title: A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

summary: The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Limited

location_country:
Italy
Austria
Spain
France
Russian Federation
Portugal
Denmark
Germany
United Kingdom

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Hospital Universitari Sagrat Cor Quironsalud

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Moscow State Medical Stomatological University n.a. A.I. Evdoki

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Centre de consultations Saint-Jean Bâtiment A

location_facility: Regional Treatment and Rehabilitation Center

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov


title: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

summary:
This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:

Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1)
Identification of molecular tumor characteristics in long-term survivors (Focus 2)
Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)
Immunological studies (Focus 4)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ipd_sharing: Undecided

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

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Greece
Belgium
United States

location_facility: Hopitaux de Paris - La Pitie Salpetriere

location_facility: CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni

location_facility: Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Hopitaux de Marseille - Hôpital de La Timone (APHM)

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Non-Randomized

intervention_type: Drug

status: Active, not recruiting

study_type: Interventional

lead_sponsor: Hoffmann-La Roche

primary_purpose: Treatment

location_country:
Italy
Hong Kong
France
Poland
Russian Federation
Spain
Turkey
United States
Korea, Republic of

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Massachusetts General Hospital Cancer Center

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

type: EudraCT Number

source: euctr

title: A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.


ReferenceType: derived

ReferenceCitation: Mahoney-Sánchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson's Disease. Prog Neurobiol. 2021 Jan;196:101890. doi: 10.1016/j.pneurobio.2020.101890. Epub 2020 Jul 26. Review.

family: Mahoney-Sánchez

full_name: Laura Mahoney-Sánchez

given: Laura

sequence: first

family: Bouchaoui

full_name: Hind Bouchaoui

given: Hind

sequence: additional

family: Ayton

full_name: Scott Ayton

given: Scott

family: Devos

full_name: David Devos

given: David

family: Duce

full_name: James A. Duce

given: James A.

family: Devedjian

full_name: Jean-Christophe Devedjian

given: Jean-Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Progress in Neurobiology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Ferroptosis and its potential role in the physiopathology of Parkinson’s Disease

ReferenceCitation: Moreau C, Duce JA, Rascol O, Devedjian JC, Berg D, Dexter D, Cabantchik ZI, Bush AI, Devos D; FAIRPARK-II study group. Iron as a therapeutic target for Parkinson's disease. Mov Disord. 2018 Apr;33(4):568-574. doi: 10.1002/mds.27275. Epub 2018 Jan 30. Review.

name: Université de Lille, CHU de Lille, INSERM UMRS_1171, Service de Neurologie NS-Park/FCRIN Network LICEND COEN Center; Lille France

family: Moreau

full_name: Caroline Moreau

given: Caroline

name: School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, West Yorkshire, UK, and Oxidation Biology Unit, Florey Institute of Neuroscience and Mental Health, University of Melbourne; Parkville Victoria Australia

name: Université de Toulouse, UPS, CHU de Toulouse, INSERM; Centre d'Investigation Clinique CIC1436, Services de Neurologie et de Pharmacologie Clinique, UMR TONIC, NS-Park/FCRIN Network, NeuroToul COEN Center; Toulouse France

family: Rascol

full_name: Olivier Rascol

given: Olivier

name: University de Lille, CHU de Lille, INSERM UMRS_1171, NS-Park/FCRIN Network LICEND COEN Center; Lille France

name: Department of Neurology; Christian-Albrechts-University of Kiel, Kiel, Germany and Hertie-Institute of Clinical Brain Research, Department of Neurodegeneration; Tübingen Germany

family: Berg

full_name: Daniela Berg

given: Daniela

family: Dexter

full_name: David Dexter

name: Della Pergola Chair, Alexander Silberman Institute of Life Sciences, Hebrew University; Jerusalem Israel

family: Cabantchik

full_name: Z. Ioav Cabantchik

given: Z. Ioav

name: Oxidation Biology Unit; Florey Institute of Neuroscience and Mental Health, University of Melbourne; Parkville Victoria Australia

family: Bush

full_name: Ashley I. Bush

given: Ashley I.

name: Université de Lille, CHU de Lille, INSERM UMRS_1171, Service de Pharmacologie Clinique et Service de Neurologie NS-Park/FCRIN Network LICEND COEN Center; Lille France

journal_name: Movement Disorders

repository_normalized: University of Melbourne - Minerva Access

version: publishedVersion

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

repository_institution: Université de Lille (University Of Lille) - LillOA

location_country:
Austria
Netherlands
Spain
France
Czechia
Portugal
Germany
United Kingdom

location_facility: CHU de Strasbourg, Hôpital de Hautepierre

location_facility: Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock

location_facility: Centro Hospitalar e universitario de Coimbra

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital, Saarland University

title: Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone"

summary: This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.


design_allocation: Randomized

ipd_sharing_description: As per GETNE guidelines and local laws

lead_sponsor: Grupo Espanol de Tumores Neuroendocrinos

enrollment_type: Actual

location_country:
Italy
Sweden
Netherlands
France
Spain
Denmark
Germany
United Kingdom

acronym: SEQTOR

location_facility: Interdisciplinary Center of Neuroendocrine Tumors of the GastroEnteroPancreatic System (GEPNET-KUM) at the University of Munich

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Istituto Nazionale Tumori (Fondazione G Pascale)

location_facility: University Hospital of Bordeaux Hôpital Saint-André

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre

location_facility: Rigshospitalet NET CoE, University of Copenhagen

location_facility: Magdeburg Universitätsklinikum Magdeburg A. ö. R

location_facility: Medizin II am Klinik und Poliklinik rechts der Isar

location_facility: UTTIOM Unité Transversale de Thérapeutiques Innovantes en Oncologie Médicale CHU Angers

location_facility: UKM Facharzt für Innere Medizin Gastroenterologie, Onkologische Gastroenterologie (DGVS)

location_facility: Medizinische Klinik und Poliklinik , Universitätsklinikum Hamburg-Eppendorf

location_facility: Marburg Universitätsklinikum Giessen und Marburg GmbH

location_facility: Clichy Neuroendocrine Tumor (NET) Center Hopital Beaujon

location_facility: Instituto Catalán de Oncología de Hospitalet

location_facility: Aarhus Aarhus University Hospital NET Centre (AUH-NET)

location_facility: Brest Hopital Augustin Morvan, Institut de Cancero-Hemato

ipd_sharing: No

title: Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)

summary: The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.


title: A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.

summary: The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

status: Completed

study_completion_date_type: Actual

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility:
Hôpital Henri Mondor
CHU de Dijon
CHU Hôtel Dieu
CHRU de Lille
CHU Lyon - Sud
CHU Pontchaillou
AZ Sint Jan
CHU Mont-Godinne
CHU Brabois
University Hospital Gent
Centre Henri Becquerel

status_simplified: Completed


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: TE-Prove

summary: The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Tamburino C, Capodanno D, Erglis A, Menown IB, Horváth IG, Moreno R, Gilbert TJ, Crowley JJ, Calabria P, Allocco DJ, Dawkins KD. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015 Mar;10(11):1261-6. doi: 10.4244/EIJY15M01_01.

family: Tamburino

full_name: Corrado Tamburino

given: Corrado

family: Capodanno

full_name: Davide Capodanno

given: Davide

family: Erglis

full_name: Andrejs Erglis

given: Andrejs

family: Menown

full_name: Ian B.A. Menown

given: Ian B.A.

family: Horváth

full_name: Iván G. Horváth

given: Iván G.

family: Moreno

full_name: Raul Moreno

given: Raul

family: Gilbert

full_name: Timothy J. Gilbert

given: Timothy J.

family: Crowley

full_name: James J. Crowley

given: James J.

family: Calabria

full_name: Paolo Calabria

given: Paolo

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ipd_sharing_description: Primary endpoint data presented at TCT 2014.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United Kingdom
France
Poland
Hungary
Belgium
Ireland
Spain
Germany
Latvia

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

location_facility: Norfolk and Norwich University Hospital NHS Trust

location_facility: Centre Hospitalier Privé Saint Martin gds


title: A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

summary: A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

lead_sponsor: ConvaTec Inc.

location_country:
France
Poland
Denmark
Germany
United Kingdom

location_facility: Fareham College Specialist Leg Care Centre (#13)

location_facility: Tissue Viability Service NHS Harrow PCT (#26)

location_facility: Mayday University Hospital Wound Clinic (#10)

location_facility: Chalfont and Gerrards Cross Hospital (#14)

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)

location_facility: Distric Nurses, The Wilson Practice, Alton Health Centre (#9)

location_facility: Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)

location_facility: Tissue Viability Service, The Willows, Centre for Health Care (#11)

intervention_type: Device


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy

summary: The purpose of this study is to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult patients with WT1-positive AML presenting a suboptimal clinical response to induction chemotherapy. The study will also assess whether this treatment induces a specific immune response to the malignancy.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
France

intervention_type: Biological


title: Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

acronym: RESCUE

summary: Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

primary_purpose: Diagnostic

lead_sponsor: Guerbet

location_country: Italy Belgium France Spain

location_facility: Azienda Ospedaliera Universitaria di Ferrara

intervention_type: Other


title: An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate

summary: To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
Sweden
Finland
France
Poland
Russian Federation
Spain
United Kingdom


title: A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast 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: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.

ReferenceCitation: Coudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Lévi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036.

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Focan

full_name: Christian Focan

given: Christian

family: Genet

full_name: Dominique Genet

given: Dominique

family: Giacchetti

full_name: Sylvie Giacchetti

given: Sylvie

family: Cvickovic

full_name: Frédérique Cvickovic

given: Frédérique

family: Zambelli

full_name: Alberto Zambelli

given: Alberto

family: Fillet

full_name: Georges Fillet

given: Georges

family: Chollet

full_name: Philippe Chollet

given: Philippe

family: Amoroso

full_name: Domenico Amoroso

given: Domenico

family: Van Der Auwera

full_name: Jaak Van Der Auwera

given: Jaak

family: Lentz

full_name: Marie Ange Lentz

given: Marie Ange

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Baron

full_name: Benoit Baron

given: Benoit

family: Gorlia

full_name: Thierry Gorlia

given: Thierry

family: Biville

full_name: Fabienne Biville

given: Fabienne

family: Lévi

full_name: Francis Lévi

given: Francis

bso_classification: Chemistry

journal_name: Chronobiology International

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: A Randomized Multicenter Study of Optimal Circadian Time of Vinorelbine Combined with Chronomodulated 5‐Fluorouracil in Pretreated Metastatic Breast Cancer Patients: EORTC Trial 05971

ReferenceCitation: Coudert B, Focan C, Genet D, et al.: Optimal circadian time of vinorelbine (V) combined with chronomodulated 5-FU in pretreated metastatic breast cancer patients. EORTC 05971 randomized multicenter study. [Abstract] J Clin Oncol 24 (Suppl 18): A-2066, 2006.

location_country: Italy Belgium France Greece

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Istituto per la Ricerca e Cura del Cancro

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

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


title: A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours

summary: The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
United States
Canada
France


ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Spain

acronym: CYCLONE 1

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Hospital General Universitario Gregorio Maranon

type: Other Identifier

title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy

summary: The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.


title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

acronym: POLAR ICE

summary: This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

location_country:
Italy
Netherlands
Croatia
France
Belgium
Germany
United Kingdom

location_facility: CHU De Brest - Hopital de la Cavale Blanche

location_facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina


title: PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK

acronym: TTRACK

summary: The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol

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

lead_sponsor: Pfizer

location_country: Italy Austria France Romania Australia Spain Slovenia

location_facility: Inherited Cardiovascular Diseases - Cardiology Institute

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie

location_facility: University Medical Centre Ljubljana - Department of Cardiology

location_facility: Hopital Henri Mondor, Service de Pharmacologie Clinique

location_facility: Cardiomyopathy Unit, Department of Cardiology

intervention_type: Diagnostic Test


title: Safety and Effectiveness of SOFIA™/SOFIA™ PLUS When Used for Direct Aspiration as a First Line Treatment Technique in Patients Suffering an Acute Ischemic Stroke in the Anterior Circulation

acronym: SESAME

summary:
Sesame is a European, multi-center, single arm, prospective, observational registry.

Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

lead_sponsor: Dr. Markus Alfred Möhlenbruch

location_country: Italy Austria Netherlands France Germany

location_facility: Groupe Hospitalier Universitaire Pitié Salpêtrière

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Le Centre Hospitalier Universitaire de Bordeaux


title: Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) as Compared With Methylphenidate in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Multicentre Randomized Clinical Study

acronym: Newrofeed

summary: The main objective of the study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.

status: Unknown status

ReferenceCitation: Purper-Ouakil D, Blasco-Fontecilla H, Ros T, Acquaviva E, Banaschewski T, Baumeister S, Bousquet E, Bussalb A, Delhaye M, Delorme R, Drechsler R, Goujon A, Häge A, Kaiser A, Mayaud L, Mechler K, Menache C, Revol O, Tagwerker F, Walitza S, Werling AM, Bioulac S, Brandeis D. Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial. J Child Psychol Psychiatry. 2021 Jun 24. doi: 10.1111/jcpp.13462. [Epub ahead of print]

name: Unit of Child and Adolescent Psychiatry (MPEA1) CHU Montpellier‐Saint Eloi Hospital University of Montpellier Montpellier France

name: Development and Trajectories INSERM CESP U 1018 Psychiatry Montpellier France

family: Purper‐Ouakil

full_name: Diane Purper‐Ouakil

given: Diane

name: Department of Psychiatry IDIPHISA‐Puerta de Hierro University Hospital ITA‐Consulting Salud Mental CIBERSAM University Autonoma of Madrid Madrid Spain

family: Blasco‐Fontecilla

full_name: Hilario Blasco‐Fontecilla

given: Hilario

name: Department of Neuroscience Campus Biotech CISA ‐ Université de Genève Genève Switzerland

family: Ros

full_name: Tomas Ros

given: Tomas

name: Child and Adolescent Psychiatry Robert Debré Hospital Assistance Publique‐Hôpitaux de Paris Paris France

family: Acquaviva

full_name: Eric Acquaviva

given: Eric

name: Department of Child and Adolescent Psychiatry and Psychotherapy Central Institute of Mental Health Medical Faculty Mannheim/Heidelberg University Mannheim Germany

family: Banaschewski

full_name: Tobias Banaschewski

given: Tobias

family: Baumeister

full_name: Sarah Baumeister

given: Sarah

family: Bousquet

full_name: Elisa Bousquet

given: Elisa

family: Bussalb

full_name: Aurore Bussalb

given: Aurore

name: Child and Adolescent Psychiatry Erasme Academic Hospital Université Libre de Bruxelles Bruxelles Belgium

family: Delhaye

full_name: Marie Delhaye

given: Marie

family: Delorme

full_name: Richard Delorme

given: Richard

name: Department of Child and Adolescent Psychiatry and Psychotherapy Psychiatric Hospital University of Zurich Zurich Switzerland

family: Drechsler

full_name: Renate Drechsler

given: Renate

family: Goujon

full_name: Allison Goujon

given: Allison

family: Häge

full_name: Alexander Häge

given: Alexander

family: Kaiser

full_name: Anna Kaiser

given: Anna

family: Mayaud

full_name: Louis Mayaud

given: Louis

family: Mechler

full_name: Konstantin Mechler

given: Konstantin

name: Clinique des Grangettes Chêne‐Bougeries Switzerland

family: Menache

full_name: Caroline Menache

given: Caroline

name: Unit of Child and Adolescent Psychiatry Hospices civils de Lyon Hôpital Femme Mère Enfant Bron Cedex France

family: Revol

full_name: Olivier Revol

given: Olivier

family: Tagwerker

full_name: Friederike Tagwerker

given: Friederike

name: Neuroscience Center Zurich University of Zurich and ETH Zurich Zurich Switzerland

name: Zurich Center for Integrative Human Physiology University of Zurich Zurich Switzerland

family: Walitza

full_name: Susanne Walitza

given: Susanne

family: Werling

full_name: Anna Maria Werling

given: Anna Maria

name: Clinique du Sommeil CHU Pellegrin Bordeaux Cedex France

family: Bioulac

full_name: Stephanie Bioulac

given: Stephanie

family: Brandeis

full_name: Daniel Brandeis

given: Daniel

journal_name: Journal of Child Psychology and Psychiatry

title: Personalized at‐home neurofeedback compared to long‐acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial

ReferenceCitation: Bioulac S, Purper-Ouakil D, Ros T, Blasco-Fontecilla H, Prats M, Mayaud L, Brandeis D. Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. BMC Psychiatry. 2019 Aug 1;19(1):237. doi: 10.1186/s12888-019-2218-0.

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

repository_institution: ETH Zurich - Repository for Publications and Research Data

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country: Switzerland France Belgium Spain Germany

location_facility: CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent

location_facility: Psychiatric Hospital, University of Zürich

location_facility: Hôpital Erasme - Cliniques universitaires de Bruxelles

location_facility: PSY Pluriel Centre europeen de psychologie medicale

location_facility: Puerta de Hierro Hospital - Department of Psychiatry

location_facility: Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant

location_facility: Medical faculty of Mannheim/Heidelberg university


title: A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)

summary: This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
France
Greece
Hungary
Belgium
Portugal
Germany
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Attikon, Panepistimiako Geniko Nosokomeio

location_facility: Augenarzt Dr. Dunker und Kollegen, Troisdorf

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light and Image

location_facility: BAZ County Hospital, Ophtalmology Department, Miskolc

location_facility: University General Hospital of Heraklion


title: A Phase 1b-2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

summary: The primary objective of this study is to evaluate the safety of ENTO with VCR in participants with relapsed or refractory B-cell NHL.

status: Terminated

lead_sponsor: Gilead Sciences

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire de Dijon Hôpital du Bocage

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU de Lille)

status_simplified: Unknown


title: A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

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

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

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

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

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

family: Harvey

full_name: R. Donald Harvey

given: R. Donald

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

family: Aransay

full_name: Noemi Reguart Aransay

given: Noemi Reguart

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

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

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

family: Lee

full_name: Jong-Seok Lee

given: Jong-Seok

name: Sarah Cannon Research Institute; London UK

family: Arkenau

full_name: Tobias Arkenau

given: Tobias

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

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

name: Seda Pharmaceutical Development Services; Alderley Edge UK

family: Dickinson

full_name: Paul A. Dickinson

given: Paul A.

name: Quantitative Clinical Pharmacology; AstraZeneca; Waltham MA USA

family: Bui

full_name: Khanh Bui

given: Khanh

family: Weilert

full_name: Doris Weilert

given: Doris

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

family: So

full_name: Karen So

given: Karen

name: Biostatistics and Informatics; AstraZeneca; Macclesfield UK

family: Thomas

full_name: Karen Thomas

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

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
France
Belgium
Spain
United States
Korea, Republic of


title: Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC

summary:
Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.

The objective of the trial is survival rate at 12 months.

ReferenceCitation: Gridelli C, Ciuleanu T, Domine M, Szczesna A, Bover I, Cobo M, Kentepozidis N, Zarogoulidis K, Kalofonos C, Kazarnowisz A, Korozan M, de Las Penas R, Majem M, Chella A, Griesinger F, Bournakis E, Sadjadian P, Kotsakis A, Chinet T, Syrigos KN, Correale P, Gallou C, Jamet JM, Vetsika EK, Kosmatopoulos K, Georgoulias V; Vx-001-201 trial team. Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. Br J Cancer. 2020 May;122(10):1461-1466. doi: 10.1038/s41416-020-0785-y. Epub 2020 Mar 25.

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

family: Ciuleanu

full_name: Tudor Ciuleanu

given: Tudor

family: Domine

full_name: Manuel Domine

given: Manuel

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: Bover

full_name: Isabel Bover

given: Isabel

family: Cobo

full_name: Manuel Cobo

family: Kentepozidis

full_name: Nikolaos Kentepozidis

given: Nikolaos

family: Zarogoulidis

full_name: Konstantinos Zarogoulidis

given: Konstantinos

family: Kalofonos

full_name: Charalabos Kalofonos

given: Charalabos

family: Kazarnowisz

full_name: Andrzej Kazarnowisz

given: Andrzej

family: Korozan

full_name: Magdalena Korozan

given: Magdalena

family: de las Penas

full_name: Ramon de las Penas

given: Ramon

family: Majem

full_name: Margarita Majem

given: Margarita

family: Chella

full_name: Antonio Chella

given: Antonio

family: Griesinger

full_name: Frank Griesinger

given: Frank

family: Bournakis

full_name: Evangelos Bournakis

given: Evangelos

family: Sadjadian

full_name: Parvis Sadjadian

given: Parvis

family: Kotsakis

full_name: Athanasios Kotsakis

given: Athanasios

family: Chinet

full_name: Thierry Chinet

given: Thierry

family: Syrigos

full_name: Kostantinos N. Syrigos

given: Kostantinos N.

family: Correale

full_name: Pierpaolo Correale

given: Pierpaolo

family: Gallou

full_name: Catherine Gallou

given: Catherine

family: Jamet

full_name: Jeanne- Menez Jamet

given: Jeanne- Menez

location_country: Italy France Czechia Greece Poland Romania Spain Germany

location_facility: Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"

location_facility: Seconda Universita degli Studi Napoli Hospital

location_facility: Mathias Spital Rheine Medizinische Klinik V

location_facility: Fundacja Hospicjum Onkologiczne św. Krzysztofa

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden

location_facility: Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie

location_facility: University General Hospital Papageorgiou

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego

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

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku

location_facility: Oncomed SRL, Department of Medical Oncology

location_facility: Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca

location_facility: General hospital of thoracic diseases Sotiria


title: A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks

summary: This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

lead_sponsor: Shire

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom

location_facility: Klinikum rechts der Isar der technischen Universität München


ReferenceCitation: Schöffski P, Kubickova M, Wozniak A, Blay JY, Strauss SJ, Stacchiotti S, Switaj T, Bücklein V, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Lee CJ, Speetjens FM, Nzokirantevye A, Neven A, Kasper B. Long-term efficacy update of crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumour from EORTC trial 90101 CREATE. Eur J Cancer. 2021 Oct;156:12-23. doi: 10.1016/j.ejca.2021.07.016. Epub 2021 Aug 13.

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Kubickova

full_name: Michaela Kubickova

given: Michaela

family: Wozniak

full_name: Agnieszka Wozniak

given: Agnieszka

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Strauss

full_name: Sandra J. Strauss

given: Sandra J.

family: Stacchiotti

full_name: Silvia Stacchiotti

given: Silvia

family: Switaj

full_name: Tomasz Switaj

given: Tomasz

family: Bücklein

full_name: Veit Bücklein

given: Veit

family: Leahy

full_name: Michael G. Leahy

given: Michael G.

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Debiec-Rychter

full_name: Maria Debiec-Rychter

given: Maria

family: Sciot

full_name: Raf Sciot

given: Raf

family: Lee

full_name: Che-Jui Lee

given: Che-Jui

family: Speetjens

full_name: Frank M. Speetjens

given: Frank M.

family: Nzokirantevye

full_name: Axelle Nzokirantevye

given: Axelle

family: Neven

full_name: Anouk Neven

given: Anouk

family: Kasper

full_name: Bernd Kasper

given: Bernd

journal_name: European Journal of Cancer

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Schöffski P, Sufliarsky J, Gelderblom H, Blay JY, Strauss SJ, Stacchiotti S, Rutkowski P, Lindner LH, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Van Cann T, Marréaud S, Nzokirantevye A, Collette S, Wozniak A. Crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumours with and without anaplastic lymphoma kinase gene alterations (European Organisation for Research and Treatment of Cancer 90101 CREATE): a multicentre, single-drug, prospective, non-randomised phase 2 trial. Lancet Respir Med. 2018 Jun;6(6):431-441. doi: 10.1016/S2213-2600(18)30116-4. Epub 2018 Apr 15.

ReferenceCitation: Schöffski P, Wozniak A, Leahy MG, Aamdal S, Rutkowski P, Bauer S, Richter S, Grünwald V, Debiec-Rychter M, Sciot R, Geoerger B, Marréaud S, Collette S, Nzokirantevye A, Strauss SJ. The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: European Organisation for Research and Treatment of Cancer phase 2 trial 90101 'CREATE'. Eur J Cancer. 2018 May;94:156-167. doi: 10.1016/j.ejca.2018.02.011. Epub 2018 Mar 20.

title: The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: European Organisation for Research and Treatment of Cancer phase 2 trial 90101 ‘CREATE’

ReferenceCitation: Schöffski P, Wozniak A, Kasper B, Aamdal S, Leahy MG, Rutkowski P, Bauer S, Gelderblom H, Italiano A, Lindner LH, Hennig I, Strauss S, Zakotnik B, Anthoney A, Albiges L, Blay JY, Reichardt P, Sufliarsky J, van der Graaf WTA, Debiec-Rychter M, Sciot R, Van Cann T, Marréaud S, Raveloarivahy T, Collette S, Stacchiotti S. Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 'CREATE'. Ann Oncol. 2018 Mar 1;29(3):758-765. doi: 10.1093/annonc/mdx774.

title: Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 ‘CREATE’

ReferenceCitation: Schöffski P, Wozniak A, Stacchiotti S, Rutkowski P, Blay JY, Lindner LH, Strauss SJ, Anthoney A, Duffaud F, Richter S, Grünwald V, Leahy MG, Reichardt P, Sufliarsky J, van der Graaf WT, Sciot R, Debiec-Rychter M, van Cann T, Marréaud S, Lia M, Raveloarivahy T, Collette L, Bauer S. Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 'CREATE'. Ann Oncol. 2017 Dec 1;28(12):3000-3008. doi: 10.1093/annonc/mdx527. Erratum in: Ann Oncol. 2019 Feb 1;30(2):344.

title: Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 ‘CREATE’

location_country:
Italy
United Kingdom
Netherlands
France
Poland
Slovakia
Norway
Belgium
Germany
Slovenia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen

location_facility: Oslo University Hospital - Radiumhospitalet

title: Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")

summary: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.


title: Open-Label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors

summary: This open-label, multicenter, dose-escalation study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors which are not amenable to standard treatment. In Part I (Dose Escalation), multiple ascending doses of RO5509554 will be administered as monotherapy in participants with solid tumors. Participants with locally advanced and/or metastatic ovarian (including fallopian tube) and breast carcinoma will receive multiple ascending doses of RO5509554 in combination with paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as monotherapy to participants with locally advanced and/or metastatic Pigmented Villonodular Synovitis (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant mesothelioma, ovarian (including fallopian tube), endometrial or breast cancer and pancreatic cancer. Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu negative breast cancer will receive RO5509554 in combination with paclitaxel. Anticipated time on study treatment is until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

ReferenceCitation: Cassier PA, Italiano A, Gomez-Roca C, Le Tourneau C, Toulmonde M, D'Angelo SP, Weber K, Loirat D, Jacob W, Jegg AM, Michielin F, Christen R, Watson C, Cannarile M, Klaman I, Abiraj K, Ries CH, Weisser M, Rüttinger D, Blay JY, Delord JP. Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour. Eur J Cancer. 2020 Dec;141:162-170. doi: 10.1016/j.ejca.2020.09.038. Epub 2020 Nov 5.

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: D'Angelo

full_name: Sandra P. D'Angelo

given: Sandra P.

family: Weber

full_name: Kristy Weber

given: Kristy

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Jacob

full_name: Wolfgang Jacob

given: Wolfgang

family: Jegg

full_name: Anna-Maria Jegg

given: Anna-Maria

family: Michielin

full_name: Francesca Michielin

given: Francesca

family: Christen

full_name: Randolph Christen

given: Randolph

family: Watson

full_name: Carl Watson

given: Carl

family: Cannarile

full_name: Michael Cannarile

given: Michael

family: Klaman

full_name: Irina Klaman

given: Irina

family: Abiraj

full_name: Keelara Abiraj

given: Keelara

family: Ries

full_name: Carola H. Ries

given: Carola H.

family: Weisser

full_name: Martin Weisser

given: Martin

family: Rüttinger

full_name: Dominik Rüttinger

given: Dominik

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

oa_host_type: publisher

ReferenceCitation: Gomez-Roca CA, Italiano A, Le Tourneau C, Cassier PA, Toulmonde M, D'Angelo SP, Campone M, Weber KL, Loirat D, Cannarile MA, Jegg AM, Ries C, Christen R, Meneses-Lorente G, Jacob W, Klaman I, Ooi CH, Watson C, Wonde K, Reis B, Michielin F, Rüttinger D, Delord JP, Blay JY. Phase I study of emactuzumab single agent or in combination with paclitaxel in patients with advanced/metastatic solid tumors reveals depletion of immunosuppressive M2-like macrophages. Ann Oncol. 2019 Aug 1;30(8):1381-1392. doi: 10.1093/annonc/mdz163.

ReferenceCitation: Cassier PA, Italiano A, Gomez-Roca CA, Le Tourneau C, Toulmonde M, Cannarile MA, Ries C, Brillouet A, Müller C, Jegg AM, Bröske AM, Dembowski M, Bray-French K, Freilinger C, Meneses-Lorente G, Baehner M, Harding R, Ratnayake J, Abiraj K, Gass N, Noh K, Christen RD, Ukarma L, Bompas E, Delord JP, Blay JY, Rüttinger D. CSF1R inhibition with emactuzumab in locally advanced diffuse-type tenosynovial giant cell tumours of the soft tissue: a dose-escalation and dose-expansion phase 1 study. Lancet Oncol. 2015 Aug;16(8):949-56. doi: 10.1016/S1470-2045(15)00132-1. Epub 2015 Jul 12.

ReferenceCitation: Ries CH, Cannarile MA, Hoves S, Benz J, Wartha K, Runza V, Rey-Giraud F, Pradel LP, Feuerhake F, Klaman I, Jones T, Jucknischke U, Scheiblich S, Kaluza K, Gorr IH, Walz A, Abiraj K, Cassier PA, Sica A, Gomez-Roca C, de Visser KE, Italiano A, Le Tourneau C, Delord JP, Levitsky H, Blay JY, Rüttinger D. Targeting tumor-associated macrophages with anti-CSF-1R antibody reveals a strategy for cancer therapy. Cancer Cell. 2014 Jun 16;25(6):846-59. doi: 10.1016/j.ccr.2014.05.016. Epub 2014 Jun 2.

title: Targeting Tumor-Associated Macrophages with Anti-CSF-1R Antibody Reveals a Strategy for Cancer Therapy

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale


title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

summary: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

lead_sponsor: Kythera Biopharmaceuticals


title: Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

acronym: Hemo-FAST

summary: The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

lead_sponsor: Swedish Orphan Biovitrum


title: Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population

summary: The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.

primary_purpose: Supportive Care

lead_sponsor: Wicab

location_facility: Hôpitaux Universitaires de Strasbourg, Reference Center for Rare Disorders in Ophthalmic Genetics


title: A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease

summary: This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease

lead_sponsor: Il-Yang Pharm. Co., Ltd.

location_facility:
CHU Limoges
CHU de Lyon HCL
Hôpital Nantes-Hotel Dieu
CHRU de Lille - Hôpital Roger Salengro
Hôpital Pitié-Salpêtrière
CHU de Rouen
Chu La Miletrie


ReferenceCitation: Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, Koetse W, Purcaru O, Bennett B, Burkhardt H. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015 May;74(5):843-50. doi: 10.1136/annrheumdis-2013-204632. Epub 2014 Jan 15.

family: Smolen

full_name: J S Smolen

given: J S

family: Emery

full_name: P Emery

given: P

family: Ferraccioli

full_name: G F Ferraccioli

given: G F

family: Samborski

full_name: W Samborski

given: W

family: Berenbaum

full_name: F Berenbaum

given: F

family: Davies

full_name: O R Davies

given: O R

family: Koetse

full_name: W Koetse

family: Purcaru

full_name: O Purcaru

given: O

family: Bennett

full_name: B Bennett

given: B

family: Burkhardt

full_name: H Burkhardt

given: H

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: UCB Pharma

location_country: Italy Austria France Poland Germany

acronym: CERTAIN

title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis


title: A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.

lead_sponsor: Centocor, Inc.

location_country:
Czech Republic
France
United Kingdom
Netherlands


title: Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

summary: The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

time_perspective: Retrospective

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Brazil
Sweden
South Africa
France
Thailand
Norway
United Kingdom


title: Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck

acronym: OPTINECK

summary:
Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment.

In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival.

While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.

lead_sponsor: Centre Henri Becquerel

location_facility:
CHRU Lille
Centre Guillaume le Conquérant
CH Saint-Quentin
CH Beauvais
Centre Henri Becquerel
Clinique du Parc
CHU Amiens


title: Dysautonomic Signs Among MECP2boys

summary: Dysautonomic signs are well known among girls with a Rett Syndrom. Rett syndrom is caused by a MECP2 mutation in 95% of cases. We want to search dysautonomic signs among boys with a MECP2 mutations because they are less studied than the girls and they have more varied phenotypes.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Lille
CHU de NIMES
Hospices Civiles de Lyon
Hôpital de la Timone
CHRU de Brest
Hôpital Robert Debre
CHU de Besançon

lead_sponsor_type: academique


title: Evelopment and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT

summary:
Only 5% of patients infected with COVID-19 develop severe or critical Coronavirus disease 2019 (COVID-19) and there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.

Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Arnaud-de-Villeneuve CHU de Montpellier


title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)

summary: 28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

lead_sponsor: Spyryx Biosciences, Inc.

location_country:
Italy
France
Portugal
Canada
United Kingdom

location_facility: Barts Health NHS Trust Saint Bartholomews Hospital

location_facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin

location_facility: Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa

location_facility: University of Calgary Heritage Medical Research Center

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Royal Devon and Exeter NHS Foundation Trust


title: A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

summary:
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase.

This is a two part study. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2.

ReferenceType: background

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, Margot N, Shao Y, Piontkowsky D, Das M, McNicholl IR, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V/I (GS-US-292-1824): Week 24 Results [Poster PE13/20]. 17th European AIDS Conference (EACS), 6-9 November 2019, Basel, Switzerland.

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single-Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 24 Results [Oral abstract]. 22nd International AIDS Conference, 23-27 July 2018, Amsterdam, The Netherlands.

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 12 Results [Poster]. XXVI International Workshop on HIV Drug Resistance and Treatment Strategies, 6-8 November 2017, Johannesburg, South Africa.

ReferenceCitation: Perez-Valero I, Llibre JM, Castagna A, Pulido F, Molina JM, Esser S, Margot N, Shao Y, Temme L, Piontkowsky D, McNicholl IR, Haubrich R. Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):490-495. doi: 10.1097/QAI.0000000000002595.

family: Perez-Valero

full_name: Ignacio Perez-Valero

given: Ignacio

family: Llibre

full_name: Josep M. Llibre

given: Josep M.

family: Castagna

full_name: Antonella Castagna

given: Antonella

family: Pulido

full_name: Federico Pulido

given: Federico

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Esser

full_name: Stefan Esser

given: Stefan

family: Margot

full_name: Nicolas Margot

given: Nicolas

family: Shao

full_name: Yongwu Shao

given: Yongwu

family: Temme

full_name: Lauren Temme

given: Lauren

family: Piontkowsky

full_name: David Piontkowsky

given: David

family: McNicholl

full_name: Ian R. McNicholl

given: Ian R.

family: Haubrich

full_name: Richard Haubrich

given: Richard

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Italy
United States
France
Spain
Germany

location_facility: CHU Tours Service de Médecine Internes et Maladies Infectieuses

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Hospital Universitario 12 de Octubre - Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Midway Immunology & Research Center, LLC


title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

acronym: COMMIT

summary: The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

ReferenceCitation: Hézode C, Almasio PL, Bourgeois S, Buggisch P, Brown A, Diago M, Horsmans Y, Serfaty L, Szalay F, Gaeta GB, Planas R, Schlag M, Lonjon-Domanec I, Omoruyi E, DeMasi R, Zeuzem S. Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1b and advanced liver disease. Liver Int. 2017 Sep;37(9):1304-1313. doi: 10.1111/liv.13376. Epub 2017 Mar 13.

name: Department of Hepatology and Gastroenterology; Hôpital Henri Mondor; Université Paris-Est; Créteil France

family: Hézode

full_name: Christophe Hézode

given: Christophe

name: Gastroenterology and Hepatology Unit; Di.Bi.M.I.S; University of Palermo; Palermo Italy

family: Almasio

full_name: Piero L. Almasio

given: Piero L.

name: Department of Gastroenterology and Hepatology; ZNA Campus Stuivenberg; Antwerp Belgium

family: Bourgeois

full_name: Stefan Bourgeois

name: Institute for Interdisciplinary Medicine at the Asklepios Klinik St. Georg; Hamburg Germany

family: Buggisch

full_name: Peter Buggisch

given: Peter

name: Department of Hepatology; St Mary's Hospital; Imperial College Healthcare NHS Trust; London UK

family: Brown

full_name: Ashley Brown

given: Ashley

name: Digestive Department; Valencia Hospital; Valencia Spain

family: Diago

full_name: Moises Diago

given: Moises

name: Department of Gastroenterology; Louvain Catholic University; Louvain Belgium

family: Horsmans

full_name: Yves Horsmans

given: Yves

name: Department of Hepatology; Hôpital Saint-Antoine; Paris France

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

name: 1st Department of Internal Medicine; Semmelweis University; Budapest Hungary

family: Szalay

full_name: Ferenc Szalay

given: Ferenc

name: Infectious Diseases; Department of Internal and Specialized Medicine; Second University of Naples; Naples Italy

family: Gaeta

full_name: Giovanni B. Gaeta

given: Giovanni B.

name: Hepatology Unit Hospital Germans Trias I Pujol and CIBERehd; Badalona Barcelona Spain

family: Planas

full_name: Ramon Planas

given: Ramon

family: Schlag

full_name: Michael Schlag

given: Michael

family: Lonjon-Domanec

full_name: Isabelle Lonjon-Domanec

given: Isabelle

name: Janssen Infectious Diseases BVBA; Beerse Belgium

family: Omoruyi

full_name: Edmund Omoruyi

given: Edmund

name: Janssen Research & Development LLC; Titusville NJ USA

family: DeMasi

full_name: Ralph DeMasi

given: Ralph

name: Department of Gastroenterology and Hepatology; J.W. Goethe University; Frankfurt Germany

family: Zeuzem

full_name: Stefan Zeuzem

journal_name: Liver International

lead_sponsor: Janssen-Cilag International NV

location_country:
France
Hungary
Belgium
Spain
Germany
United Kingdom


type: Registry Identifier

title: Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study

acronym: VVS-SAS

summary: This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.

ReferenceCitation: Puel V, Godard I, Papaioannou G, Gosse P, Pepin JL, Thoin F, Deharo JC, Roche F, Zarqane N, Gagnadoux F, Suehs CM, Molinari N. Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study. BMJ Open. 2020 Sep 30;10(9):e038791. doi: 10.1136/bmjopen-2020-038791.

family: Puel

full_name: Vincent Puel

given: Vincent

family: Godard

full_name: Isabelle Godard

family: Papaioannou

full_name: Georgios Papaioannou

given: Georgios

family: Gosse

full_name: Philippe Gosse

given: Philippe

family: Pepin

full_name: Jean Louis Pepin

given: Jean Louis

family: Thoin

full_name: Fabrice Thoin

given: Fabrice

family: Deharo

full_name: Jean Claude Deharo

given: Jean Claude

family: Roche

full_name: Frederic Roche

given: Frederic

family: Zarqane

full_name: Naïma Zarqane

given: Naïma

family: Gagnadoux

full_name: Frédéric Gagnadoux

given: Frédéric

family: Suehs

full_name: Carey Meredith Suehs

given: Carey Meredith

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

lead_sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)

location_country: Monaco France

location_facility: Public Assistance - Hospitals of Marseille


title: High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum

acronym: HAM

summary:
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.

It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.

The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.

The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Pierre Paul Riquet, CHU Purpan
Hôpital Laennec
Centre Hospitalier Lyon Sud
Groupe Hospitalier Pellegrin
Fondation A De Rothschild
CHU de Rouen
CHU Rennes


title: Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis: Study Protocol of a Randomized Double-blind Placebo-controlled Trial

acronym: GlutenSPA

summary: Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.

ReferenceCitation: Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.

family: Couderc

full_name: Marion Couderc

given: Marion

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Schaeverbeke

full_name: Thierry Schaeverbeke

given: Thierry

family: Thomas

full_name: Thierry Thomas

family: Chapurlat

full_name: Roland Chapurlat

given: Roland

family: Gaudin

full_name: Philippe Gaudin

family: Morel

full_name: Jacques Morel

given: Jacques

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Soubrier

full_name: Martin Soubrier

given: Martin

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin

intervention_type: Dietary Supplement


title: A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

summary: This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche


title: Respiratory Impairment in Mucopolysaccharidosis Patients: Impact of Glycosaminoglycans (GAG) on the Proteases/Antiproteases Balance

acronym: RespiGAG

summary: Mucopolysaccharidosis (MPS) are a group of inherited, metabolic diseases caused by a deficiency of lysosomal enzymes that degrade glycosaminoglycans (GAGs). Loss of their activity results in cellular accumulation of GAGs fragments leading to progressive multi-system manifestations, with respiratory impairment. The cellular and molecular mechanisms responsible for the pulmonary impairment remain largely unknown. Specific GAGs, such as those accumulating in MPS, may act as potent inhibitors of some respiratory enzymes, like lysosomal cathepsins, depending on the nature of GAGs and their concentration. It is well established that deregulation of cathepsins levels plays a major role in the pathophysiology of some chronic respiratory diseases, such as cystic fibrosis. The role of cathepsins and their inhibitors in respiratory samples of MPS patients has never been studied. This study will focus on the status/activity of these proteases and their endogenous inhibitors in the sputum or tracheal aspiration of patients with MPS. Our main hypothesis is that high levels of GAGs in MPS patients impair the physiological activity of cathepsins and their inhibitors.

ReferenceCitation: Khan SA, Peracha H, Ballhausen D, Wiesbauer A, Rohrbach M, Gautschi M, Mason RW, Giugliani R, Suzuki Y, Orii KE, Orii T, Tomatsu S. Epidemiology of mucopolysaccharidoses. Mol Genet Metab. 2017 Jul;121(3):227-240. doi: 10.1016/j.ymgme.2017.05.016. Epub 2017 May 26.

ReferenceCitation: Rapoport DM, Mitchell JJ. Pathophysiology, evaluation, and management of sleep disorders in the mucopolysaccharidoses. Mol Genet Metab. 2017 Dec;122S:49-54. doi: 10.1016/j.ymgme.2017.08.008. Epub 2017 Aug 25. Review.

ReferenceCitation: Kobayashi H. Recent trends in mucopolysaccharidosis research. J Hum Genet. 2019 Feb;64(2):127-137. doi: 10.1038/s10038-018-0534-8. Epub 2018 Nov 19. Review.

ReferenceCitation: Wilson S, Hashamiyan S, Clarke L, Saftig P, Mort J, Dejica VM, Brömme D. Glycosaminoglycan-mediated loss of cathepsin K collagenolytic activity in MPS I contributes to osteoclast and growth plate abnormalities. Am J Pathol. 2009 Nov;175(5):2053-62. doi: 10.2353/ajpath.2009.090211. Epub 2009 Oct 15.

ReferenceCitation: Lalmanach G, Saidi A, Marchand-Adam S, Lecaille F, Kasabova M. Cysteine cathepsins and cystatins: from ancillary tasks to prominent status in lung diseases. Biol Chem. 2015 Feb;396(2):111-30. doi: 10.1515/hsz-2014-0210. Review.

ReferenceCitation: Brömme D, Lecaille F. Cathepsin K inhibitors for osteoporosis and potential off-target effects. Expert Opin Investig Drugs. 2009 May;18(5):585-600. doi: 10.1517/13543780902832661 . Review.

ReferenceCitation: Baldo G, Tavares AM, Gonzalez E, Poletto E, Mayer FQ, Matte UD, Giugliani R. Progressive heart disease in mucopolysaccharidosis type I mice may be mediated by increased cathepsin B activity. Cardiovasc Pathol. 2017 Mar - Apr;27:45-50. doi: 10.1016/j.carpath.2017.01.001. Epub 2017 Jan 6.

ReferenceCitation: Sage J, Mallèvre F, Barbarin-Costes F, Samsonov SA, Gehrcke JP, Pisabarro MT, Perrier E, Schnebert S, Roget A, Livache T, Nizard C, Lalmanach G, Lecaille F. Binding of chondroitin 4-sulfate to cathepsin S regulates its enzymatic activity. Biochemistry. 2013 Sep 17;52(37):6487-98. doi: 10.1021/bi400925g. Epub 2013 Sep 4.

ReferenceCitation: Kubaski F, Tomatsu S, Patel P, Shimada T, Xie L, Yasuda E, Mason R, Mackenzie WG, Theroux M, Bober MB, Oldham HM, Orii T, Shaffer TH. Non-invasive pulmonary function test on Morquio patients. Mol Genet Metab. 2015 Aug;115(4):186-92. doi: 10.1016/j.ymgme.2015.06.007. Epub 2015 Jun 23.

lead_sponsor: University Hospital, Tours

location_facility: Metabolic Disease Competence Centre - Medical Genetics Department - University Hospital, Brest

location_facility: Metabolic Disease Reference Centre - Pediatrics Department - University Hospital, Toulouse

location_facility: Metabolic Disease Competence Centre - Pediatrics Department - University Hospital, Rennes

location_facility: Pediatric Resuscitation Unit - Universty Hospital, Tours

location_facility: Metabolic Disease Competence Centre - Medical Genetics Department - University Hospital, Angers

location_facility: Metabolic Disease Reference Centre - Pediatrics Department - University Hospital, Tours

location_facility: Metabolic Disease Reference Centre - Medical Genetics Department - University Hospital, Bordeaux


title: A Phase 1, FIH, Dose Escalation Study of JNJ-74856665 (Dihydroorotate Dehydrogenase [DHODH] Inhibitor) Alone or in Combination in Participants With AML or MDS

summary: The purpose of this study is to determine the safety, tolerability, maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of JNJ-74856665 as monotherapy and/or in combinations.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
France
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

lead_sponsor: Bristol-Myers Squibb

location_country: Italy Australia France Spain

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med


title: An Open-Label, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab With Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Japan
Spain

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


title: Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.

acronym: RECOMMEND

summary: Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study

ReferenceCitation: Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodríguez-Baño J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.

family: Ryan

full_name: Kellie Ryan

given: Kellie

family: Karve

full_name: Sudeep Karve

given: Sudeep

family: Peeters

full_name: Pascale Peeters

given: Pascale

family: Baelen

full_name: Elisa Baelen

given: Elisa

family: Potter

full_name: Danielle Potter

given: Danielle

family: Rojas-Farreras

full_name: Sonia Rojas-Farreras

given: Sonia

family: Pascual

full_name: Esther Pascual

given: Esther

family: Rodríguez-Baño

full_name: Jesús Rodríguez-Baño

given: Jesús

journal_name: Journal of Infection

ReferenceCitation: Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodríguez-Baño J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.

lead_sponsor: Pfizer

location_country:
Italy
Brazil
France
Greece
Russian Federation
Spain


title: A Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects With Primary Sjögren's Syndrome

summary: A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

lead_sponsor: MedImmune LLC

location_country:
United States
United Kingdom
Sweden
France


title: Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

summary:
Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.

Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.

Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.

For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Limoges
Kremlin Bicetre Hospital
Necker Hospital
HEGP
Lariboisière Hospital
Grenoble university hospital
Robert Debré Hospital


title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

acronym: PERSIST

summary: The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

ReferenceCitation: Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28.

family: Hupperts

full_name: Raymond Hupperts

given: Raymond

family: Becker

full_name: Veit Becker

given: Veit

family: Friedrich

full_name: Janne Friedrich

given: Janne

family: Gobbi

full_name: Claudio Gobbi

given: Claudio

family: Salgado

full_name: Antonio Vasco Salgado

given: Antonio Vasco

family: Sperling

full_name: Bjørn Sperling

given: Bjørn

family: You

full_name: Xiaojun You

given: Xiaojun

journal_name: Expert Opinion on Drug Delivery

publisher: Informa Healthcare

lead_sponsor: Biogen

location_country:
Sweden
Switzerland
Netherlands
France
Slovakia
Norway
Portugal
Denmark
Germany
United Kingdom


lead_sponsor: Bayer

location_country: Italy Sweden Netherlands Finland France Spain Germany

title: A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

summary:
This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

summary: The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

ReferenceCitation: D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Sandborn

full_name: William J Sandborn

given: William J

family: Colombel

full_name: Jean Frederic Colombel

given: Jean Frederic

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Brown

full_name: Kurt Brown

given: Kurt

family: Barkay

full_name: Hadas Barkay

given: Hadas

family: Sakov

full_name: Anat Sakov

given: Anat

family: Haviv

full_name: Asi Haviv

given: Asi

family: Feagan

full_name: Brian G Feagan

given: Brian G

journal_name: Gut

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
South Africa
Netherlands
France
Poland
Israel
Belgium
Spain
United Kingdom

location_facility:
Teva Investigational Site 5362
Teva Investigational Site 5361
Teva Investigational Site 3430
Teva Investigational Site 3820
Teva Investigational Site 3158
Teva Investigational Site 3819
Teva Investigational Site 8050
Teva Investigational Site 8046
Teva Investigational Site 3069
Teva Investigational Site 3070
Teva Investigational Site 5360
Teva Investigational Site 9009
Teva Investigational Site 5352
Teva Investigational Site 3713
Teva Investigational Site 8048
Teva Investigational Site 8051
Teva Investigational Site 3711
Teva Investigational Site 3164
Teva Investigational Site 5351
Teva Investigational Site 3429
Teva Investigational Site 9013
Teva Investigational Site 3432
Teva Investigational Site 3160
Teva Investigational Site 9017
Teva Investigational Site 3428
Teva Investigational Site 5363
Teva Investigational Site 8047
Teva Investigational Site 5350
Teva Investigational Site 3072
Teva Investigational Site 5353
Teva Investigational Site 5355
Teva Investigational Site 8049
Teva Investigational Site 5354
Teva Investigational Site 3712