ReferenceCitation: Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Léna H, Berruti A, Damiano V, Buikhuisen W, Grønbæk H, Lombard-Bohas C, Grohé C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Öberg K, Baudin E. Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2017 Dec;18(12):1652-1664. doi: 10.1016/S1470-2045(17)30681-2. Epub 2017 Oct 23.

family: Ferolla

full_name: Piero Ferolla

given: Piero

family: Brizzi

full_name: Maria Pia Brizzi

given: Maria Pia

family: Meyer

full_name: Tim Meyer

given: Tim

family: Mansoor

full_name: Wasat Mansoor

given: Wasat

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Do Cao

full_name: Christine Do Cao

given: Christine

family: Léna

full_name: Hervé Léna

given: Hervé

family: Berruti

full_name: Alfredo Berruti

given: Alfredo

family: Damiano

full_name: Vincenzo Damiano

given: Vincenzo

family: Buikhuisen

full_name: Wieneke Buikhuisen

given: Wieneke

family: Grønbæk

full_name: Henning Grønbæk

given: Henning

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Grohé

full_name: Christian Grohé

family: Minotti

full_name: Vincenzo Minotti

family: Tiseo

full_name: Marcello Tiseo

given: Marcello

family: De Castro

full_name: Javier De Castro

given: Javier

family: Reed

full_name: Nicholas Reed

given: Nicholas

family: Gislimberti

full_name: Gabriella Gislimberti

given: Gabriella

family: Singh

full_name: Neha Singh

given: Neha

family: Stankovic

full_name: Miona Stankovic

given: Miona

family: Öberg

full_name: Kjell Öberg

given: Kjell

family: Baudin

full_name: Eric Baudin

journal_name: The Lancet Oncology

repository_normalized: UCL Discovery

repositories_institution: University College London - UCL Discovery

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

https://www.clinicalstudydatarequest.com/

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

title: Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma of the Lung and Thymus - LUNA Trial

summary: This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus


ReferenceType: background

ReferenceCitation: Paeshuyse J, Kaul A, De Clercq E, Rosenwirth B, Dumont JM, Scalfaro P, Bartenschlager R, Neyts J. The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology. 2006 Apr;43(4):761-70.

ReferenceCitation: Inoue K, Umehara T, Ruegg UT, Yasui F, Watanabe T, Yasuda H, Dumont JM, Scalfaro P, Yoshiba M, Kohara M. Evaluation of a cyclophilin inhibitor in hepatitis C virus-infected chimeric mice in vivo. Hepatology. 2007 Apr;45(4):921-8.

ReferenceCitation: Flisiak R, Horban A, Gallay P, Bobardt M, Selvarajah S, Wiercinska-Drapalo A, Siwak E, Cielniak I, Higersberger J, Kierkus J, Aeschlimann C, Grosgurin P, Nicolas-Métral V, Dumont JM, Porchet H, Crabbé R, Scalfaro P. The cyclophilin inhibitor Debio-025 shows potent anti-hepatitis C effect in patients coinfected with hepatitis C and human immunodeficiency virus. Hepatology. 2008 Mar;47(3):817-26. doi: 10.1002/hep.22131.

ReferenceCitation: Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van Vliet A, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology. 2006 Oct;131(4):997-1002.

ReferenceCitation: Pawlotsky JM. Treatment of hepatitis C: don't put all your eggs in one basket! Gastroenterology. 2007 Apr;132(4):1611-5.

ReferenceCitation: Dienstag JL, McHutchison JG. American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):231-64; quiz 214-7. Review.

ReferenceCitation: Zeuzem S, Buti M, Ferenci P, Sperl J, Horsmans Y, Cianciara J, Ibranyi E, Weiland O, Noviello S, Brass C, Albrecht J. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol. 2006 Jan;44(1):97-103. Epub 2005 Nov 7.

ReferenceCitation: Watashi K, Hijikata M, Hosaka M, Yamaji M, Shimotohno K. Cyclosporin A suppresses replication of hepatitis C virus genome in cultured hepatocytes. Hepatology. 2003 Nov;38(5):1282-8.

ReferenceCitation: Watashi K, Ishii N, Hijikata M, Inoue D, Murata T, Miyanari Y, Shimotohno K. Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell. 2005 Jul 1;19(1):111-22.

ReferenceCitation: Rice CM, You S. Treating hepatitis C: can you teach old dogs new tricks? Hepatology. 2005 Dec;42(6):1455-8.

ReferenceCitation: Ishii N, Watashi K, Hishiki T, Goto K, Inoue D, Hijikata M, Wakita T, Kato N, Shimotohno K. Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol. 2006 May;80(9):4510-20.

ReferenceCitation: Yang F, Robotham JM, Nelson HB, Irsigler A, Kenworthy R, Tang H. Cyclophilin A is an essential cofactor for hepatitis C virus infection and the principal mediator of cyclosporine resistance in vitro. J Virol. 2008 Jun;82(11):5269-78. doi: 10.1128/JVI.02614-07. Epub 2008 Apr 2.

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Debiopharm International SA

enrollment_type: Actual

primary_purpose: Treatment

location_country: Italy France Poland Romania Belgium Spain Germany

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centrul de Diagnostic si Tratament Dr. Victor Babe

location_facility: Seconda Università di Napoli- Secondo Policlinico

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Woj

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla I

location_facility: Wojewódzki Szpital Specjalistyczny im. K. Dluskieg

location_facility: Hôpital du Haut-Levêque - C.H.U de Bordeaux

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Wojewódzki Szpital Obserwacyjno-Zakazny im. Tadeus

location_facility: Wojewódzki Szpital Specjalstyczny im. Wl. Biegansk

location_facility: Az. Osp. Universitaria S. Giovanni Battista

location_facility: "Policlinico ""Paolo Giaccone"" dell'Università di

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: "Spitalul Clinic de Urgenta ""Prof. dr. Octavian F

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

summary: The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.

lead_sponsor_type: industriel

status_simplified: Completed


title: Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain

summary: To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

ReferenceType: result

ReferenceCitation: Skljarevski V, Desaiah D, Zhang Q, Chappell AS, Detke MJ, Gross JL, Ziegler D. Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain. Diabetes Metab Res Rev. 2009 Oct;25(7):623-31. doi: 10.1002/dmrr.1000.

family: Skljarevski

full_name: Vladimir Skljarevski

given: Vladimir

sequence: first

family: Desaiah

full_name: Durisala Desaiah

given: Durisala

sequence: additional

family: Zhang

full_name: Qi Zhang

given: Qi

family: Chappell

full_name: Amy S. Chappell

given: Amy S.

family: Detke

full_name: Michael J. Detke

given: Michael J.

family: Gross

full_name: Jorge L. Gross

given: Jorge L.

family: Ziegler

full_name: Dan Ziegler

given: Dan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes/Metabolism Research and Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceType: derived

ReferenceCitation: Hall JA, Wang F, Oakes TM, Utterback BG, Crucitti A, Acharya N. Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials. Expert Opin Drug Saf. 2010 Jul;9(4):525-37. doi: 10.1517/14740338.2010.484418.

family: Hall

full_name: Jerry A Hall

given: Jerry A

family: Wang

full_name: Fujun Wang

given: Fujun

family: Myers Oakes

full_name: Tina M Myers Oakes

given: Tina M

family: Utterback

full_name: Barbara G Utterback

given: Barbara G

family: Crucitti

full_name: Antonio Crucitti

given: Antonio

family: Acharya

full_name: Nayan Acharya

given: Nayan

journal_name: Expert Opinion on Drug Safety

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Eli Lilly and Company

location_country: Italy Brazil Germany France

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 personal physician.


title: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

acronym: PRECISIONV

summary: The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma

ReferenceCitation: Vogl TJ, Lammer J, Lencioni R, Malagari K, Watkinson A, Pilleul F, Denys A, Lee C. Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: results from the PRECISION V randomized trial. AJR Am J Roentgenol. 2011 Oct;197(4):W562-70. doi: 10.2214/AJR.10.4379.

family: Vogl

full_name: Thomas J. Vogl

given: Thomas J.

family: Lammer

full_name: Johannes Lammer

given: Johannes

family: Lencioni

full_name: Riccardo Lencioni

given: Riccardo

family: Malagari

full_name: Katerina Malagari

given: Katerina

family: Watkinson

full_name: Anthony Watkinson

given: Anthony

family: Pilleul

full_name: Frank Pilleul

given: Frank

family: Denys

full_name: Alban Denys

given: Alban

family: Lee

full_name: Clara Lee

given: Clara

journal_name: American Journal of Roentgenology

publisher: American Roentgen Ray Society

publisher_dissemination: American Roentgen Ray Society

publisher_group: American Roentgen Ray Society

publisher_normalized: American Roentgen Ray Society

title: Liver, Gastrointestinal, and Cardiac Toxicity in Intermediate Hepatocellular Carcinoma Treated With PRECISION TACE With Drug-Eluting Beads: Results From the PRECISION V Randomized Trial

lead_sponsor: Boston Scientific Corporation

location_country: Austria Germany France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Fakultat fur Klinische Medizin Mannheim Universitat

intervention_type: Device


title: Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields

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 liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.

ReferenceCitation: Duffaud F, Borner M, Chollet P, Vermorken JB, Bloch J, Degardin M, Rolland F, Dittrich C, Baron B, Lacombe D, Fumoleau P; EORTC-New Drug Development Group/New Drug Development Program. Phase II study of OSI-211 (liposomal lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group study. Eur J Cancer. 2004 Dec;40(18):2748-52.

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

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
France
Belgium
Portugal
Germany
United Kingdom

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

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori


title: A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len) or Glofitamab + Len With or Without Obinutuzumab, and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Relapsed or Refractory Follicular Lymphoma

summary: This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab + lenalidomide, glofitamab + lenalidomide, and glofitamab + lenalidomide + obinutuzumab in participants with relapsed or refractory (R/R) follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
United States
United Kingdom
France
Spain

location_facility: Centre Hospitalier Lyon Sud; Direction Générale

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

status_simplified: Ongoing


title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain

summary:
This is a Phase IV, international, multicentre, randomised, double-blind, placebo controlled study in IPD patients, experiencing motor fluctuations and PD related chronic pain while on stable doses of levodopa (L-Dopa).

Participants will be randomized 2:1 to receive either active or placebo

ipd_sharing: No

lead_sponsor: Zambon SpA

location_country: Italy Austria France Spain Germany

location_facility: Ospedale San Giovanni Battista - ACISMOM

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centro per la Malattia di Parkinson e i Disturbi del Movimento

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: C.A.U de Burgos - Hospital Universitario de Burgos

location_facility: Institut für Neuroimmunologische und Neurodegenerative Erkrankungen

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Istituto Neurologico Mediterraneo Neuromed

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Hospital Universitario Vall d'Hebrón - PPDS


title: European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS)

acronym: EPAD-LCS

summary:
Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease at its very earliest stages when in theory treatments are most likely to be successful in preventing further spread of the disease in the brain and causing dementia. The aim of EPAD programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide subjects for the EPAD trial as well as data to improve understanding of disease before dementia develops.

The Investigators will approach a broad range of people over the age of 50 who have previously taken part in various research studies and consented to being recontacted for further research. Participants will be asked questions to assess their memory and other cognitive function. The participants will also undertake a brain scan, provide a sample of spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may change in Alzheimer's disease. The Investigators will then follow these participants until December 2019 repeating these tests annually. This will be called the EPAD Longitudinal Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the Investigators understand more about what happens to people before dementia develops, and to help recruit people more quickly into the EPAD trials of new medications or other interventions expected to prevent dementia.

People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention studies to see if interventions can modify the probability of developing dementia or cognitive problems (this will be subject to separate ethics approval and consent). Together EPAD LCS and EPAD PoC make up the full EPAD Programme.

status: Terminated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Vermunt L, Muniz-Terrera G, Ter Meulen L, Veal C, Blennow K, Campbell A, Carrié I, Delrieu J, Fauria K, Huesa Rodríguez G, Ingala S, Jenkins N, Molinuevo JL, Ousset PJ, Porteous D, Prins ND, Solomon A, Tom BD, Zetterberg H, Zwan M, Ritchie CW, Scheltens P, Luscan G, Brookes AJ, Visser PJ; IMI-EPAD collaborators. Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings. Alzheimers Res Ther. 2020 Jan 6;12(1):8. doi: 10.1186/s13195-019-0576-y.

family: Vermunt

full_name: Lisa Vermunt

given: Lisa

family: Muniz-Terrera

full_name: Graciela Muniz-Terrera

given: Graciela

family: ter Meulen

full_name: Lea ter Meulen

given: Lea

family: Veal

full_name: Colin Veal

given: Colin

family: Blennow

full_name: Kaj Blennow

given: Kaj

family: Campbell

full_name: Archie Campbell

given: Archie

family: Carrié

full_name: Isabelle Carrié

given: Isabelle

family: Delrieu

full_name: Julien Delrieu

given: Julien

family: Fauria

full_name: Karine Fauria

given: Karine

family: Huesa Rodríguez

full_name: Gema Huesa Rodríguez

given: Gema

family: Ingala

full_name: Silvia Ingala

given: Silvia

family: Jenkins

full_name: Natalie Jenkins

given: Natalie

family: Molinuevo

full_name: José Luis Molinuevo

given: José Luis

family: Ousset

full_name: Pierre-Jean Ousset

given: Pierre-Jean

family: Porteous

full_name: David Porteous

given: David

family: Prins

full_name: Niels D. Prins

given: Niels D.

family: Solomon

full_name: Alina Solomon

given: Alina

family: Tom

full_name: Brian D. Tom

given: Brian D.

family: Zetterberg

full_name: Henrik Zetterberg

given: Henrik

family: Zwan

full_name: Marissa Zwan

given: Marissa

family: Ritchie

full_name: Craig W. Ritchie

given: Craig W.

family: Scheltens

full_name: Philip Scheltens

given: Philip

family: Luscan

full_name: Gerald Luscan

given: Gerald

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Solomon A, Kivipelto M, Molinuevo JL, Tom B, Ritchie CW; EPAD Consortium. European Prevention of Alzheimer's Dementia Longitudinal Cohort Study (EPAD LCS): study protocol. BMJ Open. 2019 Feb 19;8(12):e021017. doi: 10.1136/bmjopen-2017-021017.

title: European Prevention of Alzheimer’s Dementia Longitudinal Cohort Study (EPAD LCS): study protocol

ipd_sharing_description: EPAD is an Innovative Medicines Initiative (IMI) project with open access to data.

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Greece
Belgium
Spain
United Kingdom

location_facility: National and Kapodistran, University of Athens, 1st Department of Neurology, Aeginition Hospital

location_facility: Unidade Deterioro Cognitivo, Servicio de Neurologia, Hospital Universitario

location_facility: Neuropsychiatric Research Unit, Sahlgrenska University Hoospital

location_facility: CHU Gui de Chauliac Département de Neurologie

location_facility: Toulouse University Hospital / Gérontopôle-Research Clinical Center

location_facility: Hôpital Universitaire de la Pitié Salpêtrière

location_facility: Greater Manchester Clinical Research Network

location_facility: Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal

location_facility: IRCCS San Giovanni di Dio - Fatebenefratelli

location_facility: CMRR du CHRU de Lille Hôpital Roger Salengro

location_facility: University of Edinburgh, Centre for Dementia Prevention

location_facility: Glasgow Clinical Research Facility; NHS Greater Glasgow and Clyde

location_facility: Univerita di Perugia, Centro Disturbi della Memoria, Clinica Neurologica

location_facility: VUmc Alzheimer Center and Alzheimer Research Center

location_facility: Centre Leenaards de la memoire- CHUV, Department of Neurosciences cliniques

location_facility: University of Oxford, Department of Psychiatry

location_facility: University of Cambridge; Department of Clinical Neurosciences

location_facility: Fundacion ACE, Institut Catala de Neurocienies Aplicades

location_facility: Cliniques Universitaires Saint-Luc ASBL, Neurology Department

location_facility: CMRR- Hôpital Laënnec Nord - CIC Neurologie / CHU de Nantes

location_facility: Fundacion CITA-alzheimer Fundazioa, Center for Research and Advanced Therapies


title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

acronym: EBC MAIN

summary: The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

status: Unknown status

ReferenceCitation: Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefèvre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.

name: Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK

family: Hildick-Smith

full_name: David Hildick-Smith

name: Freeman Hospital, Newcastle upon Tyne, UK

family: Egred

full_name: Mohaned Egred

given: Mohaned

family: Banning

full_name: Adrian Banning

given: Adrian

family: Brunel

full_name: Philippe Brunel

given: Philippe

name: Universitäts-Herzzentrum Bad Krozingem, Bad Krozingen, Germany

family: Ferenc

full_name: Miroslaw Ferenc

given: Miroslaw

name: Institute Cardiovasculaire Paris Sud, Massy, France

family: Hovasse

full_name: Thomas Hovasse

given: Thomas

name: Poland Miedziowe Centrum Zdrowia Lubin, Lubin, Poland

family: Wlodarczak

full_name: Adrian Wlodarczak

name: Department of Cardiology, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain

family: Pan

full_name: Manuel Pan

given: Manuel

name: Elisabeth Hospital Essen, Essen, Germany

family: Schmitz

full_name: Thomas Schmitz

family: Silvestri

full_name: Marc Silvestri

given: Marc

name: Paul Stradins University Hospital, Riga, Latvia

family: Erglis

full_name: Andreis Erglis

given: Andreis

name: Sibirskiy Fеdеrаl Biomedical Research Center Novosibirsk, Novosibirsk, Russia

family: Kretov

full_name: Evgeny Kretov

given: Evgeny

name: Rigshospitalet University of Copenhagen, Copenhagen, Denmark

family: Lassen

full_name: Jens Flensted Lassen

given: Jens Flensted

name: San Raffaele Scientific Institute, Milan, Italy

family: Chieffo

full_name: Alaide Chieffo

given: Alaide

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

name: Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy

family: Burzotta

full_name: Francesco Burzotta

given: Francesco

family: Cockburn

full_name: James Cockburn

given: James

name: Clinique Saint-Augustin—Elsan, 114 Avenue d’Arès, Bordeaux 33200, France

family: Darremont

full_name: Olivier Darremont

given: Olivier

name: Department of Cardiology, Clinical Centre of Serbia, University of Belgrade, Belgrade, Serbia

family: Stankovic

full_name: Goran Stankovic

given: Goran

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: Louvard

full_name: Yves Louvard

given: Yves

journal_name: European Heart Journal

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

location_country:
Italy
Serbia
United Kingdom
France
Spain
Denmark
Germany
Latvia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: University of Catania - Ferrarotto Hospital

location_facility: Rigshospitalet Copenhagen University Hospital


title: An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985 (Vanucizumab), and in Combination With Atezolizumab, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.

location_country: Belgium France Spain

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

intervention_type: Biological


ReferenceCitation: Bertini E, Dessaud E, Mercuri E, Muntoni F, Kirschner J, Reid C, Lusakowska A, Comi GP, Cuisset JM, Abitbol JL, Scherrer B, Ducray PS, Buchbjerg J, Vianna E, van der Pol WL, Vuillerot C, Blaettler T, Fontoura P; Olesoxime SMA Phase 2 Study Investigators. Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jul;16(7):513-522. doi: 10.1016/S1474-4422(17)30085-6. Epub 2017 Apr 28. Erratum in: Lancet Neurol. 2017 Aug;16(8):584.

family: Bertini

full_name: Enrico Bertini

given: Enrico

family: Dessaud

full_name: Eric Dessaud

given: Eric

family: Mercuri

full_name: Eugenio Mercuri

given: Eugenio

family: Muntoni

full_name: Francesco Muntoni

family: Kirschner

full_name: Janbernd Kirschner

given: Janbernd

family: Reid

full_name: Carol Reid

given: Carol

family: Lusakowska

full_name: Anna Lusakowska

given: Anna

family: Comi

full_name: Giacomo P Comi

given: Giacomo P

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Abitbol

full_name: Jean-Louis Abitbol

given: Jean-Louis

family: Scherrer

full_name: Bruno Scherrer

given: Bruno

family: Ducray

full_name: Patricia Sanwald Ducray

given: Patricia Sanwald

family: Buchbjerg

full_name: Jeppe Buchbjerg

given: Jeppe

family: Vianna

full_name: Eduardo Vianna

given: Eduardo

family: van der Pol

full_name: W Ludo van der Pol

given: W Ludo

family: Vuillerot

full_name: Carole Vuillerot

given: Carole

family: Blaettler

full_name: Thomas Blaettler

family: Fontoura

full_name: Paulo Fontoura

given: Paulo

family: André

full_name: Carole André

family: Bruno

full_name: Claudio Bruno

given: Claudio

family: Chabrol

full_name: Brigitte Chabrol

given: Brigitte

family: Deconinck

full_name: Nicolas Deconinck

given: Nicolas

family: Estournet

full_name: Brigitte Estournet

family: Fontaine-Carbonnel

full_name: Stephanie Fontaine-Carbonnel

given: Stephanie

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

location_country:
Italy
Netherlands
France
Poland
Belgium
Germany
United Kingdom

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

location_facility: Bambino Gesu' Research Children's Hospital

location_facility: Policlinico Universitario "Agostino Gemelli",

title: Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.

summary: Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years


title: A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

summary: The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
Italy
Switzerland
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Prof. Nigel Leigh, Academic Neuroscience Centre

location_facility: Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette

location_facility: Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

location_facility: Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Prof. Vincent Meininger, Hopital LaPitie Salpetriere

location_facility: Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

location_facility: Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

location_facility: Prof. Philippe Couratier, Hopital Duruytren

location_facility: Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil

location_facility: Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

location_facility: Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm

location_facility: Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: Dr. Chris McDermott, Royal Hallamshire Hospital

location_facility: Prof. Leonard H Van Den Berg, University Medical Center Utrecht

location_facility: Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz

location_facility: Prof. Douglas Mitchell, Royal Preston Hospital

location_facility: Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Prof. Claude Desnuelle, Hopital 1-Archet 1


title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.

ReferenceCitation: Onady GM, Stolfi A. Drug treatments for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2020 Oct 19;10:CD004730. doi: 10.1002/14651858.CD004730.pub5.

name: Boonshoft School of Medicine; Wright State University; Dayton Ohio USA

family: Onady

full_name: Gary M Onady

given: Gary M

name: Department of Pediatrics; Children's Medical Center; Dayton Ohio USA

family: Stolfi

full_name: Adrienne Stolfi

given: Adrienne

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Staab D, Hebestreit A, Naehrlich L, Nickolay T, Prinz N, Holl RW; CFRD Study Group. Repaglinide versus insulin for newly diagnosed diabetes in patients with cystic fibrosis: a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Feb;6(2):114-121. doi: 10.1016/S2213-8587(17)30400-X. Epub 2017 Dec 5. Erratum in: Lancet Diabetes Endocrinol. 2019 Apr;7(4):e4.

family: Ballmann

full_name: Manfred Ballmann

given: Manfred

family: Hubert

full_name: Dominique Hubert

given: Dominique

family: Assael

full_name: Baroukh M Assael

given: Baroukh M

family: Staab

full_name: Doris Staab

given: Doris

family: Hebestreit

full_name: Alexandra Hebestreit

given: Alexandra

family: Naehrlich

full_name: Lutz Naehrlich

given: Lutz

family: Nickolay

full_name: Tanja Nickolay

given: Tanja

family: Prinz

full_name: Nicole Prinz

given: Nicole

family: Holl

full_name: Reinhard W Holl

given: Reinhard W

family: Staden

full_name: Ute Staden

given: Ute

family: Claßen

full_name: Martin Claßen

given: Martin

family: Schuster

full_name: Antje Schuster

given: Antje

family: Mellies

full_name: Uwe Mellies

given: Uwe

family: Posselt

full_name: Hans-Georg Posselt

given: Hans-Georg

family: Wiebel

full_name: Matthias Wiebel

given: Matthias

family: Rietschel

full_name: Ernst Rietschel

given: Ernst

family: Stern

full_name: Martin Stern

family: Teschler

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Kronfeld K, Honer M, Holl RW; CFRD Study group. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus. BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.

ReferenceCitation: Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.

location_facility: Medizinische Hochschule Hannover, Abt. Kinderheilkunde

location_facility: CRCM adultes, Centre Hospitalier Lyon Sud

location_facility: Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene

location_facility: Universitätsklinik für Kinder- und Jugendmedizin

location_facility: Med. Klinik II, Allergologie und Pneumologie

location_facility: Klikum der Universität Heidelberg, Kinderklinik

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Klinik und Poliklinik für allgemeine Kinderheilkunde

location_facility: APHP, CRCM pediatrique, Hopital Robert Debre

location_facility: Klinik für Kinder und Jugendliche Erlangen

location_facility: Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde


title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

summary: Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

primary_purpose: Prevention

ReferenceCitation: Rümke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Dramé M, Sänger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.

family: Rümke

full_name: Hans C. Rümke

given: Hans C.

family: Bayas

full_name: José-María Bayas

given: José-María

family: de Juanes

full_name: José-Ramón de Juanes

given: José-Ramón

family: Caso

full_name: Covadonga Caso

given: Covadonga

family: Richardus

full_name: Jan Hendrik Richardus

given: Jan Hendrik

family: Campins

full_name: Magda Campins

given: Magda

family: Rombo

full_name: Lars Rombo

given: Lars

family: Duval

full_name: Xavier Duval

given: Xavier

family: Romanenko

full_name: Viktor Romanenko

given: Viktor

family: Schwarz

full_name: Tino F. Schwarz

given: Tino F.

family: Fassakhov

full_name: Rustem Fassakhov

given: Rustem

family: Abad-Santos

full_name: Francisco Abad-Santos

given: Francisco

family: von Sonnenburg

full_name: Frank von Sonnenburg

given: Frank

family: Dramé

full_name: Mamadou Dramé

given: Mamadou

family: Sänger

full_name: Roland Sänger

given: Roland

family: Ballou

full_name: W. Ripley Ballou

given: W. Ripley

journal_name: Vaccine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Sweden
Netherlands
France
Russian Federation
Spain
Estonia
Germany


title: Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

ReferenceCitation: Kruit WH, Suciu S, Dreno B, et al.: Immunization with recombinant MAGE-A3 protein combined with adjuvant systems AS15 or AS02B in patients with unresectable and progressive metastatic cutaneous melanoma: A randomized open-label phase II study of the EORTC Melanoma Group (16032- 18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9065, 2008.

ReferenceCitation: Louahed J, Gruselle O, Gaulis S, et al.: Expression of defined genes identified by pretreatment tumor profiling: association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032-18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9045, 2008.

ReferenceCitation: Kruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol. 2013 Jul 1;31(19):2413-20. doi: 10.1200/JCO.2012.43.7111. Epub 2013 May 28.

name: Wim H.J. Kruit, Erasmus Medical Center, Rotterdam, the Netherlands; Stefan Suciu, European Organisation for Research and Treatment of Cancer Headquarters, Brussels; Jamila Louahed, Frédéric F. Lehmann, and Vincent G. Brichard, GlaxoSmithKline Biologicals, Rixensart, Belgium; Brigitte Dreno, Centre Hospitalier Universitaire (CHU); Laurent Mortier, Centre Hospitalier Régional Universitaire (CHRU), Lille; Caroline Robert and Alexander M.M. Eggermont, Institute Gustave Roussy; Thierry Dorval, Institut Curie,...

family: Kruit

full_name: Wim H.J. Kruit

given: Wim H.J.

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Dreno

full_name: Brigitte Dreno

given: Brigitte

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Robert

full_name: Caroline Robert

given: Caroline

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

family: Maio

full_name: Michele Maio

given: Michele

family: Testori

full_name: Alessandro Testori

given: Alessandro

family: Dorval

full_name: Thierry Dorval

given: Thierry

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Becker

full_name: Juergen C. Becker

given: Juergen C.

family: Spatz

full_name: Alan Spatz

given: Alan

family: Eggermont

full_name: Alexander M.M. Eggermont

given: Alexander M.M.

family: Louahed

full_name: Jamila Louahed

given: Jamila

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

family: Brichard

full_name: Vincent G. Brichard

given: Vincent G.

family: Keilholz

full_name: Ulrich Keilholz

given: Ulrich

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Selection of Immunostimulant AS15 for Active Immunization With MAGE-A3 Protein: Results of a Randomized Phase II Study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma

ReferenceCitation: Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

name: Fernando Ulloa-Montoya, Jamila Louahed, Benjamin Dizier, Olivier Gruselle, Bart Spiessens, Frédéric F. Lehmann, and Vincent G. Brichard, GlaxoSmithKline Vaccines, Rixensart; Stefan Suciu, European Organisation for Research and Treatment of Cancer Headquarters, Brussels; Johan Vansteenkiste, University Hospital Leuven/KU Leuven, Leuven, Belgium; Wim H.J. Kruit, Erasmus Medical Center, Rotterdam, the Netherlands; and Alexander M.M. Eggermont, Institut Gustave Roussy, Villejuif, France.

family: Ulloa-Montoya

full_name: Fernando Ulloa-Montoya

given: Fernando

family: Dizier

full_name: Benjamin Dizier

given: Benjamin

family: Gruselle

full_name: Olivier Gruselle

given: Olivier

family: Spiessens

title: Predictive Gene Signature in MAGE-A3 Antigen-Specific Cancer Immunotherapy

location_country:
Italy
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Centro di Riferimento Oncologico - Aviano


title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

summary:
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.

ReferenceCitation: Ray-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065.

name: Centre Léon Bérard and UJOMM H. E. Herriot, Lyon, France;

family: Ray‐Coquard

full_name: Isabelle Ray‐Coquard

given: Isabelle

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

name: University College Hospital, London, United Kingdom;

family: Whelan

full_name: Jeremy S. Whelan

given: Jeremy S.

family: Schoffski

full_name: Patrick Schoffski

given: Patrick

family: Bui

full_name: Binh N. Bui

given: Binh N.

name: U.Z. and Erasmus, Rotterdam, The Netherlands;

family: Verweij

full_name: Jaap Verweij

given: Jaap

name: European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium;

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: van Glabbeke

full_name: Martine van Glabbeke

given: Martine

family: Hogendoorn

full_name: Pancras Hogendoorn

given: Pancras

family: Blay

full_name: Jean‐Yves Blay

given: Jean‐Yves

journal_name: The Oncologist

title: A Phase II Study of Gefitinib for Patients with Advanced HER‐1 Expressing Synovial Sarcoma Refractory to Doxorubicin‐Containing Regimens

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility: Meyerstein Institute of Oncology at University College of London Hospitals

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Nijmegen Cancer Center at Radboud University Medical Center


title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

acronym: EUROCOV

summary: This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

status: Enrolling by invitation

time_perspective: Retrospective

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

family: Du

full_name: Ronghui Du

given: Ronghui

family: Fan

full_name: Guohui Fan

given: Guohui

family: Liu

full_name: Ying Liu

given: Ying

full_name: Zhibo Liu

given: Zhibo

family: Xiang

full_name: Jie Xiang

given: Jie

family: Wang

full_name: Yeming Wang

given: Yeming

family: Song

full_name: Bin Song

given: Bin

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Guan

full_name: Lulu Guan

given: Lulu

family: Wei

full_name: Yuan Wei

given: Yuan

family: Li

full_name: Hui Li

given: Hui

full_name: Xudong Wu

given: Xudong

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Tu

full_name: Shengjin Tu

given: Shengjin

family: Zhang

full_name: Yi Zhang

given: Yi

family: Chen

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21;323(15):1510.

name: National Centre for Infectious Diseases, Singapore

name: Lee Kong Chian School of Medicine, Singapore

name: Yong Loo Lin School of Medicine, Singapore

name: Saw Swee Hock School of Public Health, Singapore

name: for the Singapore 2019 Novel Coronavirus Outbreak Research Team

lead_sponsor: European Society for Emergency Medicine (EUSEM) Research Network


title: Wright Foot & Ankle Post-Market Observational Study

summary: WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

ipd_sharing: Undecided

lead_sponsor: Wright Medical Technology

location_country:
Germany
United States
United Kingdom
France

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust


title: ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)

summary: The objective of this study is to provide preliminary evidence for the safety and effectiveness of the AblaCare Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

primary_purpose: Device Feasibility

lead_sponsor: AblaCare

location_country:
United Kingdom
Belgium
France

location_facility:
CU Saint-Luc
Bicetre Hospital
CHU Saint-Pierre
Royal Derby Hospital
Royal Hallamshire Hospital


title: A Phase Ib/II Open Label Study to Assess the Safety and Pharmacokinetics of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Agents Used in Colorectal Cancer Treatment

summary: This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents.

lead_sponsor: NuCana plc

location_country:
United States
United Kingdom
France

location_facility: The Beatson West of Scotland Cancer Centre


title: Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

summary: The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

ReferenceCitation: Bagot M, Porcu P, Marie-Cardine A, Battistella M, William BM, Vermeer M, Whittaker S, Rotolo F, Ram-Wolff C, Khodadoust MS, Bensussan A, Paturel C, Bonnafous C, Sicard H, Azim HA Jr, Kim YH. IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial. Lancet Oncol. 2019 Aug;20(8):1160-1170. doi: 10.1016/S1470-2045(19)30320-1. Epub 2019 Jun 25.

family: Bagot

full_name: Martine Bagot

given: Martine

family: Porcu

full_name: Pierluigi Porcu

given: Pierluigi

family: Marie-Cardine

full_name: Anne Marie-Cardine

given: Anne

family: Battistella

full_name: Maxime Battistella

given: Maxime

family: William

full_name: Basem M William

given: Basem M

family: Vermeer

full_name: Maarten Vermeer

given: Maarten

family: Whittaker

full_name: Sean Whittaker

given: Sean

family: Rotolo

full_name: Federico Rotolo

given: Federico

family: Ram-Wolff

full_name: Caroline Ram-Wolff

given: Caroline

family: Khodadoust

full_name: Michael S Khodadoust

given: Michael S

family: Bensussan

full_name: Armand Bensussan

given: Armand

family: Paturel

full_name: Carine Paturel

given: Carine

family: Bonnafous

full_name: Cecile Bonnafous

given: Cecile

family: Sicard

full_name: Helene Sicard

given: Helene

family: Azim

full_name: Hatem A Azim

given: Hatem A

suffix: Jr

family: Kim

full_name: Youn H Kim

given: Youn H

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

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

lead_sponsor: Innate Pharma

location_country:
United States
United Kingdom
France
Netherlands

location_facility:
Leiden University Medical Center
Stanford Cancer Center
Guy's Hospital
Ohio State University
Hôpital Saint-Louis


intervention_type: Other

lead_sponsor: CymaBay Therapeutics, Inc.

location_country: Norway Canada France Netherlands

location_facility: Endocrinologie metabolisme et prevention cardiovasulaire, Institut E3M et IHU cardiometabolique (ICAN), Hôpital Pitié Salpêtrière

title: A 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

summary: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).


title: EORTC Randomized Phase II Study of Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage Malignant Pleural Mesothelioma

summary: This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for non-progressing patients

location_country: Belgium France Netherlands

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

intervention_type: Procedure


title: Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

summary:
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

Investigate whether physicians have received any educational material related to Diane-35 or its generics
Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
Contraindications relevant to thromboembolism
Risk factors for thromboembolism
Signs and symptoms of thromboembolism

time_perspective: Other

lead_sponsor: Bayer

location_country:
Austria
Netherlands
France
Spain
Czech Republic


title: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

acronym: CHRA

summary: This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.

status: Active, not recruiting

lead_sponsor: Integra LifeSciences Corporation

location_country:
Sweden
United Kingdom
Australia
France

location_facility:
Danderyd Hospital
Barwon Health
Brisbane Hand & Upper Limb Clinic
Institut Nices
Wrightington Hospital


title: A Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Biological Activity of ATYR1940 in Adult Patients With Molecularly Defined Genetic Muscular Dystrophies

summary: The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies

lead_sponsor: aTyr Pharma, Inc.

location_country:
Italy
United States
France
Netherlands


title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

summary: This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.

ReferenceCitation: Yap TA, Winter JN, Giulino-Roth L, Longley J, Lopez J, Michot JM, Leonard JP, Ribrag V, McCabe MT, Creasy CL, Stern M, Pene Dumitrescu T, Wang X, Frey S, Carver J, Horner T, Oh C, Khaled A, Dhar A, Johnson PWM. Phase I Study of the Novel Enhancer of Zeste Homolog 2 (EZH2) Inhibitor GSK2816126 in Patients with Advanced Hematologic and Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7331-7339. doi: 10.1158/1078-0432.CCR-18-4121. Epub 2019 Aug 30.

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

status_simplified: Unknown


title: A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy

summary: Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination

ReferenceCitation: Rodon J, Curigliano G, Delord JP, Harb W, Azaro A, Han Y, Wilke C, Donnet V, Sellami D, Beck T. A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget. 2018 Aug 3;9(60):31709-31718. doi: 10.18632/oncotarget.25854. eCollection 2018 Aug 3.

name: Molecular Therapeutics Research Unit, Department of Medical Oncology, Vall d’Hebron University Hospital, Centro Cellex, 08035, Barcelona, Spain

family: Rodon

full_name: Jordi Rodon

given: Jordi

name: Division of Early Drug Development for Innovative Therapies, Department of Hematology and Oncology, University of Milano, Istituto Europeo di Oncologia, 20141, Milan, Italy

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

name: Clinical Research Unit, Institut Claudius Regaud, 31052, Toulouse, France

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

name: Horizon Oncology Center, 47905, Lafayette, IN, USA

family: Harb

full_name: Wael Harb

given: Wael

family: Azaro

full_name: Analia Azaro

given: Analia

name: Novartis Pharmaceuticals Corporation, 07936, East Hanover, NJ, USA

family: Han

full_name: Yu Han

given: Yu

name: Novartis Pharma AG, Postfach, CH-4002, Basel, Switzerland

family: Wilke

full_name: Celine Wilke

given: Celine

name: Novartis Pharma S.A.S., 92506, Rueil-Malmaison, France

family: Donnet

full_name: Valerie Donnet

given: Valerie

family: Sellami

full_name: Dalila Sellami

given: Dalila

name: Highlands Oncology Group, 72703, Fayetteville, AR, USA

family: Beck

full_name: Thaddeus Beck

given: Thaddeus

journal_name: Oncotarget

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via observed oa rate)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher: Impact Journals, LLC

publisher_dissemination: Impact Journals, LLC

publisher_group: Impact Journals, LLC

publisher_normalized: Impact Journals, LLC

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Spain

location_facility:
Novartis Investigative Site
Horizon Oncology Center BioAdvance
Highlands Oncology Group


lead_sponsor: Boehringer Ingelheim

location_country: Italy France Czechia Belgium Germany

acronym: Determination of MTD of volasertib  in paediatric patients with advanced cancer

location_facility:
University Hospital Motol
UNIV UZ Gent
Universitätsklinikum Köln (AöR)
Osp. Pediatrico Bambin Gesù
INS Curie

title: Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known

summary: The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients


title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

summary: This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.

location_facility: Dana Farber Cancer Institute DFCI - Brookline


title: Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors

summary:
Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR566658

Secondary Objectives:

To characterize the safety profile of SAR566658
To evaluate the pharmacokinetic profile of SAR566658
To assess the potential immunogenicity of SAR566658
To assess preliminary antitumor activity
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
To assess safety in the alternative schedules of SAR566658 administration

lead_sponsor: Sanofi

location_country:
United States
France
Spain

location_facility:
Investigational Site Number 840001
Investigational Site Number 724001
Investigational Site Number 840002
Investigational Site Number 250001
Investigational Site Number 724002


title: A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo

summary: Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.

primary_purpose: Other

lead_sponsor: Pfizer

location_country:
Austria
United Kingdom
Belgium
France


title: Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
France
Switzerland

location_facility: University Hospital of Basel, Clinic of Pneumology

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)


title: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study

acronym: Re-ACT

summary: The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).

lead_sponsor: Codman & Shurtleff

location_facility:
CHU de Colmar
CHU Clermont Ferrand
CHU La Timone
CHU Bordeaux
CHU Dijon
CHU Lille
CHU St Etienne
Hôpital Bretonneau


title: Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years

acronym: PreKiTQoL

summary: The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

ReferenceCitation: Sébille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morélon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.

family: Sébille

full_name: Véronique Sébille

given: Véronique

family: Hardouin

full_name: Jean-Benoit Hardouin

given: Jean-Benoit

family: Giral

full_name: Magali Giral

given: Magali

family: Bonnaud-Antignac

full_name: Angélique Bonnaud-Antignac

given: Angélique

family: Tessier

full_name: Philippe Tessier

given: Philippe

family: Papuchon

full_name: Emmanuelle Papuchon

given: Emmanuelle

family: Jobert

full_name: Alexandra Jobert

given: Alexandra

family: Faurel-Paul

full_name: Elodie Faurel-Paul

given: Elodie

family: Gentile

full_name: Stéphanie Gentile

given: Stéphanie

family: Cassuto

full_name: Elisabeth Cassuto

given: Elisabeth

family: Morélon

full_name: Emmanuel Morélon

given: Emmanuel

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Glotz

full_name: Denis Glotz

given: Denis

family: Sberro-Soussan

full_name: Rebecca Sberro-Soussan

given: Rebecca

family: Foucher

full_name: Yohann Foucher

given: Yohann

family: Meurette

full_name: Aurélie Meurette

given: Aurélie

currency_apc_doaj: GBP

journal_name: BMC Nephrology

evidence: oa journal (via doaj)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENPC

title: Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years – The PreKit-QoL study protocol

location_facility: CHU MARSEILLE - Hôpital de la Conception - Santé Publique

location_facility: AP-HP - Hôpital St Louis - Service de Néphrologie et Transplantation Rénale

location_facility: CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie

location_facility: CHU MONTPELLIER - Hôpital Lapeyronie - Service de Néphrologie

location_facility: CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN

location_facility: CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique


title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

location_country:
Italy
Germany
United States
France


title: The Nosology and Etiology of Leukodystrophies of Unknown Cause

summary:
Leukodystrophy is a disease of the white matter of the brain. White matter is the portion of the brain responsible for conducting electrical impulses from one area of the brain to the other. Insulating cells called myelin cover the brain and nerve cells in the white matter. If myelin becomes damaged electrical information cannot be transferred properly.

Many patients suffering from leukodystrophies do not fit the description of any of the defined types of leukodystrophies and are therefore considered to have a leukodystrophy of unknown cause.

The purpose of this study is to define groups of patients with leukodystrophies and to work toward finding the cause of the disorders. In order to do this, researchers will analyze patients with leukodystrophies of unknown causes. Patients will undergo clinical, neurophysiologic, biochemical, and genetic examinations and tests.

Researchers believe that by studying these patients and their disorders they will be able to better understand the causes of myelin destruction, and eventually lead to effective treatments for these disorders.

ReferenceCitation: Aicardi J. The inherited leukodystrophies: a clinical overview. J Inherit Metab Dis. 1993;16(4):733-43. Review.

ReferenceCitation: Schiffmann R, Moller JR, Trapp BD, Shih HH, Farrer RG, Katz DA, Alger JR, Parker CC, Hauer PE, Kaneski CR, et al. Childhood ataxia with diffuse central nervous system hypomyelination. Ann Neurol. 1994 Mar;35(3):331-40.

ReferenceCitation: Schiffmann R, Tedeschi G, Kinkel RP, Trapp BD, Frank JA, Kaneski CR, Brady RO, Barton NW, Nelson L, Yanovski JA. Leukodystrophy in patients with ovarian dysgenesis. Ann Neurol. 1997 May;41(5):654-61.

ReferenceCitation: McNeill N, Nasca A, Reyes A, Lemoine B, Cantarel B, Vanderver A, Schiffmann R, Ghezzi D. Functionally pathogenic EARS2 variants in vitro may not manifest a phenotype in vivo. Neurol Genet. 2017 Jul 14;3(4):e162. doi: 10.1212/NXG.0000000000000162. eCollection 2017 Aug.

family: McNeill

full_name: Nathan McNeill

given: Nathan

family: Nasca

full_name: Alessia Nasca

given: Alessia

family: Reyes

full_name: Aurelio Reyes

given: Aurelio

family: Lemoine

full_name: Benjamin Lemoine

given: Benjamin

family: Cantarel

full_name: Brandi Cantarel

given: Brandi

family: Vanderver

full_name: Adeline Vanderver

given: Adeline

family: Schiffmann

full_name: Raphael Schiffmann

given: Raphael

family: Ghezzi

full_name: Daniele Ghezzi

given: Daniele

currency_apc_doaj: USD

journal_name: Neurology Genetics

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Cambridge - Apollo

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

location_country:
Israel
United States
France
Netherlands

location_facility: Academiseh Ziuekenhuis Vrije Universiteit

location_facility: Institut National de la Sante' et de la Recherche Medicale


title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

acronym: REPLACE

summary: To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

ReferenceCitation: Rayman G, Kröger J, Bolinder J. Could FreeStyle Libre(™) sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.

family: Rayman

full_name: G. Rayman

given: G.

name: Zentrum fur Diabetologie Hamburg Bergedorf; Hamburg Germany

family: Kröger

full_name: J. Kröger

given: J.

family: Bolinder

full_name: J. Bolinder

journal_name: Diabetic Medicine

oa_colors: green hybrid

evidence: open (via crossref license)

title: Could FreeStyle Libre™ sensor glucose data support decisions for safe driving?

ReferenceCitation: Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11.

family: Haak

full_name: Thomas Haak

given: Thomas

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

family: Ajjan

full_name: Ramzi Ajjan

given: Ramzi

family: Hermanns

full_name: Norbert Hermanns

given: Norbert

family: Riveline

full_name: Jean-Pierre Riveline

given: Jean-Pierre

full_name: Gerry Rayman

given: Gerry

journal_name: Diabetes Therapy

license: implied-oa

license_normalized: implied-oa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.

location_facility: The Diabetes Centre, Ipswich Hospital NHS Trust

location_facility: FRCPath Life and Health Sciences, Aston University

location_facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust

location_facility: Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital


title: A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.

summary: This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut Jules Bordet - Centre des tumeurs de l'ULB


title: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure

acronym: eNephro

summary:
The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a telemedicine system : eNephro Application , compared with traditional care in the management of chronic renal failure in different populations :

population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria .
population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay
population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay

Two statistical analysis will be done :

a main analysis for the one year initial follow-up for each patient
a secondary analysis for the one year initial follow-up estended by one year (proposed to each patient at the end of the initial follow-up), that is a 2 years period.

The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of:

A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home.
A secure messaging for communication between health professionals and between patients and health professionals
Expert systems analyzing data from each patient
A management tool of therapeutic education

Each patient and whatever the group will perform as part of its monitoring of the CKD assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of study (24 months). These evaluations are about compliance, quality of life, anxiety - depression state. To enhance costs the point of view retained will be health insurance's point of view. Among the various costs, only direct costs are considered: disease management, hospitalizations, consultations in hospitals and private practice, prescribed medical transportation , home visits by health professionals, additional assessments related to the evaluated intervention. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.

ReferenceCitation: Thilly N, Chanliau J, Frimat L, Combe C, Merville P, Chauveau P, Bataille P, Azar R, Laplaud D, Noël C, Kessler M. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. BMC Nephrol. 2017 Apr 5;18(1):126. doi: 10.1186/s12882-017-0529-2.

family: Thilly

full_name: Nathalie Thilly

given: Nathalie

family: Chanliau

full_name: Jacques Chanliau

given: Jacques

family: Frimat

full_name: Luc Frimat

given: Luc

family: Combe

full_name: Christian Combe

given: Christian

family: Merville

full_name: Pierre Merville

given: Pierre

family: Chauveau

full_name: Philippe Chauveau

given: Philippe

family: Bataille

full_name: Pierre Bataille

family: Azar

full_name: Raymond Azar

given: Raymond

family: Laplaud

full_name: David Laplaud

given: David

family: Noël

full_name: Christian Noël

family: Kessler

full_name: Michèle Kessler

given: Michèle

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories:
HAL
PubMed Central

publisher_normalized: Springer

lead_sponsor: Pharmagest Interactive

location_facility:
TELECOM Bretagne
CH Dunkerque
CHU Bordeaux
ALTIR
CHU Lille
CHU Nancy
CH Boulogne sur Mer
AURAD Aquitaine


title: A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy

acronym: LIME

summary: The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Italy
United Kingdom
France
Spain

location_facility: CHU Créteil - Groupe Hospitalier Henri Mondor

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Università di Genova - Ospedale San Martino

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista

location_facility: Hospital Clinico Universitario de Santiago de Compostela


title: A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy

summary: The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.

ReferenceCitation: Chaussade S, Schmöcker C, Toulemonde P, Muñoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.

family: Chaussade

full_name: Stanislas Chaussade

given: Stanislas

family: Schmöcker

full_name: Christoph Schmöcker

given: Christoph

family: Toulemonde

full_name: Pierre Toulemonde

family: Muñoz-Navas

full_name: Miguel Muñoz-Navas

given: Miguel

family: O’Mahony

full_name: Valérie O’Mahony

given: Valérie

family: Henri

full_name: Franck Henri

given: Franck

journal_name: Surgical Endoscopy

lead_sponsor: Laboratoires Mayoly Spindler

location_country: Germany France Spain

location_facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

location_facility: Hospital Universitarion Gregorio Maranon

location_facility: Medizinische Klinik und Poliklinik II Munchen


title: OPTIMOX-aflibercept as First-line Therapy in 49 Patients With Unresectable Metastatic Colorectal Cancer. A GERCOR Feasibility Single-arm Phase II Study.

acronym: VELVET

summary: Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CH Mont de Marsan
Polyclinique de Bordeaux Nord
Hôpital Henri Mondor
CHU Dupuytren
Hôpital Pitié Salpêtrière
Hôpital Privé Jean Mermoz
Hôpital Saint-Antoine
Institut Mutualiste Montsouris


title: Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.

acronym: TOMMY

summary: In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.

ReferenceCitation: Wong JY, Rosenthal J, Liu A, Schultheiss T, Forman S, Somlo G. Image-guided total-marrow irradiation using helical tomotherapy in patients with multiple myeloma and acute leukemia undergoing hematopoietic cell transplantation. Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):273-9. doi: 10.1016/j.ijrobp.2008.04.071. Epub 2008 Sep 9.

ReferenceCitation: Somlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: CLCC Paul Strauss, service de radiothérapie

location_facility: CLCC Oscar Lambret, service de radiothérapie

location_facility: CHU Claude Huriez, service d'hématologie


title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

summary:
To validate the French version of the CAM, a multicenter diagnostic study will be conducted. The principle of this study is identical to the study of Inouye which initially validated the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the DSM.

A representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits:

A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.

These two evaluations will be conducted on the same day and blinded from each other.

The order of these two procedures will be balanced within each center. This process will allow the calculation of diagnostic parameters of the CAM French version (validation competitive): sensitivity, specificity, positive and negative predictive values .

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Rouen - Hôpital de Bois-Guillaume

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Montpellier - Centre Antonin Balmes

lead_sponsor_type: academique


title: A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.

acronym: SHIVA

summary:
SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer.

From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms:

Targeted therapy based on the molecular profile
Conventional therapy based on investigator's choice.

A cross-over is proposed at disease progression.

ReferenceCitation: Le Tourneau C, Delord JP, Gonçalves A, Gavoille C, Dubot C, Isambert N, Campone M, Trédan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bièche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal M, Paoletti X; SHIVA investigators. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015 Oct;16(13):1324-34. doi: 10.1016/S1470-2045(15)00188-6. Epub 2015 Sep 3.

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Delord

full_name: Jean-Pierre Delord

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Gavoille

full_name: Céline Gavoille

given: Céline

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Campone

full_name: Mario Campone

given: Mario

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Massiani

full_name: Marie-Ange Massiani

given: Marie-Ange

family: Mauborgne

full_name: Cécile Mauborgne

given: Cécile

family: Armanet

full_name: Sebastien Armanet

given: Sebastien

family: Servant

full_name: Nicolas Servant

family: Bièche

full_name: Ivan Bièche

given: Ivan

family: Bernard

full_name: Virginie Bernard

given: Virginie

family: Gentien

full_name: David Gentien

family: Jezequel

full_name: Pascal Jezequel

given: Pascal

family: Attignon

full_name: Valéry Attignon

given: Valéry

family: Boyault

full_name: Sandrine Boyault

given: Sandrine

family: Vincent-Salomon

full_name: Anne Vincent-Salomon

given: Anne

family: Servois

full_name: Vincent Servois

given: Vincent

family: Sablin

full_name: Marie-Paule Sablin

given: Marie-Paule

family: Kamal

full_name: Maud Kamal

given: Maud

family: Paoletti

full_name: Xavier Paoletti

given: Xavier

location_facility: Centre régional de lutte contre le cancer de Bourgogne Georges François Leclerc

location_facility: Institut de cancérologie de l'Ouest Centre René Gauducheau