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: Lobel, Gregg Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 02057505; Englewood Health IRB #: E-15-637 More Information (clinicaltrials.gov link)
Cardiology
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects Principal Investigator: Joseph DeGregorio Coordinator: Vincent Franco Phone: 201-894-2139 NCT #: 03618095; Englewood Health IRB #: E-19-787 More Information (clinicaltrials.gov link)
CONNECT HF Principal Investigator: Aron Schwarcz Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 03035474; Englewood Health IRB #: E-18-728 More Information (clinicaltrials.gov link)
Heart FID 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 Principal Investigator: Aron Schwarcz Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 03037931; Englewood Health IRB #: E-18-745 More Information (clinicaltrials.gov link)
XIENCE 90 Study Principal Investigator: Joseph Degregorio Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 03218787; Englewood Health IRB #: E-18-735 More Information (clinicaltrials.gov link)
Gastroenterology
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Principal Investigator: Mark Sapienza Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 03467958; Englewood Health IRB #: E-18-757 More Information (clinicaltrials.gov link)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Principal Investigator: Mark Sapienza Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 03464097; Englewood Health IRB #: E-18-756 More Information (clinicaltrials.gov link)
Induction Study #1 – A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Principal Investigator: Mark Sapienza Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 03440372; Englewood Health IRB #: E-18-755 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: Marc Fiorillo Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 01942447; Englewood Health IRB #: E-13-507 More Information (clinicaltrials.gov link)
Gynecology
A randomized controlled trial to evaluate the efficacy of acupuncture versus aromatherapy as treatments to lessen nausea and vomiting associated with Adriamycin and Cytoxan Principal Investigator: Tracy Scheller Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 04116697; Englewood Health IRB #: E-19-773 More Information (clinicaltrials.gov link)
NICU
A Pilot Study to Look at the Use of a Stabilizing (Weighted) Pacifier vs. the Use of a Traditional Non-Stabilizing (Weighted) Pacifier to Improve Infant Comfort, Caregiver Satisfaction, and Safety During Non-Nutritive Sucking Principal Investigator: Mary De Ritter, MSN, RN, CNL Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 04095702; Englewood Health IRB #: E-19-782 More Information (clinicaltrials.gov link)
Oncology
TH-138: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor asensitizing EGFR mutation or have never smoked Principal Investigator: Meghan Kaumaya Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 03786692; Englewood Health IRB #: E-20-808 More Information (clinicaltrials.gov link)
EAZ171 Taxane Therapy EAZ171, Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women. Principal Investigator: Jill Morrison Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 04001829; Englewood Health IRB #: E-19-794 More Information (clinicaltrials.gov link)
Oncology/Bladder Cancer
A phase II study of dose-dense gemcitabine plus cisplatin (ddGC) in patients with muscle-invasive bladder cancer with bladder preservation for those patients whose tumors harbor deleterios DNA damage response (DDR) gene alterations Principal Investigator: Brian Kim Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 03609216; Englewood Health IRB #: E-18-748 More Information (clinicaltrials.gov link)
Oncology/Breast Cancer
A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Principal Investigator: David Dubin Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 01901094; Englewood Health IRB #: E-18-749 More Information (clinicaltrials.gov link)
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: Jill Morrison Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 02750826; Englewood Health IRB #: E-16-663 More Information (clinicaltrials.gov link)
B-51: Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery Principal Investigator: David Dubin Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 01872975; Englewood Health IRB #: E-16-651 More Information (clinicaltrials.gov link)
COMET: Comparison Of Operative To Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial Principal Investigator: Steve Brower Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 02926911; Englewood Health IRB #: E-17-710 More Information (clinicaltrials.gov link)
Oncology/Colon Cancer
A021502: Randomized Trial of Standard Chemotherapy alone or combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer with Deficient DNA Mismatch (ATOMIC: Adjuvant Trial of Deficient Mismatch Repair in Colon Cancer) Principal Investigator: Minaxi Jhawer Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 02912559; Englewood Health IRB #: E-18-752 More Information (clinicaltrials.gov link)
A021703, Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS). Principal Investigator: Minaxi Jhawer Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 04094688; Englewood Health IRB #: E-19-792 More Information (clinicaltrials.gov link)
Oncology/Colorectal Cancer
A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination with or without Atezolizumab or Atezolizumab Monotherapy in First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer Principal Investigator: Minaxi Jhawer Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 02997228; Englewood Health IRB #: E-18-753 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: Steven Brower Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 02751086; Englewood Health IRB #: E-16-673 More Information (clinicaltrials.gov link)
Oncology/Neuroendocrine
A021602 Advanced Neuroendocrine Tumors: A021602, Randomized, Double-Blinded Phase III Study of Cabozantinib Versus Placebo in Patients with Advanced Neuroendocrine Tumors after Progression on Everolimus (CABINET) Principal Investigator: Minaxi Jhawer Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 03375320; Englewood Health IRB #: E-18-754 More Information (clinicaltrials.gov link)
Oncology/Pancreatic Cancer
A Phase III Multi-Center Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas Principal Investigator: Minaxi Jhawer Coordinator: Nathalia Clark Phone: 201-894-3088 NCT #: 03504423; Englewood Health IRB #: E-19-781 More Information (clinicaltrials.gov link)
Oncology/Renal Cancer
EA8143, A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC). Principal Investigator: Mazyar Ghanaat Coordinator: Audrey Ades Phone: 201-894-3603 NCT #: 03055013; Englewood Health IRB #: E-19-784 More Information (clinicaltrials.gov link)
Surgery/Vascular
BEST CLI: Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia Principal Investigator: Thomas Bernik Coordinator: Elizabeth Shaji Phone: 201-894-3917 NCT #: 02060630; Englewood Health IRB #: E-16-659 More Information (clinicaltrials.gov link)