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NCT ID: NCT06335082 Not yet recruiting - Atrial Fibrillation Clinical Trials

A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

DISRUPT-AF
Start date: April 15, 2024
Phase:
Study type: Observational [Patient Registry]

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).

NCT ID: NCT06335056 Enrolling by invitation - Waitlist Control Clinical Trials

Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools

ProudMe
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.

NCT ID: NCT06334731 Recruiting - COVID-19 Clinical Trials

Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic

Start date: July 6, 2021
Phase:
Study type: Observational

Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic.

NCT ID: NCT06334432 Recruiting - Pancreatic Cancer Clinical Trials

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Start date: March 14, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

NCT ID: NCT06334419 Recruiting - Fragile X Syndrome Clinical Trials

Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)

Start date: January 29, 2024
Phase: Phase 2
Study type: Interventional

This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion.

NCT ID: NCT06334393 Recruiting - Clinical trials for Zika Virus Infection

Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29). The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial.

NCT ID: NCT06334380 Enrolling by invitation - Breast Cancer Clinical Trials

VR for Surgical Prehabilitation and Rehabilitation

VR-PREP
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.

NCT ID: NCT06334354 Recruiting - Clinical trials for Breast Cancer Survivors

A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC)

TRAC
Start date: March 19, 2024
Phase:
Study type: Observational

The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants.

NCT ID: NCT06334341 Enrolling by invitation - HIV Seropositivity Clinical Trials

A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)

MOST:PrEP
Start date: February 21, 2024
Phase: N/A
Study type: Interventional

What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems.

NCT ID: NCT06334328 Completed - Physical Activity Clinical Trials

Virtual Reality-based Mindful Movement Therapy for Seniors

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach.