Use of NexoBrid for Treatment of Acute deep partial and full thickness Burn Injuries Save

Date Added
March 24th, 2020
PRO Number
Pro00095953
Researcher
Steven Kahn

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Surgery
Summary

This is an Expanded Access (treatment) protocol to expand treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study). This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from deep partial thickness (DPT) and full thickness (FT) thermal burns. Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns. Patients enrolled in this trial will undergo daily vital signs and pain assessments for 1 week starting on the morning after the start of treatment. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed. There will also be a scar quality evaluation at 3 and 12 months post wound closure confirmation visit.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR) Save

Date Added
December 18th, 2019
PRO Number
Pro00093140
Researcher
Vinaya Rao

List of Studies

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Keywords
Transplant
Summary

This study will monitor for kidney rejection using the Allosure and AlloMap test. Subjects will be followed for 3 years post transplant.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial Save

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies

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Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Neuromodulation of motor and sensory spinal pathways in subjects undergoing epidural spinal cord stimulation. Save

Date Added
October 15th, 2019
PRO Number
Pro00089881
Researcher
Nathan Rowland

List of Studies

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Keywords
Central Nervous System, Muscle, Nerve, Nervous System, Pain, Spinal Cord
Summary

Spinal cord stimulation (SCS) therapy is currently used to treat the symptoms of chronic pain. Studying the effect of SCS during muscle testing, proprioception testing and multiple gait analysis, we expect to gain understanding of exactly how SCS influences motor and sensory pathways of the spinal cord. We expect this approach to broaden our understanding in the application of SCS in the chronic pain conditions, and may lead to therapeutic advances in other populations, for example, patients with spinal cord injury.

Institution
MUSC
Recruitment Contact
Taylor Mayberry
5024423087
mayberrt@musc.edu

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
June 5th, 2017
PRO Number
Pro00061266
Researcher
Gerard Silvestri

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Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 3,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

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