Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in...
Rheumatoid ArthritisThe primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).
Avenir® Cemented Hip Stem - PMCF
Primary OsteoarthritisPost-Traumatic Osteoarthritis of Hip5 moreThe objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
Database Retrieval for the Comprehensive Shoulder
Osteoarthritis of the ShoulderAvascular Necrosis5 moreThis study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.
The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head
Femoral Head Avascular NecrosisTo determine the safety and effectiveness of pamidronate in patients with radiographically proven avascular necrosis which are the result of unstable (acute) slipped capital femoral epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in nature.
Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)...
Non-inflammatory Degenerative Joint DiseaseOsteoarthritis2 moreThis study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.
The Role of Bevacizumab in the Treatment of Radiation Necrosis in Children With Central Nervous...
Radiation NecrosisThis study is being done to learn about the safety of the study drug bevacizumab(Avastin®), when used to treat radiation necrosis. The primary objective of this study is to test the feasibility of treating Central Nervous System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2 weeks. The secondary objectives of this study are: To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed by clinical evaluation; To investigate the neuro-imaging changes in radiation necrosis associated edema, including Mass Resonance (MR) spectroscopy; To evaluate changes in corticosteroid use in patients with radiation necrosis following treatment with bevacizumab; To evaluate changes in quality of life.
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
OsteoarthritisRheumatoid Arthritis6 moreThe objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With...
OsteoarthritisPost-traumatic Arthritis4 moreThe purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
CoreHip - Post Market Clinical Follow-Up Study
Degenerative OsteoarthritisRheumatic Arthritis4 moreThe study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.
FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis...
Acute Kidney InjuryIschemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.