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NCT ID: NCT05916092 Enrolling by invitation - Clinical trials for Sacroiliac Joint Dysfunction

Post-Market Clinical Study on a Modular SI Joint Fusion System

SPARTAN
Start date: October 19, 2023
Phase:
Study type: Observational

A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.

NCT ID: NCT05913999 Enrolling by invitation - Cancer Clinical Trials

Serial PET MPI in Patients Undergoing Cancer Treatment

Start date: June 1, 2023
Phase:
Study type: Observational

This study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (MBF) and perfusion in a prospective sample of VA patients.

NCT ID: NCT05910957 Enrolling by invitation - Clinical trials for Major Depressive Disorder

Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics

Start date: August 2, 2023
Phase:
Study type: Observational

The purpose of this research is to see if information from blood and data from smartwatches can be combined to help diagnose depression and determine if transitions between active depression and treated depression can be predicted.

NCT ID: NCT05909176 Enrolling by invitation - HIV Infections Clinical Trials

Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola

Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The study objectives are to: - Evaluate implementation outcomes from piloting the Start the Conversation Initiative - Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.

NCT ID: NCT05908110 Enrolling by invitation - Clinical trials for Obstructive Sleep Apnea of Child

Evidence-based Pediatric Obstructive Sleep Apnea Detection

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are: - Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA? - Does the use of a health communication message help health care systems identify more children with OSA? Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist. In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk). Researchers will compare groups to see if the health communication message helps identify more children with OSA.

NCT ID: NCT05907018 Enrolling by invitation - Dyspnea Clinical Trials

Autonomic Monitoring in Neurocardiogenic Syncope

ANSS
Start date: May 12, 2023
Phase:
Study type: Observational

This is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.

NCT ID: NCT05906095 Enrolling by invitation - Accidental Falls Clinical Trials

Pragmatic Trial to Increase Quality of Care in State Veterans Homes

TEAM EFFORT
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Background: State Veterans Home nursing homes (SVHs) care for 51% of all Veterans receiving VA-funded nursing home care. SVHs cost VA $1.2 billion yearly in per diem payments. This critical system provides care to a population of over 20,000 vulnerable Veterans annually but has been little researched and is in urgent need of attention. In some SVHs, the COVID-19 pandemic has resulted in large numbers of preventable illnesses, hospitalizations, and even deaths. Congress, the Government Accountability Office, and the Secretary have all called for greater VA involvement in this system that lacks a national quality improvement infrastructure and lags behind VA on many quality measures, including falls. This study addresses SVHs' need to reduce high fall rates-55% of residents experience at least one fall per quarter-by implementing an effective, evidence-based program known as LOCK. In LOCK, staff (1) "Learn from bright spots" (focus on evidence of positive change); (2) "Observe" (collect data through systematic observation); (3) "Collaborate in huddles" (conduct frontline staff huddles); and (4) "Keep it bite-size" (limit activities to 5-15 minutes). The program avoids reliance on existing quality improvement infrastructures, can be easily integrated into frontline staff routines, and has demonstrated success in improving clinical outcomes, including reductions in falls. Significance: This study provides the following. (1) Timely, evidence-based research support to improve care for SVHs' vulnerable population of aging Veterans. (2) Explicit integration of frontline staff expertise, ensuring interventions are practicable and successful. (3) Direct alignment with high-reliability principles-such as sensitivity to operations and deference to expertise-helping extend VA's high-reliability focus to SVHs. Innovation and Impact: This study contributes the following. (1) Advances the science of how to intervene in settings that do not have a strong, centralized quality improvement focus through rigorous investigation of how and why an intervention works in SVHs. (2) Investigates sustainment of the investigators' intervention-the extent to which it becomes part of usual care-for up to 12 months after completion of each step of the investigators' wedge-based design. (3) Provides timely, systematic investigation of a new area for VA research, gathering information on VA researcher-SVH partnerships to support future collaborations. Specific Aims: Aim 1: Investigate the effectiveness of the LOCK program at improving the investigators' primary outcome of any resident fall. This study will also investigate other resident clinical outcomes (mobility, medication changes, restraint and alarm use) and work-process outcomes for staff (job satisfaction, work engagement, burnout). This study will use both primary and secondary data collection. Aim 2: Evaluate the LOCK program's implementation. This study will use the replicating effective programs framework and multi-modal implementation facilitation strategies to implement the program. This study will use mixed methods to evaluate the program's reach, adoption, and implementation. Aim 3: Assess the extent of program sustainment. Mixed methods will enable examination of intervention sustainment at 3, 6, and 12 months post intervention and sustainment variability among sites. Methodology: This is a 4-year hybrid (Type 2) effectiveness-implementation study. It uses a pragmatic stepped-wedge randomized trial design and employs relational coordination theory and the RE-AIM framework to guide implementation and evaluation. Next Steps: This study (1) directly improves care for aging Veterans, (2) advances understanding of how to intervene in settings lacking quality improvement infrastructure, and (3) contributes knowledge about intervention sustainment. This study also addresses VA's Research Lifecycle stages of (a) scale up and spread and (b) sustainment. Findings may help improve care in other settings (e.g., inpatient mental health and domiciliary programs).

NCT ID: NCT05905926 Enrolling by invitation - Clinical trials for Irritable Bowel Syndrome With Constipation (IBS-C)

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Start date: February 17, 2023
Phase: Phase 3
Study type: Interventional

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

NCT ID: NCT05905900 Enrolling by invitation - Stroke Clinical Trials

Emergent Prep for IV Dye in Acute Stroke Patients With Allergy

Start date: January 1, 2015
Phase:
Study type: Observational

Our institution implemented a protocol to administer an emergent IV dye preparation for stroke alert patients requiring advanced neuroimaging. The emergent IV dye preparation consists of diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once, followed immediately by Computed Tomography (CT) Angiography and/or CT Perfusion.

NCT ID: NCT05903053 Enrolling by invitation - Infant Development Clinical Trials

Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of ADHD

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.