1. Telehealth

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    The purpose of this study is to measure patient satisfaction with telecommunication visits during adjuvant chemotherapy as opposed to the more typical in-person visit. Telecommunication is defined as communication over a distance using technology. For the purposes of this study, patients will engage in video conferencing with their physician as well having in-person clinic visits. This research is being done because telecommunication visits are being considered as an alternative for in-patient visits; however, the data is currently limited. This clinical study will help investigators to evaluate feasibility and satisfaction of the visits done by telecommunication.
  2. Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    Mitral valvular disease, and specifically mitral valve regurgitation is the most common valve disease in the US. Currently mitral valve surgery (open heart surgery), either with repair or replacement, is the standard of care for patients with symptomatic mitral valve disease. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that could offer patient a less invasive alternative to open heart surgery. The goal of the APOLLO trial is to evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. The secondary objectives of this trial are to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with severe symptomatic native mitral regurgitation.
  3. TRUST (Treatment Results of Uterine Sparing Technologies) USA Study

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    Women 18 or older with untreated fibroids who wish to receive treatment and avoid hysterectomy may be eligible to receive treatment through the study. Participants will be randomly assigned to receive one of the three treatments and will subsequently be required to attend the pre- and post-operative appointments that are standard to the assigned procedure. All three procedures – myomectomy, UAE, and RFVTA – have been cleared by the Food and Drug Administration for commercial use. All three methods are currently being utilized by US gynecologists for treating fibroids.
  4. Vaginal Microbiome Seeding and Health Outcomes in Caesarean-Delivered Neonates: A Randomized Controlled Trial

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    While Caesarean section (CS) delivery can be lifesaving for both new mothers and their babies, children born by CS have an approximately 50 percent increased risk of childhood obesity, along with asthma and allergies. It is believed that the risk of diseases associated with CS delivery may be due to the lack of mother-to-newborn transfer of beneficial vaginal microbes at birth, which are known to play a role in immune and metabolic development. "Vaginal microbiome seeding,” the transfer of vaginal microbes from mother to baby, is a process that can restore the exposure of a CS-delivered newborn to their mother’s beneficial vaginal microbes. In a pilot study, vaginal microbiome seeding of CS- delivered newborns was associated with an increased abundance of bacteria typically missing or reduced in CS. However, this study was too small to determine effects on early childhood health outcomes such as obesity. At the Inova Translational Medicine Institute (ITMI) we are conducting the first randomized controlled trial in vaginal microbiome seeding in newborns delivered by CS. ITMI will thoroughly document each baby’s health throughout his or her first three years of life to fully examine microbiome development and childhood health outcomes through regular stool samples and health screenings. If vaginal microbiome seeding is shown to decrease the risk of adverse childhood health outcomes in newborns born by CS, this could improve the health of our children and change the practice of obstetrics as we know it.