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NCT ID: NCT04796896 Completed - SARS-CoV-2 Clinical Trials

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

Start date: March 15, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).

NCT ID: NCT04796870 Completed - Balance Clinical Trials

RHBS Brain and Balance Study of Older Adults

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

Brief Summary: Cognition and balance are known to decline during the aging process. Cognitive performance is essential for functional independence and determines whether an individual can perform instrumental daily living activities (e.g., finances, driving, independent living). Balance is critical for participation in everyday life activities. Impaired balance increases fall risk, and subsequent injury increased caregiver dependency and decreased independence. The purpose of this study is to investigate the outcomes of 24 sessions of online mobility and cognitive training (35 minutes/session, 3x/week, 8-12 weeks) for community-based older adults. The exercise program is progressively challenging and emphasizes balance, cardiovascular conditioning, attention, and working memory. The primary outcomes of interest are cognitive performance and balance changes, with secondary outcomes relating to self-efficacy, resilience, and physical activity.

NCT ID: NCT04796779 Completed - Type 1 Diabetes Clinical Trials

The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.

NCT ID: NCT04796571 Completed - Clinical trials for Inflammatory Bowel Diseases

Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients

CAPTURE IBD
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (PROs) and healthcare expenditures for high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.

NCT ID: NCT04796415 Completed - Clinical trials for Subjective Cognitive Decline

DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

More than 4.4 million patients receive home health services following discharge from the hospital or rehabilitation facility. A substantial number (70%) are older adults with subjective cognitive decline (SCD), an early clinical sign of Alzheimer's disease and related dementia. SCD is associated with diminished activity performance, poor quality-of-life and other adverse health outcomes (e.g., depressive symptoms). Home health patients with SCD often require more time, structure, and guidance to complete tasks and adjust to new skills and environments. Support is especially important during this high-risk period of transition between care settings. We propose a new home health care delivery model in partnership with Kindred at Home (KAH), a division of Humana that encompasses 400 programs across 40 states. DEMA-Pro builds on five preliminary studies that demonstrated high feasibility, acceptability, and positive preliminary effects on health outcomes (physical function, mood, and QoL). DEMA-Pro will be refined for delivery by home health services staff to patients with SCD and their informal caregivers. The overall goal of this research will be to conduct a pragmatic cluster randomized controlled trial (RCT) of DEMA-Pro to improve outcomes in-home health service patients with SCD. In the current R61 pilot phase, we will establish the trial's organizational structure and processes and pilot test DEMA-Pro in 4 home health services sites. In a subsequent trial, we plan to conduct a full pragmatic RCT in a group of Kindred KAH sites comparing DEMA-Pro to usual care. Consistent with the spirit of a pragmatic trial, we will use existing data sources including electronic Medicare OASIS (Outcome and Assessment Information Set) data, and QoL to characterize the cohort and measure outcomes. Thus, the focus of the pilot phase will be to ensure all processes are in place to conduct the subsequent RCT. Aim 1. Establish the organizational infrastructure and programmatic processes needed to conduct a pragmatic cluster-randomized control trial of the DEMA-Pro intervention versus usual care. A Steering Committee will lead the project and coordinate the activities of 3 Work Groups: Regulatory and Operations; DEMA-Pro Intervention Protocol; and Data Management and Analysis. Aim 2. Pilot test the DEMA-Pro training protocol in 4 KAH North Region locations and refine as indicated.

NCT ID: NCT04796207 Completed - Clinical trials for Traumatic Brain Injury (TBI)

The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes

Start date: May 28, 2019
Phase: N/A
Study type: Interventional

Determine if the daily docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of American football season among collegiate football athletes.

NCT ID: NCT04796181 Completed - Healthy Subjects Clinical Trials

Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device

Start date: February 21, 2021
Phase:
Study type: Observational [Patient Registry]

A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.

NCT ID: NCT04796077 Completed - Clinical trials for Pediatric Preoperative Anxiety, Pediatric Coping

Preparing Children for Anesthesia With an Educational Pop-Up Book

Start date: August 26, 2020
Phase: N/A
Study type: Interventional

The study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. The study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. The study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.

NCT ID: NCT04795908 Completed - Tourette Syndrome Clinical Trials

Combined CBIT and rTMS to Improve Tourette's Syndrome

STOP-TIC
Start date: December 17, 2021
Phase: N/A
Study type: Interventional

The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome. Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the primary outcome measure. Secondary outcome measures including underlying physiological effects will be measured via functional magnetic resonance imaginge (fMRI), high-density electroencephalograhy (HD-EEG), and TMS.

NCT ID: NCT04795791 Completed - Clinical trials for Implementation Science

Evaluation of Veteran-Directed Home and Community Based Services

VD-HCBS
Start date: April 27, 2017
Phase:
Study type: Observational

Veteran-Directed Home and Community Based Services (VD-HCBS) is focused on preserving Veteran's independence and the VA Office of Geriatrics and Extended Care is planning an expansion of VD-HCBS to 90 additional VA Medical Centers over the next 3 years. This proposal seeks to evaluate the VD-HCBS expansion to capture comprehensive information on the impact of VD-HCBS on Veterans' and Caregivers' outcomes, as well as, to identify how the program was implemented.