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NCT ID: NCT05311384 Completed - Stroke Clinical Trials

Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke. Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention.

NCT ID: NCT05310877 Completed - Heart Failure Clinical Trials

Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

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

Heart failure (HF) represents a significant public health concern. Medication non-adherence represents a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.

NCT ID: NCT05310747 Completed - Chronic Pain Clinical Trials

Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

The proposed study is an experimental intervention to test for the effects of exposure to art by means of a virtual museum visit. It examines the fundamental question of whether exposure to virtual art can alleviate pain. Google Arts & Culture has digitized the collections of over 2,000 museums, art galleries, and other cultural institutions. The platform is free and allows 'visitors' to explore art from around the world. For this study, the PIs have chosen artwork from this collection and created a virtual museum gallery such that research participants will visit the museum with or without art (i.e., we will remove all art from the virtual galleries). In addition, we hypothesize that individuals primed to experience social connection prior to art exposure will experience lower perceived social disconnection and pain than those who are not primed.

NCT ID: NCT05310422 Completed - Dry Eye Disease Clinical Trials

Safety Study of Tivanisiran to Treat Dry Eye

FYDES
Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).

NCT ID: NCT05310409 Completed - Clinical trials for Post-ERCP Acute Pancreatitis

PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

PAN-PROMISE
Start date: September 15, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.

NCT ID: NCT05310201 Completed - Burnout, Caregiver Clinical Trials

Impact of the Be Well Care Well Program on Early Care Education Teachers

Start date: January 15, 2021
Phase: Phase 2
Study type: Interventional

The study will address the following specific aims: (1) assess the impact of the BWCW program on teacher stress and physical activity, (2) Examine feasibility of collecting cortisol.

NCT ID: NCT05310058 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of C6 Ketone Di-ester

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

Randomized, parallel repeat dose pharmacokinetic study of C6 ketone di-ester in a ready to drink beverage matrix.

NCT ID: NCT05309941 Completed - Diet, Healthy Clinical Trials

The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

This randomized controlled trial will assess the effects of External Cues focused messaging (i.e., government recommendations of MyPlate) compared to Internal Cues focused messaging (i.e., intuitive eating). The investigators will collect data on within-person changes in psychological (e.g. affect) and physiological (e.g. heart rate variability) outcomes in female college students. Participants will be randomly assigned to one of two study conditions. In condition one, participants will view a five-minute video focusing on traditional nutrition education principles. In condition two, participants will view a five-minute video focusing on intuitive eating principles.

NCT ID: NCT05309915 Completed - Healthy Subjects Clinical Trials

A Study of STP707 Administered by IV in Healthy Subjects

Start date: February 28, 2022
Phase: Phase 1
Study type: Interventional

Single center study, randomized, to evaluate safety, tolerability, PK of single ascending dose of STP707 when administered by IV infusion in healthy subjects.

NCT ID: NCT05309694 Completed - Contraception Clinical Trials

A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

Start date: March 4, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.