Patient and Caregiver Factors Affecting the Outcomes of Voice Rehabilitation in Adults with Parkinson's Disease

Date Added
December 16th, 2023
PRO Number
Pro00133128
Researcher
Kelly Richardson

List of Studies

Keywords
Parkinsons
Summary

This study will include individuals who complain of a softer speaking volume due to their diagnosis of Parkinson's disease. Participants will receive the standard of care for voice therapy for persons with Parkinson's disease. Voice therapy will be provided three days a week, one hour per session, for 6 weeks. At the start and end of treatment, participants and their caregivers will complete surveys and questionnaires. The surveys and questionnaires will tell us about the impact of your Parkinson's disease diagnosis on the family unit, spousal relationship, communication, and quality of life. Three months after treatment ends, participants and caregivers will participate in a brief structured interview to discuss the supports and barriers to maintaining the vocal exercise program.

Institution
MUSC
Recruitment Contact
Kelly Richardson
843-792-9468
richkell@musc.edu

Content Validation of the SGRQ-C in Patients with AATD-LD: Qualitative Study

Date Added
December 15th, 2023
PRO Number
Pro00133107
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Lung, Pulmonary, Shortness of Breath
Summary

The purpose of this research study is to help us understand patients' experiences with alpha-1 antitrypsin deficiency – lung disease. AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema and other lung diseases.
During screening, participants will be asked questions to assess their eligibility to take part in this study. To be considered for enrollment into the study, participants must: be between 18 to 80 years old, have a diagnosis of severe AATD, meet the additional relevant inclusion criteria, understand the study instructions, and be willing and able to follow the study instructions. Participants will participate in a one-time, 120-minute, telephone or web-based interview. At the end of the interview, participants will complete a brief questionnaire. There is a risk of discomfort answering the questions during the interview and a risk of loss of confidentiality. There is no direct benefit from participation in the study.

Institution
MUSC
Recruitment Contact
Allison Burton
843-792-0260
burtonal@musc.edu

A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ABBV-400 in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer (mCRC)

Date Added
December 13th, 2023
PRO Number
Pro00133837
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH)

Date Added
December 12th, 2023
PRO Number
Pro00131756
Researcher
Michele Esposito

List of Studies

Keywords
Pulmonary Hypertension
Summary

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

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



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