This is a 10-year, longitudinal, observational study of patients with PSC to address knowledge gaps in the clinical presentation, natural history, epidemiology, progression, and outcomes of PSC. In addition, the study will address prognostic models and biomarker development. There will be an option to participate in specimen repository at each site for translational studies of genomics and novel biomarkers discovery.
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The purpose of this study is to establish a large, international, web based registry, using the Surgical Outcomes System (SOS), to collect baseline characteristics of patients undergoing orthopaedic and sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and costs-effectiveness associated with the surgical procedures. Additionally, baseline and outcome data for non-operative treatment procedures will b collected using the same measures in order to compare to surgical outcomes.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.
This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. This study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP, DBP, and MAP against the reference methodology in pediatric and neonatal populations.
Gore has developed and manufactures the GORE® SYNECOR Intraperitoneal Biomaterial device (GORE® SYNECOR IP Device) to offer clinicians a mesh material intended for the repair of ventral/incisional hernias that may require the addition of a nonabsorbable reinforcing or bridging material. The primary study objective is to assess SYNECOR Biomaterial performance on incisional hernia patients over an extended amount of time through multiple methods. The secondary study objective is to conduct configuration-specific assessments to address areas of medical interest.
This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body.
This study aims to learn more about the investigational drug, ASTX727, and another drug, venetoclax, when given in combination. It also aims to evaluate potential pharmocokinetics (PK) interactions for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy.
This is a single center prospective cohort study. The cohort (interventional) patients will receive the study intervention (ABCLO). The control group retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA.