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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)

Date Added
September 17th, 2024
PRO Number
Pro00136737
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).

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

NRG-CC012CD: MANAGING SYMPTOMS AND PSYCHOLOGICAL DISTRESS DURING ORAL ANTI-CANCER TREATMENT (SYMON)

Date Added
October 8th, 2024
PRO Number
Pro00139474
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study will determine if people on oral anti-cancer treatment who have these symptoms monitoring calls plus other support will have less severe symptoms and less visits to the hospital, emergency room or urgent care compared to only symptom monitoring calls. The patients are expected to participate in this study for a minimum of 12 weeks. During the trial patients will receive a telephone call to monitor symptoms.

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

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Cryoablation for Monomorphic Ventricular Tachycardia

Date Added
November 12th, 2024
PRO Number
Pro00140469
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

Institution
MUSC
Recruitment Contact
Chandler Schwede
873-792-5998
schwede@musc.edu

A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Date Added
December 10th, 2024
PRO Number
Pro00138267
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well Petosemtamab works at curing this type of cancer. The study results may be used to help others in the future.

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



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