UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

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

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

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

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Date Added
May 17th, 2023
PRO Number
Pro00128120
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants 18 to 65 years of age (inclusive, at the time of consent), with moderately to severely active UC as determined by a modified Mayo score ≥5 and a final reported endoscopy subscore ≥2 obtained during the central review of the screening video endoscopy. Participants must also have demonstrated an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). Overall, the study will evaluate 48 weeks of therapy with JNJ-7893480. The primary objective of the study is to evaluate the efficacy of JNJ-78934804 at Week 48
compared with each monotherapy (guselkumab alone and golimumab alone).

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

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
May 23rd, 2023
PRO Number
Pro00128438
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


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

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

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

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A randomized, double-blind, double-dummy, parallel group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

Date Added
June 13th, 2023
PRO Number
Pro00128476
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer Multiple Sclerosis relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio). Teriflunomide is an approved medication for the treatment of relapsing MS. This clinical study will have two parts. The first part is the masked part in which neither you nor your doctor know if you receive remibrutinib or teriflunomide and will last up for a maximum of up to 30 months (~2.5 years). This is followed by an Extension Part which will have treatment and safety follow up periods; during the treatment period remibrutinib treatment is provided to all participants who had completed core part of study for a maximum of up to 5 years.

Institution
MUSC
Recruitment Contact
Alison Line
Alison Line
line@musc.edu

Encore PFO Closure Device US IDE Randomized Trial - The PerFOrm Trial

Date Added
June 13th, 2023
PRO Number
Pro00128910
Researcher
Christopher Nielsen

List of Studies


Keywords
Heart
Summary

This study is enrolling adults between the ages of 18-60 who have a Patent Foramen Ovale (PFO). A PFO is a slit-like opening between the upper chambers (called atria) of the heart. This opening allows blood to flow between these chambers which can lead to a stroke. This study is examining an investigational device called the Encore PFO closure device. An investigational device is one that is not yet approved for commercial use by the US Food and Drug Administration (FDA) but is approved for use in this study. This study will last approximately 5 years and involve 9 visits. This is a randomized study meaning participants will be randomly assigned to receive the investigational PFO closure device or an FDA approved PFO closure device. Participants have a 50:50 chance to receive either device. Study related testing includes physical exams, blood test, echocardiogram (ultrasound test of the heart) electrocardiograms or ECG (test of the electrical activity of the heart) and the procedure to place the PFO closure device. There are risks involved with this study including access site related risks, bleeding and bruising, incomplete closure of the PFO with the closure device or other device related complications. There is potential benefit including reduced risk of a recurrent stroke.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA)

Date Added
June 14th, 2023
PRO Number
Pro00127526
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Lupus, Non-interventional
Summary

This is an observational non-medication study. The purpose of this study is to understand the immune system in people who are at risk for developing systemic lupus erythematosus ("lupus" or "SLE"). The investigators hope to develop better ways to predict who will get lupus and possibly come up with ideas for new treatments that can prevent or treat the disease.

Participants will be asked to complete 4 annual study visits and monthly telephone contacts with the study team over the course of 3 years. Visits will include a physical exam, collection of blood and urine, and the completion of some surveys/questionnaires about your health and wellbeing. The monthly phone calls will be a brief contact to check on any changes in your health and should take no longer than 15 minutes to complete.

Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Lusawasra King
843-792-7645
kinglu@musc.edu

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease

Date Added
June 21st, 2023
PRO Number
Pro00128423
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants with moderately to severely active CD who have had an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). This
dose-ranging study includes participants 18 to 65 years of age (inclusive, at the time of consent) with moderately or severely active CD (defined by a CDAI score ≥220 and ≤450) and either a mean daily abdominal pain (AP) score ≥2 (based on the unweighted CDAI component of AP) or a mean daily stool frequency (SF) count ≥4 (based on the unweighted CDAI component of the number of liquid or very soft stools), of at least 3 months duration, with colitis, ileitis, or ileocolitis previously confirmed in the past by radiology, histology and/or endoscopy. Participants must also have endoscopic evidence of active ileal
and/or colonic CD on the screening video ileocolonoscopy. Overall, the study will evaluate 48 weeks of therapy with JNJ-78934804

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

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu



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