ReferenceCitation: Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.

name: Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.

family: Schaepelynck

full_name: Pauline Schaepelynck

given: Pauline

name: Department of Diabetes and Endocrinology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.

family: Riveline

full_name: Jean-Pierre Riveline

name: Department of Endocrinology, Diabetes, Nutrition and CIC INSERM 1411, Montpellier University Hospital, Montpellier, France.

name: Institute of Functional Genomics, UMR CNRS 5203/INSERM U661, University of Montpellier I, Montpellier, France.

family: Renard

full_name: Eric Renard

given: Eric

name: Department of Cardiovascular Diseases and Metabolic Disorders, Division of Endocrinology, Diabetes and Nutrition, Toulouse University Hospital, University of Toulouse, Toulouse, France.

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

name: Department of Diabetes, Metabolic Disorders and Nutrition, Nancy University Hospital, Brabois Hospital, Vandoeuvre les Nancy, France.

family: Guerci

full_name: Bruno Guerci

given: Bruno

name: Department of Endocrinology, Diabetes and Metabolic Disorders, Dijon University Hospital, Dijon, France.

family: Baillot-Rudoni

full_name: Sabine Baillot-Rudoni

given: Sabine

name: Department of Diabetes, Paris University Hospital, Hôtel-Dieu Hospital, Paris, France.

family: Sola-Gazagnes

full_name: Agnès Sola-Gazagnes

given: Agnès

name: Department of Endocrinology, Bordeaux University Hospital, Pessac, France.

family: Catargi

full_name: Bogdan Catargi

given: Bogdan

name: Department of Endocrinology and Diabetes, Lille University Hospital, Lille, France.

family: Fontaine

full_name: Pierre Fontaine

name: Department of Endocrinology, Diabetes and Metabolism, Saint Etienne University Hospital, Saint-Etienne, France.

family: Millot

full_name: Luc Millot

given: Luc

name: Department of Diabetes, Le Mans Hospital, Le Mans, France.

full_name: Jean-François Martin

given: Jean-François

family: Tachouaft

full_name: Hocine Tachouaft

given: Hocine

name: Department of Endocrinology Diabetology, Nutrition and Addictology, Strasbourg University Hospital, Strasbourg, France.

family: Jeandidier

full_name: Nathalie Jeandidier

given: Nathalie

journal_name: Diabetes Technology & Therapeutics

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Assessment of a New Insulin Preparation for Implanted Pumps Used in the Treatment of Type 1 Diabetes

lead_sponsor: Sanofi

location_country: Sweden Belgium France Netherlands

location_facility:
Investigational Site Number 250-003
Investigational Site Number 056-001
Investigational Site Number 752-001
Investigational Site Number 250-004
Investigational Site Number 250-009
Investigational Site Number 250-010
Investigational Site Number 250-002
Investigational Site Number 528003
Investigational Site Number 250-011
Investigational Site Number 250-005
Investigational Site Number 250-001
Investigational Site Number 250-006
Investigational Site Number 528002
Investigational Site Number 250-007
Investigational Site Number 528001
Investigational Site Number 250-012
Investigational Site Number 250-008

title: Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml

summary:
Primary Objective:

To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).

Secondary Objective:

To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases


type: Other Identifier

title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

summary: The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Janssen-Cilag International NV

location_country:
Italy
France
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Centre Medico Psychologique Le Rembrandt

location_facility: Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet

location_facility: Centre Médico Psychologique De Courbevoie

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register

summary:
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).

This study aims to assess performance, clinical outcomes and safety

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Medicrea International

location_country: Belgium France

location_facility:
Centre Orthopédique Santy
Saint Etienne Hospital
CH WAPI
Hopitaux pediatriques - CHU Lenval
Polyclinique
Hopital la Timone
CHU Estaing
Hopital Trousseau
Hopital Saint Philibert
Orthopôle
La pitié Salepetrière Hospital
Les Massues

intervention_type: Device

status_simplified: Ongoing


title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

summary:
Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

Progression Free Survival
Overall Survival
Response Duration

study_type: Interventional

primary_purpose: Treatment

location_country: Austria Norway France

location_facility:
Investigational Site Number 250003
Investigational Site Number 250004
Investigational Site Number 250011
Investigational Site Number 040002
Investigational Site Number 250005
Investigational Site Number 250008
Investigational Site Number 250006
Investigational Site Number 250002
Investigational Site Number 250009
Investigational Site Number 250010
Investigational Site Number 250001
Investigational Site Number 250007
Investigational Site Number 578001


title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

summary:
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.

status: Terminated

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taillé S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-9. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.

family: Lellouche

full_name: François Lellouche

given: François

sequence: first

family: L’Her

full_name: E. L’Her

given: E.

sequence: additional

family: Abroug

full_name: F. Abroug

given: F.

family: Deye

full_name: N. Deye

given: N.

family: Rodriguez

full_name: P. O. Rodriguez

given: P. O.

family: Rabbat

full_name: A. Rabbat

given: A.

family: Jaber

full_name: S. Jaber

given: S.

family: Fartoukh

full_name: M. Fartoukh

given: M.

family: Conti

full_name: G. Conti

given: G.

family: Cracco

full_name: C. Cracco

given: C.

family: Richard

full_name: J. C. Richard

given: J. C.

family: Ricard

full_name: J. D. Ricard

given: J. D.

family: Mal

full_name: H. Mal

given: H.

family: Mentec

full_name: H. Mentec

family: Loisel

full_name: F. Loisel

family: Lacherade

full_name: J. C. Lacherade

family: Taillé

full_name: S. Taillé

family: Brochard

full_name: L. Brochard

given: L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Italy Canada Tunisia France

location_facility: Réanimation pneumologique, Hôpital Pitié Salpétrière

location_facility: Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi

location_facility: Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy

location_facility: Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli

location_facility: Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon

location_facility: Réanimation Polyvalente - CHU Fatima Bourguiba

location_facility: Département d'Anesthésie - Hôpital de l'Enfant Jésus

location_facility: Réanimation Médicale, Hôpital Charles Nicolle

location_facility: Réanimation Médicale - Hôpital Louis Mourier

location_facility: Réanimation du Service Pneumologie - Hôtel Dieu

lead_sponsor_type: academique

status_simplified: Unknown


title: Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)

summary: This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma

ReferenceType: background

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. Epub 2005 May 2.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Brière J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. Epub 2003 Aug 14.

ReferenceCitation: Ghesquières H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

name: Department of Hematology; Centre Hospitalier Lyon Sud; Pierre-Bénite France

name: Centre de Recherche en Cancérologie de Lyon - INSERM U 1052/CNRS UMR 5286/Centre Léon Bérard; Lyon France

name: Department of Health Sciences Research; Mayo Clinic; Rochester MN USA

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Larrabee

full_name: Beth R. Larrabee

given: Beth R.

name: Lymphoid Malignancies Unit, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP) and University Paris Est; Créteil France

family: Haioun

full_name: Corinne Haioun

given: Corinne

name: Holden Comprehensive Cancer Center; University of Iowa; Iowa City IA USA

family: Link

full_name: Brian K. Link

given: Brian K.

family: Verney

full_name: Aurélie Verney

given: Aurélie

family: Slager

full_name: Susan L. Slager

given: Susan L.

name: Department of Oncology; University Hospital; Lausanne Switzerland

family: Ketterer

full_name: Nicolas Ketterer

given: Nicolas

name: Division of Hematology, Department of Internal Medicine; Mayo Clinic; Rochester MN USA

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

name: Department of Hematology; Necker Hospital; Paris France

family: Delarue

full_name: Richard Delarue

given: Richard

family: Maurer

full_name: Matthew J. Maurer

given: Matthew J.

name: Onco-Hematology, Polyclinique Bordeaux-Nord; Bordeaux France

family: Fitoussi

full_name: Olivier Fitoussi

given: Olivier

family: Habermann

full_name: Thomas M. Habermann

given: Thomas M.

name: Medical Oncology, Centre Antoine Lacassagne; Nice France

family: Peyrade

full_name: Fréderic Peyrade

given: Fréderic

name: Departments of Pathology and Laboratory Medicine; Memorial Sloan Kettering Cancer Center; New York NY USA

family: Dogan

full_name: Ahmet Dogan

given: Ahmet

name: Department of Pathology; Necker Hospital; Paris France

family: Molina

full_name: Thierry J. Molina

given: Thierry J.

family: Novak

full_name: Anne J. Novak

given: Anne J.

name: Department of Hematology; Centre Henri Becquerel; Rouen France

family: Tilly

full_name: Hervé Tilly

family: Cerhan

full_name: James R. Cerhan

given: James R.

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: Hematological Oncology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: FCGR3A /2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts

ReferenceCitation: Copie-Bergman C, Cuillière-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

name: Assistance Publique–Hôpitaux de Paris, Groupe Henri Mondor–Albert Chenevier, Département de Pathologie, Creteil, France;

name: Universite Paris-Est, Faculté de Médecine, Unité Mixte de Recherche Scientifique 955, Créteil, France;

name: Institut Gustave Roussy, Villejuif, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Department of Pathology, Institut Universitaire d’Hématologie, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Hematology, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Pathology, Université Paris Descartes, Paris, France;

name: Hospices Civils de Lyon, Université Claude Bernard Lyon-1, Service d’Hématologie, Unité Mixte de Recherche 5239, Centre National de la Recherche Scientifique, Lyon, France;

name: Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, EA2406, Bordeaux, France;

name: Assistance Publique–Hôpitaux de Paris, Groupe Henri Mondor-Albert Chenevier, Unité Lymphoïde, Créteil, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Antoine, Department of Pathology, Paris, France;

name: Service d’Hématologie, Institut Universitaire du Cancer, Toulouse, France;

name: Department of Pathology, Hôpital Maisonneuve-Rosemont, Montreal, Canada;

name: Pluridisciplinary Center for Oncology, University Hospital–Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland;

name: Centre de Lutte Contre le Cancer de Nice, Nice, France;

name: Institute of Human Genetics, Christian-Albrechts-University Kiel and University Hospital Schleswig-Holstein, Kiel, Germany;

name: Centre Henri Becquerel and INSERM Unité 918, Institut de Recherche et d'Innovation Biomédicale, Rouen, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Biostatistics, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Pathology, Université Paris Descartes, EA 7324, Paris, France

ReferenceCitation: Fitoussi O, Belhadj K, Mounier N, Parrens M, Tilly H, Salles G, Feugier P, Ferme C, Ysebaert L, Gabarre J, Herbrecht R, Janvier M, Van Den Neste E, Morschhauser F, Casasnovas O, Ghesquieres H, Anglaret B, Brechignac S, Haioun C, Gisselbrecht C. Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA. Haematologica. 2011 Aug;96(8):1136-43. doi: 10.3324/haematol.2010.038109. Epub 2011 May 5.

publisher: Ferrata Storti Foundation (Haematologica)

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease

acronym: SKY

summary: The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

lead_sponsor: ApoPharma

location_country:
Germany
Canada
United Kingdom
France

location_facility: CHU de Bordeaux, Centre Expert Parkinson

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro


lead_sponsor: Pierre Fabre Medicament

primary_purpose: Prevention

location_country: Estonia Latvia France Lithuania

type: EudraCT Number

source: euctr

title: Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction

summary: The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.


title: Intracranial Aneurysms Treatment With the OPTIMA Coil System

acronym: INSTANT

summary: International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy

lead_sponsor: Balt Extrusion

location_country: Italy Austria Switzerland France Spain Germany Latvia

location_facility: HUG Hôpital cantonal universitaire de geneva

location_facility: CHU de Brest - Hôpital La Cavale Blanche

location_facility: Hospices Civils de Lyon - Hôpital Neurologique

location_facility: University of Latvia, Faculty of Medicine


ReferenceCitation: Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hébuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

family: Atreya

full_name: Raja Atreya

given: Raja

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Klymenko

full_name: Andrii Klymenko

given: Andrii

family: Augustyn

full_name: Monica Augustyn

given: Monica

family: Bakulin

full_name: Igor Bakulin

given: Igor

family: Slankamenac

full_name: Dusan Slankamenac

given: Dusan

family: Miheller

full_name: Pal Miheller

given: Pal

family: Gasbarrini

full_name: Antonio Gasbarrini

given: Antonio

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

family: Arnesson

full_name: Karin Arnesson

given: Karin

family: Knittel

full_name: Thomas Knittel

given: Thomas

family: Kowalski

full_name: Jan Kowalski

given: Jan

family: Neurath

full_name: Markus F Neurath

given: Markus F

family: Sandborn

full_name: William J Sandborn

given: William J

family: Reinisch

full_name: Walter Reinisch

given: Walter

journal_name: The Lancet Gastroenterology & Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: InDex Pharmaceuticals

location_country:
Sweden
Serbia
France
Czechia
Poland
Hungary
Russian Federation
Spain
Germany
Ukraine

acronym: CONDUCT

title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

summary: The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.


title: Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

summary: This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

time_perspective: Retrospective

lead_sponsor: Ipsen

location_country:
Italy
France
Czechia
Turkey
Germany
United Kingdom

location_facility: Klinikum der Johann Wolfgang, Goethe-Universität

location_facility: İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi

location_facility: Groupement hôspitalier est Federation d'endocrinologie.


title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study

acronym: Maverick

summary: The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

lead_sponsor: Medtronic Spinal and Biologics

location_country: Germany Canada France

location_facility: CH Antoine Béclère - Service de Chirurgie Orthopédique

location_facility: Clinique de Neurochirurgie Hôpital Roger Salengro

location_facility: Praxis für Orthopädie und Neurochirurgie Potsdam

location_facility: CH Lariboisière, Service de Neurochirurgie

location_facility: CH de Meulan - Service de Chirurgie Orthopédique

location_facility: Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon

intervention_type: Procedure


title: A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

summary: This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Austria
Netherlands
France
Germany
United Kingdom


title: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

summary:
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

ReferenceCitation: Romera I, Pérez V, Menchón JM, Schacht A, Papen R, Neuhauser D, Abbar M, Svanborg P, Gilaberte I. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol. 2012 Aug;32(4):479-86. doi: 10.1097/JCP.0b013e31825d9958.

family: Romera

full_name: Irene Romera

given: Irene

family: Pérez

full_name: Victor Pérez

given: Victor

family: Menchón

full_name: Jose Manuel Menchón

given: Jose Manuel

family: Schacht

full_name: Alexander Schacht

given: Alexander

family: Papen

full_name: Rita Papen

given: Rita

family: Neuhauser

full_name: Doris Neuhauser

given: Doris

family: Abbar

full_name: Mocrane Abbar

given: Mocrane

family: Svanborg

full_name: Pär Svanborg

given: Pär

family: Gilaberte

full_name: Inmaculada Gilaberte

given: Inmaculada

journal_name: Journal of Clinical Psychopharmacology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Early Switch Strategy in Patients With Major Depressive Disorder

lead_sponsor: Eli Lilly and Company

location_country: Italy Sweden Netherlands France Greece Romania Hungary Spain Turkey Denmark Slovenia

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: Sensitivity of Echography in Arthritis

acronym: SEA

summary:
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).

An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).

It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.

In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.

Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chalès G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.

family: Cheung

full_name: Peter P Cheung

given: Peter P

family: Mari

full_name: Karine Mari

given: Karine

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Jousse-Joulin

full_name: Sandrine Jousse-Joulin

given: Sandrine

family: D'Agostino

full_name: Maria Antonietta D'Agostino

given: Maria Antonietta

family: Chalès

full_name: Gérard Chalès

given: Gérard

family: Gaudin

full_name: Philippe Gaudin

given: Philippe

family: Mariette

full_name: Xavier Mariette

family: Saraux

full_name: Alain Saraux

given: Alain

family: Dougados

full_name: Maxime Dougados

given: Maxime

currency_apc_doaj: GBP

journal_name: RMD Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
CHU de RENNES - Hôpital Sud
CHU-Brugmann
CHU de la Cavale Blanche
CHU A. Michallon
Hôpital Cochin
Hôpital de la Pitié
Hôpital Ambroise Paré
Hôpital Bicêtre
CHU Nancy-Brabois
CHU Côte de Nacre


title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

summary: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

ipd_sharing: Yes

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:
France
Greece
Norway
Russian Federation
Estonia
Germany
United Kingdom

intervention_type: Biological


title: Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 0)

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205.

ReferenceCitation: Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6.

name: Assistance Publique–Hôpitaux de Paris, Groupe Henri Mondor–Albert Chenevier, Département de Pathologie, Creteil, France;

name: Universite Paris-Est, Faculté de Médecine, Unité Mixte de Recherche Scientifique 955, Créteil, France;

family: Copie-Bergman

full_name: Christiane Copie-Bergman

given: Christiane

family: Cuillière-Dartigues

full_name: Peggy Cuillière-Dartigues

given: Peggy

family: Baia

full_name: Maryse Baia

given: Maryse

family: Briere

full_name: Josette Briere

given: Josette

family: Delarue

full_name: Richard Delarue

given: Richard

family: Canioni

full_name: Danielle Canioni

given: Danielle

family: Salles

full_name: Gilles Salles

given: Gilles

family: Parrens

full_name: Marie Parrens

given: Marie

family: Belhadj

full_name: Karim Belhadj

given: Karim

family: Fabiani

full_name: Bettina Fabiani

given: Bettina

family: Recher

full_name: Christian Recher

given: Christian

family: Petrella

full_name: Tony Petrella

given: Tony

family: Ketterer

full_name: Nicolas Ketterer

given: Nicolas

family: Peyrade

full_name: Frederic Peyrade

given: Frederic

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Nagel

full_name: Inga Nagel

given: Inga

family: Siebert

full_name: Reiner Siebert

given: Reiner

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Leroy

full_name: Karen Leroy

given: Karen

family: Jais

full_name: Jean-Philippe Jais

given: Jean-Philippe

family: Tilly

full_name: Herve Tilly

given: Herve

family: Molina

full_name: Thierry Jo Molina

given: Thierry Jo

title: MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Centre Pluridisciplinaire d'Oncologie, CHUV

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI).

ReferenceCitation: Dumontet C, Mounier N, Munck JN, Bosly A, Morschauser F, Simon D, Marit G, Casasnovas O, Reman O, Molina T, Reyes F, Coiffier B. Factors predictive of early death in patients receiving high-dose CHOP (ACVB regimen) for aggressive non-Hodgkin's lymphoma: a GELA study. Br J Haematol. 2002 Jul;118(1):210-7.

name: Department of Hematology; Centre Hospitalier Lyon Sud; Pierre-Bénite France

name: Centre de Recherche en Cancérologie de Lyon - INSERM U 1052/CNRS UMR 5286/Centre Léon Bérard; Lyon France

name: Department of Health Sciences Research; Mayo Clinic; Rochester MN USA

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Larrabee

full_name: Beth R. Larrabee

given: Beth R.

name: Lymphoid Malignancies Unit, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP) and University Paris Est; Créteil France

name: Holden Comprehensive Cancer Center; University of Iowa; Iowa City IA USA

family: Link

full_name: Brian K. Link

given: Brian K.

family: Verney

full_name: Aurélie Verney

given: Aurélie

family: Slager

full_name: Susan L. Slager

given: Susan L.

name: Department of Oncology; University Hospital; Lausanne Switzerland

name: Division of Hematology, Department of Internal Medicine; Mayo Clinic; Rochester MN USA

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

name: Department of Hematology; Necker Hospital; Paris France

family: Delarue

full_name: Richard Delarue

given: Richard

family: Maurer

full_name: Matthew J. Maurer

given: Matthew J.

name: Onco-Hematology, Polyclinique Bordeaux-Nord; Bordeaux France

family: Fitoussi

full_name: Olivier Fitoussi

given: Olivier

family: Habermann

full_name: Thomas M. Habermann

given: Thomas M.

name: Medical Oncology, Centre Antoine Lacassagne; Nice France

full_name: Fréderic Peyrade

given: Fréderic

name: Departments of Pathology and Laboratory Medicine; Memorial Sloan Kettering Cancer Center; New York NY USA

family: Dogan

full_name: Ahmet Dogan

given: Ahmet

name: Department of Pathology; Necker Hospital; Paris France

full_name: Thierry J. Molina

given: Thierry J.

family: Novak

full_name: Anne J. Novak

given: Anne J.

name: Department of Hematology; Centre Henri Becquerel; Rouen France

full_name: Hervé Tilly

family: Cerhan

full_name: James R. Cerhan

given: James R.

name: Institut Gustave Roussy, Villejuif, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Department of Pathology, Institut Universitaire d’Hématologie, Paris, France;

ReferenceCitation: Molina TJ, Canioni D, Copie-Bergman C, Recher C, Brière J, Haioun C, Berger F, Fermé C, Copin MC, Casasnovas O, Thieblemont C, Petrella T, Leroy K, Salles G, Fabiani B, Morschauser F, Mounier N, Coiffier B, Jardin F, Gaulard P, Jais JP, Tilly H. Young patients with non-germinal center B-cell-like diffuse large B-cell lymphoma benefit from intensified chemotherapy with ACVBP plus rituximab compared with CHOP plus rituximab: analysis of data from the Groupe d'Etudes des Lymphomes de l'Adulte/lymphoma study association phase III trial LNH 03-2B. J Clin Oncol. 2014 Dec 10;32(35):3996-4003. doi: 10.1200/JCO.2013.54.9493. Epub 2014 Nov 10.

name: Thierry Jo Molina, Danielle Canioni, and Jean-Philippe Jais, Assistance Publique–Hôpitaux de Paris (AP-HP), Necker Enfants-Malades, Université Paris Descartes, EA 7324, Sorbonne Paris Cité; Josette Brière and Catherine Thieblemont, AP-HP, Saint-Louis, Université Paris Diderot, Sorbonne Paris Cité; Catherine Thieblemont, L'Institut National de la Santé et de la Recherche Médicale (INSERM) U728; Bettina Fabiani, AP-HP, Saint-Antoine, Paris; Christiane Copie-Bergman, Corinne Haioun, Karen Leroy, and...

publisher: American Society of Clinical Oncology (ASCO)

title: Young Patients With Non–Germinal Center B-Cell–Like Diffuse Large B-Cell Lymphoma Benefit From Intensified Chemotherapy With ACVBP Plus Rituximab Compared With CHOP Plus Rituximab: Analysis of Data From the Groupe d'Etudes des Lymphomes de l'Adulte/Lymphoma Study Association Phase III Trial LNH 03-2B

ReferenceCitation: Récher C, Coiffier B, Haioun C, Molina TJ, Fermé C, Casasnovas O, Thiéblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquières H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.

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

repository_institution: University of Liège - Open Repository and Bibliography

location_facility: Groupe d'étude des lymphomes de l'adulte


title: Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

ReferenceCitation: Huguet F, André T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31.

ReferenceType: result

ReferenceCitation: Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, André T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.

family: Afchain

full_name: P. Afchain

given: P.

family: Chibaudel

full_name: B. Chibaudel

given: B.

family: Lledo

full_name: G. Lledo

given: G.

family: Selle

full_name: F. Selle

given: F.

family: Bengrine-Lefevre

full_name: L. Bengrine-Lefevre

given: L.

family: Nguyen

full_name: S. Nguyen

given: S.

family: Paitel

full_name: J.-F. Paitel

family: Mineur

full_name: L. Mineur

family: Artru

full_name: P. Artru

family: André

full_name: T. André

given: T.

family: Louvet

full_name: C. Louvet

given: C.

journal_name: Bulletin du Cancer

ReferenceCitation: Louvet C, André T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
Centre Paul Papin
Hopital Saint Antoine
Hopital Drevon
Centre Hospitalier Victor Dupouy
Hopital Beaujon
American Hospital of Paris
Institut Jules Bordet
Hopital Tenon
Clinique Saint Jean


title: Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation

acronym: MARSHALL-PLAN

summary: In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan).

lead_sponsor: University Hospital, Bordeaux

location_facility:
Clermont-Ferrand University Hospital
Centre Cardiologique du Nord
Ambroise Paré Hospital
Toulouse University Hospirtal
Clinique Pasteur
AZ Sint Jan Brugge
Clinique Saint Augustin
Bordeaux University Hospital
Les Franciscaines Hospital


title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

summary: The aim of the investigation was to investigate the performance and safety of a new ostomy product.

primary_purpose: Supportive Care

lead_sponsor: Coloplast A/S

location_country:
France
Norway
Denmark
Germany
United Kingdom

location_facility: Sanitäts- und gesundheitshaus Carqueville GmbH


title: Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis

acronym: BASALT

summary: The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.

lead_sponsor: University Hospital, Limoges

location_facility: Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou

location_facility: Service de Pneumologie - CHU de Strasbourg

location_facility: Service de Pneumologie - Phtisiologie - Hôpital Bichat


title: Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

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

PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.

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

location_country: Italy Austria Switzerland Netherlands France Greece Israel Portugal

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Schneider Children's Medical Center of Israel


title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

summary: The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
United States
France

location_facility: The University Of Texas MD Anderson Cancer Center


title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation

summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

ReferenceCitation: Jaïs P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clémenty J, Haïssaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24. Erratum in: Circulation. 2009 Sep 8;120(10):e83.

name: From the Hôpital Cardiologique du Haut-Lévêque, Bordeaux-Pessac, France (P.J., M.H., F.S., P.B., J.C., M.H.); Hôpital Larriboisière, Paris, France (B.C., F.E.); Montreal Heart Institute, Montreal, Canada (L.M., P.K.); Richard M. Ross Heart Hospital, Columbus, Ohio (E.D.); Department of Cardiology, St. Vincent’s Hospital, Sydney, Australia (R.S.); University Hospital, London, Canada (G.K.); and University of Western Australia, Crawley, Western Australia (R.W.).

family: Jaïs

full_name: Pierre Jaïs

given: Pierre

family: Cauchemez

full_name: Bruno Cauchemez

given: Bruno

family: Macle

full_name: Laurent Macle

given: Laurent

family: Daoud

full_name: Emile Daoud

given: Emile

family: Khairy

full_name: Paul Khairy

given: Paul

family: Subbiah

full_name: Rajesh Subbiah

given: Rajesh

family: Hocini

full_name: Mélèze Hocini

given: Mélèze

family: Extramiana

full_name: Fabrice Extramiana

given: Fabrice

family: Sacher

full_name: Fréderic Sacher

given: Fréderic

family: Bordachar

full_name: Pierre Bordachar

family: Klein

full_name: George Klein

given: George

family: Weerasooriya

full_name: Rukshen Weerasooriya

given: Rukshen

family: Clémenty

full_name: Jacques Clémenty

given: Jacques

family: Haïssaguerre

full_name: Michel Haïssaguerre

given: Michel

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

title: Catheter Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation

lead_sponsor: Biosense Webster, Inc.

location_country:
United States
France
Switzerland

location_facility:
Hopital Cantonal de Geneve
Hopital Lariboisiere
Mid-Ohio Cardiology
University of Alabama, Birmingham
Hôpital Haut Lèvêque
Massachusetts General Hospital


title: Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

summary:
The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.

Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.

ReferenceCitation: Dreno B, Urosevic-Maiwald M, Kim Y, Guitart J, Duvic M, Dereure O, Khammari A, Knol AC, Derbij A, Lusky M, Didillon I, Santoni AM, Acres B, Bataille V, Chenard MP, Bleuzen P, Limacher JM, Dummer R. TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial. PLoS One. 2014 Feb 24;9(2):e83670. doi: 10.1371/journal.pone.0083670. eCollection 2014.

family: Dreno

full_name: Brigitte Dreno

given: Brigitte

family: Urosevic-Maiwald

full_name: Mirjana Urosevic-Maiwald

given: Mirjana

family: Kim

full_name: Youn Kim

given: Youn

family: Guitart

full_name: Joan Guitart

given: Joan

family: Duvic

full_name: Madeleine Duvic

given: Madeleine

family: Dereure

full_name: Olivier Dereure

given: Olivier

family: Khammari

full_name: Amir Khammari

given: Amir

family: Knol

full_name: Anne-Chantal Knol

given: Anne-Chantal

family: Derbij

full_name: Anna Derbij

given: Anna

family: Lusky

full_name: Monika Lusky

given: Monika

family: Didillon

full_name: Isabelle Didillon

given: Isabelle

family: Santoni

full_name: Anne-Marie Santoni

given: Anne-Marie

family: Acres

full_name: Bruce Acres

given: Bruce

family: Bataille

full_name: Vincent Bataille

given: Vincent

family: Chenard

full_name: Marie-Pierre Chenard

given: Marie-Pierre

family: Bleuzen

full_name: Pascal Bleuzen

given: Pascal

family: Limacher

full_name: Jean-Marc Limacher

given: Jean-Marc

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

currency_apc_doaj: USD

journal_name: PLoS ONE

license: cc-by

license_normalized: cc-by

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: TG1042 (Adenovirus-interferon-γ) in Primary Cutaneous B-cell Lymphomas: A Phase II Clinical Trial

ReferenceCitation: Accart N, Urosevic-Maiwald M, Dummer R, Bataille V, Kehrer N, Niculescu C, Limacher JM, Chenard MP, Bonnefoy JY, Rooke R. Lymphocytic infiltration in the cutaneous lymphoma microenvironment after injection of TG1042. J Transl Med. 2013 Sep 25;11:226. doi: 10.1186/1479-5876-11-226.

location_facility:
Hopital de l'Hotel-Dieu
Hopital Lapeyronie
Stanford University School of Medicine
University Hospital of Zurich
M.D. Anderson Cancer Center
Northwestern University Medical School


title: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

summary: Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

lead_sponsor: Ferring Pharmaceuticals

location_country:
Czech Republic
France
Netherlands

location_facility: Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a

location_facility: Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,

location_facility: Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159

location_facility: Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert

location_facility: Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057

location_facility: Centre d'Endocrinologie Pediatrique, 25 rue Boudet


title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2021 Aug 11. doi: 10.1007/s40262-021-01052-8. [Epub ahead of print]

family: Ferguson-Sells

full_name: Lisa Ferguson-Sells

given: Lisa

family: Velez de Mendizabal

full_name: Nieves Velez de Mendizabal

given: Nieves

family: Li

full_name: Baohui Li

given: Baohui

family: Small

full_name: David Small

given: David

journal_name: Clinical Pharmacokinetics

evidence: open (via crossref license)

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26. Erratum in: Circulation. 2011 Sep 6;124(10):e279. Dosage error in article text.

name: From the Institute of Cardiology, Università di Bologna, Bologna, Italy (N.G.); Heart Institute of the Cascades, Bend, Ore (B.H.B.); University Hospital, Justus-Liebig University, Giessen, Germany (H.A.G.); Los Angeles Biomedical Research Institute at Harbor–University of California at Los Angeles, Torrance, Calif (R.J.O.); Antoine Béclère University Hospital, Clamart, France (G.S.); Division of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, Tex (Z.S.); Greater Los...

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Brundage

full_name: Bruce H. Brundage

given: Bruce H.

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

family: Oudiz

full_name: Ronald J. Oudiz

given: Ronald J.

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

family: Safdar

full_name: Zeenat Safdar

given: Zeenat

family: Shapiro

full_name: Shelley Shapiro

given: Shelley

family: White

full_name: R. James White

given: R. James

family: Chan

full_name: Melanie Chan

given: Melanie

family: Beardsworth

full_name: Anthony Beardsworth

given: Anthony

family: Frumkin

full_name: Lyn Frumkin

given: Lyn

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

title: Tadalafil Therapy for Pulmonary Arterial Hypertension

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.


ReferenceCitation: Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)(☆). ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

family: Gaspar

full_name: N. Gaspar

given: N.

family: Campbell-Hewson

full_name: Q. Campbell-Hewson

given: Q.

family: Gallego Melcon

full_name: S. Gallego Melcon

given: S.

family: Locatelli

full_name: F. Locatelli

given: F.

family: Venkatramani

full_name: R. Venkatramani

given: R.

family: Hecker-Nolting

full_name: S. Hecker-Nolting

family: Gambart

full_name: M. Gambart

given: M.

family: Bautista

full_name: F. Bautista

family: Thebaud

full_name: E. Thebaud

given: E.

family: Aerts

full_name: I. Aerts

given: I.

family: Morland

full_name: B. Morland

given: B.

family: Rossig

full_name: C. Rossig

given: C.

family: Canete Nieto

full_name: A. Canete Nieto

given: A.

family: Longhi

full_name: A. Longhi

family: Lervat

full_name: C. Lervat

family: Entz-Werle

full_name: N. Entz-Werle

family: Strauss

full_name: S.J. Strauss

family: Marec-Berard

full_name: P. Marec-Berard

given: P.

family: Okpara

full_name: C.E. Okpara

family: He

full_name: C. He

family: Dutta

full_name: L. Dutta

given: L.

family: Casanova

full_name: M. Casanova

currency_apc_doaj: EUR

journal_name: ESMO Open

title: Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆

ReferenceCitation: Rutkowski P. Antiangiogenic agents combined with systemic chemotherapy in refractory osteosarcoma. Lancet Oncol. 2021 Sep;22(9):1206-1207. doi: 10.1016/S1470-2045(21)00422-8. Epub 2021 Aug 17.

ReferenceCitation: Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Universitario y Politecnico La Fe Hospital La Fe Valencia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

title: Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

summary: This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent lenvatinib) and osteosarcoma (single agent and combination lenvatinib).


title: Registry on WATCHMAN Outcomes in Real-Life Utilization

acronym: EWOLUTION

summary: The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

ReferenceCitation: Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Foley D, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW; following investigators and institutions participated in the EWOLUTION study. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.

name: Department of Cardiology, St Antonius Ziekenhuis Nieuwegein/AUMC Amsterdam, the Netherlands (L.V.B.).

family: Boersma

full_name: Lucas V. Boersma

given: Lucas V.

name: Department of Cardiology, Vivantes Klinikum Urban (H.I.).

name: Department of Cardiology, Vivantes Klinikum im Friedrichshain, Berlin, Germany (H.I., S.K.).

family: Ince

full_name: Hueseyin Ince

given: Hueseyin

family: Kische

full_name: Stephan Kische

given: Stephan

name: State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation (E.P.).

family: Pokushalov

full_name: Evgeny Pokushalov

given: Evgeny

name: Department of Cardiology, Elisabeth Krankenhaus Essen, Germany (T.S.).

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

name: Cardioangiologisches Centrum Bethanien, Frankfurt/Main (B.S.).

family: Schmidt

full_name: Boris Schmidt

given: Boris

name: Department of Cardiology, Universitätsmedizin Mainz und DZHK Standort Rhein-Main, Mainz (T.G.).

family: Gori

full_name: Tommaso Gori

given: Tommaso

name: Asklepios Klinik St Georg, Cardiology, Hamburg, Germany (F.M.).

family: Meincke

full_name: Felix Meincke

given: Felix

name: Cardiovascular Center of Regional State Hospital, Krasnoyarsk, Russia (A.V.P.).

family: Protopopov

full_name: Alexey Vladimir Protopopov

given: Alexey Vladimir

name: Department of Cardiology, Oxford University Hospitals NHS Trust, United Kingdom (T.B.).

family: Betts

full_name: Timothy Betts

given: Timothy

name: Department of Cardiology, Ospedale San Raffaele, Milano, Italy (P.M.).

family: Mazzone

full_name: Patrizio Mazzone

given: Patrizio

name: Department of Cardiology, Beaumont Hospital, Dublin, Ireland (D.F.).

family: Foley

full_name: David Foley

given: David

name: Department of Cardiology, Poznan University of Medical Sciences, Poland (M.G.).

family: Grygier

full_name: Marek Grygier

given: Marek

name: CardioVascular Center Frankfurt, Germany (H.S.).

family: Sievert

full_name: Horst Sievert

given: Horst

name: Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst (T.D.P.).

family: De Potter

full_name: Tom De Potter

given: Tom

name: Boston Scientific, Diegem, Belgium (E.V.).

family: Vireca

full_name: Elisa Vireca

given: Elisa

family: Stein

full_name: Kenneth Stein

given: Kenneth

name: Department of Cardiology, Cardiologicum, Hamburg, Germany (M.W.B.).

family: Bergmann

full_name: Martin W. Bergmann

given: Martin W.

family: Al Nooryani

full_name: Arif Al Nooryani

given: Arif

family: Fiedler

full_name: Thomas Fiedler

family: Senatore

full_name: Gaetano Senatore

given: Gaetano

family: Brigadeau

full_name: François Brigadeau

given: François

family: Defaye

full_name: Pascal Defaye

given: Pascal

journal_name: Circulation: Arrhythmia and Electrophysiology

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_country:
Italy
United Arab Emirates
Saudi Arabia
Netherlands
Spain
France
Poland
Ireland
Belgium
Russian Federation
Portugal
Germany
United Kingdom

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Groupe hospitalier Bichat Claude Bernard

location_facility: Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie

location_facility: Szpital Uniwersytecki nr 1im dr A Jurasza

location_facility: Clinical Hospital University of Medicine

location_facility: King Fahed Medical City - Prince Salman Cardiac Center

location_facility: Cardio Vasculares Centrum Sankt Katharinen


title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

summary: It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

ReferenceCitation: Rigo J, Hascoët JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radkë M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686.

family: Rigo

full_name: Jacques Rigo

given: Jacques

family: Hascoët

full_name: Jean-Michel Hascoët

given: Jean-Michel

family: Billeaud

full_name: Claude Billeaud

given: Claude

family: Picaud

full_name: Jean-Charles Picaud

given: Jean-Charles

family: Mosca

full_name: Fabio Mosca

given: Fabio

family: Rubio

full_name: Amandine Rubio

given: Amandine

family: Saliba

full_name: Elie Saliba

given: Elie

family: Radkë

full_name: Michaël Radkë

given: Michaël

family: Simeoni

full_name: Umberto Simeoni

given: Umberto

family: Guillois

full_name: Bernard Guillois

given: Bernard

family: de Halleux

full_name: Virginie de Halleux

given: Virginie

family: Jaeger

full_name: Jonathan Jaeger

given: Jonathan

family: Ameye

full_name: Laurent Ameye

given: Laurent

family: Hays

full_name: Nicholas P. Hays

given: Nicholas P.

family: Spalinger

full_name: Johannes Spalinger

given: Johannes

journal_name: Journal of Pediatric Gastroenterology & Nutrition

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Université de Lausanne - SERVAL

lead_sponsor: Nestlé

location_country: Italy Switzerland France Belgium Germany

location_facility:
Policlinico Mangiagalli e Regina Elena
Klinikum Ernest von Bergmann
CHU Caen
Hôpital de la Conception Marseille
CHR de la Citadelle
Hôpital des Enfants - CHU Pellegrin
Maternité Régionale
CHU Grenoble
Hôpital de la Croix-Rousse
Hôpital Clocheville Tours
Kinderspital

intervention_type: Dietary Supplement


title: An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

summary: The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Belgium
Spain
Germany
United Kingdom

location_facility: CHU de Nice - Hôpital de l'Archet 1 - Centre de Référence pour les Maladies Neuromusculaires et la SLA

location_facility: Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik

location_facility: Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen

location_facility: Neurologische Klinik Medizinische Hochschule

location_facility: Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux

location_facility: Centre SLA Limoges - Service de Neurologie

location_facility: Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10

location_facility: Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires

location_facility: CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement

location_facility: King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry

location_facility: Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences

location_facility: Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac

location_facility: University Hospital Gasthuisberg - Dept Neurology - Herestraat 49

location_facility: Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg

location_facility: HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel


ReferenceCitation: Witzel S, Frauhammer F, Steinacker P, Devos D, Pradat PF, Meininger V, Halbgebauer S, Oeckl P, Schuster J, Anders S, Dorst J, Otto M, Ludolph AC. Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials. Transl Neurodegener. 2021 Aug 26;10(1):31. doi: 10.1186/s40035-021-00257-y.

family: Witzel

full_name: Simon Witzel

given: Simon

family: Frauhammer

full_name: Felix Frauhammer

given: Felix

family: Steinacker

full_name: Petra Steinacker

given: Petra

family: Devos

full_name: David Devos

given: David

family: Pradat

full_name: Pierre-François Pradat

given: Pierre-François

family: Meininger

full_name: Vincent Meininger

given: Vincent

family: Halbgebauer

full_name: Steffen Halbgebauer

given: Steffen

family: Oeckl

full_name: Patrick Oeckl

given: Patrick

family: Schuster

full_name: Joachim Schuster

given: Joachim

family: Anders

full_name: Simon Anders

family: Dorst

full_name: Johannes Dorst

family: Otto

full_name: Markus Otto

given: Markus

family: Ludolph

full_name: Albert C. Ludolph

given: Albert C.

journal_name: Translational Neurodegeneration

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

ReferenceCitation: Devos D, Moreau C, Kyheng M, Garçon G, Rolland AS, Blasco H, Gelé P, Timothée Lenglet T, Veyrat-Durebex C, Corcia P, Dutheil M, Bede P, Jeromin A, Oeckl P, Otto M, Meininger V, Danel-Brunaud V, Devedjian JC, Duce JA, Pradat PF. A ferroptosis-based panel of prognostic biomarkers for Amyotrophic Lateral Sclerosis. Sci Rep. 2019 Feb 27;9(1):2918. doi: 10.1038/s41598-019-39739-5. Erratum in: Sci Rep. 2020 Feb 19;10(1):3312.

apc_source: openAPC

family: Moreau

full_name: Caroline Moreau

given: Caroline

family: Kyheng

full_name: Maeva Kyheng

repository_institution: University of Melbourne - Minerva Access

title: A ferroptosis–based panel of prognostic biomarkers for Amyotrophic Lateral Sclerosis

title: Phase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

summary: The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.


ReferenceCitation: Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. [Epub ahead of print]

name: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy

family: Cremolini

full_name: Chiara Cremolini

given: Chiara

family: Antoniotti

full_name: Carlotta Antoniotti

given: Carlotta

name: Hematology-Oncology Practice Hamburg (HOPE), University Cancer Center Hamburg, Hamburg, Germany

family: Stein

full_name: Alexander Stein

given: Alexander

name: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

family: Bendell

full_name: Johanna Bendell

given: Johanna

name: Social Medical Center South, Department of Surgery, HPB Center Vienna Clinics and Sigmund Freud University, Medical School, Vienna, Austria

family: Gruenberger

full_name: Thomas Gruenberger

given: Thomas

family: Rossini

full_name: Daniele Rossini

given: Daniele

family: Masi

full_name: Gianluca Masi

given: Gianluca

name: Unit of Medical Oncology and Cancer Prevention, Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano, IRCCS, Aviano (PN), Italy

family: Ongaro

full_name: Elena Ongaro

given: Elena

family: Hurwitz

full_name: Herbert Hurwitz

given: Herbert

family: Falcone

full_name: Alfredo Falcone

given: Alfredo

name: Department Internal Medicine IV-Hematology-Oncology, Martin-Luther-University, Halle (Saale), Germany

family: Schmoll

full_name: Hans-Joachim Schmoll

given: Hans-Joachim

name: Department of Oncology, University of Turin, Mauriziano Hospital, Turin, Italy

family: Di Maio

full_name: Massimo Di Maio

given: Massimo

journal_name: Journal of Clinical Oncology

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

version: submittedVersion

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gruenberger T, Bridgewater J, Chau I, García Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

full_name: T. Gruenberger

given: T.

family: Bridgewater

full_name: J. Bridgewater

given: J.

family: Chau

full_name: I. Chau

given: I.

family: García Alfonso

full_name: P. García Alfonso

given: P.

family: Rivoire

full_name: M. Rivoire

given: M.

family: Mudan

full_name: S. Mudan

given: S.

family: Lasserre

full_name: S. Lasserre

family: Hermann

full_name: F. Hermann

given: F.

family: Waterkamp

full_name: D. Waterkamp

given: D.

family: Adam

full_name: R. Adam

given: R.

title: A Multicentre Randomised Phase II Study to Assess the Safety and Resectability in Patients With Initially Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving First-line Treatment Either With mFOLFOX-6 Plus Bevacizumab or FOLFOXIRI Plus Bevacizumab (OLIVIA)

summary: This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is <100 individuals.


title: Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

summary:
This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use of salt and food. Excessive cortisol is usually the result of too much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in the body. The drug has been used safely to treat a few people with Cushing's syndrome and patients with certain kinds of cancer, gynecological diseases and psychiatric disorders.

People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion may be eligible for this study. Candidates are admitted to the hospital for evaluation to confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and begin mifepristone therapy.

Participants remain in the hospital for the following tests and procedures:

Physical examination, electrocardiogram (EKG) and blood and urine tests
Completion of medical questionnaires
DEXA scan to determine bone mineral density and body composition
Glucose tolerance test
Urine pregnancy test and ultrasound to measure uterine lining thickness (for women)

Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so until symptoms improve or the highest dosage allowed is reached. Patients may remain in the hospital for all or part of the dose-finding part of the study. During this period (usually 2 to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on that dose for at least 2 weeks and are then re-evaluated. Patients then return to the hospital for evaluations every 3 months. Those who do well on the drug may continue to take it for up to 12 months.

ReferenceCitation: Bertagna X, Basin C, Picard F, Varet B, Bertagna C, Hucher M, Luton JP. Peripheral antiglucocorticoid action of RU 486 in man. Clin Endocrinol (Oxf). 1988 May;28(5):537-41.

ReferenceCitation: Bertagna X, Escourolle H, Pinquier JL, Coste J, Raux-Demay MC, Perles P, Silvestre L, Luton JP, Strauch G. Administration of RU 486 for 8 days in normal volunteers: antiglucocorticoid effect with no evidence of peripheral cortisol deprivation. J Clin Endocrinol Metab. 1994 Feb;78(2):375-80.

ReferenceCitation: Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4.

lead_sponsor: HRA Pharma

location_country:
Italy
United States
Netherlands
France
Germany

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: Randomized Study for Patients With Follicular Lymphoma Needing Treatment

summary:
2 parallel studies.

For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

ReferenceCitation: Coiffier B, Neidhardt-Bérard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Péaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7.

lead_sponsor: Lymphoma Study Association

location_country: Belgium France

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: Targeted Intensification by a New Preparative Regimen for Patients With Low-Grade B-Cell Lymphoma Utilizing Standard-Dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-Dose Beam Followed by Autologous Stem Cell Transplantation (ASCT)

summary:
The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS).

The goal is to obtain a 15% increase of EFS at 2 years.

ReferenceCitation: Brice P, Simon D, Bouabdallah R, Bélanger C, Haïoun C, Thieblemont C, Tilly H, Harousseau JL, Doyen C, Martin C, Brousse N, Solal-Céligny PH; Groupe d'Etude des Lymphomes de l'Adulte (GELA). High-dose therapy with autologous stem-cell transplantation (ASCT) after first progression prolonged survival of follicular lymphoma patients included in the prospective GELF 86 protocol. Ann Oncol. 2000 Dec;11(12):1585-90.

ReferenceCitation: Mills W, Chopra R, McMillan A, Pearce R, Linch DC, Goldstone AH. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol. 1995 Mar;13(3):588-95.

ReferenceCitation: Witzig TE, White CA, Gordon LI, Wiseman GA, Emmanouilides C, Murray JL, Lister J, Multani PS. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-hodgkin's lymphoma. J Clin Oncol. 2003 Apr 1;21(7):1263-70.

ReferenceCitation: Fung HC, Forman SJ, Nademanee A, Molina A, Yamauchi D, Speilberger R, Kogut N, Sahebi F, Parker P, Rodriguez R, Krishnan A, Popplewell L, Wong J, and Raubitschek A. A new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high-dose BEAM followed by autologous hematopoietic cell transplantation (AHCT) : targeted intensification without increased transplant-related toxicity. Blood 2003, forty-fifth annual meeting of the American Society of Hematology, abstract 870.

ReferenceCitation: Nademanee A, Forman SJ, Molina A, Kogut N, Fung HC, Yamauchi D, Anderson A-L, Smith D, Liu AN, and Raubitschek A. High-dose radioimmunotherapy with yttrium 90 (90Y) ibritumomab tiuxetan with high-dose etoposide (VP-16) and cyclophosphamide (CY) followed by autologous hematopoietic cell transplantation (AHCT) for poor-risk or relapsed B-cell non-Hodgkin's lymphoma (NHL): update of a phase I/II trial. J Clin Oncol 2004, fortieth annual meeting of the American Society of Clinical Oncology, abstract 6504.

location_country: Belgium France Switzerland

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme

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

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have glioblastoma multiforme.

location_country: Italy Switzerland Netherlands France Belgium Spain

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

location_facility: Academisch Ziekenhuis der Vrije Universiteit


title: Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)

summary: This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners & Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

primary_purpose: Basic Science

lead_sponsor: University of Leeds

location_country:
Denmark
United Kingdom
France
Spain

location_facility:
CRNH-RA
University of Navarra
University of Copenhagen
University of Leeds
University of Liverpool


title: Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes

acronym: DWELL

summary: This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 800 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

ipd_sharing_description: Anonymous participant data relating to results in publications with regards to primary and secondary outcome measures will be shared through publishing platforms. Anonymised individual participant datasets may be shared via a suitable public data repository. A final report of the evaluation study will be made available via the Canterbury Christ Church University DWELL Project web page.

lead_sponsor: Canterbury Christ Church University

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility:
Arteveldehogeschool
Medway Community Healthcare
Centre Hosptalier Douai
Blackthorn Trust
Kinetic Analysis

intervention_type: Behavioral


title: A Double-Blind, Placebo-controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophisyiological, and Clinical Markers in Patients With Friedreich's Ataxia

acronym: FRAMES

summary: Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's Ataxia

lead_sponsor: Minoryx Therapeutics, S.L.

location_country: Germany Belgium France Spain

location_facility: ICM, Groupe Hospitalier Pitié Salpêtrière


title: Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

summary: The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.

status: Active, not recruiting

lead_sponsor: Zimmer Biomet

location_country: Austria Germany France Spain

location_facility: Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"

location_facility: Medizinische Universität Wien, Universitätsklinik für Orhopädie


title: Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

acronym: INDURE

summary: Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

ReferenceCitation: Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.

ReferenceCitation: Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.

ReferenceCitation: Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729. Review.

ReferenceCitation: Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244.

ReferenceCitation: Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwöger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.

family: Meuris

full_name: Bart Meuris

given: Bart

family: Borger

full_name: Michael A. Borger

given: Michael A.

family: Bourguignon

full_name: Thierry Bourguignon

given: Thierry

family: Siepe

full_name: Matthias Siepe

given: Matthias

family: Grabenwöger

full_name: Martin Grabenwöger

given: Martin

family: Laufer

full_name: Günther Laufer

given: Günther

family: Binder

full_name: Konrad Binder

given: Konrad

family: Polvani

full_name: Gianluca Polvani

family: Stefano

full_name: Pierluigi Stefano

given: Pierluigi

family: Coscioni

full_name: Enrico Coscioni

given: Enrico

family: van Leeuwen

full_name: Wouter van Leeuwen

given: Wouter

family: Demers

full_name: Philippe Demers

given: Philippe

family: Dagenais

full_name: Francois Dagenais

given: Francois

family: Canovas

full_name: Sergio Canovas

given: Sergio

family: Theron

full_name: Alexis Theron

given: Alexis

family: Langanay

full_name: Thierry Langanay

family: Roussel

full_name: Jean-Christian Roussel

given: Jean-Christian

family: Wendler

full_name: Olaf Wendler

given: Olaf

family: Mariscalco

full_name: Giovanni Mariscalco

given: Giovanni

family: Pessotto

full_name: Renzo Pessotto

given: Renzo

family: Botta

full_name: Beate Botta

given: Beate

family: Bramlage

full_name: Peter Bramlage

given: Peter

repository_institution: University of Florence - Florence Research

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

title: Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_facility: UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie


title: Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)

summary: The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

primary_purpose: Other

lead_sponsor: Janssen Research & Development, LLC

location_country: Sweden France Belgium Spain Germany

location_facility: CTC North GmbH & Co. KGim Spectrum am UKE


title: A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

summary: Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD patients developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
France
Spain
United States
United Kingdom

location_facility: Ospedale Pediatrico Bambino Gesù - UO Reumatologia

location_facility: Hôpital Necker-Enfants Malades, Unité d'Immunologie-hématologie et Rhumatologie pédiatriques


title: Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)

summary: The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.

lead_sponsor: Wissenschaftliches Institut Bethanien e.V

location_country: Denmark Germany France

location_facility: Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg

location_facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V.

location_facility: Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice

location_facility: Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin


title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis

summary:
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.

There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.

lead_sponsor: Gilead Sciences

location_country:
France
Australia
Spain
Germany
United Kingdom


title: An Observational, Prospective, Multi-center, Natural History Study of Patients With Mucopolysaccharidosis Type IIIA (MPS IIIA)

summary: Evaluate the clinical progression in patients with MPS IIIA who are untreated with any investigational product and to obtain standardized assessments: neurocognitive, behavioral, sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their families.

ipd_sharing: Undecided

lead_sponsor: LYSOGENE

location_country:
Brazil
Netherlands
France
Germany
United Kingdom

location_facility: Great Ormond Street Hospital NHS Foundation Trust

location_facility: Academic Medical Center, Emma Children's Hospital

location_facility: University Medical Center Hamburg-Eppendorf