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NCT ID: NCT06457139 Not yet recruiting - Type 2 Diabetes Clinical Trials

Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment

Start date: April 1, 2025
Phase: Phase 1
Study type: Interventional

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM.

NCT ID: NCT06456671 Not yet recruiting - Cigarette Smoking Clinical Trials

Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

MUSC-R 3a
Start date: June 16, 2024
Phase: N/A
Study type: Interventional

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

NCT ID: NCT06456658 Not yet recruiting - Education Clinical Trials

Statin Reminders for Improving Prescribing in Primary Care

Start date: July 2024
Phase: N/A
Study type: Interventional

Statins reduce cardiovascular events and mortality, but only 30% of eligible primary care patients nationally are on statins. Clinical decision support (CDS) interventions in the electronic health record (EHR) can deliver education to providers and increase adherence to guideline recommendations via many potential forms of delivery. Interruptive alerts are an effective form of CDS but disrupt clinician workflow and increase alert fatigue in an age of clinician burnout and frustration with the EHR. Non-interruptive reminders are proposed as an alternative method of delivering CDS; however, they require active pursuit by the provider, and their effectiveness compared to interruptive alerts has not been rigorously studied. The investigators propose a randomized trial comparing the effect of interruptive vs. non-interruptive reminders displayed to clinicians to increase statin prescribing in primary care clinics.

NCT ID: NCT06456463 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Start date: August 30, 2024
Phase: Phase 2
Study type: Interventional

This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp, used in combination with venetoclax and azacitidine, to determine the dose for Part 2. This determined dose, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2. Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.

NCT ID: NCT06456320 Not yet recruiting - Clinical trials for Genetic Predisposition

Mayo Clinic Tapestry 2.0: Applying Multi-Omics on Tapestry Participants for Scientific Discovery

Start date: August 26, 2024
Phase:
Study type: Observational

The purpose of this study is to use multi-omics testing on samples collected from Mayo Clinic patients to build and expand on what has been learned about genomic data.

NCT ID: NCT06456190 Not yet recruiting - Opioid Use Clinical Trials

Testing STAR and TexSTAR: A Video and Text Messaging Intervention

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

NCT ID: NCT06456073 Not yet recruiting - Clinical trials for Chronic Anal Fissure (Medical Refractory)

E-CEL UVEC Treatment for Anal Fissures

Start date: June 2024
Phase: Phase 1
Study type: Interventional

This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure.

NCT ID: NCT06456021 Not yet recruiting - Burnout Clinical Trials

Relational Playbook Pilot Study

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Background: The Veterans Health Administration (VA) is prioritizing employee well-being due to crisis levels of clinician burnout and turnover. The VA aims to achieve this by becoming a "Best Place to Work" while delivering high quality, safe and equitable care to Veterans using learning health system (LHS) and high reliability organization (HRO) principles. The National Academy of Medicine (NAM) has proposed organizations create supportive learning environments to improve workforce well-being. However, there is no one-size-fits all solution. While the VA has invested in system level well-being efforts, including the Reduce Employee Burnout and Optimize Organizational Thriving (REBOOT) initiative, there is little guidance for teams on how to create supportive learning environments. To fill this gap, we developed The Relational Playbook. The Playbook consists of research-based resources and 50 evidence-based interventions for nurse managers to implement to change their team cultures including how to create joy in work and address difficult relationships. To support managers implementing the Playbook, the investigators propose leadership coaching as a novel implementation strategy. Significance: The significance of this project is the potential to provide frontline managers with resources and research-based tools to create supportive learning environments that enhance employee well-being. Additionally, the study will contribute to the fields of implementation, LHS and HRO science and the VA efforts to enhance employee well-being and reduce burnout and turnover. Innovation and Impact: The proposed research is innovative in that it attempts to shift the current model for the creation of supportive learning environments from an organization-level focus to the team level - where Veterans receive care. The investigators will partner with VA cardiac catheterization laboratories (CCLs) as a model LHS for this work. The investigators aim to implement and establish the feasibility and acceptability of the Relational Playbook intervention combined with leadership coaching. The hypothesis is that enhanced leadership coaching will be a more feasible and acceptable approach to support Playbook implementation and the cultivation of supportive learning environments than standard implementation support. Specific Aims: Aim 1: Test the implementation, feasibility and acceptability of the Playbook intervention, coaching strategy, and study procedures. The VA Collaborative Evaluation Center (VACE), an independent group of mixed methods experts, will collect the feasibility and acceptability measures developed by Weiner et al. and select Reach, Effectiveness, Adoption, Implementation and Maintenance (REAIM) measures. Aim 2: Conduct a mixed methods process evaluation of intervention implementation. VACE will collect interview data to understand 1) intervention adaptations, ease of use, engagement, usefulness, and 2) implementation speed, costs, barriers, facilitators, and unintended consequences. Methodology: The investigators propose a pilot, site randomized trial design with an embedded mixed methods process evaluation. The investigators have enrolled 6 CCLs and will collect staff and unit level data using surveys and interviews at baseline, 6 and 12 months. All 6 sites will implement the Playbook. CCLs will be randomized to enhanced leadership coaching implementation support (n=3) or standard implementation support (n=3). The enhanced implementation group will receive 6 months of virtual leadership coaching support. The standard implementation group will receive logistical support, but no advisement or coaching. Next steps: The study findings will 1) establish the feasibility and acceptability of the Playbook intervention combined with a leadership coaching implementation strategy, and 2) inform the design of a pragmatic adaptive effectiveness trial. This trial will test the impact of the Playbook and coaching on employee well-being and factors that contribute to employee burnout, which is a new VA research priority area. This project is relevant to all aspects of VA healthcare for it will test the feasibility and acceptability of a novel Relational Playbook combined with a leadership coaching implementation strategy for frontline managers to cultivate supportive learning environments. This work will inform national efforts to enhance employee wellbeing due to crisis levels of employee burnout and turnover. The investigators will pilot the Playbook with 1:1 virtual leadership coaching to inspire nurse managers to improve their team culture. The investigators will conduct a mixed methods process evaluation to inform a pragmatic adaptive effectiveness trial. The investigators expect this study to demonstrate the Playbook combined with coaching is a feasible and acceptable approach to create supportive learning environments that improve employee well-being and address factors contributing to employee burnout and turnover.

NCT ID: NCT06455969 Not yet recruiting - Hypogonadism Clinical Trials

Adaptions and Resiliency to Multi-Stressor OpeRations

ARMOR
Start date: June 17, 2024
Phase: Phase 4
Study type: Interventional

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps. The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.

NCT ID: NCT06455826 Not yet recruiting - Eye Diseases Clinical Trials

MAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects (Wallaby)

Start date: June 2024
Phase: Phase 1
Study type: Interventional

A Phase 1 Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Intravitreally Administered VP-001 in Participants with Confirmed PRPF31 Mutation-Associated Retinal Dystrophy