title: A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.

ReferenceCitation: Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.

ReferenceCitation: Verleye L, Ottevanger PB, Kristensen GB, Ehlen T, Johnson N, van der Burg ME, Reed NS, Verheijen RH, Gaarenstroom KN, Mosgaard B, Seoane JM, van der Velden J, Lotocki R, van der Graaf W, Penninckx B, Coens C, Stuart G, Vergote I. Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial. Eur J Cancer. 2011 Jan;47(1):57-64. doi: 10.1016/j.ejca.2010.08.008. Epub 2010 Sep 16.

family: Verleye

full_name: Leen Verleye

given: Leen

family: Ottevanger

full_name: Petronella B. Ottevanger

given: Petronella B.

family: Kristensen

full_name: Gunnar B. Kristensen

given: Gunnar B.

family: Ehlen

full_name: Tom Ehlen

given: Tom

family: Johnson

full_name: Nick Johnson

given: Nick

family: van der Burg

full_name: Maria E.L. van der Burg

given: Maria E.L.

family: Reed

full_name: Nick S. Reed

given: Nick S.

family: Verheijen

full_name: René H.M. Verheijen

given: René H.M.

family: Gaarenstroom

full_name: Katja N. Gaarenstroom

given: Katja N.

family: Mosgaard

full_name: Berit Mosgaard

given: Berit

family: Seoane

full_name: Jose M. Seoane

given: Jose M.

family: van der Velden

full_name: Jacobus van der Velden

given: Jacobus

family: Lotocki

full_name: Robert Lotocki

family: van der Graaf

full_name: Winette van der Graaf

given: Winette

family: Penninckx

full_name: Björn Penninckx

given: Björn

family: Coens

full_name: Corneel Coens

given: Corneel

family: Stuart

full_name: Gavin Stuart

given: Gavin

family: Vergote

full_name: Ignace Vergote

given: Ignace

journal_name: European Journal of Cancer

title: Quality of pathology reports for advanced ovarian cancer: Are we missing essential information?

ReferenceCitation: Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

family: Tropé

full_name: Claes G. Tropé

given: Claes G.

family: Amant

full_name: Frédéric Amant

given: Frédéric

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

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

repository_institution: The University of Glasgow - Enlighten: Publications

title: Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer

ReferenceCitation: Fruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.

ReferenceCitation: Tajik P, van de Vrie R, Zafarmand MH, Coens C, Buist MR, Vergote I, Bossuyt PMM, Kenter GG. The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy. Int J Gynecol Cancer. 2018 Mar;28(3):453-458. doi: 10.1097/IGC.0000000000001186.

journal_name: International Journal of Gynecologic Cancer

ReferenceCitation: Vizzielli G, Fanfani F, Chiantera V, Tortorella L, Lucidi A, Petrillo M, Costantini B, Scambia G, Fagotti A. Does the diagnosis center influence the prognosis of ovarian cancer patients submitted to neoadjuvant chemotherapy? Anticancer Res. 2015 May;35(5):3027-32.

ReferenceCitation: van Meurs HS, Tajik P, Hof MH, Vergote I, Kenter GG, Mol BW, Buist MR, Bossuyt PM. Which patients benefit most from primary surgery or neoadjuvant chemotherapy in stage IIIC or IV ovarian cancer? An exploratory analysis of the European Organisation for Research and Treatment of Cancer 55971 randomised trial. Eur J Cancer. 2013 Oct;49(15):3191-201. doi: 10.1016/j.ejca.2013.06.013. Epub 2013 Jul 11.

location_country:
Italy
Austria
Sweden
Netherlands
Spain
Germany
France
Norway
Ireland
Argentina
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Libero Istituto Universitario Campus Bio-Medico

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: McGill Cancer Centre at McGill University

location_facility: Karolinska University Hospital - Huddinge

location_facility: Haukeland Hospital - University of Bergen

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Hospital de Clinicas "Jose De San Martin"

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Hospital Universitario Central de Asturias

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellström-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21.

family: de Witte

full_name: T. de Witte

given: T.

sequence: first

family: Hagemeijer

full_name: A. Hagemeijer

given: A.

sequence: additional

family: Suciu

full_name: S. Suciu

given: S.

family: Belhabri

full_name: A. Belhabri

family: Delforge

full_name: M. Delforge

given: M.

family: Kobbe

full_name: G. Kobbe

given: G.

family: Selleslag

full_name: D. Selleslag

given: D.

family: Schouten

full_name: H. C. Schouten

given: H. C.

family: Ferrant

full_name: A. Ferrant

family: Biersack

full_name: H. Biersack

given: H.

family: Amadori

full_name: S. Amadori

family: Muus

full_name: P. Muus

given: P.

family: Jansen

full_name: J. H. Jansen

given: J. H.

family: Hellstrom-Lindberg

full_name: E. Hellstrom-Lindberg

given: E.

family: Kovacsovics

full_name: T. Kovacsovics

family: Wijermans

full_name: P. Wijermans

family: Ossenkoppele

full_name: G. Ossenkoppele

family: Gratwohl

full_name: A. Gratwohl

family: Marie

full_name: J.-P. Marie

family: Willemze

full_name: R. Willemze

given: R.

bso_classification: Medical research

currency_apc_doaj: EUR

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

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

repositories:
LIRIAS (KU Leuven)
PubMed Central
repository.ubn.ru.nl

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

publisher: Ferrata Storti Foundation (Haematologica)

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

location_country:
Italy
Sweden
Switzerland
Netherlands
Croatia
France
Belgium
Germany
Czech Republic

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Institute of Hematology and Blood Transfusion

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Centre Hospitalier Universitaire Vaudois


title: A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.

status: Completed

ReferenceType: background

ReferenceCitation: Reman O, Pigneux A, Huguet F, Vey N, Delannoy A, Fegueux N, de Botton S, Stamatoullas A, Tournilhac O, Buzyn A, Charrin C, Boucheix C, Gabert J, Lhéritier V, Vernant JP, Fière D, Dombret H, Thomas X; GET-LALA group. Central nervous system involvement in adult acute lymphoblastic leukemia at diagnosis and/or at first relapse: results from the GET-LALA group. Leuk Res. 2008 Nov;32(11):1741-50. doi: 10.1016/j.leukres.2008.04.011. Epub 2008 May 27.

ReferenceCitation: Tavernier E, Le QH, de Botton S, Dhédin N, Bulabois CE, Reman O, Vey N, Lhéritier V, Dombret H, Thomas X. Secondary or concomitant neoplasms among adults diagnosed with acute lymphoblastic leukemia and treated according to the LALA-87 and LALA-94 trials. Cancer. 2007 Dec 15;110(12):2747-55.

ReferenceCitation: Dhédin N, Dombret H, Thomas X, Lhéritier V, Boiron JM, Rigal-Huguet F, Vey N, Kuentz M, Reman O, Witz F, Delannoy A, Kovacsovics T, Bradstock K, Charrin C, Boucheix C, Gabert J, Blaise D, Fière D, Vernant JP. Autologous stem cell transplantation in adults with acute lymphoblastic leukemia in first complete remission: analysis of the LALA-85, -87 and -94 trials. Leukemia. 2006 Feb;20(2):336-44.

ReferenceCitation: Picard C, Hayette S, Bilhou-Nabera C, Cayuela JM, Delabesse E, Frenoy N, Preudhomme C, Dupont M, Bastard C, Bories D, Vaerman JL, Davi F, Dastugue N, Raynaud S, Lafage M, Deschaseaux F, Fest T, Gaub MP, Lhéritier V, Thomas X, Charrin C, Boucheix C, Dombret H, Macintyre E, Fière D, Gabert J. Prospective multicentric molecular study for poor prognosis fusion transcripts at diagnosis in adult B-lineage ALL patients: the LALA 94 experience. Leukemia. 2006 Dec;20(12):2178-81. Epub 2006 Oct 12.

ReferenceCitation: Charrin C, Thomas X, Ffrench M, Le QH, Andrieux J, Mozziconacci MJ, Laï JL, Bilhou-Nabera C, Michaux L, Bernheim A, Bastard C, Mossafa H, Perot C, Maarek O, Boucheix C, Lheritier V, Delannoy A, Fière D, Dastugue N. A report from the LALA-94 and LALA-SA groups on hypodiploidy with 30 to 39 chromosomes and near-triploidy: 2 possible expressions of a sole entity conferring poor prognosis in adult acute lymphoblastic leukemia (ALL). Blood. 2004 Oct 15;104(8):2444-51. Epub 2004 Mar 23.

ReferenceCitation: Boissel N, Auclerc MF, Lhéritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fière D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. Epub 2003 Mar 1.

ReferenceCitation: Labar B, Suciu S, Willemze R, Muus P, Marie JP, Fillet G, Berneman Z, Jaksic B, Feremans W, Bron D, Sinnige H, Mistrik M, Vreugdenhil G, De Bock R, Nemet D, Gilotay C, Amadori S, de Witte T; EORTC Leukemia Group. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group. Haematologica. 2010 Sep;95(9):1489-95. doi: 10.3324/haematol.2009.018580. Epub 2010 Apr 7.

family: Labar

full_name: B. Labar

given: B.

family: Suciu

full_name: S. Suciu

family: Fillet

full_name: G. Fillet

family: Berneman

full_name: Z. Berneman

given: Z.

family: Jaksic

full_name: B. Jaksic

family: Feremans

full_name: W. Feremans

given: W.

family: Bron

full_name: D. Bron

family: Sinnige

full_name: H. Sinnige

family: Mistrik

full_name: M. Mistrik

family: Vreugdenhil

full_name: G. Vreugdenhil

family: De Bock

full_name: R. De Bock

family: Nemet

full_name: D. Nemet

family: Gilotay

full_name: C. Gilotay

given: C.

family: de Witte

full_name: T. de Witte

license_normalized: no license

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

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

repository_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Le QH, Thomas X, Ecochard R, Iwaz J, Lhéritier V, Michallet M, Fiere D. Proportion of long-term event-free survivors and lifetime of adult patients not cured after a standard acute lymphoblastic leukemia therapeutic program: adult acute lymphoblastic leukemia-94 trial. Cancer. 2007 May 15;109(10):2058-67.

ReferenceCitation: Tavernier E, Boiron JM, Huguet F, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lhéritier V, Vernant JP, Dombret H, Thomas X; GET-LALA Group; Swiss Group for Clinical Cancer Research SAKK; Australasian Leukaemia and Lymphoma Group. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007 Sep;21(9):1907-14. Epub 2007 Jul 5.

ReferenceCitation: Vey N, Thomas X, Picard C, Kovascovicz T, Charin C, Cayuela JM, Dombret H, Dastugue N, Huguet F, Bastard C, Stamatoulas A, Giollant M, Tournilhac O, Macintyre E, Buzyn A, Bories D, Kuentz M, Dreyfus F, Delannoy A, Raynaud S, Gratecos N, Bordessoule D, de Botton S, Preudhomme C, Reman O, Troussard X, Pigneux A, Bilhou C, Vernant JP, Boucheix C, Gabert J; GET-LALA Group the Swiss Group for Clinical Cancer Research (SAKK). Allogeneic stem cell transplantation improves the outcome of adults with t(1;19)/E2A-PBX1 and t(4;11)/MLL-AF4 positive B-cell acute lymphoblastic leukemia: results of the prospective multicenter LALA-94 study. Leukemia. 2006 Dec;20(12):2155-61. Epub 2006 Oct 12.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, Huguet F, Vey N, Boiron JM, Reman O, Cayuela JM, Lheritier V, Vernant JP, Fiere D, Macintyre E, Dombret H. Impact of TCR status and genotype on outcome in adult T-cell acute lymphoblastic leukemia: a LALA-94 study. Blood. 2005 Apr 15;105(8):3072-8. Epub 2005 Jan 6.

ReferenceCitation: Thomas X, Boiron JM, Huguet F, Dombret H, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Vernant JP, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lhéritier V, Fiere D. Outcome of treatment in adults with acute lymphoblastic leukemia: analysis of the LALA-94 trial. J Clin Oncol. 2004 Oct 15;22(20):4075-86. Epub 2004 Sep 7.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, et al.: Impact of immunophenotype and genotype on outcome in LALA94 T-ALLs: toward risk adapted stratification of adult T-ALL. [Abstract] Blood 102 (11): A-67, 2003.

ReferenceCitation: Dombret H, Gabert J, Boiron JM, Rigal-Huguet F, Blaise D, Thomas X, Delannoy A, Buzyn A, Bilhou-Nabera C, Cayuela JM, Fenaux P, Bourhis JH, Fegueux N, Charrin C, Boucheix C, Lhéritier V, Espérou H, MacIntyre E, Vernant JP, Fière D; Groupe d'Etude et de Traitement de la Leucémie Aiguë Lymphoblastique de l'Adulte (GET-LALA Group). Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia--results of the prospective multicenter LALA-94 trial. Blood. 2002 Oct 1;100(7):2357-66.

location_country:
Italy
Netherlands
Croatia
France
Slovakia
Belgium
Portugal
Turkey
Germany
Czech Republic

location_facility: Institute of Hematology & Transfusiology, University Hospital

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Universita Degli Studi di Bari Policlinico

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: Maxima Medisch Centrum - locatie Eindhoven


type: EudraCT Number

title: Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection

acronym: cASPerCF

summary: This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Armstead J, Morris J, Denning DW. Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis. PLoS One. 2014 Jun 10;9(6):e98502. doi: 10.1371/journal.pone.0098502. eCollection 2014.

ReferenceCitation: Rowbotham NJ, Smith S, Prayle AP, Robinson KA, Smyth AR. Gaps in the evidence for treatment decisions in cystic fibrosis: a systematic review. Thorax. 2019 Mar;74(3):229-236. doi: 10.1136/thoraxjnl-2017-210858. Epub 2018 Oct 9.

ReferenceCitation: Boyle M, Moore JE, Whitehouse JL, Bilton D, Downey DG. The diagnosis and management of respiratory tract fungal infection in cystic fibrosis: A UK survey of current practice. Med Mycol. 2019 Feb 1;57(2):155-160. doi: 10.1093/mmy/myy014.

ReferenceCitation: Welzen ME, Brüggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.

ReferenceCitation: Groll AH, Abdel-Azim H, Lehrnbecher T, Steinbach WJ, Paschke A, Mangin E, Winchell GA, Waskin H, Bruno CJ. Pharmacokinetics and safety of posaconazole intravenous solution and powder for oral suspension in children with neutropenia: an open-label, sequential dose-escalation trial. Int J Antimicrob Agents. 2020 Sep;56(3):106084. doi: 10.1016/j.ijantimicag.2020.106084. Epub 2020 Jul 17.

ReferenceCitation: King J, Brunel SF, Warris A. Aspergillus infections in cystic fibrosis. J Infect. 2016 Jul 5;72 Suppl:S50-5. doi: 10.1016/j.jinf.2016.04.022. Epub 2016 May 11. Review.

ReferenceCitation: Periselneris J, Nwankwo L, Schelenz S, Shah A, Armstrong-James D. Posaconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis. J Antimicrob Chemother. 2019 Jun 1;74(6):1701-1703. doi: 10.1093/jac/dkz075.

ReferenceCitation: Dolton MJ, Brüggemann RJ, Burger DM, McLachlan AJ. Understanding variability in posaconazole exposure using an integrated population pharmacokinetic analysis. Antimicrob Agents Chemother. 2014 Nov;58(11):6879-85. doi: 10.1128/AAC.03777-14. Epub 2014 Sep 8.

ReferenceCitation: Castellani C, Duff AJA, Bell SC, Heijerman HGM, Munck A, Ratjen F, Sermet-Gaudelus I, Southern KW, Barben J, Flume PA, Hodková P, Kashirskaya N, Kirszenbaum MN, Madge S, Oxley H, Plant B, Schwarzenberg SJ, Smyth AR, Taccetti G, Wagner TOF, Wolfe SP, Drevinek P. ECFS best practice guidelines: the 2018 revision. J Cyst Fibros. 2018 Mar;17(2):153-178. doi: 10.1016/j.jcf.2018.02.006. Epub 2018 Mar 3. Review.

ReferenceCitation: Patel D, Popple S, Claydon A, Modha DE, Gaillard EA. Posaconazole therapy in children with cystic fibrosis and Aspergillus-related lung disease. Med Mycol. 2020 Jan 1;58(1):11-21. doi: 10.1093/mmy/myz015.

ReferenceCitation: Krishna G, Ma L, Martinho M, Preston RA, O'Mara E. A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers. J Antimicrob Chemother. 2012 Nov;67(11):2725-30. doi: 10.1093/jac/dks268. Epub 2012 Jul 24.

ReferenceCitation: Tragiannidis A, Herbrüggen H, Ahlmann M, Vasileiou E, Gastine S, Thorer H, Fröhlich B, Müller C, Groll AH. Plasma exposures following posaconazole delayed-release tablets in immunocompromised children and adolescents. J Antimicrob Chemother. 2019 Dec 1;74(12):3573-3578. doi: 10.1093/jac/dkz359.

ipd_sharing: Yes

ipd_sharing_description: All IPD that underlie results in a publication

lead_sponsor: Bambino Gesù Hospital and Research Institute

location_country:
Italy
Switzerland
Netherlands
Spain
France
Czechia
Greece
Ireland
Portugal
Germany
United Kingdom

location_facility: Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Hospital Universitario Materno Infantil Reina Sofia

location_facility: Katholisches Klinikum Bochum gGMBH, Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum, St. Josef Hospital

location_facility: University of Parma Department of Medicine and Surgery

location_facility: Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: University Medical Center Groningen (UMCG)

location_facility: Radboud University Medical Center (RUMC)

location_facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Pädiatrische Pneumologie/Allergologie/Mukoviszidose-Zentrum

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: Centro Hospitalar Universitário Lisboa Norte EPE

location_facility: Sheffield Childrens NHS Foundation Trust

location_facility: ASST Spedali Civili Paediatric department

location_facility: Cystic Fibrosis Department, "Agia Sofia" Children's Hospital

location_facility: Universitätsklinikum Essen,Pediatric Pulmonology and Cystic Fibrosis Center

location_facility: Hospital Universitario 12 de Octubre,Unidad Multidisciplinar Fibrosis Quística

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Centre hospitalier universitaire Dijon Bourgogne

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: University Medical Center Utrecht (UMCU)

location_facility: University Hospital Nottingham (Queens Medical Centre)

location_facility: Cystic Fibrosis Center, 3rd Paediatric Dept, Aristotle University of Thessaloniki

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Phase 3b, Multi-center, Open-label, Treatment Optimization Study of Oral Asciminib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Previously Treated With 2 or More Tyrosine Kinase Inhibitors.

summary:
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations.

In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
France
Spain
Germany
United Kingdom

lead_sponsor_type: industriel


title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

acronym: RESOLVE-MR

summary: To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country: Italy Austria Switzerland Netherlands France Norway Germany

location_facility: Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern

location_facility: Lancisi Cardiovascular Center - Politechnic University of Marcher

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University Hospital Basel, Clinic for Cardiac Surgery

intervention_type: Device


title: Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

acronym: SOCRATES

summary: The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

lead_sponsor: Prof. Giovanni Torsello

location_country: Austria Netherlands France Spain Germany

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hospital Ottakring, Institute for Vascular Surgery

location_facility: Hospices Civils de lyon - Hôpital Edouard Herriot


title: Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients

acronym: COVIP

summary:
The primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group To create hypothesis for further studies, in particular on various outcome prediction

To create hypothesis for further studies, in particular on various outcome prediction

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Flaatten H, de Lange DW, Artigas A, Bin D, Moreno R, Christensen S, Joynt GM, Bagshaw SM, Sprung CL, Benoit D, Soares M, Guidet B. The status of intensive care medicine research and a future agenda for very old patients in the ICU. Intensive Care Med. 2017 Sep;43(9):1319-1328. doi: 10.1007/s00134-017-4718-z. Epub 2017 Feb 25. Review.

ReferenceCitation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjølner J, Jung C, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (≥ 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.

ReferenceCitation: Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hébert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999 Jan 16;353(9148):205-6.

ReferenceCitation: Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjølner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.

ReferenceCitation: Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30.

ReferenceCitation: Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjølner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW, Guidet B, Flaatten H; VIP1 study group. Electronic address: hans.flaatten@uib.no. A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention. J Crit Care. 2019 Aug;52:141-148. doi: 10.1016/j.jcrc.2019.04.020. Epub 2019 May 2.

ReferenceType: derived

ReferenceCitation: Jung C, Flaatten H, de Lange D, Beil M, Guidet B. The relationship between treatment limitations and pressure on intensive care units in elderly patients. Intensive Care Med. 2021 Nov 5. doi: 10.1007/s00134-021-06553-5. [Epub ahead of print]

family: Jung

full_name: Christian Jung

given: Christian

family: Flaatten

full_name: Hans Flaatten

given: Hans

family: de Lange

full_name: Dylan de Lange

given: Dylan

family: Beil

full_name: Michael Beil

given: Michael

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

journal_name: Intensive Care Medicine

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Jung C, Fjølner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Joannidis M, Oeyen S, Zafeiridis T, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H; , COVIP Study Group. Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe. Crit Care. 2021 Sep 23;25(1):344. doi: 10.1186/s13054-021-03739-7.

ReferenceCitation: Bruno RR, Wernly B, Flaatten H, Fjølner J, Artigas A, Bollen Pinto B, Schefold JC, Binnebössel S, Baldia PH, Kelm M, Beil M, Sigal S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Wollborn J, Arche Banzo MJ, Fuest K, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP Study Group. Lactate is associated with mortality in very old intensive care patients suffering from COVID-19: results from an international observational study of 2860 patients. Ann Intensive Care. 2021 Aug 21;11(1):128. doi: 10.1186/s13613-021-00911-8.

ReferenceCitation: Jung C, Flaatten H, Fjølner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, Boumendil A, De Lange DW, Guidet B; COVIP study group. The impact of frailty on survival in elderly intensive care patients with COVID-19: the COVIP study. Crit Care. 2021 Apr 19;25(1):149. doi: 10.1186/s13054-021-03551-3.

family: Fjølner

full_name: Jesper Fjølner

given: Jesper

family: Bruno

full_name: Raphael Romano Bruno

given: Raphael Romano

family: Wernly

full_name: Bernhard Wernly

given: Bernhard

family: Artigas

full_name: Antonio Artigas

given: Antonio

family: Bollen Pinto

full_name: Bernardo Bollen Pinto

given: Bernardo

family: Schefold

full_name: Joerg C. Schefold

given: Joerg C.

family: Wolff

full_name: Georg Wolff

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jung C, Bruno RR, Wernly B, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Fernandes AM, Artigas A, Pinto BB, Schefold J, Wolff G, Kelm M, De Lange DW, Guidet B, Flaatten H, Fjølner J; COVIP study group. Inhibitors of the renin-angiotensin-aldosterone system and COVID-19 in critically ill elderly patients. Eur Heart J Cardiovasc Pharmacother. 2021 Jan 16;7(1):76-77. doi: 10.1093/ehjcvp/pvaa083.

name: Department of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich-Heine-University Duesseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

name: Department of Cardiology, Paracelsus Medical University, Müllner Hauptstraße 48, A-5020 Salzburg, Austria

name: Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria

name: Department of Intensive Care 1K12IC, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Gent, Belgium

name: Intensive Care Unit, General Hospital of Larissa, Tsakalof 1, Larisa 412 21, Greece

name: Mater Misericordiae University Hospital, Eccles St, Northside, Dublin 7, D07 R2WY, Ireland

name: Department of Anaesthesia and Intensive Care, Ålesund Hospital, Åsehaugen 5, 6017 Ålesund, Norway

name: Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Prinsesse Kristinas gate 3, 7030 Trondheim, Norway

name: Unidade de Cuidados Intensivos Neurocríticos e Trauma, Hospital de São José, Centro Hospitalar Universitário de Lisboa Central, Faculdade de Ciências Médicas de Lisboa, Nova Médical School, R. José António Serrano, 1150-199 Lisboa, Portugal

name: Department of Intensive Care Medicine, CIBER Enfermedades Respiratorias, Corporacion Sanitaria Universitaria Parc Tauli, Autonomous University of Barcelona, Parc Taulí, 1, 08208 Sabadell, Spain

name: Department of Acute Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205 Genève, Switzerland

name: Department of Intensive Care Medicine, Inselspital, Universitätsspital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland

name: Department of Intensive Care Medicine, University Medical Center, University Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands

name: Assistance Publique—Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale, 184 Rue du Faubourg Saint-Antoine, Paris F-75012, France

name: Department of Clinical Medecine, University of Bergen, Jonas Lies vei 65, 5021 Bergen, Norway

name: Department of Anaesthesia and Intensive Care, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway

name: Department of Intensive Care, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus N, Denmark

journal_name: European Heart Journal - Cardiovascular Pharmacotherapy

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: New University of Lisbon - New University of Lisbon's Repository

title: Inhibitors of the renin–angiotensin–aldosterone system and COVID-19 in critically ill elderly patients

location_facility: INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine

location_facility: Department of Anaestesia and Intensive Care, Haukeland University Hospital

location_facility: Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Department of Clinical Medecine,University of Bergen


title: Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

summary:
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

lead_sponsor: Interscope, Inc.

location_country:
Italy
Germany
United States
France

location_facility: Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Humanitas Research Hospital & Humanitas University

location_facility: Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica

status_simplified: Completed


title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered Intrathecally to Adults With Multiple System Atrophy

acronym: HORIZON

summary:
The primary objective is to evaluate the safety and tolerability of multiple doses of BIIB101 administered via intrathecal (IT) injection to participants with multiple system atrophy (MSA).

The secondary objective is to evaluate the pharmacokinetic (PK) profile of BIIB101.

status: Active, not recruiting

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country: Austria Germany France

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg


title: First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

acronym: PiCSO-AMI-I

summary: The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).

lead_sponsor: Miracor Medical SA

location_country:
Switzerland
France
Denmark
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: EOC Ospedale Regionale di Lugano - Civico

location_facility: CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study

acronym: VESTIGE

summary:
The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.

Other study objectives:

To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study
To correlate nutritional status assessment on outcomes and quality of life of patients

ReferenceCitation: Smyth E, Knödler M, Giraut A, Mauer M, Nilsson M, Van Grieken N, Wagner AD, Moehler M, Lordick F. VESTIGE: Adjuvant Immunotherapy in Patients With Resected Esophageal, Gastroesophageal Junction and Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): An Open Label Randomized Controlled Phase-2-Study. Front Oncol. 2020 Jan 30;9:1320. doi: 10.3389/fonc.2019.01320. eCollection 2019.

family: Smyth

full_name: Elizabeth Smyth

given: Elizabeth

family: Knödler

full_name: Maren Knödler

given: Maren

family: Giraut

full_name: Anne Giraut

given: Anne

family: Mauer

full_name: Murielle Mauer

given: Murielle

family: Nilsson

full_name: Magnus Nilsson

given: Magnus

family: Van Grieken

full_name: Nicole Van Grieken

given: Nicole

family: Wagner

full_name: Anna Dorothea Wagner

given: Anna Dorothea

family: Moehler

full_name: Markus Moehler

given: Markus

family: Lordick

full_name: Florian Lordick

given: Florian

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Cambridge - Apollo

evidence: oa repository (via pmcid lookup)

repositories_institution:
PubMed Central - Europe PMC
University of Cambridge - Apollo
Université de Lausanne - SERVAL

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

location_country:
Italy
France
Czechia
Poland
Israel
Norway
Spain
Germany
United Kingdom

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: Azienda Ospedaliera a Papa Giovanni XXIII

location_facility: Oslo University Hospital - Ullevaal Hospital

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Institut Catalan d'Oncologia - ICO Badalona

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Other


type: Other Identifier

title: Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study

acronym: STEAM

summary: This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.

design_allocation: Non-Randomized

location_country: Austria Switzerland Netherlands France Germany

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

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

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

intervention_type: Radiation


title: A Randomised, Single-blind, Active Controlled, Multi-centre Trial to Evaluate the Efficacy, Safety, Tolerability, Acceptability and Palatability of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children Aged From 2 to Less Than 6, From 6 to Less Than 12, and Adolescents From 12 to Less Than 18 Years of Age Requiring a Diagnostic Procedure Concerning the Colon

summary: A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

lead_sponsor: Alfasigma S.p.A.

location_country: Italy Belgium France

location_facility: Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna

location_facility: University and Pediatric Hospital of Lyon

location_facility: Azienda Ospedaliera Universitaria "G. Martino"

location_facility: Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital

status_simplified: Unknown


title: A Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

summary: This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2)

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Australia
France
Spain

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

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

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust


title: Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFα and Methotrexate Combination.

acronym: RABIOPRED

summary: RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate combination therapy.

status: Terminated

lead_sponsor: TcLand Expression S.A.

location_country: Netherlands France Czechia Israel Turkey

location_facility:
CHU-Montpellier
Leiden University Medical Center
University of Marmara
CHU Nice
Istanbul University
CHU Strasbourg Hautepierre
Tel Aviv Surasky Medical Center
Institute of Rheumatology

intervention_type: Biological


title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae

acronym: AVR

summary: The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

lead_sponsor: C. R. Bard

location_country:
Italy
Austria
Saudi Arabia
Switzerland
France
Poland
Greece
Singapore
Portugal
Turkey
Germany
United Kingdom
Taiwan

location_facility: Klinika Chirurgii Naczyniowej University Hospital nr 1

location_facility: NephroCare Portugal, S.A. NephroCare Lumia

location_facility: King Abdullah International Medical Research Center

location_facility: Azienda Ospedaliera Di Pisa - Ospedale Cisanello


lead_sponsor: Bioprojet

location_country:
Italy
Netherlands
Finland
France
Russian Federation

location_facility: N.I. Balaban Crimea Repiblic Clinical Psychiatric Hospital No. 1

location_facility: Scientific-Research Medical Complex "Your Health"

location_facility: V.M. Behterev National Medical Research Psychiatry and Neurology Center

location_facility: I.M. Sechenov First Moscow State Medical University

source: euctr

title: Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without Cataplexy, Followed by a Prolonged Open-label Period

summary: The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.


title: A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria

summary: The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor treatment-naïve participants with PNH.

ReferenceCitation: Röth A, Rottinghaus ST, Hill A, Bachman ES, Kim JS, Schrezenmeier H, Terriou L, Urbano-Ispizua Á, Wells RA, Jang JH, Kulasekararaj AG, Szer J, Aguzzi R, Damokosh AI, Shafner L, Lee JW. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018 Sep 11;2(17):2176-2185. doi: 10.1182/bloodadvances.2018020644.

name: Department of Hematology, West German Cancer Center, University Hospital Essen, Essen, Germany;

family: Röth

full_name: Alexander Röth

given: Alexander

name: Alexion Pharmaceuticals, Inc, New Haven, CT;

family: Rottinghaus

full_name: Scott T. Rottinghaus

given: Scott T.

name: Department of Haematology, Leeds Teaching Hospitals, Leeds, United Kingdom;

family: Hill

full_name: Anita Hill

given: Anita

family: Bachman

full_name: Eric S. Bachman

given: Eric S.

name: Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea;

family: Kim

full_name: Jin Seok Kim

given: Jin Seok

name: Institute of Transfusion Medicine, University of Ulm, Ulm, Germany;

name: Institute for Clinical Transfusion Medicine and Immunogenetics, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen/University Hospital Ulm, Ulm, Germany;

family: Schrezenmeier

full_name: Hubert Schrezenmeier

given: Hubert

name: Clinical Immunology, Department of Internal Medicine, Centre Hospitalier Régional Universitaire de Lille–Hôpital Claude Huriez, Lille, France;

family: Terriou

full_name: Louis Terriou

given: Louis

name: Institute of Research Josep Carreras, Hospital Clinic Barcelona, Barcelona, Spain;

family: Urbano-Ispizua

full_name: Álvaro Urbano-Ispizua

given: Álvaro

name: Division of Medical Oncology and Haematology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada;

family: Wells

full_name: Richard A. Wells

given: Richard A.

name: Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Republic of Korea;

family: Jang

full_name: Jun Ho Jang

given: Jun Ho

name: Department of Haematological Medicine, King's College Hospital, National Institute for Health Research and Wellcome King’s Clinical Research Facility, London, United Kingdom;

family: Kulasekararaj

full_name: Austin G. Kulasekararaj

given: Austin G.

name: Department of Clinical Haematology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia;

family: Szer

full_name: Jeff Szer

given: Jeff

name: Alexion Pharmaceuticals, Inc, Lexington, MA; and

family: Aguzzi

full_name: Rasha Aguzzi

given: Rasha

family: Damokosh

full_name: Andrew I. Damokosh

given: Andrew I.

family: Shafner

full_name: Lori Shafner

given: Lori

name: Department of Hematology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

family: Lee

full_name: Jong Wook Lee

given: Jong Wook

journal_name: Blood Advances

oa_host_type: repository

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Alexion Pharmaceuticals

location_country:
France
Korea, Republic of
Spain
Germany
United Kingdom
Canada
Taiwan


title: A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

summary:
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
United Kingdom
France
Netherlands

location_facility: Centre hospitalier régional universitaire de Lille

location_facility: Centre Hospitalier Universiatier de Toulouse


lead_sponsor: Guerbet

primary_purpose: Diagnostic

location_country: Austria Hungary France Poland

location_facility: Borsod-Abaúj-Zemplén University County Hospital

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Instytut Pomnik -Centrum Zdrowia Dziecka

location_facility: Department of Molecular and Neurological Clinical and Research Center

title: DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

summary:
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.

DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.


title: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.

acronym: BIOSync CLS

summary: The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.

ReferenceCitation: Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.

name: Department of Cardiovascular, Neural and Metabolic Sciences, Faint & Fall Programme, IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Piazzale Brescia 20, Milano 20149, Italy

name: Department of Cardiology, Arrhythmology Centre and Syncope Unit, Ospedali del Tigullio, via don Bobbio 24, 16033 Lavagna, Italy

family: Brignole

full_name: Michele Brignole

given: Michele

name: Department of Cardiology, Chair of Cardiology, University of the Study of Campania “Luigi Vanvitelli”, Ospedale Monaldi, Via leonardo Bianchi, 80131 Napoli, Italy

family: Russo

full_name: Vincenzo Russo

given: Vincenzo

name: Department of Cardiology, Unit of Arrhythmology, A.O. Pugliese-Ciaccio, Viale Papa Pio X, 83, 88100 Castanzaro, Italy

family: Arabia

full_name: Francesco Arabia

given: Francesco

name: Cardiology Department, Santa Marta Hospital—University Central Hospital of Lisbon, Rue de Santa Marta, 50, 1150-140 Lisboa, Portugal

family: Oliveira

full_name: Mario Oliveira

given: Mario

name: Division of Arrhythmology, Virgen del Rocio University Hospital, Avenida Manuel Siurot, 40013 Sevilla, Spain

family: Pedrote

full_name: Alonso Pedrote

given: Alonso

name: Department of Cardiology, Zuyderland Medisch Centrum, Henri Dunantstraat, 5 6419PC Heerlen, The Netherlands

family: Aerts

full_name: Arnaud Aerts

given: Arnaud

name: Department of Advanced Biomedical Sciences, Federico II University of Naples, via Sergio Pansini 5, 80100 Napoli, Italy

family: Rapacciuolo

full_name: Antonio Rapacciuolo

given: Antonio

name: Heart Rhythm Department, Clinique Pasteur, 45 avenue de Lombez - BP 27617 - 31076 Toulouse Cedex 3, France

name: Universitair Ziekenhuis Brussel—VUB, Heart Rhythm Management Centre, Laarbeeklaan 101 1090 Brussels, Belgium

family: Boveda

full_name: Serge Boveda

given: Serge

name: Department of Cardiology, Hôpital La Timone Adultes, 264 Rue Saint-Pierre 13385 Marseille Cedex 5, France

family: Deharo

full_name: Jean Claude Deharo

given: Jean Claude

family: Maglia

full_name: Giampiero Maglia

given: Giampiero

family: Nigro

full_name: Gerardo Nigro

given: Gerardo

name: Research Clinical Unit, Biotronik Italy, Via delle Industrie, 11 20090 Vimodrone (MI), Italy

family: Giacopelli

full_name: Daniele Giacopelli

given: Daniele

family: Gargaro

full_name: Alessio Gargaro

given: Alessio

name: Department of Cardiology, Ospedale Generale Regionale, Via Lorenz Böhler 5 39100 Bolzano, Italy

family: Tomaino

full_name: Marco Tomaino

given: Marco

journal_name: European Heart Journal

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Brignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Paredes FA, Deharo JC, Del Rosso A, Hamdan MH, Lunati M, Moya A, Gargaro A; BIOSync Study Steering Committee. Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial. Trials. 2017 May 4;18(1):208. doi: 10.1186/s13063-017-1941-4. Erratum in: Trials. 2017 Jun 8;18(1):269.

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

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

location_country: Italy Netherlands Spain France Portugal Canada

location_facility: A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico

location_facility: Hospital Universitario Nuestra Senora de la Candelaria


title: Prospective, Randomized, Multicentre Clinical Study of the Hemoteq Ranger™ Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions

acronym: RANGER-SFA

summary: The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

ReferenceCitation: Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Ströbel A, Schult I, Scheinert D; RANGER SFA Investigators. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.

family: Bausback

full_name: Yvonne Bausback

given: Yvonne

name: Medizinische Universität Wien, Vienna, Austria

family: Willfort-Ehringer

full_name: Andrea Willfort-Ehringer

given: Andrea

name: Cardiovascular Center Frankfurt, Germany

name: Anglia Ruskin University, Chelmsford, UK

family: Sievert

full_name: Horst Sievert

given: Horst

family: Geist

full_name: Volker Geist

given: Volker

family: Lichtenberg

full_name: Michael Lichtenberg

given: Michael

name: Hôpital Européen Georges-Pompidou, Paris, France

family: Del Giudice

full_name: Costantino Del Giudice

given: Costantino

family: Sauguet

full_name: Antoine Sauguet

given: Antoine

family: Diaz-Cartelle

full_name: Juan Diaz-Cartelle

given: Juan

name: CERES GmbH Evaluation & Research, Lörrach, Germany

family: Marx

full_name: Claudia Marx

given: Claudia

family: Ströbel

full_name: Armin Ströbel

given: Armin

family: Schult

full_name: Ingolf Schult

given: Ingolf

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

name: on behalf of the RANGER SFA Investigators

journal_name: Journal of Endovascular Therapy

oa_host_type: publisher

evidence: open (via free pdf)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Hemoteq AG

location_facility: Hopital Europeen Georges-Pompidou (HEGP)


title: Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

acronym: Minitub

summary:
The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.

Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry.

The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.

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

location_country:
Italy
Switzerland
Netherlands
United Kingdom
France
Poland
Belgium
Spain
Germany
Slovenia

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Guy's and St Thomas' NHS - St Thomas Hospital

location_facility: St Helens & Knowsley NHS Trust - Whiston Hospital

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera


title: A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

summary: The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
France
Spain
Germany
United Kingdom
Portugal


title: A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

summary: The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

lead_sponsor: Clavis Pharma

location_country:
Norway
Germany
United States
France

location_facility: Charite University Hospital Benjamin Franklin


ReferenceCitation: Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24.

name: Instytut Gruźlicy i Chorób Pluc; Oddzial Terenowy im. Jana i Ireny Rudników w Rabce-Zdrój; Klinika Pneumonologii i Mukowiscydozy; Rabka-Zdrój Poland

family: Mazurek

full_name: Henryk Mazurek

given: Henryk

name: Hôpital Arnaud de Villeneuve; Centre des Maladies Respiratoires; Montpellier France

family: Chiron

full_name: Raphaël Chiron

given: Raphaël

name: Centrum Pro Cystickou Fibrosu; Pediatricka Klinika; Fakultní nemocnice v Motole; Praha Czech Republic

family: Kucerova

full_name: Tereza Kucerova

given: Tereza

name: Justus-Liebig Universität Gießen; Pädiatrische Pneumologie und Allergologie; Mukovizidose-Zentrum; Zentrum für Kinderheilkunde und Jugendmedizin; Gießen Germany

family: Geidel

full_name: Christian Geidel

given: Christian

name: Kaposi Mór Oktatókórház; Gyermekpulmonológiai Részleg; Mosdós Hungary

family: Bolbas

full_name: Katalin Bolbas

given: Katalin

name: Federal State Institution-Scientific Research Pulmonology Institute under the Roszdrav Laboratory of Cystic Fibrosis; Moscow Russia

family: Chuchalin

full_name: Alexander Chuchalin

given: Alexander

name: Complejo Hospitalario Universitario La Coruña; Servicio de Neumologia; A Coruña Spain

family: Blanco-Aparicio

full_name: Marina Blanco-Aparicio

given: Marina

name: Corporate Clinical Development; Chiesi Farmaceutici, S.p.A.; Parma Italy

family: Santoro

full_name: Debora Santoro

given: Debora

family: Varoli

full_name: Guido Varoli

given: Guido

family: Zibellini

full_name: Marco Zibellini

name: Chiesi Pharmaceuticals, Inc.; Rockville Maryland

family: Cicirello

full_name: Helen G. Cicirello

given: Helen G.

name: Institute of Pediatrics; Obstetrics and Gynecology; Department of Respiratory Diseases and Ecological Problems of Children's Health; Kyiv Ukraine

family: Antipkin

full_name: Yuriy G. Antipkin

given: Yuriy G.

journal_name: Pediatric Pulmonology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country:
France
Czechia
Poland
Hungary
Russian Federation
Spain
Germany
Ukraine

acronym: CT03 Core

location_facility: Hospital Universitario Ntra Sra. De la Candelaria

location_facility: Federal State Institution "Nizhegorodskiy Research Institute of Children's Gastroenterology of Russian Medical Technologies"

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny

location_facility: Hospital Universitario Miguel Servet (Children)

location_facility: Pädiatrische Pneumologie und Allergologie, Mukovizidose-Zentrum, Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Lviv Regional Children Specialized Clinical Hospital

location_facility: Federal State Institution: Scientific Research Pulmonology Institute under the Roszdrav

location_facility: Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine

location_facility: I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy

location_facility: State Higher Educational Institution: Bashkir State Medical University under the Roszdrav

location_facility: Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum

location_facility: Odesa Regional Children Clinical Hospital

location_facility: Saint-Petersburg State Medical Institution: City Children's Hospital of Saint Olga

location_facility: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

location_facility: Centrum pro cystickou fibrosu, Pediatricka klinika UK 2.LF, Fakultní nemocnice v Motole

location_facility: Minicipal Medical Institution: Children's Clinical Hospital #1

location_facility: Complejo Hospitalario Universitario A Coruña (Hospital Materno-Infantil Teresa Herrera)

location_facility: State Higher Educational Institution: Burdenko Voronezh State Medical Academy under the Roszdrav

location_facility: Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2

location_facility: State Medical Institution: Regional Children's Hospital Pulmonology Department

location_facility: HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin

location_facility: Zaporizhya Regional Clinical Children Hospital

location_facility: Klinika Pediatrii Instytut Matki I Dziecka

location_facility: Dnipropetrovsk City Children Clinical Hospital # 2

location_facility: Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii

location_facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: State Medical Institution: Republican Childrens Clinical Hospital under the Ministry of Health of the Republic of Tatarstan

location_facility: Regional State Medical Institution: Smolensk Regional Children's Clinical Hospital

location_facility: State Medical Institution: Filatov Chidren's City Clinical Hospital #13

location_facility: Simferopol Central District Clinical Hospital

location_facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine

title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa

summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


lead_sponsor: UCB Pharma

location_country: Italy Austria France Poland Germany

acronym: CERTAIN 2

title: A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.

summary: To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)


title: An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination With Radiotherapy, in Patients With Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum Based Chemotherapy

summary: The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

lead_sponsor: Genmab

location_country:
United Kingdom
Belgium
France

location_facility: Centre Georges-Francois Leclerc Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust


title: Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

acronym: PERTAIN

summary: The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

lead_sponsor: Janssen-Cilag International NV

location_country: Croatia France Lithuania Israel Poland Romania Germany


title: A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

summary: The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Greece
Hungary
Spain
Germany
United Kingdom
Taiwan
Colombia

location_facility:
Novartis Investigative Site
Novartis


title: Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005

summary: The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.

ReferenceCitation: Zwaan CM, Rizzari C, Mechinaud F, Lancaster DL, Lehrnbecher T, van der Velden VH, Beverloo BB, den Boer ML, Pieters R, Reinhardt D, Dworzak M, Rosenberg J, Manos G, Agrawal S, Strauss L, Baruchel A, Kearns PR. Dasatinib in children and adolescents with relapsed or refractory leukemia: results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children with Cancer Consortium. J Clin Oncol. 2013 Jul 1;31(19):2460-8. doi: 10.1200/JCO.2012.46.8280. Epub 2013 May 28.

name: C. Michel Zwaan, H. Berna Beverloo, Monique L. den Boer, and Rob Pieters, Erasmus Medical Center (MC)/Sophia Children's Hospital; Vincent H.J. van der Velden, Erasmus MC, Rotterdam, the Netherlands; Carmelo Rizzari, University of Milano-Bicocca, Hospital S. Gerardo, Monza, Italy; Francoise Mechinaud, Royal Children's Hospital, Melbourne, Victoria, Australia; Donna L. Lancaster, The Royal Marsden National Health Service Foundation Trust, London; Pamela R. Kearns, School of Cancer Sciences, University of...

family: Zwaan

full_name: C. Michel Zwaan

given: C. Michel

family: Rizzari

full_name: Carmelo Rizzari

given: Carmelo

family: Mechinaud

full_name: Francoise Mechinaud

given: Francoise

family: Lancaster

full_name: Donna L. Lancaster

given: Donna L.

family: Lehrnbecher

full_name: Thomas Lehrnbecher

given: Thomas

family: van der Velden

full_name: Vincent H.J. van der Velden

given: Vincent H.J.

family: Beverloo

full_name: B. Berna Beverloo

given: B. Berna

family: den Boer

full_name: Monique L. den Boer

given: Monique L.

family: Pieters

full_name: Rob Pieters

given: Rob

family: Reinhardt

full_name: Dirk Reinhardt

given: Dirk

family: Dworzak

full_name: Michael Dworzak

given: Michael

family: Rosenberg

full_name: Julie Rosenberg

given: Julie

family: Manos

full_name: George Manos

given: George

family: Agrawal

full_name: Shruti Agrawal

given: Shruti

family: Strauss

full_name: Lewis Strauss

given: Lewis

family: Baruchel

full_name: André Baruchel

given: André

family: Kearns

full_name: Pamela R. Kearns

given: Pamela R.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia: Results of the CA180-018 Phase I Dose-Escalation Study of the Innovative Therapies for Children With Cancer Consortium

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Netherlands
France
Germany
United Kingdom


title: Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure

acronym: ESCAPE

summary: In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.

ReferenceCitation: ESCAPE Trial Group, Wühl E, Trivelli A, Picca S, Litwin M, Peco-Antic A, Zurowska A, Testa S, Jankauskiene A, Emre S, Caldas-Afonso A, Anarat A, Niaudet P, Mir S, Bakkaloglu A, Enke B, Montini G, Wingen AM, Sallay P, Jeck N, Berg U, Caliskan S, Wygoda S, Hohbach-Hohenfellner K, Dusek J, Urasinski T, Arbeiter K, Neuhaus T, Gellermann J, Drozdz D, Fischbach M, Möller K, Wigger M, Peruzzi L, Mehls O, Schaefer F. Strict blood-pressure control and progression of renal failure in children. N Engl J Med. 2009 Oct 22;361(17):1639-50. doi: 10.1056/NEJMoa0902066.

ReferenceCitation: Tabatabaeifar M, Schlingmann KP, Litwin M, Emre S, Bakkaloglu A, Mehls O, Antignac C, Schaefer F, Weber S; ESCAPE Trial Group. Functional analysis of BMP4 mutations identified in pediatric CAKUT patients. Pediatr Nephrol. 2009 Dec;24(12):2361-8. doi: 10.1007/s00467-009-1287-6. Epub 2009 Aug 14.

ReferenceCitation: Gimpel C, Wühl E, Arbeiter K, Drozdz D, Trivelli A, Charbit M, Gellermann J, Dusek J, Jankauskiene A, Emre S, Schaefer F; ESCAPE Trial Group. Superior consistency of ambulatory blood pressure monitoring in children: implications for clinical trials. J Hypertens. 2009 Aug;27(8):1568-74. doi: 10.1097/HJH.0b013e32832cb2a8.

ReferenceCitation: Grenda R, Wühl E, Litwin M, Janas R, Sladowska J, Arbeiter K, Berg U, Caldas-Afonso A, Fischbach M, Mehls O, Sallay P, Schaefer F; ESCAPE Trial group. Urinary excretion of endothelin-1 (ET-1), transforming growth factor- beta1 (TGF- beta1) and vascular endothelial growth factor (VEGF165) in paediatric chronic kidney diseases: results of the ESCAPE trial. Nephrol Dial Transplant. 2007 Dec;22(12):3487-94. Epub 2007 Sep 26.

ReferenceCitation: Chinali M, de Simone G, Matteucci MC, Picca S, Mastrostefano A, Anarat A, Caliskan S, Jeck N, Neuhaus TJ, Peco-Antic A, Peruzzi L, Testa S, Mehls O, Wühl E, Schaefer F; ESCAPE Trial Group. Reduced systolic myocardial function in children with chronic renal insufficiency. J Am Soc Nephrol. 2007 Feb;18(2):593-8. Epub 2007 Jan 10.

ReferenceCitation: Schönfelder EM, Knüppel T, Tasic V, Miljkovic P, Konrad M, Wühl E, Antignac C, Bakkaloglu A, Schaefer F, Weber S; ESCAPE Trial Group. Mutations in Uroplakin IIIA are a rare cause of renal hypodysplasia in humans. Am J Kidney Dis. 2006 Jun;47(6):1004-12.

ReferenceCitation: Matteucci MC, Wühl E, Picca S, Mastrostefano A, Rinelli G, Romano C, Rizzoni G, Mehls O, de Simone G, Schaefer F; ESCAPE Trial Group. Left ventricular geometry in children with mild to moderate chronic renal insufficiency. J Am Soc Nephrol. 2006 Jan;17(1):218-26. Epub 2005 Nov 9.

ReferenceCitation: Wühl E, Mehls O, Schaefer F; ESCAPE Trial Group. Antihypertensive and antiproteinuric efficacy of ramipril in children with chronic renal failure. Kidney Int. 2004 Aug;66(2):768-76.

ReferenceCitation: Jourdan C, Wühl E, Litwin M, Fahr K, Trelewicz J, Jobs K, Schenk JP, Grenda R, Mehls O, Tröger J, Schaefer F. Normative values for intima-media thickness and distensibility of large arteries in healthy adolescents. J Hypertens. 2005 Sep;23(9):1707-15.

ReferenceCitation: Litwin M, Wühl E, Jourdan C, Trelewicz J, Niemirska A, Fahr K, Jobs K, Grenda R, Wawer ZT, Rajszys P, Tröger J, Mehls O, Schaefer F. Altered morphologic properties of large arteries in children with chronic renal failure and after renal transplantation. J Am Soc Nephrol. 2005 May;16(5):1494-500. Epub 2005 Mar 16.

ReferenceCitation: Wühl E, Hadtstein C, Mehls O, Schaefer F; ESCAPE Trial Group. Ultradian but not circadian blood pressure rhythms correlate with renal dysfunction in children with chronic renal failure. J Am Soc Nephrol. 2005 Mar;16(3):746-54. Epub 2005 Jan 12.

ReferenceCitation: Hadtstein C, Wühl E, Soergel M, Witte K, Schaefer F; German Study Group for Pediatric Hypertension. Normative values for circadian and ultradian cardiovascular rhythms in childhood. Hypertension. 2004 Mar;43(3):547-54. Epub 2004 Jan 26.

ReferenceCitation: Wühl E, Hadtstein C, Mehls O, Schaefer F; Escape Trial Group. Home, clinic, and ambulatory blood pressure monitoring in children with chronic renal failure. Pediatr Res. 2004 Mar;55(3):492-7. Epub 2003 Nov 19.

lead_sponsor: Heidelberg University

location_country:
Italy
Sweden
Serbia
Switzerland
France
Poland
Lithuania
Hungary
Portugal
Turkey
Germany
Czech Republic

location_facility: Azienda Ospedaliera die Padova. U.O. Nefrologia Dialisi e Trapianto - Dipartimento di Pediatria

location_facility: University Hospital Motol, 1st Department of Pediatrics

location_facility: Semmelweis University Budapest, 1st Department of Pediatrics

location_facility: Johannes Gutenberg University Mainz, Department of Pediatrics,

location_facility: Medical University of Gdansk, Pediatric Nephrology Department

location_facility: Cukurova University School of Medicine, Dept. of Pediatric Nephrology

location_facility: Division of Pediatric Nephrology, Children's Hospital, University of Heidelberg

location_facility: Clinic of Pediatrics, Pomeranian Academy of Medicine

location_facility: Urban Hospital St. Georg, Department of Pediatrics, Pediatric Nephrology Unit

location_facility: Ospedale Pediatrico Bambino Gesù, Division of Nephrology and Dialysis

location_facility: Ospedale Infantile Regina Margherita, U.O.A. Nefrologia, Dialisi, Trapianto

location_facility: Philipps University Marburg, Dept. of Pediatrics

location_facility: Istanbul University, Cerrahpasa Medical Faculty, Dept, of Pediatrics

location_facility: Hacettepe University, Faculty of Medicine, Pediatric Nephrology and Rheumatology

location_facility: Children's Memorial Health Hospital, Nephrology and Kidney Transplantation Department

location_facility: Vilnius University Children's Hospital, Pediatric Department, Nephrology Unit

location_facility: Azienda Ospedaliera, Istitui Clinici di Perfezionamento, Servizio die Emodialisi Pediatrica

location_facility: University Children's Hospital, Dept. of Nephrology

location_facility: Hannover Medical School, Children's Hospital Div. II, Pediatric Nephrology

location_facility: Hopital Necker, Division of Pediatric Nephrology

location_facility: Ege University Medical Faculty, Dept. of Pediatric Nephrology

location_facility: University Hospital Hamburg-Eppendorf, University Children's Hospital, Dept. of Pediatric Nephrology

location_facility: Karolinska Institute, Huddinge University Hospital, Dept. of Pediatrics

location_facility: University Hospital Essen, Department of Pediatrics, Pediatric Nephrology Unit

location_facility: University of Istanbul, Istanbul Medical Faculty, Dept. of Pediatrics

location_facility: Jagellonian University Medical College, Department of Pediatric Nephrology

location_facility: Humboldt University Berlin, Charité Children's Hospital, Department of Pediatric Nephrology

location_facility: Faculty of Medicine Belgrade, University Children's Hospital, Nephrology Unit

location_facility: Hospital S. Joao-Faculade de Medicina do Porto, Dept. of Pediatrics


title: A Multi-center, Phase 2, Open-Label Study of Fabrazyme (Recombinant Human a-Galactosidase A) Replacement Therapy in Pediatric Patients With Fabry Disease

summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This study explored the safety, efficacy and pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.

ReferenceCitation: Wraith JE, Tylki-Szymanska A, Guffon N, Lien YH, Tsimaratos M, Vellodi A, Germain DP. Safety and efficacy of enzyme replacement therapy with agalsidase beta: an international, open-label study in pediatric patients with Fabry disease. J Pediatr. 2008 Apr;152(4):563-70, 570.e1. doi: 10.1016/j.jpeds.2007.09.007. Epub 2007 Dec 3.

family: Wraith

full_name: J. Edmond Wraith

given: J. Edmond

family: Tylki-Szymanska

full_name: Anna Tylki-Szymanska

given: Anna

family: Guffon

full_name: Nathalie Guffon

given: Nathalie

family: Lien

full_name: Y. Howard Lien

given: Y. Howard

family: Tsimaratos

full_name: Michel Tsimaratos

given: Michel

family: Vellodi

full_name: Ashok Vellodi

given: Ashok

family: Germain

full_name: Dominique P. Germain

given: Dominique P.

journal_name: The Journal of Pediatrics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Safety and Efficacy of Enzyme Replacement Therapy with Agalsidase Beta: An International, Open-label Study in Pediatric Patients with Fabry Disease

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
United Kingdom
France
Poland

location_facility: Great Ormond Street Hospital for Sick Children


title: A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.

location_country: Italy Netherlands France Belgium Germany

location_facility:
Eberhard Karls Universitaet
Leiden University Medical Center
Hotel Dieu de Paris
Ospedale San Eugenio
Hopital Edouard Herriot
Institut Jules Bordet
Azienda Policlinico Umberto Primo
University Medical Center Nijmegen
Institut Gustave Roussy


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Open-label Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for Preventive Treatment in Patients With Chronic Cluster Headache

acronym: CHRONICLE

summary: The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
United States
France
Spain

location_facility: Michigan Headache and Neurological Institute

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS


title: PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) A Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer

acronym: PROTECT

summary: The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University of Aarhus

location_country:
Italy
Switzerland
Netherlands
France
Belgium
Denmark
Germany
United Kingdom

location_facility: University College London Hospital (UCLH)

location_facility: Stichting Maastricht Radiation Oncology (MAASTRO)

location_facility: Centro Nazionale di Adroterapia Oncologica (CNAO)

location_facility: Azienda Provinciale Per I Servizi Sanitari (APSS)


title: A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

summary: The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

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:
Spain
United States
France
Netherlands

location_facility: Columbia University Medical Center, Herbert Irving Pavilion


title: EP Device Registry

summary: This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

lead_sponsor: Abbott Medical Devices

location_country: Italy Austria Netherlands Spain France Czechia Hungary Portugal Germany

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Medizinische Einrichtungen der Universität zu Köln


title: Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Have Received Alpelisib as Part of a Compassionate Use Program (EPIK-P1)

summary:
The study is a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS). Patient-level data are abstracted from medical charts of all eligible patients at all participating sites.

Information from patients treated with alpelisib is used to describe the efficacy and safety of alpelisib in PROS patients.

time_perspective: Retrospective

location_country:
France
Ireland
Australia
Spain
United States

location_facility:
Boston Childrens Hospital
Novartis Investigative Site


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, blank 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 trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi Pasteur, a Sanofi Company

primary_purpose: Prevention

location_country: Italy Netherlands France Poland Belgium Germany

location_facility:
Investigational Site Number 2500001
Investigational Site Number 3800001
Investigational Site Number 2500003
Investigational Site Number 2500004
Investigational Site Number 0560002
Investigational Site Number 2760005
Investigational Site Number 2760004
Investigational Site Number 2760002
Investigational Site Number 3800003
Investigational Site Number 5280001
Investigational Site Number 6160003
Investigational Site Number 0560001
Investigational Site Number 2760001
Investigational Site Number 6160002
Investigational Site Number 2760003
Investigational Site Number 6160001
Investigational Site Number 6160004

title: Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

summary:
Primary Objective:

To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older.

Secondary Objective:

Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).


title: High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

acronym: WAVE-MAP AF

summary: The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

ipd_sharing: Undecided

location_country:
Italy
Austria
Netherlands
Spain
France
Czechia
Portugal
Germany
United Kingdom

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Azienda Ospedaliero Universitaria Pisana

intervention_type: Procedure