Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean DeliveriesProtocol #: 19-1896 Location: Childrens Hospital Colorado |
Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year. Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation. Protocol #: 19-2362 Locations: Pathology - SOM; University of Colorado Hospital |
Surgical or Medical Treatment for Pediatric Type 2 DiabetesSurgical 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) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. Protocol #: 19-1978 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Outcomes after Standardized Testicular Torsion Management and Follow-upProtocol #: 19-0849 Location: Childrens Hospital Colorado |
Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating RoomProtocol #: 18-2513 Location: Childrens Hospital Colorado |
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesphageal Fistula RepairComparing 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. Protocol #: 18-1823 Location: Childrens Hospital Colorado |
A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial NeoplasiaThe primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with CO2 laser ablation or ultrasonic aspiration. Women referred for treatment following diagnosis of VIN II/III will be randomized to receive CO2 laser ablation (typical treatment for these cases) or ultrasonic aspiration (approved treatment providing a more targeted technique). Secondary objectives will examine incidences of pain, scarring, and sexual and psychosocial distraught following treatment for high-grade dysplasia. Protocol #: 16-0701 Locations: Denver Health Medical Center; University of Colorado Hospital; University of Oklahoma |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)Protocol #: 18-0461 Location: Childrens Hospital Colorado |
Intermuscular adipose tissue (IMAT) - protagonist in sarcopenia and insulin resistance in humansProtocol #: 18-0582 Location: University of Colorado Hospital |
An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical ProcedureThe purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery Protocol #: 18-0546 Location: University of Colorado Hospital |
A Multi-Center, Open-Label, Prospective Study of SpinalStim (MOP-SS) as adjunctive Care following Lumbar Fusion SurgeryThe study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim. Protocol #: 17-1037 Location: University of Colorado Hospital |
Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) StudyProtocol #: 17-0873 Locations: Lone Tree Medical Center; University of Colorado Hospital |