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: Grace Kuo
Phone: 201-894-3163
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: Grace Kuo
Phone: 201-894-3163
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

“A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of anamorelin HC1 for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced non-small cell lung cancer (NSCLC)”
Principal Investigator: Lewis Attas
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT #: 03743051; Englewood Health IRB #: E-18-750
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)

A171601 “A phase II trial assessing the tolerability of palbociclib in combination with letrozole or fulvestrant in patients aged 70 and older with estrogen receptor-positive, HER2- negative metastatic breast cancer”
Principal Investigator: Jill Morrison
Coordinator: Audrey Ades
Phone: 201-894-3603
NCT #: 03633331; Englewood Health IRB #: E-19-758
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: Audrey Ades
Phone: 201-894-3603
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)