A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis

Date Added
September 15th, 2022
PRO Number
Pro00123287
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy. The duration of patient participation is up to 56 weeks, including a Screening period (up to 4 weeks), a Treatment period (48 weeks), and a Follow-up period (4 weeks).

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

A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Clinical Trial of Titrating Doses of Nabilone with Gabapentin for the Mitigation of Cannabis Withdrawal Symptoms

Date Added
September 14th, 2022
PRO Number
Pro00122680
Researcher
Aimee McRae-Clark

List of Studies


Keywords
Substance Use
Summary

This research study will include heavy, long-term cannabis users with moderate to severe use desire who want or need to discontinue cannabis use and have previously had symptoms of cannabis withdrawal. Subjects participating in this research study will receive either PP-01 higher dose or lower dose (combination of nabilone and gabapentin in a varied amount), nabilone only, gabapentin only or placebo (inactive substance). This study will assess whether the study drugs help to lessen or alleviate cannabis withdrawal symptoms in study subjects.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

Date Added
September 13th, 2022
PRO Number
Pro00122442
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.

Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Evaluating the specific role of endogenous opioids as the mechanism underlying tAN-based analgesia in healthy individuals

Date Added
September 6th, 2022
PRO Number
Pro00122762
Researcher
Bashar Badran

List of Studies


Keywords
Healthy Volunteer Studies
Summary

This study is attempting to understand whether 30-minutes of a new ear stimulation technology can reduce pain in healthy individuals. Participants in this trial will attend two experimental visits, during which they will receive ear stimulation during the intravenous administration (I.V.) of either saline or naloxone. During each visit, the amount of thermal pain participants can tolerate will be determined before and after ear stimulation. Brain scans will also be collected before and after ear stimulation. Each visit should last about 3 hours.

Institution
MUSC
Recruitment Contact
Falon Sutton
843-792-9502
suttonf@musc.edu

Determining the independent and synergistic effects of transcutaneous auricular neurostimulation (tAN) on direct brain activation in healthy individuals

Date Added
September 6th, 2022
PRO Number
Pro00122682
Researcher
Bashar Badran

List of Studies


Keywords
Healthy Volunteer Studies
Summary

In this research study, healthy participants will receive ear stimulation during brain imaging. Ear stimulation will involve the study team applying small electrodes to the outer part of your left ear and administering small amounts of electrical stimulation that may cause you to feel a "tickling" sensation on your ear. Participants will receive four, 8-min ear stimulation sessions in the scanner, and the order of the sessions is randomly assigned to you.

Knowledge gained from this study will help us better understand how stimulation of nerves in your ear turns on different parts of the brain.

Institution
MUSC
Recruitment Contact
Falon Sutton
843-792-9502
suttonf@musc.edu

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans

Date Added
September 6th, 2022
PRO Number
Pro00121552
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Military, Stage II
Summary

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans.

The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy.

This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual, TAU (i.e., B-FIT + CBT treatment) as compared to TAU alone (i.e., CBT treatment). Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 & 6 month follow-up assessments, all via telehealth.

Institution
MUSC
Recruitment Contact
Alexander Hannegan
843-7920608
alh324@musc.edu

Melanoma Margins Trial (MelMarT-II): A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma

Date Added
September 1st, 2022
PRO Number
Pro00123127
Researcher
Andrea Abbott

List of Studies


Keywords
Cancer/Skin
Summary

This study is for patients with melanoma. This study is being done to answer if a 1-centimeter margin as good as a 2-centimeter margin at reducing the risk of melanoma returning.

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

A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are colonized with Nontuberculous Mycobacteria (the ABATE study)

Date Added
September 1st, 2022
PRO Number
Pro00123092
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Nontuberculous mycobacteria (NTM)
Summary

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

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

PHASE III TRIAL OF IMMUNOTHERAPY-BASED COMBINATION THERAPY WITH OR WITHOUT CYTOREDUCTIVE NEPHRECTOMY FOR METASTATIC RENAL CELL CARCINOMA (PROBE TRIAL)

Date Added
September 1st, 2022
PRO Number
Pro00122590
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with kidney cancer that has spread outside of their kidney. The study is looking to see if adding surgery to the usual combination of drugs can lower the chances of kidney cancer growing or spreading.

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

Investigate B cell perturbations and immune reconstitution failure in response to antiretroviral therapy in HIV-infected cocaine users

Date Added
August 26th, 2022
PRO Number
Pro00119926
Researcher
Wei Jiang

List of Studies


Keywords
HIV / AIDS, Immune System, Substance Use
Summary

This proposed project is to investigate the role of cocaine use in B cell dysfunctions and poor immune recovery from antiretroviral therapy in HIV.

Institution
MUSC
Recruitment Contact
Wei Jiang
843-876-2457
jianw@musc.edu



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