title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm.

summary:
This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm.

All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause.

At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research.

A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).

Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie de L'Ouest - Site Paul Papin

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

appel_a_projets: PRTK

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

acronyme: COCABIO 000

titre: Comparaison des caractéristiques biologiques entre tumeurs mammaires triples négatives pN0 de taille = 10 mm (pT1a/b) versus pT1c T2 = 30 mm.

nom_porteur: DALENC

prenom_porteur: Florence


type: Registry Identifier

type: Other Identifier

title: A Phase 2 Study of XL184 (Cabozantinib) in Treating Patients With Relapsed Osteosarcomas and Ewing Sarcomas

summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow.

study_start_date_type: Actual

status: Active, not recruiting

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Italiano A, Mir O, Mathoulin-Pelissier S, Penel N, Piperno-Neumann S, Bompas E, Chevreau C, Duffaud F, Entz-Werle N, Saada E, Ray-Coquard I, Lervat C, Gaspar N, Marec-Berard P, Pacquement H, Wright J, Toulmonde M, Bessede A, Crombe A, Kind M, Bellera C, Blay JY. Cabozantinib in patients with advanced Ewing sarcoma or osteosarcoma (CABONE): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):446-455. doi: 10.1016/S1470-2045(19)30825-3. Epub 2020 Feb 17.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

lead_sponsor: National Cancer Institute (NCI)

location_facility: Institut de Cancerologie de l'Ouest-Rene Gauducheau

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Grant/Funding Number

title: Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome

acronym: UROPARKTENS

summary:
Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was reported at the congress of the "Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perinéologie" (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder. Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated with subjective improvement of LUTD assessed with the Patient Global Impression of Improvement (PGI-I) in 5 of the 6 patients.

In view of the encouraging results of this pilot study, we hypothesize that TENS treatment may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and multisystem atrophy (MSA).

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Castel-Lacanal E, Game X, Clanet M, Gasq D, De Boissezon X, Guillotreau J, Bourg V, Viala F, Rischmann P, Marque P. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015 Jan;34(1):32-6. doi: 10.1002/nau.22495. Epub 2013 Sep 23.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility:
University hospital
Hospital Poincare
Hospital Chenevier
UHToulouse
Huriez Hospital
Clinique Saint Augustin
Pontchaillou Hospital
Hospital Dubos
Uiversity hospital
University Hospital

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: UROPARKTENS

titre: Evaluation du traitement par stimulation du nerf tibial postérieur par neurostimulation électrique transcutanée (TENS) des troubles vésico-sphinctériens (TVS) secondaires à un syndrome parkinsonien

discipline_principale: urologie

nom_porteur: GAME

prenom_porteur: Xavier


title: Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

acronym: STORI

summary:
1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. Particularly, the need for carrying on systematic treatment with infliximab in all the patients has not been demonstrated.

1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with infliximab for at least one year.

1.3 Main objective and main judgement criteria. Determine predictive factors for relapse within one year after stopping infliximab. Main judgement criteria is the clinical relapse after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of at least 70 points over baseline for the two consecutive measures.

1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine predictive factors for short-term relapse (<2 months)after stopping infliximab.

Determine response to infliximab retreatment in these patients. Determine tolerance to infliximab retreatment in these patients. Determine predictive factors for an absence of response to retreatment. Determine predictive factors for infliximab retreatment intolerance. Determine sustained response in the retreated patients.

1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed up every two months for at least 18 months after stopping infliximab.

1.6 Justification of the number of patients Number of patients to include is at least 100. This recruitment should be reached within one year. This number should allow to disclose predictive factors associated with a relative risk of at least 2 if this factor is equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk patients).

ReferenceCitation: Vermeire S, Louis E, Carbonez A, Van Assche G, Noman M, Belaiche J, De Vos M, Van Gossum A, Pescatore P, Fiasse R, Pelckmans P, Reynaert H, D'Haens G, Rutgeerts P; Belgian Group of Infliximab Expanded Access Program in Crohn's Disease. Demographic and clinical parameters influencing the short-term outcome of anti-tumor necrosis factor (infliximab) treatment in Crohn's disease. Am J Gastroenterol. 2002 Sep;97(9):2357-63. doi: 10.1111/j.1572-0241.2002.05991.x.

ReferenceCitation: Parsi MA, Achkar JP, Richardson S, Katz J, Hammel JP, Lashner BA, Brzezinski A. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002 Sep;123(3):707-13. doi: 10.1053/gast.2002.35390.

ReferenceCitation: Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003 Apr;124(4):917-24. doi: 10.1053/gast.2003.50145.

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8. doi: 10.1056/NEJMoa020888.

ReferenceCitation: Tampo Y, Yonaha M. Antioxidant mechanism of Mn(II) in phospholipid peroxidation. Free Radic Biol Med. 1992;13(2):115-20. doi: 10.1016/0891-5849(92)90072-o.

ReferenceCitation: Parsi MA, Lashner BA. Safety of infliximab: primum non nocere. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Inflamm Bowel Dis. 2004 Jul;10(4):486-7. doi: 10.1097/00054725-200407000-00028. No abstract available.

ReferenceCitation: Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, Siegel JN, Braun MM. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104. doi: 10.1056/NEJMoa011110.

ReferenceCitation: Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Therapeutiques Des Affections Inflammatoires Digestives. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Belgium France

location_facility:
Hopital Lariboisiere
Hopital Beaujon
CHU CAEN
Ch Le Raincy Montfermeil
Hopital Saint Andre
Hopital Louis Mourier
Chu Nantes
CHU LIEGE - Sart Tilman
CHU LYON
Hopital Georges Pompidou
Chu Amiens
Chu Toulouse
CHRU Lille
Gent University Hospital
Chu Strasbourg
Chu Besancon
Chu Rouen
Hopital Saint Louis
Chu Marseille - Hopital Nord
Chu Montpellier
Chu Tours
Hopital Henri Mondor
Hopital Haut Leveque


title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

acronym: METEOR

summary:
PHASE: II
TYPE OF STUDY : With direct benefit
DESCRIPTIVE: Multicenter, randomized, double-blind study
INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
INCLUSION PERIOD: 24 months
STUDY DURATION: 36 months
EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

ReferenceCitation: Carbonnel F, Colombel JF, Filippi J, Katsanos KH, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Fumery M, Roblin X, Reinisch W, Bouhnik Y, Brixi H, Seksik P, Malamut G, Farkkila M, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti P, Sarter H, Laharie D; European Crohn's and Colitis Organisation; Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):380-8.e4. doi: 10.1053/j.gastro.2015.10.050. Epub 2015 Nov 26.

evidence: open (via free pdf)

version: publishedVersion

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

repository_institution: University of Liège - Open Repository and Bibliography

version: submittedVersion

unpaywall_oa_status: bronze

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_country: France Italy Netherlands Austria Belgium Israel

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: CHU Clermont-Ferrand - Hôpital Hotel Dieu


type: EudraCT Number

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, Marreaud S, Smithers M, Le Cesne A, Zaffaroni F, Litiere 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.

oa_host_type: repository

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

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

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, Marreaud S, van der Graaf WT, Zalcberg JR, Litiere 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.

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repository_institution: Radboud University - Radboud Repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

collaborators: Grupo Espanol de Investigacion en Sarcomas

location_country:
Germany
United Kingdom
Denmark
Australia
Spain
France

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

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

location_facility: Grupo Espanol de Investigacion del Cancer de Mama

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: Centre Hospitalier General de Mont de Marsan


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.

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. doi: 10.1111/j.1464-5491.2007.02141.x. 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: Germany Italy Austria Spain France


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.

ipd_sharing: No

lead_sponsor: Inotrem

location_facility: CHD Site la Roche sur Yon, les Oudairies

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: CHU Dijon - Bourgogne - Hôpital François Mitterrand


lead_sponsor: University of Ulm

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: Edelmann J, Holzmann K, Tausch E, Saunderson EA, Jebaraj BMC, Steinbrecher D, Dolnik A, Blatte 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, Dohner 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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

repositories_concat: PubMed Central;edoc.mdc-berlin.de

unpaywall_oa_status: gold

publisher_dissemination: 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, Dohner 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.

sponsor_collaborators: WiSP Wissenschaftlicher Service Pharma GmbH

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

source: euctr

location_country: Germany Austria France


lead_sponsor: Hoffmann-La Roche

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: Martin 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.

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

location_country:
Slovakia
Denmark
Sweden
Spain
Russian Federation
France


lead_sponsor: Genzyme, a Sanofi Company

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.

ReferenceCitation: Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gomez 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.

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

study_completion_date_type: Anticipated

location_country: Norway Denmark Sweden Switzerland Belgium Spain France


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.

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

location_country: France Italy Portugal Belgium Israel

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

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Randomized Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 System When Compared to Multiple Daily Injections for Treatment of Type 1 Diabetes (RADIANT)

acronym: RADIANT

summary: This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Insulet Corporation

location_country:
United Kingdom
Belgium
France

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire Carémeau de Nîmes

location_facility: Mersey and West Lancashire NHS Teaching Hospitals Trust

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Centre Hospitalier Universitaire Côte de Nacre

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval,


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: Germany Switzerland Netherlands Belgium France

location_facility: Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

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

location_facility: Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

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

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: HNO-Klinik des Universitätsklinikums Jena

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

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

location_facility: CEREVES Paris Jean Jaurès - Centre du sommeil


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

collaborators: EMD Serono Research & Development Institute, Inc.

location_country:
United States
Spain
France

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

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

location_facility: Fundación de Investigación Biomédica Hospital Clínico San Carlos

location_facility: Fundación de Investigación biomédica H. 12 de Octubre

location_facility: Institut Claudius Regaud - IUCT - Oncopole

location_facility: Hôpitaux Civils de Colmar - Hôpital Pasteur


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. doi: 10.1016/0140-6736(91)92033-x.

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.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repositories_concat: HAL

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Air Liquide Santé International

sponsor_collaborators:
Air Liquide Santé International
Euraxi Pharma

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

ReferenceCitation: Wengert GJ, Dabi Y, Kermarrec E, Jalaguier-Coudray A, Poncelet E, Porcher R, Thomassin-Naggara I, Rockall AG; EURAD Study Group. O-RADS MRI Classification of Indeterminate Adnexal Lesions: Time-Intensity Curve Analysis Is Better Than Visual Assessment. Radiology. 2022 Jun;303(3):566-575. doi: 10.1148/radiol.210342. Epub 2022 Mar 1. Erratum In: Radiology. 2022 May;303(2):E28.

repository_institution: Imperial College London - Spiral

publisher_dissemination: Radiological Society of North America (RSNA)

lead_sponsor: Société d'Imagerie de la Femme

location_country:
Italy
Portugal
United Kingdom
Switzerland
Austria
Croatia
Serbia
France

location_facility: Instituto Portuges de Oncologia de Lisboa Francisco Gentil

status_simplified: Unknown


acronym: CONCERT

lead_sponsor: Bayer

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.

status: Terminated

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

location_country:
Ireland
Italy
Poland
United Kingdom
Austria
Spain
France


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

location_facility: Centre Hospitalier Universitaire de Lyon


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: Germany Italy Denmark Belgium France

location_facility: Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


lead_sponsor: Gilead Sciences

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.

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.

location_facility: Azienda Ospedaliero Universitaria di Sassari

location_facility: Dipartimento di Malattie Infettive e Tropicali

location_facility: Service des Maladies Infectieuses et du Voyageur

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

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

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

location_country:
Italy
United Kingdom
Belgium
Spain
France


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.

ReferenceCitation: Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country: Germany Italy Poland Czechia France

location_facility: Hôpital Lyon Sud -Hospices Civils de Lyon


lead_sponsor: Baxter Healthcare Corporation

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.

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(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

publisher_dissemination: Wiley

location_facility: Hôpital pédiatrique Gatien de Clocheville

location_facility: Hôpital HFME - Groupement Hospitalier Est

location_facility: Groupe Hospitalier Cochin-St Vincent de Paul

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.


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.

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme 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. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.

ReferenceCitation: Pfreundschuh M, Trumper L, Kloess M, Schmits R, Feller AC, Rube 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. doi: 10.1182/blood-2003-06-2095. Epub 2004 Mar 11.

ReferenceCitation: Petrella T, Copie-Bergman C, Briere J, Delarue R, Jardin F, Ruminy P, Thieblemont C, Figeac M, Canioni D, Feugier P, Fabiani B, Leroy K, Parrens M, Andre 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.

oa_host_type: publisher

evidence: open (via crossref license)

ReferenceCitation: Ghesquieres 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.

ReferenceCitation: Copie-Bergman C, Cuilliere-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.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Delarue R, Tilly H, Mounier N, Petrella T, Salles G, Thieblemont C, Bologna S, Ghesquieres H, Hacini M, Fruchart C, Ysebaert L, Ferme 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.

lead_sponsor: Lymphoma Study Association

sponsor_collaborators:
Lymphoma Study Association
Amgen

location_country: Switzerland Belgium France

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

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

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


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 multicenter, 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.

study_start_date_type: Anticipated

status: Not yet recruiting

location_country: Belgium France

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

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

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Univerzitná nemocnica Bratislava, Nemocnica Ružinov

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: City Hospitals Sunderland NHS Foundation Trust

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)

location_country:
Germany
Slovakia
United Kingdom
Switzerland
Belgium
Spain
France


acronym: EMERALD

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.

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

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

location_country: Spain Netherlands Belgium France


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

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma Europe B.V.

location_country:
Germany
United Kingdom
Netherlands
Switzerland
Belgium
Spain
France


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.

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.

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

location_country: France Italy Netherlands Switzerland Belgium Israel

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera "Santa Maria Degli Angeli"

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

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

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Dijon


title: An Observational Study to Assess the Effectiveness and Safety of Cemiplimab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

acronym: CEMI-LUNG

summary:
Primary Objective:

Describe the overall survival rate (OS) rate in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice.

Secondary Objectives:

To describe the following in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice:

Objective response rate (ORR)
Time to response (TTR)
Time to progression
Time to first subsequent anti-NSCLC treatment (TTST)
Duration of response (DoR)
Progression-free Survival (PFS)
Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

lead_sponsor: Regeneron Pharmaceuticals

location_country: Germany Austria France

location_facility:
Investigational Site Number: 276-019
Investigational Site Number: 276-016
Investigational Site Number: 250-005
Investigational Site Number: 250-004
Investigational Site Number: 276-010
Investigational Site Number: 250-002
Investigational Site Number: 040-001
Investigational Site Number: 250-007
Investigational Site Number: 276-015
Investigational Site Number: 276-005
Investigational Site Number: 276-006
Investigational Site Number: 276-012
Investigational Site Number: 276-013
Investigational Site Number: 040-004
Investigational Site Number: 276-009
Investigational Site Number: 250-008
Investigational Site Number: 276-002
Investigational Site Number: 250-009
Investigational Site Number: 276-001
Investigational Site Number: 250-001
Investigational Site Number: 250-003
Investigational Site Number: 276-003
Investigational Site Number: 250-006


acronym: ADvantage

lead_sponsor: Almirall, S.A.

summary: The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

location_facility:
Alm Site 20
Alm Site 37
Alm Site 12
Alm Site 45
Alm Site 47
Alm Site 23
Alm Site 2
Alm Site 30
Alm Site 21
Alm Site 9
Alm Site 17
Alm Site 48
Alm Site 4
Alm Site 3
Alm Site 28
Alm Site 35
Alm Site 44
Alm Site 6
Alm Site 24
Alm Site 27
Alm Site 25
Alm Site 31
Alm Site 8
Alm Site 22
Alm Site 29
Alm Site 43
Alm Site 39
Alm Site 36
Alm Site 42
Alm Site 10
Alm Site 18
Alm Site 40
Alm Site 41
Alm Site 13
Alm Site 46
Alm Site 5
Alm Site 7
Alm Site 34
Alm Site 14
Alm Site 19
Alm Site 11
Alm Site 1
Alm Site 15
Alm Site 32
Alm Site 26
Alm Site 33
Alm Site 16
Alm Site 38

title: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.

location_country:
Germany
Poland
United Kingdom
Netherlands
Austria
Belgium
Spain
France


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

acronym: eCARE

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

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

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

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Other

appel_a_projets: PHRCI

region: Pays de la Loire

nom_etablissement: CHR ANGERS

acronyme: e-CARE

titre: Efficacité de la règle CARE associée au score HEART chez les patients présentant une douleur thoracique aux urgences

discipline_principale: médecine interne

nom_porteur: MOUMNEH

prenom_porteur: Thomas


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.

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.

license: cc-by

license_normalized: cc-by

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

publisher_dissemination: Springer-Nature

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitari Germans Trias i Pujol

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


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:
Germany
Poland
Hungary
Norway
United Kingdom
Netherlands
Czechia
France

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: Germany Italy Netherlands Austria Greece France

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

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

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


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

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.

publisher_dissemination: American Thoracic Society

lead_sponsor: Air Liquide Santé International

location_country:
Italy
United Kingdom
Tunisia
Switzerland
Belgium
France

location_facility: Les Cliniques Universitaires UCL Mont Godinne

location_facility: Centre Hospitalier Universitaire Pellegrin-Tripode

location_facility: Azienda Ospedaliera Univeritaria Careggi

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

location_facility: Centre Hospitalier Universitaire Fattouma Bourguiba


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.

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.

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.

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

location_country:
Slovenia
United Kingdom
Switzerland
Belgium
France


title: Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation

summary: The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.

lead_sponsor: Chansu Vascular Technologies

location_country: Germany France

location_facility:
Hôpital Nord Laennec - CHU de Nantes
Hôpital Paris Saint Joseph
Polyclinique Les Fleurs
DIAKO Krankenhaus Flensburg
Romed Klinikum Rosenheim
Clinique Pasteur
Jüdisches Krankenhaus Berlin
Vivantes Klinikum Neukölln


title: A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.

acronym: RAISE

summary: RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.

lead_sponsor: ETOP IBCSG Partners Foundation

collaborators:
GlaxoSmithKline
Development Limited

sponsor_collaborators:
ETOP IBCSG Partners Foundation
GlaxoSmithKline
Development Limited

location_country: Italy Switzerland Spain France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Complejo Hospitalario Universitario a Coruña

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)


title: A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)

summary: This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.

lead_sponsor: Vir Biotechnology, Inc.

location_country:
New Zealand
United Kingdom
Hong Kong
Romania
Korea, Republic of
Thailand
Moldova, Republic of
France


title: A Multicentre Single-arm Phase II Trial of Amivantamab, Lazertinib Plus Bevacizumab in Patients With EGFR-mutant Advanced NSCLC With Progression on Previous Third-generation EGFR-TKI

acronym: AMAZE-lung

summary:
AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial.

In addition, the safety of the treatment combination will be evaluated.

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Janssen Pharmaceuticals

location_country:
Italy
United Kingdom
Singapore
Netherlands
Switzerland
Spain
France

location_facility: Guy's and St Thomas' Hospital NHS Foundation Trust

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Hospital Universitario Alicante Dr Balmis ISABIAL

location_facility: SS Antonio e Biagio e Cesare Arrigo Hospital

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital clínico universitario de Valladolid

location_facility: Universitätsklinik für Medizinische Onkologie, Inselspital


title: Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly

summary: Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.

lead_sponsor: Hospital Universitario 12 de Octubre

sponsor_collaborators:
Hospital Universitario 12 de Octubre
Technical University of Munich
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Hospital Vall d'Hebron
BioMérieux
EIT Health

location_country: Germany Spain France

location_facility:
CHU Grenoble-Alpes
Hospital Universitario 12 de Octubre
Klinikum rechts der Isar
Hospital Universitari Vall d'Hebron
CHU Clermont-Ferrand
Hôpital Lyon Sud HCL
Hôpital Edouard HERRIOT

intervention_type: Diagnostic Test


lead_sponsor: Dompé Farmaceutici S.p.A

summary:
The objective of the study is to evaluate the efficacy and safety of two different doses of raloxifene orally administered compared to placebo in patients with early diagnosis of paucisymptomatic COVID-19.

Primary objectives:

Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 7 days of therapy
Evaluation of the effectiveness of therapy in reducing the proportion of subjects who requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of starting therapy

Secondary objectives:

Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 14 and 28 days of therapy
Evaluation of the effectiveness of therapy in reducing the proportion of subject patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7 or 28 days of starting therapy
7, 14 and 28 days drug safety and tolerability profile
Assessment of body temperature, blood and biochemical parameters between T0 and T28

ReferenceCitation: Nicastri E, Marinangeli F, Pivetta E, Torri E, Reggiani F, Fiorentino G, Scorzolini L, Vettori S, Marsiglia C, Gavioli EM, Beccari AR, Terpolilli G, De Pizzol M, Goisis G, Mantelli F, Vaia F, Allegretti M; Raloxifene Territorial Health COVID19 STUDY GROUP. A phase 2 randomized, double-blinded, placebo-controlled, multicenter trial evaluating the efficacy and safety of raloxifene for patients with mild to moderate COVID-19. EClinicalMedicine. 2022 Jun;48:101450. doi: 10.1016/j.eclinm.2022.101450. Epub 2022 May 12.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_facility: Clinique de l'infirmerie protestante de Lyon

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: A.O.U. Città della Salute e della Scienza

title: Multicenter, Adaptive, Randomized, Placebo-controlled, Double Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.

location_country: Italy Spain France


acronym: IP-CURE-B

lead_sponsor: ANRS, Emerging Infectious Diseases

summary: The ANRS HB07 IP-cure-B study is a proof of concept Phase II clinical trial in HBeAg negative virally suppressed non-cirrhotic CHB patients. It will explore whether stopping NUC or stopping NUC after SLGN administration can increase the rate of HBsAg decline compared to standard of care CHB treatment.

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
EUCLID Clinical Trial Platform

location_facility: Internal Medicine and Hepatology, Vall d'Hebron University Hospital

location_facility: Hepato-gastroenterology department, Hôpital Saint-Joseph

location_facility: Department of General and Specialized Medical AreaAzienda Ospedaliera, University Hospital of Parma

location_facility: Service d'Hépato-gastroentérologie, Hôpital de Brabois

location_facility: Gastroenterology and Hepatology Division, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Department of Internal Medicine Clinic for Internal Medicine II - Gastroenterology, Hepatology, Endocrinology and Infectiology, Universitat Klinikum in Freiburg

location_facility: Hepatology Department, Hospices Civils de Lyon

location_facility: Service d'Hépato-gastroentérologie Hôpital Pitié Salpêtrière

title: ANRS HB07 IP-Cure-B Proof of Concept (PoC) Clinical Trial. Educating the Liver Immune Environment Through TLR8 Stimulation Followed by NUC Discontinuation

ipd_sharing_description:
Research projects may be submitted and evaluated by the Trial Scientific committee for scientific relevance. If the projects receives a favorable opinion, a data sharing agreement shall be signed.

Participants will be informed of any further research project and will have the opportunity to refuse the use of their data

location_country: Germany Italy Spain France


title: A Phase 1b Dose Escalation and Expansion Study of CAN04, a Monoclonal Antibody Targeting IL1RAP, in Combination With Modified FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

acronym: CAPAFOUR

summary: This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.

lead_sponsor: Cantargia AB

location_country: Spain France

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: START MADRID_Hospital Universitario Fundacion Jimenez Diaz

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals


title: Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection

summary:
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.

This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.

time_perspective: Other

lead_sponsor: Balt Extrusion

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Hospital Universitario Marqués de Valdecilla (HUMV)


title: A Multicenter, Phase II, Open Label, Randomized Trial Evaluating the Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)

acronym: COMBI-TED

summary: This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal.

lead_sponsor: Fondazione Ricerca Traslazionale

location_facility: Clinica Mi Tres Torres - UOMI Cancer Center

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Universitario Regional de Málaga - Hospital Civil

location_facility: GHR Mulhouse Sud Alsace - Hôpital Emile Muller

location_facility: Nouvel Hôpital Civil - Hopitaux Universitaires de Strasbourg


acronym: SATISFACTION

lead_sponsor: NTC srl

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 single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .

location_facility: Irkutsk State Medical Academy of Postgraduate Education

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

location_facility: ASST Rhodense - Presidi di Rho e Garbagnate

location_facility: Fondazione Casa Sollievo Della Sofferenza

location_facility: Azienda USL di Modena - Ospedale Ramazzini di Carpi

location_facility: ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

location_facility: Moscow Clinical Research and Practical Center of the Department of Health

location_facility: Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit

location_facility: State Central Clinical Hospital A. N. Ryzhykh

location_facility: Medical Center of Diagnostics and Prevention

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

location_facility: Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello

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

location_facility: Fondazione Poliambulanza - Istituto Ospedaliero

location_facility: Centre Hospitalier Universitaire de Montpellier

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

location_country:
Germany
Italy
Russian Federation
France


title: A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.

summary: A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: [1] Part A: Safety run-in cohort of approximately 12 participants; [2] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.

lead_sponsor: Hoffmann-La Roche

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Centre Val Aurelle Paul Lamarque; Radiotherapie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie


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.

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(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

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

repository_institution: Queen's University Belfast - Research Portal

repository_institution: University of Warwick - Warwick Research Archive Portal

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Exeter - Open Research Exeter

repository_institution: The University of Glasgow - Enlighten: Publications

lead_sponsor: Ad scientiam

location_country: Italy Portugal Spain France

location_facility: Scientific Institute of Hospitalization and Care San Raffaele Pisana


title: A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment.

acronym: CLINGLIO

summary: The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy.

lead_sponsor: Laminar Pharmaceuticals

collaborators: Northern Institute for Cancer Research, Newcastle

location_country:
France
Italy
United Kingdom
Spain
Israel

location_facility: University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital

location_facility: Hospital Universitari i Politécnic La Fe.

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Reaserch Fund of the Hadassah Medical Organization

location_facility: Freeman Hospital's Northern Centre of Cancer Care

location_facility: Istituto Nazionale Neurologico Carlo Besta


acronym: G-PLUS

lead_sponsor: Janssen-Cilag Ltd.

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

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

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

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

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

location_country:
Germany
Italy
United Kingdom
Spain
France


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 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

ReferenceCitation: Moreno V, Calvo E, Middleton MR, Barlesi F, Gaudy-Marqueste C, Italiano A, Romano E, Marabelle A, Chartash E, Dobrenkov K, Zhou H, Connors EC, Zhang Y, Wermke M. Treatment with a retinoic acid-inducible gene I (RIG-I) agonist as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: results from two phase 1 studies. Cancer Immunol Immunother. 2022 Dec;71(12):2985-2998. doi: 10.1007/s00262-022-03191-8. Epub 2022 May 21.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Spain
United Kingdom
France

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

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

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

location_facility: Charite Campus Benjamin Franklin ( Site 4903)

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: Netherlands France

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.

lead_sponsor: ECRI bv

collaborators:
Cardialysis BV
Balton Sp.zo.o.

sponsor_collaborators:
ECRI bv
Cardialysis BV
Balton Sp.zo.o.

location_country: Italy Poland France

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