(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Status: Active not recruiting
Location: Mayo Clinic in Rochester
Conditions: Mayo Clinic in Rochester
City/State:
Rochester, Minnesota
Contact Information:
Brief Summary
This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.
Detailed Description
Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.
Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.
Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.
Read more
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients (Resonance)
Status: Active not recruiting
Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
City/State:
Anchorage, Alaska
Tucson, Arizona
La Jolla, California
San Diego
Davenport, Iowa
Baltimore, Maryland
Boston, Massachusetts
Minneapolis, Minnesota
Rochester, Minnesota
Saint Louis, Missouri
Fair Lawn, New Jersey
New York, New York
Cincinnati, Ohio
Cleveland, Ohio
Pittsburgh, Pennsylvania
Houston, Texas
Burlington, Vermont
Richmond, Virginia
Seattle, Washington
Los Angeles, California
Washington, D.C.
Chicago, Illinois
Detroit, Michigan
Dallas, Texas
Salt Lake City, Utah
Contact Information:
Study Director:John F Paolini, MD, PhD,Kiniksa Pharmaceuticals Corp
Brief Summary:
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.