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1 CARDIOLOGY SMMC : MARINER: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo In Reducing Post-Discharge Venous Thrombo-Embolism Risk Principal Investigator: George Heyrich, MD SMMC : RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial Principal Investigator: Ronald Fields, MD INTERVENTIONAL CARDIOLOGY SMMC : Closure of Patent Foramen Ovale with PFO ACCESS Registry Principal Investigator: Rakesh Shah, MD Clinical Coordinator: Kim Devine, CRNP, CCRP CARDIOTHORACIC / CRITICAL CARE SMMC : IP Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers Principal Investigator: David Drucker, MD CRITICAL CARE SMMC : IP Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers Principal Investigator: David Drucker, MD

2 SMMC : EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION Principal Investigator: Donald Marcus, MD SMMC : MARINER: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo In Reducing Post-Discharge Venous Thrombo-Embolism Risk Principal Investigator: George Heyrich, MD ENDOCRINE / DIABETES MANAGEMENT SMMC : BMS Clinical Protocol MB A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus Principal Investigator: Alan Schorr, DO Clinical Coordinator: Miki Haas, RN, BS EMERGENCY DEPARTMENT ELECTROPHYSIOLOGY SMMC : World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT) Principal Investigator: Scott Burke, MD Research Advisor: MarciPetrino, CRNP, CCRP GENERAL MEDICINE

3 GYNECOLOGY HUMANITARIAN DEVICE EXEMPTIONS SMMC : JOSTENT Coronary Stent Graft and JOSTENT GraftMaster for the treatment of free perforation, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts 2.75 mm in diameter Principal Investigator: Ronald Fields, MD SMMC : Closure of Patent Foramen Ovale with PFO ACCESS Registry Principal Investigator: Rakesh Shah, MD SMMC : CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System Principal Investigator: Robert Rosenwasser, MD SMMC : Wingspan Stent System with Gateway PTA Balloon Catheter Principal Investigator: Robert Rosenwasser, MD SMMC : Neuroform Microdelivery Stent System Principal Investigator: Robert Rosenwasser, MD

4 INFECTIOUS DISEASE SMMC : EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION Principal Investigator: Doanld Marcus, MD OBESITY PEDIATRICS NEUROSURGICAL NEUROVASCULAR SMMC : Closure of Patent Foramen Ovale with PFO ACCESS Registry Principal Investigator: Rakesh Shah, MD SMMC : MaRiss: Mild and Rapidly Improving Stroke Study Principal Investigator: Howard Natter, MD Research Advisor: Marci Petrino, RN, BSN, CCRP

5 PULMONARY RENAL DISEASE VASCULAR INTERVENTION SMMC : MARINER: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo In Reducing Post-Discharge Venous Thrombo-Embolism Risk Principal Investigator: George Heyrich, MD SMMC : Tack Optimized Balloon Angioplasty Study for the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System (TOBA II) Principal Investigator: Rakesh Shah, MD WOUND MANAGEMENT

6 ONCOLOGY BLADDER BRAIN BREAST SMMC : Prospective Registry of MammaPrint in Breast Cancer Patients with an Intermediate Score (PROMIS) Clinical Coordinator: Christine Armetta, BS, MBA, CCRP SMMC : Survivor Study: Evaluating Cancer Survivorship Care Models Principal Investigator: Jennifer Torres, RN, BSN, OCN, CCRP Clinical Coordinator: Jennifer Torres, RN, OCN SMMC : ECOG-ACRIN EA1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple Negative Basal-Like Breast Cancer Following Neo-adjuvant Chemotherapy Clinical Coordinator: Jennifer Torres, RN, BSN, OCN, CCRP Opening to Enrollment November 1, 2015 SMMC : E3108/SMMC12006 A phase II prospective trial correlating progression free survival with CYP2D6 activity in patients with metastatic breast cancer treated with single agent Tamoxifen Clinical Coordinator: Christine Armetta, BS, MBA, CCRP Suspended at this time to enrollment

7 SMMC : PUMA A study of Neratinib plus Capecitabine vs Lapatinib plus Capecitabine in patients with HER2+ metastatic breast cancer who have received two or more prior HER2-directed regimens in the metastatic setting (NALA) Clinical Coordinators: Christine Armetta, BS, MBA, CCRP SMMC : Celldex Protocol CDX A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The METRIC Study) Clinical Coordinator: Jennifer Torres, RN, BSN, OCN, CCRP SMMC : Survivor Study: Evaluating Cancer Survivorship Care Models Principal Investigator: Jennifer Torres, RN, BSN, OCN, CCRP Clinical Coordinator: Christine Armetta, BS, MBA, CCRP Closing to Enrollment December 31, 2015 CERVIX CHEMOPREVENTION COLORECTAL ENDOMETRIAL. GASTRIC OR GASTROSOPHAGEAL

8 HEAD AND NECK/LARYNX SMMC : R0920/SMMC11016 A phase III study of postoperative radiation therapy (IMRT) +/- Cetuximab for locally advanced resected head and neck cancer Clinical Coordinators: Jennifer Torres, RN, BSN, OCN, CCRP LEUKEMIA. LUNG SMMC : An Open-Label, Trial of Nivolumab and Nivolumab Plus Ipilimumab Versus Platinum Doublet Chemotherapy in Subjects With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227) Clinical Coordinators: Jennifer Torres, RN, BSN, OCN, CCRP LYMPHOMA MELANOMA MULTIPLE MYELOMA OVARIAN

9 PANCREATIC SMMC : INCB A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study) Clinical Coordinators: Jennifer Torres, RN, BSN, OCN, CCRP PROSTATE SMMC : RTOG 0815/SMMC A phase III prospective randomized trial of dose-escalated radiotherapy with or without short-term androgen deprivation therapy for patients with intermediate-risk prostate cancer Clinical Coordinators: Christine Armetta, BS, MBA, CCRP SMMC : ALLIANCE A Phase III trial of Enzalutamide (NSC # ) vs Enzalutamide, Abiraterone and Prednisone for castration resistant metastatic prostate cancer Clinical Coordinator: Jennifer Torres, RN, BSN, OCN, CCRP SMMC : Astellas TRUMPET: A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC) in the United States. Clinical Coordinator: Jennifer Torres, RN, BSN, OCN, CCRP RECTAL/ANUS REGISTRY

10 SMMC : Observational Clinical Study Protocol CBIO-BB037.V.1 Observational Study: Collection of Human Specimens for Future Scientific and Medical Research Principal Investigator: Dr. Katz Clinical Coordinator: Jennifer Torres, RN, BSN, OCN, CCRP