A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
July 18th, 2025
PRO Number
Pro00144159
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

This study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active CD. Data on currently available treatments highlights the need for new medications in addressing the high unmet need in CD. The total maximum duration of study participation for an individual is expected to be approximately 70 weeks without OLE participation. With OLE participation, treatment will continue until RO7790121 is commercially available in that region or until the Sponsor decides to terminate the study, whichever is earlier. Approximately 600 patients will be enrolled in the study.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

Use of surgical tissue to characterize immune responses in cancer and inflammatory diseases using multi-omic approaches and patient-derived organoids

Date Added
August 28th, 2025
PRO Number
Pro00145021
Researcher
Silvia Guglietta

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This research study aims to better understand how the immune system functions in human diseases such as cancer and chronic inflammation. We will collect small amounts of tissue that are already being removed during routine surgeries, such as liver transplants or colorectal cancer resections. These tissues would otherwise be discarded. By studying immune cells and molecules within these samples, our team hopes to uncover how inflammation and immune signaling contribute to disease progression. The ultimate goal is to identify new ways to diagnose, monitor, or treat these conditions in the future. Participation does not involve any extra procedures or risk beyond the surgery already being performed.

Institution
MUSC
Recruitment Contact
Silvia Guglietta
(843) 792-9702
gugliett@musc.edu

Feasibility and Acceptability of A Mobile Application "SUPPORT-T" to increase access to Palliative Care in patients with Progressive Pulmonary Fibrosis (PPF) and their Caregivers.

Date Added
September 10th, 2025
PRO Number
Pro00146761
Researcher
Kathleen Lindell

List of Studies

Keywords
Education, Interstitial Lung Disease (ILD)
Summary

The goal of this research study is to explore and evaluate the acceptability and feasibility of a 8-week, nurse-led Palliative Care program (SUPPORT-T) delivered over the internet to help educate and support individuals with Progressive Pulmonary Fibrosis (PFF) and their caregivers. In this study, we will enroll 80 PFF patients and 80 careparnters (total N=160 participants) who will then either receive the online SUPPORT-T program or enhanced usual care (educational handouts). At the end of the study, 15 PFF patients and caregivers who received SUPPORT-T and 5 community partners will take part in one-on-one interviews with the researchers to provide their feedback on the program; so as to improve it for a larger study. This study is being conducted by the Medical University of South Carolina in South Carolina and Mount Sinai Hospital in New York.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu

A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Date Added
September 12th, 2025
PRO Number
Pro00143084
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study aims to evaluate how effective and safe the 100 mg daily dose of ritlecitinib is for participants. By including the already approved 50 mg daily dose as a reference point, the study seeks to draw direct comparisons between these two dosages. This comparison will help determine if increasing the dosage offers additional benefits or poses any new risks. Participants in this study will be closely monitored to assess both their response to treatment and any potential side effects that may arise. The findings from this investigation are expected to provide valuable insights into optimizing ritlecitinib dosing regimens for better therapeutic outcomes.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III Heart Failure Patients

Date Added
November 12th, 2025
PRO Number
Pro00147296
Researcher
Vishal Rao

List of Studies

Keywords
Heart, Pulmonary Hypertension
Summary

This study is enrolling patients diagnosed with New York Heart Association (NYHA) Class II and III Heart Failure (HF). The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure Hospitalizations (HFH). The study is divided into 3 time periods: a screening period, implant/treatment period, and a follow-up period.

The study involves implanting a Cordella™ Pulmonary Artery Sensor during a right-heart catheterization, after which, you will be randomized into the treatment group (your study doctor will use the data from your daily weight, blood pressure, heart rate measurements, and your daily sensor readings to treat your heart failure) or the active control group (your study doctor will only use the data from your daily weight, blood pressure, and heart rate measurements to treat your heart failure). You will have a 66% (2 in 3) chance of being in the treatment group and a 33% (1 in 3) chance of being in the active control group. Randomization is much like a like drawing straws where you have a 66/33 chance of being assigned to the treatment group or the active control group.

After you have been implanted for 6 months, you and your study doctor will be "unblinded" (able to see) the daily measurements from the Cordella™ Pulmonary Artery Sensor System. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months, then annually up to 5 years.

Risks include complications from the implant procedure (bleeding, infection, damage to blood vessels, allergic reactions), risks from contrast dye, anesthesia, or medications (e.g., bleeding from blood thinners), and potential unknown device-related risks.

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

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Date Added
November 18th, 2025
PRO Number
Pro00147339
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is testing a new treatment for people with a dangerous heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, leading to fainting, heart failure, or even sudden death. Some people continue to have VT even after taking medicines and undergoing standard ablation procedures. For these patients, current treatment options are very limited.

The investigational treatment uses the Thermedical Ablation System with the Durablate™ catheter. This device delivers both heat and saline (salt water) deep into the heart muscle to target the areas causing abnormal rhythms. The goal is to safely and effectively reduce or eliminate VT episodes in patients who have not responded to other therapies.

About 130 patients will be enrolled at up to 25 hospitals in the U.S. and Canada. Participants will have the procedure and then be followed for six months with regular checkups to see if the treatment reduces their VT episodes and improves their quality of life. This study will help determine if the new system should be approved for wider clinical use.

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



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