SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistula Study

Date Added
December 3rd, 2024
PRO Number
Pro00140475
Researcher
Cary Brewton

List of Studies

Keywords
Kidney
Summary

This multi-center, prospective, randomized, clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of the SelfWrap, a bioabsorbable perivascular wrap, for supporting surgically-created AVFs and using them for dialysis.

This study will involve approximately 200 participants. Half of the subjects in this trial will receive AVFs supported by the SelfWrap, while the other half will receive a traditional AVF alone. Participants will be followed for a duration of 36 months.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Patricia Robinson
843-674-5175
robinpat@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 Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
January 24th, 2025
PRO Number
Pro00137514
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the long term 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. You could be eligible to participate in the study if you completed the first double blind study successfully and your study doctor see's that you meet all the criteria for this study.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@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

A Multicenter, Open Label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients who are not Candidates for Intensive Therapy

Date Added
February 7th, 2025
PRO Number
Pro00139765
Researcher
Alexander Coltoff

List of Studies

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

The purpose of this study is to see if the investigational study drug, called cusatuzumab, is safe and effective when given together with other standard of care drugs used to treat Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow. Cusatuzumab is a new type of drug for AML. Cusatuzumab is designed to target a protein found on the surface of AML tumor cells, called human cluster of differentiation CD70. CD70 is not widely found in healthy cells. By targeting and killing cells expressing CD70, cusatuzumab has been shown in the laboratory and in animal studies to reduce tumor growth. In this study, cusatuzumab is being tested together with two other drugs that are commonly used to treat AML as a standard of care. These standard of care drugs are called venetoclax and azacitidine. In this consent form, cusatuzumab, venetoclax, and azacitidine will be referred to as "study drugs".

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929300
salzers@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Date Added
March 7th, 2025
PRO Number
Pro00140123
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the effectiveness of ruxolitinib cream compared to a placebo (vehicle) cream in treating vitiligo in children aged 2 to 12 years. The vehicle cream looks identical to the ruxolitinib cream but contains no active medication. By comparing these two treatments, researchers hope to determine whether ruxolitinib is more effective than the placebo in improving facial and body vitiligo symptoms. This study could provide important insights into new treatment options for young children affected by this condition.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Nonsmall Cell Lung Cancer

Date Added
March 21st, 2025
PRO Number
Pro00138993
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

The main purpose of this study is to measure overall survival (OS) and safety of ivonescimab (study drug) when combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel compared to pembrolizumab combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel. Participants will undergo screening procedures done to determine if they meet the requirements to be in this study. Screening will be completed within 28 days before receiving the study drug. Many of these screening measures are likely part of regular cancer care and may be done even if it turns out that you do not participate in the research study.

Once enrolled in the study, participants will visit the clinic every three weeks for 4 cycles of ivonescimab plus chemotherapy or pembrolizumab and chemotherapy for up to four infusions, followed by ivonescimab or pembrolizumab every three weeks for up to 24 months. If a participant's physician decides to use nab-paclitaxel chemotherapy for the first 4 cycles of treatment, the schedule of treatment is different and will require that the participant comes to the clinic for this infusion on days 1, 8, and 15 of each cycle. There will be follow-up check-up visits with the study team approximately 7 days, 30 days and 90 days after the last treatment or before the participant starts a new treatment for the cancer. Ninety (90) days after the participant stops taking the study drug, there will be a call or a visit scheduled to review how the they are feeling. This is a survival call/visit and will happen every 90 days until the end of the study. Participation in this study will last about 4 years, 2 years in active treatment and 2 years in follow up.

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



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