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Solid foods and infant growth
Your baby may be eligible if they are: - Exclusively breastfed - Younger than six months of age - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a 7-month long study, with visits occurring once every month. The first visit, 9-month visit, an... |
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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... |
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University of Colorado Alzheimer's and Cognition Center Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD Study)
This study will establish a large bank of samples and data for future research into the causes of and treatments for Alzheimer’s disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems.... |
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Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches
Regular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movemen... |
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Effects of complementary feeding on infant growth and gut health
Your baby may be eligible if they are: - Breastfed and/or formula fed - Younger than five months of age - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a seven month-long study, from 5 to 12 months of age, with visits occurring every month. ... |
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Blueberry intake and infant gut health
Your breastfed baby may be eligible if they are: - Younger than six months of age - Exclusively breastfed - Full term (> 37-weeks’ gestation) - Have not yet been introduced to solid foods This is a 7-month long study, with visits occurring once every other month. The first and last ... |
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Early iron exposure on the gut microbiota in young infants
This is a four month-long study, beginning at birth. The first study visit is conducted at the University of Colorado Hospital and the last visit takes place at Children’s Hospital Colorado. The other four visits are conducted in your home. Formula is provided to all study participants for... |
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Relationship between Cardiac Health and Exercise Capacity in Men and Women with and without Type 2 Diabetes
CTRC-adult, University of Colorado Hospital Participants will undergo baseline testing of their heart, blood vessel, and skeletal muscle function, and perform tests to determine exercise ability. Participants will then do exercise training for 15 weeks, and all testing will be repeated.... |
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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.... |
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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... |
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Contraceptive Hormone and Reward Measurement (CHARM Study)
The study is looking at the effects of birth control pills on brain processes and emotional wellbeing. During the study you will be asked to take a birth control pill or a placebo pill (a sugar pill) for 21 days. You won't know which pill you are taking. Birth control is a medication t... |
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Social Information Processing in Teens (SIP Study)
Interested in how irritability affects social information processing in teens? Our goal is to learn more about how people commonly react to social ambiguity and how irritable mood may relate to negative interpretations of social signals in adolescence.... |
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Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Adult
The purpose of MoTrPAC is to learn about how exercise benefits health. We know that being physically active is good for our health, but we don’t completely understand how it changes the cells in our bodies. Understanding the cellular benefits of exercise could help scientists develop new... |
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The short-chain fatty acid acetate for improving age-associated arterial dysfunction
If you join this study, you will participate in Screening, Baseline, Study Period, and End of Study visits over a ~4-month period. These visits will take about 14 hours of your time total. The study visits will take place at the Division of Renal Diseases and Hypertension Clinical Research... |
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Cannabis Teens and Choice Study (CATCH Study)
We are currently seeking participants ages 14-21 for a two visit (one remote, one on campus) study at CU Anschutz. The purpose of this research is to better understand the effects of substance use on decision making and biologic-systems in adolescents. Compensation is provided. ... |
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The Child Bipolar Disorder Network (CBN): A Collaborative Treatment Study of Youth With or at High Risk for Bipolar Disorder
Does your child have symptoms of bipolar disorder? We are looking for children, teens, and young adults (ages 9 to 21 years) who have moods that alternate between depression and periods of excessive energy and activity for this study. Participants will get a full diagnostic evaluation fro... |
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Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
This research studies how hormones impact headache and how different parts of the brain talk to each other. You are invited to participate if you are (or your child is): • 9 years to 20 years of age • With or without history of headache • Male sex, male gender identity • Health... |
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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 groups to learn about their effects on blood sugar and metabolism. Participants will be randomly assigned to one of two groups. The first will complete 45-minutes of brisk walking at least 5 days per week and the second... |
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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 ... |
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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... |
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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 ... |
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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 ... |
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Volunteers needed for research study on changing eating behaviors
Study volunteers will be asked to complete an MRI scan, during which they will watch pictures of foods. Participants will also complete a 12-week intervention that involves viewing food or food images, with once-weekly study visits. After the intervention, we will ask volunteers to complet... |
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Cannabis Driving Study
We want to learn more about how people are affected by cannabis in different ways. We will use a driving simulator to compare the driving of adults who use cannabis daily, sometimes, or do not use cannabis. Participants must sign a form saying that they have a safe way to get home after th... |
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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... |
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Ovaprene: Non-hormonal Vaginal Ring Birth Control Study
Clinical trial looking at a monthly, non-hormonal vaginal product as birth control. The vaginal product, called Ovaprene, is a round piece of woven material surrounded by a soft, flexible rubber ring. The material in the vaginal product is released slowly to create an environment that make... |
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Integrated Lifestyle Intervention to Promote Weight Loss Study (COMIRB 23-1154)
If you join the study, you will undergo 2-3 screening visits to see if you are eligible to be in the study. If you are eligible to be in the study, you will receive a 6-month integrated lifestyle intervention program. This integrated program includes PreventT2 (formally known as the Diabet... |
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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... |
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Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias
CU OB-Gyn providers are committed to addressing racial inequities in healthcare. We invite patients, advocates and members of the community who identify as Black, African American, African, Afro-Latinx or Afro-Caribbean to share your experiences and feedback, especially those that have rec... |
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Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
The study is looking for 200 adults diagnosed with T2D within the last 12 months. CU will enroll 100 of those participants. Participants will be assigned to one of two groups. The first group will receive individualized routine care. The second group will receive individualized routine car... |
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A Study Evaluating an Intermittent Fasting Intervention in Adults with Breast Cancer and Overweight or Obesity
If you decide to participate in the study, you will be on an intermittent fasting diet three days per week to reduce what you are eating for 6 months. On the intermittent fasting diet days, you will only eat about 500 calories per day. On the other four non-fasting diet days per week, you ... |
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How When you Eat and Exercise Affect Metabolism in Adults
As a participant in this study, you will be assigned to 4 different diet and exercise groups where the time of your meals and when you exercise will be different. This will last for 4 consecutive days, and you will be provided meals on 2-3 of the days. On the 5th day of each exercise and d... |
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Effects of psilocybin with psychological support on anhedonia in treatment-resistant depression
Participants will be randomly assigned to receive either active psilocybin or placebo. Participation in the study will last a minimum of 13 weeks, up to a maximum of 26 weeks. The study will involve completion of a physical exam, blood draw, two MRI scans, surveys and psychological assessm... |
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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 5.5 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 Blood Lipids Screening; Blood Press... |
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Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (=18 years) transgender women and other individuals identifying as female or transfeminine but with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy (ART) and not curr... |
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Perioperative Informatics of Colorado (PICO) Database
University of Colorado Hospital The development of this database will allow us to study various aspects of care provided by members of the Department of Anesthesiology at the University of Colorado School of Medicine (CU-DOA) and their association with perioperative outcomes or hospital resource utilization. The informat... |
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A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF KPI-012 OPHTHALMIC SOLUTION IN PARTICIPANTS WITH PERSISTENT CORNEAL EPITHELIAL DEFECT (PCED)
University of Colorado Hospital PCED is a persistent non-healing corneal defect or wound that does not heal with traditional treatments. There are many causes of PCED including mechanical trauma, corneal dryness, neurotrophic disease, post-surgical changes, and infection. In patients with PCED, the corneal epithelium (ou... |
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Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)
Childrens Hospital Colorado Enrolling now through August 31st. This study is testing a nasal spray vaccine for RSV. Participants will need to attend 3-5 study visits, 2-4 blood draws, and e-diary entries to monitor for RSV-like illness. Participants will also need to return for any illness visits. ... |
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Protocol S1900K, "A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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An Observational Study in Subjects to Follow the Progression of
Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic
Autosomal Recessive Mutations in the ATP Binding Cassette
Subfamily A Member 4 (ABCA4) Gene
(POLARIS)
University of Colorado Hospital This is a prospective, observational, non-interventional, multi-center, global clinical study of subjects with early to advanced stage STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene, confirmed genotypically by an accredited genotyping laboratory. T... |
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)
Outpatient CTRC, Renal Research Center, University of Colorado Hospital Access to the investigational medication (ravulizumab) will be available to participants following the double-blinded portion of the trial. ... |
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A multicenter, observational study to evaluate corneal neurosensory abnormalities in patients with Sjogren's dry eye
University of Colorado Hospital This clinical study has been designed to evaluate the proportion of patients with confirmed Sjogren's dry eye who present with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity.... |
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A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenone chewable tablets on bone mineral density (BMD) in adolescent and adult women in comparison with non-users of hormonal contraceptive methods.
Comprehensive Women's Health Center, Outpatient CTRC, University of Colorado Hospital Approximately 1700 adolescents and adults will take part in this study at approximately 40 study sites in US and Europe. Participants in the USA who choose to use a hormonal contraceptive method will have an opportunity to use the LF111 tablets or the DRSP 3.5 mg chewable tablets. Approxim... |
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Protocol NRG-BR009, A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score less than or equal to 25 (OFSET)
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids or Moderate to Severe Pain Associated with Endometriosis
Outpatient CTRC, University of Colorado Hospital |
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Master protocol of two independent, randomized,
double-blind, Phase 3 studies comparing efficacy and
safety of frexalimab (SAR441344) to teriflunomide in
adult participants with relapsing forms of multiple
sclerosis
Brain Imaging Center (BIC) - Scan Read, Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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A randomized, double-blind, Phase 3 study comparing
efficacy and safety of frexalimab (SAR441344) to
placebo in adult participants with nonrelapsing
secondary progressive multiple sclerosis
Brain Imaging Center (BIC) - Scan Read, Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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An International, Multicenter, Randomized, Double-Blind, Parallel
Group, Vehicle-Controlled, Phase 2/3 Study with Open-Label Extension
Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the
Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)
Childrens Hospital Colorado International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study with Open-Label Extension ... |
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Postoperative Utilization of Incentive Spirometry with and without Electronic Patient Reminders
University of Colorado Hospital All eligible patients arriving to the PACU every day will be provided with a Vyaire Medical's AirLife volumetric incentive spirometer and instructions to perform 3 IS breaths every 20 minutes until discharge from PACU. The IS device will be set up with the breath volume considered adequate... |
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A Phase 1 study evaluating SC291, a hypoimmune, allogeneic
CD19-directed CAR T cell therapy, in subjects with severe
relapsed or refractory autoimmune diseases (GLEAM)
Outpatient CTRC, Renal Research Center, University of Colorado Hospital Screening and tapering of current immunosuppression therapy for up to 30 days; treatment with lymphodepleting therapy for 3 days followed by one treatment, via infusion, of SC291. Follow-up will be for at least one year. ... |
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A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced
Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540
(BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells,
Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple
Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS)
Brain Imaging Center (BIC) - Scan Read, Outpatient CTRC, University of Colorado Hospital |
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GOG-3091- Nykode VB-C-04: A Two-Arm Randomized, Double-Blind, Placebo-
Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination with Atezolizumab in Patients with HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer who are Refractory to Pembrolizumab with Chemotherapy
with/without Bevacizumab
University of Colorado Hospital |
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BEGIN Substudy: Continuous Glucose Monitoring in Healthy Children
Childrens Hospital Colorado This data is being collected as a sub-study of a larger study, which is looking at blood sugars in children with Cystic Fibrosis (CF). A device called a continuous glucose monitor (CGM) will be used to collect data for this study. The device brand is the Dexcom G6 and it is an FDA-approv... |
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A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy
Brain Imaging Center (BIC) - Scan Read, Department Specific Free Standing Clinic, 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
CTRC Inpatient, University of Colorado Hospital |
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A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial)
University of Colorado Hospital |
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A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Memorial Hospital Central, Memorial Hospital North |
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Early-life determinants of child health: A new Denver-based cohort
Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital This study will focus on collecting information from moms and their babies to understand how the environment and things that happen early in children's life (including before they are conceived or born) influence a broad range of child health outcomes, including their development, health a... |
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The Effects of Hemp-Derived CBD on the Neural Basis of Cannabis-Cue and Emotion Related Processing
Brain Imaging Center (BIC) - Scan Read, Outpatient CTRC We will recruit young adults (ages 18-25). Participants will be selected to achieve a diverse gender and ethnic sample, with roughly balanced male/female participation We will enroll up to 75 participants to achieve a sample size of ~52 participants with usable data. ... |
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A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)
Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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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
Childrens Hospital Colorado This research is being done to better understand Cystic-Fibrosis Related Diabetes (CFRD) and to see the effects of GLP-1 (dulaglutide) in individuals with abnormal glucose tolerance. GLP-1 (dulaglutide) helps the pancreas release insulin, which controls blood sugar levels from getting too... |
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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
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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A 52-week randomized, double-blind, placebocontrolled,
multi-center Phase 2b study with a 52-week blinded extension
assessing safety and efficacy of frexalimab, a
CD40Lantagonist
monoclonal antibody, for preservation of
pancreatic β-cell function in adults and adolescents with newly
diagnosed type 1 diabetes on insulin therapy
Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital DRI17476 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, efficacy, and tolerability of frexalimab in participants with newly diagnosed T1D on insulin therapy: adults (18-35 y.o.)... |
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Accelerating Medicines Partnership:
Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis
Barbara Davis Center, University of Colorado Hospital If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove... |
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A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate long-term safety of Sogroya? (somapacitan) in adults with growth hormone deficiency (AGHD) under normal routine practice (REAL 7)
University of Colorado Hospital We are doing this study to collect information about how safe and effective Sogroya ? (somapacitan) is, when used for treatment of people with Adult Growth Hormone Deficiency (AGHD) such as yourself. Sogroya ? (somapacitan), which is prescribed to you by your doctor. It is commercially ava... |
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Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults with Prediabetes
Anschutz Health and Wellness, Outpatient CTRC Baseline (no exercise) will be performed first with testing done on the fourth day of this condition. Testing will include a full day at the Anschutz Health Science Building Clinical and Translational Research Core clinic and will involve direct measurements of insulin action on the body, ... |
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A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER
CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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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
Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED,
PARALLEL-GROUP PHASE 3 STUDY TO EVALUATE THE EFFICACY AND
SAFETY OF EPITHELIUM-ON CORNEAL CROSS-LINKING IN SUBJECTS 8 TO
45 YEARS OF AGE WITH KERATOCONUS (APRICITY-B)
University of Colorado Hospital To evaluate the efficacy of the riboflavin-sodium iodide solution followed by ultraviolet A (UVA) exposure and epithelium-on corneal crosslinking (CXL) assessed by visual acuity measurement in subjects with keratoconus.... |
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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"
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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A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
Outpatient CTRC This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl... |
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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)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley 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)
Childrens Hospital Colorado Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries... |
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Protocol A012103, "OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy"
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled
Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Barbara Davis Center, University of Colorado Hospital This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec... |
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A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCSZ11 as a Monotherapy and in Combination in Patients with Advanced or Metastatic Solid Tumors
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Efficacy and mechanisms of dapagliflozin in promoting kidney function and cardiovascular health in kidney transplant recipients
Renal Research Center, University of Colorado Hospital Main procedures done in the study: - Physical exam and medical history - Blood draw - Blood pressure - Blood vessel function testing - Urine collection - Kidney function measures - Kidney and cardiac MRI You will take study drug daily for 12 months You will have approximately ... |
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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)"
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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A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants with Thyroid Eye Disease
University of Colorado Hospital The purpose of this dose ranging study is to study the efficacy and safety of TOUR006 SC compared with placebo in participants with moderate to severe TED.... |
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A randomized, sham-controLled, blinded (paTient and evaluators) Feasibility triaL Of the EdWards APTURE transcatheter shunt system
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System... |
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CALIBRATE: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Childrens Hospital Colorado Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)... |
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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
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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Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Brain Imaging Center (BIC), Brain Imaging Center (BIC) - Scan Read, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital This study plans to investigate if taking a protein nutrition supplement (EAA) for 8 weeks may reduce fat that is stored in the liver. This will be compared to 8 weeks of placebo (a “fake” supplement that does not contain protein). Participants will be assigned randomly either the protein ... |
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NRG-BR008, "A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)
Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd? to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype
Barbara Davis Center, Childrens Hospital Colorado A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd? to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype... |
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Validation of Instruments Measuring Caregiver Experiences (Caregiver VOICE Study)
Lone Tree Medical Center, University of Colorado Hospital Attention, Dementia Caregiving Dementia caregivers have important roles in supporting someone with Dementia. We are interested in hearing the voices of those caregivers. Participation in this telephone based study will take approx. 30-45 minutes. We are interested in your perspective o... |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)
Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN) (G0102598)
Childrens Hospital Colorado, University of Colorado Hospital Assess efficacy and safety of iptacopan compared to placebo and standard of care in adults and adolescents (12-17) with IC-MPGN in native Kidneys... |
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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
CTRC Inpatient, Outpatient CTRC The study involves two separate study periods of 12 days each, where you will: • Take the study drug or placebo through a puffer for 7 days. You will not know which drug you are taking during which period • Wear a continuous heart monitor for 12 days • Have blood tests drawn during 5 vi... |
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ASCT2031: A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)
Childrens Hospital Colorado Matched Unrelated Donor (MUD) versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)... |
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Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients with Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital Study participants will undergo testing to identify patterns of right ventricular dysfunction. If a study participant decides to participate in exercise training, the participant will complete an optional Part 2 of the study. Optional Part 2 includes an exercise training intervention follo... |
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Study of the Association between Cellular Processes in the Lung & Blood and Patient Health in Individuals with Rheumatoid Arthritis with and without Evidence of Interstitial Lung Disease
Barbara Davis Center, University of Colorado Hospital This study involves blood tests, sputum collection, physical exams, and questionnaires; it may also involve pulmonary function tests (PFTs) and a high-resolution computed tomography (HRCT) scan of your lungs. PFTs involve breathing into a tube to determine any lung abnormalities while HRCT... |
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A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing
Childrens Hospital Colorado A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study with 6 month treatment phase and 6 month observation phase. ... |
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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)
CTRC Inpatient, Outpatient CTRC, 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
CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with associated Inferior vena cava tumor thrombus (NEOPAX)
University of Colorado Hospital The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can decrease the IVC TT burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patie... |
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TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes
Barbara Davis Center, University of Colorado Hospital This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. We are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with docu... |
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Randomized, controlled trial of Rybelsus (semaglutide) among adults with AUD
Outpatient CTRC, University of Colorado Hospital You will be randomly assigned to one of two groups. You will have a 50% (1 in 2) chance of receiving semaglutide and a 50% chance of receiving placebo. This is a double-blind study, which means neither you nor the study investigator will make the choice to which group you are assigned, an... |
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Brain Imaging Center (BIC), 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
Rocky Mountain Regional VA Medical Center |
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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
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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HOME-BASED CARDIAC REHABILITATION USING A NOVEL MOBILE HEALTH EXERCISE REGIMEN FOLLOWING TRANSCATHETER HEART VALVE INTERVENTIONS
Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital This study is looking at a home-based cardiac rehabilitation mobile app delivered through an iPhone and Apple watch.... |
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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)
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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A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to
Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke
Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
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
Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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A Phase 1/2 Trial of Uproleselan Combined with High Dose Busulfan Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for Patients with Chemotherapy Resistant Acute Myeloid Leukemia
Childrens Hospital Colorado This is a phase 1/2 trial comprised of a dose-finding phase (phase 1) to determine the RP2D of uproleselan followed by a dose expansion phase (phase 2) to further assess safety and to make a preliminary assessment of efficacy of the RP2D. In both phases, uproleselan will be combined with a... |
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A phase 2, randomized, double-blind, placebo-controlled, efficacy and safety study of daxdilimab subcutaneous injection in adult participants with adequately controlled dermatomyositis or anti-synthetase inflammatory myositis
Barbara Davis Center, University of Colorado Hospital This study is a phase 2, randomized controlled proof of concept study to assess the efficacy and safety of daxdilimab in participants 18 to 75 years old with DM or ASIM. The estimated total study duration is 60 weeks with visits to clinic every 4 weeks. Participants will be randomized in a... |
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A 36-week, single-arm, open-label study to evaluate the safety and tolerability of ferric citrate in children with hyperphosphatemia related to chronic kidney disease.
Childrens Hospital Colorado A single arm trial evaluating efficacy of ferric citrate over 36 weeks in pediatric patients with hyperphosphatemia related to CKD.... |
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Boomerang Early Feasibility Study: Prospective, multi-center, single-arm early feasibility study (EFS)
Outpatient CTRC, University of Colorado Hospital Researchers in the BOOM-IBD Clinical Trial are studying whether nerve stimulation can be effective in treating patients with Crohn's disease and ulcerative colitis.... |
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A Phase 1 / 2, Open Label, Study of Amivantamab (JNJ-61186372) Among Participants with Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination with Tyrosine Kinase Inhibitors
Outpatient CTRC, University of Colorado Hospital, University of Michigan, University of Michigan Comprehensive Cancer Center |
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A single and repeat dosing study of the safety, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis
Outpatient CTRC, University of Colorado Hospital A single and repeat dosing study of the safety, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis... |
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The Impact of Auditory Access on the Development of Speech Perception
Cherry Creek Medical Center, Childrens Hospital Colorado, Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital Both infants with and without hearing loss can be enrolled. Infants will complete non-invasive research procedures (i.e., hearing tests, EEG measurements) from 1 month of age up to a year following enrollment. Infants will complete research procedures throughout up to 4 scheduled study vis... |
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Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy
Outpatient CTRC We are recruiting individuals with or without prostate cancer to participate in a research study to help us understand how androgen deprivation therapy affects cardiovascular health. Men with prostate cancer will be studied at the start and after 2 months of androgen deprivation therapy. H... |
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Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
University of Colorado Hospital This study involves interviews with couples facing metastatic colorectal cancer to learn about their experiences and challenges in coping with this disease. From what we learn, we will develop a mindfulness program for couples to lower their stress and help them cope better. ... |
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S2101: Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726)
(BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study
Rocky Mountain Regional VA Medical Center |
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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
Memorial Hospital Central, Memorial Hospital North |
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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
Childrens Hospital Colorado |
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A 2-part Phase 2 Study of Safety, Pharmacokinetics and Biomarkers
in Children with Duchenne Muscular Dystrophy including a Randomized, Double-Blind, Placebo-Controlled Part A, Followed by an Open-Label Part B
Childrens Hospital Colorado This is a 2-part multi-center, Phase 2 study to evaluate the effect of EDG-5506 on safety, PK and biomarkers of muscle damage in approximately 27 children with DMD treated with oral, once daily EDG-5506 for 12 months. Part A will include a 12-week, randomized, double-blind, placebo-contr... |
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DEFIANCE: ClotTriever vs. Anticoagulation for DVT
Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservativ... |
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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)
Childrens Hospital Colorado The primary objective of this phase 2 trial is to decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-... |
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Menstrual profiles and cardiovascular disease risk among female adolescent athletes with and without menstrual irregularities
Childrens Hospital Colorado, Department Specific Free Standing Clinic, Outpatient CTRC Participants will undergo a bone scan, 15 minutes of metabolic testing, and blood draw to assess markers of cardiovascular disease as well as hormone levels. ... |
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A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months. Sponsor Protocol No. mRNA-1273-P206 (BabyCOVE)
Childrens Hospital Colorado The BabyCOVE Study is evaluating an investigational bivalent vaccine. The investigational vaccine cannot make someone sick with COVID-19 and is not a gene therapy, which means it does not cross the nucleus of a cell to integrate with the host genome. The total duration of participation is... |
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Randomized Controlled Multicenter Clinical Trial of Multi-Periscopic Prism Glasses for Homonymous Hemianopia
University of Colorado Hospital In this research study we want to learn more about prism glasses for people with hemianopia (the loss of one half of the field of vision on the same side in both eyes). We will compare a new design of high power prism glasses (called multi-periscopic prisms or MPP glasses) to commercially... |
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Mothers Optimizing Resources Everyday (MORE)
University of Colorado Hospital This study plans to learn more about perinatal mood disorders and sources of support for pregnant and postpartum individuals. Personal and social resources can help individuals cope with the demands associated with the transition to motherhood. Interventions that support personal resources... |
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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)
CTRC Inpatient, 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
Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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NRG-BN011, A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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TELLTALE- NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Medical Center of the Rockies Transcatheter aortic valve implantation (TAVR) may cause life threatening coronary artery obstruction, whether implanted in native aortic stenosis or bioprosthetic aortic valve failure. Transmural Systems and NHLBI have developed a purpose-built electrosurgical guidewire system (TELLTAL... |
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A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ... |
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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
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
CU Sports Medicine - Denver, Department Specific Free Standing Clinic, UCHealth Central Park Medical Center During this study, we will enroll n=48 total subjects who have recently sustained an mTBI. Subjects will be randomized to one of two study groups, followed throughout the duration of the 8-week vNDT intervention period, returned for post-intervention period testing, and then followed via m... |
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A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy
Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6- C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopat... |
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Effects of high- vs. low-dose edible THC on alcohol consumption and neural correlates of reward and aversion
Brain Imaging Center (BIC), Outpatient CTRC Alcohol and cannabis are often used together such that their effects overlap. Such simultaneous use is associated with greater risk for negative consequences, but little is known about the neural mechanisms that underlie simultaneous use. Legal-market cannabis products such as cannabis edi... |
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A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Tirzepatide Study of Renal Function in People with Overweight or Obesity and
Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney
Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic
Resonance Imaging (TREASURE-CKD)
Brain Imaging Center (BIC), CU-RIC, Outpatient CTRC, University of Colorado Hospital |
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NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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
Outpatient CTRC, University of Colorado Hospital 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... |
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Feasibility study of empagliflozin in patients with autosomal dominant polycystic kidney disease
Brain Imaging Center (BIC), Brain Imaging Center (BIC) - Scan Read, Renal Research Center, University of Colorado Hospital 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... |
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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
Childrens Hospital Colorado 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.... |
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PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER
CTRC Inpatient, Department Specific Free Standing Clinic, LSU Health Sciences Center, Mt. Sinai Comprehensive Cancer Center, University of Colorado Hospital, USD Moores Cancer Center, UW Carbone Cancer Center |
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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)
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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GALAXY: Generating Advancements through Longitudinal Analysis in X and Y Syndromes
Childrens Hospital Colorado, Outpatient CTRC Participants who join the GALAXY Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. If participants are seen outside of Children’s Colorado, they can sign a Releas... |
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Understanding How Sleep Health Affects Recovery from Adolescent Concussion
Boulder Health Center, Childrens Hospital Colorado We will conduct a prospective cohort study, with two groups (concussed and control). They will undergo an initial assessment (within 14 days of concussion) and a follow up ~28 days post-concussion. Controls will follow a similar timeline. During the ~two-week period between Visits 1 & 2, p... |
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Feasibility of VR Programs for Anxiety Related Disorders in an Outpatient Care Setting
Department Specific Free Standing Clinic For this project, semi-structured interviews will be conducted with up to 10 providers specializing in mental health care for adolescents and up to 20 adolescents, ages 14-18, with mild to moderate social anxiety symptoms. Adolescent interviews will focus on using the VR program and provi... |
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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
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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A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
Brain Imaging Center (BIC), CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of fatumumab 20mg SC Monthly in Treatment Naive, Very Early Relapsing Remitting Multiple
Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
Brain Imaging Center (BIC), Outpatient CTRC, 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
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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Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA
University of Colorado Hospital In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d... |
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LIMA: LIPID ANTI-FLAMMATORY MEDIATORS IN ASTHMA TO REDUCE HYPERRESONSIVENESS IN OBESE ASTHMATICS
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital The research plan is designed to test the beneficial metabolic and anti-inflammatory actions of an endogenously present class of modified fats, termed nitro-fatty acids. This project provides a novel precision pharmacology therapy, oral CXA-10, for the treatment of obese asthma, a disease ... |
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A prospective, randomized, multi-center evaluation of the Safety and Effectiveness of the STREAMLINE?SURGICAL SYSTEM compared to iStent Inject W? in Patients with Open-Angle Glaucoma
University of Colorado Hospital The STREAMLINE? Surgical System consists of a surgical grade stainless steel disposable cannula (hollow tube) and a manual handset. The stainless steel cannula (hollow tube) is placed along the drainage duct of the eye (also called the trabecular meshwork) and a button is pressed that acti... |
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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
Renal Research Center Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu... |
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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
Childrens Hospital Colorado For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os... |
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ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
Childrens Hospital Colorado |
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A Phase 1/2, dose escalation, dose expansion, and dose optimization study of the safety, tolerability, and anti-tumor activity of SAR444881 administered alone and in combination with pembrolizumab, cetuximab, and/or chemotherapy in participants with advanced solid tumors
University of Colorado Hospital |
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Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease
Childrens Hospital Colorado Understanding the impact of gaps in care on healthcare utilization, long-term co-morbidities, and patient reported outcomes are the highest priority topics from patients, families and researchers. Additionally, knowledge about the factors associated with these gaps in care was a key facto... |
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An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
University of Colorado Hospital |
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Phase I clinical trial utilizing direct peritoneal resuscitation in liver transplant recipient population at increased risk of return to the operating room and early allograft dysfunction.
University of Colorado Hospital This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreci... |
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Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients with Recurrent Medulloblastoma and Ependymoma
Childrens Hospital Colorado Stratum1 - This study is being done to see if we can lower the chance of the brain tumor growing or spreading by adding a new drug called 131I-omburtamab to the usual combination of chemotherapy drugs? We are doing this study because we want to find out if this approach is better or worse ... |
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Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss
Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver 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... |
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PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)
Childrens Hospital Colorado, University of Colorado Hospital The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ... |
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Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
Childrens Hospital Colorado 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... |
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A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling
Childrens Hospital Colorado There are two parts planned for this study, the Phase 1 that will test different doses of avapritinib to identify the recommended dose of avapritinib for the Phase 2. The Phase 2 will continue to test this recommended dose of avapritinib to determine if it is a tolerable, safe, and effecti... |
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Pilot Study of suction as a mechanism of IUD Expulsion with Concomitant Menstrual Cup Use.
Comprehensive Women's Health Center Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences ... |
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The Intersection of Oncology Care and Worker Well-Being
Grandview Hospital, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Saint Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor... |
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Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors
Childrens Hospital Colorado Interviews will be conducted by a member of the study team at two separate time points. Questions about your treatment and different factors that are important to you when making decisions about your treatment. The interviews will be audio and video recorded by the study team. Only study ... |
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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
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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Group Cognitive Behavioral Treatment for Anxiety in Adolescents with Autism and Intellectual Disability: A Randomized Controlled Trial
Department Specific Free Standing Clinic What is the study about? This study investigates an adapted Cognitive Behavior Therapy (CBT) group treatment to determine if it is more effective than therapy services that adolescents with Autism (ASD) and Intellectual Disability (ID) are already receiving. What does the study entail? ... |
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Glucose Monitoring in Youth with Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
Childrens Hospital Colorado 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... |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3, PIVOTAL STUDY WITH AN OPEN-LABEL EXTENSION PERIOD TO EVALUATE THE
EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT
PARTICIPANTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG)
ANTIBODY-ASSOCIATED DISEASE (MOG-AD)
Brain Imaging Center (BIC), 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
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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A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)
Outpatient CTRC, University of Colorado Hospital In the best standard of care (control) arm, each patient will receive best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk‑benefit assessment, institutional protocols, the local Prescribing Information, local regulations o... |
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Harnessing Cells from Human Milk; Linking Lactation to Metabolism
CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital 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... |
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Genetic and epigenomic determinants of hearing loss in Hispanic populations
Boulder Health Center, Childrens Hospital Colorado, University of Colorado Hospital This study aims to identify genes and variants that are related to sensorineural hearing loss (SNHL) in children, including Hispanic children from multiple recruitment sites and non-Hispanic children from Colorado who are diagnosed with severe-to-profound congenital SNHL. We will collect D... |
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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)
Childrens Hospital Colorado 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... |
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Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Renal Research Center, University of Colorado Hospital Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil... |
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A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion
Childrens Hospital Colorado All participants will receive the study drug, larotrectinib. Patients may continue to take the study drug for up to 20 months if there aren't any side effects and their brain tumor does not get worse. Patients will be given a diary to write down the amount of study drugs (number of pills o... |
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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*)
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 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Childrens Hospital Colorado This is a prospective phase 1/2 trial designed to assess the hypothesis that vorinostat, in addition to standard graft versus host disease (GVHD) prophylaxis, is feasible and safe in children, adolescent and young adult patients. All subjects will undergo allogeneic BMT according to local ... |
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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)
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
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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Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease
Brain Imaging Center (BIC) - Scan Read, University of Colorado Hospital 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.... |
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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)
Cherry Creek Medical Center, University of Colorado Hospital |
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Effect of Lower Limb Osseointegration Amputation across Multiple Biomechanical Domains
Brain Imaging Center (BIC), Department Specific Free Standing Clinic, University of Colorado Hospital This study will use a combination of MRI and motion capture data collected in the laboratory to measure forces at the joints during common activities of daily living.... |
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Using Oscillometry in Toddler Aerodigestive Patients to Monitor Lung Function Response to Treatment
Childrens Hospital Colorado In this study, we will 1. Assess different mouthpiece options to help make the test easier to do in young children 2. Obtain AOS measurements in children who are patients in the aerodigestive clinic at Children's Hospital Colorado 3. Compare these measurements to those obtained in chil... |
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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
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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Improving the Timeliness and Quality of Care for Rural Cancer Patients with Solid Tumors
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, UCHealth - Parkview Medical Center, University of Colorado Hospital, Yampa Valley Medical Center |
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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
Childrens Hospital Colorado The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T... |
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Microbiome and Neutrophil associated factors in Rheumatoid Arthritis and Autoimmune-related Interstitial Lung Disease (MINERAL)
Barbara Davis Center, Childrens Hospital Colorado, Denver Health and Hospital Authority, National Jewish Health, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Children's Hospital National (CHN), Children's Hospital National (CHN), Childrens Hospital Colorado, Colorado State University, Uniformed Services University of Health Sciences (USUHS), Uniformed Services University of Health Sciences (USUHS) |
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A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN
ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
Childrens Hospital Colorado SIngle-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patieths with aHUS.... |
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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)
Childrens Hospital Colorado This is a Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and PK of alpelisib in pediatric and adult participants with PROS.... |
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A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone
or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus
Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
Barbara Davis Center, University of Colorado Hospital |
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A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
Renal Research Center, University of Colorado Hospital Each patient will go through a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period. ... |
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Treatment for Alcohol Use Disorder: Emotion Regulation and Brain Function
Brain Imaging Center (BIC), University of Colorado Hospital This study plans to learn more about the brain's role alcohol use problems and recovery. Prominent theories about alcohol use disorder suggest that it is a disorder of the brain. However, it remains unclear what parts of the brain work differently in alcohol use disorder. This study intend... |
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A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
Outpatient CTRC, University of Colorado Hospital This is a phase 3 double-blind (DB), randomized, placebo-controlled study with an open-label long term extension (LTE) evaluating the efficacy and safety of Elafibranor 80 mg once daily versus placebo in patients with PBC and inadequate response or intolerance to ursodeoxycholic acid (UD... |
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Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury: Prospective Observational Study
University of Colorado Hospital Blood, urine, and bone marrow will be collected to analyze biomarkers of acute kidney injury risk. Sublingual microscopy will be used to collect images in the mouth. This is to study the following aims: Aim 1: Determine the effect of pulsatility during CPB on endothelial function. We wil... |
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Werewolf FLOW 50 During ACL Reconstruction: A Randomized Control Trial
Brain Imaging Center (BIC), Childrens Hospital Colorado Participation in this study will not affect the pre, post, or intra-operative care of ACL reconstruction in any way other than either the use of the use of the Werewolf FLOW 50 device or not and the performance of MRI at 6 months postoperative. All involvement and participation will be com... |
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A Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital, Yampa Valley Medical Center |
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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]
Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).
Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, University of Colorado Hospital |
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ALZHEIMER'S CLINICAL TRIAL CONSORTIUM FOR DOWN SYNDROME (ACTC-DS)
TRIAL-READY COHORT - DOWN SYNDROME (TRC-DS)
Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital TRC-DS is part of a larger movement working with people with Down syndrome to advance Alzheimer's disease therapies and potential cures for this population. The Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS) is a large collaboration of researchers conducting clinical trials... |
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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
University of Colorado Hospital What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin... |
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A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Outpatient CTRC, University of Colorado Hospital This study will be conducted in 2 sequential stages. You are being invited to participate in both stages of this study. The entire study period will be of approximately 39 months. Stage 1 (Phase 2b) will include approximately 315 patients and will consist of a screening period (about 2... |
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A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Childrens Hospital Colorado Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br... |
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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
Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital 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.... |
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S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab(NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
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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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3
Outpatient CTRC, University of Colorado Hospital 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... |
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Clonal hematopoiesis, mild cognitive impairment and kidney function decline.
Renal Research Center, University of Colorado Hospital CH is a common aging-associated biological state that predisposes to subsequent cardiovascular death, however, whether it plays a role in MCI, dementia and kidney disease progression is unknown and understanding this novel risk factor may uncover new ways to reduce the burden of cognitiv... |
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Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth (PUBERTY)
Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital 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 ... |
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A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)
University of Colorado Hospital Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable... |
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Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy
Childrens Hospital Colorado, University of Colorado Hospital This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a... |
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Embolization of the Middle Meningeal Artery with ONYX(TM) Liquid Embolic System in the Treatment of Subactue and Chronic Subdural Hematoma (EMBOLISE)
University of Colorado Hospital The purpose of this study is to evaluate the safety (short and long term side effects) and effectiveness (how well it helps) of Onyx Liquid Embolic System(LES) (study device) embolization of the middle meningeal artery when used in addition to the standard treatment that is used to treat a... |
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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)
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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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn... |
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Inspiring New Science in Guiding Healthcare in Turner Syndrome (INSIGHTS) Registry
Ann & Robert H. Lurie Children's Hospital of Chicago, Childrens Hospital Colorado, Childrens Hospital of Philadelphia, Childrens National Medical Center, University of North Carolina Children's Hospital, University of Texas Health Science Center at Houston Participants who join the INSIGHTS Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. In addition to the basic registry, individuals can join a recruitment list f... |
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Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB Suture Anchor, MICRORAPTOR Knotless REGENESORB Suture Anchor and MICRORAPTOR Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
Highlands Ranch Hospital, UCHealth Steadman Hawkins Clinic - Denver (Inverness), 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
Broomfield Hospital, Cherry Creek Medical Center, Childrens Hospital Colorado, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Outpatient CTRC, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry What Happens If I Join the Study? - You will have 4 study visits during pregnancy and 1 study visit after your baby is born - You will be asked to prick your finger to monitor blood sugar and blood triglyceride levels 4 times a day for 4 days after each visit (total of 64 finger pokes) ... |
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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
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 A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia... |
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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"
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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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
University of Colorado Hospital Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B c... |
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Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study
Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp... |
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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
University of Colorado Hospital 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... |
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ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Childrens Hospital Colorado |
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The use of thoracic epidural, paravertebral nerve blockade and video-assisted intercostal nerve cryoablation for postoperative analgesia after minimally invasive repair of pectus excavatum
Childrens Hospital Colorado The study is to learn more about treating pain after having a minimally invasive repair of pectus excavatum while randomly assigning different pain methods that are typically used for this procedure.... |
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A Preliminary Patient Cohort Study to Investigate Long Bone Fracture Healing Prediction Using Electromagnetic Resonance Coupling of Orthopedic Hardware
Medical Center of the Rockies Screened patients will be briefed of the study protocol and if interested in participating in the study, will complete informed consent. During their regular follow-up visits, patients will have an antenna attached to their affected limb using velcro straps and stand on a flat platform tha... |
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CLASP II TR- Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial
Harmony Campus, Medical Center of the Rockies 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... |
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In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study
Boulder Sports Clinic, CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee inject... |
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Deep Brain Stimulation (DBS) for Methamphetamine Use Disorder
Brain Imaging Center (BIC), University of Colorado Hospital In a randomized cross-over design of DBS of the nucleus accumbens (NAc) for treatment refractory methamphetamine use disorder (MUD, n=5), we will test safety, feasibility, effect on clinical outcomes (craving and use), and seek to identify biological targets (using cue craving during recor... |
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Research Study 19-2335
Brain Imaging Center (BIC), Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and tw... |
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RADIANT:Rare and Atypical Diabetes Network
Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, Outpatient CTRC, Steadman Hawkins Clinic - Denver, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital |
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Effects of puberty and pubertal suppression on insulin sensitivity, metabolic rate and vascular health
Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital This study will involve 4-5 in person visits. There will be screening visit for some patients and then a baseline visit over two days. The first day will involve an IV and drinking a sugary drink with blood draws as well as measuring the resting metabolic rate and answering questionnaires.... |
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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
Childrens Hospital Colorado |
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MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME
Childrens Hospital Colorado 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... |
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Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Childrens Hospital Colorado, University of Colorado Hospital Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D)... |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
University of Colorado Hospital 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... |
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Monitoring and Predicting Outcomes of Birdshot Chorioretinopathy: A Clinicogenomics Study
University of Colorado Hospital For patients with BSCR, blood sample draw will be obtained (with option for minimally invasive cheek/saliva swab) in the clinic and clinical data will be collected. There are no planned interventions outside of their normal standard of care. Patients will then be contacted by our clinical... |
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Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
University of Colorado Hospital 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... |
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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)
Childrens Hospital Colorado |
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Research Study 19-1658
Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital Few medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may... |
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Safety and efficacy of tofacitinib for immune skin conditions in Down syndrome
Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital 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... |
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PrecISE: Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (adolescents, age 12-18)
Childrens Hospital Colorado PrecISE: A breath of fresh air from the National Institutes of Health (NIH). Severe asthma is different for everyone. That is why we need you for PrecISE. Join a severe asthma study unlike any other. Have the opportunity to try many different therapies not available otherwise. Talk with a... |
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Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome (PCOS) (RESTORE Study)
Childrens Hospital Colorado, Outpatient CTRC For this study, participants will complete a screening visit to determine eligibility. They will collect 4-months of daily urine to determine rates of ovulation prior to starting semaglutide treatment. They will complete an oral sugar tolerance test (drink a sugary drink) to measure their ... |
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Sex-based differences in the neuronal mechanisms of food intake behavior
Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital Participants will: -Complete 2 to 4 MRI scans -Complete food, attention, and mood questionnaires -Complete blood draws for measuring hormones -Receive a free Fitbit... |
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Prevention of enamel demineralization in fixed appliance orthodontic patients using CPP-ACP-NaF varnish compared to blank varnish base. A randomized split mouth controlled clinical trial
Dental Clinic, UCD Dental Clinic The hypothesis is that casein phosphopeptide stabilized amorphous calcium phosphate fluoride releasing (CPP-ACP-NaF) dental varnish will be more effective at reducing enamel demineralization than the control varnish base that does not contain CPP-ACP-NaF. ... |
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Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
Rocky Mountain Regional VA Medical Center, University of Colorado Hospital This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c... |
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CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3
Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic
Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Barbara Davis Center, University of Colorado Hospital This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ... |
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A Phase 1/2, Multi-regional, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Gene Therapy for Leber's Hereditary Optic Neuropathy (LHON) Associated with ND1 Mutation
University of Colorado Hospital The study drug is an investigational gene therapy product. Gene therapy is a technique that uses genes to treat or cure disease. “Investigational” means that the study drug is currently being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States... |
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SANDIA: Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control
Outpatient CTRC, University of Colorado Hospital This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline to controller therapy in obese late onset asthmatics: a) improves asthma control, and b) increases FeNO levels. Secondary research questions are to determine if L-citrull... |
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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)
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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Multiomics Investigation of Marijuana Use
Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital This research study seeks to learn more about biomarkers and biological pathways associated with marijuana use. We are enrolling adults who are marijuana users or non-users. The study involves filling out online surveys and one on-campus visit to give a blood, urine, and hair sample. If yo... |
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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)
Harmony Campus, Medical Center of the Rockies 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.... |
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Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
Renal Research Center, University of Colorado Hospital This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ... |
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IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
University of Colorado Hospital Study IMVT-1401-3201 is a Phase 3, multi-center, randomized, quadruple‑masked (Sponsor, Investigator, assessor, and participant), placebo‑controlled study was designed to assess the efficacy and safety of batoclimab in adult participants with active, moderate to severe TED. The study durat... |
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PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations
Childrens Hospital Colorado This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dos... |
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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)
Childrens Hospital Colorado |
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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
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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)
Arizona Centers for Digestive Health, Connecticut Clinical Research Institute, Gastrointestinal Associates, P.C. Knoxville, Geisinger Medical Center, Kaiser Permanente of Colorado, Kaiser Permanente, CA, Mayo Clinic, Arizona, Mayo Clinic, Rochester, Northwell (Long Island Jewish Medical Center), Northwestern University, Suncoast Endoscopy of Sarasota, UCLA, Jonsson Cancer Center, University of Colorado Hospital, University of Michigan, University of North Carolina - Division of Gastroenterology and Hepatology, University of Rochester Medical Center, Weill Cornell Medicine |
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A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula Repair
Childrens Hospital Colorado Comparing using a transanastomotic tube and not using a transanastomotic tube when repairing esophageal atresia with distal tracheoesophageal fistula by collecting different factors related to the procedure.... |
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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
Childrens Hospital Colorado |
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A 2-and-5-year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with or without additional stabilization using the coflex? ? Interlaminar Technology for FDA Actual Conditions of Use Study.
Highlands Ranch Hospital, University of Colorado Hospital The first objective addresses coflex? performance in actual conditions of use settings at two years and at five years relative to pivotal trial device performance. The second objective compares coflex? performance in actual conditions of use settings to decompression alone using data from ... |
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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
Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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VA Protocol: Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital Adults diagnosed with schizophrenia are needed for a clinical trial to learn more about how a new medication may affect the brain. Study participants will complete MRI scans, clinical interviews, and cognitive tests. Duration of participation: 14 weeks. Participants will be compensated for... |
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The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
University of Colorado Hospital The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compa... |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY,
SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN
PATIENTS WITH ANTIN-METHYL-D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTILEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A study of the genetics of pulmonary fibrosis
University of Colorado Hospital This study plans to learn more about pulmonary fibrosis and determine if some diseases that cause scarring in the lung might be inherited diseases. We are especially interested in the genetics of pulmonary fibrosis and cases where it might run in families. What we learn may be helpful in... |
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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")
University of Colorado Hospital 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... |
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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
Outpatient CTRC, University of Colorado Hospital This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at we... |
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Impact of Fever Prevention in Brain Injured Patients (INTREPID)
University of Colorado Hospital Patients randomized to the fever prevention group will have ArcticGel Pads placed on their body. These will be connected to the Arctic Sun System. The system will be programmed to keep the patient's body temperature at 98.6. Treatment will last for 14 days or until ready to be discharge... |
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A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
Outpatient CTRC, University of Colorado Hospital Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad... |
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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ... |
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Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado
Childrens Hospital Colorado This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to iden... |
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Phase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma
Childrens Hospital Colorado Because of your cancer diagnosis, we previously received your permission to make HER2 CAR T cells from the blood you provided. Now, because we have successfully made your HER2 CAR T cells, you will be asked to enroll on the Phase 1 treatment study. The treatment for the Phase 1 study will ... |
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The Physical, Mental, and Emotional Effects of Youth Girls Flag Football: A Prospective Investigation
Childrens Hospital Colorado Participants will complete three in person visits (1) mid-August 2023 (2) mid/late October 2023 (3) April 2024. They will complete 20 minutes of questionnaires and 20 minutes of functional tests at each visit and receive $50 for each visit completed. Participants will also complete weekly ... |
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Study to improve dEployment related Asthma by using L-citrulline Supplementation (SEALS)
Outpatient CTRC, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital 2. This is a proof-of-concept, randomized, double blinded, placebo controlled study to determine if adding on L-citrulline for deployment related asthmatics: a) improves asthma control, and b) increases FeNO levels.... |
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Effects of pubertal blockade and hormone therapy on cardiometabolic risk markers in transgender adolescents
Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital There will be 6 study visits over about a year. They will take place over 2 days before starting testosterone and then 1 month and 12 months after starting testosterone. The first study visit will involve a blood draw, an oral glucose tolerance test (sugar drink) and answering questionnair... |
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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017
Boulder Sports Clinic, University of Colorado Hospital This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (... |
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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
CTRC-adult, Outpatient CTRC, University of Colorado Hospital 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... |
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Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/Obesity
Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital In this study, we will be evaluating the effects of a reverse-diet compared to standard weight loss maintenance advice.... |
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JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus
Barbara Davis Center, University of Colorado Hospital This phase 2 trial is a double-blind, randomized, placebo-controlled clinical trial in male and female adolescent and adult participants (ages 12-35 years) with newly diagnosed Stage 3 T1D (within 100 days of diagnosis). Enrollment into abrocitinib and ritlecitinib arms and the shared ... |
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The Assessment of Long Term Durability, Safety and Effectiveness of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valve and Surgical Aortic
Valve Replacement in Intermediate Risk Patients Suffering from Severe
Symptomatic Aortic Stenosis
University of Colorado Hospital he PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control ar... |
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Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)
University of Colorado Hospital The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthri... |
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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)
Memorial Hospital Central, Memorial Hospital North |
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Randomized Trial of Sedative Choice for Intubation ("RSI") Trial
University of Colorado Hospital Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient ou... |
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Protocol A022102, A Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma (NCT05677490)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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Clinical trial to validate the 2015 ATA thyroid nodule management guidelines, assess diagnostic performance of a thyroid nodule management algorithm based upon a published malignancy risk estimation model relative to TI-RADS and ATA categories, and to evaluate inter-observer variability of assessment of sonographic features and risk patterns of thyroid nodules
Colorado Research Center, Department Specific Free Standing Clinic, 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
Harmony Campus, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Yampa Valley Medical Center |
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Mindfulness-Based Intervention for Adolescents with Chronic Migraine
Childrens Hospital Colorado Learning from YOU will help us improve a program that can help teens with chronic migraine live a better life! We would like to interview you and your parent for 1 hour each. Interviews can be over Zoom or in person. Interviews will help us understand your experience living with migr... |
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An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
University of Colorado Hospital Study IMVT-1401-3203 is a 2-cohort extension study for eligible participants completing the Week 24 visit on the feeder studies, IMVT-1401-3201 or IMVT-1401-3202. Participants will be assessed as proptosis responders or non-responders at Week 24 in the feeder studies. Based upon this as... |
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A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies
Barbara Davis Center, Cherry Creek Medical Center, CTRC Inpatient, University of Colorado Hospital Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Tr... |
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(AG348-C-023) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency
Who Are Not Regularly Transfused, Followed by a 5-Year Open-label Extension Period
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
Outpatient CTRC, Renal Research Center, University of Colorado Hospital Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)... |
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NEWLY DIAGNOSED CHILDREN (LESS THAN 10 YEARS OLD) WITH MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS: CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO EITHER SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR
CELL RESCUE
Childrens Hospital Colorado |
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A 52-week, randomised, double-blind, double-dummy, parallel group,
multi-centre, non-inferiority study assessing exacerbation rate, additional measures of
asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab
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
Memorial Hospital Central Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site.... |
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Real-Time Assessment of Lung Structure and Function in Children and Young Adults with CF using Electrical Impedance Tomography
Childrens Hospital Colorado Single visit to Children's Hospital Colorado - During this visit your height, weight, date of birth, and gender will be recorded. You will also have some tests done including pulmonary function testing (spirometry), EIT, and multiple breath washout (MBW).... |
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Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
Lone Tree Medical Center, University of Colorado Hospital The primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and ear... |
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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)
Medical Center of the Rockies Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site.... |
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis
Barbara Davis Center, University of Colorado Hospital This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to pla... |
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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
Memorial Hospital Central, Memorial Hospital North |
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MECHANISTIC INVESTIGATION OF THERAPIES FOR DOWN SYNDROME REGRESSION DISORDER
Childrens Hospital Colorado Individuals with Down syndrome (DS) have an increased risk of numerous co-occurring conditions, including the neuropsychiatric condition known as Down Syndrome Regression Disorder (DSRD). A DSRD diagnosis often includes a sub-acute onset of catatonia, mutism, depersonalization, loss of abi... |
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An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma
CTRC Inpatient, University of Colorado Hospital |
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An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta
Childrens Hospital Colorado A clinical trial examining the efficacy of Setrusumab in reducing fractures compared to a placebo for patients with Osteogenesis Imperfecta.... |
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NRG-GY026, "A Phase II/III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) or pertuzumab trastuzumab and hyaluronidase-zzfx (PHESGO) in HER2 positive, stage I-IV endometrial serous carcinoma or carcinosarcoma," (#NCT05256225)
Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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Blood Disorder Symptomatology Outcomes Network Patient Reported Outcomes (BISON-PRO) Quality of Life Study
Cherry Creek Medical Center, University of Colorado Hospital The BISON-PRO Quality of Life Study is a research study to measure symptoms and quality of life using online surveys in patients with blood disorders.... |
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PIKture-01: First-in-Human Study of the PI3KalphaH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants with Advanced Solid Tumors and in Combination with Endocrine Therapy or HER2 Targeted Therapy in Participants with Advanced Breast Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A PHASE I, MULTICENTER, OPEN-LABEL,UNCONTROLLED STUDY TO EVALUATE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OFSATRALIZUMAB IN ADULT PATIENTS WITH AQP4 ANTIBODYPOSITIVE NEUROMYELITIS OPTICA SPECTRUM DISORDER WITH BODYWEIGHT 100 KG
Outpatient CTRC, University of Colorado Hospital |
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Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia - SCOPELeukemia
University of Colorado Hospital This is a cluster randomized comparative effectiveness trial of primary palliative care (PC) versus specialty PC in 1150 patients with acute myeloid leukemia (AML) and their caregivers.... |
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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
Cherry Creek Medical Center, Denver Health and Hospital Authority, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |