About the Clinical Research Center
Englewood Hospital and Medical Center is committed to providing state-of-the-art patient care. As part of that mission, our physician-investigators are actively researching innovative new treatment options for their patients. This clinical research effort provides our patients with access to cutting-edge therapies and advances the development of future treatments.
About the Clinical Research Center
Englewood Hospital and Medical Center is committed to providing state-of-the-art patient care. As part of that mission, our physician-investigators are actively researching innovative new treatment options for their patients. This clinical research effort provides our patients with access to cutting-edge therapies and advances the development of future treatments.
Services for EHMC Physicians
The Clinical Research Center can support EHMC physicians in facilitating the standard start-up activities required to open an industry-sponsored clinical trial, including site qualification surveys and visits, IRB submissions, budget and contract negotiation, regulatory documents, study coordination, and other requirements. The Clinical Research Center is also available to assist with the additional steps needed to start an investigator-initiated trial, including FDA submissions, clinicaltrials.gov postings, biostatistical support, publicity/recruiting, and any other study-specific requirements. Our IRB is available for individual consultations prior to document submission or to review investigator training requirements.
All clinical trials must comply with the Clinical Research Center Financial Conflict of Interest Policy: Promoting Objectivity In Research.
Services for EHMC Physicians
The Clinical Research Center can support EHMC physicians in facilitating the standard start-up activities required to open an industry-sponsored clinical trial, including site qualification surveys and visits, IRB submissions, budget and contract negotiation, regulatory documents, study coordination, and other requirements. The Clinical Research Center is also available to assist with the additional steps needed to start an investigator-initiated trial, including FDA submissions, clinicaltrials.gov postings, biostatistical support, publicity/recruiting, and any other study-specific requirements. Our IRB is available for individual consultations prior to document submission or to review investigator training requirements.
All clinical trials must comply with the Clinical Research Center Financial Conflict of Interest Policy: Promoting Objectivity In Research.
Open Clinical Trials
Englewood Hospital’s physician-investigators are currently recruiting research subjects for participation in several clinical trials across various departments.
Anesthesiology
REGAIN: “A Randomized Controlled Trial of Regional versus General Anesthesia for Promoting Independence After Hip Fracture”
Principal Investigator: Dr. Aryeh Shander
Coordinator: Andrew Brunnquell
Phone: 201-894-3186
NCT#: NCT02057505; EHMC IRB#: E-15-637
More Information (clinicaltrials.gov link)
Cardiology
“CONNECT HF”
Principal Investigator: Dr. Aron Schwarcz
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT03035474; EHMC IRB# 18-728
More Information (clinicaltrials.gov link)
Cardiology
“STOP Persistent AF”
Principal Investigator: Dr. Grant Simons
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03012841; EHMC IRB# 17-712
More Information (clinicaltrials.gov link)
Cardiology
Redo-FIRM: “Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures.”
Principal Investigator: Dr. Grant Simons
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02799043; EHMC IRB#: E-17-690
More Information (clinicaltrials.gov link)
Critical Care
TAK-954: “A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients with Enteral Feeding Intolerance.”
Principal Investigator: Dr. Carmine Gianatiempo
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03477903; EHMC IRB#: E-18-726
More Information (clinicaltrials.gov link)
Critical Care
“A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Endocarditis”
Principal Investigator: Dr. Carmine Gianatiempo
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03163446; EHMC IRB#: E-17-704
More Information (clinicaltrials.gov link)
Gastroenterology/C Diff
“Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)”
Principal Investigator: Dr. Marc Fiorillo
Coordinator: Rosabel (Rosy) Cascina
Phone: 201-945-6564
NCT#: NCT01942447; EHMC IRB#: E-13-507
More Information (clinicaltrials.gov link)
Hematology (Benign)
“An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure”
Principal Investigator: Dr. Maxwell Jonosky
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT03326843; EHMC IRB#: E-18-727
More Information (clinicaltrials.gov link)
Oncology/Brain Cancer
“Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases”
Principal Investigator: Dr. Maxwell Janosky
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02490878; EHMC IRB# E-17-711
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
“COMET: “”Comparison Of Operative To Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial”
Principal Investigator: Dr. Steven Brower
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02926911; EHMC IRB # E-17-710
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
B-51: “Standard or Comprehensive Radiation Therapy in Treating Patients with Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery”
Principal Investigator: Dr. David Dubin
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT01872975; EHMC IRB#: E-16-651
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
PALLAS: “PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer”
Principal Investigator: Dr. Michael Schleider
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02513394; EHMC IRB#: E-15-628
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
A011401: “Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer”
Principal Investigator: Dr. Jill Morrison
Coordinator: Audrey Ades
Phone: 201-894-3608
NCT#: NCT02750826; EHMC IRB#: E-16-663
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
“Aspirin in Preventing Recurrence of Cancer in Patients With Node Positive HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy”
Principal Investigator: Dr. Jill Morrison
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02927249; EHMC IRB#: E-17-682
More Information (clinicaltrials.gov link)
Oncology/Colorectal Cancer
N1048 PROSPECT: “A Phase II/ III Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs. Preoperative Combined Modality Chemoradiation for locally Advanced Rectal Cancer Pts. Undergoing Low Anterior Resection with Total Mesorectal Excision”
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT01515787; EHMC IRB#: E-15-632
More Information (clinicaltrials.gov link)
Oncology/Colorectal Cancer
NRG-GI002: “A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer”
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT02921256; EHMC IRB#: E-18-722
More Information (clinicaltrials.gov link)
Oncology/Gastric Cancer
IMIGASTRIC II: “Prospective, observational, multicenter study on minimally invasive gastrectomy for gastric cancer: robotic, laparoscopic and open surgery compared on operative and follow-up outcomes.”
Principal Investigator: Dr. Steven Brower
Coordinator: Andrew Brunnquell
Phone: 201-894-3186
NCT#: NCT02751086; EHMC IRB#: E-16-673
More Information (clinicaltrials.gov link)
Oncology/Gynecologic Cancer
OVARIO: “A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Niraparib Combined with Bevacizumab as Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-Line Platinum-Based Chemotherapy with Bevacizumab”
Principal Investigator: Dr. Nimesh Nagarsheth
Coordinator: Sam Nossir
Phone: 201-894-2139
NCT#: NCT03326193; EHMC IRB#: E-18-725
More Information (clinicaltrials.gov link)
Oncology/Lung Cancer
NRG-CC003: “Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer”
Principal Investigator: Dr. David Dubin
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02635009; EHMC#: E-16-672
More Information (clinicaltrials.gov link)
Oncology/Lymphoma
Magnify: “A Phase 3b Randomized Study of Lenalidomide (CC-5013) Plus Rituximab maintenance therapy followed by Lenalidomide single-agent maintenance versus Rituximab maintenance in subjects with relapsed/refractory follicular, marginal zone or mantle cell lymphoma”
Principal Investigator: Dr. Francis Forte
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT01996865; EHMC IRB#: E-14-558
More Information (clinicaltrials.gov link)
Oncology/Pancreatic
A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02993731; EHMC IRB#: E-17-698
More Information (clinicaltrials.gov link)
Surgery/Vascular
SeCure Study: “BEST CLI: “Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia”
Principal Investigator: Dr. Thomas Bernik
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02060630; EHMC IRB#: E-16-659
More Information (clinicaltrials.gov link)
Surgery/Vascular
Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
Principal Investigator: Dr. Thomas Bernik
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02954835; EHMC IRB#: E-16-679
More Information (clinicaltrials.gov link)
Open Clinical Trials
Englewood Hospital’s physician-investigators are currently recruiting research subjects for participation in several clinical trials across various departments.
Anesthesiology
REGAIN: “A Randomized Controlled Trial of Regional versus General Anesthesia for Promoting Independence After Hip Fracture”
Principal Investigator: Dr. Aryeh Shander
Coordinator: Andrew Brunnquell
Phone: 201-894-3186
NCT#: NCT02057505; EHMC IRB#: E-15-637
More Information (clinicaltrials.gov link)
Cardiology
“CONNECT HF”
Principal Investigator: Dr. Aron Schwarcz
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT03035474; EHMC IRB# 18-728
More Information (clinicaltrials.gov link)
Cardiology
“STOP Persistent AF”
Principal Investigator: Dr. Grant Simons
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03012841; EHMC IRB# 17-712
More Information (clinicaltrials.gov link)
Cardiology
Redo-FIRM: “Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures.”
Principal Investigator: Dr. Grant Simons
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02799043; EHMC IRB#: E-17-690
More Information (clinicaltrials.gov link)
Critical Care
TAK-954: “A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients with Enteral Feeding Intolerance.”
Principal Investigator: Dr. Carmine Gianatiempo
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03477903; EHMC IRB#: E-18-726
More Information (clinicaltrials.gov link)
Critical Care
“A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Endocarditis”
Principal Investigator: Dr. Carmine Gianatiempo
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT03163446; EHMC IRB#: E-17-704
More Information (clinicaltrials.gov link)
Gastroenterology/C Diff
“Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)”
Principal Investigator: Dr. Marc Fiorillo
Coordinator: Rosabel (Rosy) Cascina
Phone: 201-945-6564
NCT#: NCT01942447; EHMC IRB#: E-13-507
More Information (clinicaltrials.gov link)
Hematology (Benign)
“An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure”
Principal Investigator: Dr. Maxwell Jonosky
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT03326843; EHMC IRB#: E-18-727
More Information (clinicaltrials.gov link)
Oncology/Brain Cancer
“Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases”
Principal Investigator: Dr. Maxwell Janosky
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02490878; EHMC IRB# E-17-711
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
“COMET: “”Comparison Of Operative To Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial”
Principal Investigator: Dr. Steven Brower
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02926911; EHMC IRB # E-17-710
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
B-51: “Standard or Comprehensive Radiation Therapy in Treating Patients with Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery”
Principal Investigator: Dr. David Dubin
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT01872975; EHMC IRB#: E-16-651
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
PALLAS: “PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer”
Principal Investigator: Dr. Michael Schleider
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02513394; EHMC IRB#: E-15-628
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
A011401: “Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer”
Principal Investigator: Dr. Jill Morrison
Coordinator: Audrey Ades
Phone: 201-894-3608
NCT#: NCT02750826; EHMC IRB#: E-16-663
More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
“Aspirin in Preventing Recurrence of Cancer in Patients With Node Positive HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy”
Principal Investigator: Dr. Jill Morrison
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02927249; EHMC IRB#: E-17-682
More Information (clinicaltrials.gov link)
Oncology/Colorectal Cancer
N1048 PROSPECT: “A Phase II/ III Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs. Preoperative Combined Modality Chemoradiation for locally Advanced Rectal Cancer Pts. Undergoing Low Anterior Resection with Total Mesorectal Excision”
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT01515787; EHMC IRB#: E-15-632
More Information (clinicaltrials.gov link)
Oncology/Colorectal Cancer
NRG-GI002: “A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer”
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Sam Nossir
Phone: 201-608-2139
NCT#: NCT02921256; EHMC IRB#: E-18-722
More Information (clinicaltrials.gov link)
Oncology/Gastric Cancer
IMIGASTRIC II: “Prospective, observational, multicenter study on minimally invasive gastrectomy for gastric cancer: robotic, laparoscopic and open surgery compared on operative and follow-up outcomes.”
Principal Investigator: Dr. Steven Brower
Coordinator: Andrew Brunnquell
Phone: 201-894-3186
NCT#: NCT02751086; EHMC IRB#: E-16-673
More Information (clinicaltrials.gov link)
Oncology/Gynecologic Cancer
OVARIO: “A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Niraparib Combined with Bevacizumab as Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-Line Platinum-Based Chemotherapy with Bevacizumab”
Principal Investigator: Dr. Nimesh Nagarsheth
Coordinator: Sam Nossir
Phone: 201-894-2139
NCT#: NCT03326193; EHMC IRB#: E-18-725
More Information (clinicaltrials.gov link)
Oncology/Lung Cancer
NRG-CC003: “Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer”
Principal Investigator: Dr. David Dubin
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT#: NCT02635009; EHMC#: E-16-672
More Information (clinicaltrials.gov link)
Oncology/Lymphoma
Magnify: “A Phase 3b Randomized Study of Lenalidomide (CC-5013) Plus Rituximab maintenance therapy followed by Lenalidomide single-agent maintenance versus Rituximab maintenance in subjects with relapsed/refractory follicular, marginal zone or mantle cell lymphoma”
Principal Investigator: Dr. Francis Forte
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT01996865; EHMC IRB#: E-14-558
More Information (clinicaltrials.gov link)
Oncology/Pancreatic
A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.
Principal Investigator: Dr. Minaxi Jhawer
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02993731; EHMC IRB#: E-17-698
More Information (clinicaltrials.gov link)
Surgery/Vascular
SeCure Study: “BEST CLI: “Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia”
Principal Investigator: Dr. Thomas Bernik
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02060630; EHMC IRB#: E-16-659
More Information (clinicaltrials.gov link)
Surgery/Vascular
Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
Principal Investigator: Dr. Thomas Bernik
Coordinator: Francesca Flink
Phone: 201-894-3917
NCT#: NCT02954835; EHMC IRB#: E-16-679
More Information (clinicaltrials.gov link)
Research Developments Newsletter
Research Developments Newsletter
Contact Us
For questions about clinical trials and research at Englewood Hospital and Medical Center, please contact:
Jamie Ketas
Director, Clinical Research Center and Institutional Review Board
jamie.ketas@ehmchealth.org
201-894-3418
Renee Lockwood
Coordinator, Institutional Review Board
renee.lockwood@ehmchealth.org
201-894-3852
For more information on clinical trials, including information for prospective and current participants, visit clinicaltrials.gov, a service of the U.S. National Institutes of Health.
Contact Us
For questions about clinical trials and research at Englewood Hospital and Medical Center, please contact:
Jamie Ketas
Director, Clinical Research Center and Institutional Review Board
jamie.ketas@ehmchealth.org
201-894-3418
Renee Lockwood
Coordinator, Institutional Review Board
renee.lockwood@ehmchealth.org
201-894-3852
For more information on clinical trials, including information for prospective and current participants, visit clinicaltrials.gov, a service of the U.S. National Institutes of Health.