The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

CORD clamping among neonates with Congenital Heart Disease

Date Added
December 11th, 2023
PRO Number
Pro00131976
Researcher
Sinai Zyblewski

List of Studies


Keywords
Heart, Pediatrics, Pregnancy
Summary

A randomized clinical trial study that compares 2 different timepoints to clamp the cord at birth. The study involves babies with heart disease born between 37 0/7- 41 6/7 weeks of pregnancy. Doctors will clamp the umbilical cord around 30 seconds (between 1-<60 seconds) after birth vs. around 120 seconds (between 60-<180 seconds) after birth. Doctors consider both treatment groups to be "usual care." A goal of this study is to find out which umbilical cord clamping timepoint is best for babies with heart disease.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@musc.edu

Video Interventions for Dependence On Smoking (VIDeOS) for Cancer Patients Intervention Development

Date Added
December 7th, 2023
PRO Number
Pro00131304
Researcher
Kinsey Pebley

List of Studies

Keywords
Cancer, Smoking
Summary

This study aims to learn more about the experiences of people with cancer who smoke who are ages 18 or older. We want to learn more about what has helped or made it difficult to quit smoking, and what patients think about using videos to help quit smoking. Interviews and surveys will be used to help us learn more about the unique needs of cancer patients who smoke, and will guide the development of interventions to help with smoking cessation.

Institution
MUSC
Recruitment Contact
Kinsey Pebley
843-779-5794
pebley@musc.edu

A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Date Added
December 6th, 2023
PRO Number
Pro00130605
Researcher
Garth Swanson

List of Studies

Keywords
Complementary Medicine, Crohn's Disease, Inflammation, Inflammatory Bowel Disease
Summary

IBD affects over 1.5 million individuals in the US with an estimated direct cost of $6.1 billion. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potential modifiable risk factor. The hypothesis is that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL). A Re-Timer device will be used to administer BLT efficiently and safely to test this hypothesis. Prior to treatment subjects will be screened for subclinical inflammation using a validated questionnaire and fecal calprotectin level. They will also complete questionnaires about their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease. The subjects will be randomized and given BLT or the placebo non -BLT device for 4 weeks. The proposed studies will assess whether BLT has an impact on IBD patients' inflammation, intestinal permeability, and intestinal microbiota.

Institution
MUSC
Recruitment Contact
Michelle Potter
8438764261
potterm@musc.edu

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

Date Added
December 5th, 2023
PRO Number
Pro00131771
Researcher
Haley Burdge

List of Studies

Keywords
Breastfeeding
Summary

This study aims to improve the breastfeeding skills of premature or sick term infants with non-invasive, transcutaneous vagus nerve stimulation (taVNS). taVNS is microcurrent stimulation to the ear, which targets a vagus nerve branch. Pairing taVNS with motor activity, such as breast feeding, may help with motor learning in infants as it does in adults with stroke. Ten premature infants older than or equal to 35 weeks gestational age, or convalescing sick term infants whose mothers want to breastfeed will participate in this study with parental consent. Infants will receive 1 taVNS treatment paired with breastfeeding per day for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort. This level of electrical stimulation will be delivered by a TENS unit (Transcutaneous elecrical nerve stimulation) and neonatal electrodes applied just in front of the ear and our custom made carbon electrode used in the BabyStrong studies (#10881, #67997). Stimulation will be timed with latching and sucking for the duration of the feed and will be on with sucking and off with rest. Pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow efficiency will be recorded. Parental satisfaction will be assessed by questionnaires at the beginning, after 1 and 2 weeks, and 3 months after the end of treatment to assess infants' progress in and maintenance of breastfeeding abilities.
If pairing breastfeeding with taVNS is able to improve effective breastfeeding in infants in the neonatal intensive care units, it might help premature and sick term infants to successfully breastfeed at the time of discharge and maintain breast feeding at home after discharge. Premature infants may benefit from longer time receiving maternal breastmilk.

Institution
MUSC
Recruitment Contact
Haley Burdge
843-214-4089
burdge@musc.edu

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the treatment of anxiety comorbid with autism spectrum disorder (ASD)

Date Added
December 5th, 2023
PRO Number
Pro00128238
Researcher
Stewart Cox

List of Studies

Keywords
Adolescents, Anxiety, Autism, Psychiatry
Summary

This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will learn how to self-administer ear stimulation treatments at home before starting the study. Over the course of a month, participants will self-administer ear stimulation treatments twice a day for a month. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. There will also be a smaller number of questionnaires completed electronically on a weekly basis. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Listening to Women and Pregnant and Postpartum People: Qualitative Research with American Indian and Hispanic Women

Date Added
December 1st, 2023
PRO Number
Pro00133257
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Pregnancy, Women's Health
Summary

The purpose of this research study is to gather feedback via focus groups/individual interviews and surveys from American Indian and Hispanic pregnant and postpartum people about 1) mental health and substance use concerns and 2) a text message based mental health and substance use disorder screening, referral and treatment program for pregnant and postpartum people called Listening to Women & Pregnant and Postpartum People (LTWP). By gaining the feedback of American Indian and Hispanic people we hope to improve accessibility and efficacy of this program for these populations. Participation involves one individual interview or focus group (a small group discussion) and surveys.

Institution
MUSC
Recruitment Contact
Tychia Brown
843-872-2439
broty@musc.edu

Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

Date Added
December 1st, 2023
PRO Number
Pro00132788
Researcher
Anbukarasi Maran

List of Studies


Keywords
Cardiovascular, Women's Health
Summary

This observational study is enrolling women only who are undergoing a heart catheterization with planned percutaneous coronary intervention (PCI) using the Shockwave . A heart catheterization is a procedure in which a long thin tube called a catheter is directed through an artery to your heart, to look for blockages in the heart arteries. If there is a blockage that needs opening, a PCI can be performed to open the blockage. This study involves collecting data only from women participants who undergo a heart catheterization and PCI using the Shockwave IVL System. IVL stands for intravascular lithotripsy. The Shockwave IVL System is approved for use and commercial sale by the Food and Drug Administration. (FDA). Participation in this study will take about 3 years. Participants will be seen before the procedure, during the procedure, before hospital discharge following the procedure, and then seen in clinic or contacted by phone at 30 days, 1,2 and 3 years. This study will collect data from each of these visits including demographic data, medical history and medications, lab results, ECG results, procedure details, and any complications if applicable.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Controlled, 16-week Study to Evaluate the Efficacy and Safety of a Digital Therapeutic (CT-155) as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants with Experiential Negative Symptoms of Schizophrenia

Date Added
November 29th, 2023
PRO Number
Pro00132018
Researcher
Mark Hamner

List of Studies


Keywords
Complementary Medicine, Mental Health
Summary

The Convoke study is looking for people diagnosed with schizophrenia who are are at least 18 years of age; have a primary diagnosis of schizophrenia; have been on a stable dose of antipsychotic medication for at least 12 weeks
before the study treatment period; and own a smartphone compatible with Android 10 or greater, or iOS 14 or greater. The Convoke Study will look at 2 mobile applications (apps) to see if they can support people with moderate to severe negative schizophrenia symptoms. These apps are investigational prescription digital therapeutics (PDTs) that are downloaded onto your smartphone. This study will see if an app can be part of a schizophrenia treatment plan.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II)

Date Added
November 28th, 2023
PRO Number
Pro00132875
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu



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