A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer
NCT05714202
Recruiting
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Gender:
All
Ages:
18 years and above
Locations: Colorado Clinical Research, Lakewood, Colorado +76 locations
Conditions: Bladder Cancer
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NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
NCT05666713
Recruiting
Background: Replacing a valve in the heart can save many people s lives. The procedure is called transcatheter aortic valve replacement (TAVR). In rare cases, a flap of tissue called a leaflet can shift during TAVR; the leaflet may block blood flow to the coronary arteries, which supply blood to the heart muscle. About 50% of people who experience this problem will die. To reduce this risk, doctors will cut this leaflet during TAVR. But the tools used to cut the leaflet were originally designed... Read More
Gender:
All
Ages:
Between 21 years and 109 years
Locations: University of Colorado Health, Fort Collins, Colorado +9 locations
Conditions: Valvular Heart Disease, Aortic Valve Failure
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A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT05627362
Recruiting
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the stud... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Locations: Peak Gastroenterology Associates, Colorado Springs, Colorado +12 locations
Conditions: Primary Sclerosing Cholangitis
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Siplizumab in T1DM
NCT05574335
Recruiting
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. Blood samples f... Read More
Gender:
All
Ages:
Between 8 years and 45 years
Locations: University of Colorado School of Medicine: Barbara Davis Center for Diabetes, Aurora, Colorado +19 locations
Conditions: Type 1 Diabetes Mellitus
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Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
NCT05538897
Recruiting
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made... Read More
Gender:
Female
Ages:
18 years and above
Locations: University of Colorado Hospital, Aurora, Colorado +9 locations
Conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Metastatic Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Stage IV Uterine Corpus Cancer AJCC v8
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Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
NCT05436535
Recruiting
This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these expression patterns and endotypes in response to standard-of-care treatment. Participants will complete up to ten study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all stud... Read More
Gender:
All
Ages:
6 years and above
Locations: National Jewish Health: Division of Pediatric Allergy and Clinical Immunology, Denver, Colorado +9 locations
Conditions: Atopic Dermatitis
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Clinical Study of DTX301 AAV- Mediated Gene Transfer for Ornithine Transcarbamylase(OTC) Deficiency
NCT05345171
Recruiting
The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.
Gender:
All
Ages:
12 years and above
Locations: University of Colorado, Aurora, Colorado +22 locations
Conditions: OTC Deficiency
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A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy
NCT05337553
Recruiting
This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen or risdiplam or have a history of onasemnogene abeparvovec-xioi, compared to placebo.
Gender:
All
Ages:
Between 4 years and 21 years
Locations: Children's Hospital Colorado, Aurora, Colorado +58 locations
Conditions: Spinal Muscular Atrophy, Neuromuscular Diseases, SMA
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Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
NCT05308446
Recruiting
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in t... Read More
Gender:
All
Ages:
18 years and above
Locations: University of Colorado Hospital, Aurora, Colorado +207 locations
Conditions: Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma
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Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
NCT05256225
Recruiting
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 recept... Read More
Gender:
Female
Ages:
18 years and above
Locations: University of Colorado Hospital, Aurora, Colorado +236 locations
Conditions: Endometrial Serous Adenocarcinoma, Uterine Corpus Carcinosarcoma
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A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer
NCT05198804
Recruiting
This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer.
Gender:
Female
Ages:
18 years and above
Locations: Rocky Mountain Cancer Centers, Aurora, Colorado +18 locations
Conditions: Ovarian Cancer, Platinum-resistant Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
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Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study
NCT05136820
Recruiting
The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.
Gender:
All
Ages:
18 years and above
Locations: University of Colorado Health Memorial Hospital, Colorado Springs, Colorado +17 locations
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Reduced Ejection Fraction (HFrEF)
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