Open Clinical Trials

Englewood Health laboratory

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)