Seattle, WA Paid Clinical Trials

The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model. Read Less

When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, the investigators will perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, the investigators will use both patient reported outcomes, and measurements of the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. The investigators propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Participants will be randomly assigned and fit with either a prosthesis made with study helper assistance and digital methods, or one made wholly by a prosthetist using traditional methods. Patient reported outcome metrics will be collected while the subject is still wearing their as-prescribed socket at the beginning of the study (baseline), and again after wearing the study prosthesis for two weeks. Specific Aim 2: Determine if distal end residual limb pressure, measured from a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are no worse than those measured from a group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. Concurrent with the human subject procedures briefly described above, the investigators propose to fabricate duplicates (copies) of the two prosthetic sockets used by each subject in Specific Aim 1. A novel sensor will be embedded in these duplicate sockets which can measure the pressure applied to the distal end of the residual limb. Measurements of distal end residual limb pressure while standing and walking for both the as-prescribed and study sockets will be collected at the beginning of the study (baseline), and again after two weeks. The data from the investigators' experiments will be used to determine if residual limb shape capture by a helper using digital technologies can be used to make prosthetic sockets that fit at least as well as those made by a prosthetist using traditional, hand casting techniques. One third of all Veterans live in rural communities far from VA Medical Centers. When Veterans with a lower limb amputation need a new prosthetic socket, attending in-person clinical visits can be a challenge. If the hypotheses are supported, this research will provide evidence to support the use of digital technology as part of clinical practice, enabling a remote, study helper enabled alternative to one of the in-person clinical visits needed to fabricate a well-fitting prosthesis. Read Less

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Read Less

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened. Read Less

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America. Read Less

Investigators will conduct a hybrid implementation-effectiveness trial of a trauma-adapted Comprehensive School Physical Activity Program (CSPAP) intervention. A clustered stepped wedge design will be used, with the duration of the trial being 3 years. Read Less

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes. Read Less

The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease. The names of the study drugs involved in this study are: * 9-ING-41 * Losartan * Ferumoxytol * FOLFIRINOX (made up of 4 different drugs): * 5-Fluorouracil (5-FU) * Oxaliplatin * Irinotecan * Leucovorin Read Less

The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV Read Less

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby. Read Less

The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections. Read Less

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD). Read Less