An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Date Added
February 25th, 2025
PRO Number
Pro00141996
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) in people with subjects with c-Met over-expressed refractory metastatic colorectal cancer

The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if ABBV-400 monotherapy is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.

This is a phase 3 study; ABBV-400 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, anemia, muscle aches, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Date Added
March 5th, 2025
PRO Number
Pro00138827
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 myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group 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

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for low Tumor Burden Follicular Lymphoma

Date Added
March 6th, 2025
PRO Number
Pro00142136
Researcher
Brian Hess

List of Studies


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

This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.

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

Drowning Risks of Patients Presenting to the Pediatric Emergency Department at MUSC's Shawn Jenkins Children's Hospital

Date Added
March 11th, 2025
PRO Number
Pro00142153
Researcher
M. Titus

List of Studies


Keywords
Pediatrics
Summary

This study is seeking to assess two known risk factors of drowning, swimming ability and water safety knowledge, in parents of children and adolescents presenting to the pediatric emergency department using questionnaires.

By collecting this data, we hope to highlight factors that contribute to disparities in drowning rates in minority racial and ethnic groups and to aid local and federal governments in developing programs that effectively combat the number one cause of unintentional injury-associated death in children ages 1-4 years. This will also provide data that may help guide pediatricians in effective anticipatory guidance for families regarding water safety. All in the effort to minimize disparities in medicine and provide more equitable care to the patients that we see.

Institution
MUSC
Recruitment Contact
M. Titus
8434753656
titusda@musc.edu

Dynamic motor cortical responses to subdural electrical stimulation.

Date Added
March 18th, 2025
PRO Number
Pro00142103
Researcher
Nathan Rowland

List of Studies


Keywords
Parkinsons
Summary

Current surgical treatments for Parkinson's disease have associated risks that may prevent patients from being offered surgery called "deep brain stimulation" or DBS. This is mainly because electrodes have to be placed through brain tissue to reach the target. Stimulation at the surface of the brain might be a potential alternative, but current research has not shown consistent results, and this may be because the mechanism of action is not clear. In this study, we aim to stimulate and record the brain at the surface to help answer this question and potentially improve the consistency and effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
M S Zobaer
8329557191
zobaer@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). 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.

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

A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients REASON

Date Added
March 25th, 2025
PRO Number
Pro00136825
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

This is a Phase 3b, multicenter, open-label study to evaluate transmural healing and the disease modifying effect of guselkumab in participants aged 18 years or older, with active Crohn's disease. Eligible participants must be diagnosed with luminal Crohn's disease (confirmed by radiography, histology, and/or endoscopy) for a minimum of 3 months, have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or Advanced therapy (for example, biologic or jak inhibitor), or have medical contraindications to such therapies. Participants with active moderate‐to‐severe Crohn's disease will be enrolled in this study. About 112 participants will take part in this study worldwide at approximately 90 study sites. Participants will be in the study for about 104 weeks and will need to visit the study site approximately 28 times, this number may also vary depending on the study treatment group and whether the option of self-administration of the study drug at home at certain timepoints.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction

Date Added
March 25th, 2025
PRO Number
Pro00142732
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

The Impact of a 12 Week Deep Neck Flexor Training Program on Cervical Muscle Thickness and Endurance: an Observational Study

Date Added
April 4th, 2025
PRO Number
Pro00143664
Researcher
Bryan O'Halloran

List of Studies

Keywords
Exercise, Muscle, Physical Therapy, Rehabilitation Studies
Summary

The purpose of the study is to examine whether certain neck strengthening exercises result in change in size of the neck muscles being targeted.

Musculoskeletal Ultrasound is a non invasive, safe tool that will be used to measure the size of certain muscles in your neck. This will allow us to determine if these muscles actually get bigger in response to targeted exercise. Muscle size is a factor associated with strength.

This study will help us tease out the time it takes to create neck muscle hypertrophy, or increase in muscle size, in order to develop effective protocols for neck strengthening which may be useful in the management of chronic neck pain.

Weakness in certain neck muscles may be associated with the development of neck pain and we hope to determine effective training protocols for these neck muscle groups.

Institution
MUSC
Recruitment Contact
Bryan O'Halloran
8437928224
ohallora@musc.edu

Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.

This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu



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