Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
Heart DefectsCongenital4 moreThis study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Vanguard Rocc Post Market Surveillance
OsteoarthritisKnee7 moreThe objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.
Serum-Free Thymus Transplantation in DiGeorge Anomaly
DiGeorge AnomalyThe study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is a safe and effective treatment for atypical and typical complete DiGeorge anomaly. [Funding Source - FDA OOPD]
Global Utilization And Registry Database for Improved heArt preservatioN
Heart DiseasesHeart Failure2 moreThe primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Acute Instabilities ThoracicLumbar and Sacral Spine4 moreThis postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.
Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury
Wound (Morphologic Abnormality)The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage. The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment. Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.
Evaluating Prenatal Exome Sequencing Study
Congenital AnomaliesMendelian Disorders2 moreThis study evaluates the impact of the various outcomes of pES (definitive diagnosis, probable diagnosis and IF) on clinical decision making and on parental psychological wellbeing, compared between different analysis strategies to investigate the clinical utility, defined as the balance between potential harms and benefits.
Ambulation With Labor Epidural in Obese Women
ObesityLabor Onset and Length AbnormalitiesThe purpose of this study is to determine if ambulation with a labor epidural in place is associated with decreased rate of cesarean delivery in obese patients.
Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction...
Fused VertebraeAnkylosing Spondylitis2 moreThis study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures.
Volume Versus Pressure Ventilation on Lung Atelectasis
Cardiac Congenital DefectsThis prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.