International Guillain-Barré Syndrome Outcome Study

NCT ID: NCT01582763

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-01

Study Completion Date

2024-12-02

Brief Summary

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International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

Detailed Description

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GBS is a post-infectious immune-mediated polyradiculoneuropathy with a highly diverse clinical course and outcome despite partially effective forms of treatment(immunoglobulins and plasma exchange). Outcome in patients with GBS has not improved in the last two decades. At present about 10 to 20% of patients remain severely disabled and about 5% die. One explanation for this stagnation is the highly variable clinical course of GBS and the lack of knowledge about the factors that determine the clinical course in individual patients with GBS. GBS may consist of distinct pathogenic subgroups, in which disease onset and progression is influenced by different types of preceding infections, anti-neural antibodies and genetic polymorphisms. Optimal treatment of individual patients may depend on the pathogenesis and clinical severity. Patients with severe forms of GBS may possibly need more intensive treatment to recover. Patients with a milder course that fully recover after standard therapy could suffer from possibly more side effects of more aggressive forms of treatment. This could only be possible if there are prognostic models that accurately predict the clinical course in individual patients. Ideally such models should be based on clinical and biological predictors that are strongly associated with disease course and known as early as possible in the acute phase of illness, when treatment with immunomodulatory therapy is most effective. Prognostic models could help to guide selective trials in specific GBS subtypes. Because of this it will be possible to treat GBS with more effective and more individual therapy.

This study aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. This information will be used to understand the diversity in clinical presentation and response to treatment of GBS. This information will also be used to develop new prognostic models to predict the clinical course and outcome accurately in individual patients with GBS.

To address these research questions it is required to conduct a prospective study with standardized collection of clinical data and biomaterials from a large group of well-defined GBS patients during a long follow-up period. Such an extensive study in a relatively rare disease as GBS can be addressed only by intensive international collaboration.

Conditions

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Guillain-Barré Syndrome Miller Fisher Syndrome

Keywords

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Guillain-Barré syndrome Polyneuropathy Autoimmune Diseases Immune System Diseases Neuromuscular Diseases Outcome Quality of life Disability Prognostic Determinants Treatment Immunoglobulins Prognosis Infections Anti-ganglioside antibodies Genetic polymorphisms Electrophysiology Cerebrospinal Fluid Serum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GBS

Guillain-Barré syndrome \>1000, follow-up 1-3 years

No interventions assigned to this group

NC

Normal controls (NC)

No interventions assigned to this group

IC

Infectious controls (IC)

No interventions assigned to this group

OND

Other neurological diseases (OND)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of GBS, including overlap syndromes, can be included.
* Inclusion of all males and females of all ages, independent of disease severity and treatment
* Inclusion within two weeks of onset of weakness
* Inclusion of patients transferred from another hospital if the stay in the first hospital was less than one week
* Opportunity to conduct a follow-up of at least one year
* Informed consent of patient or, in case of children, of parents or legal guardians
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. B.C. Jacobs

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bart Jacobs, Dr.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Barrows Neurological Institute

Phoenix, Arizona, United States

Site Status

UC Irvine Health

Orange, California, United States

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Yale University School of medicine

New Haven, Connecticut, United States

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University of Florida

Jacksonville, Florida, United States

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Northwestern University

Chicago, Illinois, United States

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Southern Illinois University School of Medicine

Springfield, Illinois, United States

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University of Iowa

Iowa City, Iowa, United States

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University of Kansas Medical Center

Kansas City, Kansas, United States

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University of Maryland School of Medicine

Baltimore, Maryland, United States

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Johns Hopkins

Baltimore, Maryland, United States

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Lahey clinic Boston

Boston, Massachusetts, United States

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Tufts University School of Medicine

Boston, Massachusetts, United States

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Spectrum Health System

Grand Rapids, Michigan, United States

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University of Minnesota

Minneapolis, Minnesota, United States

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Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

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University of New Mexico

Albuquerque, New Mexico, United States

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University at Buffalo

Buffalo, New York, United States

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Mt. Sinai School of Med

New York, New York, United States

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Columbia University

New York, New York, United States

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Montefiore MC

New York, New York, United States

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Wexner Medical Center at The Ohio State University

Columbus, Ohio, United States

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University of Tennessee

Memphis, Tennessee, United States

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UT Southwestern

Dallas, Texas, United States

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The university of Texas Health Science Center

Houston, Texas, United States

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University of Utah School of Medicine

Salt Lake City, Utah, United States

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University of Vermont College of Medicine

Burlington, Vermont, United States

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Hospital Austral

Buenos Aires, , Argentina

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Hospital Britanico

Buenos Aires, , Argentina

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Hospital Cesar Milstein

Buenos Aires, , Argentina

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Hospital de Clinicas

Buenos Aires, , Argentina

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Hospital Fleni

Buenos Aires, , Argentina

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Hospital Garrahan

Buenos Aires, , Argentina

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Hospital Militar

Buenos Aires, , Argentina

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Royal Melbourne Hospital

Parkville, Victoria, Australia

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Concord Repatriation General Hospital Sydney

Sydney, , Australia

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Dhaka Medical College & Hospital

Dhaka, , Bangladesh

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ICDDR,B

Dhaka, , Bangladesh

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Clinique Universitaire St. Luc

Brussels, , Belgium

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University Hospital Leuven

Leuven, , Belgium

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University of Calgary

Calgary, , Canada

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Queens University

Kingston, , Canada

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University hospital LHSC

London, , Canada

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University Health Network

Toronto, , Canada

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

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Xiang Hospital Central South University

Changsha, Hunan, China

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The affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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Affiliated Hospital of Jining Medical University

Jining, Shandong, China

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Aalborg Hospital

Aalborg, , Denmark

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Aarhus University Hospital

Aarhus, , Denmark

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National Hospital Copenhagen

Copenhagen, , Denmark

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Glostrup Hospital Copenhagen

Glostrup Municipality, , Denmark

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Odense University Hospital

Odense, , Denmark

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Hôpital St. Louis de Paris

Paris, Paris, France

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Hospital de la Timone

Marseille, , France

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Nantes University Hospital

Nantes, , France

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University Strassbourg

Strasbourg, , France

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Universitätsklinikum der RWTH

Aachen, , Germany

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University of Cologne

Cologne, , Germany

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Universitatsklinikum Dresden

Dresden, , Germany

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Heinrich Heine University

Düsseldorf, , Germany

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University Hospital of Saarland

Homburg, , Germany

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Universitatsklinikum Würzburg

Würzburg, , Germany

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University of Thessaly

Larissa, Thessaly, Greece

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University of Genova

Genova, , Italy

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Ospedale Sant'Andrea La Spezia

La Spezia, , Italy

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Ospedale Luigi Sacco

Milan, , Italy

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Ospedale San Raffaele

Milan, , Italy

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University of Milan

Milan, , Italy

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University of Modena

Modena, , Italy

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University of Milano-Bicocca

Monza, , Italy

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Universita FedericoII di Napoli

Napoli, , Italy

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University of Padova

Padua, , Italy

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Policlinico Tor Vergata

Roma, , Italy

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Sant' Andrea Hospital

Rome, , Italy

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Chiba University School of Medicine

Chiba, , Japan

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Kinki University School of Medicine

Osaka, , Japan

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Hokkaido Medical Center

Sapporo, , Japan

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Dokkyo Medical Univeristy

Tochigi, , Japan

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National Defense Medical College

Tokorozawa, , Japan

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Toho University Medical Center

Tokyo, , Japan

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University of Malaya

Kuala Lumpur, , Malaysia

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Erasmus Medical Center

Rotterdam, South Holland, Netherlands

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Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

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AMC Amsterdam

Amsterdam, , Netherlands

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Gelre ziekenhuis

Apeldoorn, , Netherlands

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Rode Kruis Ziekenhuis

Beverwijk, , Netherlands

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Reinier de Graaf Groep

Delft, , Netherlands

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Van Weel-Bethesda Hospital

Dirksland, , Netherlands

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Albert Schweitzer Hospital

Dordrecht, , Netherlands

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Elkerliek hospital

Helmond, , Netherlands

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Westfriesgasthuis Hoorn

Hoorn, , Netherlands

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LUMC

Leiden, , Netherlands

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University Hospital Maastricht

Maastricht, , Netherlands

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CWZ Nijmegen

Nijmegen, , Netherlands

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Maasstad Hospital

Rotterdam, , Netherlands

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Sint Franciscus Gasthuis

Rotterdam, , Netherlands

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SSVZ

Schiedam, , Netherlands

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HAGA ziekenhuis

The Hague, , Netherlands

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MCH Westeinde

The Hague, , Netherlands

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St. Elisabeth hospital

Tilburg, , Netherlands

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University of Puerto Rico

San Juan, , Puerto Rico

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University of Cape Town

Cape Town, , South Africa

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Hospital de Bellvitge

Barcelona, , Spain

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Hospital Santa Creu I Sant Pau

Barcelona, , Spain

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Hospital Universitario Reina Sofia

Córdoba, , Spain

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Clinica Hospital 2 de Octubre

Madrid, , Spain

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Hospital Universitario Infanta Sofia

Madrid, , Spain

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Hospital Universitario Central de Asturias

Oviedo, , Spain

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Complejo Hospitalario de Navarra

Pamplona, , Spain

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Hospital Marques de Valdecilla

Santander, , Spain

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Hospital de Santiago

Santiago de Compostela, , Spain

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Hospital Virgen de Sevilla

Seville, , Spain

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Universityhospital Bern, Inselspital

Bern, , Switzerland

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HFR - Cantonal Hospital

Fribourg, , Switzerland

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Hôpitaux Universitaires de Genève

Geneva, , Switzerland

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Lausanne University Hospital

Lausanne, , Switzerland

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Ospeale Civico Lugano

Lugano, , Switzerland

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Kantonspital St. Gallen

Sankt Gallen, , Switzerland

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Hopital du Valais

Sion, , Switzerland

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National Taiwan University Hospital

Taipei, , Taiwan

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Queen Elizabeth Hospital

Birmingham, , United Kingdom

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Bradford Royal Infirmary

Bradford, , United Kingdom

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Addenbrooke's Hospital

Cambridge, , United Kingdom

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Western General Hospital

Edinburgh, , United Kingdom

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University of Glasgow

Glasgow, , United Kingdom

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Hinching Brooke Hospital

Huntingdon, , United Kingdom

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NHS Forth Valley Hospital

Larbert, , United Kingdom

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Leeds General Infirmary

Leeds, , United Kingdom

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The Walton Centre

Liverpool, , United Kingdom

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Charing Cross Hospital

London, , United Kingdom

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King's College Hospital

London, , United Kingdom

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National Hospital of Neurology and Neurosurgery

London, , United Kingdom

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St. George's Hospital

London, , United Kingdom

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James Cook University Hospital

Middlesbrough, , United Kingdom

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Royal Victoria Infirmary

Newcastle, , United Kingdom

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University of Oxford

Oxford, , United Kingdom

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Royal Hallamshire Hospital

Sheffield, , United Kingdom

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Pinderfields Hospital

Wakefield, , United Kingdom

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Countries

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Brazil India Mexico United States Argentina Australia Bangladesh Belgium Canada China Denmark France Germany Greece Italy Japan Malaysia Netherlands Puerto Rico South Africa Spain Switzerland Taiwan United Kingdom

References

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Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Pereon Y, Burmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutierrez-Gutierrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barre Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.

Reference Type DERIVED
PMID: 34937789 (View on PubMed)

Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barre Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barre syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

Reference Type DERIVED
PMID: 28406555 (View on PubMed)

Related Links

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Other Identifiers

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3290

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2011-477

Identifier Type: -

Identifier Source: org_study_id