Seattle, WA Paid Clinical Trials

For the approximately one in five children with social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the United States, schools are the primary service setting for children's SEB service delivery but EBPPs are rarely adopted or implemented by educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance adoption. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement. Read Less

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Patients' health discussion networks function to support individuals in health related matters and may provide critical support during the lung transplant journey. Increasing awareness of lung transplant, and promoting the process of deliberation and utilization of social support, could reduce the number of people with CF who die without lung transplant. Additionally, the most common patient-endorsed barrier to lung transplant discussions is a worry about being a burden on family and friends after lung transplant. For lung transplant recipients with complex post-operative courses, low social support is associated with increased mortality. Additionally, adequate social support is a requirement at all lung transplant programs in the US. Investigators are interested in understanding how caregivers may benefit from using lung transplant educational resources and how caregivers prepare for having discussions with their loved ones and/or helping them make decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether an investigator-designed research website compared to no caregiver intervention reduces caregiver burden (assessed with the Brief Assessment Scale for Caregivers, BASC), caregiver preparedness for lung transplant discussions, and caregiver lung transplant knowledge as an ancillary study in a multicenter RCT. Further, investigators will assess patient perceptions of caregiver support as measured by the Social Support Effectiveness Questionnaire (SSE-Q) and evaluate caregivers' willingness to provide support through semi-structured interviews in patient-caregiver dyads. Study involvement will span 6 months and study activities will involve the following: * Three Zoom research sessions (15-90 minutes each) * Survey assessments and an interview * Access to a research website that contains educational resources about lung transplant Read Less

The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1) Read Less

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts). The investigators hypothesize that: 1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery. 2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke. 3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future. Read Less

A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN). Read Less

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Read Less

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD. Read Less

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status. Read Less

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: * To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) * To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I * To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care Read Less

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed. Read Less

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19. Read Less

Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers. Read Less