12 Clinical Trials for Various Conditions
The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use. Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.
The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use. Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT. Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations.
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI. Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients. Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.
The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.
The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.
The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, benefits of ERP for this group have not been studied and are not standard of care in pediatric ICUs. Objectives. The aims of this study are 1) To better understand current practices and barriers to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be superior compared to the usual care group. Methods. The first task of this research program is to survey healthcare professionals (physicians, nurses, allied health) and families of children in the ICU about their hospital's resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of ICU admission and those in the usual care group will begin therapies when these services are ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to the ICU \> 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child's clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS) pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical and cognitive function as well as behavior. Other tests will be performed that assesses child and family quality of life and length of hospital admission. Our outcome tests were chosen because 1) They are the most important outcomes to families of children as surveyed in our ICU and 2) They are outcomes that can be influenced by ERP. Summary. This is the first and largest study designed to evaluate whether ERP improves outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will have superior adaptive and quality of life outcomes, outcomes important to families, without increasing adverse events compared to patients in the usual care group.
Brain injury patients who meet defined criteria will be assigned to intensive insulin treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary outcome measure will be neurological outcome at 12 months according to Karnofsky Performance Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+ moderate disability), unfavorable (severely disabled+ vegetative state), and dead. Secondary outcome measures will be blood glucose levels and death.The investigators will also record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction, ventricular arrhythmias, and pneumonia.