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NCT03893448
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
NCT04532242
Community participants will visit the neuroimaging facilities at CU Boulder for a single experimental session. In all studies, participants will complete pre-task questionnaires (trait measures), and a brief mood measure, followed by a task training in which a research assistant describes and gives examples of cognitive reappraisal in response to negative images. Then, participants complete an event-related, picture-based cognitive reappraisal task for 30-45 minutes, during which whole-brain BOLD signal will be collected. Following the task, participants will once again respond to a mood measure, and answer a series of questions regarding the task they have completed, including difficulty of regulation, or any images that were personally relevant. The researchers predict that the positive emotion induction will result in powerful effects on self-reported emotion which may or may not interact with the cognitive reappraisal condition. Participants will be trained to use reappraisal to increase positive emotion, and they will be asked to respond with the reappraisal tactic category that best fits the reappraisal they used for each image. The researchers predict greater use of future-focused tactics will be associated with greater reappraisal success, which in turn will result in greater recruitment of vmPFC and connectivity between vmPFC and other prefrontal regions.
NCT02988817
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
NCT02032628
Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women. Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.
NCT02694978
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
NCT05687253
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
NCT02214160
The primary objective of this study is to evaluate the long-term safety and efficacy of UX007 in participants with LC-FAOD. The secondary objectives of this study are to evaluate the effect of UX007 on energy metabolism in LC-FAOD and evaluate the impact of UX007 on clinical events associated with LC-FAOD.
NCT05006885
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
NCT03200340
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment. The trial will be performed in 2 stages: Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the study will evaluate both safety and efficacy. Stage 2 will consist of eighty (80) subjects who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1.
NCT05962710
The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
NCT04507204
The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.
NCT03861481
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
NCT05271656
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic, during this appointment, the C-Scan Track will be placed on the participant's back. The participant will then be asked to swallow the C-Scan capsule whereafter they are free to continue their routine. Participants will start intake of fiber pills 5 days, and contrast agent 48 hours prior to C-Scan capsule ingestion and will continue intake up to the capsule's natural excretion. A standard colonoscopy procedure will be performed within 60 days following C-Scan Cap ingestion.
NCT02844933
The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of cannabidiol oral solution in patients with PWS.
NCT02763579
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
NCT05059080
This study will evaluate the long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 \[CV43043\]), for approximately 6 months after the end of the parent study.
NCT04096326
The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).
NCT02632552
Transition from hospital to home places patients in jeopardy of adverse events and increases their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S. adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent significant burdens for the VHA healthcare system. Care transitions can be supported through multi-component interventions, but are costly to implement. Virtual nurses provide an effective medium for explaining health concepts to patients, and previous work indicates patients find virtual nurses acceptable. The investigators will implement and evaluate a virtual nurse intervention to provide automated, tailored, and timely support to Veterans transitioning from hospital to home. As effective care transition interventions incorporate both inpatient and outpatient components, the virtual nurse will first engage with patient onscreen during their inpatient stay and then via text message post-discharge. This project has the potential to improve the care transition experience for patients, caregivers and healthcare providers.
NCT03745989
This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib.
NCT03007953
The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.
