intervention_type: Combination Product

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

acronym: ARION

location_facility:
CHU Rangueil Larrey
Iuct, Clcc Unicancer
Hôpital Saint Louis, APHP
Centre Oscar Lambret, CLCC UNICANCER
Centre Paul Strauss, CLCC UNICANCER
Centre Hospitalier Universitaire
Hôpital Haut-Lévêque

title: Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial

summary: This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial


title: A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

summary: The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
Italy
Austria
Switzerland
Netherlands
France
Belgium
Germany
United Kingdom

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

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

location_facility: Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien

location_facility: Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

location_facility: Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

location_facility: University of Sheffield - Academic Neurology Unit

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm

location_facility: Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial

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

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

ReferenceType: background

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

ReferenceType: result

ReferenceCitation: van den Bent MJ, Taphoorn MJ, Brandes AA, Menten J, Stupp R, Frenay M, Chinot O, Kros JM, van der Rijt CC, Vecht ChJ, Allgeier A, Gorlia T; European Organization for Research and Treatment of Cancer Brain Tumor Group. Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. J Clin Oncol. 2003 Jul 1;21(13):2525-8.

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

location_country:
Italy
Switzerland
Netherlands
France
Slovakia
Belgium
Portugal
Germany
United Kingdom

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT

summary:
The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.

Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: France Israel Norway Hungary Belgium Germany

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: United St. Istvan and St. Laszlo Hospital


title: Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial

acronym: DIAMOND GLP1

summary:
Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion associated with glucotoxicity. Previous trials have indicated that treatment with a Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function might improve glycemic control, reduce dose of insulin and risk of hypoglycemia.

The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose

After initial screening to select insulin microsecretors and a run-in period of one month, patients will be randomized into two arms and followed in parallel for 24 weeks :

Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual insulin regimen
Control group receiving placebo s.c weekly in addition to their usual insulin regimen.

The primary endpoint is HbA1c value at 24 weeks

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud

location_facility: Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques

location_facility: Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,

location_facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain

location_facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche

location_facility: Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032

location_facility: Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud

lead_sponsor_type: academique


title: Response to CFTR-modulators in Intestinal Organoids of Patients With CF Having at Least One R334W Mutation

summary: In contrary to what is seen in FRT cells, rectal organoids of patients with a R334W mutation do respond to CFTR modulators ivacaftor and lumacaftor. The present study will investigate the response to modulators in organoids of 30 patients with CF and a R334W mutation, to allow further stratificaton for a future clinical trial assessing the clinical effect of ivacaftor/tezacaftor in patients with CF and a R334W mutation.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Universitaire Ziekenhuizen Leuven

location_country: Italy France Belgium Spain Portugal

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Régional Universitaire Montpellier

location_facility: Sapienza university - Centra Fibrosi Cistica Regione Lazio

location_facility: Azieda Ospedaliera Universitaria Integrata

intervention_type: Procedure

status_simplified: Ongoing


title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta

summary: This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

status: Recruiting

lead_sponsor: EusaPharma (UK) Limited

location_country:
Italy
Austria
France
Poland
Spain
Germany
United Kingdom

location_facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell

location_facility: Hôpital de la Timone, Hôpital des Enfants

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

intervention_type: Other


type: EudraCT Number

type: Other Grant/Funding Number

acronym: TUDCA-ALS

summary: This is a Phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS).

ipd_sharing: Yes

ipd_sharing_description:
Once the dataset has been analysed, a complete, cleaned, anonymized copy of the final data used in conducting the final analyses will be made available to be used in further studies by the research partners or by other research groups and clinicians.

To prevent misuse and misinterpretation, relevant study metadata (such as the study protocol, case report forms, documentation providing information about the methodology and procedures used to collect the data, definition of variables and statistical code) will be shared in a data repository with a stable URL. Patient anonymity and legal compliance will be assured throughout all the steps of data transfer.

lead_sponsor: Humanitas Mirasole SpA

location_country:
Italy
Netherlands
France
Ireland
Belgium
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Regional Universitaire de Tours

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: NEuroMuscular Omnicentre. Fondazione Serena Onlus

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"


title: A Prospective Multinational European Study on Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

acronym: Eurotaclub

summary:
In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).

lead_sponsor: University Hospital, Toulouse

location_country:
Italy
Austria
France
Poland
Greece
Russian Federation
Spain
Germany

location_facility: Interventional Cardiology Clinic, Jagiellonina University

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Hospital Universitario Central de la Defensa "Gomez Ulla"

intervention_type: Device


lead_sponsor: RECORDATI GROUP

location_country: Portugal France Czechia Poland

location_facility: Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G

location_facility: Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités

source: euctr

title: Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study

summary: Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury


title: Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

acronym: FenSim

summary: Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
Austria
Netherlands
France
Germany
United Kingdom

location_facility: University Hospital, Campus Benjamin Franklin


title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

acronym: SWISS-APERO

summary: Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Galea R, De Marco F, Meneveau N, Aminian A, Anselme F, Gräni C, Huber AT, Teiger E, Iriart X, Babongo Bosombo F, Heg D, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Räber L, Valgimigli M. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2021 Nov 6. doi: 10.1161/CIRCULATIONAHA.121.057859. [Epub ahead of print]

family: Galea

full_name: Roberto Galea

given: Roberto

sequence: first

name: Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy

family: De Marco

full_name: Federico De Marco

given: Federico

sequence: additional

name: Besancon University Hospital, EA3920, University of Burgundy Franche-Comté, Besancon, France

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

name: Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium

family: Aminian

full_name: Adel Aminian

given: Adel

name: Department of Cardiology, University Hospital of Rouen, Rouen, France

family: Anselme

full_name: Frédéric Anselme

given: Frédéric

family: Gräni

full_name: Christoph Gräni

given: Christoph

name: Department of Diagnostic, Interventional and Pediatric Radiology, Bern University Hospital, University of Bern, Bern, Switzerland

family: Huber

full_name: Adrian T. Huber

given: Adrian T.

name: Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

name: Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut- Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France

family: Iriart

full_name: Xavier Iriart

given: Xavier

name: Department of Clinical Research, Clinical Trials Unit and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

family: Babongo Bosombo

full_name: Flora Babongo Bosombo

given: Flora

family: Heg

full_name: Dik Heg

given: Dik

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

family: Franzone

full_name: Anna Franzone

given: Anna

name: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

name: Department of Neurology, Bern University Hospital, University of Bern, Bern, Switzerland and Department of Neurology, University Hospital Basel, University of Basel, Switzerland

family: Fischer

full_name: Urs Fischer

given: Urs

family: Pedrazzini

full_name: Giovanni Pedrazzini

given: Giovanni

family: Bedogni

full_name: Francesco Bedogni

given: Francesco

family: Räber

full_name: Lorenz Räber

given: Lorenz

name: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute and Università della Svizzera Italiana (USI), Lugano, Switzerland

family: Valgimigli

full_name: Marco Valgimigli

given: Marco

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Galea R, De Marco F, Aminian A, Meneveau N, Anselme F, Gräni C, Huber AT, Teiger E, Iriart X, Angelillis M, Brugger N, Spirito A, Corpataux N, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Windecker S, Räber L, Valgimigli M. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. J Cardiovasc Transl Res. 2021 Oct;14(5):930-940. doi: 10.1007/s12265-020-10095-4. Epub 2021 Apr 21.

journal_name: Journal of Cardiovascular Translational Research

location_facility: Department of Cardiology, Cardiocentro Ticino

location_facility: Centre Hospitalier Universitaire Hôpitaux De Rouen

location_facility: Hopital cardiologique Haut Lévêque CHU de Bordeaux

location_facility: Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

location_facility: Hôpital Hôpitaux Universitaires Henri-Mondor


title: Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation

acronym: SCOPE II

summary: Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

ReferenceCitation: Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetchè D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Søndergaard L, Butter C, Trillo-Nouche R, Lotfi S, Möllmann H, Joner M, Abdel-Wahab M, Bogaerts K, Hengstenberg C, Capodanno D. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Dec 22;142(25):2431-2442. doi: 10.1161/CIRCULATIONAHA.120.051547. Epub 2020 Oct 15.

name: Department of General Surgery and Medical-Surgical Subspecialties, University of Catania, Italy (C.T., D.C.).

family: Tamburino

full_name: Corrado Tamburino

given: Corrado

name: Department of Cardiothoracic Surgery (S.B.), Heart and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany.

family: Bleiziffer

full_name: Sabine Bleiziffer

given: Sabine

name: Department of Cardiology, Heart Center Leipzig at University Leipzig, Germany (H.T., M.A.-W.).

family: Thiele

full_name: Holger Thiele

given: Holger

name: Department of Interventional Cardiology (S.S.), Heart and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany.

family: Scholtz

full_name: Smita Scholtz

given: Smita

name: Department of Cardiology, Brighton and Sussex University Hospitals National Health Service Trust, Brighton, United Kingdom (D.H.-S.).

family: Hildick-Smith

full_name: David Hildick-Smith

given: David

name: Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals National Health Service Trust, United Kingdom (M.C.).

family: Cunnington

full_name: Michael Cunnington

given: Michael

name: Department of Cardiology, Elisabeth Hospital Essen, Germany (A.W.).

family: Wolf

full_name: Alexander Wolf

given: Alexander

name: Department of Cardio-Thoracic-Vascular Diseases and Transplantations, Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico-San Marco,” Catania, Italy (M.B.).

family: Barbanti

full_name: Marco Barbanti

name: Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France (D.T.).

family: Tchetchè

full_name: Didier Tchetchè

given: Didier

name: Hôpital Privé Jacques Cartier, Institut Cardio-vasculaire Paris-Sud, Ramsay-Santé, Massy, France (P.G.).

family: Garot

full_name: Philippe Garot

given: Philippe

name: Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy (P.P.).

family: Pagnotta

full_name: Paolo Pagnotta

given: Paolo

name: Department of Cardiology, Brest University Hospital, France (M.G.).

family: Gilard

full_name: Martine Gilard

given: Martine

name: Cardiology Department, Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milano, Italy (F.B.).

name: Department of Cardiology, University Hospital, Lille, France (E.V.B.).

family: Van Belle

full_name: Eric Van Belle

given: Eric

name: Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany (M.V.-N.).

family: Vasa-Nicotera

full_name: Mariuca Vasa-Nicotera

given: Mariuca

name: Interventional Cardiology Unit, Istituti di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy (A.C.).

family: Chieffo

full_name: Alaide Chieffo

given: Alaide

name: Department of Cardiovascular Surgery, German Heart Centre Munich, Germany (O.D.).

family: Deutsch

full_name: Oliver Deutsch

given: Oliver

name: Deutsches Herzzentrum Berlin, Charité Universitätsmedizin, Berlin, Germany (J.K.).

family: Kempfert

full_name: Jörg Kempfert

given: Jörg

name: The Heart Center-Rigshospitalet, Copenhagen, Denmark (L.S.).

family: Søndergaard

full_name: Lars Søndergaard

given: Lars

name: Department of Cardiology, Heart Center Brandenburg in Bernau and Brandenburg Medical School, Germany (C.B.).

family: Butter

full_name: Christian Butter

given: Christian

name: Servicio de Cardiología, Complejo Hospitalario Universitario de Santiago de Compostela, Spain (R.T.-N.).

family: Trillo-Nouche

full_name: Ramiro Trillo-Nouche

given: Ramiro

name: Department of Cardiovascular Surgery, University Hospital RWTH Aachen, Germany (S.L.).

family: Lotfi

full_name: Shahram Lotfi

given: Shahram

name: Department of Cardiology, St Johannes Hospital, Dortmund, Germany (H.M.).

family: Möllmann

full_name: Helge Möllmann

given: Helge

name: Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany (M.J.).

name: Department of Public Health and Primary Care, I-BioStat, KU Leuven, Belgium (K.B.).

name: I-BioStat, Universiteit Hasselt, Belgium (K.B.).

name: Department of Internal Medicine II, Medical University of Vienna, Austria (C.H.).

location_country:
Italy
France
Spain
Denmark
Germany
United Kingdom

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Brighton and sussex University hospital NHS trust

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München

location_facility: Herzzentrum Brandenburg, Immanuel Klinikum Bernau

location_facility: Heart Center, Rigshospitalet, University of Copenhagen

location_facility: Herzzentrum Leipzig - Universitätsklinik

location_facility: University of Catania, Ferrarotto Hospital


ReferenceCitation: Ständer S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, Bieber T, Misery L, Wollenberg A, Reich A, Ahmad F, Piketty C. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716. doi: 10.1056/NEJMoa1908316.

name: From the Department of Dermatology and Center for Chronic Pruritus, University Hospital Münster, Münster (S.S.), the Department of Dermatology and Allergy, Christine Kühne Center for Allergy Research and Education, University Hospital, Bonn (T.B.), and the Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich (A.W.) — all in Germany; the Itch Center, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, Miami (G.Y.); the...

family: Ständer

full_name: Sonja Ständer

given: Sonja

family: Yosipovitch

full_name: Gil Yosipovitch

given: Gil

family: Legat

full_name: Franz J. Legat

given: Franz J.

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

family: Paul

full_name: Carle Paul

given: Carle

family: Narbutt

full_name: Joanna Narbutt

given: Joanna

family: Bieber

full_name: Thomas Bieber

given: Thomas

family: Misery

full_name: Laurent Misery

given: Laurent

family: Wollenberg

full_name: Andreas Wollenberg

given: Andreas

family: Reich

full_name: Adam Reich

given: Adam

family: Ahmad

full_name: Faiz Ahmad

given: Faiz

family: Piketty

full_name: Christophe Piketty

given: Christophe

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Galderma R&D

location_country: Austria Germany France Poland

acronym: Safety and Efficacy of Nemolizumab in PN

location_facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

location_facility: Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie

location_facility: Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br

location_facility: Centre Hospitalier Universitaire De Toulouse

location_facility: Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl

location_facility: Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie

location_facility: Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

title: A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

summary: The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.


ReferenceCitation: Levy B, Paz-Ares L, Bennouna J, Felip E, Abreu DR, Isla D, Barlesi F, Molinier O, Madelaine J, Audigier-Valette C, Kim SW, Kim HR, Ozguroglu M, Erman M, Badin FB, Mekhail TM, Scheff R, Chisamore MJ, Sadrolhefazi B, Riess JW. Afatinib With Pembrolizumab for Treatment of Patients With Locally Advanced/Metastatic Squamous Cell Carcinoma of the Lung: The LUX-Lung IO/KEYNOTE 497 Study Protocol. Clin Lung Cancer. 2019 May;20(3):e407-e412. doi: 10.1016/j.cllc.2018.12.022. Epub 2019 Jan 4.

family: Levy

full_name: Benjamin Levy

given: Benjamin

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Abreu

full_name: Delvys Rodríguez Abreu

given: Delvys Rodríguez

family: Isla

full_name: Dolores Isla

given: Dolores

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Madelaine

full_name: Jeannick Madelaine

given: Jeannick

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Kim

full_name: Sang-We Kim

given: Sang-We

full_name: Hye Ryun Kim

given: Hye Ryun

family: Ozguroglu

full_name: Mustafa Ozguroglu

given: Mustafa

family: Erman

full_name: Mustafa Erman

family: Badin

full_name: Firas Benyamine Badin

given: Firas Benyamine

family: Mekhail

full_name: Tarek M. Mekhail

given: Tarek M.

family: Scheff

full_name: Ronald Scheff

given: Ronald

family: Chisamore

full_name: Michael J. Chisamore

given: Michael J.

family: Sadrolhefazi

full_name: Behbood Sadrolhefazi

given: Behbood

family: Riess

full_name: Jonathan W. Riess

given: Jonathan W.

journal_name: Clinical Lung Cancer

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
France
Spain
Turkey
United States
Korea, Republic of

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hacettepe Universitesi Tip Fakultesi, Onkoloji ABD

title: LUX-Lung IO: A Phase II, Open Label, Non-randomised Study of Afatinib in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Lung

summary:
The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment.

The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.


type: Registry Identifier

title: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

summary: The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

design_allocation: Non-Randomized

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
France
Poland
Singapore
Hungary
Australia
Germany
United Kingdom
Korea, Republic of

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services

location_facility: National University Cancer Institute Singapore


title: A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease progression; they are no longer deriving clinical benefit; or any other reason.

ReferenceCitation: Harvey RD, Aransay NR, Isambert N, Lee JS, Arkenau T, Vansteenkiste J, Dickinson PA, Bui K, Weilert D, So K, Thomas K, Vishwanathan K. Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin. Br J Clin Pharmacol. 2018 Dec;84(12):2877-2888. doi: 10.1111/bcp.13753. Epub 2018 Oct 10.

name: Winship Cancer Institute of Emory University; Atlanta GA USA

family: Harvey

full_name: R. Donald Harvey

given: R. Donald

name: Department of Medical Oncology, Hospital Clinic Barcelona; Translational Genomics and Targeted Therapeutics in Solid Tumors; IDIBAPS; Barcelona Spain

family: Aransay

full_name: Noemi Reguart Aransay

given: Noemi Reguart

name: Department of Medical Oncology; Centre GF Leclerc; Dijon France

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

name: Seoul National University, Bundang Hospital; Seoul South Korea

family: Lee

full_name: Jong-Seok Lee

given: Jong-Seok

name: Sarah Cannon Research Institute; London UK

family: Arkenau

full_name: Tobias Arkenau

given: Tobias

name: Respiratory Oncology Unit (Respiratory Diseases); University Hospital KU Leuven; Leuven Belgium

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

name: Seda Pharmaceutical Development Services; Alderley Edge UK

family: Dickinson

full_name: Paul A. Dickinson

given: Paul A.

name: Quantitative Clinical Pharmacology; AstraZeneca; Waltham MA USA

family: Bui

full_name: Khanh Bui

given: Khanh

family: Weilert

full_name: Doris Weilert

given: Doris

name: Global Medicines Development/Global Clinical Development; AstraZeneca; Royston UK

family: So

full_name: Karen So

given: Karen

name: Biostatistics and Informatics; AstraZeneca; Macclesfield UK

family: Thomas

full_name: Karen Thomas

name: Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit; AstraZeneca; Waltham MA USA

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

bso_classification: Chemistry

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: AstraZeneca

location_country:
United States
United Kingdom
France
Spain


title: Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein

summary: This multicenter, open-label dose-escalation study with an extension phase will evaluate the safety and pharmacokinetics of lumretuzumab in combination with pertuzumab and paclitaxel in participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of participants will receive escalating doses of lumretuzumab intravenously (IV) every three weeks (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of dose-limiting toxicity period (21 days), the study will be conducted in two extension phase cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Schneeweiss A, Park-Simon TW, Albanell J, Lassen U, Cortés J, Dieras V, May M, Schindler C, Marmé F, Cejalvo JM, Martinez-Garcia M, Gonzalez I, Lopez-Martin J, Welt A, Levy C, Joly F, Michielin F, Jacob W, Adessi C, Moisan A, Meneses-Lorente G, Racek T, James I, Ceppi M, Hasmann M, Weisser M, Cervantes A. Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer. Invest New Drugs. 2018 Oct;36(5):848-859. doi: 10.1007/s10637-018-0562-4. Epub 2018 Jan 19.

family: Schneeweiss

full_name: Andreas Schneeweiss

given: Andreas

family: Park-Simon

full_name: Tjoung-Won Park-Simon

given: Tjoung-Won

family: Albanell

full_name: Joan Albanell

given: Joan

family: Lassen

full_name: Ulrik Lassen

given: Ulrik

family: Cortés

full_name: Javier Cortés

given: Javier

family: Dieras

full_name: Veronique Dieras

given: Veronique

family: May

full_name: Marcus May

given: Marcus

family: Schindler

full_name: Christoph Schindler

given: Christoph

family: Marmé

full_name: Frederik Marmé

given: Frederik

family: Cejalvo

full_name: Juan Miguel Cejalvo

given: Juan Miguel

family: Martinez-Garcia

full_name: Maria Martinez-Garcia

given: Maria

family: Gonzalez

full_name: Iria Gonzalez

given: Iria

family: Lopez-Martin

full_name: Jose Lopez-Martin

given: Jose

family: Welt

full_name: Anja Welt

given: Anja

family: Levy

full_name: Christelle Levy

given: Christelle

family: Joly

full_name: Florence Joly

given: Florence

family: Michielin

full_name: Francesca Michielin

given: Francesca

family: Jacob

full_name: Wolfgang Jacob

given: Wolfgang

family: Adessi

full_name: Céline Adessi

given: Céline

family: Moisan

full_name: Annie Moisan

given: Annie

family: Meneses-Lorente

full_name: Georgina Meneses-Lorente

given: Georgina

family: Racek

full_name: Tomas Racek

given: Tomas

family: James

full_name: Ian James

given: Ian

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories:
PubMed Central
Pure (Denmark)
repositori.upf.edu

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

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

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

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung)


title: A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

acronym: NIVOREN

summary: The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.

ReferenceCitation: Billon E, Chanez B, Rochigneux P, Albiges L, Vicier C, Pignot G, Walz J, Chretien AS, Gravis G, Olive D. Soluble BTN2A1 Is a Potential Prognosis Biomarker in Pre-Treated Advanced Renal Cell Carcinoma. Front Immunol. 2021 Apr 20;12:670827. doi: 10.3389/fimmu.2021.670827. eCollection 2021.

family: Billon

full_name: Emilien Billon

given: Emilien

family: Chanez

full_name: Brice Chanez

given: Brice

family: Rochigneux

full_name: Philippe Rochigneux

given: Philippe

family: Albiges

full_name: Laurence Albiges

given: Laurence

family: Vicier

full_name: Cécile Vicier

given: Cécile

family: Pignot

full_name: Géraldine Pignot

given: Géraldine

family: Walz

full_name: Jochen Walz

given: Jochen

family: Chretien

full_name: Anne-Sophie Chretien

given: Anne-Sophie

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Olive

full_name: Daniel Olive

given: Daniel

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Flippot R, Dalban C, Laguerre B, Borchiellini D, Gravis G, Négrier S, Chevreau C, Joly F, Geoffrois L, Ladoire S, Mahammedi H, Rolland F, Gross-Goupil M, Deluche E, Priou F, Laramas M, Barthélémy P, Narciso B, Houedé N, Culine S, Oudard S, Chenot M, Tantot F, Chabaud S, Escudier B, Albiges L. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019 Aug 10;37(23):2008-2016. doi: 10.1200/JCO.18.02218. Epub 2019 Jun 13.

name: Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France

family: Flippot

full_name: Ronan Flippot

given: Ronan

family: Dalban

full_name: Cécile Dalban

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

name: Centre Antoine Lacassagne, Université Côte d’Azur, Nice, France

family: Borchiellini

full_name: Delphine Borchiellini

given: Delphine

name: Institut Paoli Calmettes, Marseille, France

full_name: Gwénaelle Gravis

given: Gwénaelle

family: Négrier

full_name: Sylvie Négrier

given: Sylvie

name: Institut Universitaire du Cancer Toulouse–Oncopole, Toulouse, France

family: Chevreau

full_name: Christine Chevreau

given: Christine

name: Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France

name: Centre Georges François Leclerc, Dijon, France

name: Centre Jean Perrin, Clermont-Ferrand, France

name: Centre René Gauducheau, Saint Herblain, France

name: Bordeaux University Hospital, Bordeaux, France

name: Limoges University Hospital, Limoges, France

name: Centre Hospitalier de Vendée, La Roche sur Yon, France

name: Alpes University Hospital, Grenoble, France

name: Strasbourg University Hospital, Strasbourg, France

name: Tours University Hospital, Tours, France

name: Nimes University Hospital, Nimes, France

name: Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France

name: Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France

name: Université Montpellier, Montpellier, France

publisher: American Society of Clinical Oncology (ASCO)

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients

acronym: LUPUS

summary: Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hopital Pellegrin
CHU Hôtel Dieu
CHR d'Orléans
Chru de Tours
Hopital Pontchaillon - Chu de Rennes
Chu de Brest
CH du MANS


title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

acronym: HYCOREMA

summary: The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Centre Léon Bérard
CH Bastia
Centre Paul Strauss
CHRU de Brest
APHM La Timone
Chu Bordeaux-Pellegrin
Institut de Cancerologie de Lorraine

status_simplified: Unknown


title: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

acronym: SCOLEVOL

summary: The hypothesis of this study is that progressive AIS is characterized by a disorder of orthostatic postural control. The analysis and the treatment of posturographic signal on computerized integrate force plates, coupled to clinical and radiographic examinations, could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the clinician in his therapeutic approach, based on the postural control improvement (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by corset). This method is non-invasive, without side effects, fast and achievable in routine care at the moment of the diagnosis of AIS.

lead_sponsor: Lille Catholic University

location_facility: Centre de MPR pour enfants de Bois Larris


type: Other Identifier

title: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

acronym: MICROPRUNG

summary:
Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.

primary_purpose: Basic Science

ipd_sharing_description: Case Report Form

lead_sponsor: Rennes University Hospital

location_facility:
Poitiers University Hospital
Brest University Hospital
Rennes University Hospital
Tours University Hospital
Angers University Hospital
Caen Univeristy Hospital
Nantes University Hospital


title: PERCEVAL Pivotal Trial

summary: The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.

lead_sponsor: LivaNova

location_country: Germany Belgium France Switzerland

location_facility:
UZ Leuven
Inselspital Bern
Westdeutsches Herzzentrum
CHRU de Lille
Hopital Guillaume et René Laennec
Ruhr Universität Bochum
Medizinische Hochschule Hannover
Hôpital Cardiologique du Haut-Lévêque
Institut Mutualiste Montsouris


title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

lead_sponsor: Edwards Lifesciences

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst

location_facility: Hamburg University Cardiovascular Center


title: Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

summary: The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.

primary_purpose: Prevention

ReferenceCitation: D'Agostino MA, Boers M, Wakefield RJ, Berner Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Gaillez C, Le Bars M. Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study. RMD Open. 2016 May 5;2(1):e000237. doi: 10.1136/rmdopen-2015-000237. eCollection 2016.

family: D'Agostino

full_name: Maria-Antonietta D'Agostino

given: Maria-Antonietta

family: Boers

full_name: Maarten Boers

given: Maarten

family: Wakefield

full_name: Richard J Wakefield

given: Richard J

family: Berner Hammer

full_name: Hilde Berner Hammer

given: Hilde

family: Vittecoq

full_name: Olivier Vittecoq

given: Olivier

family: Filippou

full_name: Georgios Filippou

given: Georgios

family: Balint

full_name: Peter Balint

given: Peter

family: Möller

full_name: Ingrid Möller

given: Ingrid

family: Iagnocco

full_name: Annamaria Iagnocco

given: Annamaria

family: Naredo

full_name: Esperanza Naredo

given: Esperanza

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: Gaillez

full_name: Corine Gaillez

given: Corine

family: Le Bars

full_name: Manuela Le Bars

given: Manuela

currency_apc_doaj: GBP

journal_name: RMD Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_normalized: Pure (Denmark)

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

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Golinski ML, Vandhuick T, Derambure C, Fréret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loët X, Vittecoq O, Lequerré T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFα inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.

ReferenceCitation: D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709. Epub 2015 Nov 20.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Italy
France
Norway
Hungary
Spain
Denmark
Germany
United Kingdom


title: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)

summary: Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.

ReferenceCitation: Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.

family: Mohkam

full_name: Kayvan Mohkam

given: Kayvan

family: Rayar

full_name: Michel Rayar

given: Michel

family: Adam

full_name: Jean-Philippe Adam

given: Jean-Philippe

family: Muscari

full_name: Fabrice Muscari

given: Fabrice

family: Rode

full_name: Agnès Rode

given: Agnès

family: Merle

full_name: Philippe Merle

given: Philippe

family: Pradat

full_name: Pierre Pradat

given: Pierre

family: Bauler

full_name: Stéphanie Bauler

given: Stéphanie

family: Delfour

full_name: Isabelle Delfour

given: Isabelle

family: Chiche

full_name: Laurence Chiche

given: Laurence

family: Ducerf

full_name: Christian Ducerf

given: Christian

family: Boudjema

full_name: Karim Boudjema

given: Karim

family: Lesurtel

full_name: Mickaël Lesurtel

given: Mickaël

family: Laurent

full_name: Christophe Laurent

given: Christophe

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

journal_name: BMC Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative

acronym: THEODORA

summary: THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A & MS bioassays on tumor control by radiotherapy.

ReferenceCitation: Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. Erratum in: Cancer. 2006 Aug 1;107(3):660.

ReferenceCitation: Bentzen SM, Heeren G, Cottier B, Slotman B, Glimelius B, Lievens Y, van den Bogaert W. Towards evidence-based guidelines for radiotherapy infrastructure and staffing needs in Europe: the ESTRO QUARTS project. Radiother Oncol. 2005 Jun;75(3):355-65. Epub 2005 Mar 16.

ReferenceCitation: Lievens Y, Grau C. Health economics in radiation oncology: introducing the ESTRO HERO project. Radiother Oncol. 2012 Apr;103(1):109-12. doi: 10.1016/j.radonc.2011.12.026. Epub 2012 Feb 8.

ReferenceCitation: Dörr W, Hendry JH. Consequential late effects in normal tissues. Radiother Oncol. 2001 Dec;61(3):223-31. Review.

ReferenceCitation: Bodgi L, Granzotto A, Devic C, Vogin G, Lesne A, Bottollier-Depois JF, Victor JM, Maalouf M, Fares G, Foray N. A single formula to describe radiation-induced protein relocalization: towards a mathematical definition of individual radiosensitivity. J Theor Biol. 2013 Sep 21;333:135-45. doi: 10.1016/j.jtbi.2013.05.020. Epub 2013 Jun 2.

ReferenceCitation: Foray N, Colin C, Bourguignon M. 100 years of individual radiosensitivity: how we have forgotten the evidence. Radiology. 2012 Sep;264(3):627-31. doi: 10.1148/radiol.12112560.

ReferenceCitation: Joubert A, Zimmerman KM, Bencokova Z, Gastaldo J, Chavaudra N, Favaudon V, Arlett CF, Foray N. DNA double-strand break repair defects in syndromes associated with acute radiation response: at least two different assays to predict intrinsic radiosensitivity? Int J Radiat Biol. 2008 Feb;84(2):107-25. doi: 10.1080/09553000701797039.

ReferenceCitation: Granzotto A, Joubert A, Viau M, Devic C, Maalouf M, Thomas C, Vogin G, Malek K, Colin C, Balosso J, Foray N. [Individual response to ionising radiation: What predictive assay(s) to choose?]. C R Biol. 2011 Feb;334(2):140-57. doi: 10.1016/j.crvi.2010.12.018. Review. French.

ReferenceCitation: Rothkamm K, Löbrich M. Evidence for a lack of DNA double-strand break repair in human cells exposed to very low x-ray doses. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5057-62. Epub 2003 Apr 4.

ReferenceCitation: COPERNIC project investigators, Granzotto A, Benadjaoud MA, Vogin G, Devic C, Ferlazzo ML, Bodgi L, Pereira S, Sonzogni L, Forcheron F, Viau M, Etaix A, Malek K, Mengue-Bindjeme L, Escoffier C, Rouvet I, Zabot MT, Joubert A, Vincent A, Dalla Venezia N, Bourguignon M, Canat EP, d'Hombres A, Thébaud E, Orbach D, Stoppa-Lyonnet D, Radji A, Doré E, Pointreau Y, Bourgier C, Leblond P, Defachelles AS, Lervat C, Guey S, Feuvret L, Gilsoul F, Berger C, Moncharmont C, de Laroche G, Moreau-Claeys MV, Chavaudra N, Combemale P, Biston MC, Malet C, Martel-Lafay I, Laude C, Hau-Desbat NH, Ziouéche A, Tanguy R, Sunyach MP, Racadot S, Pommier P, Claude L, Baleydier F, Fleury B, de Crevoisier R, Simon JM, Verrelle P, Peiffert D, Belkacemi Y, Bourhis J, Lartigau E, Carrie C, De Vathaire F, Eschwege F, Puisieux A, Lagrange JL, Balosso J, Foray N. Influence of Nucleoshuttling of the ATM Protein in the Healthy Tissues Response to Radiation Therapy: Toward a Molecular Classification of Human Radiosensitivity. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):450-60. doi: 10.1016/j.ijrobp.2015.11.013. Epub 2015 Nov 14.

ReferenceCitation: Bodgi L, Foray N. The nucleo-shuttling of the ATM protein as a basis for a novel theory of radiation response: resolution of the linear-quadratic model. Int J Radiat Biol. 2016;92(3):117-31. doi: 10.3109/09553002.2016.1135260.

ReferenceCitation: Zaider M, Minerbo GN. Tumour control probability: a formulation applicable to any temporal protocol of dose delivery. Phys Med Biol. 2000 Feb;45(2):279-93.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Gérard A, Buyse M, Nordlinger B, Loygue J, Pène F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14.

ReferenceCitation: Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40.

ReferenceCitation: Fleming FJ, Påhlman L, Monson JR. Neoadjuvant therapy in rectal cancer. Dis Colon Rectum. 2011 Jul;54(7):901-12. doi: 10.1007/DCR.0b013e31820eeb37. Review.

ReferenceCitation: Movsas B, Diratzouian H, Hanlon A, Cooper H, Freedman G, Konski A, Sigurdson E, Hoffman J, Meropol NJ, Weiner LM, Coia L, Lanciano R, Stein J, Kister D, Eisenberg B. Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer. Am J Clin Oncol. 2006 Oct;29(5):435-41.

ReferenceCitation: Wagman R, Minsky BD, Cohen AM, Guillem JG, Paty PP. Sphincter preservation in rectal cancer with preoperative radiation therapy and coloanal anastomosis: long term follow-up. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):51-7.

ReferenceCitation: Pisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. J Clin Oncol. 1996 Mar;14(3):859-68.

ReferenceCitation: Yang JC, Chang AE, Baker AR, Sindelar WF, Danforth DN, Topalian SL, DeLaney T, Glatstein E, Steinberg SM, Merino MJ, Rosenberg SA. Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol. 1998 Jan;16(1):197-203.

ReferenceCitation: Koshy M, Rich SE, Mohiuddin MM. Improved survival with radiation therapy in high-grade soft tissue sarcomas of the extremities: a SEER analysis. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):203-9. doi: 10.1016/j.ijrobp.2009.04.051. Epub 2009 Aug 11.

ReferenceCitation: Strander H, Turesson I, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in soft tissue sarcomas. Acta Oncol. 2003;42(5-6):516-31. Review.

ReferenceCitation: Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, Piovesan C, Dileo P, Torri V, Gronchi A, Casali PG. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology. 2009 May;251(2):447-56. doi: 10.1148/radiol.2512081403. Epub 2009 Mar 4.

ReferenceCitation: Stahl R, Wang T, Lindner LH, Abdel-Rahman S, Santl M, Reiser MF, Issels RD. Comparison of radiological and pathohistological response to neoadjuvant chemotherapy combined with regional hyperthermia (RHT) and study of response dependence on the applied thermal parameters in patients with soft tissue sarcomas (STS). Int J Hyperthermia. 2009 Jun;25(4):289-98. doi: 10.1080/02656730902873616.

ReferenceCitation: O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41.

ReferenceCitation: Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7.

ReferenceCitation: Ishikura S, Nihei K, Ohtsu A, Boku N, Hironaka S, Mera K, Muto M, Ogino T, Yoshida S. Long-term toxicity after definitive chemoradiotherapy for squamous cell carcinoma of the thoracic esophagus. J Clin Oncol. 2003 Jul 15;21(14):2697-702.

ReferenceCitation: Morota M, Gomi K, Kozuka T, Chin K, Matsuura M, Oguchi M, Ito H, Yamashita T. Late toxicity after definitive concurrent chemoradiotherapy for thoracic esophageal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):122-8. doi: 10.1016/j.ijrobp.2008.10.075. Epub 2009 Mar 26.

ReferenceCitation: Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1:122S-50S. doi: 10.2967/jnumed.108.057307. Review.

lead_sponsor: Centre Leon Berard

location_facility: Hopital Nord Ouest Villefranche Sur Saone

location_facility: ICL - Institut de Cancérologie de la Lorraine

intervention_type: Radiation


title: Dysfunctions of Human Muscle Stem Cells in Sepsis

acronym: DISCUSS

summary: Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning from mechanical ventilation and with long-term functional. Several mechanisms have been incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well investigated in this context, even though its involvement is suggested by the protracted functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the post-injury muscle recovery.

ReferenceCitation: Rocheteau P, Chatre L, Briand D, Mebarki M, Jouvion G, Bardon J, Crochemore C, Serrani P, Lecci PP, Latil M, Matot B, Carlier PG, Latronico N, Huchet C, Lafoux A, Sharshar T, Ricchetti M, Chrétien F. Sepsis induces long-term metabolic and mitochondrial muscle stem cell dysfunction amenable by mesenchymal stem cell therapy. Nat Commun. 2015 Dec 15;6:10145. doi: 10.1038/ncomms10145.

lead_sponsor: Institut Pasteur

location_facility: Hôpital Pitié Salpétrière, Salle de surveillance post-interventionnelle, Accueil des Polytraumatisés

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Hépatobiliaire et de Transplantation Hépatique

location_facility: Hopital Henri Mondor, Service de Réanimation chirurgicale polyvalente

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Générale, Viscérale et Endocrinienne

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-réanimation

location_facility: Hôpital Pitié Salpêtrière, Anesthésie et Réanimation, Institut de Cardiologie

location_facility: Hôpital Pitié Salpêtrière, Service de réanimation chirurgicale polyvalente


title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.

lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Germany Finland France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopital Cantonal Universitaire de Geneve


title: An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

summary: To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment

lead_sponsor: Bayer

location_country:
Moldova, Republic of
France


title: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

acronym: CHASE

summary: This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Sweden
United Kingdom
France
Poland
Spain
Germany
Czech Republic


title: Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program

acronym: STROKE 69

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).

The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.

The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.

The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.

After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.

AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.

lead_sponsor: Hospices Civils de Lyon

location_facility: Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot

location_facility: Department of stroke unit - Hospices Civils de Lyon


title: Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

summary: HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

location_facility:
LONGO Raphaelle
AZEMAR Marc
SAVOYE Aude-Marie
KURTZ Jean-Emmanuel
KALBACHER Elsa
BENGRINE-LEVEVRE Leïla
GAVOILLE Céline


title: Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.

acronym: STIMCONE

summary:
Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure.

The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level.

In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation.

The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.

lead_sponsor: Nantes University Hospital

location_facility:
Colmar Hospital
Clinic Catherine de Sienne
Lyon University Hospital
Lille University Hospital
Nantes Hospital
Hôpital Foch
Bordeaux University Hospital


ReferenceCitation: Le Gouill S, Morschhauser F, Chiron D, Bouabdallah K, Cartron G, Casasnovas O, Bodet-Milin C, Ragot S, Bossard C, Nadal N, Herbaux C, Tessoulin B, Tchernonog E, Rossi C, McCulloch R, Gastinne T, Callanan MB, Rule S. Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. Blood. 2021 Feb 18;137(7):877-887. doi: 10.1182/blood.2020008727.

name: Service d’hématologie clinique du Centre Hospitalier Universitaire (CHU) de Nantes, INSERM Centre de Recherche en Cancérologie et Immunologie Nantes Angers (CRCINA) Nantes-Angers, Nantes Excellence Trajectory (NeXT) Université de Nantes, Nantes, France;

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: CHU Lille, Université de Lille, Lille, France;

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: INSERM, CNRS, Université de Nantes, Nantes, France;

family: Chiron

full_name: David Chiron

given: David

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

name: CHU Montpellier, Institut de Génétique Moléculaire de Montpellier, INSERM, Université de Montpellier, Montpellier, France;

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Casasnovas

full_name: Olivier Casasnovas

given: Olivier

name: Service de médecine nucléaire CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France;

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

name: Université de Bourgogne Faculté de Médecine, INSERM, CHU Dijon, Dijon, France;

family: Ragot

full_name: Sylviane Ragot

given: Sylviane

name: Service d’anatomopathologie, CHU de Nantes, Nantes, France;

family: Bossard

full_name: Céline Bossard

given: Céline

family: Nadal

full_name: Nathalie Nadal

given: Nathalie

family: Herbaux

full_name: Charles Herbaux

given: Charles

family: Tessoulin

full_name: Benoit Tessoulin

given: Benoit

family: Tchernonog

full_name: Emmanuelle Tchernonog

given: Emmanuelle

family: Rossi

full_name: Cédric Rossi

given: Cédric

name: Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom; and

family: McCulloch

full_name: Rory McCulloch

given: Rory

name: Service d’hématologie clinique du CHU de Nantes, Nantes, France

family: Gastinne

full_name: Thomas Gastinne

given: Thomas

family: Callanan

full_name: Mary B. Callanan

given: Mary B.

family: Rule

full_name: Simon Rule

given: Simon

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_country:
United Kingdom
France

acronym: OAsIs

location_facility: Derriford Hospital _ Plymouth Hospitals NHS Trust

title: A Phase I/II Trial of Obinutuzumab, ABT-199 (GDC-0199) Plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma Patients

summary:
This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.

The study will be conducted in 3 steps. The first one (step A) will be to ensure the safety of the combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or refractory Mantle Cell Lymphoma (MCL).

A total of 9 patients have been included in the first step with grouped inclusions of three patients (safety evaluation performed at each inclusion of 3 patients).

No unacceptable toxicity has been observed during step A, thefore the second step (step B) was initiated. The aim of the second step was to determine the MTD of the GDC-0199 (400-600-800mg/d) in combination of GA101 and Ibrutinib (both respecting the previous doses) by using a Continual Reassessment Method. This dose escalation method was used until the 12th patient (3 patients included at 400mg/d of GDC-0199-(no DLT), 3 at 600mg/d- (no DLT) and 6 at 800mg/d, (not DLT reported so far). Once the last patient of the 800mg cohort is evaluated for DLT, all other patients will be treated at the dose of 400mg/d of GDC-0199.

The third step (step C) for untreated patients will be conducted at the dose of 400mg/d of GDC-0199. The aim of step C is to confirm the safety profile of the GA101 + Ibrutininb + GDC-199 combination according to step B result. 15 patients will be included in this step.


title: Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients

summary:
Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX) deficiency. According to the intensity of the defect, there are three forms of haemophilia: severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic manifestations are variable from one patient to the other. Moreover, several studies showed that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that haemophilic A patients.

The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the amplification pathway being strongly altered because of factor VIII or IX deficiency, thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
AP-HM
CHRU Lille
Chu Nancy
Chu Reims
Chu Tours
CHU Saint-Etienne
HCL


title: Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

acronym: Epis-AKI

summary:
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.

lead_sponsor: University Hospital Muenster

location_country:
Italy
United States
Libyan Arab Jamahiriya
Saudi Arabia
North Macedonia
France
Malta
Palestinian Territory, occupied
Russian Federation
Egypt
Spain
Turkey
Germany
Slovenia

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Hospital Universitario Funcacion Alcorcón

location_facility: Cardioanestesia - Azienda Ospedaliera San Carlo di Potenza

location_facility: Izmir Democracy University School of Medicine

location_facility: Health Sciences University Medical School

location_facility: Hospital Cliínico Universitario Virgen de las Nieves

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

location_facility: Suleyman Demirel University School of Medicine

location_facility: Centre de Lutte contre le Cancer Francois Baclesse


lead_sponsor: University Hospital, Lille

location_country: Belgium France

location_facility: Département d'Hématologie et Oncologie Hôpitaux Universitaires de Strasbourg

location_facility: service hématologie CH Bretagne Atlantique

location_facility: Service Hématologie Centre Hospitalier Yves le Foll

location_facility: Médecine interne Centre hospitalier départemental

location_facility: Onco-hématologie CHRU Hôpital Bretonneau

location_facility: Unité de Recherche Clinique - CH Périgueux

location_facility: Service d'Hématologie Clinique Institut de Cancérologie Lucien Neuwirth

location_facility: Clinique - ICH CHU de Brest Hôpital Morvan

location_facility: Sce Hématologie Thérapie Cellulaire CHU Limoges

location_facility: Hôpital du Haut Lévêque Centre François Magendie

title: A Multicenter Open Label Phase II Study of Daratumumab in Combination With Dexamethasone in Multiple Myeloma Resistant or Refractory to Bortezomib and Lenalidomide and Pomalidomide - an IFM 2014-04 Study

summary:
This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.

There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.


title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma

acronym: FOXAGAST

summary:
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.

In neoadjuvant setting : 3 months of treatment

Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.

Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

acronym: MACMAN

summary: The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

ReferenceCitation: Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.

ReferenceCitation: Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.

name: Medical-Surgical Intensive Care Unit, District Hospital Centre, La Roche-sur-Yon, France

family: Lascarrou

full_name: Jean Baptiste Lascarrou

given: Jean Baptiste

name: Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France3EA 7293, Fédération de Médecine Translationnelle de Strasbourg, Faculté de Médecine, Université de Strasbourg, Strasbourg, France

family: Boisrame-Helms

full_name: Julie Boisrame-Helms

given: Julie

family: Bailly

full_name: Arthur Bailly

given: Arthur

name: Clinical Research Unit, District Hospital Centre, La Roche-sur-Yon, France5Delegation a la Recherche Clinique et a l’Innovation-CHU Hotel Dieu, Nantes, France

family: Le Thuaut

full_name: Aurelie Le Thuaut

given: Aurelie

name: Medical Intensive Care Unit, Regional Hospital Centre, Orleans, France

family: Kamel

full_name: Toufik Kamel

given: Toufik

name: Medical Intensive Care Unit, University Hospital Centre, Tours, France

family: Mercier

full_name: Emmanuelle Mercier

name: AP-HP, Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, F-92700, Colombes, France9INSERM, IAME 1137, Sorbonne Paris Cité, F-75018, Paris, France

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

name: APHP Hôpital Saint Louis, Service de Réanimation Médicale, Paris, France

family: Lemiale

full_name: Virginie Lemiale

given: Virginie

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

name: Medical Intensive Care Unit, Cochin University Hospital Centre, Paris, France

family: Mira

full_name: Jean Paul Mira

given: Jean Paul

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Messika

full_name: Jonathan Messika

given: Jonathan

family: Dequin

full_name: Pierre Francois Dequin

given: Pierre Francois

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Champigneulle

full_name: Benoit Champigneulle

name: Medical Intensive Care Unit, University Hospital Centre, Nantes, France13EA 3826, Clinical and Experimental Treatments for Infections, University of Medicine, Nantes, France

family: Reignier

full_name: Jean Reignier

given: Jean

name: for the Clinical Research in Intensive Care and Sepsis (CRICS) Group

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Saint Louis
CHU Louis Mourier
CHU Paris Cochin
CHU Orleans
CHU Tours
CHD Vendee
CHU Strasbourg Nouvel Hôpital Civil


title: Open-label, Multicenter, Dose-escalating Phase II Study to Investigate the Safety, Tolerability, and Early Signs of Efficacy of Subcutaneous Administrations of Tadekinig Alfa (IL-18BP) in Patients With Adult -Onset Still's Disease (AoSD) During 12 Weeks

summary:
The objective of this study is to assess safety, tolerability and early signs of efficacy of the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic auto-inflammatory disorder for which treatment remains empirical.

This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin rashes with frequent components of sore throat, lymphadenopathies and neutrophilic leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features, the diagnosis includes some laboratory components that reflect the systemic inflammation: high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of interleukin 18 (IL-18).

Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and rheumatoid arthritis patients in phase I studies. It demonstrated good safety and tolerability profile with only mild adverse events in the injection site.

ReferenceCitation: Bagnari V, Colina M, Ciancio G, Govoni M, Trotta F. Adult-onset Still's disease. Rheumatol Int. 2010 May;30(7):855-62. doi: 10.1007/s00296-009-1291-y. Epub 2009 Dec 18. Review.

ReferenceCitation: Bywaters EG. Still's disease in the adult. Ann Rheum Dis. 1971 Mar;30(2):121-33.

ReferenceCitation: Efthimiou P, Kontzias A, Ward CM, Ogden NS. Adult-onset Still's disease: can recent advances in our understanding of its pathogenesis lead to targeted therapy? Nat Clin Pract Rheumatol. 2007 Jun;3(6):328-35. Review.

ReferenceCitation: Fautrel B. Adult-onset Still disease. Best Pract Res Clin Rheumatol. 2008 Oct;22(5):773-92. doi: 10.1016/j.berh.2008.08.006. Review.

ReferenceCitation: Kawashima M, Yamamura M, Taniai M, Yamauchi H, Tanimoto T, Kurimoto M, Miyawaki S, Amano T, Takeuchi T, Makino H. Levels of interleukin-18 and its binding inhibitors in the blood circulation of patients with adult-onset Still's disease. Arthritis Rheum. 2001 Mar;44(3):550-60.

ReferenceCitation: Yamaguchi M, Ohta A, Tsunematsu T, Kasukawa R, Mizushima Y, Kashiwagi H, Kashiwazaki S, Tanimoto K, Matsumoto Y, Ota T, et al. Preliminary criteria for classification of adult Still's disease. J Rheumatol. 1992 Mar;19(3):424-30.

ReferenceCitation: Gabay C, Fautrel B, Rech J, Spertini F, Feist E, Kötter I, Hachulla E, Morel J, Schaeverbeke T, Hamidou MA, Martin T, Hellmich B, Lamprecht P, Schulze-Koops H, Courvoisier DS, Sleight A, Schiffrin EJ. Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease. Ann Rheum Dis. 2018 Jun;77(6):840-847. doi: 10.1136/annrheumdis-2017-212608. Epub 2018 Feb 22.

family: Gabay

full_name: Cem Gabay

given: Cem

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Rech

full_name: Jürgen Rech

given: Jürgen

family: Spertini

full_name: François Spertini

given: François

family: Feist

full_name: Eugen Feist

given: Eugen

family: Kötter

full_name: Ina Kötter

given: Ina

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Morel

full_name: Jacques Morel

given: Jacques

family: Schaeverbeke

full_name: Thierry Schaeverbeke

family: Hamidou

full_name: Mohamed A Hamidou

given: Mohamed A

family: Martin

full_name: Thierry Martin

family: Hellmich

full_name: Bernhard Hellmich

given: Bernhard

family: Lamprecht

full_name: Peter Lamprecht

given: Peter

family: Schulze-Koops

full_name: Hendrik Schulze-Koops

given: Hendrik

family: Courvoisier

full_name: Delphine Sophie Courvoisier

given: Delphine Sophie

family: Sleight

full_name: Andrew Sleight

given: Andrew

family: Schiffrin

full_name: Eduardo Jorge Schiffrin

given: Eduardo Jorge

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

title: Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still’s disease

location_facility: CHU Paris-GH La Pitié Salpêtrière-Charles Foix - Hôpital Pitié-Salpêtrière

location_facility: Medizinische Klinik - Rheumatologie und Klinische

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin III Rheumatologie/Osteologie

location_facility: UNIVERSITÄTSMEDIZIN der Johannes-Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Rheumatologie

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Innere Medizin II - Rheumatologie Schlosspark-Klinik

location_facility: St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Rheumazentrum Ruhrgebiet