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Clinical Trial Highlights

 

For more information regarding the below studies, please contact Donna Walsh at (215) 255-7879.

Department

Study Title

Anesthesiology

A Randomized, Double-Blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Anesthesiology

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in Adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoling short surgical procedures in out-patient surgicenters assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures.

Cardiovascular Medicine & Surgery

Gore Embolic Filter in Carotid Stenting for High Risk Surgical Subjects

Cardiovascular Medicine & Surgery

The HeartMate II LVAS Pivotal Study

Cardiovascular Medicine & Surgery

Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

Cardiovascular Medicine & Surgery

Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy

Cardiovascular Medicine & Surgery

Prospective AneurYsm Trial: High AnGle AORfix™ BifurcAted Stent Graft.

Cardiovascular Medicine & Surgery

XIENCE V Everolimus Eluting Coronary Stent System USA Post-Approval Study

Emergency Medicine

Phase 2 SBIR Grant N00014-05-C-0516 from the Department of the Navy for support of a project

Medicine - CME

The Effect of Sulodexide in Overt Type 2 Diabetiic Nephropathy

Medicine - Endocrinology

A Multi Center, Double Blind Palacebo-Controlled, Parallel-Group Randomized, Phase 2 Trial to evaluate the glycemic efficacy, renal safety, pharmacokinetics and pharmacodynamics of Dapagliflozin in subjects with Type 2 Diabetes Mellitus and Moderate Renal Impairment who have inadquate Glycemic Control

Medicine - EPS Card

SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV)

Medicine - EPS Card

Ovatio CRT and Situs OTW LV Lead Post Approval Study (Ovatio CRT PAS)

Medicine - EPS Card

A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) with Oral Adjusted Dose Warfarin in the Preventive of Stroke and Systemicthrombioembolic Events in Patient with Atrial Fibrillation.

Medicine - EPS Card

Attain StarFix® Model 4195 LV Lead Extraction Study

Medicine - EPS Card

Registry of AT/AF Episodes in the CRM Device Population: RATE Registry with RATE CRT Sub-registry

Medicine - EPS Card

St. Jude Medical Product Longevity and Performance (SCORE) Registry

Medicine - EPS Card

BLOCK HF (Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block)

Medicine - EPS Card

A Phase III Clinical Trial Comparing Rivaroxaban to Warfarin in Patients with Non-Valvular Atrial Fibrillation

Medicine - GIM

A Phase 3, Randomized, Open Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer

Medicine - Heart Failure

CSPP100A2368 A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure

Medicine - Heart Failure

"A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction

Medicine - Heart Failure

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of RLY5016 in Congestive Heart Failure Patients

Medicine - Heart Failure

A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and efficacy of Apixaban for Prophylaxis of venous Thromboembolism in Acutely III medical subjects during and following hospitalization

Medicine - Heart Failure

Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)

Medicine - Heart Failure

Medtronic Chronicle ICD Implantable Cardioverter Defibrillator Clinical Investigational Plan Metronic desires the investigator to perform a study of the medrronic Chronicle implantable cardioverter Defibrillator(Dive and the Medtronic senor lead (lead) us

Medicine - Heart Failure

A Facilitated Access Program to Provide Everolimus for Maintenance Patients Completing Therapy in RAD trials in Solid Organ Transplantation.

Medicine - Heart Failure

Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure ASCEND-HF

Medicine - Heart Failure

Who Benefits from Cardiac Resynhronization Therapy

Medicine - Heart Failure

A Randomized Open-Label Study to Compare the Safety and Efficacy of Conversion from a Calcineurin Inhibitor to Sirolimus Versus Continued Use of a Calcineurin Inhibitor in Cardiac Transplant Recipients with Mild to Moderate Renal Insufficency

Medicine - Heart Failure

Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE)

Medicine - Heart Failure

Long Term,Open Label Follow-Up Treatment of Patients with Atrial Fibrillation Who Have Been Previously Treated with BIBR 1048 in the PETRO Trial (Trial 1160.20)

Medicine - Heart Failure

A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0 g MMF with standard dose Neoral in de novo heart transplant recipients

Medicine - Infectious Disease

Prospective Study of Ophthalmologic Funciton in Patients Receiving Linezolid for Two Months or Greater

Medicine - Infectious Disease

A Phase II Study Testing the Activity and Safety of AGS 004 as an Immunotherapeutic in Successfully ART-Treated Subjects Infected with HIV-1 in Combination with ART Followed by ART Interruption

Medicine - Infectious Disease

A Mult-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h with 125 mg Vancomycin Taken q6h for Ten Days in Subjects with Clostridium Difficile-Associated Diarrhea

Medicine - Infectious Disease

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

Medicine - Infectious Disease

A Randomized, Observer-Blind, Active-Controlled Phase III Study to Demonstrate the Superior Efficacy of GSK Biologicals’ Adjuvanted Influenza Candidate Vaccine [GSK2186877A] Administered Intramuscularly in Elderly Aged 65 Years or Above as Compared to Flu

Medicine - Neoplastics

A Phase III, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and safety of Lenalidomide (Revlimid) as Maintenance Therapy for Patients with B-Cell Chronic Lymphocytic Leukemia Following second-line Therapy ( The Continuum Trial)

Medicine - Neoplastics

A Study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma

Medicine - Nephrology

A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus

Medicine - Nuclear Cardiology

A Phase 3b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in Subjects Administered Regadenoson

Medicine - Nuclear Cardiology

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism Samples for Pfizer’s Exploratory Research Biobank

Medicine - Nuclear Cardiology

A Safety And Efficacy Trial Evaluating The Use Of Apixaban For The Extended Treatment Of Deep Vein Thrombosis And Pulmonary Embolism

Medicine - Nuclear Cardiology

A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized with Acute Decompensated Heart Failure and Renal Dysfunction

Medicine - Nuclear Cardiology

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia

Neurology

Investigational Drug/Device for use in patients with Amyotrophic Lateral Sclerosis

Neurology

An International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Year Treatment With Teriflunomide 7 Mg Once Daily And 14 Mg Once Daily Versus Placebo In Patients With A First Clinical Episode Suggestive Of Multiple Sclerosis

Neurology

An International, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Teriflunomide 7mg Once Daily And 14mg Once Daily Versus Placebo In Patients With Relapsing Multiple Sclerosis Using Interferon-Beta 1a (Rebif®) As An Open-Label Rater-Blind Calibrator

Neurology

Case-Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Neurology

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to determine the Pharmacokinetics fo two doses of AVP-923 (Dextromethorphan/Quinidine) in the treatment of Pseudobulbar Affect (PBA) in Poatients with

Neurology

TYGRIS: TYSABRI Global Observational; program in safety

Neurology

A 52-week, multi-center, randomized, double-blind,placebo-controlled, parallel group study in patients with mild Alzheimer's disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD 106

Obsterics / Gynecology

A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding as Treatment for the Reduction of Fibroid Associated Bleeding

Obsterics / Gynecology

Comparison of SureCALL™ EMG Labor Monitor and Tocodynamometer to Intrauterine Pressure Catheter Measurements in Pregnant Women

Obsterics / Gynecology

Non-Invasive and Invasive Technology

Orthopedic Surgery

Post-Approval Study Protocol Stelkast Surpass

Orthopedic Surgery

A Prospective Study on Revision Knee Arthroplasty Using Stelkast Revision Knee Prosthesis (Stelkast TM)

Pediatrics

Long Term Administration of Inhaled Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Safety and Efficacy Study

Pediatrics

Mepilex Ag / An Open, Parallel, Randomized, Comparative, Multi-Centre Investigation In US Evaluating The Cost-Effectiveness, Efficacy, Safety And Tolerance Of Mepilex® Ag Versus Silvadene® In The Treatment Of Partial Thickness Burns.

Pediatrics

A Randomized Comparison Study of a Flexible Hydrogel Nanoparticle Wound Dressing with Silver (AltrazealTM Silver) Versus a Sodium Carboxymethyl-cellulose Dressing with Silver (AquacelÒ Ag) for Partial Thickness Skin Donor Sites

Pediatrics

A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting

Pediatrics

SINCERE: Safety in Idiopathic Arthritis: NSAIDS and Celebrex Evaluation Registry: A Prospective Observational Registry of Patients with Juvenile Idiopathic Arthritis (JIA) Treated with NSAIDS

Pediatrics

Exjade CICL670AUS32 A single-arm, open-label study of the Palatability and Tolerability of Exjade Taken with Meals, with Different Liquids or Crushed and Added to Food

Pediatrics

The Risk of Thrombotic Events in Neonates Following the Use of Recombinant Factor VIIa

Pediatrics

The EPIC Observational Study

Pediatrics

A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease and P. aeruginosa (AIR-CF4 Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4)

Pediatrics

An Open-Label, Non-comparative, Multi-centre Study to Assess The Efficacy and Safetyof Bicalutamide when used in Combination with Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotozicosis

Pediatrics

Participation in Norditropin National Registry - Novo Nordisk National Registry

Pediatrics

Pfizer International Growth Study_KIGS" Protocol: TRN 87-052-45[CCID:A6281276 An International Non-Interventional Safety Multi-Center and Consist of Data Collection on Paitents Receiving Treatment with Pfizer Product Genotropin as Part of their Standard

Pediatrics

Prospective Advate Immune Tolerance Induction Registry

Pediatrics

An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the Efficacy, Safety and Pharmacokinetics, of B-Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Children with Hemophilia A

Pediatrics

A Phase III. Randomized, Open-Label Study Comparing the Safety and Efficacy of switching stavudine or Zidovudine to Tenofovir Disoproxil Fumarate versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV Infected Children taking highly act

Pediatrics

Prospective Evaluation of the Effects of Topical Therapy with Sulfamylon for 5% Topical Solution on Autograft Healing in Subjects with Thermal Injuries Requiring Meshed Autografts: A Comparison to a Historical Control Group Sulfamylon® For 5% Topical Solution on Autograft Healingin Subjects with Thermal Injuries Requiring Meshed Autografts: A Comparison to a Historical Control Group

Psychiatry

Protocol No. 64,185-01-3W- Long-Term Clinical Follow-up of Children Enrolled in Stannsoporfin clinical Trial

Psychiatry

Risperidone in the Treatment of Children and Adolescents with Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety Followed by an Open-Label Extension Study

Pulmonary

A Double-Blind, Multicenter, Multinational, Randomized,Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease and P. Aeruginosa (AIR-CF4) Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4)

Pulmonary

A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa

Pulmonary

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrois Patients

Pulmonary

Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection who have limited treatment options and are at risk for Disease Progression

Pulmonary

Linezolid in the Treatment of Subjects with Nosocomial Pneumonia proven to be due to Methicillin-Resistant Staphylococcus Aureus

Surgery

One Year exploratory study to evaluate the safety fof partial replacement of CNI with chronic administration of Simulect® in de novo normal-risk kidney transplant recipients treated with MPA

Surgery

A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

Surgery

A Phase 2, Multicenter, Open Label, Active Comparator-Controlled, Extension Trial To Evaluate The Long Term Safety And Efficacy Of CP690,550 In Renal Allograft Recipients

Surgery

A 24-Month, Multi-Center, Randomized, Open Label Non-Inferiority Study Of Efficacy And Safety Comparing Concentration-Controlled Certican In Two Doses (1.5 Ad 3.0 Mg/Day Starting Doses) With Reduced Neoral Versus 1.44 Mg Myfortic With Standard Dose Neoral In De Novo Renal Transplant Recipientsation-Controlled

Surgery

A Phase 2, Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Codministration of CP-690,550 and Mycophenolate Mycophenolate Sodium in De Novo Kidney Allograft Recipients

Surgery

Maintenance with Sirolimus based Immunosuppression in HIV Positive Renal

Surgery

A Case Controlled Database Analysis To Evaluate If Simulect® (Basiliximab) Enables Two Day Steroid Withdrawalin Kidney Re-Transplantation

Surgery

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation

Surgery

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression

Surgery

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immuno- suppression Trial - Extended criteria donors

Surgery

A phase IV, non-interventional, multi-center, open-label, prospective, observational study of the safty, effectiveness, tolerablity, and compliance of immunosuppressive regimens using mycophendic acid to treat de novo renal transplant patients in a routine

 

 

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