Seattle, WA Paid Clinical Trials

The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery. Read Less

The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Read Less

Phase 1: In 51 patients undergoing shoulder arthroplasties, total serum testosterone, free testosterone and sex hormone binding globulin levels obtained in the clinic before surgery were correlated with the levels of Cutibacterium on the skin in clinic, in the operating room prior to surgery, and in the skin incision. Phase 2: The investigators wish to determine if preoperative serum testosterone levels are associated with risk for shoulder PJI (periprosthetic joint infection) in patients undergoing primary shoulder arthroplasty. Also to determine if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty. Read Less

The investigators will screen all mechanically ventilated ED patients for study eligibility and will enroll all consecutive patients satisfying inclusion and exclusion criteria. The study design is a pragmatic, multicenter, stepped wedge cluster randomized trial, enrolling at five sites over a 3-year period, divided into six time periods of six months. Prior to the study, each site will be randomized to their position within the design. One site will cross to the intervention period (i.e. succinylcholine as default neuromuscular blocker) every six months from the 2nd to 6th time period. Cluster order will be determined by computer-based randomization. To begin, each site will be exposed to control conditions; by the end of the study, each site will be exposed to intervention conditions. Patients in the control phase will receive usual care, and this phase will be entirely observational. After six months, a site will enter a 2-month transition phase. In this phase, the investigators will implement the intervention, similar to how they have implemented other ED-based interventions for mechanically ventilated patients. The investigators will engage and educate ED clinicians on the importance of AWP prevention and the study objectives. The intervention framework relies on the use of "nudges", without restricting choice. The use of neuromuscular blockers (i.e. "paralytic" medications) is already part of routine care in the ED in order to facilitate endotracheal intubation and initiation of mechanical ventilation for patients with acute respiratory failure. The two most common neuromuscular blockers used in the ED are succinylcholine and rocuronium. The preliminary data show a strong association between rocuronium (a longer-acting neuromuscular blocker) use and AWP. Therefore, this study aims to improve care by educating caregivers on AWP and the use of the neuromuscular blockers, which are already routinely used, and studying that process in a rigorous fashion. The default neuromuscular blocker in the intervention phase will be succinylcholine. Succinylcholine will be the default over rocuronium because: 1) it has safely been the default neuromuscular blocker of choice in the ED for \>40 years ; 2) its 5-minute duration of action greatly reduces AWP risk; 3) the preliminary data regarding an increased risk of AWP with rocuronium and 4) ED rocuronium use has increased despite no patient-centered studies showing benefit over succinylcholine. Passive alerts (i.e. graphics, pocket cards) will also be strategically placed in the ED, and active alerts will be used as reminders before every nursing shift (i.e. "the huddle"). After this transition phase, the site will begin the intervention phase, and patients will again receive clinician-directed care, just after the intervention. Read Less

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward. Read Less

The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups. Read Less

The increased prevalence of autism spectrum disorder (1 in 36 youth) in the United States along with the exorbitant cost of care of supporting one autistic individual with and without intellectual disability across their lifespan ($2.4 and $1.4 million, respectively) creates a sense of urgency to improve outcomes for autistic youth. Schools are the primary setting in which autistic children receive intervention. Despite a growing array of evidence-based interventions (EBI) such as behavioral management, EBIs often are unavailable in schools due to misalignment of existing implementation strategies (IS) with that setting. Large numbers of IS have been described for the education sector, but there is a dire need to identify the most efficient IS to support use of EBI in resource-strapped public schools. This project will apply the local Discover, Design/Build and Test (DDBT) framework to redesign and pilot a multifaceted IS to support educator use of a behavioral skills EBI for autistic children in public schools. Read Less

Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS). Read Less

The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible? Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment. Read Less

The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study. Read Less

This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs. We will also examine the effect of tSCS on lower urinary tract (LUT) and bowel functions as secondary outcomes. The main questions this study aims to answer are: 1. Assess the safety of single and repeated tSCS session(s) on cardiovascular function in the acute SCI: We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge (i.e., situ-up tests) at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI ≥ T6. 2. Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase: We will investigate the efficacy of long-term (total 18 sessions) tSCS on cardiovascular and pelvic organ functions. 3. Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI: We will assess the sustained effect of repeated tSCS sessions (18 sessions) on cardiovascular and pelvic organ functions at 6-month post-SCI. Participants will: * Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while inpatient in the first 8 weeks (Part A). * Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks (Part B), with a follow-up period of 6 months. All participants will receive tSCS during this outpatient follow-up portion of the study. * During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, bladder and bowel, physical, and autonomic exam, and will ask questions about quality of life and functioning. Participants will be asked to complete a test of how well their bowels are functioning (colonic transit test) and an abdominal X-Ray. Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the body's autonomic functioning following recent-onset SCI. Read Less

This randomized controlled factorial trial will examine whether and how relaxation training, behavioral activation, and cognitive therapy improve fatigue and functioning in fatigued adults living with multiple sclerosis. Read Less