List of Clinical Studies

Cardiology

Study Name	Sponsor

GraftMaster® RX Coronary Stent Graft System	Abbott Vascular Devices

A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Left Ventricular Systolic Dysfunction following Myocardial Infarction	Armaron Bio Pty Ltd

ARTEMIS Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study	AstraZeneca

Cardiovascular Inflammation Reduction Trial (CIRT): A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome	Brigham and Women's Hospital / NIH

Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE-STEMI for Seniors)	Duke Clinical Research Institute

Care Optimization Through Patient And Hospital Engagement Clinical Trial For Heart Failure—Connect-Hf	Duke Clinical Research Institute (DCRI)

Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Acute Coronary Syndrome (UPSTREAM): An EDBased Clinical Registry	Hospital Quality Foundation

NJ Demonstration C-PORT Project Workscope	Johns Hopkins Medical Institutions - clinical coordinating center

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency	Luitpold Pharmaceuticals / Duke Clinical Research Institute

Long-term legacy effects of LDL-C lowering with alirocumab: observational follow-up of the ODYSSEY OUTCOMES study	Sanofi R&D

Endocrinology

Study Name	Sponsor

Efficacy and Safety of Oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus	Novo Nordisk

Gastroenterology

Study Name	Sponsor

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)	Eli Lilly and Company

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study	RedHill Biopharma Ltd.

A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease	RedHill Biopharma Ltd.

Infectious Diseases

Study Name	Sponsor

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection	Janssen Research & Development

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus	Janssen Research & Development

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection	Rebiotix Inc.

Efficacy, Immunogenicity, and Safety Study of Clostridiumdifficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection (Cdiffense™)	Sanofi Pasteur Inc.

Interventional Radiology

Study Name	Sponsor

MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects with Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE)	Biomet Biologics

Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System® (TOBA II BTK)	Intact Vascular

A Pilot Study To Investigate The Safety, Effectiveness, And Feasibility Of The Limflow Stent Graft System For Creating An Av Fistula For The Treatment Of Critical Limb Ischemia	LimFlow, Inc.

A multi-center, non-randomized study to evaluate the safety and effectiveness of the Abre venous selfexpanding stent system in patients with symptomatic iliofemoral venous outflow obstruction.	Medtronic Vascular Inc.

IN.PACT™ AV Access Paclitaxel-Coated PTA Balloon Catheter (“IN.PACT™ AV Access DCB”)	Medtronic Vascular, Inc.

TANGO: Temsirolimus adventitial delivery to improve ANGiographic Outcomes below the knee	Mercator MedSystems, Inc.

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for Revascularization (PACE Study)	Pluristem Ltd.

The Detour Ii Study - PQ Bypass System For Femoropopliteal Bypass Ii	PQ Bypass, Inc.

The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral Drug-Coated Balloon TRANSCEND Study	SurModics, Inc.

Multiple Sclerosis

Study Name	Sponsor

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies (AFFINITY)	Biogen MA Inc.

A Phase Iii, Multicentre, Randomized, Parallel-Group, Double Blinded, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Adults With Primary Progressive Multiple Sclerosis	F. Hoffmann-La Roche LTD

An Open-Label Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Relapsing Remitting Multiple Sclerosis Who Have Had A Suboptimal Response To An Adequate Course Of Disease-Modifying Treatment	Genentech, Inc.

long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409)	Genzyme Corporation - A Sanofi Company

Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study	MedDay Pharmaceuticals SA

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy (PASSAGE)	Novartis Pharmaceuticals Corporation

NULLA 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsingremitting multiple sclerosis	Novartis Pharmaceuticals Corporation

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY).	TG Therapeutics, Inc.

Oncology

Study Name	Sponsor

Alternate approaches for clinical Stage II and III Estrogen receptor positive breast cancer neoadjuvant treatment (ALTERNATE) in postmenopausal women: a Phase III Study	A011106/ CTSU/CIRB

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer	A011401/ CTSU/CIRB

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects with Different HRD Tumor Status and with Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Ovarian, Fallopian Tube, or primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy	AstraZeneca Pharmaceuticals LP

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors are PD-L1 Positive (TPS = 50%) (KEYNOTE-598)	Merck Sharp & Dohme

A randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin plus Cyclohosphamide followed by weekly Paclitaxel with or without Carboplatin for node-positive ir high-risk Node-negative invasive breast cancer	NRG-BR003/ CTSU/CIRB

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (veliparib) in metastatic triple-negative Breast Cancer and/or BRCA mutation-associated Breast Cancer	S1416/ CTSU/CIRB

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy	TESARO, Inc.