A prospective trial of varenicline and incentives for e-cigarette cessation in adults who co-use cannabis

Date Added
June 4th, 2024
PRO Number
Pro00136601
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A prospective trial of varenicline and incentives for e-cigarette cessation in adults who co-use cannabis

Date Added
June 4th, 2024
PRO Number
Pro00136601
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@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 Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable older adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

Date Added
June 3rd, 2024
PRO Number
Pro00137085
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

Imagine you're flipping through a medical journal and stumble upon a study about lung cancer treatment. This study is not just any ordinary research; it's focused on a group often overlooked in clinical trials: older adults. The researchers are curious about how well a new treatment, called immunotherapy, works for these older folks who might have other health issues besides cancer. They've noticed that most studies tend to include younger, healthier people, so they want to see if the same treatments work as well for Grandma and Grandpa. They found that immunotherapy, which boosts the body's immune system to fight cancer, can be a game-changer for older adults with lung cancer. But here's the twist: they're not sure if it's always the best option, especially for those with a certain type of lung cancer marker. So, they're calling for more studies to figure out the best treatment plan for older adults with different levels of this marker. It's like a puzzle they're trying to solve to make sure Grandma and Grandpa get the best care possible.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

Qutenza® 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy: A Prospective Study.

Date Added
May 28th, 2024
PRO Number
Pro00136049
Researcher
Matthew Sherrier

List of Studies

Keywords
Healthy Volunteer Studies, Pain
Summary

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to your skin.

If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they will be treated with Qutenza 8% capsaicin topical system and can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if you will need to be retreated at each visit based on your symptoms). This is an open-label study and all participants will receive Qutenza 8% capsaicin topical system. The study visits are estimated to take 90 minutes upwards to 120 minutes.

Institution
MUSC
Recruitment Contact
Jenna Williams
843-792-6639
wiljenna@musc.edu

Pivotal Clinical Trial Evaluating Safety and Efficacy of Cardiac Radioablation versus Catheter Ablation for Patients with High-risk refractory Ventricular Tachycardia

Date Added
May 28th, 2024
PRO Number
Pro00135334
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects with an abnormal heart rhythm called ventricular tachycardia (VT - rapid heart beat coming from the bottom of the heart) that has come back despite treatment. This is a randomized study meaning subjects will be assigned to one of two groups and then undergo either a standard catheter ablation or a new treatment called cardiac radioablation for their VT. You will have a 50:50 chance of being assigned to either group. A standard catheter ablation is done by placing catheters (long hollow tubes) into a large blood vessel at the top of the leg, guiding them to the heart to first identify the signals causing the VT and then use radiofrequency (heat) energy to burn and stop these signals to stop the VT. The cardiac radioablation is an investigational treatment meaning it is not yet approved for routine clinical use by the Food and Drug Administration (FDA). Cardiac radioablation is performed in the radiation oncology department and uses radiation therapy to treat the signals causing the VT. Participation in this study will last up to 5 years and inlcude about 15 visits. Study related procedures include medical record review and data collection, electrocardiogram (tracing of heart's electrical activity), echocardiogram (ultrasound test of the heart), CT scans, blood work, questionnaires, implantable cardioverter defibrillation (ICD - device implanted in your chest that monitors and treats abnormal heart rhythms), and ablation procedure per randomization. Risks include fatigue, changes in the appearance of the lungs in the cardiac radioablation group, fatigue, pain, low or high blood pressure or excessive bruising or bleeding at the catheter insertion side in the cardiac ablation arm. There are also study procedure related risks, and risks that are not known. There is potential benefit to you and to others in learning how to better treat others in the future with this condition.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
May 28th, 2024
PRO Number
Pro00135072
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. Participation in this study is expected to last approximately 18 to 20 weeks, or about 4 months.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Development of a mHealth Post-Stroke Home Exercise Program with Remote Monitoring and Intervention

Date Added
May 21st, 2024
PRO Number
Pro00137156
Researcher
Na Jin Seo

List of Studies


Keywords
Exercise, Movement Disorders, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Adherence to home exercise is important to achieve upper limb recovery after stroke. However, adherence is typically low. Therefore, a new home exercise program with an Apple Watch and iPhone app was created to improve adherence to upper limb exercises for stroke survivors at home. Participants will come to our lab to experience the new home exercise program. Participants who opt for home use will bring the device home to try the new home exercise program at home. The purpose of this study is for researchers to examine usability and feasibility of participants using the new home exercise program.

Institution
MUSC
Recruitment Contact
Ja'Quann Gallant
843-792-0162
gallantj@musc.edu

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients with End-Stage Renal Disease

Date Added
May 21st, 2024
PRO Number
Pro00130588
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.

Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.

Institution
MUSC
Recruitment Contact
virginia anderson
8033953878
andersvi@musc.edu

Clinical Evaluation of The APEX 3D™ Total Ankle Replacement System

Date Added
May 16th, 2024
PRO Number
Pro00136072
Researcher
Christopher Gross

List of Studies


Keywords
Joint, Pain
Summary

The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.

Institution
MUSC
Recruitment Contact
Seth Tysor
3362122921
tysor@musc.edu



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