title: The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg

acronym: DESTINY

summary: The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.

ReferenceCitation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

family: Bosiers

full_name: Marc Bosiers

given: Marc

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

family: Peeters

full_name: Patrick Peeters

given: Patrick

family: Torsello

full_name: Giovanni Torsello

given: Giovanni

family: Zeller

full_name: Thomas Zeller

given: Thomas

family: Deloose

full_name: Koen Deloose

given: Koen

family: Schmidt

full_name: Andrej Schmidt

given: Andrej

family: Tessarek

full_name: Jörg Tessarek

given: Jörg

family: Vinck

full_name: Erwin Vinck

given: Erwin

family: Schwartz

full_name: Lewis B. Schwartz

given: Lewis B.

journal_name: Journal of Vascular Surgery

lead_sponsor: Flanders Medical Research Program

location_country: Germany Belgium France

location_facility:
Polyclinique Les Fleurs
Herz-zentrum Bad Krozingen
AZ Sint-Blasius
Imelda Hospital
Herzzentrum

intervention_type: Device


title: Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

summary:
The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: LEO Pharma

location_country:
Germany
France
Denmark
Canada
United Kingdom

location_facility: Hørsholm Hospital, Dermatological Department

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

location_facility: Monklands Hospital, Department of Dermatology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Longitudinal Study Comparing Markers of Frailty in Geriatric Assessment to Detect Vulnerability to Chemotherapy in Patients Aged 70 Years or Older With Colon Cancer

acronym: MOST

summary: MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are better at detecting vulnerable patients and that they are a better "Adverse Events" predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients referred for chemotherapy. The second hypothesis is that a brief screening tool based on a combination of some frailty markers and some used in the CGA would help the oncologist detect patients requiring a more complete geriatric assessment

study_start_date_type: Actual

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Retornaz F, Seux V, Sourial N, Braud AC, Monette J, Bergman H, Soubeyrand J. Comparison of the health and functional status between older inpatients with and without cancer admitted to a geriatric/internal medicine unit. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):917-22.

ReferenceCitation: Retornaz F, Monette J, Batist G, Monette M, Sourial N, Small D, Caplan S, Wan-Chow-Wah D, Puts MT, Bergman H. Usefulness of frailty markers in the assessment of the health and functional status of older cancer patients referred for chemotherapy: a pilot study. J Gerontol A Biol Sci Med Sci. 2008 May;63(5):518-22.

lead_sponsor: Association Sud pour la Recherche en Oncogériatrie

location_facility: Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique

location_facility: Hôpital de Pontoise Centre Hospitalier René Dubos

location_facility: Centre Hospitalier Universitaire Intercommunal des Alpes du Sud

intervention_type: Other


title: ADVATE 2 mL (Reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY

summary: This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Germany
Hungary
France
United Kingdom

location_facility: American Memorial Hospital, Service de Pédiatrie

location_facility: Universitätskliniken des Saarlandes, Klinik für pädiatrische Onkologie und Hämatologie

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Josa Andras Egyetemi Oktatokorhaz, Department of Pediatrics

location_facility: CHU de Nancy - Hôpital de Brabois- CRTH - Laboratoire Hémato-Hémostase

location_facility: Heim Pál Children's Hospital, Department of Oncology

location_facility: Birmingham Children's Hospital NHS Trust

location_facility: Mohacsi Korhaz, Department of Pediatrics

location_facility: CRTH Laboratoire d'Hématologie CHRU - Hôpital du Bocage

location_facility: Borsod-Abaúj-Zemplén County Hospital, Pediatric Dep

location_facility: Klinikum Stuttgart, Olgahospital, Pädiatrie 5

intervention_type: Biological


type: Other Identifier

title: Evaluation of the Impact of the Update Multiple Myeloma Criteria on the Natural History of Smoldering Myeloma in Order to Establish New Recommendations About Follow-up and Prognostic Evaluation of Smoldering Myeloma (CARRISMM)

acronym: CARRISMM

summary: This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Screening

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Intergroupe Francophone du Myelome

location_country: Monaco Belgium France

location_facility: Centre Hospitalier de Quimper Cornouaille

location_facility: CHRU Hôpital Bretonneau - Centre Henry Kaplan

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: CH Bretagne Atlantique Vannes et Auray - P. Chubert

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre de Recherche Clinique / GHT des Landes

location_facility: CHU Carémeau, Institut de Cancérologie du Guard

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: Institut Bergonié - Pavillon Saint Genès - 1er étage

location_facility: CHV André Mignot - Université de Versailles

location_facility: CHU Poitiers - Pôle régional de Cancérologie

intervention_type: Procedure

status_simplified: Ongoing


title: Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2

summary: The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft

primary_purpose: Diagnostic

ReferenceCitation: Rubio MT, Bouillié M, Bouazza N, Coman T, Trebeden-Nègre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4(-) invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Institut Universitaire du Cancer de Toulouse

intervention_type: Diagnostic Test

lead_sponsor_type: academique


title: Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

acronym: NURSIE

summary:
Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

ipd_sharing: Undecided

lead_sponsor: French Society for Intensive Care

location_country: Luxembourg Belgium France Switzerland

location_facility:
CHU Marseille
CHU Strasbourg
Hopital Civil Marie Curie
CHU Necker Enfant Malade
CH Andre Migniot
CHU Nantes
Centre Hospitalier Emile Mayrisch
CH de la Dracénie
CHRU Lille
CHU Ambroise Paré
Hopital de la Tour
Hopital Jeanne De Flandre
CHU Toulouse
CHU Charleroi
CHU La Pitié Salpétrière
CHU Besançon
Hopital Europeen George Pompidou
CH Sud Francilien
CHU Lariboisière
CH de Dax
CHR Orléans
CH Valence
Hopital de Bruxelles
CHI Lucie & Raymond Aubrac
CHU Nice
CHU Nimes


title: A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)

acronym: IRMYG

summary: Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

status: Active, not recruiting

lead_sponsor: Institut de Cancérologie de la Loire

location_country: Lebanon Belgium Algeria France

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP

acronym: Epi-RCHOP

summary:
Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21.

Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients :

DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Sarkozy C, Morschhauser F, Dubois S, Molina T, Michot JM, Cullières-Dartigues P, Suttle B, Karlin L, Le Gouill S, Picquenot JM, Dubois R, Tilly H, Herbaux C, Jardin F, Salles G, Ribrag V. A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features. Clin Cancer Res. 2020 Jul 1;26(13):3145-3153. doi: 10.1158/1078-0432.CCR-19-3741. Epub 2020 Mar 2.

family: Sarkozy

full_name: Clémentine Sarkozy

given: Clémentine

sequence: first

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

sequence: additional

family: Dubois

full_name: Sydney Dubois

given: Sydney

family: Molina

full_name: Thierry Molina

given: Thierry

family: Michot

full_name: Jean Marie Michot

given: Jean Marie

family: Cullières-Dartigues

full_name: Peggy Cullières-Dartigues

given: Peggy

family: Suttle

full_name: Benjamin Suttle

given: Benjamin

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Picquenot

full_name: Jean-Michel Picquenot

given: Jean-Michel

full_name: Romain Dubois

given: Romain

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Herbaux

full_name: Charles Herbaux

given: Charles

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Salles

full_name: Gilles Salles

given: Gilles

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Association for Cancer Research (AACR)

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.

acronym: HORTOCI

summary: It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.

ReferenceCitation: Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24.

family: Samson

full_name: Maxime Samson

given: Maxime

family: Devilliers

full_name: Hervé Devilliers

family: Ly

full_name: Kim Heang Ly

given: Kim Heang

family: Maurier

full_name: François Maurier

given: François

family: Bienvenu

full_name: Boris Bienvenu

given: Boris

family: Terrier

full_name: Benjamin Terrier

family: Charles

full_name: Pierre Charles

given: Pierre

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

family: Besancenot

full_name: Jean-François Besancenot

given: Jean-François

family: Liozon

full_name: Eric Liozon

given: Eric

family: Fauchais

full_name: Anne Laure Fauchais

given: Anne Laure

family: Loffroy

full_name: Romaric Loffroy

given: Romaric

family: Binquet

full_name: Christine Binquet

given: Christine

family: Audia

full_name: Sylvain Audia

given: Sylvain

family: Seror

full_name: Raphaèle Seror

given: Raphaèle

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

journal_name: European Journal of Internal Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Hôpitaux privés de Metz - Site Sainte Blandine


title: Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study " PADIS HTP "

acronym: PADIS-HTP

summary: Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

status: Terminated

lead_sponsor: University Hospital, Brest

location_facility: Hôpital de Bellevue - CHU de Saint-Etienne

status_simplified: Unknown


title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

acronym: SOURCE 3

summary:
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

ReferenceCitation: Tarantini G, Nai Fovino L, Le Prince P, Darremont O, Urena M, Bartorelli AL, Vincent F, Hovorka T, Alcalá Navarro Y, Dumonteil N, Ohlmann P, Wendler O. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020 Jul;13(7):e008972. doi: 10.1161/CIRCINTERVENTIONS.120.008972. Epub 2020 Jun 25.

name: Cardiology Clinic, Department of Cardiac, Thoracic, and Vascular Sciences and Public Health Padova, University of Padua, Italy (G.T., L.N.F.).

family: Tarantini

full_name: Giuseppe Tarantini

given: Giuseppe

family: Nai Fovino

full_name: Luca Nai Fovino

given: Luca

name: La Pitié Salpétrière, Paris, France (P.L.P.).

family: Le Prince

full_name: Pascal Le Prince

given: Pascal

name: Clinique Saint-Augustin, Bordeaux, France (O.D.).

family: Darremont

full_name: Olivier Darremont

given: Olivier

family: Urena

full_name: Marina Urena

given: Marina

name: Centro Cardiologico Monzino IRCCS, University of Milan, Italy (A.L.B.).

family: Bartorelli

full_name: Antonio L. Bartorelli

given: Antonio L.

family: Vincent

full_name: Flavien Vincent

given: Flavien

name: Edwards Lifesciences, Prague, Czech Republic (T.H., Y.A.N.).

family: Hovorka

full_name: Tomas Hovorka

given: Tomas

family: Alcalá Navarro

full_name: Yasmina Alcalá Navarro

given: Yasmina

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

family: Dumonteil

full_name: Nicolas Dumonteil

given: Nicolas

name: Department of Interventional Cardiology, University Hospital of Strasbourg, France (P.O.).

family: Ohlmann

full_name: Patrick Ohlmann

given: Patrick

name: King’s College Hospital, London, United Kingdom (O.W.).

family: Wendler

full_name: Olaf Wendler

given: Olaf

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Fernandez-Santos S, Théron A, Pibarot P, Collart F, Gilard M, Urena M, Hovorka T, Kahlert P, Zamorano Gomez JL. Valve hemodynamic performance and myocardial strain after implantation of a third-generation, balloon-expandable, transcatheter aortic valve. Cardiol J. 2020;27(6):789-796. doi: 10.5603/CJ.a2019.0049. Epub 2019 May 20.

apc_source: doaj

family: Fernandez-Santos

full_name: Sara Fernandez-Santos

given: Sara

family: Théron

full_name: Alexis Théron

given: Alexis

family: Pibarot

full_name: Philippe Pibarot

given: Philippe

family: Collart

full_name: Frédéric Collart

given: Frédéric

family: Gilard

ReferenceCitation: Tarantini G, Lefèvre T, Terkelsen CJ, Frerker C, Ohlmann P, Mojoli M, Eltchaninoff H, Pinaud F, Redwood S, Windecker S. One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk. Circ Cardiovasc Interv. 2019 Jan;12(1):e006724. doi: 10.1161/CIRCINTERVENTIONS.118.006724.

name: Department of Cardiac, Thoracic and Vascular Science, Interventional Cardiology, University of Padova, Italy (G.T., M.M.).

name: Department of Interventional Cardiology, Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Massy, France (T.L.).

name: Department of Cardiology, Aarhus University Hospital, Denmark (C.J.T.).

name: Department of Interventional Vascular Therapy, Asklepios Klinik St Georg, Hamburg, Germany (C.F.).

name: Department of Cardiovascular Surgery, Les Hôpitaux Universitaires de Strasbourg, France (P.O.).

name: Department of Cardiology, Hôpital Charles Nicolle, University of Rouen, France (H.E.).

name: Department of Cardiovascular and Cardiothoracic Surgery, Angers University Hospital, France (F.P.).

name: Department of Cardiology, King’s Health Partners, London, United Kingdom (S.R.).

name: Department of Cardiology, Swiss Cardiovascular Center Bern, Switzerland (S.W.).

ReferenceCitation: Frank D, Abdel-Wahab M, Gilard M, Digne F, Souteyrand G, Caussin C, Collart F, Letocart V, Wöhrle J, Kuhn C, Hovorka T, Baumgartner H. Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry. Clin Res Cardiol. 2019 Jul;108(7):763-771. doi: 10.1007/s00392-018-1404-2. Epub 2018 Dec 14.

ReferenceCitation: Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Neumann FJ, Tarantini G, Zamorano JL, Vahanian A. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017 Sep 21;38(36):2717-2726. doi: 10.1093/eurheartj/ehx294.

name: Department of Cardiothoracic Surgery, King’s Health Partners, King’s College Hospital, Denmark Hill, London SE5 9RS, UK

name: Department of Internal Medicine, Municipal Hospital, Moltkestrasse 90, 76133 Karlsruhe, Germany

name: Department of Cardiac Surgery, Mid German Heart Centre, University Hospital, Ernst-Grube-Straße 40, 06120 Halle (Saale), Germany

name: Department of Cardiovascular Medicine, University Hospital Muenster, Albert-Schweitzer-Campus 1, 48149 Münster, Germany

name: Department of Cardiology, Clinique Pasteur, 45, avenue du Lombez BP 27617, 31076 Toulouse Cedex 3, France

name: Department of Cardiology/Angiology, University Heart Centre, Südring 15, 79189 Bad Krozingen, Germany

name: Department of Cardiac, Thoracic and Vascular Sciences, University Padua, Via 8 febbraio 2, 35122 Padova, Italy

name: Department of Cardiology, CiberCV Hospital Ramon y Cajal, Carretera de Colmenar Viejo KM 9, 28034 Madrid, Spain

name: Department of Cardiology, Hopital Bichat, 46 Rue Henri Huchard, 75018 Paris, France

repository_institution: University of Padova - Padua Research Archive

location_country:
Italy
Switzerland
Netherlands
Finland
France
Slovakia
Spain
Denmark
Germany
United Kingdom

location_facility: Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG

location_facility: Evangelisches Klinikum Niederrhein Herzzentrum Duisburg

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Centre Cardiologique du Nord - Saint-Denis

location_facility: Azienda A.R.N.A.S. Ospedale Civico di Palermo

location_facility: Narodny ustav srdcovych a cievnych chorob, a. s.

location_facility: Institut Hospitalier Jacques Cartier Massy

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Staedtisches Klinikum Karlsruhe GmbH (SKK)

location_facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen

location_facility: Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson


summary: The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Medicament


type: EudraCT Number

title: Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Non-treated Matched Healthy Volunteers as Control Group

acronym: EXPO

summary: Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

lead_sponsor: Abbott

location_country:
Germany
Russian Federation
France
Poland

location_facility:
Site Reference ID 93953
Site Reference ID 93914
Site Reference ID 93918
Site reference ID/Investigator # 109455
Site Reference ID 93913
Site Reference ID 93957
Site reference ID ORG-000901
Site reference ID ORG-000903
Site Reference ID 93893
Site reference ID ORG-000904
Site Reference ID 93894
Site Reference ID 93973
Site Reference ID 93955
Site Reference ID 93933
Site Reference ID 93956
Site Reference ID 93896
Site reference ID ORG-000900
Site Reference ID 93917
Site Reference ID 94015
Site Reference ID 93975
Site reference ID ORG-000920
Site reference ID ORG-000907
Site Reference ID 93958
Site reference ID ORG-000906
Site Reference ID 93895
Site Reference ID 93935
Site Reference ID 94014
Site Reference ID 93915
Site Reference ID 93954
Site Reference ID 93916
Site reference ID ORG-000905
Site Reference ID 93974


title: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG

acronym: QT long

summary: The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.

status: Unknown status

lead_sponsor: Nantes University Hospital

location_facility:
Nantes Universitary Hospital
Rennes Universitary Hospital
CHU Toulouse
Bordeaux Universitary Hospital
Marseille Universitary Hospital
CHU Montpellier
CHU Tours
CHU Rouen


title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.

acronym: AVCPOSTIM

summary: The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rennes-Pontchaillou
CHU Reims
CHU Lyon
IRF Nancy
CHU Grenoble
CHU Lille
CHU Lariboisière-Saint Louis Paris
Centre de Rééducation de Kerpape


title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

acronym: IPSY

summary: This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

lead_sponsor: Centre Oscar Lambret

location_facility:
Paul PAPIN Center
Val D'AURELLE Center
CHOLET Hospital
Georges-François LECLERC Center
Oscar Lambret Center
François Baclesse Center
Léon BERARD Center
Jean GODINOT Institut


title: Impact of the Absence of Steroids on the Evolution of Renal Function and on the Progression of Graft Fibrosis, Quantified by Numerical Method, in Patients With Renal Transplant

acronym: Astronef

summary: The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral corticosteroids.The secondary objectives of the study consist to compare on various parameters (fibrosis progression, renal function, dialysis, ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical and biological tolerance) therapy with no corticosteroids post-transplantation in comparison to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary objectives of the study consist also to compare the two techniques for assessing fibrosis by numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical pathologists).

location_facility:
CHU de Saint-Etienne
AP-HP - Hôpital Necker
CHU de Nice
AP-HP - Hôpital Bicêtre
CHRU de Tours
CHU de Lyon
Nantes University Hospital
CHU de Toulouse


type: Registry Identifier

title: Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses

acronym: Highlow

summary:
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

primary_purpose: Prevention

ReferenceCitation: Greer IA. Thrombosis in pregnancy: maternal and fetal issues. Lancet. 1999 Apr 10;353(9160):1258-65. Review.

ReferenceCitation: Pabinger I, Grafenhofer H, Kyrle PA, Quehenberger P, Mannhalter C, Lechner K, Kaider A. Temporary increase in the risk for recurrence during pregnancy in women with a history of venous thromboembolism. Blood. 2002 Aug 1;100(3):1060-2.

ReferenceCitation: White RH, Chan WS, Zhou H, Ginsberg JS. Recurrent venous thromboembolism after pregnancy-associated versus unprovoked thromboembolism. Thromb Haemost. 2008 Aug;100(2):246-52.

ReferenceCitation: Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.

ReferenceCitation: Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005 Jul 15;106(2):401-7. Epub 2005 Apr 5. Review.

ReferenceCitation: Tooher R, Gates S, Dowswell T, Davis LJ. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2010 May 12;(5):CD001689. doi: 10.1002/14651858.CD001689.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;2:CD001689.

ReferenceCitation: Sanson BJ, Lensing AW, Prins MH, Ginsberg JS, Barkagan ZS, Lavenne-Pardonge E, Brenner B, Dulitzky M, Nielsen JD, Boda Z, Turi S, Mac Gillavry MR, Hamulyák K, Theunissen IM, Hunt BJ, Büller HR. Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost. 1999 May;81(5):668-72. Review.

ReferenceCitation: Lepercq J, Conard J, Borel-Derlon A, Darmon JY, Boudignat O, Francoual C, Priollet P, Cohen C, Yvelin N, Schved JF, Tournaire M, Borg JY. Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies. BJOG. 2001 Nov;108(11):1134-40.

ReferenceCitation: Pabinger I, Grafenhofer H, Kaider A, Kyrle PA, Quehenberger P, Mannhalter C, Lechner K. Risk of pregnancy-associated recurrent venous thromboembolism in women with a history of venous thrombosis. J Thromb Haemost. 2005 May;3(5):949-54.

ReferenceCitation: Roeters van Lennep JE, Meijer E, Klumper FJ, Middeldorp JM, Bloemenkamp KW, Middeldorp S. Prophylaxis with low-dose low-molecular-weight heparin during pregnancy and postpartum: is it effective? J Thromb Haemost. 2011 Mar;9(3):473-80. doi: 10.1111/j.1538-7836.2011.04186.x.

ReferenceCitation: Lindqvist PG, Bremme K, Hellgren M; Working Group on Hemostatic Disorders (Hem-ARG), Swedish Society of Obstetrics and Gynecology. Efficacy of obstetric thromboprophylaxis and long-term risk of recurrence of venous thromboembolism. Acta Obstet Gynecol Scand. 2011 Jun;90(6):648-53. doi: 10.1111/j.1600-0412.2011.01098.x. Epub 2011 Apr 15.

ReferenceCitation: Roshani S, Cohn DM, Stehouwer AC, Wolf H, van der Post JA, Büller HR, Kamphuisen PW, Middeldorp S. Incidence of postpartum haemorrhage in women receiving therapeutic doses of low-molecular-weight heparin: results of a retrospective cohort study. BMJ Open. 2011 Nov 14;1(2):e000257. doi: 10.1136/bmjopen-2011-000257. Print 2011.

ReferenceCitation: Kaandorp SP, Goddijn M, van der Post JA, Hutten BA, Verhoeve HR, Hamulyák K, Mol BW, Folkeringa N, Nahuis M, Papatsonis DN, Büller HR, van der Veen F, Middeldorp S. Aspirin plus heparin or aspirin alone in women with recurrent miscarriage. N Engl J Med. 2010 Apr 29;362(17):1586-96. doi: 10.1056/NEJMoa1000641. Epub 2010 Mar 24.

ReferenceCitation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3:CD001689. doi: 10.1002/14651858.CD001689.pub4.

name: Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute; Adelaide Australia

family: Middleton

full_name: Philippa Middleton

given: Philippa

name: Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School; The University of Adelaide; Adelaide Australia

family: Shepherd

full_name: Emily Shepherd

given: Emily

name: Women and Kids, South Australian Health and Medical Research Institute; Adelaide Australia

family: Gomersall

full_name: Judith C Gomersall

given: Judith C

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Middeldorp S. New studies of low-molecular-weight heparin in pregnancy. Thromb Res. 2015 Feb;135 Suppl 1:S26-9. doi: 10.1016/S0049-3848(15)50436-2. Epub 2015 Feb 9. Review.

family: Middeldorp

full_name: Saskia Middeldorp

given: Saskia

journal_name: Thrombosis Research

ReferenceCitation: Bleker SM, Coppens M, Middeldorp S. Sex, thrombosis and inherited thrombophilia. Blood Rev. 2014 May;28(3):123-33. doi: 10.1016/j.blre.2014.03.005. Epub 2014 Apr 1. Review.

family: Bleker

full_name: Suzanne M. Bleker

given: Suzanne M.

family: Coppens

full_name: Michiel Coppens

given: Michiel

journal_name: Blood Reviews

lead_sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_country:
United States
Netherlands
France
Norway
Ireland
Belgium
Russian Federation
Spain
Canada

location_facility: Weill Cornell Medicine | NewYork-Presbyterian

location_facility: Federal State Institution "Research Center for Obstetrics, Gynecology and Perinatology"


title: A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

acronym: Ro-CHOP

summary:
This study is an open label, multicenter study with two phases:

A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.
An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.

ReferenceCitation: Dupuis J, Morschhauser F, Ghesquières H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, Coiffier B. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015 Apr;2(4):e160-5. doi: 10.1016/S2352-3026(15)00023-X. Epub 2015 Mar 17.

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Tilly

full_name: Hervé Tilly

family: Casasnovas

full_name: Olivier Casasnovas

given: Olivier

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Bossard

full_name: Céline Bossard

given: Céline

family: Bras

full_name: Fabien Le Bras

given: Fabien Le

family: Bachy

full_name: Emmanuel Bachy

given: Emmanuel

family: Hivert

full_name: Bénédicte Hivert

given: Bénédicte

family: Nicolas-Virelizier

full_name: Emmanuelle Nicolas-Virelizier

given: Emmanuelle

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Bastie

full_name: Jean-Noel Bastie

given: Jean-Noel

family: Amorim

full_name: Sandy Amorim

given: Sandy

family: Lazarovici

full_name: Julien Lazarovici

given: Julien

family: Martin

full_name: Antoine Martin

given: Antoine

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

journal_name: The Lancet Haematology

location_facility:
Hôpital Henri Mondor
Centre Léon Bérard
Hôpital St Louis
CHU de Dijon
Hôpital Claude Huriez
Centre Hospitalier Lyon Sud
Centre Henri Becquerel
Institut Gustave Roussy


lead_sponsor: GlaxoSmithKline

location_country: Germany France

source: euctr

title: Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination

summary:
The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.

This protocol posting deals with objectives & outcome measures of the persistence and booster epochs. The objectives & outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)


title: Médulloblastome of the Child and After-effects Cognitive: Study Anatomo-functional by IRM of the Working Memory

acronym: MEDIR

summary:
The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school performances. By studying a troop of 32 children, we could show that the disorders of the working memory prevail during the handling of information presented visually and with verbal contents. However, the specific engagement of the cerebellum in the tasks of working memory according to the sensory method of presentation (visual or auditive) and the nature (verbal or not verbal) of information to treat vague remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in these children. The best comprehension of the bases anatomo-functional calculuses which underlie their cognitive deficits is essential to develop new strategies of treatment and rehabilitation.

Objectives:

To describe in IRMf of the common and specific networks engaged during the execution of the tasks of working memory according to the sensory type and the nature of information to be memorized.
To describe in IRMf the cortical reorganizations necessary to the execution of the mnemic tasks among patients.
To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and cerebral, cortical and subcortical associated with these disorders.
To study the correlations radio-private clinics between data IRM and the data neurological and neuropsychological of the children explored according to protocol ONCORAP

lead_sponsor: University Hospital, Grenoble

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Hôpital Frédéric Joliot Orsay - Hôpital Necker


title: Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes

acronym: TRIMECO

summary: Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transplantation.

ReferenceCitation: Alejandro R, Barton FB, Hering BJ, Wease S; Collaborative Islet Transplant Registry Investigators. 2008 Update from the Collaborative Islet Transplant Registry. Transplantation. 2008 Dec 27;86(12):1783-8. doi: 10.1097/TP.0b013e3181913f6a.

ReferenceCitation: Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems JA, Bretzel RG, Bertuzzi F, Froud T, Kandaswamy R, Sutherland DE, Eisenbarth G, Segal M, Preiksaitis J, Korbutt GS, Barton FB, Viviano L, Seyfert-Margolis V, Bluestone J, Lakey JR. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318-30.

ReferenceCitation: Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96.

ReferenceCitation: Vantyghem MC, Kerr-Conte J, Arnalsteen L, Sergent G, Defrance F, Gmyr V, Declerck N, Raverdy V, Vandewalle B, Pigny P, Noel C, Pattou F. Primary graft function, metabolic control, and graft survival after islet transplantation. Diabetes Care. 2009 Aug;32(8):1473-8. doi: 10.2337/dc08-1685.

ReferenceCitation: Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: an assessment of beta-cell function after islet transplantation. Diabetes Care. 2005 Feb;28(2):343-7.

ReferenceCitation: Bahougne T, Olagne J, Munch M, Braun-Parvez L, Chenard MP, Frémeaux-Bacchi V, Caillard S, Baltzinger P, Greget M, Kessler L, Moulin B. Atypical hemolytic and uremic syndrome due to C3 mutation in pancreatic islet transplantation: a case report. BMC Nephrol. 2020 Sep 19;21(1):405. doi: 10.1186/s12882-020-02062-7.

family: Bahougne

full_name: Thibault Bahougne

given: Thibault

family: Olagne

full_name: Jérome Olagne

given: Jérome

family: Munch

full_name: Marion Munch

given: Marion

family: Braun-Parvez

full_name: Laura Braun-Parvez

given: Laura

family: Chenard

full_name: Marie-Pierrette Chenard

given: Marie-Pierrette

family: Frémeaux-Bacchi

full_name: Véronique Frémeaux-Bacchi

given: Véronique

family: Caillard

full_name: Sophie Caillard

given: Sophie

family: Baltzinger

full_name: Philippe Baltzinger

given: Philippe

family: Greget

full_name: Michel Greget

given: Michel

family: Kessler

full_name: Laurence Kessler

given: Laurence

family: Moulin

full_name: Bruno Moulin

given: Bruno

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8:CD009966. doi: 10.1002/14651858.CD009966.pub3.

name: School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

name: Diabetes and Vascular Medicine Unit; Monash Health; Clayton Australia

family: Lo

full_name: Clement Lo

given: Clement

name: The George Institute for Global Health, UNSW; Sydney Australia

name: Department of Nephrology and Laboratory Medicine; Kanazawa University; Kanazawa Japan

name: Innovative Clinical Research Center (iCREK); Kanazawa University Hospital; Kanazawa Japan

family: Toyama

full_name: Tadashi Toyama

name: Melbourne Medical School; The University of Melbourne; Melbourne Australia

name: Department of Nephrology; Princess Alexandra Hospital; Woolloongabba Australia

name: Australasian Kidney Trials Network, Diamantina Institute; The University of Queensland; Brisbane Australia

name: Translational Research Institute; Brisbane Australia

ReferenceCitation: Lablanche S, Vantyghem MC, Kessler L, Wojtusciszyn A, Borot S, Thivolet C, Girerd S, Bosco D, Bosson JL, Colin C, Tetaz R, Logerot S, Kerr-Conte J, Renard E, Penfornis A, Morelon E, Buron F, Skaare K, Grguric G, Camillo-Brault C, Egelhofer H, Benomar K, Badet L, Berney T, Pattou F, Benhamou PY; TRIMECO trial investigators. Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):527-537. doi: 10.1016/S2213-8587(18)30078-0. Epub 2018 May 15.

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital Besançon, Department of Endocrinology

location_facility: University Hospital, Department of General Surgery and Endocrinology

location_facility: University Hospital Gabriel Montpied, Department of Endocrinology

location_facility: Hopitaux Universitaires de Genève, Department of Visceral Surgery and Transplant


title: Chimiodiet Study:Impact of Early and Active Nutritional and Dietary Management on grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer.

acronym: CHIMIODIET

summary:
Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist will be assigned to each research centre. She will cover active nutritional support during a one-hour consultation and assist the investigating oncologist in filling out the e-CRF data. A two-day meeting prior to the beginning of the study will enable the standardization of active nutritional support strategy across all research centres:

The nutritionist will explain the consequences of the side effects of chemotherapy on appetite levels and nutritional status.
Spontaneous oral intake and eating habits will be assessed based on a qualitative and quantitative 3-day food record.
Then the nutritionist will explain to patients how to adapt their diet (fortification, portion control etc.) according to personal preferences and dietary habits, appetite fluctuation and side effects.
A booklet containing an overview of the nutritional counsel, recipe ideas, an example of a daily menu, energy equivalence tables and specific diet and hygiene tips for each possible side effects of chemotherapy will be given to all patients.
During each consultation, patients will be weighed, appetite and food intake will be evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12, V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional counsel will be adapted to each patient's individual situation. In case of decrease in food intake and/or weight loss, a protein- and energy-rich oral supplement will be given.

In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month period or > 10% in total) and/or food intake less than 50% of estimated daily requirements, an oral supplement will be given after approval of the oncologist. If this measure is insufficient, artificial nutrition (enteral or parenteral) will be considered.

ReferenceCitation: 1. Situation du cancer en France en 2007 - Synthèses rapports INCa - http://www.e-cancer.fr 2.Dewys et al.,Pronostic effect of weight loss prior to CT in cancer patient. Am J.Med 1980; 69 (4): 491-7; 3. Étude Nutricancer 2005, Hébuterne et al, Nutr Clin Metabol 2006.4.Gupta D, Lis CG, Granick J, Grutsch JF, Vashi PG, Lammersfeld CA. Malnutrition associated with poor quality of life in CR cancer:retrospective analysis.J Clin Epidemiol 2006 Jul;59(7):704-9. Epub 2006 Apr 19. 5. Andreyev et al., Why do patients with weight loss have a worse outcome when undergoing CT for gastrointestinal malignancies, Eur J Cancer 1998 Mar; 34(4): 503-9;6. Schneider et al, Malnutrition is an independant factor associated with nosocomial infections, Br J Nutr 2004 Jul; 92(1): 105-11. 7.Tucker HN, Miquel SG. : cost containment through nutrition intervention. Nutr Rev 1996 Apr; 54: 111-21.8. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N et al . Gruppo Oncologico Dell'Italia Meridionale. Phase III randomized trial of FOLFIRI VS FOLFOX4 in the treatment of advanced CCR: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005 Aug 1;23(22):4866-75. Epub 2005 Jun 6.9. Douillard JY, Sobrero A, Carnaghi C, Comella P, Díaz-Rubio E, Santoro A et al. Metastatic CR cancer: integrating irinotecan into combination and sequential CT. Ann Oncol. 2003;14 Suppl 2:ii7-12. Review.10. Hurwitz HI, Fehrenbacher L, Hainsworth JD, Heim W, Berlin J, Holmgren E et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer.J Clin Oncol. 2005 May 20;23(15):3502-8.11. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory CR cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004 Apr 1;22(7):1201-8. Epub 2004 Mar 1

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre

location_facility: Assistance Publique des hopitaux de Marseille


title: Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals

summary: Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service MPR des Kermes - Hôpital René Sabran

location_facility: Groupe Hospitalier Raymond Poincaré - APHP

location_facility: Centre de Réadaptation fonctionnelle - UGECAM

location_facility: Centre de Rééducation de la Tour de Gassie

location_facility: Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape


title: Multicenter Prospective Study for a Rational Management of Appendicitis in Children

acronym: ALGAP

summary: Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. Evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.An algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. The main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.

location_facility:
WEIL Dominique
PETIT Thierry
AZZIS Olivier
GARIGNON Cynthia
LARDY Hubert
DE VRIES Philine
PODEVIN Guillaume
MCHEIK Jiad


title: An Open-label, Dose Escalating Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion

summary: The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

lead_sponsor: Fovea Pharmaceuticals SA

location_facility: Centre Hospitalier National d'Ophthalmologies des XV-XX


ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country: Germany France Spain

location_facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg

location_facility: Zentralinstitut fuer Seelische Gesundheit Mannheim

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

location_facility: Universitatsklinikum und Poliklinik der Uni Bonn

title: A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

summary: The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.


title: A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy

acronym: CIPN

summary: The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.

lead_sponsor: Hoffmann-La Roche

location_facility: Centre Léon Bérard Département de Soins de Support

location_facility: Centre Oscar Lambret Département de Sénologie

location_facility: Hôpital Nord CHU Saint Etienne Centre de la douleur

location_facility: Hôpital Privé de l'Ouest Parisien Service d'Oncologie

location_facility: C.R.L.C Val d'Aurelle Service d'Oncologie Médicale

location_facility: Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie


title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

summary:
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

lead_sponsor: Forest Laboratories

location_country:
Italy
Netherlands
France
Poland
Hungary
Belgium
Russian Federation
Spain
Germany

location_facility: Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii

location_facility: Service de cardiologie Hopitaux de Brabois/CHRU Nancy

location_facility: Centre Hospitalier General Hospital De Girac

location_facility: Servizio di Cardiologia Azienda Ospedaliera S. Anna

location_facility: Gottsegen Gyorgy National Institute of Cardiology

location_facility: Cardiovascular Disease Unit University of Bari-Ploiclinico

location_facility: County Hospital, Dept. of Internal Medicine

location_facility: Department Cardiology Canisius Wilhelmina Hospital

location_facility: Hospital Clinico Universitario San Carlos Servicio de Cardiologia

location_facility: S. Paolo Hospital University of Milan Department of Cardiology

location_facility: Cardiology Department St. Petersburg State Pavlov Medical University

location_facility: Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie

location_facility: Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies

location_facility: Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie

location_facility: Instytut Kardiologii CMUJ Klinika Choroby Wiencowej

location_facility: Klinika Kardiologii IV Wojskowy Szpital Kliniczny

location_facility: Service de Cardiologie Hopital Lariboisiere

location_facility: Franz-Volhard-Klinik Abteilung fur Elektrophysiologie

location_facility: Department of Internal Medicine (DIMI) University of Genova

location_facility: Ospedale Civile Umberto I Cardiology Division

location_facility: Service de Cardiologie Hopital Saint Philibert

location_facility: Cardiology Department St Petersburg Hospital No. 2

location_facility: Cardiology Department Moscow Sechenov Medical Academy

location_facility: Hospital Universitari San Juan Servicio di Cardiologia

location_facility: Cardiology Division Hospital "Santa Croce e Carle"

location_facility: Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie

location_facility: Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51

location_facility: Kerckhhoff-Klinik Abteilung Klinische Pharmakologie

location_facility: Wojewodzki Szpital Zespolony Oddzial Kardilolgii

location_facility: Erzgebirgskrankenhaus Klinik fur Innere Medizin

location_facility: Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny

location_facility: Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou

location_facility: Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64

location_facility: Klinkum Lippe-Detmold Med. Klink II-Kardiologie

location_facility: Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie

location_facility: Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela

location_facility: Myocardial Infarction Department St Elizabeth Hospital

location_facility: County Hospital, Dept. of Internal Medicine I.

location_facility: Universitate zu Koeln Klinik III fur Innere Medizin

location_facility: Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia

location_facility: Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia

location_facility: Gornoslaskie Centrum Medyczne I Klinika Kardiologii

location_facility: Cardiology Unit University of Naples "Frederico II"

location_facility: National Institiute of Pulmonology, Dept. of Cardiology

location_facility: Hospital Civil De Basurto Cardiology Service

location_facility: Radomski Szpital Specjalistyczny Oddzial Kardiologii

location_facility: Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii

location_facility: Oddzial Kardiologii Wojewodzkie Centrum Medyczne

location_facility: Cardiology Department, State Research Institute

location_facility: Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50

location_facility: Hospital Universitario De Getafe Cardiology Service

location_facility: Cardiology Department, Moscow Clinical Hospital No. 59

location_facility: Oddizial Kardiologii Szpital Wojewodzki nr 2

location_facility: Cardiologie CHRU St Etienne/Hopital Nord

location_facility: Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum

location_facility: Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva

location_facility: Medizinische Klinik und Poliklinik Innere Medizin C

location_facility: Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1

location_facility: Toldi Ferenc Hospital, Dept. of Internal Medicine II.

location_facility: Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie

location_facility: Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie

location_facility: Divisione di Cardiologia Ospedale Civile

location_facility: Medizinische Klinik und Poliklnik Innere Medizin C

location_facility: Oddizial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11

location_facility: Department of Emergency Cardiology Russian Cardiology Research Centre

location_facility: Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie

location_facility: Semmelweis University, Dept. of Internal Medicine III.

location_facility: Cardiology Department, St Petersburg Hospital, No. 15

location_facility: Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan

location_facility: Osp. Civile di Piacenza-Div. di Cardiologia

location_facility: Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I

location_facility: St Elisabeth Ziekenhuis Afdeling Cardiologie

location_facility: Cardilolgie Hopital Guillaume et Rene Laennec

location_facility: Clinique Generale Saint Jean Service de cardiologie

location_facility: Klinik am See REHA-Zentrum fur Herz und Kreislauf

location_facility: Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4

location_facility: Hospital Valle de Hebron Servicio de Cardiologia

location_facility: Reinhard-Nieter-Krankenhaus Med. Klinik 1

location_facility: Oddzial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Myocardial Infarction Department St Petersburg Hospital, No. 28

location_facility: Service de Cardiologie A Hopital Cardiologique

location_facility: Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48

location_facility: Markusovszky Hospital, Dept. of Internal Medicine III.

location_facility: Cardiology Department Alexandrovskiy Hospital

location_facility: Medizinische Universitats-und Ploiklinik Innere Medizin 3

location_facility: Fundacion Jimenez Diaz Cardiology Service

location_facility: Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute

location_facility: Academisch Ziekenhuis Maastricht Afdeling Cardiologie

location_facility: Department of Cardiology No. 3 Pokrovskiy Hospital

location_facility: I Klinika Chorob Serca Instytut Kardiologii AM

location_facility: Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29

location_facility: Myocardial Infarction Department St Petersburg Hodpital, No. 29

location_facility: Szent Imre Hospital, Dept. of Internal MedicineI.

location_facility: Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii


title: Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients

acronym: AQUARiUS

summary: The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).

ReferenceCitation: Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5.

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

family: Poulsen

full_name: Mads Hvid Poulsen

given: Mads Hvid

family: Lagneau

full_name: Edouard Lagneau

given: Edouard

family: Ploussard

full_name: Guillaume Ploussard

given: Guillaume

family: Birtle

full_name: Alison Birtle

given: Alison

family: Dourthe

full_name: Louis-Marie Dourthe

given: Louis-Marie

family: Beal-Ardisson

full_name: Dominique Beal-Ardisson

given: Dominique

family: Pintus

full_name: Elias Pintus

given: Elias

family: Trepiakas

full_name: Redas Trepiakas

given: Redas

family: Lefresne

full_name: Florence Lefresne

given: Florence

family: Lukac

full_name: Martin Lukac

given: Martin

family: Van Sanden

full_name: Suzy Van Sanden

given: Suzy

family: Pissart

full_name: Genevieve Pissart

given: Genevieve

family: Reid

full_name: Alison Reid

journal_name: European Urology

evidence: open (via crossref license)

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Denmark
United Kingdom
France


title: Phase II, Open-Label Study Evaluating Efficacy of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

summary: This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity

summary: To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.

name: Medical University of Vienna, Vienna, Austria, and National Institute of Rheumatology and Physiotherapy; Budapest; Hungary

family: Mandl

full_name: P. Mandl

given: P.

family: Balint

full_name: P. V. Balint

given: P. V.

family: Brault

full_name: Y. Brault

given: Y.

name: University Hospital Charité; Berlin; Germany

family: Backhaus

full_name: M. Backhaus

given: M.

name: Versailles-Saint Quentin en Yvelines University; AP-HP, Ambroise-Paré Hospital; Boulogne-Billancourt; France

family: D'Agostino

full_name: M. A. D'Agostino

given: M. A.

name: Università Politecnica delle Marche; Jesi; Ancona; Italy

family: Grassi

full_name: W. Grassi

given: W.

name: Leiden University Medical Center; Leiden; The Netherlands

family: van der Heijde

full_name: D. van der Heijde

given: D.

name: La Paz University Hospital; Madrid; Spain

family: de Miguel

full_name: E. de Miguel

given: E.

name: University of Leeds and Chapel Allerton Hospital; Leeds; UK

family: Wakefield

full_name: R. J. Wakefield

given: R. J.

family: Logeart

full_name: I. Logeart

given: I.

name: Paris-Descartes University; UPRES-EA 4058; AP-HP; Cochin Hospital; Paris; France

family: Dougados

full_name: M. Dougados

journal_name: Arthritis Care & Research

title: Clinical and Ultrasound-Based Composite Disease Activity Indices in Rheumatoid Arthritis: Results From a Multicenter, Randomized Study

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.

full_name: M.-A. D'Agostino

title: Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: Results of a multicenter, randomized study

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
United Kingdom
France
Poland
Hungary
Spain
Turkey
Germany
Czech Republic


ReferenceCitation: Campone M, Bachelot T, Treilleux I, Pistilli B, Salleron J, Seegers V, Arnedos M, Loussouarn D, Wang Q, Vanlemmens L, Jimenez M, Rios M, Diéras V, Leroux A, Paintaud G, Rezai K, André F, Lion M, Merlin JL. A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial). Eur J Cancer. 2021 Oct 19;158:169-180. doi: 10.1016/j.ejca.2021.09.017. [Epub ahead of print]

family: Campone

full_name: Mario Campone

given: Mario

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Treilleux

full_name: Isabelle Treilleux

given: Isabelle

family: Pistilli

full_name: Barbara Pistilli

given: Barbara

family: Salleron

full_name: Julia Salleron

given: Julia

family: Seegers

full_name: Valérie Seegers

given: Valérie

family: Arnedos

full_name: Monica Arnedos

given: Monica

family: Loussouarn

full_name: Delphine Loussouarn

given: Delphine

family: Wang

full_name: Qing Wang

given: Qing

family: Vanlemmens

full_name: Laurence Vanlemmens

given: Laurence

family: Jimenez

full_name: Marta Jimenez

given: Marta

family: Rios

full_name: Maria Rios

given: Maria

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Leroux

full_name: Agnès Leroux

given: Agnès

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: André

full_name: Fabrice André

given: Fabrice

family: Lion

full_name: Maëva Lion

given: Maëva

family: Merlin

full_name: Jean-Louis Merlin

given: Jean-Louis

journal_name: European Journal of Cancer

lead_sponsor: UNICANCER

acronym: RADHER

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

title: A Phase II, Randomized, Multi-center Study, Assessing Value of Adding Everolimus (RAD001) to Trastuzumab as Preoperative Therapy of HER-2 Positive Primary Breast Cancer Amenable to Surgery.

summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.


title: Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.

acronym: BEFIRTH

summary: An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hopital Paul Brousse
Hopital Pellegrin Tripode
Hôpital Pontchaillou
University Hospital
Hopital Saint-Eloi
Hopital de L'Archet
Hôpital Cochin
La CONCEPTION hospital


title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion

acronym: RTD

summary: In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

ReferenceCitation: Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245-50. doi: 10.2337/dc09-0750. Epub 2009 Sep 18.

family: Raccah

full_name: D. Raccah

given: D.

family: Sulmont

full_name: V. Sulmont

given: V.

family: Reznik

full_name: Y. Reznik

given: Y.

family: Guerci

full_name: B. Guerci

given: B.

family: Renard

full_name: E. Renard

given: E.

family: Hanaire

full_name: H. Hanaire

given: H.

family: Jeandidier

full_name: N. Jeandidier

given: N.

family: Nicolino

full_name: M. Nicolino

given: M.

journal_name: Diabetes Care

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Incremental Value of Continuous Glucose Monitoring When Starting Pump Therapy in Patients With Poorly Controlled Type 1 Diabetes: The RealTrend study

lead_sponsor: Medtronic Diabetes

location_facility:
American Memorial Hospital
Hôpitaux Universitaires de Strasbourg
Hôpital Jeanne D'Arc
CH La Peyronie
Hôpital Sainte Marguerite
Hôpital Universitaire Debrousse
CHU Rangueil
CHU Côte de Nacre


title: A Prospective Multicentric Randomized Study of Glivec® in Patients With Advanced Gastrointestinal Stromal Tumors Expressing C-kit Comparing Treatment Interruption After 5 Years vs Treatment Maintenance

summary: Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.

ReferenceCitation: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Pérol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13.

ReferenceCitation: Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Pérol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.

ReferenceCitation: Blesius A, Cassier PA, Bertucci F, Fayette J, Ray-Coquard I, Bui B, Adenis A, Rios M, Cupissol D, Pérol D, Blay JY, Le Cesne A. Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial. BMC Cancer. 2011 Feb 15;11:72. doi: 10.1186/1471-2407-11-72.

ReferenceCitation: Blay JY, Pérol D, Le Cesne A. Imatinib rechallenge in patients with advanced gastrointestinal stromal tumors. Ann Oncol. 2012 Jul;23(7):1659-65. doi: 10.1093/annonc/mdr622. Epub 2012 Feb 21. Review.

ReferenceCitation: Patrikidou A, Domont J, Chabaud S, Ray-Coquard I, Coindre JM, Bui-Nguyen B, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Pérol D, Emile JF, Blay JY, Le Cesne A; French Sarcoma Group. Long-term outcome of molecular subgroups of GIST patients treated with standard-dose imatinib in the BFR14 trial of the French Sarcoma Group. Eur J Cancer. 2016 Jan;52:173-80. doi: 10.1016/j.ejca.2015.10.069. Epub 2015 Dec 11.

family: Patrikidou

full_name: Anna Patrikidou

given: Anna

family: Domont

full_name: Julien Domont

given: Julien

family: Chabaud

full_name: Sylvie Chabaud

given: Sylvie

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Coindre

full_name: Jean-Michel Coindre

given: Jean-Michel

family: Bui-Nguyen

full_name: Binh Bui-Nguyen

given: Binh

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Bertucci

full_name: François Bertucci

given: François

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Pérol

full_name: David Pérol

given: David

family: Emile

full_name: Jean-François Emile

given: Jean-François

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

lead_sponsor: Centre Leon Berard

location_facility:
Hopitaux de La Timone
Centre Alexis Vautrin
Centre Oscar Lambret
Hopital Edouard Herriot
Institut Paoli Calmette
Centre Leon Berard
Institut Bergonié
Institut Gustave Roussy


title: First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Retraction--Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2011 Feb;12(2):116. doi: 10.1016/S1470-2045(11)70011-0.

ReferenceCitation: Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21.

ReferenceType: result

ReferenceCitation: Bonnefoi H, Piccart M, Bogaerts J, Mauriac L, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Blot E, Zaman K, Cufer T, Lortholary A, Lidbrink E, André S, Litière S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigators. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Lancet Oncol. 2011 Jun;12(6):527-39. doi: 10.1016/S1470-2045(11)70094-8. Epub 2011 May 11. Erratum in: Lancet Oncol. 2013 Feb;14(2):e47.

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Piccart

full_name: Martine Piccart

given: Martine

family: Bogaerts

full_name: Jan Bogaerts

given: Jan

family: Mauriac

full_name: Louis Mauriac

given: Louis

family: Fumoleau

full_name: Pierre Fumoleau

given: Pierre

family: Brain

full_name: Etienne Brain

given: Etienne

family: Petit

full_name: Thierry Petit

given: Thierry

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Blot

full_name: Emmanuel Blot

given: Emmanuel

family: Zaman

full_name: Khalil Zaman

given: Khalil

family: Cufer

full_name: Tanja Cufer

given: Tanja

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Lidbrink

full_name: Elisabet Lidbrink

given: Elisabet

family: André

full_name: Sylvie André

family: Litière

full_name: Saskia Litière

given: Saskia

family: Lago

full_name: Lissandra Dal Lago

given: Lissandra Dal

family: Becette

full_name: Véronique Becette

given: Véronique

family: Cameron

full_name: David A Cameron

given: David A

family: Bergh

full_name: Jonas Bergh

given: Jonas

family: Iggo

full_name: Richard Iggo

given: Richard

journal_name: The Lancet Oncology

oa_host_type: repository

ReferenceCitation: Bonnefoi HR, Bogaerts J, Piccart M, et al.: Phase III trial (EORTC 10994/BIG 00-01) assessing the value of p53 using a functional assay to predict sensitivity to a taxane versus nontaxane primary chemotherapy in breast cancer: final analysis. [Abstract] J Clin Oncol 28 (Suppl 18): A-LBA503, 2010.

ReferenceCitation: Collingridge D. Expression of concern--validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2010 Sep;11(9):813-4. doi: 10.1016/S1470-2045(10)70185-6. Epub 2010 Jul 26.

title: Expression of concern—validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial

ReferenceCitation: Bonnefoi H, Zimmer AS, Piccart M, et al.: P53 functional assay in yeast: evaluation in 1856 patients in a large prospective clinical trial: EORTC 10994/BIG 00-01. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1067, 2008.

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2007 Dec;8(12):1071-1078. doi: 10.1016/S1470-2045(07)70345-5. Epub 2007 Nov 19. Retraction in: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Lancet Oncol. 2011 Feb;12(2):116.

title: RETRACTED: Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial

ReferenceCitation: Karina M, Bogaerts J, Piccart M, et al.: Preliminary safety data of the EORTC 10994/BIG 00-01 neoadjuvant trial comparing 3 cycles of docetaxel followed by 3 cycles of epirubicin-docetaxel versus 6 cycles of FEC 100 in patients with locally advanced/inflammatory or large operable breast cancer. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3067, S146-7, 2006.

ReferenceCitation: Bonnefoi H, Farmer P, Delorenzi M, et al.: Is there a regimen-specific gene signature predicting for pathological complete response after neoadjuvant chemotherapy in hormone-negative breast cancer patients? A microarray substudy of 101 patients included in EORTC 10994/BIG 00-01 trial. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.

ReferenceCitation: Farmer P, Iggo R, Becette V, et al.: High quality gene expression microarray data from a multicentre prospective trial: results of the first microarray analysis in the EORTC 10994/ BIG 00-01 study. [Abstract] Eur J Cancer 2 (Suppl 3): A-155, 99, 2004.

ReferenceCitation: Chatzipli A, Bonnefoi H, MacGrogan G, Sentis J, Cameron D, Poncet C; EORTC 10994/BIG 1-00 Consortium, Iggo R. Patterns of genomic change in residual disease after neoadjuvant chemotherapy for estrogen receptor-positive and HER2-negative breast cancer. Br J Cancer. 2021 Nov;125(10):1356-1364. doi: 10.1038/s41416-021-01526-3. Epub 2021 Sep 3.

ReferenceCitation: Bonnefoi H, Litière S, Piccart M, MacGrogan G, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Moldovan C, Bodmer A, Zaman K, Cufer T, Campone M, Luporsi E, Malmström P, Werutsky G, Bogaerts J, Bergh J, Cameron DA; EORTC 10994/BIG 1-00 Study investigators. Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Ann Oncol. 2014 Jun;25(6):1128-36. doi: 10.1093/annonc/mdu118. Epub 2014 Mar 11.

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

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL
reroDoc Digital Library

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

location_country:
Sweden
Switzerland
Netherlands
United Kingdom
Poland
France
Belgium
Portugal
Slovenia

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Swiss Institute for Applied Cancer Research

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Sahlgrenska University Hospital - Molndal at Gothenburg University

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

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

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Karolinska University Hospital - Huddinge

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology


title: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.

acronym: FIRST

summary:
The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms.

All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study.

The patient's inclusion and follow up in the study will occur as part of their usual standard of care.

lead_sponsor: Balt Extrusion

location_country: Italy Austria Netherlands Croatia France Israel Belgium Spain Germany

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospices Civils de Lyon - Hôpital Neurologique


title: A Single-Arm, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of Necitumumab in Combination With Abemaciclib in Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

summary: This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV non-small-cell lung cancer).

lead_sponsor: Eli Lilly and Company

location_country: Belgium France Spain

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

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


title: BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

acronym: BIOFLOW-III

summary: This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

ReferenceCitation: Toelg R, Slagboom T, Waltenberger J, Lefèvre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

name: HerzzentrumSegeberger Kliniken GmbH Bad Segeberg Germany

family: Toelg

full_name: Ralph Toelg

given: Ralph

name: HeartcenterOLVG Amsterdam The Netherlands

family: Slagboom

full_name: Ton Slagboom

given: Ton

name: Klinik für Innere Med. ISRH Zentralklinikum Suhl gGmbH Suhl Germany

family: Waltenberger

full_name: Johannes Waltenberger

given: Johannes

name: Hospital Privé Jacques Cartier Massy France

family: Lefèvre

full_name: Thierry Lefèvre

name: Department of CardiologyOkinawa Tokushukai Shonan Kamakura General Hospital Kamakura Japan

family: Saito

full_name: Shigeru Saito

given: Shigeru

name: Piedmont Heart Institute Atlanta Georgia USA

family: Kandzari

full_name: David E. Kandzari

given: David E.

name: Catharina Hospital Eindhoven The Netherlands

family: Koolen

full_name: Jacques Koolen

given: Jacques

family: Richardt

full_name: Gert Richardt

given: Gert

journal_name: Catheterization and Cardiovascular Interventions

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Fröbert O, Seige M, Friedrich G, Erglis A, Winkens M, Hegeler-Molkewehrum C, Neef M, Hoffmann S; BIOFLOW-III Investigators. Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent. Cardiovasc Revasc Med. 2020 Jan;21(1):63-69. doi: 10.1016/j.carrev.2019.03.004. Epub 2019 Mar 15.

family: Brachmann

full_name: Johannes Brachmann

family: van der Heyden

full_name: Jan van der Heyden

given: Jan

family: Fröbert

full_name: Ole Fröbert

given: Ole

family: Seige

full_name: Markus Seige

given: Markus

family: Friedrich

full_name: Guy Friedrich

given: Guy

family: Erglis

full_name: Andrejs Erglis

given: Andrejs

family: Winkens

full_name: Mark Winkens

given: Mark

family: Hegeler-Molkewehrum

full_name: Christian Hegeler-Molkewehrum

given: Christian

family: Neef

full_name: Martin Neef

given: Martin

family: Hoffmann

full_name: Stefan Hoffmann

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Fröbert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, Klein N, Hoffmann S; BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016 Feb;11(10):1106-10. doi: 10.4244/EIJY15M03_08.

location_country:
Italy
Austria
Chile
Sweden
Switzerland
Netherlands
Spain
United Kingdom
France
Portugal
Denmark
Germany
Latvia

location_facility: Riga Eastern Clinical University Hospital

location_facility: Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland

location_facility: Uniklinik Heidelberg, Medizinische Uniklinik

location_facility: HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin

location_facility: Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I

location_facility: Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata

location_facility: Klinikum Landshut-Achdorf Medizinische Klinik I

location_facility: Universitetssjukhuset Oerebro, Kardiologiska Kliniken

location_facility: Pauls Stradins Clinical University Hospital


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

lead_sponsor: GlaxoSmithKline

location_country: Germany Canada France

title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

summary: This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.