Education and Training

  • Vitamin C, Thiamine, and Steroids in Sepsis

    The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable placebos for patients with sepsis. The objective of this study is to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality and improving organ function in critically ill patients with sepsis.

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  • Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder

    This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.

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  • Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

    This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma.

    The study will start with monotherapy dose escalation followed by combination cohorts.

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  • Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes

    This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.

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  • Thrombolysis in Pediatric Stroke (TIPS)

    Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of acute AIS.

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  • Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)

    This was a multi-center Phase II study investigating the efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia (ALL) who were treated with tisagenlecleucel and experience B cell recovery.

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  • The Dynamics of Human Atrial Fibrillation

    The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.

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  • TRIAD - Treatment of Insomnia and Depression

    The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.

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  • Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)

    This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

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  • Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery

    This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.

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  • Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment

    This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD). Understanding how cognitive training protects cognitive function in MCI can contribute to development of effective interventions to slow progression to AD in individuals at risk, thereby reducing the significant morbidity and health care costs associated with AD.

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  • Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial

    While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. older women.

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  • Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures

    THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. The use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. This study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can safely prevent desaturation events in children under anesthesia.

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  • TARGET BP I Clinical Trial

    The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

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  • Thromboelastography in Non-elective Cesarean Delivery

    The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

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  • Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

    The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

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  • Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

    This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).

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  • Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)

    The purpose of this study is to expand access to medications for opioid use disorder (MOUD) in specialty addiction programs in Washington State. Sixty-four addiction treatment programs will participate in an adaptive implementation strategy trial that uses a stagewise implementation-to-target (stepped "care" type) approach whereby organizations engage in increasingly intensive implementation strategies as needed. Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets described below. The design also includes an external comparator arm, which consists of 510 addiction treatment programs that are not participating in the study and will mimic as study controls.

    The sequence of implementation strategies are:

    1. Enhanced Monitoring and Feedback

    2. NIATx/MAT Academy

    3. Randomization to either NIATx Internal Facilitation or NIATx External Facilitation

    4. Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

    Implementation targets are:

    1. Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months

    2. Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD

    3. Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

    Contextual moderators and mediators of performance on target outcomes as a function of the implementation strategy step will be examined, as will the costs associated with participation in the sequence of implementation strategies.

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  • Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

    A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

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  • Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

    Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.

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