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The short-chain fatty acid acetate for improving age-associated arterial dysfunction
Specific Aim: To determine the following before and after 12 weeks of oral supplementation with calcium acetate vs. placebo (calcium citrate) in healthy men and women 50+ years of age: a) Endothelium-dependent dilation, assessed as brachial artery flow-mediated dilation (FMDBA) [primary o... Protocol #: 22-0473 |
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Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of posoleucel (ALVR105) as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC. Approximately ... Protocol #: 22-0182 Location: Childrens Hospital Colorado |
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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
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)... Protocol #: 22-1850 Location: Renal Research Center, University of Colorado Hospital |
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PARTNER 3 VIV: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve
Protocol #: 17-6104 Location: Harmony Campus, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Yampa Valley Medical Center |
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A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutations
This multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in at least 120 patients with NYHA functional Class II and III DCM secondary to LMNA mutations. NYHA functional Class IV patients (u... Protocol #: 17-2345 Location: CTRC-adult, Outpatient CTRC, University of Colorado Hospital |
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure
This study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 1... Protocol #: 18-0158 Location: University of Colorado Hospital |
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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at we... Protocol #: 17-2349 Location: Outpatient CTRC, University of Colorado Hospital |
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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")
Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site hea... Protocol #: 18-0505 Location: University of Colorado Hospital |
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A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative
Protocol #: 18-1893 Location: Childrens Hospital Colorado |
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A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study dru... Protocol #: 18-6511 Location: Memorial Hospital Central |
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REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)
This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.... Protocol #: 19-6030 Location: Harmony Campus, Medical Center of the Rockies |
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Cardiopulmonary and Right Ventricular Function in Health and Disease
The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as... Protocol #: 19-1141 Location: Brain Imaging Center - BIC, CTRC Inpatient, University of Colorado Hospital |
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Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with t... Protocol #: 19-1823 Location: University of Colorado Hospital |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa... Protocol #: 19-1874 Location: University of Colorado Hospital |
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CLASP II TR- Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid reg... Protocol #: 19-6129 Location: Harmony Campus, Medical Center of the Rockies |
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Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective o... Protocol #: 20-0254 Location: University of Colorado Hospital |
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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c... Protocol #: 20-0288 Location: University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune
Thrombocytopenia (ITP)
Protocol #: 20-2156 Location: Childrens Hospital Colorado |
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A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
Protocol #: 20-2082 Location: Childrens Hospital Colorado |
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Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury: Prospective Observational Study
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... Protocol #: 20-2465 Location: University of Colorado Hospital |
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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
Protocol #: 20-2626 Location: Childrens Hospital Colorado |
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AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged Greater than or equal to 1 to < 31 Years Old with First Relapse
Protocol #: 21-3049 Location: Childrens Hospital Colorado |
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A Phase II Pilot Study of Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults with High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant: A Multicenter Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) Study (EXCEL Trial)
Protocol #: 21-2662 Location: Childrens Hospital Colorado |
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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
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 ... Protocol #: 20-2018 Location: Childrens Hospital Colorado |
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Protocol A011-13 (HYPERION): A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Protocol #: 21-3600 Location: University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in
Infants and Children at Increased Risk for Severe RSV Disease
This trial is testing a study medicine to learn if it can help prevent RSV infection in babies who are more likely to get severe RSV illness. Infants will be randomized to receive either Synagis or the study drug. There are approximately 3 blood draws per season, and participants will be ... Protocol #: 21-4176 Location: Childrens Hospital Colorado |
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Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
This is a prospective, multicenter phase II study designed to evaluate the outcomes of patients with bone marrow failure diseases (BMFD) undergoing HLA-matched related, HLA-matched unrelated, or single HLA-class 1 allele or HLA-DQB1 antigen or allele mismatched unrelated hematopoietic cell... Protocol #: 21-3994 Location: Childrens Hospital Colorado |
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PEERLESS Study
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. The study will collect data on demograp... Protocol #: 21-4920 Location: University of Colorado Hospital |
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ALLIANCE- Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Prospective, single arm, multicenter study... Protocol #: 22-0486 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center |
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DEFIANCE: ClotTriever vs. Anticoagulation for DVT
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... Protocol #: 22-1788 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |