PHASE III TRIAL OF IMMUNOTHERAPY-BASED COMBINATION THERAPY WITH OR WITHOUT CYTOREDUCTIVE NEPHRECTOMY FOR METASTATIC RENAL CELL CARCINOMA (PROBE TRIAL)

Date Added
September 1st, 2022
PRO Number
Pro00122590
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with kidney cancer that has spread outside of their kidney. The study is looking to see if adding surgery to the usual combination of drugs can lower the chances of kidney cancer growing or spreading.

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

Identification of Differences in Verb Learning between Late Talkers and Typically Developing Children

Date Added
October 4th, 2022
PRO Number
Pro00123522
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

This study explores the best way to teach two-year-old toddlers new verbs, and whether there are differences in what is best between late talkers and typically developing children. In a series of two, one-hour visits, children will watch videos on an eye-tracker, which will capture their face and gaze patterns. This data will be analyzed to see how children are making sense of what they are hearing. In one task, we ask whether it is better for children to hear a new verb before they see the action it denotes, or whether it is better to see the new action before hearing the verb. In the second task, we consider how quickly children are able to make sense of the language they hear, and whether this has any relationship to how they learn new verbs (Task 1). Results will help shape new clinical interventions for late talkers.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
843-792-9363
horvaths@musc.edu

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor

Date Added
October 11th, 2022
PRO Number
Pro00122311
Researcher
Christine Cooper

List of Studies


Keywords
Movement Disorders
Summary

The purpose of this study is to see if the study drug BOTOX®, is safe and helps to reduce upper limb essential tremor in adults who experience persistent tremor during movement. The study is 38 weeks long and includes 12 clinic visits. Participants will be injected with the study drug or placebo 3 times over the 38 week period. The participant will have to complete a set of questionnaires and assessments at each visit.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer.

Date Added
October 20th, 2022
PRO Number
Pro00124481
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for women with inflammatory breast cancer. This study is being done to see if by adding the drug olaparib to the usual radiation therapy will lower the chance of their cancer returning.

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

A PHASE II/III STUDY OF PACLITAXEL/CARBOPLATIN ALONE OR COMBINED WITH EITHER TRASTUZUMAB AND HYALURONIDASE-OYSK (HERCEPTIN HYLECTA) OR PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF (PHESGO) IN HER2 POSITIVE, STAGE I-IV ENDOMETRIAL SEROUS CARCINOMA OR CARCINOSARCOMA

Date Added
January 3rd, 2023
PRO Number
Pro00124595
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological
Summary

This study is for women with endometrial cancer. This study is being done to see if by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs.

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

The efficacy of the Smart Pass filter to Reduce the Risk for inappropriate subcutaneous implantable cardioverter-defibrillator shocks from myopotential interference

Date Added
January 23rd, 2023
PRO Number
Pro00117025
Researcher
Michael Gold

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Date Added
January 25th, 2023
PRO Number
Pro00126162
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with brain cancer. The study is being done to see if giving radiation before surgery will improve the length of time without the cancer returning, worsening or causing scarring in the brain.

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

Exploratory Phase 2A, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of HU6 for the Treatment of Subjects with Obese Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
February 14th, 2023
PRO Number
Pro00123447
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Obesity, Weight Control
Summary

Subjects meet inclusion for this study based on obesity (a high body mass index (BMI), which means too much weight for an individual's height), and they have Heart Failure with Preserved Ejection Fraction (HFpEF). This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal.
This study will help to find the best dose of HU6 for treating HFpEF, will help to see its impact on weight reduction, and will help to see its effect on subjects' ability to exercise and on how well they feel.
The study is a placebo-controlled double-blind study that will last approximately 28 weeks. There will be 8 clinic visits (approx. 6-8 hours), and 7 phone visits (approx. 20 minutes). The study drug will be capsules taken orally in the morning before eating.
Possible risks are loose bowel movements/diarrhea which was most prominent within the first 2-3 three weeks of dosing and seemed to improve with time and flushing, especially when alcohol is consumed.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@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



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