A Phase 2, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects with Pulmonary Arterial Hypertension (PAH)

Date Added
July 15th, 2024
PRO Number
Pro00136733
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a research study involving an investigational drug called RT234. RT234 is being developed to treat pulmonary arterial hypertension (PAH). Eligible subjects must have a confirmed diagnosis of PAH and be on stable disease-specific PAH background therapy. The purpose of this study is to collect more information about the ability of RT234 to improve exercise capacity and safety of RT234 for the treatment of pulmonary arterial hypertension. The total duration of participation in the study, including screening, will be up to 4 study visits and a follow-up telephone call, over a period of up to 14 weeks. Up to 60 subjects will take part in this study.

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

Establishing Normative Reference Values for Pressure and Impedance-Derived Swallow Metrics for High-Resolution Pharyngeal Manometry

Date Added
July 9th, 2024
PRO Number
Pro00136546
Researcher
Ashli O'Rourke

List of Studies


Keywords
Healthy Volunteer Studies
Summary

The purpose of this research study is to establish normal reference values for metrics used during high-resolution pharyngeal manometry (HRPM). HRPM is a test that measures pressures in the pharynx (throat) during swallowing. In this study, healthy adults who do not have a swallowing problem will undergo a single procedure that involves placing a small catheter in the nose and pharynx to measure pressure while swallowing liquids and foods. A single, one-hour visit is required for study participation. The HRPM procedure will take approximately 10 minutes. Participants will be compensated for their time and effort.

Institution
MUSC
Recruitment Contact
Kate Davidson
(843) 410-9682
vscresearch@musc.edu

Phase 1 Dose Escalation Study for a Trispecific Antibody (SAIL66), Targeting Solid Tumors Expressing CLDN-6 and CD3/CD137+ T-cells

Date Added
July 8th, 2024
PRO Number
Pro00136650
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with Claudin 6 (CLDN6)-positive locally advanced or metastatic solid tumors. The primary objectives for this study in part 1 is to evaluate the safety and tolerability of SAIL66 and to determine the maximum tolerated dose (MTD) or maximum administered dos(MAD) and the recommended dose (RD) of SAIL66. In part 2 it is to evaluate the preliminary anti-tumor activity of SAIL66 when administered at
selected dose(s) in each cohort and o evaluate the safety of SAIL66 when administered at selected dose(s).

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

Rapid Onsite Cytopathologic Evaluation for Improved Molecular Marker Testing via Endobronchial Ultrasound Bronchoscopy - A Randomized Controlled Trial

Date Added
July 3rd, 2024
PRO Number
Pro00128969
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

In this study, all eligible study participants will have a clinically indicated reason to undergo a bronchoscopy procedure, using a EBUS-TBNA scope, before enrolling in the study. EBUS-TBNA stands for "endobronchial ultrasound-guided transbronchial needle aspiration" which is a procedure to collect lymph node tissue from within the lungs by inserting a flexible tube-like camera through the mouth, then down into the lungs.

After providing consent to participate in this study, each subject will be randomly assigned (by chance, like the flip of a coin) to either have or not have a cytopathology technologist (person who looks at samples under a microscope) in the room during your bronchoscopy, and then randomly assigned again (by chance, like the flip of a coin) to either have your tissue specimen prepared with clot or liquid preparation. Clot preparation is placing the tissue biopsy in a gel prior to being viewed under a microscope, whereas liquid preparation is placing the tissue biopsy in a liquid prior to being viewed under a microscope.

It is important to note that, by participating in this study, subjects will still receive the standard of care with a proven track record for obtaining lymph node tissue.

The reason for this research study is to determine whether rapid on-site cytopathologic evaluation, or the clot based method, can increase the chances of gathering adequate tissue for Next Generation Sequencing. Next generation sequencing is a test which detects molecular markers from tissue, or blood, samples and can provide possible treatment options for specific forms of lung cancer.

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

Combining rTMS & aerobic exercise to treat depression and improve post-stroke walking (RESTORATION)

Date Added
July 2nd, 2024
PRO Number
Pro00137804
Researcher
Chris Gregory

List of Studies


Keywords
Depression, Rehabilitation Studies, Stroke Recovery
Summary

We will determine if aerobic exercise (AEx) and/or repetitive transcranial magnetic stimulation (rTMS) are effective in treating symptoms of depression following stroke. This project is based on the idea that depression negatively affects the brain so that it doesn't change in the same way following treatment, the result being less effective recovery. We believe that effective treatment for depression will help improve how the brain in people with depression responds to other types of treatment. That is, effectively treating depression will enable individuals to better recover other forms of function following their stroke.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

A Comparison of Specific and Shared Effects Associated with Physical Therapy Interventions

Date Added
July 2nd, 2024
PRO Number
Pro00137661
Researcher
Bryan O'Halloran

List of Studies

Keywords
Exercise, Muscle, Pain, Physical Therapy, Rehabilitation Studies
Summary

The purpose of this study is to evaluate how certain procedures work for individuals with chronic neck pain.

Individuals who are 18 years of age or older and have chronic neck pain will participate in this study. The study involves randomly assigning individuals into two treatment groups (i.e. manual therapy and resistance exercise). Both treatments are recommended treatments and are part of clinical practice guidelines and are well supported in the literature.

Participants will be asked to complete a 4-week training program which includes physical examination, education, treatment, and an exercise plan. Participants will also complete a brief set of questionnaires at their baseline visit, 4 weeks, and 6 months after their initial visit

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

Investigating the direct brain effects of activating the auricular branch of the vagus nerve from the cymba concha or mastoid process: a sham-controlled fMRI study

Date Added
July 2nd, 2024
PRO Number
Pro00137424
Researcher
Xiaolong Peng

List of Studies


Keywords
Healthy Volunteer Studies
Summary

The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. We will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.

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

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Date Added
July 1st, 2024
PRO Number
Pro00136775
Researcher
Evan Graboyes

List of Studies


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

This phase II/III study purpose is to see if neck and shoulder function and pain are better after sentinel lymph node (SLN) biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. If decided to participate in this study participants will go through a pre-treatment period to determine if they are eligible for the study including a PET/CT scan to determine if their cancer has spread. They will also receive a quality of life questionnaire to determine their physical well-being. Participants will complete these questionnaires 5 times: before surgery; at 3 weeks after surgery; and at 3, 6 and 12 months after surgery. If their cancer has not spread participants will be randomized to receive SLN or the SOC Elective Neck Dissection (END) to remove their cancer/lymph nodes during the treatment period. Following treatment, participants will enter the follow-up period and the study doctor will continue to follow participates condition and watch for side effects of the surgery. Participants will visit in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for their lifetime. The study duration for the phase II portion is about 37 months (~3.1 years) and around 132 months (11 years) for the phase III portion. The main risk associated with this study are leakage of lymph fluid called "chyle" into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.

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

A Phase 3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)

Date Added
June 28th, 2024
PRO Number
Pro00134570
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Movement Disorders
Summary

This study is intended to determine the efficacy and safety of the study drug AMX0035 in people living with Progressive Supranuclear Palsy (PSP). Participants will between the ages of 40 and 80 and will be randomized to receive AMX0035 or placebo. Study participation will last 52 weeks with 7 visits to the clinic. After study participation ends, there is the option for the participant to continue into the open-label extension period where they would receive AMX0035 for another 56 weeks.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu



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