A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Date Added
August 28th, 2025
PRO Number
Pro00144472
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is the first time the drug PF-07868489 will be tested in humans. The goal is to see if the drug is safe and how the body reacts to it. In the first part, healthy adults will receive a single dose to check for any side effects and how the drug moves through the body. In the second part, patients with a specific lung condition called Pulmonary Arterial Hypertension (PAH) will receive multiple doses to see if the drug helps their condition and to further check its safety and effects.

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

E-Care Breast Cancer Risk Assessment Study

Date Added
August 27th, 2025
PRO Number
Pro00145415
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer/Breast, Women's Health
Summary

We will evaluate the ability of a technology-based intervention E-Care to improve communication of information about breast cancer risk and improve discussion about breast cancer screening in the primary care setting. Women ages 25-75 seen by their primary care clinician are potentially eligible to participate. Study activities include completion of a health questionnaire, reviewing a video on breast cancer screening, completion of a post-visit survey, and potential opportunity for a brief interview.

Institution
MUSC
Recruitment Contact
Mattie Banks
843-876-2926
banksmat@musc.edu

A Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair

Date Added
August 27th, 2025
PRO Number
Pro00145325
Researcher
Charles Daly

List of Studies

Keywords
Nerve, Surgery
Summary

The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

Quantification of phosphorylated alpha-synuclein in patients with Parkinson's disease and REM sleep behavior disorder (Syn-Q)

Date Added
August 27th, 2025
PRO Number
Pro00143143
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study aims to study the natural progression of P-SYN quantification by conducting skin biopsies in patients with Parkinson's Disease (PD) and REM sleep behavior disorder (RBD). Participation will be over an 18-month period and will include skin biopsies and clinical examinations every six months. Subjects will be male or female between the ages of 50-100 and have a diagnosis of PD or RBD.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
MovementResearch@musc.edu

Fostering Healthy Relationships through Tele-PCIT for Families of South Carolina

Date Added
August 24th, 2025
PRO Number
Pro00146035
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Children's Health, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via tele-health for young children with disruptive behavior problems who are at risk for life stressors. Participants will go through a screening to determine eligibility. Once screening is complete, eligible families who choose to participate will complete questionnaires, 3 virtual visits, and will receive 10 tele-health therapy sessions, at no cost. Families will be compensated for their time.

El propósito de este estudio de investigación es evaluar la Terapia de la Interacción Padre-Hijo (PCIT, por sus siglas en inglés) mediante telesalud para niños pequeños con dificultades de comportamiento que están en riesgo de factores de estrés en la vida. Los participantes pasarán un cernimiento para determinar su elegibilidad. Una vez que se complete, las familias elegibles que decidan participar completarán cuestionarios, 3 visitas virtuales y recibirán 10 sesiones de terapia por telesalud, que serán gratuitas. Las familias recibirán compensación por su tiempo.

Institution
MUSC
Recruitment Contact
Franchesca Araya
843-714-1352
pcitfamilias@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Date Added
August 21st, 2025
PRO Number
Pro00146402
Researcher
Stephen Stripling

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

This will be a Phase 2, multicenter, randomized, double-blind study conducted at
investigator sites in the US and Puerto Rico. Each participant will participate in the study for approximately 16 to 19 months. The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of PG4 in both the M1 and M2 formulations, in healthy infants when administered at 2, 4, 6, and 12 through 15 months of age. Safety, tolerability, and immunogenicity data will support further development of PG4 in the pediatric population.

Institution
MUSC
Recruitment Contact
Meghan Armistead
8434736623
mea301@musc.edu



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