ReferenceCitation: Aberer W, Maurer M, Reshef A, Longhurst H, Kivity S, Bygum A, Caballero T, Bloom B, Nair N, Malbrán A. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema. Allergy. 2014 Mar;69(3):305-14. doi: 10.1111/all.12303.

name: Department of Dermatology and Venerology; Medical University Graz; Graz Austria

family: Aberer

full_name: W. Aberer

given: W.

name: Allergie-Centrum-Charité; Department of Dermatology and Allergy; Charité - Universitätsmedizin; Berlin Germany

family: Maurer

full_name: M. Maurer

given: M.

name: Allergy; Clinical Immunology and Angioedema Unit; The Sheba Medical Center; Tel-Hashomer Israel

family: Reshef

full_name: A. Reshef

given: A.

name: Immunology Department; Bart's and The London Hospital; London UK

family: Longhurst

full_name: H. Longhurst

given: H.

name: The Allergy and Immunology Unit; The Tel Aviv Medical Center; Sackler Medical School; Tel Aviv Israel

family: Kivity

full_name: S. Kivity

given: S.

name: Department of Dermatology and Allergy Centre; Odense University Hospital; Odense Denmark

family: Bygum

full_name: A. Bygum

name: The Hospital La Paz Health Research Institute (IdiPaz); Biomedical Research Network on Rare Diseases (CIBERER, U754); Madrid Spain

family: Caballero

full_name: T. Caballero

given: T.

name: Department of Clinical Development; Shire; Lexington MA

family: Bloom

full_name: B. Bloom

given: B.

name: Global Clinical Research; Shire; Lexington MA USA

family: Nair

full_name: N. Nair

given: N.

name: Department of Allergy, Asthma and Immunology; Hospital Británico de Buenos Aires; Buenos Aires Argentina

family: Malbrán

full_name: A. Malbrán

journal_name: Allergy

lead_sponsor: Shire

location_country:
Italy
Austria
Switzerland
France
Israel
Argentina
Spain
Denmark
Germany
United Kingdom

acronym: EASSI

location_facility: Bnai-Zion M.C. Clinical Immunology and Allergy Division

location_facility: Centre Hospitalier Universitaire/ Service de Dermatologie

location_facility: Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria

location_facility: Hospital Universitario La Paz, Servicio de Alergia

location_facility: Universitätsspital Zürich / Dermatologische Klinik

location_facility: Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen

location_facility: Hopital Europeen Georges Pompidou Immunologie Clinique

location_facility: The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit

location_facility: Derriford Combined Laboratory, Department of Clinical Immunology & Allergy

location_facility: Barts & The London NHS Trust, Pathology and Pharmacy Building

location_facility: Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität

location_facility: Universita degli Studi di Napoli 'Federico II'

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario La Fe, Servicio de Alergia

location_facility: Hopital Claude Huriex/ Service de medicine interne

location_facility: Clinique Universitaire de Medicine/ Centre National de reference

location_facility: Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité

location_facility: Tel Aviv Sourasky Medical Center - Allergy Unit

location_facility: Universitätsklinik für Dermatologie und Venerologie

location_facility: Southmead Hospital, Department of Immunology

location_facility: Klinkum der Johann Wolfgang Goethe-Universitat

title: Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

summary: This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.


type: EudraCT Number

title: A Multicenter, Open Label, Phase I Trial of the MEK Inhibitor MSC1936369B Given Orally to Subjects With Solid Tumours

summary: This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lebbé C, Italiano A, Houédé N, Awada A, Aftimos P, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Raymond E, Faivre S, Pages C, Gomez-Roca C, Schueler A, Goodstal S, Massimini G, Delord JP. Selective Oral MEK1/2 Inhibitor Pimasertib in Metastatic Melanoma: Antitumor Activity in a Phase I, Dose-Escalation Trial. Target Oncol. 2021 Jan;16(1):47-57. doi: 10.1007/s11523-020-00767-1.

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

sequence: first

family: Italiano

full_name: Antoine Italiano

given: Antoine

sequence: additional

family: Houédé

full_name: Nadine Houédé

given: Nadine

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Aftimos

full_name: Philippe Aftimos

given: Philippe

family: Lesimple

full_name: Thierry Lesimple

given: Thierry

family: Dinulescu

full_name: Monica Dinulescu

given: Monica

family: Schellens

full_name: Jan H. M. Schellens

given: Jan H. M.

family: Leijen

full_name: Suzanne Leijen

given: Suzanne

family: Rottey

full_name: Sylvie Rottey

given: Sylvie

family: Kruse

full_name: Vibeke Kruse

given: Vibeke

family: Kefford

full_name: Richard Kefford

given: Richard

family: Raymond

full_name: Eric Raymond

given: Eric

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

family: Pages

full_name: Celine Pages

given: Celine

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Schueler

full_name: Armin Schueler

given: Armin

family: Goodstal

full_name: Samantha Goodstal

given: Samantha

family: Massimini

full_name: Giorgio Massimini

given: Giorgio

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Targeted Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Delord JP, Italiano A, Awada A, Aftimos P, Houédé N, Lebbé C, Pages C, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Faivre S, Gomez-Roca C, Scheuler A, Massimini G, Raymond E. Selective Oral MEK1/2 Inhibitor Pimasertib: A Phase I Trial in Patients with Advanced Solid Tumors. Target Oncol. 2021 Jan;16(1):37-46. doi: 10.1007/s11523-020-00768-0.

location_facility: Netherlands Cancer Institute - Antonie van Leeuwenhoek Hospital


ReferenceType: background

ReferenceCitation: Baurain JF, Robert C, Mortier L, Neyns B, Grange F, Lebbe C, Ulloa-Montoya F, De Sousa Alves PM, Gillet M, Louahed J, Jarnjak S, Lehmann FF. Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic. ESMO Open. 2018 Jul 25;3(5):e000384. doi: 10.1136/esmoopen-2018-000384. eCollection 2018.

intervention_type: Biological

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

lead_sponsor: GlaxoSmithKline

location_country: Belgium France

acronym: MAGE3-AS15-MEL-004 (MET)

ipd_sharing: Yes

source: euctr

title: Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary: The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

summary:
Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

Immunogenicity

To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects

Safety

- To describe the safety profile after vaccination in each group

Acceptability

To describe the pain at the injection site
To describe the comfort of the injection

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.

family: Van Damme

full_name: Pierre Van Damme

given: Pierre

family: Arnou

full_name: Robert Arnou

given: Robert

family: Kafeja

full_name: Froukje Kafeja

given: Froukje

family: Fiquet

full_name: Anne Fiquet

given: Anne

family: Richard

full_name: Patrick Richard

given: Patrick

family: Thomas

full_name: Stéphane Thomas

given: Stéphane

family: Meghlaoui

full_name: Gilles Meghlaoui

given: Gilles

family: Samson

full_name: Sandrine Isabelle Samson

given: Sandrine Isabelle

family: Ledesma

full_name: Emilio Ledesma

given: Emilio

currency_apc_doaj: GBP

journal_name: BMC Infectious Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
irua

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Sanofi Pasteur, a Sanofi Company

lead_sponsor_type: academique


ReferenceCitation: Koné-Paut I, Lachmann HJ, Kuemmerle-Deschner JB, Hachulla E, Leslie KS, Mouy R, Ferreira A, Lheritier K, Patel N, Preiss R, Hawkins PN; Canakinumab in CAPS Study Group. Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study. Arthritis Res Ther. 2011;13(6):R202. doi: 10.1186/ar3535. Epub 2011 Dec 9.

family: Koné-Paut

full_name: Isabelle Koné-Paut

given: Isabelle

family: Lachmann

full_name: Helen J Lachmann

given: Helen J

family: Kuemmerle-Deschner

full_name: Jasmin B Kuemmerle-Deschner

given: Jasmin B

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Leslie

full_name: Kieron S Leslie

given: Kieron S

family: Mouy

full_name: Richard Mouy

given: Richard

family: Ferreira

full_name: Alberto Ferreira

given: Alberto

family: Lheritier

full_name: Karine Lheritier

given: Karine

family: Patel

full_name: Neha Patel

given: Neha

family: Preiss

full_name: Ralph Preiss

given: Ralph

family: Hawkins

full_name: Philip N Hawkins

given: Philip N

name: on behalf of the Canakinumab in CAPS Study Group

journal_name: Arthritis Research & Therapy

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, Leslie KS, Hachulla E, Quartier P, Gitton X, Widmer A, Patel N, Hawkins PN; Canakinumab in CAPS Study Group. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med. 2009 Jun 4;360(23):2416-25. doi: 10.1056/NEJMoa0810787.

full_name: Helen J. Lachmann

given: Helen J.

family: Kone-Paut

full_name: Isabelle Kone-Paut

full_name: Jasmin B. Kuemmerle-Deschner

given: Jasmin B.

full_name: Kieron S. Leslie

given: Kieron S.

title: Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome

location_country:
United States
India
France
Spain
Germany
United Kingdom

location_facility:
Novartis Investigative Site
Novartis Investigational Site

title: A Three-part,Multicenter Study,With a Randomized,Double-blind,Placebo Controlled,Withdrawal Design in Part II to Assess Efficacy,Safety,and Tolerability of ACZ885(Anti-interleukin-1beta Monoclonal Antibody)in Patients With Muckle-Wells Syndrome

summary:
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo.

Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.


title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

ReferenceCitation: Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

family: Williamson

full_name: Owen D. Williamson

given: Owen D.

family: Schroer

full_name: Melissa Schroer

given: Melissa

family: Ruff

full_name: Dustin D. Ruff

given: Dustin D.

family: Ahl

full_name: Jonna Ahl

given: Jonna

family: Margherita

full_name: Anthony Margherita

given: Anthony

family: Sagman

full_name: Doron Sagman

given: Doron

family: Wohlreich

full_name: Madelaine M. Wohlreich

given: Madelaine M.

journal_name: Clinical Therapeutics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Onset of Response with Duloxetine Treatment in Patients with Osteoarthritis Knee Pain and Chronic Low Back Pain: A Post Hoc Analysis of Placebo-Controlled Trials

ReferenceCitation: Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.

family: Skljarevski

full_name: Vladimir Skljarevski

given: Vladimir

family: Zhang

full_name: Shuyu Zhang

given: Shuyu

family: Chappell

full_name: Amy S. Chappell

given: Amy S.

family: Walker

full_name: Daniel J. Walker

given: Daniel J.

family: Murray

full_name: Isabelle Murray

family: Backonja

full_name: Miroslav Backonja

given: Miroslav

journal_name: Pain Medicine

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Maintenance of Effect of Duloxetine in Patients with Chronic Low Back Pain: A 41-week Uncontrolled, Dose-blinded Study

ReferenceCitation: Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.

family: Desaiah

full_name: Durisala Desaiah

given: Durisala

family: Liu-Seifert

full_name: Hong Liu-Seifert

given: Hong

full_name: Qi Zhang

given: Qi

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Efficacy and Safety of Duloxetine in Patients With Chronic Low Back Pain

location_country: Brazil Netherlands Mexico France Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p


ReferenceCitation: Walz G, Budde K, Mannaa M, Nürnberger J, Wanner C, Sommerer C, Kunzendorf U, Banas B, Hörl WH, Obermüller N, Arns W, Pavenstädt H, Gaedeke J, Büchert M, May C, Gschaidmeier H, Kramer S, Eckardt KU. Everolimus in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2010 Aug 26;363(9):830-40. doi: 10.1056/NEJMoa1003491. Epub 2010 Jun 26. Erratum in: N Engl J Med. 2010 Nov 11;363(20):1977. N Engl J Med. 2010 Sep 16;363(12):1190.

family: Walz

full_name: Gerd Walz

given: Gerd

family: Budde

full_name: Klemens Budde

given: Klemens

family: Mannaa

full_name: Marwan Mannaa

given: Marwan

family: Nürnberger

full_name: Jens Nürnberger

given: Jens

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Sommerer

full_name: Claudia Sommerer

given: Claudia

family: Kunzendorf

full_name: Ulrich Kunzendorf

given: Ulrich

family: Banas

full_name: Bernhard Banas

given: Bernhard

family: Hörl

full_name: Walter H. Hörl

given: Walter H.

family: Obermüller

full_name: Nicholas Obermüller

given: Nicholas

family: Arns

full_name: Wolfgang Arns

given: Wolfgang

family: Pavenstädt

full_name: Hermann Pavenstädt

given: Hermann

family: Gaedeke

full_name: Jens Gaedeke

family: Büchert

full_name: Martin Büchert

given: Martin

family: May

full_name: Christoph May

family: Gschaidmeier

full_name: Harald Gschaidmeier

given: Harald

family: Kramer

full_name: Stefan Kramer

given: Stefan

family: Eckardt

full_name: Kai-Uwe Eckardt

given: Kai-Uwe

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Everolimus in Patients with Autosomal Dominant Polycystic Kidney Disease

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

location_country: Austria Germany France

acronym: ADPKD

title: A Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

summary: This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.


title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone

summary: The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

ReferenceType: result

ReferenceCitation: van der Lely AJ, Bernabeu I, Cap J, Caron P, Colao A, Marek J, Neggers S, Birman P. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011 Mar;164(3):325-33. doi: 10.1530/EJE-10-0867. Epub 2010 Dec 10.

family: van der Lely

full_name: Aart-Jan van der Lely

given: Aart-Jan

family: Bernabeu

full_name: Ignacio Bernabeu

given: Ignacio

family: Cap

full_name: Jan Cap

given: Jan

family: Caron

full_name: Philippe Caron

given: Philippe

family: Colao

full_name: Annamaria Colao

given: Annamaria

family: Marek

full_name: Josef Marek

given: Josef

family: Neggers

full_name: Sebastian Neggers

given: Sebastian

family: Birman

full_name: Pascal Birman

given: Pascal

journal_name: European Journal of Endocrinology

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

lead_sponsor: Ipsen

location_country:
Italy
Sweden
Netherlands
France
Czechia
Greece
Spain
Denmark
Germany
United Kingdom

location_facility: Groupe Hospitalier Henri Mondor- Albert Chenevier

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Klinikum Johann Wolfgang Goethe-Universität

location_facility: Christie Hospital and Holt Radium Institute


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]

summary: To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.

lead_sponsor: UCB Pharma

location_country: Poland France Greece Hungary Belgium Spain


title: A Multicenter, Open-label Phase I/II Trial to Evaluate the Safety and Activity of CPC-P501 Protein Formulated With the Adjuvant AS15 as First-line Treatment in Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

summary: Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.


summary: Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.

lead_sponsor: Eli Lilly and Company

location_country: Germany Finland France

location_facility: "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."

location_facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.


title: A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

summary:
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age).

Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.

The primary aim is to assess MRD status at 6 months in both arms.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Universite Catholique de Louvain Mont Godinne

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Chu de Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Universite Libre de Bruxelles - Hopital ERASME

location_facility: CH de Bretagne Atlantique - Hopital CHUBERT

status_simplified: Ongoing


title: Careful Ventilation in Acute Respiratory Distress Syndrome

acronym: CAVIARDS

summary:
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS).

The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).

status: Recruiting

lead_sponsor: Unity Health Toronto

location_country:
Italy
Chile
France
Spain
United States
Canada

location_facility: Hopital de la Cavale Blanche - CHRU Brest

location_facility: Pontificia Universidad Católica de Chile

location_facility: Centre hospitalier universitaire d'Angers

location_facility: New York University Grossman School of Medicine

location_facility: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility: Policlinico Universitario Agostino Gemelli IRCCS

intervention_type: Other


ReferenceCitation: Gonzalez Martin A, Sanchez Lorenzo L, Colombo N, dePont Christensen R, Heitz F, Meirovitz M, Selle F, van Gorp T, Alvarez N, Sanchez J, Marqués C. A phase III, randomized, double blinded trial of platinum based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal, or peritoneal cancer and platinum treatment free interval of more than 6 months: ENGOT-Ov41/GEICO 69-O/ANITA Trial. Int J Gynecol Cancer. 2021 Apr;31(4):617-622. doi: 10.1136/ijgc-2020-001633. Epub 2020 Dec 14.

family: Gonzalez Martin

full_name: Antonio Gonzalez Martin

given: Antonio

family: Sanchez Lorenzo

full_name: Luisa Sanchez Lorenzo

given: Luisa

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: dePont Christensen

full_name: René dePont Christensen

given: René

family: Heitz

full_name: Florian Heitz

given: Florian

family: Meirovitz

full_name: Mihai Meirovitz

given: Mihai

family: Selle

full_name: Frederic Selle

given: Frederic

family: van Gorp

full_name: Toon van Gorp

given: Toon

family: Alvarez

full_name: Nuria Alvarez

given: Nuria

family: Sanchez

full_name: Javier Sanchez

given: Javier

family: Marqués

full_name: Carmen Marqués

given: Carmen

journal_name: International Journal of Gynecologic Cancer

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Grupo Español de Investigación en Cáncer de Ovario

location_country: Italy France Belgium Spain Germany

acronym: ANITA

location_facility: Hospital Clínico Universitario de Valencia

location_facility: AO Città della Salute e della Scienza- Ospedale Sant'Anna

location_facility: Complejo Hospitalario Regional de Málaga

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: ONCOGARD - Institut de Cancérologie du Gard

location_facility: Institut Curie - Hôpital René Huguenin- SAINT CLOUD

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: Complejo Hospitalario Universitario de A Coruña

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut Curie - Hopital Claudius Régaud

type: Other Identifier

title: A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

summary:
Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision.

Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles.

Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination.

The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.


title: Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients

acronym: EarlyMob

summary:
The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.

This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.

At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.

The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.

status: Unknown status

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers

location_country: Belgium France Switzerland

location_facility: CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques

location_facility: CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet

location_facility: CHU de Liege - Service de soins intensifs généraux

location_facility: CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro

location_facility: CHD Vendée - Service de Réanimation Polyvalente

location_facility: Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil

location_facility: CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon

location_facility: Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod

location_facility: CH de Pontoise - Serive de réanimation médicale - CH René Dubos

location_facility: CH St Joseph St Luc - Service de Réanimation Polyvalente

location_facility: CHU de Brest - Service de réanimation médicale

location_facility: AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou

location_facility: Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale

location_facility: CHU de Nantes - Service de Réanimation Médicale Polyvalente

location_facility: AP-HP Hôpital Tenon - Service de Réanimation

location_facility: AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale

location_facility: Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux

location_facility: Cliniques Universitaires Saint-Luc - Service des soins intensifs

location_facility: CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare

location_facility: CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil

location_facility: Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente

intervention_type: Procedure

status_simplified: Unknown


title: Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

acronym: JIR-cohorte

summary: The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Pouletty M, Borocco C, Ouldali N, Caseris M, Basmaci R, Lachaume N, Bensaid P, Pichard S, Kouider H, Morelle G, Craiu I, Pondarre C, Deho A, Maroni A, Oualha M, Amoura Z, Haroche J, Chommeloux J, Bajolle F, Beyler C, Bonacorsi S, Carcelain G, Koné-Paut I, Bader-Meunier B, Faye A, Meinzer U, Galeotti C, Melki I. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 mimicking Kawasaki disease (Kawa-COVID-19): a multicentre cohort. Ann Rheum Dis. 2020 Aug;79(8):999-1006. doi: 10.1136/annrheumdis-2020-217960. Epub 2020 Jun 11.

family: Pouletty

full_name: Marie Pouletty

given: Marie

family: Borocco

full_name: Charlotte Borocco

given: Charlotte

family: Ouldali

full_name: Naim Ouldali

given: Naim

family: Caseris

full_name: Marion Caseris

given: Marion

family: Basmaci

full_name: Romain Basmaci

given: Romain

family: Lachaume

full_name: Noémie Lachaume

given: Noémie

family: Bensaid

full_name: Philippe Bensaid

family: Pichard

full_name: Samia Pichard

given: Samia

family: Kouider

full_name: Hanane Kouider

given: Hanane

family: Morelle

full_name: Guillaume Morelle

given: Guillaume

family: Craiu

full_name: Irina Craiu

given: Irina

family: Pondarre

full_name: Corinne Pondarre

given: Corinne

family: Deho

full_name: Anna Deho

given: Anna

family: Maroni

full_name: Arielle Maroni

given: Arielle

family: Oualha

full_name: Mehdi Oualha

given: Mehdi

family: Amoura

full_name: Zahir Amoura

given: Zahir

family: Haroche

full_name: Julien Haroche

given: Julien

family: Chommeloux

full_name: Juliette Chommeloux

given: Juliette

family: Bajolle

full_name: Fanny Bajolle

given: Fanny

family: Beyler

full_name: Constance Beyler

given: Constance

family: Bonacorsi

full_name: Stéphane Bonacorsi

given: Stéphane

family: Carcelain

full_name: Guislaine Carcelain

given: Guislaine

family: Koné-Paut

full_name: Isabelle Koné-Paut

given: Isabelle

family: Bader-Meunier

location_country: Switzerland Morocco France Belgium Germany

location_facility: Klinik für Rheumatologie und internistische Rehabilitation

location_facility: Ospedale Regionale di Bellinzona e valli


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

summary: This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

ReferenceCitation: Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hézode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Dusheiko

full_name: Geoffrey M. Dusheiko

given: Geoffrey M.

family: Salupere

full_name: Riina Salupere

given: Riina

family: Mangia

full_name: Alessandra Mangia

given: Alessandra

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Hyland

full_name: Robert H. Hyland

given: Robert H.

family: Illeperuma

full_name: Ari Illeperuma

given: Ari

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: Symonds

full_name: William T. Symonds

given: William T.

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Weiland

full_name: Ola Weiland

given: Ola

family: Reesink

full_name: Hendrik W. Reesink

given: Hendrik W.

family: Ferenci

full_name: Peter Ferenci

given: Peter

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Esteban

full_name: Rafael Esteban

given: Rafael

oa_host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Leiden University - Leiden Repository

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

title: Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3

ReferenceCitation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

evidence: oa repository (via OAI-PMH title and last author match)

repository_institution: The Pennsylvania State University - CiteSeer X

location_country:
Italy
Austria
Sweden
Netherlands
France
Poland
Spain
Estonia
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Complejo Hospitalario de Especialidades Virgen de la Victoria

location_facility: Hospital General Universitario de Valencia

location_facility: Southampton University Hospital NHS Trust

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista di Torino

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

location_facility: Wojewodzki Szpital Specjalistyczny im Dluskeigo

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Département Hépatogastroentérologie - CHU de Grenoble

location_facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH


title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

acronym: EPICLIN

summary: To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.

ReferenceCitation: Vergnenègre A, Carrato A, Thomas M, Jernigan C, Medina J, Cruciani G. Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):463-70. doi: 10.1185/03007995.2013.860373. Epub 2013 Nov 18.

name:
Hôpital le Cluzeau, Service de l’Information Médicale et de l’Evaluation (SIME)
LimogesFrance

family: Vergnenègre

full_name: A. Vergnenègre

given: A.

name:
Ramón y Cajal University Hospital
MadridSpain

family: Carrato

full_name: A. Carrato

name:
Internistische Onkologie der Thoraxtumoren, Thoraxklinik am Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), University of Heidelberg
HeidelbergGermany

family: Thomas

full_name: M. Thomas

given: M.

name:
Instat Services, Inc.
Chatham, NJUSA

family: Jernigan

full_name: C. Jernigan

given: C.

name:
AstraZeneca Farmacéutica Spain
MadridSpain

family: Medina

full_name: J. Medina

given: J.

name:
Ospedale S. Maria delle Croci
RavennaItaly

family: Cruciani

full_name: G. Cruciani

given: G.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Carrato A, Vergnenègre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):447-61. doi: 10.1185/03007995.2013.860372. Epub 2013 Nov 18.

name:
Hôpital le Cluzeau
LimogesFrance

name:
Instat Services Inc.
Chatham, NJUSA

family: McBride

full_name: K. McBride

given: K.

lead_sponsor: AstraZeneca

location_country: Italy Spain France Greece Belgium Portugal Turkey Germany


title: A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

acronym: CYSIF

summary:
PHASE: IV

TYPE OF STUDY: With direct benefit.

DESCRIPTIVE: Multicenter, randomized, open label study.

INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.

OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory attacks of ulcerative colitis.

STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6.

NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients.

INCLUSION PERIOD: 24 months.

STUDY DURATION: 27 months.

MAIN EVALUATION CRITERIA:

Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98 according to the Mayo Disease Activity Index score

SECONDARY EVALUATION CRITERIA:

Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic response Colectomy rate Tolerance

ReferenceCitation: EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. Gut. 1963 Dec;4:299-315.

ReferenceCitation: Truelove SC, Willoughby CP, Lee EG, Kettlewell MG. Further experience in the treatment of severe attacks of ulcerative colitis. Lancet. 1978 Nov 18;2(8099):1086-8.

ReferenceCitation: D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9.

ReferenceCitation: Lichtiger S, Present DH, Kornbluth A, Gelernt I, Bauer J, Galler G, Michelassi F, Hanauer S. Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med. 1994 Jun 30;330(26):1841-5.

ReferenceCitation: Van Assche G, D'Haens G, Noman M, Vermeire S, Hiele M, Asnong K, Arts J, D'Hoore A, Penninckx F, Rutgeerts P. Randomized, double-blind comparison of 4 mg/kg versus 2 mg/kg intravenous cyclosporine in severe ulcerative colitis. Gastroenterology. 2003 Oct;125(4):1025-31.

ReferenceCitation: Arts J, D'Haens G, Zeegers M, Van Assche G, Hiele M, D'Hoore A, Penninckx F, Vermeire S, Rutgeerts P. Long-term outcome of treatment with intravenous cyclosporin in patients with severe ulcerative colitis. Inflamm Bowel Dis. 2004 Mar;10(2):73-8.

ReferenceCitation: Actis GC, Bresso F, Astegiano M, Demarchi B, Sapone N, Boscaglia C, Rizzetto M. Safety and efficacy of azathioprine in the maintenance of ciclosporin-induced remission of ulcerative colitis. Aliment Pharmacol Ther. 2001 Sep;15(9):1307-11.

ReferenceCitation: Cohen RD, Stein R, Hanauer SB. Intravenous cyclosporin in ulcerative colitis: a five-year experience. Am J Gastroenterol. 1999 Jun;94(6):1587-92.

ReferenceCitation: Ardizzone S, Maconi G, Russo A, Imbesi V, Colombo E, Bianchi Porro G. Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. Gut. 2006 Jan;55(1):47-53. Epub 2005 Jun 21.

ReferenceCitation: Shibolet O, Regushevskaya E, Brezis M, Soares-Weiser K. Cyclosporine A for induction of remission in severe ulcerative colitis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004277. Review.

ReferenceCitation: Järnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlén P, Grännö C, Vilien M, Ström M, Danielsson A, Verbaan H, Hellström PM, Magnuson A, Curman B. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005 Jun;128(7):1805-11.

ReferenceCitation: Su C, Salzberg BA, Lewis JD, Deren JJ, Kornbluth A, Katzka DA, Stein RB, Adler DR, Lichtenstein GR. Efficacy of anti-tumor necrosis factor therapy in patients with ulcerative colitis. Am J Gastroenterol. 2002 Oct;97(10):2577-84.

ReferenceCitation: Gornet JM, Couve S, Hassani Z, Delchier JC, Marteau P, Cosnes J, Bouhnik Y, Dupas JL, Modigliani R, Taillard F, Lemann M. Infliximab for refractory ulcerative colitis or indeterminate colitis: an open-label multicentre study. Aliment Pharmacol Ther. 2003 Jul 15;18(2):175-81.

ReferenceCitation: Kohn A, Prantera C, Pera A, Cosintino R, Sostegni R, Daperno M. Infliximab in the treatment of severe ulcerative colitis: a follow-up study. Eur Rev Med Pharmacol Sci. 2004 Sep-Oct;8(5):235-7.

ReferenceCitation: Eidelwein AP, Cuffari C, Abadom V, Oliva-Hemker M. Infliximab efficacy in pediatric ulcerative colitis. Inflamm Bowel Dis. 2005 Mar;11(3):213-8.

ReferenceCitation: Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. Erratum in: N Engl J Med. 2006 May 18;354(20):2200.

ReferenceCitation: Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, Filippi J, Zerbib F, Savoye G, Vuitton L, Moreau J, Amiot A, Cosnes J, Ricart E, Dewit O, Lopez-Sanroman A, Fumery M, Carbonnel F, Bommelaer G, Coffin B, Roblin X, van Assche G, Esteve M, Farkkila M, Gisbert JP, Marteau P, Nahon S, de Vos M, Lambert J, Mary JY, Louis E; Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives. Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab. Gut. 2018 Feb;67(2):237-243. doi: 10.1136/gutjnl-2016-313060. Epub 2017 Jan 4.

family: Laharie

full_name: D Laharie

given: D

family: Bourreille

full_name: A Bourreille

given: A

family: Branche

full_name: J Branche

given: J

family: Allez

full_name: M Allez

given: M

family: Bouhnik

full_name: Y Bouhnik

given: Y

family: Filippi

full_name: J Filippi

family: Zerbib

full_name: F Zerbib

given: F

family: Savoye

full_name: G Savoye

given: G

family: Vuitton

full_name: L Vuitton

given: L

family: Moreau

full_name: J Moreau

family: Amiot

full_name: A Amiot

family: Cosnes

full_name: J Cosnes

family: Ricart

full_name: E Ricart

given: E

family: Dewit

full_name: O Dewit

given: O

family: Lopez-Sanroman

full_name: A Lopez-Sanroman

family: Fumery

full_name: M Fumery

family: Carbonnel

full_name: F Carbonnel

family: Bommelaer

full_name: G Bommelaer

family: Coffin

full_name: B Coffin

given: B

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, Filippi J, Zerbib F, Savoye G, Nachury M, Moreau J, Delchier JC, Cosnes J, Ricart E, Dewit O, Lopez-Sanroman A, Dupas JL, Carbonnel F, Bommelaer G, Coffin B, Roblin X, Van Assche G, Esteve M, Färkkilä M, Gisbert JP, Marteau P, Nahon S, de Vos M, Franchimont D, Mary JY, Colombel JF, Lémann M; Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet. 2012 Dec 1;380(9857):1909-15. doi: 10.1016/S0140-6736(12)61084-8. Epub 2012 Oct 10.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Rennes
Hospital de la Princesa
Hopital Haut Leveque
Hopital Henri Mondor
Chu Strasbourg
Helsinki University Hospital
Hopital Beaujon
Ulb - Clinique Saint Luc
Ch Le Raincy Montfermeil
Chu Saint Etienne
Chru Lille
Hospital Mutua de Terressa
Chu Clermont-Ferrand
Hopital Saint Louis
Leuven University Hospital
Hospital Clinic
Hopital St Antoine
Chu Nantes
CHU NICE
CHU LYON
Istituto Clinico Humanitas
Hopital Bichat
Chu Besancon
Hopital Louis Mourrier
Chu Reims
Hopital Lariboisiere
Chu Rouen
Chu Tours
Gent University Hospital
Institut Mutualiste Montsouris (Imm)
Chu Marseille - Hopital Nord
Hopital Georges Pompidou
Hopital Erasme
Chu Nancy
Hospital Ramon Y Cajal
CHU CAEN
Ch Avignon
Hopital Cochin
Chu Amiens
Chu Toulouse
Hopital Bicetre


title: Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study

acronym: HELIOS

summary: The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

ReferenceCitation: Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

family: Fabbri

full_name: Leonardo M Fabbri

given: Leonardo M

family: Calverley

full_name: Peter MA Calverley

given: Peter MA

family: Izquierdo-Alonso

full_name: José Luis Izquierdo-Alonso

given: José Luis

family: Bundschuh

full_name: Daniela S Bundschuh

given: Daniela S

family: Brose

full_name: Manja Brose

given: Manja

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

family: Rabe

full_name: Klaus F Rabe

given: Klaus F

journal_name: The Lancet

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201. Review.

family: Cazzola

full_name: Mario Cazzola

given: Mario

family: Picciolo

full_name: Stefano Picciolo

given: Stefano

family: Matera

full_name: Maria G Matera

given: Maria G

journal_name: Expert Opinion on Pharmacotherapy

location_country:
Italy
Austria
France
Hungary
Spain
Germany
United Kingdom

location_facility: Altana Pharma/Nycomed Investigational Site


title: Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Interest of a Long-term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-responder Chronic Hepatitis C Patients.

summary: Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Hépatogastroentérologie - Hôpital Nord

location_facility: Service d'Hépatogastroentérologie - Hôpital Tenon

location_facility: Service d'Hépatogastroentérologie - Hôpital La Pitié Salpétrière

location_facility: Service d'Hépatogastroentérologie et d'Assistance nutritive - Hôpital Haut-Lévêque

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Service d'Hépatogastroentérologie - CHU d'ESTAING

location_facility: Service d'Hépatogastroentérologie - Hôpital Purpan

location_facility: Service d'Hépatogastroentérologie - Hôpital Avicenne

location_facility: Service d'Hépatogastroentérologie, Clinique médicale B - Hôpital Civil

location_facility: Service d'Hépatologie - Gastroentérologie - Cancérologie digestive - CHU Angers

location_facility: Service d'Hépatogastroentérologie - Hôpital du Bocage

location_facility: Service d'Hépatogastroentérologie - Hôpital Saint Joseph

location_facility: Service d'Hépatogastroentérologie - CH La Roche sur Yon

location_facility: Service d'Hépatogastroentérologie - CHU Rouen

location_facility: Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix

location_facility: Service d' Hépatogastroentérologie - Hôpital Jean Verdier

location_facility: Service d'Hépatogastroentérologie - Hôpital Brabois

location_facility: Service d'Hépatogastroentérologie - Hôpital de la Source

location_facility: Service d'Hépatogastroentérologie - Hôpital Trousseau

location_facility: Service d'Hépatogastroentérologie - CH Sud Francilien

location_facility: Département d'Hépatogastroentérologie - CH Le Mans

location_facility: Service d'Hépatogastroentérologie - Hôpital Pontchaillou

location_facility: Service d'Hépatogastroentérologie - Hôpital de la Cavale Blanche

location_facility: Service d'Hépatogastroentérologie - CH Montélimar

location_facility: Service d'Hépatogastroentérologie - Hôpital Saint Eloi

location_facility: Service d'Hépatologie - Gastroentérologie - Nutrition -Hôpital de la Côte de Nacre

location_facility: Service d'Hépatogastroentérologie - Hotel de la Croix Rousse

location_facility: Service d'Hépatogastroentérologie - CH Montauban

location_facility: Service d'Hépatogastroentérologie - CHRU - Hôpital Claude Huriez

location_facility: Service d'Hépatogastroentérologie - Hôtel Dieu

location_facility: Service des Maladies du Foie et de l'appareil Digestif - Hôpital de Bicêtre


title: Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.

summary: To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

lead_sponsor: Pfizer

location_country:
Italy
South Africa
Sweden
Hong Kong
Spain
Switzerland
France
Israel
Belgium
Portugal
Denmark
Germany
United Kingdom
Korea, Republic of
Taiwan
Ukraine


title: Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

ReferenceCitation: Mariette C, Robb WB, Piessen G. Reply to Letter: "The Role of Surgery for Patients With a Complete Clinical Response After Chemoradiation for Esophageal Cancer". Ann Surg. 2015 Dec;262(6):e101-2. doi: 10.1097/SLA.0000000000000668.

ReferenceCitation: Mariette C, Seitz JF, Maillard E, et al.: Surgery alone versus chemoradiotherapy followed by surgery for localized esophageal cancer: analysis of a randomized controlled phase III trial FFCD 9901. [Abstract] J Clin Oncol 28 (Suppl 15): A-4005, 2010.

ReferenceCitation: Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

name: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille–Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite...

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Mornex

full_name: Françoise Mornex

given: Françoise

family: Maillard

full_name: Emilie Maillard

given: Emilie

family: Thomas

full_name: Pascal-Alexandre Thomas

given: Pascal-Alexandre

family: Meunier

full_name: Bernard Meunier

given: Bernard

family: Boige

full_name: Valérie Boige

given: Valérie

family: Pezet

full_name: Denis Pezet

given: Denis

family: Robb

full_name: William B. Robb

given: William B.

family: Le Brun-Ly

full_name: Valérie Le Brun-Ly

family: Bosset

full_name: Jean-François Bosset

given: Jean-François

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

family: Triboulet

full_name: Jean-Pierre Triboulet

given: Jean-Pierre

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

family: Seitz

full_name: Jean-François Seitz

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Surgery Alone Versus Chemoradiotherapy Followed by Surgery for Stage I and II Esophageal Cancer: Final Analysis of Randomized Controlled Phase III Trial FFCD 9901

ReferenceCitation: Robb WB, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Fédération Française de Cancérologie Digestive, Société Française de Radiothérapie Oncologique, Union des Centres de Lutte Contre le Cancer, Groupe Coopérateur Multidisciplinaire en Oncologie, French EsoGAstric Tumour working group, Fédération de Recherche En Chirurgie. Impact of neoadjuvant chemoradiation on lymph node status in esophageal cancer: post hoc analysis of a randomized controlled trial. Ann Surg. 2015 May;261(5):902-8. doi: 10.1097/SLA.0000000000000991.

title: Impact of Neoadjuvant Chemoradiation on Lymph Node Status in Esophageal Cancer

ReferenceCitation: Robb WB, Messager M, Dahan L, Mornex F, Maillard E, D'Journo XB, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Fédération Francophone de Cancérologie Digestive; Société Française de Radiothérapie Oncologique; Union des Centres de Lutte Contre le Cancer; Groupe Coopérateur Multidisciplinaire en Oncologie; French EsoGAstric Tumour working group - Fédération de Recherche En Chirurgie. Patterns of recurrence in early-stage oesophageal cancer after chemoradiotherapy and surgery compared with surgery alone. Br J Surg. 2016 Jan;103(1):117-25. doi: 10.1002/bjs.9959. Epub 2015 Oct 29.

name: Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France

name: Institut National de la Santé et de la Recherche Médicale (INSERM), UMR S-1172, Jean Pierre Aubert Research Centre, Lille, France

name: SIRIC, ONCOLille and Université Lille Nord de France, Lille, France

name: Department of Digestive Oncology, La Timone Hospital, Université d'Aix Marseille, Marseille, France

name: Department of Radiotherapy, Pierre-Bénite Hospital, Lyons, France

name: Department of Biostatistics, Fédération Francophone de Cancérologie Digestive, Dijon, France

name: Department of Thoracic Surgery, Hôpital Nord, Marseille, France

name: Department of Gastroenterology, University Hospital of Dijon, Dijon, France

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Klinikum der Albert - Ludwigs - Universitaet Freiburg

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre Hospitalier General De Saint-Malo

location_facility: CHU Brest - Hopital De La Cavale Blanche

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.

ReferenceCitation: Bonnetain F, Bosset JF, Gerard JP, Calais G, Conroy T, Mineur L, Bouché O, Maingon P, Chapet O, Radosevic-Jelic L, Methy N, Collette L. What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question? Eur J Cancer. 2012 Aug;48(12):1781-90. doi: 10.1016/j.ejca.2012.03.016. Epub 2012 Apr 14.

ReferenceCitation: den Dulk M, Putter H, Collette L, Marijnen CAM, Folkesson J, Bosset JF, Rödel C, Bujko K, Påhlman L, van de Velde CJH. The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer. 2009 May;45(7):1175-1183. doi: 10.1016/j.ejca.2008.11.039. Epub 2009 Jan 6.

ReferenceCitation: Monnien F, Zaki H, Borg C, Mougin C, Bosset JF, Mercier M, Arbez-Gindre F, Kantelip B. Prognostic value of phosphorylated STAT3 in advanced rectal cancer: a study from 104 French patients included in the EORTC 22921 trial. J Clin Pathol. 2010 Oct;63(10):873-8. doi: 10.1136/jcp.2010.076414.

family: Monnien

full_name: F. Monnien

given: F.

family: Zaki

full_name: H. Zaki

given: H.

family: Borg

full_name: C. Borg

given: C.

family: Mougin

full_name: C. Mougin

full_name: J.-F. Bosset

family: Mercier

full_name: M. Mercier

given: M.

family: Arbez-Gindre

full_name: F. Arbez-Gindre

family: Kantelip

full_name: B. Kantelip

given: B.

journal_name: Journal of Clinical Pathology

ReferenceCitation: Tiv M, Puyraveau M, Mineur L, Calais G, Maingon P, Bardet E, Mercier M, Bosset JF. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial. Cancer Radiother. 2010 Oct;14(6-7):530-4. doi: 10.1016/j.canrad.2010.06.017. Epub 2010 Aug 24.

family: Tiv

full_name: M. Tiv

family: Puyraveau

full_name: M. Puyraveau

family: Mineur

full_name: L. Mineur

given: L.

family: Calais

full_name: G. Calais

given: G.

family: Maingon

full_name: P. Maingon

given: P.

family: Bardet

full_name: É. Bardet

given: É.

journal_name: Cancer/Radiothérapie

ReferenceCitation: Collette L, Bosset JF, den Dulk M, Nguyen F, Mineur L, Maingon P, Radosevic-Jelic L, Piérart M, Calais G; European Organisation for Research and Treatment of Cancer Radiation Oncology Group. Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. J Clin Oncol. 2007 Oct 1;25(28):4379-86.

ReferenceCitation: Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. Erratum in: N Engl J Med. 2007 Aug 16;357(7):728.

ReferenceCitation: Bosset J, Calais G, Mineur L, et al.: Preoperative radiotherapy in rectal cancer: role and place of fluorouracil-based chemotherapy. Final results of the EORTC 22921 phase III trial. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-255, 2005.

ReferenceCitation: Bosset JF, Calais G, Mineur L, et al.: Preoperative radiation (Preop RT) in rectal cancer: effect and timing of additional chemotherapy (CT) 5-year results of the EORTC 22921 trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-3505, 247s, 2005.

ReferenceCitation: Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Briffaux A, Collette L. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results--EORTC 22921. J Clin Oncol. 2005 Aug 20;23(24):5620-7. Epub 2005 Jul 11.

ReferenceCitation: Bosset JF, Calais G, Mineur L, et al.: Does the addition of chemotherapy (CT) to preoperative radiotherapy (preopRT) increase the pathological response in patients with resected rectal cancer: report of the 22921 EORTC phase III trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-3504, 246, 2004.

ReferenceCitation: Bosset JF, Calais G, Daban A, et al.: Does the addition of chemotherapy to preoperative radiation increase acute toxicity in patients with rectal cancer: report of 22921 EORTC phase III trial . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1179, 2003.

ReferenceCitation: Kouloulias VE, Bosset JF, van Tienhoven G, Davis BJ, Pierart M, Poortmans P; EORTC Radiotherapy Group. European Organization for Research and Treatment of Cancer. Quality assurance in the EORTC 22921 trial on preoperative radiotherapy with or without chemotherapy for resectable rectal cancer: evaluation of the individual case review procedure. Eur J Cancer. 2002 Sep;38(14):1849-56.

ReferenceCitation: Bosset JF, Calais G, Mineur L, Maingon P, Stojanovic-Rundic S, Bensadoun RJ, Bardet E, Beny A, Ollier JC, Bolla M, Marchal D, Van Laethem JL, Klein V, Giralt J, Clavère P, Glanzmann C, Cellier P, Collette L; EORTC Radiation Oncology Group. Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol. 2014 Feb;15(2):184-90. doi: 10.1016/S1470-2045(13)70599-0. Epub 2014 Jan 17.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Serbia Switzerland Netherlands France Poland Israel Belgium Spain Turkey Germany

location_facility: Dokuz Eylul University School of Medicine

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Service Cancerologie Polyclinique Clairval

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Hospital General Universitari Vall d'Hebron


title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia

acronym: REVERSE-IT

summary: This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.

lead_sponsor: Valbiotis

location_country: Italy France Bulgaria Hungary Germany

location_facility: Unité de Recherche Clinique en Immunologie Lyon Sud

location_facility: 4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement

location_facility: Zentrum für Klinische Ernährung Stuttgart

location_facility: University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases

location_facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

location_facility: Azienda Ospedaliera Universitaria "Mater Domini"

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

location_facility: MHAT Sveta Karidad, First department of Internal Diseases

location_facility: Diagnostic Consultative Center "ALEXANDROVSKA"

location_facility: Gemeinschaftspraxis Dr. Med C. Klein/J Minnich

intervention_type: Dietary Supplement


title: Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia

acronym: Oesophagix

summary: The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

ReferenceCitation: Schneider A, Gottrand F, Bellaiche M, Becmeur F, Lachaux A, Bridoux-Henno L, Michel JL, Faure C, Philippe P, Vandenplas Y, Dupont C, Breton A, Gaudin J, Lamireau T, Muyshont L, Podevin G, Viola S, Bertrand V, Caldari D, Colinet S, Wanty C, Sauleau E, Leteurtre E, Michaud L. Prevalence of Barrett Esophagus in Adolescents and Young Adults With Esophageal Atresia. Ann Surg. 2016 Dec;264(6):1004-1008.

lead_sponsor: University Hospital, Lille

location_country: Luxembourg Canada Belgium France

location_facility: Department of Pediatric Gastroenterology, HUDERF,

location_facility: Department of Pediatric Gastroenterology, AZ VUB,

location_facility: Department of Gastroenterology CHC, Liège

location_facility: University Hospital, Hôpital Jeanne de Flandres

location_facility: Hôpital Mère-Enfants Ste Justine, Montréal, Canada


title: A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate

summary: The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.

ReferenceCitation: de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for ≥24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.

apc_source: openAPC

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

family: Feyerabend

full_name: Susan Feyerabend

given: Susan

family: Elliott

full_name: Tony Elliott

given: Tony

family: Grande

full_name: Enrique Grande

given: Enrique

family: Melhem-Bertrandt

full_name: Amal Melhem-Bertrandt

given: Amal

family: Baron

full_name: Benoit Baron

given: Benoit

family: Hirmand

full_name: Mohammad Hirmand

given: Mohammad

family: Werbrouck

full_name: Patrick Werbrouck

given: Patrick

family: Fizazi

full_name: Karim Fizazi

given: Karim

journal_name: European Urology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
France
Belgium
Spain
Germany
United Kingdom

location_facility:
Site FR33001
Site BE32004
Site ES34006
Site GB44010
Site BE32001
Site GB44004
Site DE49010
Site FR33008
Site FR33011
Site FR33012
Site FR33010
Site DE49005
Site DE49016
Site FR33007
Site GB44006
Site DE49006
Site BE32002
Site DE49007
Site ES34009
Site ES34011
Site FR33014
Site DE49014
Site GB44007
Site ES34003
Site FR33013
Site DE49002
Site ES34010
Site GB44003
Site FR33005
Site DE49004
Site ES34008
Site DE49012
Site GB44002
Site DE49003
Site DE49009
Site ES34001
Site ES34002
Site DE49001
Site BE32003
Site FR33003
Site ES34004
Site BE32007
Site GB44009
Site DE49015
Site FR33009
Site GB44001
Site DE49008
Site FR33015
Site FR33002
Site DE49017


title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.

ReferenceCitation: Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. Epub 2006 Aug 17.

ReferenceCitation: van den Bent MJ, Chinot O, Boogerd W, Bravo Marques J, Taphoorn MJ, Kros JM, van der Rijt CC, Vecht CJ, De Beule N, Baron B. Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. Ann Oncol. 2003 Apr;14(4):599-602.

location_country:
Italy
Austria
Sweden
Netherlands
Finland
France
Hungary
Belgium
Portugal
Denmark
Germany
United Kingdom

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Neurologische Klinik der Henriettenstiftung


status: Terminated

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Austria Switzerland Netherlands France Australia Belgium Germany

acronym: HCT versus CT elderly AML

location_facility: Centre hospitalier et universitaire (CHU) de Nice

location_facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse

location_facility: Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität

location_facility: Centre hospitalier et universitaire (CHU) de Limoges

location_facility: II. Medizinische Klinik, Hämatologie/Internistische Onkologie

location_facility: Centre hospitalier et universitaire (CHU) d´ Estaing

location_facility: ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen

location_facility: Academisch Ziekenhuis bij de Universiteit Amsterdam

location_facility: Erasmus MC-Daniel den Hoed Cancer Centre

title: Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

summary: A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.


lead_sponsor: Ipsen

location_country:
United Kingdom
Poland
France
Lithuania
Belgium
Spain
Latvia
Ukraine

acronym: Not applicable

location_facility: Academisch Ziekenhuis Vrije Universiteit Brussel

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Paula Stradina Kliniska Universitates slimnica

location_facility: Ivano Frankovsk State Medical University

location_facility: UAB 'Vilniaus onkourologijos-ginekologijos klinika

location_facility: Scientific Research Institute of Urology

title: A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer

summary: To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.


title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

acronym: Tailored-AF

summary:
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

ReferenceCitation: Seitz J, Bars C, Théodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

family: Seitz

full_name: Julien Seitz

given: Julien

family: Bars

full_name: Clément Bars

given: Clément

family: Théodore

full_name: Guillaume Théodore

given: Guillaume

family: Beurtheret

full_name: Sylvain Beurtheret

given: Sylvain

family: Lellouche

full_name: Nicolas Lellouche

given: Nicolas

family: Bremondy

full_name: Michel Bremondy

given: Michel

family: Ferracci

full_name: Ange Ferracci

given: Ange

family: Faure

full_name: Jacques Faure

given: Jacques

family: Penaranda

full_name: Guillaume Penaranda

family: Yamazaki

full_name: Masatoshi Yamazaki

given: Masatoshi

family: Avula

full_name: Uma Mahesh R. Avula

given: Uma Mahesh R.

family: Curel

full_name: Laurence Curel

given: Laurence

family: Siame

full_name: Sabrina Siame

given: Sabrina

family: Berenfeld

full_name: Omer Berenfeld

given: Omer

family: Pisapia

full_name: André Pisapia

given: André

family: Kalifa

full_name: Jérôme Kalifa

given: Jérôme

journal_name: Journal of the American College of Cardiology

oa_colors: green hybrid

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

location_country:
United States
Netherlands
France
Belgium
Germany

location_facility: Hôpital Louis Pradel - Hospices Civils de Lyon


lead_sponsor: Hoffmann-La Roche

location_country:
United States
France

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

summary: This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.


title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus)

summary: The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

ReferenceCitation: François B, Mercier E, Gonzalez C, Asehnoune K, Nseir S, Fiancette M, Desachy A, Plantefève G, Meziani F, de Lame PA, Laterre PF; MASTER 1 study group. Safety and tolerability of a single administration of AR-301, a human monoclonal antibody, in ICU patients with severe pneumonia caused by Staphylococcus aureus: first-in-human trial. Intensive Care Med. 2018 Nov;44(11):1787-1796. doi: 10.1007/s00134-018-5229-2. Epub 2018 Oct 21.

family: François

full_name: Bruno François

given: Bruno

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Gonzalez

full_name: Céline Gonzalez

given: Céline

family: Asehnoune

full_name: Karim Asehnoune

family: Nseir

full_name: Saad Nseir

given: Saad

family: Fiancette

full_name: Maud Fiancette

given: Maud

family: Desachy

full_name: Arnaud Desachy

given: Arnaud

family: Plantefève

full_name: Gaëtan Plantefève

given: Gaëtan

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: de Lame

full_name: Paul-André de Lame

given: Paul-André

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

journal_name: Intensive Care Medicine

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
United States
Belgium
France
Spain

location_facility:
Site 11
Site 52
Site 83
Site 32
Site 35
Site 37
Site 51
Site 41
Site 31
Site 33
Site 36
Site 34
Site 81
Site 80
Site 16
Site 40
Site 38
Site 39


title: A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings

summary: The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country: Netherlands France Belgium Spain Germany


title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

acronym: ReSPECT

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217. Review.

name: Department of Pharmacy, Oregon Health & Science University, Portland, OR 97239, USA

name: Department of Internal Medicine Division of Infectious Diseases & Department of Medical Microbiology & Immunology; University of California Davis Medical Center, Sacramento, CA 95817, USA

family: Ham

full_name: Young Yoon Ham

given: Young Yoon

family: Lewis

full_name: James S Lewis

given: James S

suffix: II

family: Thompson

full_name: George R Thompson

given: George R

suffix: III

journal_name: Future Microbiology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Cidara Therapeutics Inc.

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom
Canada

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven

location_facility: Hamilton Health Sciences' Juravinski Hospital

location_facility: Puerta de Hierro Majadahonda University Hospital

location_facility: Grenoble Alpes University Hospital Center

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Johannes Gutenberg University Medical Center


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy

summary: The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). These patients are at high risk for progression of kidney disease, which can result in end-stage renal failure.

status: Active, not recruiting

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Sweden
Philippines
France
Malaysia
Singapore
Spain
Canada
United Kingdom
Taiwan


title: Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial

acronym: FAVOR III EJ

summary: Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

primary_purpose: Diagnostic

ReferenceCitation: Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

ReferenceCitation: Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Bøtker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14). pii: e009603. doi: 10.1161/JAHA.118.009603.

name: Department of Cardiology Aarhus University Hospital Skejby Denmark

family: Westra

full_name: Jelmer Westra

given: Jelmer

family: Andersen

full_name: Birgitte Krogsgaard Andersen

given: Birgitte Krogsgaard

name: Cardiovascular Institute Azienda Ospedaliero‐Universitaria di Ferrara Cona Italy

name: Maria Cecilia Hospital GVM Care and Research Cotignola (RA) Italy

family: Campo

full_name: Gianluca Campo

given: Gianluca

name: Department of Cardiovascular Medicine Gifu Heart Center Gifu City Japan

family: Matsuo

full_name: Hitoshi Matsuo

given: Hitoshi

name: Department of Cardiology Medical University of Warsaw Warszawa Poland

family: Koltowski

full_name: Lukasz Koltowski

given: Lukasz

family: Eftekhari

full_name: Ashkan Eftekhari

given: Ashkan

name: Department of Cardiology Hagaziekenhuis The Hague The Netherlands

family: Liu

full_name: Tommy Liu

given: Tommy

name: Division of Cardiology Department of Advanced Biomedical Sciences University of Naples Federico II Naples Italy

family: Di Serafino

full_name: Luigi Di Serafino

given: Luigi

name: Azienda Ospedaliera Sant'Anna e San Sebastiano Caserta Italy

family: Di Girolamo

full_name: Domenico Di Girolamo

given: Domenico

name: Hospital Clinico San Carlos IDISSC Complutense University Madrid Spain

family: Escaned

full_name: Javier Escaned

given: Javier

name: Department of Cardiology and Angiology University of Giessen Giessen Germany

family: Nef

full_name: Holger Nef

given: Holger

name: Klinik für Kardiologie und Angiologie Essen Germany

family: Naber

full_name: Christoph Naber

given: Christoph

name: Emodinamica Aziendale AULSS 3 Serenissima Ospedale Dell'Angelo Mestre Italy

family: Barbierato

full_name: Marco Barbierato

given: Marco

name: School of Biomedical Engineering Shanghai Jiao Tong University Shanghai China

family: Tu

full_name: Shengxian Tu

given: Shengxian

family: Neghabat

full_name: Omeed Neghabat

given: Omeed

name: Department of Clinical Epidemiology Aarhus University Hospital Skejby Denmark

family: Madsen

full_name: Morten Madsen

given: Morten

family: Tebaldi

full_name: Matteo Tebaldi

given: Matteo

family: Tanigaki

full_name: Toru Tanigaki

given: Toru

family: Kochman

full_name: Janusz Kochman

given: Janusz

family: Somi

full_name: Samer Somi

given: Samer

family: Esposito

full_name: Giovanni Esposito

given: Giovanni

family: Mercone

full_name: Giuseppe Mercone

given: Giuseppe

family: Mejia‐Renteria

full_name: Hernan Mejia‐Renteria

name: The Lambe Institute for Translational Medicine and Curam National University of Ireland Galway Galway Ireland

journal_name: Journal of the American Heart Association

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

title: Diagnostic Performance of In‐Procedure Angiography‐Derived Quantitative Flow Reserve Compared to Pressure‐Derived Fractional Flow Reserve: The FAVOR II Europe‐Japan Study

ReferenceCitation: Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bøttcher M, Bøtker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.

ReferenceCitation: Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

location_country: Italy Sweden Switzerland Netherlands France Japan Lithuania Poland Spain Denmark Germany Latvia

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg Klinik und Poliklinik für Kardiologie

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara

location_facility: Arcispedale S. Maria Nuova di Reggio Emilia

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier

location_facility: Hospital Clinico Universitario de Valladolid