|
Title |
Role | Design | Planned Enrollment | Actual Enrollment | # of Sites |
|---|
|
Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA)
| DCC |
Purpose: This comparative effectiveness trial among adult subjects with Sickle Cell Disease (SCD) is designed to determine whether: 1) cognitive behavioral therapy (cCBT) will confer greater benefit on daily pain intensity and pain interference at 6 months, compared to medical education (m-education); and, 2) cCBT will confer greater benefit on depressive symptoms, health care utilization, and opioid misuse behaviors compared to m-education.
| 350 randomized to receive either cCBT (n = 175) or m-Education (n = 175). | Recruitment pending | Multicenter study- 5 sites and 3 SCD Community Based Organizations along with virtual subject enrollment |
|
A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care
(AFib LITT)
| DCC |
Purpose: This randomized clinical trial is designed to evaluate the effect of a smartphone-based intervention on health outcomes in people with the heart disease called atrial fibrillation.
Intervention participants will receive a smartphone with an application (or app) called a relational agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will also receive a smartphone with WebMD.
| 240 subjects > 21 years of age with Atrial Fibrillation on anticoagulants. | Recruitment commenced January 22, 2020 | Single center study within 8 UPMC Health System clinics |
| Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
(FAM ACT)
| DCC |
Purpose:The objective of this experimental study is to compare the effectiveness of a novel program—Family Partners for Health Action (FAM-ACT)—to individual patient-focused diabetes self-management education and care management
(I-DSME/CM). This is a randomized comparative effectiveness trial comparing two interventions.
| 268 dyads (adult patient with diabetes and support person) | Recruitment commenced September 26, 2019 | Single Center study |
|
Minimize Menorrhagia in Women with Type 1 Von Willebrand Disease (VWDMin) | DCC |
Purpose: The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.
Subjects randomized to Group I will receive Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles. Subjects randomized to Group II will receive Arm B, then be crossed over to Arm A.
| 60 women age 18-45 years with mild to moderate VWD and menorrhagia | Ongoing | 19 clinical sites |
| A Phase IIb Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Assess the Safety, Tolerability, and Efficacy of Riociguat in Patients with Sickle Cell Diseases
(STERIO-SCD)
| DCC |
Purpose: phase II, multicenter trial to evaluate the safety and tolerability of 12-weeks of treatment with riociguat versus placebo in high-risk patients with sickle cell disease (SCD).
100 adults with sickle cell disease at high risk of sickle cell complications. | 100 adults with sickle cell disease at high risk of sickle cell complications. | Ongoing; commenced in Spring 2017 | Up to 19 clinical sites |
| TAME-PKD: Trial of Administration of Metformin – Autosomal Dominant Polycystic Kidney Disease | DCC | Purpose: phase II, multicenter clinical trial to evaluate the safety and tolerability of metformin versus placebo over a two-year period.
Participants will be randomized in a 1:1 ratio to receive either placebo or metformin, titrated to 1000 mg twice daily, or maximal tolerated dose, over a 6-week period.
| 96 adults aged 18-60 with ADPKD. | Closed to recruitment as of 12/12/2018
Anticipate study closeout December 2020 | 2 |
| A Clinical Research Study to HALT Progression of Polycystic Kidney Disease (HALT PKD Study A) | DCC |
Purpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).
2x2 factorial design where participants were randomized to one of four study arms: 1) combination ACE-I/ARB with standard blood pressure (BP) control (systolic 120-130 and diastolic 70-80 mm Hg); 2) ACE-I monotherapy with standard BP control; 3) combination ACEI/ARB treated to a low BP target (systolic 95-110 and diastolic 60-75 mm Hg); and 4) ACE-I treated to the low BP goal. The primary outcome was the percent change in total kidney volume measured by magnetic resonance (MR) imaging.
| 558 participants with early disease defined by GFR >60 mL/min/1.73 m2. | Completed | 7 |
| A Clinical Research Study to HALT Progression of Polycystic Kidney Disease (HALT PKD Study B) | DCC | Purpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).
Participants were randomized to 1) ACE-I/ARB combination therapy or 2) ACE-I monotherapy to assess impact on composite endpoint of time to a 50% reduction of baseline eGFR, ESRD or death.
| 486 participants with moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2. | Completed | 7 |
