First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF-β Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called BCA101. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get BCA101 alone or BCA101 in combination with pembrolizumab. Participants will receive either BCA101 alone, BCA101 in combination with pembrolizumab or BCA101 and enforafenib, depending on your cancer until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Date Added
July 22nd, 2021
PRO Number
Pro00111458
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Leukemia, Cancer/Lymphoma
Summary

This study is for newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The purpose of this study is to find out if starting treatment with the investigational products, venetoclaz and obinutuzumab (V-O) early (before symptoms occur) affect how long you live compared to the usual approach of starting treatment after showing symptoms. Participants can expect to receive treatment for up to 12 months, until the cancer gets worse or until the side effects are too great. After study completion, participants will continue to be followed for up to 10 years.

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

Combined Deep Brain Stimulation and Functional Magnetic Resonance Imaging

Date Added
July 20th, 2021
PRO Number
Pro00111668
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Brain, Movement Disorders, Parkinsons
Summary

The purpose of this research study is to identify brain activation patterns in response to deep brain stimulation (DBS). To participate in this study, participants are required to have had a DBS implant or to be healthy controls without a history of a neurological disorder. Participants will undergo screening, a motor assessment session and a 30-minute Magnetic Resonance Imaging (MRI) session where their DBS device will be turned on and off in a cycled pattern. This study will be separated over 3 visits (Visit 1 for screening, Visit 2 for motor assessments and Visit 3 for the MRI scans). The total study duration will be approximately 5 hours.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease

Date Added
July 13th, 2021
PRO Number
Pro00107924
Researcher
Shayla Bergmann

List of Studies


Keywords
Blood Disorders
Summary

Vaso-occulsive crisis is a complication of Sickle cell disease in which the red blood cells (RBC) change shape, causing congestion within the blood vessels that leads to pain and tissue damage.

The study medication FT-4202, an oral tablet, is believed to reduce the rate of sickle cell polymerization and improve RBC membrane function, thereby reduction sickling of RBCs and their hemolysis (breakdown of red cells) that causes vascular obstruction and anemia.

This study will consist of a 52-week, randomized (volunteers are selected by chance to receive study either study medication or placebo) , placebo controlled (a placebo is a look-alike pill that contains no active medication). There will be 17 study visits.

The study is followed by a 52-week open label extension study in which all participants will receive study medication. There will be 11 study visits.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

Assessment of cortical network connectivity in individuals with impaired walking coordination post-stroke

Date Added
July 6th, 2021
PRO Number
Pro00111026
Researcher
Steven Kautz

List of Studies


Keywords
Muscle, Non-interventional, Rehabilitation Studies, Stroke Recovery
Summary

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method often used to assess connectivity between the brain and specific muscles. This research study is aimed at finding the changes in the manner brain communicates with leg muscles post-stroke and its effects on movement coordination during walking.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
8437926165
srivasts@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu



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