An investigation of reward brain circuitry structure and function in individuals with co-occurring alcohol use disorder and bipolar disorder and their unaffected offspring

Date Added
October 5th, 2021
PRO Number
Pro00114068
Researcher
Will Mellick

List of Studies


Keywords
Adolescents, Alcohol, Brain, Depression, Mental Health, Substance Use
Summary

The purpose of this two-visit brain imaging (magnetic resonance imaging, MRI) study is to identify brain targets for improving treatment and preventative interventions for individuals at risk for co-occurring bipolar disorder and alcohol use disorder. The preliminary visit for a parent and his/her biological child will include completion of clinical interviews, surveys, and labwork to determine study eligibility. If they are considered eligible for the study, brain imaging visits will occur within 1-2 weeks at which a 1-hour MRI will be completed along with additional clinical interviews, surveys, and labwork. Brief follow-up phone call interviews will be completed with participants every 3 months for 1 year. Study participation is confidential and compensated.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-7500
hixs@musc.edu

Non-cigarette tobacco products as harm reduction tools in smokers who failed to quit with traditional methods

Date Added
January 3rd, 2023
PRO Number
Pro00125514
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Institution
MUSC
Recruitment Contact
J'Neice Hunter
843-876-2291
paynejne@musc.edu

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

Date Added
May 1st, 2023
PRO Number
Pro00127835
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Surgery
Summary

There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.

In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.

Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Date Added
June 4th, 2024
PRO Number
Pro00135785
Researcher
Ronald Acierno

List of Studies

Keywords
Anxiety, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).

AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).

The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.

This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.

This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)

Date Added
September 17th, 2024
PRO Number
Pro00136737
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Cryoablation for Monomorphic Ventricular Tachycardia

Date Added
November 12th, 2024
PRO Number
Pro00140469
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

Institution
MUSC
Recruitment Contact
Chandler Schwede
873-792-5998
schwede@musc.edu



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