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Clinical Trials: Surgery


A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (IRB# 589257)

(Infection, Surgery)
  • Principal Investor
    Patrick Lee, MD
  • Summary

    The purpose of this study is to see if one of two different dosing regimens for an antibiotic already being used in adults, Dalvavancin, is safe and more effective. This antibiotic is currently approved by the FDA for the treatment of acute bacterial skin and skin structure infections.


    Participation in this trial would require 2 visits for IV antibiotic infusion and 3 other follow up visits

  • More Information

    Eligibility:


    To participate in this study you must be 18-85 years old and have an acute skin and/or skin structure infection requiring intravenous antibiotics.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Courtney Reyes, RN
    413.794.2412

A Phase II Multi-Center, Parallel-Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) (IRB# 524174)

(Heart, Surgery)
  • Principal Investor
    John Rousou, MD
  • Summary

    The purpose of this study is to see if an investigational medication is effective to prevent acute kidney injury in patients who are undergoing cardiac surgery. 


    Subjects will receive 4 doses in total investigational drug of either THR-184 (2 different dose levels) or placebo.


    Subjects will be followed until 90 Days after surgery for safety measurements.

  • More Information

    Eligibility

    In order to participate in this trial you must be at least 18 years old and having open heart surgery. Participants must meet eligibility requirements that deem them to be at risk for acute kidney injury post-operatively.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Courtney Reyes, RN
    413.794.2412

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix ECM for Pericardial Reconstruction (IRB# 589061)

(Heart, Surgery)
  • Principal Investor
    David Deaton, MD
  • Summary

    The purpose of this study is to gather additional information on CorMatrix ECM for Pericardial Closure.  This device has received FDA clearance and is intended to close and repair of the sac surrounding the heart during cardiac surgery. To participate in this study, the CorMatrix ECM device must be used during cardiac surgery. 

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 In Patients With Clostridium Difficile Associated Diarrhea (IRB# BH-12-161)

(Infection, Surgery)
  • Principal Investor
    Patrick Lee, MD
  • Summary

    The purpose of this research study is to look at the safety and effectiveness of the study drug or oral vancomycin against Clostridium difficile Associated Diarrhea (CDAD). 

  • More Information

    Eligibility:

    To participate in the study you must be age 18-89, have a positive C. difficile toxin test and have 3 unformed bowel movements.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy (IRB# IRB08-086)

(Surgery)
  • Principal Investor
    John Romanelli, MD
  • Summary

    The purpose of this study is to determine if an experimental surgery to remove the gallbladder through the vagina is a safe and effective.

  • More Information

    Eligibility:

    To participate in this study you must by a female, at least 18 years old, with no history of prior pelvic surgery (with the exception of C-section and tubal ligation).

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

Per-Oral Endoscopic Myotomy (POEM) for Esophageal Achalasia (IRB# BH-11-079)

(Surgery)
  • Principal Investor
    David Earle, MD
  • Summary

    The purpose of this study is to determine if an experimental minimally invasive surgery for achalasia is  safe and effective  to treat this condition. 

  • More Information

    Eligibility:

    To be eligible for this study you must be over 18 years old and have no history of prior esophageal surgery or perforation.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email