Clinical trials: sponsored by University of Colorado, Denver
Suicidal Ideas, Suicidal Ideation
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
The purpose of this study is to test whether a lethal means safety planning intervention, TEEN LENS ED, is acceptable to teens at elevated suicide risk and their caregivers in the Emergency Department.
- Conditions
- Suicidal Ideas, Suicidal Ideation, Suicidal Thoughts, Firearm Safety
- Trial name
- TEEN LENS ED (NCT07916792)
- Testing
- TEEN LENS, Usual Care
- Volunteers
- 200 people
- Sponsor
- University of Colorado, Denver
Overweight Adolescents, Sleep
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Many teenagers get too little and late timed sleep. High body weight and diabetes are increasing in teenagers as well. This study plans to learn more about whether improving sleep habits can help improve how the body regulates…
- Conditions
- Overweight Adolescents, Sleep, Insulin Sensitivity
- Trial name
- REST (NCT07618117)
- Testing
- Circadian/Sleep (C/S)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
Migraine, Migraine in Adolescence
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and…
- Trial name
- HEADS-UP (NCT07513662)
- Testing
- BREATHE with Headache (BREATHE-HA), Enhanced Standard-of-Care: Headache Education
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Colorado, Denver
Diabetes Mellitus, Type 1 Diabetes
Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
This study plans to learn more about whether a support program delivered in Spanish or both English and Spanish for bilingual families helps Latino youth with Type 1 Diabetes (T1D) successfully use the Medtronic MiniMed 780G…
- Trial name
- APOYO780G (NCT07720388)
- Testing
- Culturally and linguistically tailored onboarding and support program, Medtronic MiniMed 780G Insulin Pump System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Colorado, Denver
Charcot-Marie-Tooth Disease, Type Ia (Disorder), HMSN
Genetics of Charcot Marie Tooth (CMT) - Modifiers of CMT1A, New Causes of CMT2
This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has.
- Trial name
- INC-6602 (NCT01193088)
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Childhood Cancer, Survivorship
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
More than 80% of childhood cancer survivors develop serious or life-threatening late effects after cancer therapy, but <20% receive recommended survivorship care offered at cancer center survivorship clinics.
- Conditions
- Childhood Cancer, Survivorship, Health Care Utilization, Health Knowledge, Attitudes, Practice
- Trial name
- BRIDGES (NCT05448560)
- Testing
- Multi-level Intervention of shared model of survivorship care, Comparison Group
- Where
- 4 sites in United States
- Volunteers
- 240 people
- Sponsor
- Georgetown University
Charcot Marie Tooth Disease
Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and Others
This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C…
- Trial name
- INC-6601 (NCT01193075)
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Michael Shy
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
International PPB/DICER1 Registry
PPB has strong genetic implications, with a unique set of conditions in an individual or their family, occurring mostly in childhood and adolescence.
- Conditions
- Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor, DICER1 Syndrome, Cystic Nephroma
- Trial name
- NCT03382158
- Where
- United States
- Volunteers
- 3,400 people, healthy volunteers welcome
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Diabetes Mellitus
Multicenter Assessment of the Pancreas in Type 1 Diabetes
The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative…
- Trial name
- MAP-T1D (NCT03585153)
- Testing
- Non-contrast magnetic resonance imaging
- Where
- 5 sites in United States, Australia
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Adenovirus, Primary Immune Deficiency Disorder
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with…
- Trial name
- NCT03266627
- Testing
- cytotoxic t-lymphocytes
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- New York Medical College
Pelvic Pain, Pelvic Floor Dysfunction
HOme PElvic Floor Improvement Trainer Trial
This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain.
- Conditions
- Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
- Trial name
- HoPe FIT (NCT06909539)
- Testing
- Home Pelvic Floor Trainer
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Colorado, Denver
Diabetes Mellitus, Diabetes Mellitus, Type 1
Day and Night Closed-loop in Young People With Type 1 Diabetes
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases
- Trial name
- DAN05 (NCT02925299)
- Testing
- FlorenceM (US) and FlorenceX (UK), Insulin pump therapy
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 133 people
- Sponsor
- Jaeb Center for Health Research
Child Obesity
Community Active and Healthy Families Pragmatic Trial
This is a randomized pragmatic trial of the Community-AHF intervention to evaluate its effectiveness at decreasing body mass index in 5-12 year old children.
- Trial name
- NCT07868471
- Testing
- Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment
- Volunteers
- 416 people
- Sponsor
- University of Colorado, Denver
Human Immunodeficiency Virus, Mental Disorder
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya.
- Trial name
- NCT06117163
- Testing
- Collaborative Care Model
- Where
- Kenya
- Volunteers
- 900 people
- Sponsor
- University of Colorado, Denver
Type 2 Diabetes
SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and…
- Trial name
- NCT07409714
- Testing
- Montelukast
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Colorado, Denver
Autism Spectrum Disorder
Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are: Does occupational therapy integrating horses improve self-regulation in…
- Trial name
- NCT05846932
- Testing
- OTEE HORS, OT Clinic
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Colorado State University
Acanthamoeba Keratitis
Parasitic Ulcer Treatment Trial
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis…
- Trial name
- PUTT (NCT06213649)
- Testing
- Polyhexamethylene biguanide (PHMB), Topical corticosteroid
- Where
- 22 sites in United States, Brazil and 2 more
- Volunteers
- 232 people
- Sponsor
- Jeremy Keenan, MD, MPH
Medication Abuse, Harm Reduction
Evaluation of Clinical Decision Support in Opioid Tapering
The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the…
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing
- Trial name
- NCT06527079
- Testing
- Observational study without a prospective intervention
- Volunteers
- 200,000 people
- Sponsor
- University of Colorado, Denver
Medication Abuse, Harm Reduction
Clinical Decision Support to Improve System Naloxone Co-prescribing
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
- Trial name
- NCT06271668
- Testing
- Naloxone Co-prescribing Clinical Decision Support (CDS)
- Where
- United States
- Volunteers
- 114,272 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Hydrocephalus
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen.
- Trial name
- ESTHI (NCT04177914)
- Testing
- Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), Ventriculoperitoneal Shunt
- Where
- 21 sites in United States, Canada
- Volunteers
- 165 people
- Sponsor
- University of Utah