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NCT ID: NCT04772820 Completed - Depression Clinical Trials

Feasibility of Remote Home Support Coaches (SOCIAL Study)

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.

NCT ID: NCT04772755 Completed - Syncope, Vasovagal Clinical Trials

Presyncope (Syncope) Prevention Study

PS^2
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions that might prevent post-vaccination presyncope, and by extension syncope. The two interventions evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and electronic game); or 2) control (usual care) to assess for acceptability and efficacy. Detailed data were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to assess their acceptability of the intervention.

NCT ID: NCT04772638 Completed - Activity, Motor Clinical Trials

Preschoolers Learning and Active in PLAY (PLAY Extension)

PLAY
Start date: February 26, 2021
Phase: N/A
Study type: Interventional

The PLAY 2 Study is the continuation of an R21 pilot PLAY study. In the R21, we tested the acceptability, feasibility and initial efficacy of three early childhood education setting- based, multi-level interventions to promote preschoolers' physical activity using wearable technology and additional behavior change techniques to engage educators and parents. We have selected one of these 3 as the main intervention for the R33 portion of the grant. The intervention will contain components of teacher wellness, parent engagement, and activity level monitoring.

NCT ID: NCT04772612 Completed - Hepatic Impairment Clinical Trials

A Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Sitravatinib

Start date: March 12, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Single-Dose Pharmacokinetics of Sitravatinib

NCT ID: NCT04772560 Completed - Astigmatism Clinical Trials

Toric Contact Lens Digital Performance and Comfort Study

Start date: March 16, 2021
Phase: N/A
Study type: Interventional

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

NCT ID: NCT04772547 Completed - Coma Clinical Trials

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

VIGAB-STAT
Start date: September 22, 2021
Phase: Phase 2
Study type: Interventional

This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

NCT ID: NCT04772482 Completed - Dermatitis Clinical Trials

Study on Hypoallergenic Hair Dye

Start date: April 1, 2021
Phase:
Study type: Observational

Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.

NCT ID: NCT04772391 Completed - Clinical trials for Cardiovascular Diseases

Fitness Trial in Adults With Sickle Cell Disease (SCD Fit): A Feasibility Study

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

The purpose of this project is to develop novel approaches to promote health and longevity while enhancing quality of life among persons with Sickle cell disease (SCD). Therefore, investigators are aiming to adapt an evidence-based exercise intervention for adults with SCD informed by culturally- relevant and biologic factors and pre-test the adapted exercise program in a small sample of adults with SCD.

NCT ID: NCT04772313 Completed - Uncontrolled Gout Clinical Trials

Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy

Start date: March 8, 2021
Phase: Phase 4
Study type: Interventional

This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit) 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up

NCT ID: NCT04772261 Completed - Gastroparesis Clinical Trials

GEBT Lot-to-Lot and Biological Variability

Start date: February 5, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.