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Discover 8,049 clinical trials near Seattle, Washington. Find research studies in your area.
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NCT04974528
INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and \<18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: * Up to 5-week screening/run-in period * 26 week randomized treatment period * 26-week treatment extension * 4-week follow-up period
NCT03569891
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10\^13 gc/kg.
NCT06746051
The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.
NCT02616484
The objective of this research study is to conduct a pivotal phase 3 trial of treatment with the investigational drug dichloroacetate (DCA) in young children with deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which no proven treatment exists. The investigators predict that DCA represents targeted potential therapy for PDCD because of its ability to increase both the catalytic activity and stability of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are consistent with this postulate and have led to the designation of DCA as an Orphan Product for congenital lactic acidosis by the Food and Drug Administration. A novel Observer reported outcome (ObsRO) survey that is completed by study participant's parent/caregiver, is the efficacy outcome measure. Funding Source - FDA OOPD
NCT05305989
Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213
NCT04518943
Regular physical activity (PA) is essential to healthy aging. Unfortunately, only 5% of US adults meet guideline of 150 minutes of moderate exercise; Veterans and non-Veterans have similar levels of PA. A patient incentive program for PA may help. Behavioral economics suggests that the chronic inability to start and maintain a PA routine may be the result of "present bias," which is a tendency to value immediate rewards over rewards in the future. With present bias, it is always better to exercise tomorrow because the immediate gratification of watching television or surfing the internet is a more powerful motivator than the intangible and delayed benefit of future health. Patient incentives may overcome present bias by moving the rewards for exercise forward in time. Recent randomized trials suggest that incentives for PA can be effective, but substantial gaps in knowledge prevent the implementation of a PA incentive program in Veterans Affairs (VA). First, incentive designs vary considerably. They vary by the size of the incentive, the type of incentive (cash or non-financial), the probability of earning an incentive (an assured payment for effort or a lottery-based incentive), or whether the incentive is earned after the effort is given (a gain-framed incentive) or awarded up-front and lost if the effort is not given (a loss-framed incentive). The optimal combination of these components for a Veteran population is unknown. Second, the evidence about the effective components of incentives comes from studies conducted in populations that were overwhelmingly female; often employees at large companies, with high levels of education and income. VA users, in contrast, are mostly male and lower income, and most are not employed. This is important because the investigators have theoretical reasons to believe that the effects of components of incentives are likely to vary by income and gender. Finally, few studies have managed to design an incentive such that the physical activity was maintained after the incentive was removed. Indeed, a common theme in incentivizing health behavior change is the difficulty in sustaining behavior change once the incentives are removed.
NCT03517722
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
NCT06654804
Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury. The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes.
NCT03933215
To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable disease-modifying drugs (DMDs) approved in the United States (US) for RMS in a real-world setting.
NCT06314438
The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are: * Is the Family Care Project workbook useful for families? * Is the Family Care Project workbook easy to use? * Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds? Participants will complete surveys that elicit their feedback on their use of the workbook.
NCT03227224
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.
NCT02076009
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
NCT02085265
To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease in order to determine if there is less global brain atrophy over one year, as measured by ventricular enlargement as a primary outcome measure, when patients are randomized to treatment with an angiotensin receptor blocker (ARB) compared to an angiotensin converting enzyme inhibitor (ACEI).
NCT04741646
We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.
NCT02632448
The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
NCT06465745
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
NCT04503395
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
NCT06015282
This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.
NCT03345342
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
NCT02476916
Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.
