An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Date Added
March 16th, 2023
PRO Number
Pro00125361
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The primary objective of this study is to determine how bictegravir (BIC) plus lenacapvir (LEN) in two different doses affects an HIV-1 infection in the body compared with current standard treatment regimens. Other objectives are to determine which of these treatments are the most effective for treating HIV-1 infection, the safety and tolerability of these two doses for people with HIV, as well as how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems experienced during the study.

Institution
MUSC
Recruitment Contact
Marion Campbell
843-792-8894
cammario@musc.edu

RANDOMIZED PHASE II STEREOTACTIC ABLATIVE RADIATION THERAPY (SABR) FOR METASTATIC UNRESECTED RENAL CELL CARCINOMA (RCC) RECEIVING IMMUNOTHERAPY (SAMURAI)

Date Added
March 8th, 2023
PRO Number
Pro00127408
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with lymph node positive or metastatic kidney cancer that is inoperable. The purpose of the study is to see if we increase the time without a patient's kidney cancer getting worse or requiring surgery by adding radiation therapy to the usual immune therapy

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

Probing mechanisms of procedural memory transformation with cross-frequency transcranial alternating current stimulation (cf-tACS) as an avenue to sculpt sensorimotor behavior

Date Added
March 7th, 2023
PRO Number
Pro00126392
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Aging, Central Nervous System, Healthy Volunteer Studies, Memory Loss
Summary

Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano. Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke. With this study, we experimentally test the brain mechanisms that control the change of pre-existing stable memories of a motor skill with electroencephalography (EEG). We will then use non-invasive brain stimulation to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill.

Institution
MUSC
Recruitment Contact
Valerie Salisbury
843-792-6150
iNRLab@musc.onmicrosoft.com

Pediatrics Biorepository for Gastroenterology Clinical Research

Date Added
March 7th, 2023
PRO Number
Pro00126239
Researcher
Benjamin Kuhn

List of Studies

Keywords
Digestive System, Esophagus, Inflammation
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.

Institution
MUSC
Recruitment Contact
Benjamin Kuhn
(843) 876-0444
kuhnbe@musc.edu

Ketamine-assisted Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder

Date Added
March 7th, 2023
PRO Number
Pro00126022
Researcher
Emily Amador

List of Studies

Keywords
Drug Studies, Smoking
Summary

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for tobacco use disorder when delivered in conjunction with brief motivational enhancement therapy. Subjects will receive ketamine assisted motivational enhancement therapy weekly for three weeks. If you are eligible and you decide to enroll in the study, your overall participation will last approximately 8 weeks.

Institution
MUSC
Recruitment Contact
Emily Amador
843-906-6171
amador@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu



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