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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
Protocol #23-1949 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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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
Protocol #23-0061 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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PEPN2113: A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy
Protocol #22-1539 Location: Childrens Hospital Colorado |
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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)
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-... Protocol #22-1340 Location: Childrens Hospital Colorado |
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Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing Anti- D22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute
Lymphoblastic Leukemia (B-ALL)
Protocol #22-1502 Location: CTRC Inpatient, University of Colorado Hospital |
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A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
Protocol #22-1050 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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
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... Protocol #20-3065 Location: Childrens Hospital Colorado |
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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)
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.... Protocol #20-2825 Location: Childrens Hospital Colorado |
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A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered IO-202 and IO-202 + Azacitidine ? Venetoclax in Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Chronic Myelomonocytic Leukemia (CMML) Patients (IO-202-CL-001)
Protocol #20-1388 Location: Outpatient CTRC, Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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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
Protocol #19-2157 Location: Childrens Hospital Colorado |
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
Protocol #19-1634 Location: Childrens Hospital Colorado |
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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)
Protocol #18-2424 Location: Childrens Hospital Colorado |
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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
Protocol #22-0054 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia - SCOPELeukemia
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.... Protocol #23-2210 Location: University of Colorado Hospital |
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Cannabis in Adolescents Study
(Arm 1) If you join the study, you will have a total of six study visits over about two months. Half of these visits will be held via Zoom and the other half will be held in person at a clinic on the CU Anschutz Campus in Aurora. You will be asked questions; complete questionnaires; and gi...more > Protocol #20-0553 |
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University of Colorado Age-Related Macular Degeneration Registry
Do you have dry Age-Related Macular Degeneration (AMD)? If yes, you may be eligible to participate in our research study....more > Protocol #14-0740 |
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NightWare Therapeutic Platform for improving Cardiovascular Health in Adults With Nightmares Associated with PTSD
We are recruiting individuals who experience PTSD-associated nightmares to participate in a research study to help us understand if improving sleep quality, by reducing the impact of nightmares can improve cardiovascular health....more > Protocol #21-5027 |
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Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)
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...more > Protocol #20-3013 |
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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...more > Protocol #22-0473 |
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Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
Our study is seeking individuals aged 18-60, who have been diagnosed with a traumatic brain injury (TBI) to participate. The study plans to learn more about the impacts of cannabidiol (CBD) on individuals with TBI. The 12-weeks of the study will involve using CBD or placebo....more > Protocol #22-1427 |
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BURST2D Study: Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes
The purpose of the study is to compare two different physical activity interventions (BREAK or ONE) to learn about their effects on blood sugar and metabolism. Participants will be randomized to one of two interventions: ONE (45-minutes of brisk walking at least 5 days per week) and BREAK ...more > Protocol #20-1900 |
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PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life - The PROMISE Study
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...more > Protocol #22-1840 |
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The ROSIE Study
Two, in-person visits between 1-2 hours over approximately a 3-month period....more > Protocol #23-1234 |
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BfedBwell cancer survivorship nutrition program: proof-of-concept pilot study
Cancer survivors who have completed active treatment within the last five years and who have BMI 25-45 kg/m2 will take part in a 12-week study of the BfedBwell survivorship nutrition program. BfedBwell includes group nutrition education and discussion, skills development sessions and cooki...more > Protocol #23-1501 Location: Colorado Research Center, CTRC-adult, CU Anschutz non-hospital research facilities |
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Please help us learn more about autism spectrum disorders!
Study participants will complete MRI Scans, blood draws, tests of cognitive abilities, such as memory and attention, questionnaires about physical activity and emotions, and may be asked to participate in 10 weeks of exercise or social gaming....more > Protocol #14-1282 Location: CU Anschutz non-hospital research facilities |
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Assessment of Cochlear Dysfunction in Black and White Adults with Stage 2 Hypertension Using High-Frequency Distortion Product Otoacoustic Emissions
If you join the study, you will have your blood pressure measured and undergo a variety of hearing tests including one specific to inner ear health. We will perform a variety of hearing tests. Some tests require you to indicate if you hear tones or words. Other tests require no response...more > Protocol #22-2100 Location: CU Anschutz non-hospital research facilities, University of Colorado, Boulder |
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Phase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma
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 ...more > Protocol #21-5057 Location: Childrens Hospital Colorado |
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Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy
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...more > Protocol #22-2201 Location: Outpatient CTRC |
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CU-GENES (Genetic Engagement, Education, and Screening)
Inclusion Criteria: • Over the age of 25 • At least one grandparent of Jewish ancestry OR be of Spanish ancestry with roots in the San Luis Valley • No prior genetic testing • No personal history of bone marrow transplants or blood cancers • Currently live in Colorado OR New Mexico ...more > Protocol #23-0584 |
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CU-GENES (Genetic Engagement, Education, and Screening)
Inclusion Criteria: • Over the age of 25 • At least one grandparent of Jewish ancestry OR be of Spanish ancestry with roots in the San Luis Valley • No prior genetic testing • No personal history of bone marrow transplants or blood cancers • Currently live in Colorado OR New Mexico ...more > Protocol #23-0584 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |
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The Intersection of Oncology Care and Worker Well-Being
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...more > Protocol #21-4139 Location: 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 |
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Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE)
The Applied Biomarkers of Late Effects of Childhood Cancer (ABLE) study, in collaboration with the Pediatric Transplantation & Cellular Therapy Consortium (PTCTC), have recently focused on biological correlates (such as T- and B-cells and their respective subsets, NK cells and their subset...more > Protocol #21-3395 Location: Childrens Hospital Colorado |
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Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
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. ...more > Protocol #22-2246 Location: University of Colorado Hospital |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...more > Protocol #19-0400 Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ...more > Protocol #18-0392 Location: Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord?, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
Protocol #18-1272 Location: Childrens Hospital Colorado |
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Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study
This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ...more > Protocol #21-3018 |
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Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study
This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ...more > Protocol #21-3018 Location: University of Colorado Hospital |
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A Translational Study of the Interactions between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction
Protocol #09-0583 Location: Cherry Creek Medical Center, Denver Health and Hospital Authority, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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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 ...more > Protocol #20-2018 Location: Childrens Hospital Colorado |
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Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease
Participants will be instructed in inspiratory muscle strength training (IMST) during baseline and will be evaluated during a 3 month period to see the effects of the device on systolic blood pressure. There will be a "placebo" arm. Participants will not know which arm they are in....more > Protocol #21-3000 Location: Brain Imaging Center - BIC, University of Colorado Hospital |
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Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ...more > Protocol #19-0149 Location: Renal Research Center, University of Colorado Hospital |
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Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***
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 ...more > Protocol #22-1207 |
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Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***
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 ...more > Protocol #22-1207 Location: Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra? / Beriplex?]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding
Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site....more > Protocol #22-0056 Location: Memorial Hospital Central |
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A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra? / Beriplex?]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding (Pro00058284)
Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site....more > Protocol #22-0103 Location: Medical Center of the Rockies |
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Human Trisome Project
Additional information about this study can be found at www.trisome.org....more > Protocol #15-2170 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME
This study plans to learn more about lung health in children with Down syndrome. Sometimes children with Down syndrome breathe food or liquids into their lungs, which is called aspiration. We want to learn more about how aspiration affects the lungs and quality of life of children with Do...more > Protocol #19-2092 Location: Childrens Hospital Colorado |
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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
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...more > Protocol #23-1267 Location: Childrens Hospital Colorado |
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The Nephrotic Syndrome Study Network (NEPTUNE)
Collection of blood, urine and tissue (optional)...more > Protocol #22-0895 Location: Renal Research Center, University of Colorado Hospital |
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Glucose Monitoring in Youth with Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
The purpose of this study is to determine if pulmonary exacerbations in youth with cystic fibrosis cause blood sugars to vary during and after an exacerbation. Blood sugars will be monitored using a continuous glucose monitor (CGM) for 2 weeks both during and 6 weeks after an exacerbation...more > Protocol #21-3666 Location: Childrens Hospital Colorado |
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Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health
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....more > Protocol #19-2109 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Gene Expression of Cerebral Aneurysms
In this study, we will collect tissue and blood from participants during their epilepsy surgery. ...more > Protocol #19-0182 Location: University of Colorado Hospital |
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A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study To Evaluate EDP-938 Regimens In Subjects Aged 28 Days To 36 Months Infected With Respiratory Syncytial Virus (RSV)
Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries...more > Protocol #23-1409 Location: Childrens Hospital Colorado |
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Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ Dysfunction
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....more > Protocol #23-0581 Location: University of Colorado Hospital |
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Menstrual profiles and cardiovascular disease risk among female adolescent athletes with and without menstrual irregularities
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. ...more > Protocol #22-1372 Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic, Outpatient CTRC |
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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...more > Protocol #20-2465 Location: University of Colorado Hospital |
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Microfluidic models of bleeding and thrombosis
This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. ...more > Protocol #19-2408 |
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Microfluidic models of bleeding and thrombosis
This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. ...more > Protocol #19-2408 Location: Department Specific Free Standing Clinic, Hemophilia and Thrombosis Center (HTC), Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Accelerating Medicines Partnership:
Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis
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...more > Protocol #23-0022 Location: Barbara Davis Center, University of Colorado Hospital |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
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 ...more > Protocol #21-3844 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
The ASSERVO study is testing a potential medicine for infants to see if it may help prevent lower respiratory infections caused by RSV. Study participation includes 1 dose of the medicine or placebo, approximately 3 blood draws, e-diary entries, and nasal swabs collected during any respir...more > Protocol #21-3387 Location: Childrens Hospital Colorado |
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REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated....more > Protocol #20-2723 |
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REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated....more > Protocol #20-2723 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....more > Protocol #20-0593 Location: Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital |
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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
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...more > Protocol #20-1262 Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital |
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Multiomics Investigation of Marijuana Use
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...more > Protocol #18-0853 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Effects of pubertal blockade and hormone therapy on cardiometabolic risk markers in transgender adolescents
There will be 6 study visits over about a year. They will take place over 2 days before starting testosterone and then 1 month and 12 months after starting testosterone. The first study visit will involve a blood draw, an oral glucose tolerance test (sugar drink) and answering questionnair...more > Protocol #17-2328 Location: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital |
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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)...more > Protocol #22-1850 Location: Outpatient CTRC, Renal Research Center, University of Colorado Hospital |
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Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)
Protocol #15-1110 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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Feasibility study of empagliflozin in patients with autosomal dominant polycystic kidney disease
Participation involves taking the study drug empagliflozin or a placebo for 12 months. Blood sample collection, magnetic resonance imaging (MRI) of the kidneys and blood vessel stiffness testing during visits at baseline, 3-month and 12-month to the Renal Research Clinic located at the...more > Protocol #22-0616 Location: Brain Imaging Center (BIC), Brain Imaging Center - BIC, Renal Research Center, University of Colorado Hospital |
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Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss
Aim 1: We will collect samples from of clinically well-characterized trios (products of conception (POC), biological mother, and biological father) with a history of unexplained RPL. Specially, we will recruit a cohort of 1,000 RPL trios that are rigorously-phenotyped and not attributable...more > Protocol #21-3533 Location: Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver |
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Improving the Timeliness and Quality of Care for Rural Cancer Patients with Solid Tumors
Protocol #21-2666 Location: Greeley Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, Pueblo, San Juan Cancer Center, St. Marys Hospital, Grand Junction, University of Colorado Hospital, Yampa Valley Medical Center |
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Effect of weight loss on intermuscular adipose tissue (IMAT) signaling
Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were complete...more > Protocol #23-0545 |
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Effect of weight loss on intermuscular adipose tissue (IMAT) signaling
Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were complete...more > Protocol #23-0545 Location: Brain Imaging Center - BIC, CTRC Inpatient, Outpatient CTRC |
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Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults with Prediabetes
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, ...more > Protocol #23-1721 Location: Anschutz Health and Wellness, Outpatient CTRC |
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Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
The study will randomize 200 adults diagnosed with T2D within the last 12 months. Participants will be randomized to individualized RC or RC paired with individualized post-nutrient glucose excursion minimization (GEM) (RC+GEM). A Randomized Control Trial (RCT) with 1:1 randomization will ...more > Protocol #23-1398 Location: Outpatient CTRC, University of Colorado Hospital |
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Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA
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...more > Protocol #21-4765 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...more > Protocol #20-0288 Location: University of Colorado Hospital |
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis
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...more > Protocol #22-1945 Location: University of Colorado Hospital |
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Acute Equol Supplementation and Vascular Function in Postmenopausal Women with and without CKD
-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: ...more > Protocol #23-0070 Location: Renal Research Center, University of Colorado Hospital |
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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
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...more > Protocol #21-4712 Location: Childrens Hospital Colorado |
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Phase 1 Trial of Hu5F9-G4 (magrolimab) combined with dinutuximab in children and young adults with relapsed and refractory neuroblastoma or relapsed osteosarcoma
This study is being done to answer the following questions: -Is it safe to give magrolimab with dinutuximab to children, adolescents, and young adults with relapsed/refractory neuroblastoma or relapsed osteosarcoma? -What is the best dose of magrolimab to give with dinutuximab in childre...more > Protocol #21-3374 Location: Childrens Hospital Colorado |
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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"
Protocol #23-1258 Location: 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 |
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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
Protocol #23-1448 Location: Lone Tree Medical Center, University of Colorado Hospital |
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NRG-BR008, "A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)
Protocol #23-0798 Location: 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 |
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S2107, "Randomized Phase II trial of encorafenib and cetuximab with or without nivolumab (NSC #748726) for patients with previously treated, microsatellite stable, BRAFV600E metastatic and/or unresectable colorectal cancer," (NCT #05308446)
Protocol #23-0193 Location: 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 |
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A082002: A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or without SBRT for PD-L1-Negative, Advanced Non-small Cell Lung Cancer
Protocol #22-1109 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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Assessing the Risk for Hereditary Cancer in Transmasculine Individuals that are Assigned-Female-at-Birth and the Influence of Genetic Counseling on Surgery Decision
Protocol #22-1357 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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A mixed methods approach to examining decisional needs and contextual factors influencing fertility status assessment outcomes among young female survivors of childhood cancer
This study involves answering online survey questions. These questions will ask about how you feel during this time in your life, your reproductive health and sexual behaviors, if you’ve seen a reproductive specialist, and how you feel about your future fertility....more > Protocol #21-4897 Location: Childrens Hospital Colorado |
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PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER
Protocol #21-5033 Location: 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 |
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NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
Protocol #22-0175 Location: 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 |
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A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
Protocol #22-0306 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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
Protocol #21-4582 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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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
Protocol #21-4711 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients with Brain Metastasis due to HR+/Her2- Breast Cancer
Protocol #21-4199 Location: Cancer Care Northwest, Duke University Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Protocol #21-3855 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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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
Protocol #21-3607 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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Quantification of Endo- and Phytocannabinoids and Comparison to Pain Medication Requirements for Patients Undergoing Surgery for Cancer
To determine how daily cannabis use affects surgical outcomes....more > Protocol #21-3544 Location: University of Colorado Hospital |
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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*)
Protocol #21-2970 Location: 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 |
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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)
Protocol #20-2773 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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A Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
Protocol #19-1536 Location: 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 |
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NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
Protocol #20-2079 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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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)
Protocol #23-1150 Location: Memorial Hospital Central, Memorial Hospital North |
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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)
Protocol #22-0504 Location: 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 |
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S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"
Protocol #20-0359 Location: 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 |
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NRG-HN010, A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naive, Unresectable HER2-Positive Salivary Gland Cancer (NCT05408845)
Protocol #22-2363 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
Protocol #19-0476 Location: 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 |
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LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Protocol #19-0267 Location: 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 |
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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
Protocol #18-2252 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
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...more > Protocol #15-2316 Location: Lone Tree Medical Center, University of Colorado Hospital |
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Efficacy and mechanisms of dapagliflozin in promoting kidney function and cardiovascular health in kidney transplant recipients
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 ...more > Protocol #23-1360 Location: Renal Research Center, University of Colorado Hospital |
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Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
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...more > Protocol #21-3447 Location: Renal Research Center, University of Colorado Hospital |
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The early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy
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) ...more > Protocol #20-0706 Location: 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 |
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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)
This study will involve 6 research visits at 3 timepoints for transgender individuals (before starting estrogen and 6 and 12 months after starting estrogen). No medications are given as a part of this study. Cisgender (non-transgender) participants will have 4 visits at two timepoints ...more > Protocol #19-1226 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus
Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be ...more > Protocol #20-1641 Location: University of Colorado Hospital |
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Monitoring and Predicting Outcomes of Birdshot Chorioretinopathy: A Clinicogenomics Study
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...more > Protocol #22-1985 Location: University of Colorado Hospital |
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Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome
This study is designed to determine whether tofacitinib is a safe and effective treatment for immune skin conditions in adults with Down syndrome, and to further our understanding of the immune system in Down syndrome. This is a single arm, open-label study. All participants will receiv...more > Protocol #19-1362 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Lipids to Energy (LTE) Research Study
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...more > Protocol #21-2860 |
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Lipids to Energy (LTE) Research Study
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...more > Protocol #21-2860 Location: Outpatient CTRC |
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Birth Control Hormonal Injection/Shot Study
-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3...more > Protocol #19-2820 |
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Birth Control Hormonal Injection/Shot Study
-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3...more > Protocol #19-2820 Location: Comprehensive Women's Health Center, University of Colorado Hospital |
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3
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 the rate of disease progression. Aerobic exercise is a treatment with the most compelling evidence for its p...more > Protocol #20-1854 Location: Outpatient CTRC, University of Colorado Hospital |
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The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia
A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia...more > Protocol #21-4972 Locations: Baylor Scott & 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 |
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A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum-Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)
Protocol #21-4100 Location: University of Colorado Hospital |
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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
Protocol #23-1523 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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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
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...more > Protocol #23-0463 Location: CTRC Inpatient, Outpatient CTRC |
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Harnessing Cells from Human Milk; Linking Lactation to Metabolism
In this study: - Participants will complete 2 study visits (in late pregnancy & 2 wks postpartum) - Participants will have their milk production measured and provide blood and breastmilk samples If you join the study, you will be part of the study for up to a month and a half, lasting...more > Protocol #21-2835 Location: CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Sex-based differences in the neuronal mechanisms of food intake behavior
Participants will: -Complete 2 to 4 MRI scans -Complete food, attention, and mood questionnaires -Complete blood draws for measuring hormones -Receive a free Fitbit...more > Protocol #19-1148 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes
If you choose to participate, you will take the study medication, ertugliflozin, or placebo over 4 so-called treatment blocks of 20 days each. You will be recommended foods based on a sodium-controlled diet for approximately 23 weeks. There will be 5 study visits total over 23 weeks, which...more > Protocol #22-0224 Location: Outpatient CTRC, University of Colorado Hospital |
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An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first-line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura
Protocol #23-0481 Location: CTRC Inpatient, University of Colorado Hospital |
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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...more > Protocol #22-1788 Location: Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital |
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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...more > Protocol #21-3994 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 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
Protocol #14-2371 Location: 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 |
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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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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 Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients with Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)
Protocol #18-2431 Location: Kaiser Permanente of Colorado, Mayo Clinic, Arizona, UCLA, Jonsson Cancer Center, University of Colorado Hospital, University of Michigan |
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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 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
Protocol #23-1465 Location: Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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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)
Protocol #23-1322 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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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)"
Protocol #23-0936 Location: 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 |
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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
Protocol #23-0867 Location: 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 |
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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)
Protocol #23-0452 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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
Protocol #22-1819 Location: Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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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
Protocol #22-2095 Location: Memorial Hospital Central, Memorial Hospital North |
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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
Protocol #22-1554 Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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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
Protocol #22-1394 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination with the CDK4/6 Inhibitor Ribociclib or with the PI3K Inhibitor Alpelisib in Adult Subjects with Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
Protocol #22-1277 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/ Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Protocol #21-3077 Location: Cherry Creek Medical Center, University of Colorado Hospital |
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An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, with or without BI 754091, in Patients with Stage IV Colorectal Cancer
Protocol #21-3062 Location: CTRC Inpatient, University of Colorado Hospital |
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A PHASE 2 STUDY OF MECBOTAMAB VEDOTIN (BA3011) ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHO HAD PRIOR DISEASE PROGRESSION ON OR ARE INTOLERANT TO A PD-1/L1, EGFR, OR ALK INHIBITOR
Protocol #21-2670 Location: Outpatient CTRC, University of Colorado Hospital |
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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
Protocol #21-2558 Location: 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 |
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Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer
Protocol #18-2209 Location: University of Colorado Hospital |
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A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naive Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)
Protocol #22-0076 Location: Memorial Hospital Central, Memorial Hospital North |
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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
Protocol #22-2399 Location: Memorial Hospital Central, Memorial Hospital North |
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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
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...more > Protocol #21-4551 Location: Renal Research Center |
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Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD).
Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. Sargramostim has been approved by the FDA for the past thirty years to treat patients who have had chemotherapy to boost the body’s innate immune system. This research study hopes to ...more > Protocol #19-2727 |
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Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD).
Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. Sargramostim has been approved by the FDA for the past thirty years to treat patients who have had chemotherapy to boost the body’s innate immune system. This research study hopes to ...more > Protocol #19-2727 Location: Brain Imaging Center (BIC), CU-RIC, Outpatient CTRC, University of Colorado Hospital |
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FONTANA: A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics,
and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors
Protocol #23-2128 Location: CTRC Inpatient, University of Colorado Hospital |
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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
Protocol #23-0488 Location: CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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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
Protocol #23-0174 Location: Rocky Mountain Regional VA Medical Center |
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A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
Protocol #21-4384 Location: Memorial Hospital Central, Memorial Hospital North |