A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Date Added
December 10th, 2024
PRO Number
Pro00138267
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well Petosemtamab works at curing this type of cancer. The study results may be used to help others in the future.

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

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System vs. Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study).

Date Added
December 10th, 2024
PRO Number
Pro00141175
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study involves a procedure called renal denervation with an investigational device called the TIVUS™ system for the treatment of resistant hypertension (high blood pressure). Investigational means it is not yet approved for commercial use by the Food and Drug Administration (FDA). Renal denervation is a procedure done by introducing a catheter (long tube) into the large blood vessel in your groin (top of leg) and guiding it to your renal arteries, which are the blood vessels that go to your kidneys. The catheter will be placed in the renal arteries and ultrasound energy will be delivered to the renal arteries.
This study is randomized, meaning you will be assigned to one of two groups, by chance, like drawing straws. Two out of three participants will be randomized to renal denervation while one out of three will be randomized to sham. Sham means you will go through all the steps of the procedure but will not receive the treatment. Those participants randomized to sham will have the option to crossover and have the procedure after the 6 month follow up.
This study will involve at least 12 visits over the course of 36 months. Study related procedures include CT scan, ultrasound test of your heart and kidneys, blood work, urine studies, physical exams, questionnaire, and keeping home blood pressure diaries.
Study related risks include risks related to the procedure including pain, bleeding, damage to the blood vessels, risks related to the study related testing such as radiation risks, blood draw risks and loss of confidentiality. There may be benefit to you as well as others in the future with high blood pressure.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing with a Left Ventricular Epicardial Lead in Patients with Heart Failure (HF) with Left Ventricular Ejection Fraction (LVEF) ≤ 50% and with either a Wide QRS Complex (> 130 ms) or with/anticipated > 40% Pacing Randomized Clinical Trial (RCT) (Left vs Left RCT)

Date Added
December 17th, 2024
PRO Number
Pro00140157
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart, Men's Health, Women's Health
Summary

The purpose of this study is to determine if patients with heart failure (HF, meaning a weak heart) with left ventricular ejection fraction (LVEF) ≤ 50% and with an abnormal heart beat can benefit from having pacemaker leads placed in a different location in the heart. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. Participants in this study will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the "His" or the left bundle branch)

The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy

Date Added
January 6th, 2025
PRO Number
Pro00139544
Researcher
Kimberly Hashemi

List of Studies

Keywords
Lupus, Skin
Summary

This is a Phase III, multicenter, multinational, operationally seamless 2-stage study. The study will be conducted in 2 stages: Stage 1 and Stage 2. Participants will take part in either Stage 1 or Stage 2.Each stage has a randomized, 24-week double-blind, placebo controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of a SC treatment regimen of anifrolumab (120 mg, once weekly dosing) in adult participants with chronic and/or subacute CLE. The primary endpoint will be assessed at Week 24. The doubleblind, placebo-controlled study period of 24 weeks will be followed by an open-label, uncontrolled treatment period in which all participants will receive SC treatment with anifrolumab (120 mg, once weekly) from Week 24 to Week 51. After the open label treatment period, participants will enter a 12-week Safety Follow-up Period. The study will be performed in approximately 460 adult participants aged 18 to 70 years (inclusive). Stage 1 of the study is planned to be performed in approximately 100 participants (n ~ 50 per treatment arm). Stage 2 of the study is planned to be performed in approximately 360 participants (n ~ 180 per treatment arm).

Institution
MUSC
Recruitment Contact
Jordan Gertz
843-876-3209
gertzj@musc.edu

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Date Added
January 14th, 2025
PRO Number
Pro00141768
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

Task-based synchronous electroencephalography and functional magnetic resonance imaging (EEG-fMRI) to explore neural representations of memory maintenance in the aging brain.

Date Added
January 21st, 2025
PRO Number
Pro00141769
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Aging, Healthy Volunteer Studies
Summary

The purpose of this study is to better understand how practicing a new skill builds a stable memory and how this memory is maintained over time as one gets older. A better understanding how memories are controlled in healthy aging may help to develop better treatments for memory problems.
The study's main question is how the different brain regions communicate with each other when one is retrieving memories of a well-practiced skill. Specifically, when and where the brain waves that are related to skill memory are produced. The brief changes in the brain will be recorded with functional magnetic resonance imaging (fMRI), a medical technology that looks at blood flow in the brain. To assess electrical changes in the brain, the brain waves, electroencephalography (EEG) will be used. Combining EEG and fMRI will allow the precise detection of the exact location where the brain is active at any moment in time.
This study is conducted at the Medical University of South Carolina (MUSC). The study will take about one to two weeks and involves two visits to MUSC including an interview and combined brain recording and brain scan during task practice (EEG-fMRI) and up to 7 days of online skill practice at home. Volunteers in this research study must be free of any brain disease or brain injuries and have to be in good health status. Approximately 40 volunteers will take part in this study.

Institution
MUSC
Recruitment Contact
Kirstin-Friederike Heise
(843)792-3435
heisek@musc.edu

A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

Date Added
January 24th, 2025
PRO Number
Pro00142015
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.

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

BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)

Date Added
January 28th, 2025
PRO Number
Pro00141987
Researcher
Sergio Pinski

List of Studies

Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is enrolling subjects with high blood pressure who just received a pacemaker (an implantable device placed in the upper chest that monitors the heart rate and can send an electrical signal if needed to pace the heart to maintain a normal heart rate) or are about to undergo a pacemaker implant. This is a randomized study meaning subjects will be assigned by chance to have a new program downloaded to the pacemaker to help control blood pressure or to not receive the program. Subjects will have a 50:50 chance to receive the program. The new program is called AVIM therapy and it is investigational meaning it has not been approved by the US Food and Drug Administration. (FDA) Participation in this study will last about 36 months and include about 10 visits. Study related procedures include blood pressure monitoring including wearing a 24 hour blood pressure monitor, blood work, questionnaires, echocardiogram - an ultrasound test of the heart, pacemaker interrogation (meaning your pacemaker is checked to obtain the information stored on it) and randomization. Study related risks include risks related to the software download such as the risk that the software will not help control blood pressure, risks related to study related procedures and the risk of the loss of confidentiality.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-5783
szymankr@musc.edu

A Phase 3, Open-Label, Multicenter Study of I-124 evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis using Positron Emission Tomography Computed Tomography (PET/CT)

Date Added
January 28th, 2025
PRO Number
Pro00141834
Researcher
Jan Griffin

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.

This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II

Date Added
February 11th, 2025
PRO Number
Pro00141326
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

This study is asking for volunteers who have been diagnosed with acute pulmonary embolism (PE). PE is a blood clot that blocks and stops blood flow to an artery in the lung. PE usually results from a blood clot in the leg that travels to the lung. Patients with PE may have shortness of breath, chest pain and/or an irregular heartbeat. This study will use a device known as the Vertex Pulmonary Embolectomy System. The Vertex Pulmonary Embolectomy System is a medical device which is indicated for use in the pulmonary arteries for the non-surgical removal of blood clots from blood vessels. The Vertex System has not yet been approved for use by the Food and Drug Administration (FDA) but is approved for use in this study for PE removal. Your study doctor will inform you about the risks that are related to your PE procedure. The risks associated with the study include loss of confidentiality and unknown risks. There will be no benefit to you, but it is hoped the information gained will add to the understanding of treatment options for others in the future. You do not have to participate to have your condition treated. This study will take 30 days to complete.

Institution
MUSC
Recruitment Contact
Kara Loutzenhiser
843-792-1238
loutzenh@musc.edu



-- OR --