California Paid Clinical Trials

This research will assess the ability of nightly objective sleep scheduling and sleep heart rate data to predict variation in suicidal ideation in U.S. military veterans identified as high-risk according to actuarial and/or clinical indicators. These data will be recorded using one of two low-cost, commercial, zero-burden, mattress actigraphic systems that enable remote, centralized, data access. Participants will be veterans accrued both from the REACH VET and local high-risk lists, a process involving collaboration with the Suicide Prevention Coordinator at the VA Palo Alto HCS. In order to minimize burden, participants will be screened by telephone, consented by mail and telephone, administered a brief admission psychometric interview by telephone, and mailed a sleep sensor system and instructions for its installation in their home. Once sleep data collection has commenced, a trained interviewer will contact the participant by telephone weekly and administer the Columbia-Suicide Severity Rating Scale. Data collection will continue for three months. The study targets a sample of 40 veterans. Longitudinal mixed effects modeling will be employed to determine whether changes in sleep scheduling and sleep heart rate predict changes in suicidal ideation. Read Less

With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Mild traumatic brain injury (mTBI) is the most common type of brain injury sustained by military personnel and may result in chronic cognitive impairment.Unfortunately, many service members (SMs) have a history of multiple head injuries as well as psychological co-morbidities that negatively influence recovery. Advances in treatment options for cognitive rehabilitation following mTBI have been of increasing interest to the medical community and may increase treatment efficacy for injured SMs to ensure force readiness. Cognitive Rehabilitation (CR) for severe brain injury focuses on compensatory strategies for activities of daily living such as using lists to remember grocery items or reminders to take medications and attend medical appointments. Research has shown CR interventions to have considerable effectiveness in the acute and sub-acute phase of recovery after severe TBI. But there is insufficient evidence that they improve rates of individuals returning to work, independence in activities of daily living (ADL), community re-integration, or quality of life. Read Less

The present study D5272C00001 (Legacy # 3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy. Read Less

Fibula free flaps (FFF) and radial forearm free flaps (RFFF) are necessary to reconstruct parts of the face after cancer surgery, traumas, or debilitating infections. Oftentimes, after we take the flap from the arm or leg, there is a large skin defect that must be filled. A split thickness skin graft (STSG) usually from the thigh can be used to fill this defect. Split thickness skin grafts get their blood supply from the underlying tissue, Hence, pressure must be applied to the skin grafts to ensure that they "stick" to the underlying tissue and are properly perfused. A bolster and cast is placed onto the skin graft to apply pressure and to immobilize the skin graft to optimize healing. However, skin grafts still often do not take well. Thus, the objective of this study is to see if the duration of the cast and bolster over the skin graft has an effect on how well it integrates into the wound bed. The study will compare 2 groups: the standard of care 5-7 day cast group versus the experiment 10-14 day cast group. The hypothesis is that people with longer cast and bolster duration will have better healing rates. Surveys will also be administered to see if cast and bolster duration will affect quality of life and self-esteem. Read Less

The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment. Read Less

This is an open-label extension (OLE) study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of BION-1301 in adults with IgA nephropathy Read Less

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System Read Less

The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction. The current clinical trial will assess the Kaihani Score in 3 groups: Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). Group 2: 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). Group 3: 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). The goal of the study is to confirm preliminary efficacy of the Kaihani Score as a blood based means of assessing gambling propensity. Read Less

A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). Subjects are randomized to KDR2-2 or placebo dosing (6:2 for SDE, or 8:2 for RDE) in each cohorts of relative dosing levels. Read Less

The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 5 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=745. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and N=63 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel. Read Less

This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure. Read Less

To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d Read Less