title: Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.

PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.

ReferenceCitation: Gronchi A, Bonvalot S, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom HJ, van Coevorden F, Penel N, Kopp HG, Duffaud F, Goldstein D, Broto JM, Wardelmann E, Marréaud S, Smithers M, Le Cesne A, Zaffaroni F, Litière S, Blay JY, Casali PG. Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib. JAMA Surg. 2020 Jun 1;155(6):e200397. doi: 10.1001/jamasurg.2020.0397. Epub 2020 Jun 17.

name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

family: Gronchi

full_name: Alessandro Gronchi

given: Alessandro

family: Bonvalot

full_name: Sylvie Bonvalot

given: Sylvie

name: Instituto Valenciano De Oncologia, Valencia, Spain

family: Poveda Velasco

full_name: Andres Poveda Velasco

given: Andres

name: Adelaide Cancer Centre, Kurralta Park, and Division of Medicine, University of Adelaide, Adelaide, Australia

family: Kotasek

full_name: Dusan Kotasek

given: Dusan

name: Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Mannheim University Medical Center, Mannheim, Germany

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Fumagalli

full_name: Elena Fumagalli

given: Elena

family: Judson

full_name: Ian R. Judson

given: Ian R.

family: Italiano

full_name: Antoine Italiano

given: Antoine

name: Leiden University Medical Center, Leiden, the Netherlands

family: Gelderblom

full_name: Hans J. Gelderblom

given: Hans J.

name: The Netherland Cancer Institute, Amsterdam, the Netherlands

family: van Coevorden

full_name: Frits van Coevorden

given: Frits

family: Penel

full_name: Nicolas Penel

given: Nicolas

name: Medizinische Universitätsklinik II, Tübingen, Germany

family: Kopp

full_name: Hans-Georg Kopp

given: Hans-Georg

name: Hôpital La Timone, Aix-Marseille Université, Marseille, France

family: Duffaud

full_name: Florence Duffaud

given: Florence

name: Prince of Wales Hospital, Sydney, Australia

family: Goldstein

full_name: David Goldstein

given: David

name: Hospital Universitario Viergen del Rocio Sevilla, Seville, Spain

family: Broto

full_name: Javier Martin Broto

given: Javier Martin

name: University Hospital Münster, Münster, Germany

family: Wardelmann

full_name: Eva Wardelmann

given: Eva

family: Marréaud

full_name: Sandrine Marréaud

given: Sandrine

name: Princess Alexandra Hospital, The University of Queensland, Brisbane, Australia

family: Smithers

full_name: Mark Smithers

given: Mark

name: Institute Gustave Roussy, Villejuif, France

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Zaffaroni

full_name: Facundo Zaffaroni

given: Facundo

family: Litière

full_name: Saskia Litière

given: Saskia

name: Department of Medicine, NetSARC and LYRIC, Centre Leon Berard, Lyon, France

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

name: Oncology and Hemato-Oncology Department, University of Milan, Milan, Italy

ReferenceCitation: Casali PG, Le Cesne A, Poveda Velasco A, Kotasek D, Rutkowski P, Hohenberger P, Fumagalli E, Judson IR, Italiano A, Gelderblom H, Adenis A, Hartmann JT, Duffaud F, Goldstein D, Broto JM, Gronchi A, Dei Tos AP, Marréaud S, van der Graaf WT, Zalcberg JR, Litière S, Blay JY. Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas. J Clin Oncol. 2015 Dec 20;33(36):4276-83. doi: 10.1200/JCO.2015.62.4304. Epub 2015 Nov 16.

name: Paolo G. Casali, Elena Fumagalli, and Alessandro Gronchi, Fondazione Istituto di Recovero e Cura a Carattere Scientifico Istituto Nazionale Tumori, Milano; Angelo P. Dei Tos, Azienda Unità Locale Socio Sanitaria 9 Treviso, Treviso, Italy; Axel Le Cesne, Gustave Roussy, Villejuif; Antoine Italiano, Institut Bergonie, Bordeaux; Antoine Adenis, Centre Oscar Lambret, Lille; Florence Duffaud, Hôpital de La Timone, Aix-Marseille Université, Marseille; Jean-Yves Blay, Centre Leon Berard, Lyon, France; Andres...

repository_institution: The University of Sydney - The Sydney eScholarship Repository

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
France
Australia
Spain
Denmark
Germany
United Kingdom

location_facility: Grupo Espanol de Investigacion del Cancer de Mama

location_facility: Centre Hospitalier General de Mont de Marsan

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

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

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


title: A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

summary: This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes. Diabet Med. 2007 Jun;24(6):618-25. Epub 2007 Apr 2. Erratum in: Diabet Med. 2010 May;27(5):611.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country: Italy Austria France Spain Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients With ventiLatory Support (ESSENTIAL) A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features

acronym: ESSENTIAL

summary:
This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo.

All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and 14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Inotrem

location_country: Belgium France

location_facility: CHU Dijon - Bourgogne - Hôpital François Mitterrand

location_facility: CHD Site la Roche sur Yon, les Oudairies

location_facility: Centre Hospitalier Universitaire Dupuytren

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Edelmann J, Holzmann K, Tausch E, Saunderson EA, Jebaraj BMC, Steinbrecher D, Dolnik A, Blätte TJ, Landau DA, Saub J, Estenfelder S, Ibach S, Cymbalista F, Leblond V, Delmer A, Bahlo J, Robrecht S, Fischer K, Goede V, Bullinger L, Wu CJ, Mertens D, Ficz G, Gribben JG, Hallek M, Döhner H, Stilgenbauer S. Genomic alterations in high-risk chronic lymphocytic leukemia frequently affect cell cycle key regulators and NOTCH1-regulated transcription. Haematologica. 2020 May;105(5):1379-1390. doi: 10.3324/haematol.2019.217307. Epub 2019 Aug 29.

family: Edelmann

full_name: Jennifer Edelmann

given: Jennifer

sequence: first

family: Holzmann

full_name: Karlheinz Holzmann

given: Karlheinz

sequence: additional

family: Tausch

full_name: Eugen Tausch

given: Eugen

family: Saunderson

full_name: Emily A. Saunderson

given: Emily A.

family: Jebaraj

full_name: Billy M. C. Jebaraj

given: Billy M. C.

family: Steinbrecher

full_name: Daniela Steinbrecher

given: Daniela

family: Dolnik

full_name: Anna Dolnik

given: Anna

family: Blätte

full_name: Tamara J. Blätte

given: Tamara J.

family: Landau

full_name: Dan A. Landau

given: Dan A.

family: Saub

full_name: Jenny Saub

given: Jenny

family: Estenfelder

full_name: Sven Estenfelder

given: Sven

family: Ibach

full_name: Stefan Ibach

given: Stefan

family: Cymbalista

full_name: Florence Cymbalista

family: Leblond

full_name: Veronique Leblond

given: Veronique

family: Delmer

full_name: Alain Delmer

given: Alain

family: Bahlo

full_name: Jasmin Bahlo

given: Jasmin

family: Robrecht

full_name: Sandra Robrecht

given: Sandra

family: Fischer

full_name: Kirsten Fischer

given: Kirsten

family: Goede

full_name: Valentin Goede

given: Valentin

family: Bullinger

full_name: Lars Bullinger

given: Lars

family: Wu

full_name: Catherine J. Wu

given: Catherine J.

family: Mertens

full_name: Daniel Mertens

given: Daniel

family: Ficz

full_name: Gabriella Ficz

given: Gabriella

family: Gribben

full_name: John G. Gribben

given: John G.

family: Hallek

full_name: Michael Hallek

given: Michael

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Steinbrecher D, Jebaraj BMC, Schneider C, Edelmann J, Cymbalista F, Leblond V, Delmer A, Ibach S, Tausch E, Scheffold A, Bloehdorn J, Hallek M, Dreger P, Döhner H, Stilgenbauer S. Telomere length in poor-risk chronic lymphocytic leukemia: associations with disease characteristics and outcome. Leuk Lymphoma. 2018 Jul;59(7):1614-1623. doi: 10.1080/10428194.2017.1390236. Epub 2017 Oct 24.

name: Department of Internal Medicine III, University of Ulm, Ulm, Germany;

name: Barts Cancer Institute, Queen Mary University of London, London, UK;

name: Service d’Hematologie Biologique, Hôpital Avicenne, Bobigny, France;

name: Service d’Hématologie, Hôpital Pitié-Salpêtrière, Paris, France;

name: Service d’Hématologie Clinique, CHU de Reims, Reims, France;

name: WiSP Wissenschaftliche Service Pharma GmbH, Langenfeld, Germany;

name: Internal Medicine I, University Cologne, Cologne, Germany;

name: Internal Medicine V, University of Heidelberg, Heidelberg, Germany

location_facility: Centre Hospitalier Marechal Joffre Hôpital Saint-Jean Perpignan

title: A Prospective, Multi-center Phase II Study of Subcutaneous Alemtuzumab Combined With Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allogeneic Stem-cell Transplantation, in Chronic Lymphocytic Leukemia Which is Associated With 17p Deletion or is Refractory to Fludarabine

summary:
Aims and objectives

Assessment of the efficacy of the study treatment in the study population in terms of response rate, progression-free survival, failure-free survival and overall survival.
Acquisition of further data to expand the data base on the toxicity of the study treatment.
Assessment of the efficacy of the study treatment in biological risk groups.
Assessment of response in terms of minimal residual disease. Number of patients and estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65 fludarabine-refractory irrespective of 17p status).

Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two years maintenance treatment.


ReferenceCitation: Martín M, Makhson A, Gligorov J, Lichinitser M, Lluch A, Semiglazov V, Scotto N, Mitchell L, Tjulandin S. Phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment for HER-2-positive locally recurrent or metastatic breast cancer. Oncologist. 2012;17(4):469-75. doi: 10.1634/theoncologist.2011-0344. Epub 2012 Mar 30.

name: aHospital Gregorio Maraňon, Universidad Complutense, Madrid, Spain;

family: Martín

full_name: Miguel Martín

given: Miguel

name: bMoscow Oncological Hospital No. 62, Moscow, Russia;

family: Makhson

full_name: Anatoly Makhson

given: Anatoly

name: cAPHP Tenon APREC, CancerEst, University Paris VI, Paris, France;

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

name: dNN Blokhin Russian Cancer Research Center, Moscow, Russia;

family: Lichinitser

full_name: Mikhail Lichinitser

given: Mikhail

name: eHospital Clinico de Valencia, INCLIVA, Universidad de Valencia, Valencia, Spain;

family: Lluch

full_name: Ana Lluch

given: Ana

name: fNN Petrov Research Institute of Oncology, St Petersburg, Russia;

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

name: gF. Hoffmann‐La Roche Ltd, Basel, Switzerland

family: Scotto

full_name: Nana Scotto

given: Nana

family: Mitchell

full_name: Lada Mitchell

given: Lada

family: Tjulandin

full_name: Sergei Tjulandin

given: Sergei

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Oncologist

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

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

repository_institution: University of Valencia - Repository of Digital Objects for Teaching Research and Culture

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Phase II Study of Bevacizumab in Combination with Trastuzumab and Capecitabine as First‐Line Treatment for HER‐2‐positive Locally Recurrent or Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Sweden
France
Slovakia
Russian Federation
Spain
Denmark

source: euctr

title: A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer

summary: This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


ReferenceCitation: Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. doi: 10.1016/S1470-2045(12)70335-2. Epub 2012 Aug 14.

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: Bastholt

full_name: Lars Bastholt

family: Krause

full_name: Thomas Krause

given: Thomas

family: de la Fouchardiere

full_name: Christelle de la Fouchardiere

given: Christelle

family: Tennvall

full_name: Jan Tennvall

given: Jan

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Gómez

full_name: José Manuel Gómez

given: José Manuel

family: Bonichon

full_name: Françoise Bonichon

given: Françoise

family: Leenhardt

full_name: Laurence Leenhardt

given: Laurence

family: Soufflet

full_name: Christine Soufflet

given: Christine

family: Licour

full_name: Muriel Licour

given: Muriel

family: Schlumberger

full_name: Martin J Schlumberger

given: Martin J

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Other

status: Active, not recruiting

lead_sponsor: Genzyme, a Sanofi Company

location_country: Sweden Switzerland France Norway Belgium Spain Denmark

type: EudraCT Number

type: Other Identifier

title: A Randomized, Double Blind, Placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Vandetanib (ZD6474) in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy

summary:
This is a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) confers an improvement in PFS as compared to placebo in subject with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient size so that if vandetanib (ZD6474) is truly active there is a high probability that it will demonstrate an effect sufficiently promising to warrant a follow-up assessment.

Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all subjects (both active and placebo) will be unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All subjects will be followed to collect survival data until ≥50% of subjects have died. Subjects who are taking vandetanib (ZD6474) at the time of study closure and wish to remain on therapy will be allowed to continue for as long as the Investigator feels that they are obtaining clinical benefit, or until they are given another anti-cancer therapy. The safety data from all subjects will be assessed on an ongoing basis, including discontinuation and follow up.
Radiologic evaluation using RECIST criteria will be performed every 12 weeks (± 2 weeks). All medical images will be centralized assessed at the site and centrally reviewed. Subjects will be evaluated until progression, and will then be followed up for survival, regardless of whether they continue randomized treatment, unless they withdraw consent. Post progression open-label vandetanib (ZD6474) will be offered at the investigators discretion.
All subjects must submit a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample is not available within 2 weeks prior to randomization, a fresh tumor sample must be obtained in its place prior to randomization. If a subject undergoes the fresh tumor biopsy procedure, this specimen will satisfy the first optional tumor biopsy submission should they consent to the exploratory part of the study.


title: Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.

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

location_country: Italy France Israel Belgium Portugal

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

location_facility: Centre Hospital Regional Universitaire de Limoges


title: A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.

acronym: EliSA

summary: The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

lead_sponsor: Nyxoah S.A.

location_country: Switzerland Netherlands France Belgium Germany

location_facility: Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie

location_facility: HNO-Klinik des Universitätsklinikums Jena

location_facility: Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

location_facility: Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin

location_facility: Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

location_facility: CEREVES Paris Jean Jaurès - Centre du sommeil

location_facility: Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg

location_facility: Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

location_facility: Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

intervention_type: Device


title: Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX

acronym: POSITIVE

summary:
This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.

A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.

The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4.

ReferenceCitation: Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813.

family: Gaudard

full_name: Philippe Gaudard

given: Philippe

family: Barbanti

full_name: Claudio Barbanti

given: Claudio

family: Rozec

full_name: Bertrand Rozec

given: Bertrand

family: Mauriat

full_name: Philippe Mauriat

family: M’rini

full_name: Mimoun M’rini

given: Mimoun

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Liet

full_name: Jean Michel Liet

given: Jean Michel

family: Girard

full_name: Claude Girard

given: Claude

family: Leger

full_name: Pierre Louis Leger

given: Pierre Louis

family: Assaf

full_name: Ziad Assaf

given: Ziad

family: Damas

full_name: Pierre Damas

given: Pierre

family: Loron

full_name: Gauthier Loron

given: Gauthier

family: Lecourt

full_name: Laurent Lecourt

given: Laurent

family: Amour

full_name: Julien Amour

given: Julien

family: Pouard

full_name: Philippe Pouard

journal_name: Anesthesia & Analgesia

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

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

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Air Liquide Santé International

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve


title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"

acronym: EURAD

summary:
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility.

This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.

Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice.

Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years.

Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.

status: Unknown status

lead_sponsor: Société d'Imagerie de la Femme

location_country:
Italy
Austria
Serbia
Switzerland
Croatia
France
Portugal
United Kingdom

location_facility: Instituto Portuges de Oncologia de Lisboa Francisco Gentil

status_simplified: Unknown


status: Terminated

lead_sponsor: Bayer

location_country:
Italy
Austria
France
Poland
Ireland
Spain
United Kingdom

acronym: CONCERT

title: A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

summary: This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.


title: Open Label, Multicentre Study, Evaluating the Safety, Tolerability, Efficacy, Compliance and Acceptability of Alkalising Treatments at Long-term in Patients With Cystinuria

summary: This is an open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and acceptability of alkalising treatments at long-term in patients with cystinuria.

design_allocation: Non-Randomized

lead_sponsor: Advicenne Pharma

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Hôpital Ténon - Explorations fonctionnelles Mutlidisciplinaires et INSERM UMR S 1155


title: Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study

acronym: CHOICE

summary: The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.

lead_sponsor: Embo-Flüssigkeiten A.G.

location_country: Italy France Belgium Denmark Germany

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus


ReferenceCitation: Maggiolo F, Rizzardini G, Raffi F, Pulido F, Mateo-Garcia MG, Molina JM, Ong E, Shao Y, Piontkowsky D, Das M, McNicholl I, Haubrich R. Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial. Lancet HIV. 2019 Oct;6(10):e655-e666. doi: 10.1016/S2352-3018(19)30195-X.

family: Maggiolo

full_name: Franco Maggiolo

given: Franco

family: Rizzardini

full_name: Giuliano Rizzardini

given: Giuliano

family: Raffi

full_name: François Raffi

given: François

family: Pulido

full_name: Federico Pulido

given: Federico

family: Mateo-Garcia

full_name: Maria Gracia Mateo-Garcia

given: Maria Gracia

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Ong

full_name: Edmund Ong

given: Edmund

family: Shao

full_name: Yongwu Shao

given: Yongwu

family: Piontkowsky

full_name: David Piontkowsky

given: David

family: Das

full_name: Moupali Das

given: Moupali

family: McNicholl

full_name: Ian McNicholl

given: Ian

family: Haubrich

full_name: Richard Haubrich

given: Richard

journal_name: The Lancet HIV

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

lead_sponsor: Gilead Sciences

location_country:
Italy
France
Belgium
Spain
United Kingdom

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria di Sassari

location_facility: Dipartimento di Malattie Infettive e Tropicali

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Service des Maladies Infectieuses et du Voyageur

title: A Phase 3b, Randomized, Open-Label Study to Evaluate Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 60 Years

summary: The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.


title: A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.

summary: The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

lead_sponsor: Ipsen

location_country: Italy France Czechia Poland Germany

location_facility: Hôpital Lyon Sud -Hospices Civils de Lyon


ReferenceCitation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10:CD012273. doi: 10.1002/14651858.CD012273.pub2.

name: Neonatology; National Center for Child Health and Development; Tokyo Japan

family: Amari

full_name: Shoichiro Amari

given: Shoichiro

name: Hamilton Health Sciences; Hamilton Canada

family: Shahrook

full_name: Sadequa Shahrook

given: Sadequa

name: Department of Pediatrics; Saitama Medical Center, Saitama Medical University; Kawagoe Japan

family: Namba

full_name: Fumihiko Namba

given: Fumihiko

name: Global Health Nursing, Graduate School of Nursing Science; St. Luke's International University; Tokyo Japan

family: Ota

full_name: Erika Ota

given: Erika

name: Graduate School of Medicine; Kyoto University; Kyoto Japan

family: Mori

full_name: Rintaro Mori

given: Rintaro

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Baxter Healthcare Corporation

location_facility: Hôpital HFME - Groupement Hospitalier Est

location_facility: Groupe Hospitalier Cochin-St Vincent de Paul

location_facility: Hôpital pédiatrique Gatien de Clocheville

title: Safety During Use of Paediatric Triple Chamber Bag Formulas, Administered IV at a Weight Dependant Dose During 5 Consecutive Days, in Paediatric Patients up to 18 Years Requiring Parenteral Nutrition.

summary: The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.


title: Intensified CHOP Plus Rituximab (R-CHOP 14) Versus CHOP Plus Rituximab (R-CHOP 21) and Frontline/Prophylactic Darbepoetin Alfa Treatment Versus Usual Symptomatic Treatment of Anemia in Patients Aged 60 to 80 Years With Diffuse Large B-cell Lymphoma.

summary: This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large B-cell lymphoma.

ReferenceType: background

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

ReferenceCitation: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rübe C, Rudolph C, Reiser M, Hossfeld DK, Eimermacher H, Hasenclever D, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):634-41. Epub 2004 Mar 11.

ReferenceCitation: Petrella T, Copie-Bergman C, Brière J, Delarue R, Jardin F, Ruminy P, Thieblemont C, Figeac M, Canioni D, Feugier P, Fabiani B, Leroy K, Parrens M, André M, Haioun C, Salles GA, Gaulard P, Tilly H, Jais JP, Molina TJ. BCL2 expression but not MYC and BCL2 coexpression predicts survival in elderly patients with diffuse large B-cell lymphoma independently of cell of origin in the phase 3 LNH03-6B trial. Ann Oncol. 2017 May 1;28(5):1042-1049. doi: 10.1093/annonc/mdx022.

family: Petrella

full_name: T. Petrella

given: T.

family: Copie-Bergman

full_name: C. Copie-Bergman

given: C.

family: Brière

full_name: J. Brière

given: J.

family: Delarue

full_name: R. Delarue

given: R.

family: Jardin

full_name: F. Jardin

given: F.

family: Ruminy

full_name: P. Ruminy

given: P.

family: Thieblemont

full_name: C. Thieblemont

family: Figeac

full_name: M. Figeac

given: M.

family: Canioni

full_name: D. Canioni

given: D.

family: Feugier

full_name: P. Feugier

family: Fabiani

full_name: B. Fabiani

given: B.

family: Leroy

full_name: K. Leroy

given: K.

family: Parrens

full_name: M. Parrens

family: André

full_name: M. André

family: Haioun

full_name: C. Haioun

family: Salles

full_name: G.A. Salles

family: Gaulard

full_name: P. Gaulard

family: Tilly

full_name: H. Tilly

given: H.

family: Jais

full_name: J.P. Jais

full_name: T.J. Molina

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

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

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

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

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

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

name: Department of Oncology; University Hospital; Lausanne Switzerland

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

name: Department of Hematology; Necker Hospital; Paris France

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

name: Medical Oncology, Centre Antoine Lacassagne; Nice France

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

name: Department of Pathology; Necker Hospital; Paris France

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

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

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

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

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

name: Institut Gustave Roussy, Villejuif, France;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ReferenceCitation: Delarue R, Tilly H, Mounier N, Petrella T, Salles G, Thieblemont C, Bologna S, Ghesquières H, Hacini M, Fruchart C, Ysebaert L, Fermé C, Casasnovas O, Van Hoof A, Thyss A, Delmer A, Fitoussi O, Molina TJ, Haioun C, Bosly A. Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):525-33. doi: 10.1016/S1470-2045(13)70122-0. Epub 2013 Apr 9.

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

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung

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


title: A Multicentre, Randomized, Controlled Versus Placebo, Double-blinded, 4 Parallel Arms, Dose-ranging Main Study, to Evaluate the Efficacy, Safety and Tolerability and Acceptability of Repeated Doses of ADV7103, After 7 Days of Treatment, in Patients With Cystinuria, and an Efficacy and Safety Exploratory Study in the Youngest Children.

summary: This is a multicentre, randomized, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children.

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital Femme Mère Enfant

location_facility: Hôpital Ténon - Explorations fonctionnelles Mutlidisciplinaires et INSERM UMR S 1155


lead_sponsor: Oxurion

location_country:
Switzerland
France
Slovakia
Belgium
Spain
Germany
United Kingdom

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: City Hospitals Sunderland NHS Foundation Trust

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: Univerzitná nemocnica Bratislava, Nemocnica Ružinov

location_facility: Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

title: A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)

summary: This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).


location_country: Spain Belgium France Netherlands

acronym: EMERALD

location_facility:
Investigational Site Number 724006
Investigational Site Number 250003
Investigational Site Number 724005
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 724001
Investigational Site Number 056002
Investigational Site Number 250006
Investigational Site Number 250008
Investigational Site Number 056001
Investigational Site Number 250002
Investigational Site Number 528002
Investigational Site Number 250009
Investigational Site Number 250010
Investigational Site Number 724004
Investigational Site Number 724003
Investigational Site Number 250001
Investigational Site Number 250007
Investigational Site Number 724002
Investigational Site Number 528001

title: Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA

summary:
Primary Objective:

To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.


title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing Kidney Transplantation

acronym: SENIOR

summary: Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.

primary_purpose: Prevention

lead_sponsor: Astellas Pharma Inc

location_country:
Switzerland
Netherlands
France
Belgium
Spain
Germany
United Kingdom


title: PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.

ReferenceCitation: Lefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; EORTC Head and Neck Cancer Cooperative Group; EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. doi: 10.1093/jnci/djn460. Epub 2009 Jan 27.

family: Lefebvre

full_name: J. L. Lefebvre

given: J. L.

family: Rolland

full_name: F. Rolland

family: Tesselaar

full_name: M. Tesselaar

family: Bardet

full_name: E. Bardet

given: E.

family: Leemans

full_name: C. R. Leemans

given: C. R.

family: Geoffrois

full_name: L. Geoffrois

given: L.

family: Hupperets

full_name: P. Hupperets

family: Barzan

full_name: L. Barzan

family: de Raucourt

full_name: D. de Raucourt

family: Chevalier

full_name: D. Chevalier

family: Licitra

full_name: L. Licitra

family: Lunghi

full_name: F. Lunghi

family: Stupp

full_name: R. Stupp

family: Lacombe

full_name: D. Lacombe

family: Bogaerts

full_name: J. Bogaerts

family: Horiot

full_name: J. C. Horiot

given: J. C.

family: Bernier

full_name: J. Bernier

family: Vermorken

full_name: J. B. Vermorken

given: J. B.

name: for the EORTC Head and Neck Cancer Cooperative Group and the EORTC Radiation Oncology Group

journal_name: JNCI Journal of the National Cancer Institute

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

title: Phase 3 Randomized Trial on Larynx Preservation Comparing Sequential vs Alternating Chemotherapy and Radiotherapy

ReferenceCitation: Lefebvre J, Horiot J, Rolland F, et al.: Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-22950. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA6016, 303s, 2007.

ReferenceCitation: Bottomley A, Tridello G, Coens C, Rolland F, Tesselaar ME, Leemans CR, Hupperets P, Licitra L, Vermorken JB, Van Den Weyngaert D, Truc G, Barillot I, Lefebvre JL. An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer. 2014 Feb 1;120(3):390-8. doi: 10.1002/cncr.28392. Epub 2013 Oct 25.

name: Quality of Life Department; European Organization for Research and Treatment of Cancer; Brussels Belgium

name: Pediatric Hematology Oncology Department; University Hospital of Verona; Verona Italy

name: Medical Oncology Department; Centre R. Gauducheau; Saint-Herblain France

name: Division of Medical Oncology; Leiden University Medical Center; Leiden the Netherlands

name: Otolaryngology - Head and Neck Surgery Department; Vrije Universiteit University Medical Center; Amsterdam the Netherlands

name: Oncology and Radiotherapy Department; Radiotherapy Institute Limburg; University Hospital of Maastricht; Maastricht The Netherlands

name: Medical Oncology; Fondazione IRCCS; National Tumor Institute; Milan Italy

name: Medical Oncology Department; Antwerp University Hospital; Antwerp Belgium

name: Radiotherapy Department; Middelheim University Hospital; Middelheim Antwerp Belgium

name: Radiotherapy Department; Centre G.F. Leclerc; Dijon France

name: Head and Neck surgery Department; Oscar Lambret Center; Lille France

title: An international phase 3 trial in head and neck cancer: Quality of life and symptom results

location_country: Italy Switzerland Netherlands France Israel Belgium

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Azienda Ospedaliera "Santa Maria Degli Angeli"

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori


ReferenceCitation: Maggiolo F, Rizzardini G, Molina JM, Pulido F, De Wit S, Vandekerckhove L, Berenguer J, D'Antoni ML, Blair C, Chuck SK, Piontkowsky D, Martin H, Haubrich R, McNicholl IR, Gallant J. Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Infect Dis Ther. 2021 Jun;10(2):775-788. doi: 10.1007/s40121-021-00419-5. Epub 2021 Mar 9.

family: Maggiolo

full_name: Franco Maggiolo

given: Franco

family: Rizzardini

full_name: Giuliano Rizzardini

given: Giuliano

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Pulido

full_name: Federico Pulido

given: Federico

family: De Wit

full_name: Stephane De Wit

given: Stephane

family: Vandekerckhove

full_name: Linos Vandekerckhove

given: Linos

family: Berenguer

full_name: Juan Berenguer

given: Juan

family: D’Antoni

full_name: Michelle L. D’Antoni

given: Michelle L.

family: Blair

full_name: Christiana Blair

given: Christiana

family: Chuck

full_name: Susan K. Chuck

given: Susan K.

family: Piontkowsky

full_name: David Piontkowsky

given: David

family: Martin

full_name: Hal Martin

given: Hal

family: Haubrich

full_name: Richard Haubrich

given: Richard

family: McNicholl

full_name: Ian R. McNicholl

given: Ian R.

family: Gallant

full_name: Joel Gallant

given: Joel

journal_name: Infectious Diseases and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: cc-by

license_normalized: cc-by

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: P.O. Spirito Santo - U.O. Malattie Infettive e Tropicali

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

title: A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years

summary: The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.


title: A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.

summary:
The study will consist of two parts :

In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation.

In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies.

In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies.

In both phases, tumor response will be evaluated on local assessment using RECIST 1.1.

All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.

lead_sponsor: Transgene

location_country:
United States
France
Spain

location_facility: Hôpitaux Civils de Colmar - Hôpital Pasteur

location_facility: Centre Paul Strauss - ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Fundación de Investigación Biomédica Hospital Clínico San Carlos

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Institut Claudius Regaud - IUCT - Oncopole

location_facility: Fundación de Investigación biomédica H. 12 de Octubre


title: A Randomized, Double-blind, Multi-centre Study to Assess Safety and Efficacy of Incremental Doses of QGC001 in Patients With NYHA Class II/III Chronic Heart Failure (HF) With Left Ventricular Systolic Dysfunction Versus Placebo.

acronym: QUID-HF

summary:
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.

A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway, may lead to improve HF.

QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.

This study investigates the safety and efficacy of QGC001 in HF patients.

ipd_sharing_description: Individual participant date would be available only by the center via eCRF

lead_sponsor: Quantum Genomics SA

location_country:
Netherlands
France
Czechia
Poland
Norway
Hungary
Germany
United Kingdom

location_facility: Heart and Vascular Center of Semmelweis University

location_facility: University of Birmingham Institute of Cardiovascular Sciences City Hospital,


title: A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)

acronym: PAROS

summary:
This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.

No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.

lead_sponsor: Santhera Pharmaceuticals

location_country: Italy Austria Netherlands France Greece Germany

location_facility: Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase I/II Trial to Compare the Safety, Tolerability and Immunogenicity of the Therapeutic THV01 Vaccination at 5.10E+6 TU (Transducing Unit) , 5.10E+7 TU (Transducing Unit) or 5.10E+8 TU (Transducing Unit) Doses to Placebo in HIV-1 Clade B Infected Patients Under Highly Active Antiretroviral Therapy (HAART)

summary:
The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies).

THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus): lentiviral vectors. They are non-replicative and not infectious. They will be injected intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.

Eligible patients must have an undetectable viral load and must be treated by HAART for more than 12 months. They will be randomly allocated to one of the study group and will receive the experimental drugs at one of the three doses or a matching placebo.

Their anti-HIV treatment will be alleviated around each experimental drugs' administration to enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited immune response. Stringent anti-HIV treatments resumption criteria have been implemented, based on the CD4+ T cell counts and the viral load.

38 patients were enrolled in THV01-11-01 study and received the 2 injections.

A long-term follow-up of all enrolled patients will be performed for 5 years post-prime administration. This will provide additional data on the safety and the potential long-term risks/benefits associated with THV01.

The final study report will be written after the last patient last visit in the long-term follow-up.

lead_sponsor: Theravectys S.A.

location_country: Belgium France

location_facility:
Hôpital Nord
CHU Croix-Rousse
CHU Strasbourg
Hôpital Purpan
CIC Cochin-Pasteur; Hôpital Cochin
CHU Saint-Pierre
CHU Clermont-Ferrand
CHU Dijon
CHU Liège
CHU Rennes
Hôpital Saint-Louis

intervention_type: Biological


title: An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.

acronym: ECHO/ICU

summary: The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

ReferenceCitation: Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC. Erratum in: Am J Respir Crit Care Med. 2018 Mar 15;197(6):839-840.

name: Intensive Care and Burn Unit, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

family: Jolliet

full_name: Philippe Jolliet

given: Philippe

name: Fattouma Bourguiba University Hospital, Monastir, Tunisia

family: Ouanes-Besbes

full_name: Lamia Ouanes-Besbes

given: Lamia

family: Abroug

full_name: Fekri Abroug

given: Fekri

name: Abderrahmen Mami Hospital, Ariana, Tunisia

family: Ben Khelil

full_name: Jalila Ben Khelil

given: Jalila

family: Besbes

full_name: Mohamed Besbes

given: Mohamed

family: Garnero

full_name: Aude Garnero

given: Aude

family: Arnal

full_name: Jean-Michel Arnal

family: Daviaud

full_name: Fabrice Daviaud

given: Fabrice

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

name: Georges Pompidou European Hospital, Paris, France

family: Lortat-Jacob

full_name: Benoît Lortat-Jacob

given: Benoît

family: Diehl

full_name: Jean-Luc Diehl

given: Jean-Luc

name: Angers University Hospital, Angers, France

family: Lerolle

full_name: Nicolas Lerolle

given: Nicolas

family: Mercat

full_name: Alain Mercat

given: Alain

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

name: Institut national de la santé et de la recherche médicale, UMR 955, Université Paris Est, Créteil, France

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

name: Air Liquide Santé International, Medical R&D, Jouy-en-Josas, France

family: Texereau

full_name: Joëlle Texereau

given: Joëlle

name: University Hospital of Geneva, Intensive Care Unit, Geneva, Switzerland

name: Li Ka Shing Institute and Keenan Research Centre, St Michael’s Hospital, Toronto, Ontario, Canada; and

name: University of Toronto, Interdepartmental Division of Critical Care Medicine, Toronto, Ontario, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

location_country:
Italy
Switzerland
France
Tunisia
Belgium
United Kingdom

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse

location_facility: Azienda Ospedaliera Univeritaria Careggi

location_facility: Les Cliniques Universitaires UCL Mont Godinne

location_facility: Centre Hospitalier Universitaire Fattouma Bourguiba

location_facility: Centre Hospitalier Universitaire Pellegrin-Tripode


ReferenceCitation: Bonnefoi H, Jacot W, Saghatchian M, Moldovan C, Venat-Bouvet L, Zaman K, Matos E, Petit T, Bodmer A, Quenel-Tueux N, Chakiba C, Vuylsteke P, Jerusalem G, Brain E, Tredan O, Messina CG, Slaets L, Cameron D. Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study. Ann Oncol. 2015 Feb;26(2):325-32. doi: 10.1093/annonc/mdu551. Epub 2014 Dec 1.

family: Bonnefoi

full_name: H. Bonnefoi

given: H.

family: Jacot

full_name: W. Jacot

given: W.

family: Saghatchian

full_name: M. Saghatchian

given: M.

family: Moldovan

full_name: C. Moldovan

given: C.

family: Venat-Bouvet

full_name: L. Venat-Bouvet

given: L.

family: Zaman

full_name: K. Zaman

given: K.

family: Matos

full_name: E. Matos

given: E.

family: Petit

full_name: T. Petit

given: T.

family: Bodmer

full_name: A. Bodmer

given: A.

family: Quenel-Tueux

full_name: N. Quenel-Tueux

given: N.

family: Chakiba

full_name: C. Chakiba

family: Vuylsteke

full_name: P. Vuylsteke

given: P.

family: Jerusalem

full_name: G. Jerusalem

given: G.

family: Brain

full_name: E. Brain

family: Tredan

full_name: O. Tredan

given: O.

family: Messina

full_name: C.G.M. Messina

family: Slaets

full_name: L. Slaets

family: Cameron

full_name: D. Cameron

given: D.

bso_classification: Chemistry

ReferenceCitation: Bonnefoi H, Zaman K, Debled M, Fiche M, Fournier M, Nobahar M, Pierga JY, Koch KM, Bartlett J, Zimmer A, Marreaud S, Bogaerts J, Cameron D. An European Organisation for Research and Treatment of Cancer phase I study of lapatinib and docetaxel as neoadjuvant treatment for human epidermal growth factor receptor 2 (HER2) positive locally-advanced/inflammatory or large operable breast cancer. Eur J Cancer. 2013 Jan;49(2):281-9. doi: 10.1016/j.ejca.2012.08.006. Epub 2012 Sep 18.

title: An European Organisation for Research and Treatment of Cancer phase I study of lapatinib and docetaxel as neoadjuvant treatment for Human Epidermal Growth Factor Receptor 2 (HER2) positive locally-advanced/inflammatory or large operable breast cancer

location_country:
Switzerland
France
Slovenia
Belgium
United Kingdom

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

title: A Phase I-II Study of Lapatinib and Docetaxel as Neoadjuvant Treatment for HER-2 Positive Locally Advanced/Inflammatory or Large Operable Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.


ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Diagnostic

location_country: France Spain

acronym: GuidePath

title: Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

summary:
The current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.

Approximately 190 participants will be enrolled to ensure at least 152 participants to complete the [18F]CTT1057 PET/CT scan procedure (i.e. investigational imaging agent administration and successful completion of the PET/CT scan), which will be required for the calculation of the co-primary endpoints.


lead_sponsor: NTC srl

location_country:
Italy
Germany
Russian Federation
France

acronym: SATISFACTION

location_facility: Medical Center of Diagnostics and Prevention

location_facility: ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

location_facility: ASST Rhodense - Presidi di Rho e Garbagnate

location_facility: Azienda USL di Modena - Ospedale Ramazzini di Carpi

location_facility: Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello

location_facility: State Central Clinical Hospital named after A. N. Ryzhykh

location_facility: Fondazione Poliambulanza - Istituto Ospedaliero

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias

location_facility: ASL Roma 1 - Presidio Nuovo Regina Margherita

location_facility: Private educational organization of higher education "Medical University "Reaviz"

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

location_facility: Clinical Hospital of Russian Railways named after N.A. Semashko

location_facility: Fondazione Casa Sollievo Della Sofferenza

location_facility: State budget institution of health care of the city of Moscow "Moscow Clinical Research and Practical Center of the Department of Health of the City of Moscow"

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità

location_facility: Irkutsk State Medical Academy of Postgraduate Education - a branch of the Russian Medical Academy of Continuing Professional Education, Ministry of Health of the Russian Federation

title: Efficacy and Safety of mAnniTol in Bowel Preparation: Assessment of Adequacy and Presence of Intestinal levelS of Hydrogen and Methane During Elective Colonoscopy aFter mAnnitol or Standard Split 2-liter Polyethylene Glycol Solution Plus asCorbaTe - a Phase II/III, International, Multicentre, Randomized, Parallel-group, endoscOpist-bliNded, Dose-finding/Non-inferiority Study - SATISFACTION

summary: The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .


title: Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure

acronym: DE-RISK WF

summary:
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT). Continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.

All patients on mechanical ventilation in the ICU meeting the eligibility criteria shall undergo a daily screen for weaning readiness. If any of the components of the daily screen is not met, the patient will not undergo a SBT that day and continued to be screened daily. Patients passing daily screening criteria shall automatically receive an SBT.

The SBT shall last for 30-120 minutes and be performed on continuous positive airway pressure up to 5 cm H2O and pressure support up to 7 cm H2O. The SBT shall be terminated and mechanical ventilation reinstituted at the original settings if the patient meets any of the SBT failure criteria.

A trial is considered successful and physicians will be asked to approve extubation when the patient can breathe spontaneously for the whole trial.

Patients shall be continued to be screened daily until extubation, 21 days after enrolment, performance of tracheostomy, death, or withdrawal of care. All patients shall be followed until hospital discharge or death.

ipd_sharing: Undecided

lead_sponsor: Respinor AS

location_country: Italy Norway France

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Saint Joseph Saint Luc


title: Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome

summary:
Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.

After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting.

Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle.

A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement.

Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max.

The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR.

The mobile application CardiCare™ consists of several modules:

A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm
Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life
Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit
Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Other

ReferenceCitation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11:CD001800. doi: 10.1002/14651858.CD001800.pub4. Review.

name: MRC/CSO Social and Public Health Sciences Unit; Institute of Health and Well Being, University of Glasgow; Glasgow UK

family: Dibben

full_name: Grace Dibben

given: Grace

name: Faculty Health and Wellbeing, School of Sport, Health and Community; University of Winchester; Winchester UK

family: Faulkner

full_name: James Faulkner

given: James

name: College of Health Sciences; University of Wisconsin-Milwaukee; Milwaukee Wisconsin USA

family: Oldridge

full_name: Neil Oldridge

given: Neil

name: Division of Health Sciences, Warwick Medical School; University of Warwick; Coventry UK

family: Rees

full_name: Karen Rees

given: Karen

name: School of Nursing and Midwifery; Queen's University Belfast; Belfast UK

family: Thompson

full_name: David R Thompson

given: David R

name: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care; Odense University Hospital; Nyborg Denmark

name: Department of Clinical Research; University of Southern Denmark; Odense Denmark

family: Zwisler

full_name: Ann-Dorthe Zwisler

given: Ann-Dorthe

name: MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being; University of Glasgow; Glasgow UK

name: National Institute of Public Health; University of Southern Denmark; Copenhagen Denmark

family: Taylor

full_name: Rod S Taylor

given: Rod S

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

repository_institution: University of Warwick - Warwick Research Archive Portal

repository_institution: Queen's University Belfast - Research Portal

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

version: acceptedVersion

lead_sponsor: Ad scientiam

location_country: Italy Spain France Portugal

location_facility: Scientific Institute of Hospitalization and Care San Raffaele Pisana


ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Italy
France
Spain
Germany
United Kingdom

acronym: G-PLUS

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

title: A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

summary: The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.


title: A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of MK-4621/JetPEI as Monotherapy or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Solid Tumors

summary: The purpose of this study is to evaluate safety and tolerability, pharmacokinetics (PK), and preliminary antitumor activity of intratumoral (IT) / intralesional injections of MK-4621 delivered via the JetPEI™in vivo linear polyethylenimine nucleic acid delivery system (MK-4621/JetPEI™) as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Germany
United Kingdom
France
Spain

location_facility: Centro Integral Oncologico Clara Campal START Madrid ( Site 3402)

location_facility: Charite Campus Benjamin Franklin ( Site 4903)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 4901)

location_facility: Oxford University Hospital NHS Foundation Trust ( Site 4401)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 3401)


title: A Randomized and Open-label Dose-finding, Ph. 2, Efficacy, Safety, and Pharmacokinetic Study of Once-per-cycle Prophylactic Injections of ANF-RHO™ Versus Pegfilgrastim (Neulasta®) in Non-metastatic Breast Cancer Patients at High-risk of Chemotherapy-induced Neutropenia

summary: Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia

lead_sponsor: Prolong Pharmaceuticals

location_country: France Netherlands

location_facility: Hôpital Saint Louis - Center des Maladies du Sein


title: POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)

acronym: POLBOS LM

summary: The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared with a prespecified performance goal.

status: Suspended

lead_sponsor: ECRI bv

location_country: Italy France Poland

location_facility:
Research Centre PL-001
Research Centre PL-007
Research Centre FRA-001
Research Centre PL-006
Research Centre PL-005
Research Centre ITA-002
Research Centre FRA-004
Research Centre ITA-001
Research Centre ITA-003
Research Centre PL-002
Research Centre FRA-003
Research Centre PL-004
Research Centre PL-003
Research Centre FRA-002
Research Centre PL-008


title: A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.

summary:
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.

This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).

time_perspective: Retrospective

ReferenceCitation: Pugin J, Daix T, Pagani JL, Morri D, Giacomucci A, Dequin PF, Guitton C, Que YA, Zani G, Brealey D, Lepape A, Creagh-Brown B, Wyncoll D, Silengo D, Irincheeva I, Girard L, Rebeaud F, Maerki I, Eggimann P, François B. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Crit Care. 2021 Apr 20;25(1):151. doi: 10.1186/s13054-021-03576-8.

family: Pugin

full_name: Jérôme Pugin

given: Jérôme

family: Daix

full_name: Thomas Daix

given: Thomas

family: Pagani

full_name: Jean-Luc Pagani

given: Jean-Luc

family: Morri

full_name: Davide Morri

given: Davide

family: Giacomucci

full_name: Angelo Giacomucci

given: Angelo

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Que

full_name: Yok-Ai Que

given: Yok-Ai

family: Zani

full_name: Gianluca Zani

given: Gianluca

family: Brealey

full_name: David Brealey

given: David

family: Lepape

full_name: Alain Lepape

given: Alain

family: Creagh-Brown

full_name: Ben Creagh-Brown

given: Ben

family: Wyncoll

full_name: Duncan Wyncoll

given: Duncan

family: Silengo

full_name: Daniela Silengo

given: Daniela

family: Irincheeva

full_name: Irina Irincheeva

given: Irina

family: Girard

full_name: Laurie Girard

given: Laurie

family: Rebeaud

full_name: Fabien Rebeaud

given: Fabien

family: Maerki

full_name: Iwan Maerki

given: Iwan

family: Eggimann

full_name: Philippe Eggimann

given: Philippe

family: François

full_name: Bruno François

given: Bruno

currency_apc_doaj: GBP

journal_name: Critical Care

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories:
PubMed Central
Research Square
boris.unibe.ch

location_facility: Ospedale Santa Maria delle Croci, Terapia Intensiva

location_facility: Royal Surrey County Hospital, Intensive Care Medicine

location_facility: CH Le Mans, Service de Réanimation Médico Chirurgicale & USC

location_facility: Ospedale Santa Maria della Misericordia, Terapia Intensiva

location_facility: Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation

location_facility: University College London Hospitals, Anaesthetics Department

location_facility: CH Lyon-Sud, Services de soins critiques

location_facility: Guy's & St Thomas' Hospital, Department of Critical Care

location_facility: Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI

location_facility: Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione

location_facility: Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care

location_facility: Ospedale Infermi, Dept Anesthesia and ICU

location_facility: Bern University Hospital, Universitätsklinik für Intensivmedizin


ReferenceCitation: O'B Hourihane J, Beyer K, Abbas A, Fernández-Rivas M, Turner PJ, Blumchen K, Nilsson C, Ibáñez MD, Deschildre A, Muraro A, Sharma V, Erlewyn-Lajeunesse M, Zubeldia JM, De Blay F, Sauvage CD, Byrne A, Chapman J, Boralevi F, DunnGalvin A, O'Neill C, Norval D, Vereda A, Skeel B, Adelman DC, du Toit G. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 Oct;4(10):728-739. doi: 10.1016/S2352-4642(20)30234-0. Epub 2020 Jul 20.

family: O'B Hourihane

full_name: Jonathan O'B Hourihane

given: Jonathan

family: Beyer

full_name: Kirsten Beyer

given: Kirsten

family: Abbas

full_name: Allyah Abbas

given: Allyah

family: Fernández-Rivas

full_name: Montserrat Fernández-Rivas

given: Montserrat

family: Turner

full_name: Paul J Turner

given: Paul J

family: Blumchen

full_name: Katharina Blumchen

given: Katharina

family: Nilsson

full_name: Caroline Nilsson

given: Caroline

family: Ibáñez

full_name: Maria D Ibáñez

given: Maria D

family: Deschildre

full_name: Antoine Deschildre

given: Antoine

family: Muraro

full_name: Antonella Muraro

given: Antonella

family: Sharma

full_name: Vibha Sharma

given: Vibha

family: Erlewyn-Lajeunesse

full_name: Michel Erlewyn-Lajeunesse

given: Michel

family: Zubeldia

full_name: José Manuel Zubeldia

given: José Manuel

family: De Blay

full_name: Frederic De Blay

given: Frederic

family: Sauvage

full_name: Christine D Sauvage

given: Christine D

family: Byrne

full_name: Aideen Byrne

given: Aideen

family: Chapman

full_name: John Chapman

given: John

family: Boralevi

full_name: Franck Boralevi

given: Franck

family: DunnGalvin

full_name: Audrey DunnGalvin

given: Audrey

family: O'Neill

full_name: Charmaine O'Neill

given: Charmaine

family: Norval

full_name: David Norval

family: Vereda

full_name: Andrea Vereda

given: Andrea

family: Skeel

full_name: Ben Skeel

family: Adelman

full_name: Daniel C Adelman

given: Daniel C

family: du Toit

full_name: George du Toit

given: George

location_country:
Italy
Sweden
France
Ireland
Spain
Germany
United Kingdom

location_facility: Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie

location_facility: Guy & St Thomas' Hospital, NHS Foundation Trust

location_facility: Hopital Saint Vincent de Paul, Service d'Allergologie

location_facility: University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose

location_facility: Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46

location_facility: Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital

location_facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin

location_facility: Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos

location_facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

location_facility: University Hospitals Southampton Foundation NHS Trust

location_facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia

location_facility: UCC Dept. of Paediatrics and Child, Cork University Hospital

location_facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon

title: AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

summary: The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.


lead_sponsor: GWT-TUD GmbH

location_country: Germany France

acronym: SAMBA

location_facility: Technische Universität München, Klinikum rechts der Isar

location_facility: Klinikum Chemnitz gGmbH, Klinik für innere Medizin III

title: Single Agent JNJ-56022473 in MDS and AML Patients Failing Hypomethylating Agent Based Therapy

summary: The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5 months after failure, representing a significant unmet medical need due to the very limited treatment options. In this context, a specific targeting of the leukemic stem cell (LSC) seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123 is overexpressed in AML and MDS progenitors making it an attractive target for immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered with regard to this strategy and the current phase II trial has the aim to evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS patients.


title: ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.

summary: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.

lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Italy France Switzerland Spain

location_facility: Azienda Ospedaliera Universitaria Integrate Verona (AOUI)

location_facility: Centro Integral Oncológico Clara Campal - Hospital Universitario HM Sanchinarro

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Complejo Hospital Universitario de Santiago de Compostela

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: AOU "Maggiore della Carità" di S.C. di Oncologia

location_facility: Centre de lutte contre le cancer Léon Bérard

location_facility: Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale S.C.

location_facility: Fondazione Oncologia / Oncologia ematologia

location_facility: Hospital General Universitario Morales Meseguer