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NCT ID: NCT04585464 Completed - Healthy Volunteer Clinical Trials

A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults

Start date: October 12, 2020
Phase: Phase 1
Study type: Interventional

EDG-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers. This Phase 1 study of EDG-5506 will assess the safety, tolerability, and pharmacokinetics (PK) and of EDG-5506 in adult healthy volunteers and in adults with Becker muscular dystrophy (BMD).

NCT ID: NCT04585451 Completed - Chronic Pain Clinical Trials

Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Start date: July 23, 2020
Phase:
Study type: Observational

PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.

NCT ID: NCT04585295 Completed - Healthy Clinical Trials

The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat

Start date: January 21, 2020
Phase: N/A
Study type: Interventional

This will be a double blind, placebo-controlled, randomized, counterbalanced, crossover study designed to assess the impact of preloaded betaine supplementation on thermoregulation and exercise metabolism in the heat. The study, outlined in Figure 7 and described in detail below, will consist of seven total visits to the Institute of Sports Science and Medicine (ISSM) or Sandels laboratories at Florida State University, two of which will be experimental visits. On the first visit, participants will be informed as to the details of the study before giving their oral and written informed consent (Appendix A). Thereafter, anthropometrics will be measured and participants will complete an incremental exercise test on an electronically-braked cycle ergometer to volitional exhaustion to determine peak oxygen consumption (VO2 peak). Days 1-6 participants will consume a full dosage of supplementation, whereas day 0 and 7 participants will consume half a dose of the supplement, with the last dosage being consumed 60 minutes prior to experimental visits, days 7 and 21. On days 2 and 4, familiarization trials will be completed to standardize training loads and to reduce any potential learning effect. These visits will be implemented in the heat. On day 7, participants will complete the first experimental trial described in detail below. Afterwards, participants will enter a seven day washout period 167 before crossing over to the second supplemental condition on day 14. On days 16 and 18, participants will undergo the same familiarization trials as they did on days 2 and 4. On day 21, participants will complete their second experimental trial. Each experimental trial will be separated by 14 days. This study will be approved by the Florida State University Insitutional Review Board (Appendix B).

NCT ID: NCT04585217 Completed - Ptosis, Eyelid Clinical Trials

A Comparison of the Effect of Suture Material on Blepharoplasty Incision

Start date: May 30, 2020
Phase: N/A
Study type: Interventional

The objective is to compare the effect of suture material on blepharoplasty incision. Outcomes of blepharoplasty scar and/or cosmesis will be compared between plain gut and polypropylene suture. Additionally, the study will assess whether certain Fitzpatrick skin types are associated with increased rates of poor outcomes after blepharoplasty.

NCT ID: NCT04585139 Completed - Diabetes Mellitus Clinical Trials

Assessing Non-adjunctive CGM Safety at Home and in New Markets

ANSHIN
Start date: October 6, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.

NCT ID: NCT04584970 Completed - Pain, Postoperative Clinical Trials

Virtual Reality After Pediatric Scoliosis Surgery

VRAS-PS
Start date: December 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.

NCT ID: NCT04584879 Completed - Anxiety Disorders Clinical Trials

Transdiagnostic Treatment Personalization

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

The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. The present study will specifically use treatment components drawn from an evidence-based psychological intervention, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP). This intervention has strong empirical support for patients presenting with anxiety, depressive, and related disorders and contains therapeutic skills that are common in psychological interventions (e.g., psychoeducation, mindfulness training, cognitive restructuring, countering emotional avoidance, increasing interoceptive tolerance). This study will determine if prioritizing the order of treatment modules to capitalize on patient strengths or compensate for weakensses increases treatmen efficacy. Additionally, it will also identify under what conditions briefer treatment modules may be appropriate.

NCT ID: NCT04584645 Completed - Stroke Clinical Trials

A Digital Flu Intervention for People With Cardiovascular Conditions

CardioFlu
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions

NCT ID: NCT04584554 Completed - Clinical trials for Brain Injuries, Traumatic

Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

R03
Start date: February 17, 2021
Phase: N/A
Study type: Interventional

Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI) discharged home from acute hospital care without inpatient rehabilitation. To enhance the standard of TBI care, we will develop and refine a patient- and family-centered TBI transitional care intervention that addresses specific needs and preferences for patients with TBI (age < 65 years) and families and will assess the feasibility, acceptability, and preliminary efficacy of the intervention.

NCT ID: NCT04584528 Completed - Sickle Cell Disease Clinical Trials

Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease

ALIGN
Start date: October 27, 2020
Phase: N/A
Study type: Interventional

The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients' SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we will provide access to the IPP for both adult patients with SCD and ED providers. The proposed multisite study will use a pre-post study design, with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice, and patients will be invited to participate and enroll in the study. We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention.