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NCT ID: NCT05392075 Completed - COVID-19 Clinical Trials

COVID-19 Breakthrough Infection in Fully Vaccinated People and in People Who Received a Booster Dose

Start date: March 15, 2023
Phase:
Study type: Observational

A novel coronavirus, SARS-CoV-2 (formerly known as the 2019 novel coronavirus [2019-nCoV]) was identified as the agent that caused an outbreak of pneumonia (termed COVID-19) in Wuhan, China in December 2019. The virus quickly spread to other countries and on March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. By March 2021, many nations and organizations embarked on finding a cure or vaccine for this devastating viral infection. The Pfizer COVID-19 mRNA vaccine was the first to obtain emergency use authorization (EUA) from the Food & Drug Administration (FDA) on December 11, 2020, followed by the Moderna COVID-19 mRNA vaccine on December 18, 2020, and the Janssen COVID-19 viral vector vaccine on February 27, 2021. The mRNA vaccines and the viral vector vaccine are designed based on the spike protein of SARS-COV-2. These vaccines had been administered to millions of Americans prior to July 2021.

NCT ID: NCT05391893 Completed - Atrial Fibrillation Clinical Trials

Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation

Start date: June 19, 2020
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.

NCT ID: NCT05391724 Completed - Hepatic Impairment Clinical Trials

Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects

Start date: February 2011
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.

NCT ID: NCT05391594 Completed - Cerebral Palsy Clinical Trials

Effect of Trunk Support on Academic Engagement of Children With Severe Disability

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effect of optimizing trunk support based on segmental principles of trunk control, on academic engagement of children in academic settings.

NCT ID: NCT05391438 Completed - Pediatric Obesity Clinical Trials

Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

In adolescents, conventional obesity treatment comprehensively addresses nutritional, activity, and behavioral topics. Due to limited resources in historically marginalized communities, implementation of nutrition-based interventions that require easy access to fresh food and ability to change the home environment is difficult, which may exacerbate health disparities. It is critical to find nutrition strategies and recommendations that are impactful, sustainable, and cost effective across all communities. There is growing interest in time-based interventions focusing on "when" food is consumed rather than on prescribed macronutrient composition. Time-restricted eating (TRE) is a type of meal-timing which involves fasting for at least 14-hours per day and eating over a 10-hour eating window initiated in the morning, mid-day, or afternoon. TRE recommendations are simple in merely dictating when eating occurs and thus may represent a more straightforward approach for adolescents than other caloric restriction regimens relying on numeracy (kilocalories and macronutrients) and goal setting. In adults, early-day TRE has been shown to reduce body weight, fasting glucose, and insulin resistance. By contrast, restricting food intake to the evening has produced mostly null results or even worsened post prandial glucose levels and β-cell responsiveness. To date, there has been no trial comparing early vs. late TRE on glycemic profiles in adolescents, and it is unclear how meal-timing impacts glycemic profiles in youth. The optimal timing of food intake for adolescents may be very different than adults due to increasing sex steroids and growth hormone levels overnight which may contribute to increased insulin resistance in the early morning. The proposed proof-of-concept study addresses this question by measuring metabolic response to a test meal consumed in the morning, afternoon, and evening among 30 adolescents with obesity using a within participant design. These findings will provide the needed research base for the refinement of TRE interventions in adolescence.

NCT ID: NCT05391022 Completed - Solid Tumor Clinical Trials

Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Start date: July 20, 2021
Phase: Phase 1
Study type: Interventional

Phase 1 2-part study to evaluate the effect of food on pharmacokinetics of pelabresib (CPI-0610) and the effect of pelabresib on QTc in patients with advanced malignancies

NCT ID: NCT05390775 Completed - Clinical trials for Post Traumatic Stress Disorder

Written Exposure Therapy to Improve Lives After Stress Exposure

WISE
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.

NCT ID: NCT05390736 Completed - Accidental Fall Clinical Trials

Evaluating the Cost Effectiveness of STEADI

STEADI
Start date: July 29, 2020
Phase: N/A
Study type: Interventional

Stopping Elderly Accidents, Deaths, and Injuries (STEADI) is an intervention to prevent falls among older adults developed by the Centers for Disease Control & Prevention (CDC). Studies piloting the intervention have shown promising results; however, more evidence is needed to show that the intervention can be implemented cost-effectively on a larger scale in a real-world integrated health system. To this end, NORC partnered with Emory University School of Medicine to evaluate the effectiveness and cost-effectiveness of the STEADI intervention. This study aims to answer the following research questions to fill remaining knowledge gaps about STEADI: 1. Does STEADI significantly reduce falls among the target population compared to the standard of care? 2. Does partial implementation of some selected STEADI modules, also significantly reduce falls among the target population as compared to the standard of care? 3. Does the net present value of falls and resulting injuries averted by STEADI implementation exceed the net present value of the costs of STEADI implementation and the incremental costs that result from it? Using a mixture of qualitative interview and quantitative performance measures, the study evaluates and describes this case of STEADI implementation within selected primary care clinics of Emory Healthcare. NORC partnered with Emory University School of Medicine to implement different aspects of STEADI in a real-world primary care setting, document experiences implementing the intervention, measure implementation costs, and compare the outcomes of the STEADI intervention compared to control version of the intervention.

NCT ID: NCT05390385 Completed - Exogenous Ketosis Clinical Trials

Acceptability and Tolerability of Ketone Supplements and Effects of BHB Concentrations in Young Adults

Start date: September 23, 2022
Phase: N/A
Study type: Interventional

Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.

NCT ID: NCT05390333 Completed - Caregiver Stress Clinical Trials

Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

To determine the effectiveness of the Self-care Sampler for Family Care Partners program in reducing caregiver stress over the 6-week program period. Hypothesis: Participants who attend the 6 class sessions over 6 weeks of the program will have a lower score on the Modified Caregiver Strain Index (MCSI) when compared to baseline. This will indicate a decrease in overall stress.