A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime/GOG-3076 Study)

Date Added
January 4th, 2024
PRO Number
Pro00132648
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.

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

A randomized, double-blind, placebo-controlled, multicenter phase 2 study of AK117/placebo in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes

Date Added
May 22nd, 2024
PRO Number
Pro00136718
Researcher
Praneeth Baratam

List of Studies

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

This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@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

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Date Added
August 29th, 2024
PRO Number
Pro00136755
Researcher
Sami Al Kasab

List of Studies


Keywords
Stroke
Summary

This study aims to establish the best clinical practice for the management of acute ischemic stroke related to narrowing or blockage of the neck vessels. Currently, the treating physicians use one of two surgical approaches based on their preference. However, we do not know which technique is the best. In this study, you will undergo mechanical thrombectomy using one of the techniques (stenting vs. non-stenting approaches) to determine which technique is better compared to the other.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu

The Development of Patient-Centered Clinical AFO prescription Guidelines to Optimize Post-Stroke Function and Quality of Life

Date Added
September 25th, 2024
PRO Number
Pro00138736
Researcher
Steven Kautz

List of Studies


Keywords
Stroke Recovery
Summary

The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.

Institution
MUSC
Recruitment Contact
Kelly Krajeck
843-792-9329
krajeck@musc.edu

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843 792 8606
lemattyc@musc.edu

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

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

Telehealth-Enhanced Assessment and Management after Stroke-Blood Pressure (TEAMS-BP)

Date Added
March 12th, 2025
PRO Number
Pro00142851
Researcher
Christine Holmstedt

List of Studies


Keywords
Hypertension/ High Blood Pressure, Stroke, Stroke Recovery
Summary

The purpose of this study is to determine the best strategy to help individuals improve blood pressure control after a stroke. The study will test two different interventions (an intervention is an action taken to prevent or treat disease and/or improve health).

1) Intensive Clinic Management (ICM), which consists of clinic visits, home blood pressure monitoring, text message health reminder from Carium®, a care management application, and health education.
2) Intensive Tailored Telehealth Management (ITTM), which consists of telehealth (video) visits, health coaching with lifestyle coaching company INTERVENT International, LLC, and remote blood pressure monitoring captured in Carium®.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
(843) 792-8606
lemattyc@musc.edu

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Date Added
March 18th, 2025
PRO Number
Pro00142451
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The purpose of this research study is to learn how Deep Brain Stimulation (DBS), which targets a part of the brain called the subthalamic nucleus (STN), may affect thinking and memory in people with Parkinson's Disease (PD). We plan to include about 55 people with PD who have already had DBS surgery at MUSC's Clinical DBS Program.

As part of the study, participants will attend two visits after their DBS surgery. The first visit, which will last about three hours, includes going over the study information and consent form, collecting background information (demographics), and completing tests that measure thinking and memory (cognitive assessments) and speech. The second visit, also about three hours, will involve an MRI scan to look at how the brain's networks change when the DBS device is turned on and off. Participant's will also be invited to undergo an optional second scan. If participants consent, the second scan will be performed on a separate day than the first scan and therefore, there will be a total of 3 study visits.

These findings may help doctors and researchers make better decisions about which patients are most likely to benefit from DBS surgery and how to choose the best stimulation settings to reduce unwanted changes in thinking and memory.

Institution
MUSC
Recruitment Contact
Niloufar Malakouti
843-792-0235
malakout@musc.edu

Circuitry-guided repetitive transcranial magnetic stimulation (rTMS) for tobacco use in Veterans: A comparison of insula-rTMS and prefrontal-rTMS

Date Added
May 6th, 2025
PRO Number
Pro00141919
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking, Substance Use
Summary

Quitting smoking is hard, and many Veterans struggle even with current treatments. This study is testing a safe, non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS), which is already FDA-approved to help people stop smoking. We're comparing two types—standard and personalized—to see which works better. We aim to find the best option to help Veterans quit for good.

Institution
MUSC
Recruitment Contact
Cyra Valente
843 792-0136
VA email in process (valentec@musc.edu)



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