title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment

acronym: EQOLOC

summary: Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.

ReferenceCitation: Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z. Review.

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

family: Mallet

full_name: Luc Mallet

given: Luc

family: Polosan

full_name: Mircea Polosan

given: Mircea

family: Jaafari

full_name: Nematollah Jaafari

given: Nematollah

family: Baup

full_name: Nicolas Baup

given: Nicolas

family: Welter

full_name: Marie-Laure Welter

given: Marie-Laure

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Montcel

full_name: Sophie Tezenas du Montcel

given: Sophie Tezenas du

family: Yelnik

full_name: Jérôme Yelnik

given: Jérôme

family: Chéreau

full_name: Isabelle Chéreau

given: Isabelle

family: Arbus

full_name: Christophe Arbus

given: Christophe

family: Raoul

full_name: Sylvie Raoul

given: Sylvie

family: Aouizerate

full_name: Bruno Aouizerate

given: Bruno

family: Damier

full_name: Philippe Damier

given: Philippe

family: Chabardès

full_name: Stephan Chabardès

given: Stephan

family: Czernecki

full_name: Virginie Czernecki

given: Virginie

family: Ardouin

full_name: Claire Ardouin

given: Claire

family: Krebs

full_name: Marie-Odile Krebs

given: Marie-Odile

family: Bardinet

full_name: Eric Bardinet

given: Eric

family: Chaynes

full_name: Patrick Chaynes

given: Patrick

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

family: Cornu

full_name: Philippe Cornu

family: Derost

full_name: Philippe Derost

family: Bougerol

full_name: Thierry Bougerol

title: Subthalamic Nucleus Stimulation in Severe Obsessive–Compulsive Disorder

ReferenceCitation: Kohl S, Schönherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.

ReferenceCitation: Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.

ReferenceCitation: Mataix-Cols D, Fernández de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299.

ReferenceCitation: Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardès S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.

ReferenceCitation: Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.

location_country: Italy Sweden Switzerland France Israel Germany

location_facility: University Hospital of Grenoble Michallon

location_facility: Hadassah Medical Center The Hebrew University


title: Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)

acronym: STRENGTH

summary: The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: European Cardiovascular Research Center

location_country: Germany France

location_facility:
St Josefs Hospital
Hôpital Privé Jacques Cartier
Universitätsklinikum Bonn
Clinique Pasteur
CHU Rangueil
Hôpital Privé Claude Galien
Cardiovasculares Centrum Frankfurt

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

acronym: SMILE

summary:
A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.

The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Habteab A, Castañeda J, de Valk H, Choudhary P, Bosi E, Lablanche S, de Portu S, Da Silva J, Vorrink-de Groot L, Shin J, Cohen O. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial. Diabetes Technol Ther. 2020 Sep;22(9):681-685. doi: 10.1089/dia.2019.0495.

name: Medtronic Bakken Research Center, Maastricht, The Netherlands.

family: Habteab

full_name: Aklilu Habteab

given: Aklilu

sequence: first

family: Castañeda

full_name: Javier Castañeda

given: Javier

sequence: additional

name: Department of Internal Medicine, University Medical Center, Utrecht, The Netherlands.

family: de Valk

full_name: Harold de Valk

given: Harold

name: Department of Internal Medicine King's College Hospital, Diabetes Research Group, London, United Kingdom.

family: Choudhary

full_name: Pratik Choudhary

given: Pratik

name: Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milano, Italy.

family: Bosi

full_name: Emanuele Bosi

given: Emanuele

name: Department of Diabetology, Grenoble University Hospital, Service d'Endocrinologie, Grenoble, France.

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

name: Medtronic International Trading Sàrl, Tolochenaz, Switzerland.

family: de Portu

full_name: Simona de Portu

given: Simona

family: Da Silva

full_name: Julien Da Silva

given: Julien

family: Vorrink-de Groot

full_name: Linda Vorrink-de Groot

given: Linda

family: Shin

full_name: John Shin

given: John

family: Cohen

full_name: Ohad Cohen

given: Ohad

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Technology & Therapeutics

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

ReferenceCitation: Bosi E, Choudhary P, de Valk HW, Lablanche S, Castañeda J, de Portu S, Da Silva J, Ré R, Vorrink-de Groot L, Shin J, Kaufman FR, Cohen O; SMILE Study Group. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.

full_name: Harold W de Valk

given: Harold W

location_facility:
Ospedale S. Raffaele
Ospedale S. Gionanni di Dio
APHM - La Conception
Maasstad Ziekenhuis
UMC Utrecht
CHU Montpellier - Hôpital Lapeyronie
Manchester Diabetes Center
King's College London
Harrogate District Hospital
CHU Grenoble
Groene Hart Ziekenhuis
Isala
Ospedale Papa Giovanni XXIII
CHU de Besançon


publications_result: Powles, T., et al., A phase II study investigating the safety and efficacy of neoadjuvant atezolizumab in muscle invasive bladder cancer (ABACUS). Journal of Clinical Oncology, 2018. 36(15_suppl): p. 4506-4506.

ReferenceType: result

ReferenceCitation: Powles T, Kockx M, Rodriguez-Vida A, Duran I, Crabb SJ, Van Der Heijden MS, Szabados B, Pous AF, Gravis G, Herranz UA, Protheroe A, Ravaud A, Maillet D, Mendez MJ, Suarez C, Linch M, Prendergast A, van Dam PJ, Stanoeva D, Daelemans S, Mariathasan S, Tea JS, Mousa K, Banchereau R, Castellano D. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial. Nat Med. 2019 Nov;25(11):1706-1714. doi: 10.1038/s41591-019-0628-7. Epub 2019 Nov 4. Erratum in: Nat Med. 2020 Jun;26(6):983.

family: Powles

full_name: Thomas Powles

given: Thomas

family: Kockx

full_name: Mark Kockx

given: Mark

family: Rodriguez-Vida

full_name: Alejo Rodriguez-Vida

given: Alejo

family: Duran

full_name: Ignacio Duran

given: Ignacio

family: Crabb

full_name: Simon J. Crabb

given: Simon J.

family: Van Der Heijden

full_name: Michiel S. Van Der Heijden

given: Michiel S.

family: Szabados

full_name: Bernadett Szabados

given: Bernadett

family: Pous

full_name: Albert Font Pous

given: Albert Font

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Herranz

full_name: Urbano Anido Herranz

given: Urbano Anido

family: Protheroe

full_name: Andrew Protheroe

given: Andrew

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Maillet

full_name: Denis Maillet

given: Denis

family: Mendez

full_name: Maria Jose Mendez

given: Maria Jose

family: Suarez

full_name: Cristina Suarez

given: Cristina

family: Linch

full_name: Mark Linch

family: Prendergast

full_name: Aaron Prendergast

given: Aaron

family: van Dam

full_name: Pieter-Jan van Dam

given: Pieter-Jan

family: Stanoeva

full_name: Diana Stanoeva

given: Diana

family: Daelemans

full_name: Sofie Daelemans

given: Sofie

family: Mariathasan

full_name: Sanjeev Mariathasan

given: Sanjeev

family: Tea

full_name: Joy S. Tea

given: Joy S.

family: Mousa

full_name: Kelly Mousa

given: Kelly

family: Banchereau

full_name: Romain Banchereau

given: Romain

family: Castellano

full_name: Daniel Castellano

repository_institution: University of Southampton - ePrints Soton

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

repository_institution: University College London - UCL Discovery

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

title: A Phase II Study Investigating Preoperative MPDL3280A in Operable Transitional Cell Carcinoma of the Bladder (ABACUS)

summary: ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data.


title: Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

summary:
Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance.

Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Switzerland
Netherlands
Spain
France
Poland
Greece
Israel
Georgia
Hungary
Portugal
Germany
United Kingdom
Korea, Republic of

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Herz- und Gefäßzentrum Oberallgäu-Kempten

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2

status_simplified: Completed


title: A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma

summary: CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.

status: Active, not recruiting

ReferenceCitation: Michot JM, Bouabdallah R, Vitolo U, Doorduijn JK, Salles G, Chiappella A, Zinzani PL, Bijou F, Kersten MJ, Sarmiento R, Mosulen S, Mendez C, Uttamsingh S, Pourdehnad M, Hege K, Chen T, Klein C, Hagner PR, Nikolova Z, Ribrag V. Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study. Lancet Haematol. 2020 Sep;7(9):e649-e659. doi: 10.1016/S2352-3026(20)30208-8. Epub 2020 Aug 3.

family: Michot

full_name: Jean-Marie Michot

given: Jean-Marie

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Vitolo

full_name: Umberto Vitolo

given: Umberto

family: Doorduijn

full_name: Jeanette K Doorduijn

given: Jeanette K

family: Salles

full_name: Gilles Salles

given: Gilles

family: Chiappella

full_name: Annalisa Chiappella

given: Annalisa

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Bijou

full_name: Fontanet Bijou

given: Fontanet

family: Kersten

full_name: Marie José Kersten

given: Marie José

family: Sarmiento

full_name: Rafael Sarmiento

given: Rafael

family: Mosulen

full_name: Silvia Mosulen

given: Silvia

full_name: Cristina Mendez

family: Uttamsingh

full_name: Shailaja Uttamsingh

given: Shailaja

family: Pourdehnad

full_name: Michael Pourdehnad

given: Michael

family: Hege

full_name: Kristen Hege

given: Kristen

family: Chen

full_name: Tianlei Chen

given: Tianlei

family: Klein

full_name: Christian Klein

given: Christian

family: Hagner

full_name: Patrick R Hagner

given: Patrick R

family: Nikolova

full_name: Zariana Nikolova

given: Zariana

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Celgene

location_country: Italy France Netherlands

location_facility: Institute of Hematology and Medical Oncology L. and A. Seragnoli

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

intervention_type: Drug


type: EudraCT Number

title: A Phase III, Double Blind, Randomised, Placebo Controlled Study To Assess The Efficacy And Safety Of A Single Treatment Of Clostridium Botulinum Toxin Type A To Improve The Appearance Of Moderate To Severe Glabellar Lines

acronym: BTX-A-HAC NG

summary: The purpose of this study was to demonstrate the safety and the efficacy of a single treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used for the improvement in the appearance of moderate to severe glabellar lines (the lines between the eyebrows).

lead_sponsor: Ipsen

location_facility: Rzany & Hund Privatpraxis für Dermatologie


ReferenceCitation: Geoerger B, Morland B, Jiménez I, Frappaz D, Pearson ADJ, Vassal G, Maeda P, Kincaide J, Mueller U, Schlief S, Teufel M, Ploeger BA, Cleton A, Agostinho AC, Marshall LV. Phase 1 dose-escalation and pharmacokinetic study of regorafenib in paediatric patients with recurrent or refractory solid malignancies. Eur J Cancer. 2021 Aug;153:142-152. doi: 10.1016/j.ejca.2021.05.023. Epub 2021 Jun 20.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Morland

full_name: Bruce Morland

given: Bruce

family: Jiménez

full_name: Irene Jiménez

given: Irene

family: Frappaz

full_name: Didier Frappaz

given: Didier

family: Pearson

full_name: Andrew D.J. Pearson

given: Andrew D.J.

family: Vassal

full_name: Gilles Vassal

family: Maeda

full_name: Patricia Maeda

given: Patricia

family: Kincaide

full_name: Jasmine Kincaide

given: Jasmine

family: Mueller

full_name: Udo Mueller

given: Udo

family: Schlief

full_name: Sarah Schlief

given: Sarah

family: Teufel

full_name: Michael Teufel

family: Ploeger

full_name: Bart A. Ploeger

given: Bart A.

family: Cleton

full_name: Adriaan Cleton

given: Adriaan

family: Agostinho

full_name: Andrea C. Agostinho

given: Andrea C.

family: Marshall

full_name: Lynley V. Marshall

given: Lynley V.

bso_classification: Chemistry

journal_name: European Journal of Cancer

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

design_allocation: Non-Randomized

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

primary_purpose: Other

location_country:
Italy
United Kingdom
France
Spain

ipd_sharing: No

source: euctr

title: A Multi-center, Open-label, Non-randomized, Phase I Dose Escalation Study of Regorafenib (BAY 73-4506) in Pediatric Subjects With Solid Malignant Tumors That Are Recurrent or Refractory to Standard Therapy.

summary:
Dose escalation phase of the study :

To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors recurrent or refractory to standard therapy. To characterize the pharmacokinetics (PK) of regorafenib The dose escalation phase of the study has been completed.

Expansion phase:

To define the safety profile, MTD and the RP2D of regorafenib administered orally in combination with backbone chemotherapy (vincristine and irinotecan) at relapse in pediatric subjects with rhabdomyosarcoma (RMS) and other solid malignant tumors recurrent or refractory to standard therapy.

status_simplified: Ongoing


title: A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria

summary: The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

lead_sponsor: OxThera

location_country:
Germany
United Kingdom
France

location_facility: Hôpital Necker-Enfants Malades,Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA)

location_facility: Universitätsklinikum Bonn, Dept of Paediatric Nephrology

location_facility: Birmingham Children's Hospital NHS Foundation Trust - Dept of Nephrology

location_facility: Royal Free Hospital -UCL Centre for Nephrology

location_facility: Hôpital Femme Mère Enfant, Lyon - Paediatric Dept

location_facility: Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest (SORARE), CHU de Bordeaux

location_facility: Hôpital Robert-Debré, Néphrologie Pédiatrique

location_facility: Great Ormond Street Hospital for Children NHS Trust


lead_sponsor: Italfarmaco

location_country:
Italy
France
Poland
Germany
United Kingdom

location_facility: Azienda Ospedaliero-Universitaria Careggi, Florence

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: Azienda ospedaliero universitaria Consorziale Policlinico di Bari

location_facility: Università degli Studi di Napoli Federico II, Facoltà di Medicina e Chirurgia

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hopital Saint Vincent de Paul - GHICL Lille

location_facility: Hôpital Saint-Louis (AP-HP), Centre Investigations Cliniques

location_facility: Istituto Tumori Giovanni Paolo II - IRCCS Ospedale Oncologico di Bari

title: A Two-part Study Top Assess the Safety and Preliminary Efficacy of Givinostat in Patients With JAK2V617F Positive Polycythemia Vera

summary:
This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or Part B and transition from one part to the other is not allowed.

Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization criteria. Only if the enrolment in Part A is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may be expanded to all patients with chronic myeloproliferative neoplasms.

Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e. at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study. All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess the clinico-haematological response.

The study will last up to a maximum of 24 weeks of treatment. However, after completion of the trial, all patients achieving clinical benefit will be allowed to continue treatment with Givinostat (at the same dose and schedule) in a long-term study.

Safety will be monitored at each visit throughout the entire duration of the study. Treatment will be administered on an outpatient basis and patients will be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalization, the treatment will be continued or interrupted according to the Investigators' decision.


title: Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).

summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country: Italy Germany France


title: A Phase 2A, Open-label Dose Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With BETA(b)-THALASSEMIA.

summary: Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

ReferenceType: background

ReferenceCitation: Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galactéros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor β ligand trap, improves anemia in β-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.

ReferenceCitation: Cappellini M, et al. A Phase 2a, Open-Label, Dose-Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta ( )-Thalassemia: Interim Results. Presented at the 55th Annual Meeting of the American Society of Hematology (ASH), December 7-10, 2013, New Orleans, LA. Abstract No. 3448

ReferenceCitation: "Porter J, et al. Interim Results From a Phase 2A, Open-Label, Dose-Finding Study To Determine The Safety, Efficacy, And Tolerability of Sotatercept (ACE-001) In Adults with Beta-Thalassemia. Presented at the 19thCongress of the European Hematology Association, June 12-15, 2015, Milan, Italy. Abstract No. S622 "

location_country:
Italy
United Kingdom
France
Greece

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Universita degli Studi di Cagliari - ASL8


title: A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines

summary: The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

location_facility:
Charité hospital
Private practice
Private clinic


title: Phase 2b Study to Select a Once Daily Oral Dose of GSK2248761 Administered With Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

acronym: SIGNET

summary: This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.

status: Terminated

ReferenceCitation: 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992 Dec 18;41(RR-17):1-19.

lead_sponsor: ViiV Healthcare

location_country: Germany France Spain


type: Other Identifier

title: A LONG-TERM, PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF THE SAFETY AND EFFECTIVENESS OF ETANERCEPT IN THE TREATMENT OF PAEDIATRIC PSORIASIS PATIENTS IN A NATURALISTIC SETTING: A POST-AUTHORISATION SAFETY STUDY (PASS)

acronym: PURPOSE

summary:
Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis.

Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.

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 Netherlands Spain France Greece Hungary Portugal Germany

location_facility: Universita degli Studi di Napoli Federico II

location_facility: University of Athens, Andreas Syngros Hospital

location_facility: Centre Hospitalier Victor Dupouy / Service de Dermatologie

location_facility: Kinderklinik der Johannes-Gutenberg Universitat Mainz

location_facility: Università Cattolica del Sacro Cuore Policlinico A.


ReferenceCitation: Novello S, Besse B, Felip E, Barlesi F, Mazieres J, Zalcman G, von Pawel J, Reck M, Cappuzzo F, Ferry D, Carcereny E, Santoro A, Garcia-Ribas I, Scagliotti G, Soria JC. A phase II randomized study evaluating the addition of iniparib to gemcitabine plus cisplatin as first-line therapy for metastatic non-small-cell lung cancer. Ann Oncol. 2014 Nov;25(11):2156-2162. doi: 10.1093/annonc/mdu384. Epub 2014 Aug 19.

family: Novello

full_name: S. Novello

given: S.

family: Besse

full_name: B. Besse

given: B.

family: Felip

full_name: E. Felip

given: E.

family: Barlesi

full_name: F. Barlesi

given: F.

family: Mazieres

full_name: J. Mazieres

given: J.

family: Zalcman

full_name: G. Zalcman

given: G.

family: von Pawel

full_name: J. von Pawel

family: Reck

full_name: M. Reck

given: M.

family: Cappuzzo

full_name: F. Cappuzzo

family: Ferry

full_name: D. Ferry

given: D.

family: Carcereny

full_name: E. Carcereny

family: Santoro

full_name: A. Santoro

given: A.

family: Garcia-Ribas

full_name: I. Garcia-Ribas

given: I.

family: Scagliotti

full_name: G. Scagliotti

family: Soria

full_name: J.-C. Soria

journal_name: Annals of Oncology

oa_colors: green hybrid

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

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

lead_sponsor: Sanofi

location_country:
Italy
France
Spain
Germany
United Kingdom

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 276003

location_facility: Sanofi-Aventis Investigational Site Number 826001

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 250003

title: Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer

summary:
Primary Objective:

to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin (GC) in patients with stage IV non small cell lung cancer.

Secondary objectives are:

to assess the safety profiles of the study combination GCS and of the standard regimen GC;
to assess the progression free survival and the overall survival in both arms;
to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease.
to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United Kingdom
France
Netherlands

title: A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Chronic Phase (CP) Ph+ CML, With CP or Accelerated Phase (AP) Ph+ CML Resistant/Intolerant to Imatinib and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

summary: This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.


lead_sponsor: Bristol-Myers Squibb

location_country: Italy Netherlands Poland France Romania Spain Germany

title: A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure

summary: The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.


title: A PHASE I/IIa DOSE ESCALATION STUDY IN ASIA OF REPEATED ADMINISTRATION OF "CYT107" (Glyco-r-hIL-7) ADDED ON TREATMENT IN GENOTYPE 1 HCV INFECTED PATIENTS RESISTANT TO PEGYLATED INTERFERON-ALPHA AND RIBAVIRIN

acronym: ECLIPSE 1

summary: This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.

lead_sponsor: Cytheris SA

location_country: Italy France Switzerland

location_facility: Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi


title: A Phase I/IIa Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Add-On Treatment in Genotype 1 or 4 Hcv Infected Patients Resistant to Pegylated Interferon-Alpha and Ribavirin

acronym: Eclipse 2

summary: This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.


title: A Multi-center, Randomized, Double-blind, Controlled Dose-finding Study to Evaluate the Safety and Efficacy of MP4OX Treatment Plus Standard of Care in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and and as a result of its molecular size and unique oxygen dissociation characteristics, targets oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.

ReferenceCitation: Olofsson C, Ahl T, Johansson T, Larsson S, Nellgård P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63.

ReferenceCitation: Olofsson C, Nygårds EB, Ponzer S, Fagrell B, Przybelski R, Keipert PE, Winslow N, Winslow RM. A randomized, single-blind, increasing dose safety trial of an oxygen-carrying plasma expander (Hemospan) administered to orthopaedic surgery patients with spinal anaesthesia. Transfus Med. 2008 Feb;18(1):28-39. doi: 10.1111/j.1365-3148.2007.00811.x.

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. Epub 2004 Jan 16.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. Epub 2006 Jul 20.

ReferenceCitation: van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Górecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.

lead_sponsor: Sangart

location_country:
South Africa
Germany
United Kingdom
France


ReferenceCitation: Steigerwald I, Müller M, Kujawa J, Balblanc JC, Calvo-Alén J. Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study. J Pain Res. 2012;5:121-38. doi: 10.2147/JPR.S30540. Epub 2012 Jun 15.

family: Steigerwald

full_name: Ilona Steigerwald

given: Ilona

family: Müller

full_name: Müller

family: Kujawa

full_name: Kujawa

family: Balblanc

full_name: Balblanc

family: Calvo-Alén

full_name: Calvo-Alén

currency_apc_doaj: USD

journal_name: Journal of Pain Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Grünenthal GmbH

location_country:
France
Poland
Spain
Germany
United Kingdom

location_facility:
Site 08
Site 2
Site 5
Site 06
Site 3
Site 4
Site 1
Site 7
Site 6
Site 8
Site 9

title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.


title: Immunological Equivalence Between GSK2340272A and GSK2340274A Influenza Vaccines in Adults Aged 18 to 60 Years

summary: The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.

ReferenceCitation: Launay O, Duval X, Fitoussi S, Jilg W, Kerdpanich A, Montellano M, Schwarz TF, Watanveerade V, Wenzel JJ, Zalcman G, Bambure V, Li P, Caplanusi A, Madan A, Gillard P, Vaughn DW. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 2013 Sep 16;13:435. doi: 10.1186/1471-2334-13-435.

family: Launay

full_name: Odile Launay

given: Odile

family: Duval

full_name: Xavier Duval

given: Xavier

family: Fitoussi

full_name: Serge Fitoussi

given: Serge

family: Jilg

full_name: Wolfgang Jilg

given: Wolfgang

family: Kerdpanich

full_name: Angkool Kerdpanich

given: Angkool

family: Montellano

full_name: May Montellano

given: May

family: Schwarz

full_name: Tino F Schwarz

given: Tino F

family: Watanveerade

full_name: Veerachai Watanveerade

given: Veerachai

family: Wenzel

full_name: Jürgen J Wenzel

given: Jürgen J

full_name: Gerard Zalcman

given: Gerard

family: Bambure

full_name: Vinod Bambure

given: Vinod

family: Li

full_name: Ping Li

given: Ping

family: Caplanusi

full_name: Adrian Caplanusi

given: Adrian

family: Madan

full_name: Anuradha Madan

given: Anuradha

family: Gillard

full_name: Paul Gillard

given: Paul

family: Vaughn

full_name: David W Vaughn

given: David W

currency_apc_doaj: GBP

journal_name: BMC Infectious Diseases

repository_institution: Uni Regensburg - Publikationsserver der Universität Regensburg

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

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

repositories:
HAL
PubMed Central
epub.uni-regensburg.de

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


title: A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and Older

summary: The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

ReferenceCitation: Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2.

family: Laurichesse

full_name: Henri Laurichesse

given: Henri

family: Zimmermann

full_name: Ulrich Zimmermann

given: Ulrich

family: Galtier

full_name: Florence Galtier

given: Florence

family: Richard

full_name: Patrick Richard

given: Patrick

family: Sadorge

full_name: Christine Sadorge

given: Christine

family: Soubeyrand

full_name: Benoit Soubeyrand

given: Benoit

journal_name: Human Vaccines & Immunotherapeutics

evidence: open (via free pdf)

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_facility: Hôpital Gabriel Montpied - CHU Clermont-Ferrand

location_facility: Groupe Hospitalier Cochin - Saint-Vincent de Paul

intervention_type: Biological

lead_sponsor_type: academique


ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

family: Dimopoulos

full_name: M. A. Dimopoulos

given: M. A.

family: Orlowski

full_name: R. Z. Orlowski

given: R. Z.

family: Facon

full_name: T. Facon

given: T.

family: Sonneveld

full_name: P. Sonneveld

given: P.

family: Anderson

full_name: K. C. Anderson

given: K. C.

family: Beksac

full_name: M. Beksac

given: M.

family: Benboubker

full_name: L. Benboubker

given: L.

family: Roddie

full_name: H. Roddie

given: H.

family: Potamianou

full_name: A. Potamianou

given: A.

family: Couturier

full_name: C. Couturier

given: C.

family: Feng

full_name: H. Feng

family: Ataman

full_name: O. Ataman

given: O.

family: van de Velde

full_name: H. van de Velde

family: Richardson

full_name: P. G. Richardson

given: P. G.

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

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

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Janssen-Cilag International NV

location_country:
Serbia
France
Poland
Lithuania
Greece
Hungary
Spain
Turkey
Germany
United Kingdom

acronym: SEQUENTIAL

title: Efficacy and Safety of Velcade Plus Dexamethasone (VD), VD+Cyclophosphamide or VD Plus Lenalidomide in MMY Patients Who Are Refractory or Have Relapsed After Their Primary Therapy for MMY and Have Achieved Stable Disease After 4 Cycles of VD

summary: The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.


title: A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate

summary:
This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is <100 individuals.

location_country:
Switzerland
Netherlands
Poland
France
Greece
Spain
Germany
United Kingdom


title: An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

summary: This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

location_country:
Netherlands
France
Spain
Germany
United Kingdom


title: Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.

acronym: RHODES

summary: The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.

ReferenceCitation: Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104.

ReferenceCitation: Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21.

ReferenceCitation: Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.

name: Department of NephrologyHôpital BraboisCHU Vandoeuvre‐lès‐Nancy France

family: Kessler

full_name: Michèle Kessler

given: Michèle

family: Gangemi

full_name: Concetta Gangemi

given: Concetta

family: Gutierrez Martones

full_name: Alberto Gutierrez Martones

given: Alberto

family: Lacombe

full_name: Jean‐Louis Lacombe

given: Jean‐Louis

family: Krier‐Coudert

full_name: Marie‐Jeanne Krier‐Coudert

given: Marie‐Jeanne

family: Galland

full_name: Roula Galland

given: Roula

family: Kielstein

full_name: Jan T. Kielstein

given: Jan T.

family: Moureau

full_name: Frédérique Moureau

given: Frédérique

family: Loughraieb

full_name: Nathalie Loughraieb

given: Nathalie

journal_name: Hemodialysis International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Heparin‐grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: A prospective proof‐of‐concept study

lead_sponsor: Baxter Healthcare Corporation

location_country: Italy Germany Sweden France

location_facility:
Medizinische Hochschule
Borgo Trento Hospital
ALTIR Dialysis center
Calydial dialysis unit
Clinique St Exupéry
Karolinska Hospital
Hopital Brabois

intervention_type: Device


title: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

summary:
This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

lead_sponsor: Genzyme, a Sanofi Company

location_country: Sweden France

location_facility:
Chu Hotel Dieu
Akademiska Sjukhuset
Hopital Lariboisiere
CHRU de Lille, Hopital Huriez
Hopital de la Croix Rousse
University Hospital
Karolinska University Hospital


title: A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-endocrine Tumors

summary: To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

location_country:
Italy
Sweden
Netherlands
Poland
France
Spain
Germany
United Kingdom


title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

summary:
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

To assess how well treatment with pemetrexed works for patients with your type of cancer
To assess for any side effects that might be associated with pemetrexed.
To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.

lead_sponsor: Eli Lilly and Company

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.


lead_sponsor: Novo Nordisk A/S

location_country: Germany France

title: An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy

summary: This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.


ReferenceCitation: Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. doi: 10.3324/haematol.2011.053173. Epub 2012 Feb 7.

family: Renner

full_name: C. Renner

family: Zinzani

full_name: P. L. Zinzani

given: P. L.

family: Gressin

full_name: R. Gressin

given: R.

family: Klingbiel

full_name: D. Klingbiel

given: D.

family: Dietrich

full_name: P.-Y. Dietrich

family: Hitz

full_name: F. Hitz

given: F.

family: Bargetzi

full_name: M. Bargetzi

family: Mingrone

full_name: W. Mingrone

given: W.

family: Martinelli

full_name: G. Martinelli

given: G.

family: Trojan

full_name: A. Trojan

family: Bouabdallah

full_name: K. Bouabdallah

given: K.

family: Lohri

full_name: A. Lohri

family: Gyan

full_name: E. Gyan

given: E.

family: Biaggi

full_name: C. Biaggi

family: Cogliatti

full_name: S. Cogliatti

given: S.

family: Bertoni

full_name: F. Bertoni

family: Ghielmini

full_name: M. Ghielmini

family: Brauchli

full_name: P. Brauchli

given: P.

family: Ketterer

full_name: N. Ketterer

given: N.

name: on behalf of the Swiss SAKK and the French GOELAMS group from the European Mantle Cell Lymphoma Network

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Swiss Group for Clinical Cancer Research

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Centre Hospitalier Universitaire Vaudois

title: Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma

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

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.


title: A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.

summary: The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

ReferenceCitation: Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12.

family: Eisen

full_name: T Eisen

given: T

family: Marais

full_name: R Marais

given: R

family: Affolter

full_name: A Affolter

given: A

family: Lorigan

full_name: P Lorigan

given: P

family: Robert

full_name: C Robert

given: C

family: Corrie

full_name: P Corrie

family: Ottensmeier

full_name: C Ottensmeier

family: Chevreau

full_name: C Chevreau

family: Chao

full_name: D Chao

given: D

family: Nathan

full_name: P D Nathan

given: P D

family: Jouary

full_name: T Jouary

family: Harries

full_name: M Harries

given: M

family: Negrier

full_name: S Negrier

given: S

family: Montegriffo

full_name: E Montegriffo

given: E

family: Ahmad

full_name: T Ahmad

family: Gibbens

full_name: I Gibbens

given: I

family: James

full_name: M G James

given: M G

family: Strauss

full_name: U P Strauss

given: U P

family: Prendergast

full_name: S Prendergast

family: Gore

full_name: M E Gore

given: M E

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa


title: Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer

summary: The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.

lead_sponsor: R-Pharm

location_country: Italy France Greece Spain Turkey


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.

location_country: Italy Netherlands France Spain Germany

ipd_sharing: Yes

title: A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer

summary: The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.


title: Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain

acronym: e-CARE

summary:
Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations.

The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is <2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is > 1 (positive rule).

The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire de Rennes


title: International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis

summary:
This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients

The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A&B study which was conducted in the same patient population.

ReferenceCitation: Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmelé T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5). pii: 98960. doi: 10.1172/jci.insight.98960.

family: Francois

full_name: Bruno Francois

given: Bruno

family: Jeannet

full_name: Robin Jeannet

given: Robin

family: Daix

full_name: Thomas Daix

given: Thomas

family: Walton

full_name: Andrew H. Walton

given: Andrew H.

family: Shotwell

full_name: Matthew S. Shotwell

given: Matthew S.

family: Unsinger

full_name: Jacqueline Unsinger

given: Jacqueline

family: Monneret

full_name: Guillaume Monneret

given: Guillaume

family: Rimmelé

full_name: Thomas Rimmelé

family: Blood

full_name: Teresa Blood

given: Teresa

family: Morre

full_name: Michel Morre

given: Michel

family: Gregoire

full_name: Anne Gregoire

given: Anne

family: Mayo

full_name: Gail A. Mayo

given: Gail A.

full_name: Jane Blood

given: Jane

family: Durum

full_name: Scott K. Durum

given: Scott K.

family: Sherwood

full_name: Edward R. Sherwood

given: Edward R.

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

journal_name: JCI Insight

repository_institution: Washington University School of Medicine - Digital Commons@Becker

publisher: American Society for Clinical Investigation

ipd_sharing_description: Study results will be published Individual data can't be shared and are protected by the new GDPR rule

lead_sponsor: Revimmune


ReferenceCitation: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44.

ReferenceCitation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24.

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Margery

full_name: Jacques Margery

given: Jacques

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Corre

full_name: Romain Corre

given: Romain

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Gounant

full_name: Valérie Gounant

given: Valérie

family: Rivière

full_name: Frédéric Rivière

given: Frédéric

family: Janicot

full_name: Henri Janicot

given: Henri

family: Gervais

full_name: Radj Gervais

given: Radj

family: Locher

full_name: Chrystèle Locher

given: Chrystèle

family: Milleron

full_name: Bernard Milleron

given: Bernard

family: Tran

full_name: Quan Tran

given: Quan

family: Lebitasy

full_name: Marie-Paule Lebitasy

given: Marie-Paule

family: Morin

full_name: Franck Morin

given: Franck

family: Creveuil

full_name: Christian Creveuil

given: Christian

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

journal_name: The Lancet

ReferenceCitation: Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.

ReferenceCitation: Melero I, Berman DM, Aznar MA, Korman AJ, Pérez Gracia JL, Haanen J. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015 Aug;15(8):457-72. doi: 10.1038/nrc3973. Review.

ReferenceCitation: Soto-Ortiz L, Finley SD. A cancer treatment based on synergy between anti-angiogenic and immune cell therapies. J Theor Biol. 2016 Apr 7;394:197-211. doi: 10.1016/j.jtbi.2016.01.026. Epub 2016 Jan 27.

ReferenceCitation: Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Cañamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.

ReferenceCitation: Tsiouris A, Walesby RK. Malignant pleural mesothelioma: current concepts in treatment. Nat Clin Pract Oncol. 2007 Jun;4(6):344-52. Review.

ReferenceCitation: Fennell DA, Gaudino G, O'Byrne KJ, Mutti L, van Meerbeeck J. Advances in the systemic therapy of malignant pleural mesothelioma. Nat Clin Pract Oncol. 2008 Mar;5(3):136-47. doi: 10.1038/ncponc1039. Review.

ReferenceCitation: Nowak AK. Chemotherapy for malignant pleural mesothelioma: a review of current management and a look to the future. Ann Cardiothorac Surg. 2012 Nov;1(4):508-15. doi: 10.3978/j.issn.2225-319X.2012.10.05.

ReferenceCitation: Armato SG 3rd, Nowak AK. Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1). J Thorac Oncol. 2018 Jul;13(7):1012-1021. doi: 10.1016/j.jtho.2018.04.034. Epub 2018 May 9. Erratum in: J Thorac Oncol. 2019 Mar;14(3):560.

ReferenceCitation: Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2.

location_country:
Italy
Switzerland
France
Belgium
Spain
United Kingdom

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: SS Antonio e Biagio e Cesare Arrigo Hospital

location_facility: Istituto Oncologica della Svizzera Italiana

location_facility: Fondazione IRCCS Istituto Nazionale die Tumori

location_facility: Vall Hebron University Hospital/Vall Hebron Institue Oncology

location_facility: IRCCS Instituto Tumori Giovanni Paolo II

title: A Multicentre Randomised Phase III Trial Comparing Atezolizumab Plus Bevacizumab and Standard Chemotherapy Versus Bevacizumab and Standard Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma

summary: The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.


title: Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries

summary: The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

time_perspective: Cross-Sectional

location_country: Austria Germany Sweden France

location_facility:
CHU Tours Hopital Bretonneau
CHU Brest Hopital La Cavale Blanche
CHU Clemont Ferrand
CHU Bordeaux Hopital Pellegrin
CHU Toulouse Hopital Rangueli
APHP Hopital Henri Mondor
UK Mannheim
Local Institution


title: A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

acronym: HIJAK

summary: Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.

ReferenceCitation: Van Den Neste E, André M, Gastinne T, Stamatoullas A, Haioun C, Belhabri A, Reman O, Casasnovas O, Ghesquieres H, Verhoef G, Claessen MJ, Poirel HA, Copin MC, Dubois R, Vandenberghe P, Stoian IA, Cottereau AS, Bailly S, Knoops L, Morschhauser F. A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in advanced relapsed/refractory Hodgkin lymphoma. Haematologica. 2018 May;103(5):840-848. doi: 10.3324/haematol.2017.180554. Epub 2018 Jan 19.

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: André

full_name: Marc André

given: Marc

family: Gastinne

full_name: Thomas Gastinne

given: Thomas

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Belhabri

full_name: Amine Belhabri

given: Amine

family: Reman

full_name: Oumedaly Reman

given: Oumedaly

family: Casasnovas

full_name: Olivier Casasnovas

family: Ghesquieres

full_name: Hervé Ghesquieres

given: Hervé

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Claessen

full_name: Marie-José Claessen

given: Marie-José

family: Poirel

full_name: Hélène A. Poirel

given: Hélène A.

family: Copin

full_name: Marie-Christine Copin

given: Marie-Christine

family: Dubois

full_name: Romain Dubois

family: Vandenberghe

full_name: Peter Vandenberghe

given: Peter

family: Stoian

full_name: Ioanna-Andrea Stoian

given: Ioanna-Andrea

family: Cottereau

full_name: Anne S. Cottereau

given: Anne S.

family: Bailly

full_name: Sarah Bailly

given: Sarah

family: Knoops

full_name: Laurent Knoops

given: Laurent

family: Morschhauser

full_name: Franck Morschhauser

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

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

repositories:
HAL
LIRIAS (KU Leuven)
LillOA (Lille Open Archive)
PubMed Central
repub.eur.nl

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

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

publisher_group: Ferrata Storti Foundation (Haematologica)

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Université Catholique de Louvain Mont Godinne


acronym: PREMYA

summary:
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.

The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

ReferenceCitation: Fernandez H, Descamps P, Koskas M, Lopès P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.

family: Fernandez

full_name: H. Fernandez

given: H.

family: Descamps

full_name: P. Descamps

given: P.

family: Koskas

full_name: M. Koskas

given: M.

family: Lopès

full_name: P. Lopès

family: Brun

full_name: J.L. Brun

family: Darai

full_name: E. Darai

given: E.

family: Agostini

full_name: A. Agostini

given: A.

journal_name: Journal of Gynecology Obstetrics and Human Reproduction

lead_sponsor: PregLem SA

location_country:
Italy
Austria
Spain
France
Poland
Romania
Hungary
Portugal
Germany
United Kingdom

location_facility: Epsom & St Helier University Hospitals NHS Trust

location_facility: North Cumbria University Hospitals NHS Trust

location_facility: Gynaekologische Praxisklinik Harburger Ring

location_facility: Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa

location_facility: Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Nottingham University Hospital NHS trust

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Clinica ospedale san martino e cliniche universitarie convenzionate di genova

location_facility: IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano

location_facility: Fachaerzte fuer Frauenheilkunde und Geburtshilfe

location_facility: Semmelweis University Faculty of Medicine

location_facility: Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde

location_facility: Medizinisches Zentrum Bonn Friedensplatz


title: A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma

summary: This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.

status: Recruiting

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

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Spain

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale; Dipartimento Neoplasie Addominali

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; Dip. Scienze Mediche e Chirurgiche

location_facility: Hospital General Universitario Gregorio Maranon; Unidad de Investigacion de Oncologia Medica

location_facility: SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia


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

lead_sponsor: Takeda

location_country: Austria France Czechia Israel Spain Germany

acronym: ASPIRE

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

location_facility: CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Lyon Sud - Gastroenterology

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Klinikum Dresden, University Hospital Dresden

type: Registry Identifier

title: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

summary: The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.


title: Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry

acronym: TATAM

summary:
A new endovascular route for the treatment of brain AVMs may be possible in some cases: Trans-Venous Embolization (TVE). The technique uses microcatheters to navigate to the draining veins of AVM, to reach and then fill the AVM nidus retrogradely with liquid embolic agents until the lesion is occluded. This technique has the potential to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate. However, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of AVMs: to preserve the draining vein until all afferent vessels have been occluded. Nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications.

The method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. Care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.

ReferenceCitation: van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632. Review.

ReferenceCitation: Iosif C, Mendes GA, Saleme S, Ponomarjova S, Silveira EP, Caire F, Mounayer C. Endovascular transvenous cure for ruptured brain arteriovenous malformations in complex cases with high Spetzler-Martin grades. J Neurosurg. 2015 May;122(5):1229-38. doi: 10.3171/2014.9.JNS141714. Epub 2015 Mar 20.

ReferenceCitation: Kessler I, Riva R, Ruggiero M, Manisor M, Al-Khawaldeh M, Mounayer C. Successful transvenous embolization of brain arteriovenous malformations using Onyx in five consecutive patients. Neurosurgery. 2011 Jul;69(1):184-93; discussion 193. doi: 10.1227/NEU.0b013e318212bb34.

ReferenceCitation: Mendes GAC, Kalani MYS, Iosif C, Lucena AF, Carvalho R, Saleme S, Mounayer C. Transvenous Curative Embolization of Cerebral Arteriovenous Malformations: A Prospective Cohort Study. Neurosurgery. 2018 Nov 1;83(5):957-964. doi: 10.1093/neuros/nyx581.

ReferenceCitation: Zhang G, Zhu S, Wu P, Xu S, Shi H. The transvenous pressure cooker technique: A treatment for brain arteriovenous malformations. Interv Neuroradiol. 2017 Apr;23(2):194-199. doi: 10.1177/1591019916682357. Epub 2016 Dec 5.

ReferenceCitation: Raymond J, Darsaut TE, Altman DG. Pragmatic trials can be designed as optimal medical care: principles and methods of care trials. J Clin Epidemiol. 2014 Oct;67(10):1150-6. doi: 10.1016/j.jclinepi.2014.04.010. Epub 2014 Jul 16.

ReferenceCitation: Raymond J, Fahed R, Darsaut TE. Randomize the first patient. J Neuroradiol. 2017 Sep;44(5):291-294. doi: 10.1016/j.neurad.2017.03.004. Epub 2017 May 3.

ReferenceCitation: Fahed R, Darsaut TE, Mounayer C, Chapot R, Piotin M, Blanc R, Mendes Pereira V, Abud DG, Iancu D, Weill A, Roy D, Nico L, Nolet S, Gevry G, Raymond J. Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial. Interv Neuroradiol. 2019 Jun;25(3):305-309. doi: 10.1177/1591019918821738. Epub 2019 Feb 4.

name: Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France

family: Fahed

full_name: Robert Fahed

given: Robert

name: Department of Surgery, University of Alberta Hospital, Edmonton, Canada

family: Darsaut

full_name: Tim E Darsaut

given: Tim E

name: Service de Neuroradiologie, CHU Dupuytren, Service de Neuroradiologie, Limoges, France

family: Mounayer

full_name: Charbel Mounayer

given: Charbel

name: Department of Neuroradiology, Alfried-Krupp Krankenhaus Hospital, Essen, Germany

family: Chapot

full_name: René Chapot

given: René

family: Piotin

full_name: Michel Piotin

given: Michel

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

name: Department of Medical Imaging, Toronto Western Hospital, Toronto, Canada

family: Mendes Pereira

full_name: Vitor Mendes Pereira

given: Vitor

name: Division of Interventional Neuroradiology, Medical School of Ribeirão Preto, University of São Paulo, Brazil

family: Abud

full_name: Daniel G Abud

given: Daniel G

name: Department of Radiology, Centre Hospitalier de l’Université de Montréal (CHUM), Montreal, Canada

family: Iancu

full_name: Dana Iancu

given: Dana

family: Weill

full_name: Alain Weill

given: Alain

family: Roy

full_name: Daniel Roy

given: Daniel

family: Nico

full_name: Lorena Nico

given: Lorena

name: Interventional Neuroradiology Laboratory, Centre Hospitalier de l’Université de Montréal (CHUM), Montreal, Canada

family: Nolet

full_name: Suzanne Nolet

given: Suzanne

family: Gevry

full_name: Guylaine Gevry

given: Guylaine

family: Raymond

full_name: Jean Raymond

given: Jean

journal_name: Interventional Neuroradiology

oa_host_type: repository

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre hospitalier régional universitaire de Brest

location_facility: Hôpital Forndation Adolphe de Rothschild

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre hospitalier universitaire de la Réunion

location_facility: Centre hospitalier universitaire de Grenoble

location_facility: Centre hospitalier universitaire Limoges

location_facility: Centre hospitalier universitaire de Bordeaux

location_facility: Centre hospitalier universitaire de Rouen Normandie

intervention_type: Procedure


title: A Multi-centre Proof-of-performance Clinical Study to Validate Blood-based Biomarker Candidates for the Diagnosis of Alzheimer's Disease

acronym: ADDIA

summary:
The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD).

ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit.

About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age).

400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD,
200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
200 controls (healthy as compared to their age).

lead_sponsor: Amoneta Diagnostics SAS

location_country: Italy Switzerland France Belgium Turkey

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: IRCCS Centro San Giovanni di Dio Fatenenefratelli

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Hôpitaux Civils (Hopital Louis Pasteur) de Colmar

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: APHP-Hôpitaux Universitaires Pitié Salpêtrière


location_country:
Italy
Netherlands
France
Poland
Belgium
Germany
United Kingdom

location_facility: IRCCS Istituto G. Gaslini; UOC Neurologia Pediatrica e Malattie Muscolari

location_facility: Hopital Armand Trousseau; centre reference Maladies Neuro-musculaires Est parisien Neuropediatrie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie; Klinika Neurologii

location_facility: Hôpital Raymond Poincare; Serv. Neurologie et Réanimation pédiatriques - Centre réf. neuromusculaire

location_facility: Azienda Ospedaliera Universitaria Policlinico G.Martino; Dip. Neurologia e Malattie neuromuscolari

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Hopital des Enfants; Unite de Neurologie Pediatrique

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA;NEMO (NEuroMuscular Omnicentre);Centro clinico - Fonda

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Hopital Jeanne De Flandre; CIC pediatrique

location_facility: Hopital la Timone Enfants; Service de Pediatrie et Neurologie Pediatrique

location_facility: I.R.C.C.S. Cà Granda - Ospedale Maggiore Policlinico; Dip. di Salute Mentale

location_facility: Ospedale Pediatrico Bambino Gesù; Dip. Neuroscienze e Salute Mentale

location_facility: Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Neuropädiatrie und Muskelerkrankungen

title: Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Effectiveness of 10 mg/kg BID Olesoxime in Patients With Spinal Muscular Atrophy

summary: The purpose of this open-label, single arm study is to further evaluate long-term tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular Atrophy (SMA) who previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind, randomized, placebo-controlled, multicenter, multinational study).


title: Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)

acronym: BRAVO 2/3

summary: The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

ReferenceCitation: Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18.

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Hengstenberg

full_name: Christian Hengstenberg

given: Christian

family: Lefevre

full_name: Thierry Lefevre

given: Thierry

family: Kupatt

full_name: Christian Kupatt

family: Debry

full_name: Nicolas Debry

given: Nicolas

family: Husser

full_name: Oliver Husser

given: Oliver

family: Pontana

full_name: François Pontana

given: François

family: Kuchcinski

full_name: Grégory Kuchcinski

given: Grégory

family: Deliargyris

full_name: Efthymios N. Deliargyris

given: Efthymios N.

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Bernstein

full_name: Debra Bernstein

given: Debra

family: Anthopoulos

full_name: Prodromos Anthopoulos

given: Prodromos

family: Dangas

full_name: George D. Dangas

given: George D.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Dangas GD, Lefèvre T, Kupatt C, Tchetche D, Schäfer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15.

family: Lefèvre

full_name: Thierry Lefèvre

family: Tchetche

full_name: Didier Tchetche

given: Didier

family: Schäfer

full_name: Ulrich Schäfer

given: Ulrich

family: Dumonteil

full_name: Nicolas Dumonteil

location_country:
Italy
Switzerland
Netherlands
France
Germany
United Kingdom
Canada

location_facility: Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle

location_facility: Universitätsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: LMU Munich, Klinikum der Universität München

location_facility: University Heart Centre, Clinic of Inner Medicine 1 Cardiology

location_facility: Clinique Pasteur, Unité de Cardiologie Interventionnelle

location_facility: Ferraroto Hospital, University of Catania

location_facility: Ospedale San Raffaele U.O. Cardiologia Interventistica

location_facility: St. Paul´s Hospital Providence Health Care

location_facility: Policlinico Umberto I, Università La Sapienza