RANDOMIZED CONTROLLED TRIAL OF WEEKLY ORAL ISOTRETINOIN VS. ORAL TETRACYCLINES FOR THE TREATMENT OF MODERATE ACNE VULGARIS

Date Added
May 7th, 2024
PRO Number
Pro00131877
Researcher
Alexandra Richmond

List of Studies

Keywords
Drug Studies, Skin
Summary

In the effort to find better treatments for moderate acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While isotretinoin, a vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, we propose a randomized controlled trial comparing weekly isotretinoin to daily doxycycline over four months. This study could confirm the safety and effectiveness of weekly isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

Institution
MUSC
Recruitment Contact
Alexandra Richmond
‭(757) 777-6673‬
ritteral@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 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

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 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

NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Date Added
June 4th, 2024
PRO Number
Pro00136484
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that are breast cancer survivors suffering from cancer-related cognitive impairment. This study is being done to determine if breast cancer survivors suffering from cancer-related cognitive impairment have improvement in concentrating, learning new things, remembering, and making decisions by receiving computerized cognitive training. Patients can expect to be in the study 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation

Date Added
June 4th, 2024
PRO Number
Pro00137256
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Stroke Recovery
Summary

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

Institution
MUSC
Recruitment Contact
Brenna Baker-Vogel
843-792-9502
bakebren@musc.edu

(SUMMIT) A MULTI-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 CLINICAL STUDY OF THE SAFETY AND EFFICACY OF CGT9486 IN SUBJECTS WITH NONADVANCED SYSTEMIC MASTOCYTOSIS

Date Added
June 21st, 2024
PRO Number
Pro00136659
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Nonadvanced Systemic Mastocytosis. The investigational drug is known as bezuclastinib and will be taken daily orally. Participation in the study is expected to be approximately 3 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Phase 2 Study of Alisertib in Patients with Extensive Stage Small Cell Lung Cancer

Date Added
July 11th, 2024
PRO Number
Pro00135995
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

In this study, researchers are testing a drug called Alisertib in people with a specific type of lung cancer that has spread extensively. These patients have already undergone the first round of treatment, but unfortunately, their cancer has started growing again. The drug alisertib works by targeting certain molecules involved in cell division, which are often overactive in cancer cells.

Patients will take alisertib as pills twice a day for a week, followed by a break. To manage side effects, they'll also receive another medication to support their blood cell production. Throughout the study, researchers will closely monitor how much alisertib is in the patients' blood and how they're responding to treatment.

The study will continue until patients either see their cancer progress, experience intolerable side effects, or decide to leave the study. Even if the cancer spreads to the brain during the study, patients might still be able to continue treatment if it's deemed helpful by their doctor. This research hopes to find out if alisertib can offer a new option for people whose lung cancer has come back after initial treatment.

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

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu



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