Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III "CLEAR III"

Completed

Phase 3 Results N/A

Update History

26 Jan '16
The Summary of Purpose was updated.
New
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Old
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
28 Oct '15
The Summary of Purpose was updated.
New
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Old
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
17 Jan '15
A location was updated in Birmingham.
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The overall status was removed for University of Alabama at Birmingham.
A location was updated in Phoenix.
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The overall status was removed for Mayo Clinic, Arizona.
A location was updated in Los Angeles.
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The overall status was removed for Cedars-Sinai Medical Center.
A location was updated in Los Angeles.
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The overall status was removed for University of California Los Angeles.
A location was updated in Los Angeles.
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The overall status was removed for University of Southern California - Keck School of Medicine.
A location was updated in Palo Alto.
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The overall status was removed for Stanford University.
A location was updated in Hartford.
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The overall status was removed for Hartford Hospital.
A location was updated in New Haven.
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The overall status was removed for Yale University.
A location was updated in Washington DC.
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The overall status was removed for Georgetown University.
A location was updated in Jacksonville.
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The overall status was removed for Mayo Clinic, Jacksonville.
A location was updated in Sarasota.
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The overall status was removed for Intercoastal Medical Center.
A location was updated in Tampa.
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The overall status was removed for University of South Florida.
A location was updated in Chicago.
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The overall status was removed for Rush University.
A location was updated in Chicago.
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The overall status was removed for University of Chicago.
A location was updated in Chicago.
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The overall status was removed for University of Illinois at Chicago.
A location was updated in Des Moines.
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The overall status was removed for Ruan Neurology Clinical and Research Center.
A location was updated in Iowa City.
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The overall status was removed for University of Iowa.
A location was updated in Kansas City.
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The overall status was removed for Kansas University Medical Center.
A location was updated in Baltimore.
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The overall status was removed for Johns Hopkins University.
A location was updated in Baltimore.
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The overall status was removed for University of Maryland.
A location was updated in Detroit.
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The overall status was removed for Henry Ford Health System.
A location was updated in Kansas City.
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The overall status was removed for St. Luke's Brain and Stroke Institute.
A location was updated in Springfield.
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The overall status was removed for Springfield Neurological and Spine Institute.
A location was updated in St. Louis.
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The overall status was removed for St. Louis University.
A location was updated in Camden.
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The overall status was removed for Cooper University Hospital.
A location was updated in Edison.
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The overall status was removed for New Jersey Neuroscience Institute at JFK.
A location was updated in Buffalo.
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The overall status was removed for University of Buffalo.
A location was updated in Manhasset.
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The overall status was removed for Northshore University Hospital Long Island.
A location was updated in New York.
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The overall status was removed for Columbia University.
A location was updated in New York.
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The overall status was removed for Mount Sinai Hospital.
A location was updated in Syracuse.
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The overall status was removed for SUNY Upstate Medical Center.
A location was updated in Winston-Salem.
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The overall status was removed for Wake Forest University.
A location was updated in Cincinnati.
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The overall status was removed for University of Cincinnati.
A location was updated in Cleveland.
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The overall status was removed for Case-Western Reserve University Hospital.
A location was updated in Columbus.
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The overall status was removed for Ohio State University Medical Center.
A location was updated in Portland.
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The overall status was removed for Maine Medical Center.
A location was updated in Portland.
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The overall status was removed for Providence Stroke Center.
A location was updated in Abington.
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The overall status was removed for Abington Memorial Hospital.
A location was updated in Hershey.
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The overall status was removed for Penn State Hershey Medical Center.
A location was updated in Philadelphia.
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The overall status was removed for Albert Einstein Medical Center.
A location was updated in Philadelphia.
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The overall status was removed for Temple University Hospital.
A location was updated in Philadelphia.
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The overall status was removed for Thomas Jefferson University Hospital.
A location was updated in Pittsburgh.
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The overall status was removed for Allegheny General Hospital.
A location was updated in Pittsburgh.
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The overall status was removed for University of Pittsburgh Medical Center.
A location was updated in Charleston.
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The overall status was removed for Medical University of South Carolina.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt.
A location was updated in Dallas.
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The overall status was removed for University of Texas, Southwestern, Dallas.
A location was updated in Houston.
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The overall status was removed for University of Texas, Houston.
A location was updated in San Antonio.
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The overall status was removed for University of Texas, San Antonio.
A location was updated in Salt Lake City.
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The overall status was removed for University of Utah.
A location was updated in Richmond.
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The overall status was removed for Virginia Commonwealth University.
A location was updated in Milwaukee.
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The overall status was removed for Medical College of Wisconsin.
A location was updated in Joinville.
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The overall status was removed for Hospital Sao Jose, Joinville.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Clinicas de Porto Alegre.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Pronto Socorro de Porto Alegre.
A location was updated in Ribeirão Preto.
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The overall status was removed for Hospital de Clinicas de Ribeirao Preto.
A location was updated in Sao Paulo.
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The overall status was removed for Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP.
A location was updated in Edmonton.
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The overall status was removed for University of Alberta.
A location was updated in Montreal.
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The overall status was removed for Montreal Neurological Institute at McGill University.
A location was updated in Erlangen.
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The overall status was removed for University of Erlangen.
A location was updated in Halle.
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The overall status was removed for University of Halle.
A location was updated in Heidelberg.
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The overall status was removed for University of Heidelberg.
A location was updated in Leipzig.
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The overall status was removed for University of Leipzig.
A location was updated in Mainz.
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The overall status was removed for University of Mainz.
A location was updated in Tübingen.
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The overall status was removed for University of Tubingen.
A location was updated in Szeged.
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The overall status was removed for University of Szeged.
A location was updated in Budapest.
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The overall status was removed for Honved Korhaz.
A location was updated in Debrecen.
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The overall status was removed for University of Debrecen.
A location was updated in Pecs.
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The overall status was removed for University of Pecs.
A location was updated in Haifa.
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The overall status was removed for Rambam Medical Center.
A location was updated in Jerusalem.
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The overall status was removed for Hadassah Hebrew University Hospital.
A location was updated in Ramat-Gan.
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The overall status was removed for Chaim Sheba Medical Center.
A location was updated in Tel Aviv.
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The overall status was removed for Sourasky Medical Center.
A location was updated in Barcelona.
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The overall status was removed for Bellvitge Hospital.
A location was updated in Barcelona.
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The overall status was removed for Hospital de la Santa Creu i Sant Pau.
A location was updated in Barcelona.
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The overall status was removed for Vall d'Hebron University Hospital.
A location was updated in Zurich.
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The overall status was removed for University of Zurich.
A location was updated in Bern.
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The overall status was removed for University Hospital, Inselpital, Bern.
A location was updated in Salford.
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The overall status was removed for Salford Royal NHS Foundation Trust.
A location was updated in Newcastle upon Tyne.
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The overall status was removed for Newcastle General Hospital.
A location was updated in Southampton.
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The overall status was removed for University of Southampton Hospital.
24 Apr '14
A location was updated in Phoenix.
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The overall status was removed for Mayo Clinic, Arizona.
A location was updated in Washington DC.
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The overall status was removed for Georgetown University.
A location was updated in Sarasota.
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The overall status was removed for Intercoastal Medical Center.
A location was updated in Tampa.
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The overall status was removed for University of South Florida.
A location was updated in St. Louis.
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The overall status was removed for St. Louis University.
A location was updated in Philadelphia.
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The overall status was removed for Albert Einstein Medical Center.
A location was updated in Charleston.
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The overall status was removed for Medical University of South Carolina.
A location was updated in Richmond.
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The overall status was removed for Virginia Commonwealth University.
A location was updated in Joinville.
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The overall status was removed for Hospital Sao Jose, Joinville.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Pronto Socorro de Porto Alegre.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Clinicas de Porto Alegre.
A location was updated in Ribeirão Preto.
New
The overall status was removed for Hospital de Clinicas de Ribeirao Preto.
A location was updated in Sao Paulo.
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The overall status was removed for Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP.
A location was updated in Budapest.
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The overall status was removed for Honved Korhaz.
A location was updated in Haifa.
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The overall status was removed for Rambam Medical Center.
A location was updated in Bern.
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The overall status was removed for University Hospital, Inselpital, Bern.
29 Jan '14
A location was updated in New York.
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The overall status was removed for Columbia University.
A location was updated in Houston.
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The overall status was removed for University of Texas, Houston.
8 Jan '14
The Summary of Purpose was updated.
New
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Old
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA, Cathflo® Activase® Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
7 Dec '13
A location was updated in Phoenix.
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The overall status was removed for Mayo Clinic, Arizona.
A location was updated in Washington DC.
New
The overall status was removed for Georgetown University.
A location was updated in Tampa.
New
The overall status was removed for University of South Florida.
A location was updated in St. Louis.
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The overall status was removed for St. Louis University.
A location was updated in Charleston.
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The overall status was removed for Medical University of South Carolina.
A location was updated in Dallas.
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The overall status was removed for University of Texas, Southwestern, Dallas.
A location was updated in Joinville.
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The overall status was removed for Hospital Sao Jose, Joinville.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Pronto Socorro de Porto Alegre.
A location was updated in Ribeirão Preto.
New
The overall status was removed for Hospital de Clinicas de Ribeirao Preto.
A location was updated in Budapest.
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The overall status was removed for Honved Korhaz.
A location was updated in Bern.
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The overall status was removed for University Hospital, Inselpital, Bern.
5 Apr '13
A location was updated in Sarasota.
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The overall status was removed for Intercoastal Medical Center.
A location was updated in Haifa.
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The overall status was removed for Rambam Medical Center.