Comprehensive Women's Health Center

Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences ...

A Prospective and Retrospective Registry and Biomarker Study to Evaluate the Natural History of Pediatric Patients with Cardiomyopathy due to MYBPC3 Mutations

Childrens Hospital Colorado

This is a natural history study. ...

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

University of Colorado Hospital

This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5)....

The Intersection of Oncology Care and Worker Well-Being

Grandview Hospital, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Saint Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center

You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor...

Young Women's Breast Cancer Awareness and Survivorship Needs in Underserved Communities

Cherry Creek Medical Center, Lone Tree Medical Center, University of Colorado Hospital

Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors

Childrens Hospital Colorado

Interviews will be conducted by a member of the study team at two separate time points. Questions about your treatment and different factors that are important to you when making decisions about your treatment. The interviews will be audio and video recorded by the study team. Only study ...

EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients [Ar...

Group Cognitive Behavioral Treatment for Anxiety in Adolescents with Autism and Intellectual Disability: A Randomized Controlled Trial

Department Specific Free Standing Clinic

What is the study about? This study investigates an adapted Cognitive Behavior Therapy (CBT) group treatment to determine if it is more effective than therapy services that adolescents with Autism (ASD) and Intellectual Disability (ID) are already receiving. What does the study entail? ...

NRG-CC009: Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer

Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measu...

S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy. SECONDARY OBJECTIVES: I. To evaluate the saf...

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

CTRC Inpatient, University of Colorado Hospital

Assignment of patients to a cohort will be based on prior treatment as outlined in the eligibility criteria. Participants who discontinue pembrolizumab or vibostolimab+pembrolizumab after 35 infusions for reasons other than disease progression or intolerability, or who discontinue pembr...

Decision making for urinary diversion in patients with bladder cancer

University of Colorado Hospital

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

Outpatient CTRC, University of Colorado Hospital

In the best standard of care (control) arm, each patient will receive best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk‑benefit assessment, institutional protocols, the local Prescribing Information, local regulations o...

Phase 1/1b Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients with Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)

Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

Contraceptive Hormone and Reward Measurement (CHARM Study)

Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC

The study is looking at the effects of birth control pills on brain processes and emotional wellbeing. During the study you will be asked to take a birth control pill or a placebo pill (a sugar pill) for 21 days. You won't know which pill you are taking. Birth control is a medication t...

Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

Renal Research Center, University of Colorado Hospital

Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil...

A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Childrens Hospital Colorado

All participants will receive the study drug, larotrectinib. Patients may continue to take the study drug for up to 20 months if there aren't any side effects and their brain tumor does not get worse. Patients will be given a diary to write down the amount of study drugs (number of pills o...

Does when you exercise matter? Healthy adults needed for study looking at differences between morning exercise and nighttime exercise.

Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

You will be asked to attend several screening visits to make sure you are eligible to be in the research study and that it is safe for you to participate. Research study participants will be randomized to exercise either in the morning or the evening. Randomization is like flipping a coin,...

NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

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

PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of...

A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about the safety of a study drug called TJ033721 (givastomig). The study is designed in 2 Parts: Part 1 and Part 2. This consent from describes the details of Part 1, which will test different dose levels to find out what effects, both good and/or bad, the s...

EVALUATION OF REFERRING PROVIDER- AND PATIENT-LEVEL BARRIERS TO ACCESSING CHIMERIC ANTIGEN RECEPTOR T-CELL (CAR-T) TRIALS

Childrens Hospital Colorado

A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

Childrens Hospital Colorado

This is a prospective phase 1/2 trial designed to assess the hypothesis that vorinostat, in addition to standard graft versus host disease (GVHD) prophylaxis, is feasible and safe in children, adolescent and young adult patients. All subjects will undergo allogeneic BMT according to local ...

Observational Protocol: Trametinib therapy for Symptomatic Patients with RAS/MAPK-Pathway Mutation-Positive Disorders

Childrens Hospital Colorado

A MULTICENTER PROSPECTIVE STUDY EVALUATING OUTCOMES OF ENDOSCOPIC ERADICATION THERAPY IN PATIENTS WITH BARRETT'S ESOPHAGUS ASSOCIATED NEOPLASIA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM

Moffit Cancer Center, University of South Florida, Northwestern University, UCLA - University of California, University of Colorado Hospital, University of Kansas Cancer Center, Washington University, Siteman Cancer Center

Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)

CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

What is involved: • Measurements of bone mineral density • Completion of sleep questionnaires/assessments • Randomization to sleep with a simulated night shift schedule or normal sleep schedule • A general physical exam • Activity monitoring with a wrist monitor • Blood/urine collec...

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Cherry Creek Medical Center, University of Colorado Hospital

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 with Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients with Advanced Cancers Associated with Expression of Delta-like Canonical Notch Ligand 3 (DLL3)

Outpatient CTRC, University of Colorado Hospital

This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of MK-6070 alone, MK-6070 with Atezolizumab and MK-6070 with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonic...

COMIRB title: Retrospective Study of Pediatric Myelodysplastic Syndromes

Childrens Hospital Colorado

S1914 A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Rocky Mountain Regional VA Medical Center

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

Childrens Hospital Colorado

Do decreased dietary fat and increased fiber reduce recurrence of Clostridioides difficile infection in oncology patients?

Childrens Hospital Colorado, University of Colorado Hospital

A PHASE 1 OPEN-LABEL STUDY OF KPT-9274 IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE MYELOID LEUKEMIA

Lone Tree Medical Center, University of Colorado Hospital

A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

Cherry Creek Medical Center, 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

AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Childrens Hospital Colorado

The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T...

A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)

Childrens Hospital Colorado

SIngle-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patieths with aHUS....

EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

Childrens Hospital Colorado

This is a Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and PK of alpelisib in pediatric and adult participants with PROS....

Relationship between Cardiac Health and Exercise Capacity in Men and Women with and without Type 2 Diabetes

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Participants will undergo baseline testing of their heart, blood vessel, and skeletal muscle function, and perform tests to determine exercise ability. Participants will then do exercise training for 15 weeks, and all testing will be repeated....

A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNA-GUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease

Childrens Hospital Colorado

This is a Phase 1/2 single-arm, open-label, multicenter study evaluating the safety and efficacy of a single unit dose of EDIT-301 for autologous hematopoietic stem cell transplant (HSCT) in subjects with severe SCD. Planned study subjects will be comprised of male and female adult and ado...

Volunteers needed for research study on changing eating behaviors

Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Study volunteers will be asked to complete an MRI scan, during which they will watch pictures of foods. Participants will also complete a 12-week intervention that involves viewing food or food images, with once-weekly study visits. After the intervention, we will ask volunteers to complet...

Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury: Prospective Observational Study

University of Colorado Hospital

Blood, urine, and bone marrow will be collected to analyze biomarkers of acute kidney injury risk. Sublingual microscopy will be used to collect images in the mouth. This is to study the following aims: Aim 1: Determine the effect of pulsatility during CPB on endothelial function. We wil...

PFAS Exposure and Health Effects in El Paso County

Department Specific Free Standing Clinic

A Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients

Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital, Yampa Valley Medical Center

In this study, subjects with prostate cancer will be randomized to metformin plus educational material for lifestyle modification versus educational material for lifestyle modification alone and followed for up to 10 years. Population-based, retrospective studies have reported improved out...

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

Childrens Hospital Colorado

ALZHEIMER'S CLINICAL TRIAL CONSORTIUM FOR DOWN SYNDROME (ACTC-DS) TRIAL-READY COHORT - DOWN SYNDROME (TRC-DS)

Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

TRC-DS is part of a larger movement working with people with Down syndrome to advance Alzheimer's disease therapies and potential cures for this population. The Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS) is a large collaboration of researchers conducting clinical trials...

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis

University of Colorado Hospital

What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin...

A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease Study of Tecovirimat for Human Monkeypox Virus (STOMP)

Childrens Hospital Colorado

Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br...

A Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NS-089/NCNP-02 in Boys with Duchenne Muscular Dystrophy (DMD)

Childrens Hospital Colorado

Treatment of Duchenne muscular dystrophy (DMD) with dystrophin deletion amenable to exon 44 skipping...

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

University of Colorado Hospital

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of M3814 (peposertib) in combination with hypofractionated radiotherapy in patients receiving treatment for locally advanced pancreatic adenocarcinoma (LAPC). (Phase I) II. To determine the difference in progression free sur...

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

Childrens Hospital Colorado

TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

Childrens Hospital Colorado

Evaluation of Compensatory Reserve in Obstetrical Patients

Childrens Hospital Colorado, University of Colorado Hospital

A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....

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

Rocky Mountain Regional VA Medical Center

A Phase 1 Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of BXQ-350 in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

Childrens Hospital Colorado

A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

Memorial Hospital Central, Memorial Hospital North

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

Rocky Mountain Regional VA Medical Center

The Effects of Aerobic Exercise on Parkinson's Disease

Outpatient CTRC, University of Colorado Hospital

This is an exercise research study for people who have been recently diagnosed with Parkinson's disease. Aerobic exercise is a vital treatment for people living with Parkinson's disease. Although anti-parkinsonian medication helps alleviate Parkinson's symptoms, it is not known to slow ...

Clonal hematopoiesis, mild cognitive impairment and kidney function decline.

Renal Research Center, University of Colorado Hospital

CH is a common aging-associated biological state that predisposes to subsequent cardiovascular death, however, whether it plays a role in MCI, dementia and kidney disease progression is unknown and understanding this novel risk factor may uncover new ways to reduce the burden of cognitiv...

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

Rocky Mountain Regional VA Medical Center

S1827: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Rocky Mountain Regional VA Medical Center

A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)

University of Colorado Hospital

Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable...

Endovascular treatment of acutely ruptured shallow intradural aneurysms not amendable to clipping and coiling with the pipeline vantage embolization device

University of Colorado Hospital

The purpose of this study is to assess the safety (short and long term side effects) and effectiveness (how well it stops the blood flow into the aneurysm) of the study device for the treatment of adults (22 – 80 years of age) with acutely ruptured, intradural (inside the head) aneurysms t...

NRG-GU011: A PHASE II DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL OF PROSTATE OLIGOMETASTATIC RADIOTHERAPY WITH OR WITHOUT ANDROGEN DEPRIVATION THERAPY IN OLIGOMETASTATIC PROSTATE CANCER (NRG PROMETHEAN)

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

PRIMARY OBJECTIVE: I. Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with stereotactic ablative body radiation therapy (SA...

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

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

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

ARST2032- A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Childrens Hospital Colorado

Inspiring New Science in Guiding Healthcare in Turner Syndrome (INSIGHTS) Registry

Ann &amp; Robert H. Lurie Children's Hospital of Chicago, Childrens Hospital Colorado, Childrens Hospital of Philadelphia, Childrens National Medical Center, University of North Carolina Children's Hospital, University of Texas Health Science Center at Houston

Participants who join the INSIGHTS Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. In addition to the basic registry, individuals can join a recruitment list f...

Protocol S2212, Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study (NCT TBD)

Memorial Hospital Central, Memorial Hospital North

The early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy

Broomfield Hospital, Cherry Creek Medical Center, Childrens Hospital Colorado, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Outpatient CTRC, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry

What Happens If I Join the Study? - You will have 4 study visits during pregnancy and 1 study visit after your baby is born - You will be asked to prick your finger to monitor blood sugar and blood triglyceride levels 4 times a day for 4 days after each visit (total of 64 finger pokes) ...

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

Childrens Hospital Colorado

The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia

Baylor Scott &amp; White Health, Case Western Reserve University, Cleveland Clinic, Main, Columbia University, Dartmouth University, Florida Digestive, Geisinger Medical Center, Johns Hopkins/The Sidney Kimmel Cancer Center, Kaiser Permanente of Colorado, Mayo Clinic, Jacksonville, Mayo Clinic, Rochester, Medical University of South Carolina, Northwestern University, Thomas Jefferson University Hospital Cancer Center, UCLA - University of California, University of Colorado Hospital, University of Michigan, University of North Carolina, University of Pennsylvania, Washington University, Siteman Cancer Center

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia...

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

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

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: ...

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

University of Colorado Hospital

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c...

Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study

Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp...

The use of thoracic epidural, paravertebral nerve blockade and video-assisted intercostal nerve cryoablation for postoperative analgesia after minimally invasive repair of pectus excavatum

Childrens Hospital Colorado

The study is to learn more about treating pain after having a minimally invasive repair of pectus excavatum while randomly assigning different pain methods that are typically used for this procedure....

AN OPEN-LABEL, MULTICENTER, PHASE 1B/2 STUDY OF RP1 IN SOLID ORGAN TRANSPLANT RECIPIENTS WITH ADVANCED CUTANEOUS MALIGNANCIES

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, trial evaluating the objective response rate and the safety and tolerability, biodistribution,...

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

Childrens Hospital Colorado

Microfluidic models of bleeding and thrombosis

Department Specific Free Standing Clinic, Hemophilia and Thrombosis Center (HTC), Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

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. ...

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

Boulder Sports Clinic, CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital

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

Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder

Brain Imaging Center (BIC), University of Colorado Hospital

In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recor...

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)

Childrens Hospital Colorado

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Schacht Research Study 19-2335

Brain Imaging Center (BIC), Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and tw...

Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health

Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

This study will involve 4-5 in person visits. There will be screening visit for some patients and then a baseline visit over two days. The first day will involve an IV and drinking a sugary drink with blood draws as well as measuring the resting metabolic rate and answering questionnaires....

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

Childrens Hospital Colorado

NRG-HN010, A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable HER2-Positive Salivary Gland Cancer (NCT05408845)

Highlands Ranch Hospital, University of Colorado Hospital

This phase II trial tests whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is ...

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Childrens Hospital Colorado, University of Colorado Hospital

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)...

Monitoring and Predicting Outcomes of Birdshot Chorioretinopathy: A Clinicogenomics Study

University of Colorado Hospital

For patients with BSCR, blood sample draw will be obtained (with option for minimally invasive cheek/saliva swab) in the clinic and clinical data will be collected. There are no planned interventions outside of their normal standard of care. Patients will then be contacted by our clinical...

The National Myelodysplastic Syndromes (MDS) Study

Rocky Mountain Regional VA Medical Center

Schacht Research Study 19-1658

Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

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...

PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)

Childrens Hospital Colorado

PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a...

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)

Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Longs Peak Hospital, University of Colorado Hospital

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective ...

A Pediatric Brain Tumor Consortium Phase I/ II and Surgical Study of CX-4945 in Patients with Recurrent SHH Medulloblastoma

Childrens Hospital Colorado

An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using Zalifrelimab (AGEN1884) or Botensilimab (AGEN1181) with Balstilimab (AGEN2034) for Advanced or Metastatic Soft Tissue Sarcomas

University of Colorado Hospital

The primary endpoint for the study is PFS6mo by RECIST 1.1. The sample size calculation is based on a Simon Two-Stage design with incorporation of early stopping rules for safety and futility (See section 9 for statistical considerations). The Investigators will enroll up to 35 patients on...

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

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)

University of Colorado Hospital

You are being asked to be in this research study because you have Synovial Sarcoma that has grown or not responded to treatment, and you completed the Pre-screening tests for this study. Your blood tested positive for certain proteins and your cancer cells tested positive for protein. T...

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

University of Colorado Hospital

You are being asked to be in this research study because you have previously had surgery to remove your cancer and are now considered clinically disease-free. This study plans to learn more about whether or not the combination of pembrolizumab and mRNA-4157 (a personalized cancer vacci...

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult

Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

The purpose of MoTrPAC is to learn about how exercise benefits health. We know that being physically active is good for our health, but we don’t completely understand how it changes the cells in our bodies. Understanding the cellular benefits of exercise could help scientists develop new...

Improving Carpediem Outcomes in Neonates and Infants through Collaboration (ICONIC)

Childrens Hospital Colorado

Develop a multi-center quality collaborative network (ICONIC) to share best practices, treatment hurdles, and quality metrics in infant CRRT utilizing the Carpediem device in the US....

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

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

Clinical outcomes following standard of care therapy for resectable esophageal and gastroesophageal junction adenocarcinoma are suboptimal, with low rates of pathologic complete response (pCR) to current neoadjuvant treatment strategies. Although significant progress has been made by incor...

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

Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

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

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

Cherry Creek Medical Center, 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

Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiother...

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Barbara Davis Center, University of Colorado Hospital

This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ...

A Phase 1/2, Multi-regional, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Gene Therapy for Leber's Hereditary Optic Neuropathy (LHON) Associated with ND1 Mutation

University of Colorado Hospital

The study drug is an investigational gene therapy product. Gene therapy is a technique that uses genes to treat or cure disease. “Investigational” means that the study drug is currently being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States...

SANDIA: Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control

Outpatient CTRC, University of Colorado Hospital

This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline to controller therapy in obese late onset asthmatics: a) improves asthma control, and b) increases FeNO levels. Secondary research questions are to determine if L-citrull...

CBD for Individuals with Mild Cognitive Impairment and at Risk for Alzheimer's Disease

Outpatient CTRC, University of Colorado Hospital

This study plans to learn more about different types of CBD in reducing symptoms of MCI (sleep and cognitive dysfunction, anxiety, and inflammation)....

Total Joint Arthroplasty in a Pediatric Population

Childrens Hospital Colorado

Involves two surveys for approximately 10 mintues...

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

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

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) ...

Multiomics Investigation of Marijuana Use

Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

This research study seeks to learn more about biomarkers and biological pathways associated with marijuana use. We are enrolling adults who are marijuana users or non-users. The study involves filling out online surveys and one on-campus visit to give a blood, urine, and hair sample. If yo...

PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Childrens Hospital Colorado

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

Childrens Healthcare of Atlanta, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

This study is designed to test the experimental combination of Losartan and Sunitinib in the hope of finding a drug combination that is safe and effective against osteosarcoma that has come back or not responded to standard therapy. There are two parts to this study. The first part is the...

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

Anschutz Health and Wellness, UCD Anschutz Health &amp; Wellness Center

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients with Metastatic Triple Negative Breast Cancer

University of Colorado Hospital

Gene Expression of Cerebral Aneurysms

University of Colorado Hospital

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

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

Renal Research Center, University of Colorado Hospital

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 ...

IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)

University of Colorado Hospital

Study IMVT-1401-3201 is a Phase 3, multi-center, randomized, quadruple‑masked (Sponsor, Investigator, assessor, and participant), placebo‑controlled study was designed to assess the efficacy and safety of batoclimab in adult participants with active, moderate to severe TED. The study durat...

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

Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

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

Department Specific Free Standing Clinic, University of Colorado Cancer Center, 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

Childrens Hospital Colorado

This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dos...

PHASE 1/2 DOSE ESCALATION AND PRELIMINARY EFFICACY OF CD19 DIRECTED CAR T CELLS GENERATED USING THE MILTENYI CLINIMACS PRODIGY SYSTEM (UCD19 CART) IN PEDIATRIC PATIENTS WITH REPLASED AND/OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) AND B-CELL NON-HODGKIN'S LYMPHOMA (B-NHL)

Childrens Hospital Colorado

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

Cherry Creek Medical Center, 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

PRIMARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall surviv...

A Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma and other genitourinary tumors with DNA-Repair Defects.

University of Colorado Hospital

PRIMARY OBJECTIVE: I. To evaluate the efficacy of olaparib in two cohorts of patients with metastatic/advanced non prostate genitourinary (GU) cancer pre-selected by DNA-repair defects as measured by overall response rate (ORR). SECONDARY OBJECTIVES: I. To describe the effect of t...

A 2-and-5-year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with or without additional stabilization using the coflex® ® Interlaminar Technology for FDA Actual Conditions of Use Study.

Highlands Ranch Hospital, University of Colorado Hospital

The first objective addresses coflex® performance in actual conditions of use settings at two years and at five years relative to pivotal trial device performance. The second objective compares coflex® performance in actual conditions of use settings to decompression alone using data from ...

Protocol A022104, The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified fluorouracil, irinotecan, leucovorin, and oxalip...

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

University of Colorado Hospital

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

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

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A study of the genetics of pulmonary fibrosis

University of Colorado Hospital

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...

PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma or Ependymoma, and Feasibility and Efficacy Trial of Optune in Conjunction with Radiation Therapy for children with Newly Diagnosed DIPG

Childrens Hospital Colorado

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

Outpatient CTRC, University of Colorado Hospital

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

AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS

Greeley Campus, Harmony Campus, Poudre Valley Hospital

Impact of Fever Prevention in Brain Injured Patients (INTREPID)

University of Colorado Hospital

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

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

Outpatient CTRC, University of Colorado Hospital

Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad...

Establishing the Efficacy of Parent Management Training for Irritability

Childrens Hospital Colorado

Children ages 10-14 will complete an assessment with a licensed mental health professional to determine diagnosis, IQ and behavior at baseline. Parents will complete 12 sessions of parent management training for irritability. The child will be re-assessed in the middle and at the end of t...

EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital

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. ...

ARET2121-Intravitreal Melphalan for Intraocular Retinoblastoma

Childrens Hospital Colorado

Phase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma

Childrens Hospital Colorado

Because of your cancer diagnosis, we previously received your permission to make HER2 CAR T cells from the blood you provided. Now, because we have successfully made your HER2 CAR T cells, you will be asked to enroll on the Phase 1 treatment study. The treatment for the Phase 1 study will ...

The Physical, Mental, and Emotional Effects of Youth Girls Flag Football: A Prospective Investigation

Childrens Hospital Colorado

Participants will complete three in person visits (1) mid-August 2023 (2) mid/late October 2023 (3) April 2024. They will complete 20 minutes of questionnaires and 20 minutes of functional tests at each visit and receive $50 for each visit completed. Participants will also complete weekly ...

A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Study to improve dEployment related Asthma by using L-citrulline Supplementation (SEALS)

Outpatient CTRC, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

2. This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline for deployment related asthmatics: a) improves asthma control, and b) increases FeNO levels....

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

Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital

There will be 6 study visits over about a year. They will take place over 2 days before starting testosterone and then 1 month and 12 months after starting testosterone. The first study visit will involve a blood draw, an oral glucose tolerance test (sugar drink) and answering questionnair...

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

Boulder Sports Clinic, University of Colorado Hospital

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 (...

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

Childrens Hospital Colorado

Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study

Outpatient CTRC, University of Colorado Hospital

Transgender women (TW) are the fastest-growing group of people with HIV (PWH). Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medication in TW...

A Safety and Preliminary Efficacy trial of Pembrolizumab (MK-3475) 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

Childrens Hospital Colorado

EA8134: InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

University of Colorado Hospital

We want to see if we can improve the treatment of patients with penis cancer that has spread, like yours. The purpose of this study is to test treatments which might reduce the chances of the cancer coming back. Combinations of four different treatments are being studied: Surgery to rem...

JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

Barbara Davis Center, University of Colorado Hospital

This phase 2 trial is a double-blind, randomized, placebo-controlled clinical trial in male and female adolescent and adult participants (ages 12-35 years) with newly diagnosed Stage 3 T1D (within 100 days of diagnosis). Enrollment into abrocitinib and ritlecitinib arms and the shared ...

Copeptin and Nonalcoholic Fatty Liver Disease

Anschutz Health and Wellness, Outpatient CTRC, UCD Anschutz Health &amp; Wellness Center, University of Colorado Hospital

See above...

Effect of pelvic radiation therapy on the urinary and musculoskeletal systems of survivors of childhood cancer.

Childrens Hospital Colorado

A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users

Outpatient CTRC

Your study participation will include 4 visits over about 12 weeks, with an on-campus screening visit and three home-based visits in our mobile pharmacology lab, a specially equipped van. ...

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

University of Colorado Hospital

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

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)

Memorial Hospital Central, Memorial Hospital North

ACCL2031-A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND# 149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors

Childrens Hospital Colorado

The ENERGY 3 Study: A Randomized, Controlled, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of INZ-701 in Children with Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 (ENPP1) Deficiency

Childrens Hospital Colorado

A Randomized, Controlled, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of INZ-701 in Children with Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 (ENPP1) Deficiency...

Protocol A022102, A Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma (NCT05677490)

Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital

The Role of Digital and Mobile Health Technology in Hereditary Cancer Care

Department Specific Free Standing Clinic, University of Colorado Hospital

Protocol 10553, "A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer,"

University of Colorado Hospital

This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) ...

Protocol 10505, A phase 1 and randomized phase 2 trial of selinexor and temozolomide in recurrent glioblastoma

University of Colorado Hospital

This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy vs. the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that ha...

Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital

Our study is seeking individuals aged 18-60, who have been diagnosed with a traumatic brain injury (TBI). The goal of the study is to see whether cannabinoids (CBD) can improve TBI symptoms. ...

Human Trisome Project

Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

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

Mindfulness-Based Intervention for Adolescents with Chronic Migraine

Childrens Hospital Colorado

If eligible, your teen would participate in a 6-week virtual group program with other teens with migraine. Your teen would also complete questionnaires before and after the group program. Possible benefits of the study include learning mindfulness-based skills, feeling less stressed, p...

An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

University of Colorado Hospital

Study IMVT-1401-3203 is a 2-cohort extension study for eligible participants completing the Week 24 visit on the feeder studies, IMVT-1401-3201 or IMVT-1401-3202. Participants will be assessed as proptosis responders or non-responders at Week 24 in the feeder studies. Based upon this as...

A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies

Barbara Davis Center, Cherry Creek Medical Center, CTRC Inpatient, University of Colorado Hospital

Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Tr...

Postoperative Respiratory and Activity Monitoring

University of Colorado Hospital

The ExSpiron and ActivPal devices will be used post-operatively for 7 days, or until the patient meets the ambulatory requirements. ...

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

Childrens Hospital Colorado

A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis

Outpatient CTRC, Renal Research Center, University of Colorado Hospital

Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)...

Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 with Dose Expansion Phase, in Subjects with Advanced Solid Tumors

CTRC Inpatient, University of Colorado Hospital

Phase I Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adult Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Minimal Residual Disease (MRD) Positivity at First Complete Remission

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Recruitment Database Protocol for Patients With Inflammatory Kidney Disease

University of Colorado Hospital

Study subjects will consent to allow their information to be stored in the database and for the collection of blood, urine, and tissue to be stored in the data and biobank....

A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab. COMPLETED - Part A (metastatic and locally advanced P...

Phase 2 Study of the MEK inhibitor MEKTOVI (binimetinib) for the treatment of pediatric adamantinomatous craniopharyngioma

Childrens Hospital Colorado

AR22.001 Vigilant ObservatIon of G1IadeL Wafer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel Wafer (Carmustine Implant) Used in Usual Medical Practice

University of Colorado Hospital

051/02 A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Childrens Hospital Colorado

A Phase II, Open Label, Two-Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat For Recurrent or Progressive High-Risk Neuroblastoma Subjects (Optimum Trial)

Childrens Hospital Colorado

Multicenter Cohort Study To Evaluate Outcomes after Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults with Solid Tumors: The iCat2, GAIN Consortium Study

Childrens Hospital Colorado

How When you Eat and Exercise Affect Metabolism in Adults

CTRC Inpatient

As a participant in this study, you will be assigned to 4 different diet and exercise groups where the time of your meals and when you exercise will be different. This will last for 4 consecutive days, and you will be provided meals on 2-3 of the days. On the 5th day of each exercise and d...

Neurological - PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE

University of Colorado Hospital

Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer

Lone Tree Medical Center, University of Colorado Hospital

The primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and ear...

14-1076 Molecular Biology and Phase I Study of GM-CSF and Intrathecal Trastuzumab in Children with Recurrent Ependymoma

Childrens Hospital Colorado

EA7211: A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

University of Colorado Hospital

Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)

Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital

This study plans to learn more about how to improve standard cancer care. Cancer is a tough disease to treat because few cancers behave in the same way. Recent research suggests that information stored in your blood, tissues and body fluids can be studied to change the way we treat cancer ...

A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients with Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Childrens Hospital Colorado

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Memorial Hospital Central, Memorial Hospital North

GOG-3088: A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

Highlands Ranch Hospital, University of Colorado Hospital

Physical Activity and Autosomal Dominant Polycystic Kidney Disease

Renal Research Center

This research study is being conducted to learn more about physical activity habits in those with ADPKD....

Fatigue Screening and Rehabilitation Triage for the Management of Pediatric Cancer-Related Fatigue (FAST-PEDS)- Phase 1

Childrens Hospital Colorado

Effects of early as compared to late time restricted eating on weight loss and metabolic outcomes in adults with obesity

Anschutz Health and Wellness, Outpatient CTRC

Volunteers needed for a 12 month weight loss research study who are willing to try time restricted eating (eating only during an assigned 8 hour time window each day) in order to lose weight. ...

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With Urothelial Carcinoma (KEYMAKER-U04): Master Protocol

University of Colorado Hospital

Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n...

A Phase II Study of FOLFIRINOX Combined with the Glycogen Synthase Kinase-3 Beta (GSK-3 Beta) Inhibitor Elraglusib and the Transforming Growth Factor-B (TGF-B) Inhibitor Losartan in Patients with Untreated Metastatic Pancreas Adenocarcinoma.

CU-RIC, University of Colorado Hospital

This is a multi-institutional, open label, four-arm, non-comparator Phase 2 study of FOLFIRINOX in combination with 9-ING-41 and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma (PAC). This research study will begin with a Safety Run-In phase...

Blood Disorder Symptomatology Outcomes Network Patient Reported Outcomes (BISON-PRO) Quality of Life Study

Cherry Creek Medical Center, University of Colorado Hospital

The BISON-PRO Quality of Life Study is a research study to measure symptoms and quality of life using online surveys in patients with blood disorders....

PIKture-01: First-in-Human Study of the PI3KalphaH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants with Advanced Solid Tumors and in Combination with Endocrine Therapy or HER2 Targeted Therapy in Participants with Advanced Breast Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

ORACLE: Observation of ResiduAl Cancer with Liquid Biopsy Evaluation

University of Colorado Hospital

This study plans to learn more about if a blood test can predict whether cancer will recur (come back) after initial treatment. In some cases, cancer is cured after initial treatment, but in other cases, cancer cells remain in the body. These remaining cancer cells can grow over time. If...

A Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy

University of Colorado Hospital

The study comprises of screening period that lasts upto 60 days and ends with the participant's randomization, the treatment period starts with the administration of first dose of study drug and lasts 12 months. Participants who complete the treatment period will be offered to enter a 12 m...

A Phase II, Multicenter, Single-Arm Clinical Trial of Definitive Radiotherapy And CeMiPlimAb-Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Highlands Ranch Hospital, University of Colorado Hospital

Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia - SCOPELeukemia

University of Colorado Hospital

This is a cluster randomized comparative effectiveness trial of primary palliative care (PC) versus specialty PC in 1150 patients with acute myeloid leukemia (AML) and their caregivers....

A211801, "BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation,"

University of Colorado Hospital

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial Of DAY101 Monotherapy Versus Standard Of Care Chemotherapy In Patients With Pediatric Low-Grade Glioma Harboring An Activating RAF Alteration Requiring First-Line Systemic Therapy

Childrens Hospital Colorado

A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients with HER2 Mutant Non-Small Cell Lung Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

here are 4 parts to the trial. Part 1 is a dose escalation with ELVN-002 monotherapy for people with advanced stage solid tumors that have a HER2 mutation, amplification or high HER2 over-expression. Part 2 is an ELVN-002 monotherapy dose exploration where additional people may be enrolled...

A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants with Aggressive and Indolent B-cell Malignancies

CTRC Inpatient, University of Colorado Hospital