title: Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

acronym: ENTRACT

summary:
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.

The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.

We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study

ReferenceCitation: Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.

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ReferenceCitation: Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.

ReferenceCitation: Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

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ReferenceCitation: Laurent I, Monchi M, Chiche JD, Joly LM, Spaulding C, Bourgeois B, Cariou A, Rozenberg A, Carli P, Weber S, Dhainaut JF. Reversible myocardial dysfunction in survivors of out-of-hospital cardiac arrest. J Am Coll Cardiol. 2002 Dec 18;40(12):2110-6. doi: 10.1016/s0735-1097(02)02594-9.

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ReferenceCitation: Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. doi: 10.1097/01.ccx.0000126090.06275.fe.

ReferenceCitation: Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

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ReferenceCitation: Balija TM, Lowry SF. Lipopolysaccharide and sepsis-associated myocardial dysfunction. Curr Opin Infect Dis. 2011 Jun;24(3):248-53. doi: 10.1097/QCO.0b013e32834536ce.

ReferenceCitation: Zhou J, Huang WQ, Li C, Wu GY, Li YS, Wen SH, Lei WL, Liu KX. Intestinal ischemia/reperfusion enhances microglial activation and induces cerebral injury and memory dysfunction in rats. Crit Care Med. 2012 Aug;40(8):2438-48. doi: 10.1097/CCM.0b013e3182546855.

ReferenceCitation: Marshall JC, Foster D, Vincent JL, Cook DJ, Cohen J, Dellinger RP, Opal S, Abraham E, Brett SJ, Smith T, Mehta S, Derzko A, Romaschin A; MEDIC study. Diagnostic and prognostic implications of endotoxemia in critical illness: results of the MEDIC study. J Infect Dis. 2004 Aug 1;190(3):527-34. doi: 10.1086/422254. Epub 2004 Jul 2.

ReferenceCitation: Korth U, Krieter H, Denz C, Janke C, Ellinger K, Bertsch T, Henn C, Klein J. Intestinal ischaemia during cardiac arrest and resuscitation: comparative analysis of extracellular metabolites by microdialysis. Resuscitation. 2003 Aug;58(2):209-17. doi: 10.1016/s0300-9572(03)00119-9.

ReferenceCitation: Gill RS, Lee TF, Sergi C, Bigam DL, Cheung PY. Early versus delayed cyclosporine treatment in cardiac recovery and intestinal injury during resuscitation of asphyxiated newborn piglets. Intensive Care Med. 2012 Jul;38(7):1215-23. doi: 10.1007/s00134-012-2577-1. Epub 2012 May 10.

ReferenceCitation: Albrecht M, Gruenewald M, Zitta K, Zacharowski K, Scholz J, Bein B, Meybohm P. Hypothermia and anesthetic postconditioning influence the expression and activity of small intestinal proteins possibly involved in ischemia/reperfusion-mediated events following cardiopulmonary resuscitation. Resuscitation. 2012 Jan;83(1):113-8. doi: 10.1016/j.resuscitation.2011.06.038. Epub 2011 Jul 18.

ReferenceCitation: Gill RS, Manouchehri N, Lee TF, Cho WJ, Thiesen A, Churchill T, Bigam DL, Cheung PY. Cyclosporine treatment improves mesenteric perfusion and attenuates necrotizing enterocolitis (NEC)-like intestinal injury in asphyxiated newborn piglets during reoxygenation. Intensive Care Med. 2012 Mar;38(3):482-90. doi: 10.1007/s00134-011-2436-5. Epub 2011 Dec 6.

ReferenceCitation: Bedell SE, Fulton EJ. Unexpected findings and complications at autopsy after cardiopulmonary resuscitation (CPR). Arch Intern Med. 1986 Sep;146(9):1725-8.

ReferenceCitation: Piton G, Barbot O, Manzon C, Moronval F, Patry C, Navellou JC, Belle E, Capellier G. Acute ischemic pancreatitis following cardiac arrest: a case report. JOP. 2010 Sep 6;11(5):456-9.

ReferenceCitation: Gaussorgues P, Gueugniaud PY, Vedrinne JM, Salord F, Mercatello A, Robert D. Bacteremia following cardiac arrest and cardiopulmonary resuscitation. Intensive Care Med. 1988;14(5):575-7. doi: 10.1007/BF00263532.

ReferenceCitation: Grootjans J, Lenaerts K, Derikx JP, Matthijsen RA, de Bruine AP, van Bijnen AA, van Dam RM, Dejong CH, Buurman WA. Human intestinal ischemia-reperfusion-induced inflammation characterized: experiences from a new translational model. Am J Pathol. 2010 May;176(5):2283-91. doi: 10.2353/ajpath.2010.091069. Epub 2010 Mar 26.

ReferenceCitation: Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.

ReferenceCitation: Crenn P, Messing B, Cynober L. Citrulline as a biomarker of intestinal failure due to enterocyte mass reduction. Clin Nutr. 2008 Jun;27(3):328-39. doi: 10.1016/j.clnu.2008.02.005. Epub 2008 Apr 28.

ReferenceCitation: Grimaldi D, Guivarch E, Neveux N, Fichet J, Pene F, Marx JS, Chiche JD, Cynober L, Mira JP, Cariou A. Markers of intestinal injury are associated with endotoxemia in successfully resuscitated patients. Resuscitation. 2013 Jan;84(1):60-5. doi: 10.1016/j.resuscitation.2012.06.010. Epub 2012 Jun 26.

ReferenceCitation: L'Her E, Cassaz C, Le Gal G, Cholet F, Renault A, Boles JM. Gut dysfunction and endoscopic lesions after out-of-hospital cardiac arrest. Resuscitation. 2005 Sep;66(3):331-4. doi: 10.1016/j.resuscitation.2005.03.016.

ReferenceCitation: Jacobs I, Nadkarni V, Bahr J, Berg RA, Billi JE, Bossaert L, Cassan P, Coovadia A, D'Este K, Finn J, Halperin H, Handley A, Herlitz J, Hickey R, Idris A, Kloeck W, Larkin GL, Mancini ME, Mason P, Mears G, Monsieurs K, Montgomery W, Morley P, Nichol G, Nolan J, Okada K, Perlman J, Shuster M, Steen PA, Sterz F, Tibballs J, Timerman S, Truitt T, Zideman D; International Liason Committee on Resusitation. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries. A statement for healthcare professionals from a task force of the international liaison committee on resuscitation (American Heart Association, European Resuscitation Council, Australian Resuscitation Council, New Zealand Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa). Resuscitation. 2004 Dec;63(3):233-49. doi: 10.1016/j.resuscitation.2004.09.008.

ReferenceCitation: Savoye G, Ben Soussan E, Hochain P, Lerebours E. [How and how far to investigate ischemic colitis?]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B12-23. No abstract available. French.

ReferenceCitation: Grimaldi D, Legriel S, Pichon N, Colardelle P, Leblanc S, Canoui-Poitrine F, Ben Hadj Salem O, Muller G, de Prost N, Herrmann S, Marque S, Baron A, Sauneuf B, Messika J, Dior M, Creteur J, Bedos JP, Boutin E, Cariou A. Ischemic injury of the upper gastrointestinal tract after out-of-hospital cardiac arrest: a prospective, multicenter study. Crit Care. 2022 Mar 14;26(1):59. doi: 10.1186/s13054-022-03939-9.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repositories_concat: PubMed Central;dipot.ulb.ac.be

lead_sponsor: Versailles Hospital

location_country: Belgium France

location_facility: Cotentin Hospital, Medical intensive care unit

location_facility: Dupuytren hospital, Medical intensive care unit

location_facility: Sud Francilien Hospital, Medicla care unit

location_facility: Henri Mondor Hospital, Medical Intensive care unit

location_facility: Cochin Hospital, Médical intensive care unit

location_facility: André Mignot Hospital, Intensive care unit

location_facility: Orléans Hospital, Medical intensive care unit


title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

summary: The aim of the investigation was to investigate the performance and safety of a new ostomy product.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

lead_sponsor: Coloplast A/S

location_country:
Germany
United Kingdom
Norway
Denmark
France

location_facility: Sanitäts- und gesundheitshaus Carqueville GmbH

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis

acronym: BASALT

summary: The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.

status: Terminated

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Limoges

location_facility: Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,

location_facility: Service de Pneumologie - Phtisiologie - Hôpital Bichat

location_facility: Service de Pneumologie - CHU de Strasbourg

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.

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

location_country: France Italy Portugal Netherlands Austria Switzerland Greece Israel

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Schneider Children's Medical Center of Israel

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

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


title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

acronym: fAMHOPE

summary: This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Erasme University Hospital

sponsor_collaborators:
Erasme University Hospital
University Hospital, Lille

location_country: Italy Belgium France

location_facility:
Ospedale San Martino
CHC-Saint Vincent
CHIREC- Hospital Delta
CHRU Lille
CUB-Hôpital Erasme
Centre Oscar Lambret

status_simplified: Ongoing


type: EudraCT Number

title: Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

summary: The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Germany
France

location_facility: The University Of Texas MD Anderson Cancer Center


title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation

summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

ReferenceType: derived

ReferenceCitation: Jais P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clementy J, Haissaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24. Erratum In: Circulation. 2009 Sep 8;120(10):e83.

lead_sponsor: Biosense Webster, Inc.

location_country:
United States
Switzerland
France

location_facility:
Massachusetts General Hospital
Hopital Lariboisiere
University of Alabama, Birmingham
Hôpital Haut Lèvêque
Mid-Ohio Cardiology
Hopital Cantonal de Geneve


title: Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

summary:
The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.

Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.

ReferenceCitation: Dreno B, Urosevic-Maiwald M, Kim Y, Guitart J, Duvic M, Dereure O, Khammari A, Knol AC, Derbij A, Lusky M, Didillon I, Santoni AM, Acres B, Bataille V, Chenard MP, Bleuzen P, Limacher JM, Dummer R. TG1042 (Adenovirus-interferon-gamma) in primary cutaneous B-cell lymphomas: a phase II clinical trial. PLoS One. 2014 Feb 24;9(2):e83670. doi: 10.1371/journal.pone.0083670. eCollection 2014.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Zurich - Zurich Open Repository and Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Accart N, Urosevic-Maiwald M, Dummer R, Bataille V, Kehrer N, Niculescu C, Limacher JM, Chenard MP, Bonnefoy JY, Rooke R. Lymphocytic infiltration in the cutaneous lymphoma microenvironment after injection of TG1042. J Transl Med. 2013 Sep 25;11:226. doi: 10.1186/1479-5876-11-226.

repositories_concat: PubMed Central;www.zora.uzh.ch

publisher_dissemination: Springer

lead_sponsor: Transgene

location_facility:
Northwestern University Medical School
University Hospital of Zurich
Hopital de l'Hotel-Dieu
M.D. Anderson Cancer Center
Stanford University School of Medicine
Hopital Lapeyronie

intervention_type: Genetic


title: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

summary: Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

lead_sponsor: Ferring Pharmaceuticals

location_country:
France
Netherlands
Czech Republic

location_facility: Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert

location_facility: Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,

location_facility: Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159

location_facility: Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a

location_facility: Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057

location_facility: Centre d'Endocrinologie Pediatrique, 25 rue Boudet


title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26. Erratum In: Circulation. 2011 Sep 6;124(10):e279. Dosage error in article text.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
ICOS Corporation

location_country:
United States
Italy
France

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


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

acronym: ADORE

summary: Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.

status: Active, not recruiting

lead_sponsor: Ferrer Internacional S.A.

sponsor_collaborators:
Ferrer Internacional S.A.
Julius Clinical
Stichting TRICALS Foundation

location_country:
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
Belgium
Spain
France

location_facility: Centre Hospitalo-Universitaire La Timone

location_facility: Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania "Luigi Vanvitelli"

location_facility: University of Torino - Rita Levi Montalcini Department of Neuroscience

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Azienda Ospedaliera Universitaria Cagliari

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Universitario La Paz-Carlos III

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: University of Padua - Azienda Ospedaliera di Padova

location_facility: Trinity College Dublin/Beaumont Hospital


acronym: PRADO

lead_sponsor: Hoffmann-La Roche

summary: This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

title: A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

source: euctr


title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

summary:
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.

Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.

This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.

Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.

After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.

Evaluation will occur at 3 months post intensification.

ReferenceType: result

ReferenceCitation: Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pegourie B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myelome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Intergroupe Francophone du Myelome

location_facility: Service of Clinical Hematology - Army Instruction Hospital of Percy

location_facility: Service of Clinical Hematology - A. Morvan Hospital

location_facility: Service of Hematology -Gustave Roussy Institute

location_facility: Service of Hematology - Claude Hurriez Hospital

location_facility: Service of Clinical Hematology - Purpan hospital TSA 40031

location_facility: Service of Onco-Hematology - Bretonneau Hospital

location_facility: Service of Clinical Hematology - F. Baclesse Center

location_facility: Service of Clinical Hematology - Bocage Hospital

location_facility: Service of Hematology - Pontchaillou Hospital

location_facility: Service of Hematology - Lyon Sud Hospital

location_facility: Service of Hematology - General Hospital

location_facility: Service of Clinical Hematology - Archet 1 Hospital

location_facility: Service of Clinical Hematology - Cote Basque Hospital

location_facility: Service of Blood Deseases - UH of Nantes

location_facility: Service of Hematology - Hautepierre Hospital

location_facility: Service of Hematology - Brabois Hospital

location_facility: Service of Hematology - Notre Dame du Bon Secours Hospital

location_facility: Service of Hematology -Henri Becquerel Center

location_facility: Service of Blood Deseases - South Hospital

location_facility: Service of Blood Deseases - Saint Antoine Hospital

location_facility: Service of Clinical Hematology - UH of Clermont-Ferrand

location_facility: Service of Hematology - Léon Bérard Center

location_facility: Service of Hematology - Edouard Herriot Hospital

location_facility: Service of Hematology - Jean Bernard Hospital

location_facility: Service of Clinical Hematology - Avicenne Hospital

location_facility: Service of Oncohematology - Louis Pasteur Hospital

location_facility: Service of Hematology - A. Michallon Hospital

location_facility: Service of Hematology - Paoli Calmette Institute

location_facility: Service of Clinical Hematology - Minjoz Hospital

location_facility: Service of Hematology - R.Debré Hospital


lead_sponsor: Eisai Limited

summary: This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent lenvatinib) and osteosarcoma (single agent and combination lenvatinib).

ReferenceCitation: Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

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

repository_normalized: HAL

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
HAL
PubMed Central
UCL Discovery
univOAK

publisher_dissemination: Elsevier

ReferenceCitation: Rutkowski P. Antiangiogenic agents combined with systemic chemotherapy in refractory osteosarcoma. Lancet Oncol. 2021 Sep;22(9):1206-1207. doi: 10.1016/S1470-2045(21)00422-8. Epub 2021 Aug 17. No abstract available.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: UCL Discovery

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

publisher_dissemination: Informa

sponsor_collaborators:
Eisai Limited
Merck Sharp & Dohme LLC

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Universitario y Politecnico La Fe Hospital La Fe Valencia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

title: Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

location_country:
Germany
Italy
United Kingdom
United States
Spain
France


type: Other Identifier

title: Registry on WATCHMAN Outcomes in Real-Life Utilization

acronym: EWOLUTION

summary: The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Foley D, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW; following investigators and institutions participated in the EWOLUTION study. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Erasmus University Rotterdam - EUR Research Repository

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Netherlands
Belgium
United Arab Emirates
Saudi Arabia
Spain
Russian Federation
France

location_facility: Groupe hospitalier Bichat Claude Bernard

location_facility: King Fahed Medical City - Prince Salman Cardiac Center

location_facility: Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Clinical Hospital University of Medicine

location_facility: Szpital Uniwersytecki nr 1im dr A Jurasza

location_facility: State Research Institute of Circulation Pathology

location_facility: Cardio Vasculares Centrum Sankt Katharinen


title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

summary: It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

ReferenceCitation: Rigo J, Hascoet JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radke M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686.

oa_host_type: repository

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Université de Lausanne - SERVAL

unpaywall_oa_status: green

lead_sponsor: Société des Produits Nestlé (SPN)

location_country: Germany Italy Switzerland Belgium France

location_facility:
Kinderspital
CHU Grenoble
Policlinico Mangiagalli e Regina Elena
Hôpital de la Conception Marseille
Hôpital Clocheville Tours
Maternité Régionale
CHU Caen
Klinikum Ernest von Bergmann
CHR de la Citadelle
Hôpital des Enfants - CHU Pellegrin
Hôpital de la Croix-Rousse

intervention_type: Dietary Supplement


title: An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

summary: The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

location_country:
Germany
United Kingdom
Belgium
Spain
France

location_facility: HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel

location_facility: University Hospital Gasthuisberg - Dept Neurology - Herestraat 49

location_facility: Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik

location_facility: Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires

location_facility: CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement

location_facility: Neurologische Klinik Medizinische Hochschule

location_facility: Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences

location_facility: Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux

location_facility: King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry

location_facility: Centre SLA Limoges - Service de Neurologie

location_facility: Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg

location_facility: CHU de Nice - Hôpital de l'Archet 1 - Centre de Référence pour les Maladies Neuromusculaires et la SLA

location_facility: Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen

location_facility: Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac

location_facility: Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10


acronym: MITOTARGET

summary: The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.

ReferenceCitation: Witzel S, Frauhammer F, Steinacker P, Devos D, Pradat PF, Meininger V, Halbgebauer S, Oeckl P, Schuster J, Anders S, Dorst J, Otto M, Ludolph AC. Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials. Transl Neurodegener. 2021 Aug 26;10(1):31. doi: 10.1186/s40035-021-00257-y.

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

repository_institution: Ulm University - OPen Access Repositorium der Universität Ulm (OPARU)

repositories:
HAL
PubMed Central
oparu.uni-ulm.de

repositories_concat: HAL;PubMed Central;oparu.uni-ulm.de

ReferenceCitation: Devos D, Moreau C, Kyheng M, Garcon G, Rolland AS, Blasco H, Gele P, Timothee Lenglet T, Veyrat-Durebex C, Corcia P, Dutheil M, Bede P, Jeromin A, Oeckl P, Otto M, Meininger V, Danel-Brunaud V, Devedjian JC, Duce JA, Pradat PF. A ferroptosis-based panel of prognostic biomarkers for Amyotrophic Lateral Sclerosis. Sci Rep. 2019 Feb 27;9(1):2918. doi: 10.1038/s41598-019-39739-5. Erratum In: Sci Rep. 2020 Feb 19;10(1):3312.

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

repository_normalized: LillOA (Lille Open Archive)

repository_institution: University of Cambridge - Apollo

repositories_concat: LillOA (Lille Open Archive);PubMed Central;University of Melbourne - Minerva Access;eprints.whiterose.ac.uk;www.repository.cam.ac.uk

sponsor_collaborators:
Hoffmann-La Roche
European Commission

title: Phase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

primary_purpose: Other


summary: This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is <100 individuals.

ReferenceCitation: Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.

evidence: open (via free pdf)

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

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

repository_institution: reroDoc Digital Library

title: A Multicentre Randomised Phase II Study to Assess the Safety and Resectability in Patients With Initially Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving First-line Treatment Either With mFOLFOX-6 Plus Bevacizumab or FOLFOXIRI Plus Bevacizumab (OLIVIA)

location_country:
Spain
United Kingdom
Austria
France


title: Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

summary:
This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use of salt and food. Excessive cortisol is usually the result of too much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in the body. The drug has been used safely to treat a few people with Cushing's syndrome and patients with certain kinds of cancer, gynecological diseases and psychiatric disorders.

People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion may be eligible for this study. Candidates are admitted to the hospital for evaluation to confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and begin mifepristone therapy.

Participants remain in the hospital for the following tests and procedures:

Physical examination, electrocardiogram (EKG) and blood and urine tests
Completion of medical questionnaires
DEXA scan to determine bone mineral density and body composition
Glucose tolerance test
Urine pregnancy test and ultrasound to measure uterine lining thickness (for women)

Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so until symptoms improve or the highest dosage allowed is reached. Patients may remain in the hospital for all or part of the dose-finding part of the study. During this period (usually 2 to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on that dose for at least 2 weeks and are then re-evaluated. Patients then return to the hospital for evaluations every 3 months. Those who do well on the drug may continue to take it for up to 12 months.

ReferenceType: background

ReferenceCitation: Bertagna X, Basin C, Picard F, Varet B, Bertagna C, Hucher M, Luton JP. Peripheral antiglucocorticoid action of RU 486 in man. Clin Endocrinol (Oxf). 1988 May;28(5):537-41. doi: 10.1111/j.1365-2265.1988.tb03688.x.

ReferenceCitation: Bertagna X, Escourolle H, Pinquier JL, Coste J, Raux-Demay MC, Perles P, Silvestre L, Luton JP, Strauch G. Administration of RU 486 for 8 days in normal volunteers: antiglucocorticoid effect with no evidence of peripheral cortisol deprivation. J Clin Endocrinol Metab. 1994 Feb;78(2):375-80. doi: 10.1210/jcem.78.2.8106625.

ReferenceCitation: Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.

lead_sponsor: HRA Pharma

location_country:
Germany
Italy
Netherlands
United States
France

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: Randomized Study for Patients With Follicular Lymphoma Needing Treatment

summary:
2 parallel studies.

For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

ReferenceCitation: Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7. doi: 10.1023/a:1008347425795.

lead_sponsor: Lymphoma Study Association

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

intervention_type: Procedure


title: Targeted Intensification by a New Preparative Regimen for Patients With Low-Grade B-Cell Lymphoma Utilizing Standard-Dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-Dose Beam Followed by Autologous Stem Cell Transplantation (ASCT)

summary:
The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS).

The goal is to obtain a 15% increase of EFS at 2 years.

ReferenceCitation: Brice P, Simon D, Bouabdallah R, Belanger C, Haioun C, Thieblemont C, Tilly H, Harousseau JL, Doyen C, Martin C, Brousse N, Solal-Celigny PH; Groupe d'Etude des Lymphomes de l'Adulte (GELA). High-dose therapy with autologous stem-cell transplantation (ASCT) after first progression prolonged survival of follicular lymphoma patients included in the prospective GELF 86 protocol. Ann Oncol. 2000 Dec;11(12):1585-90. doi: 10.1023/a:1008399623564.

ReferenceCitation: Mills W, Chopra R, McMillan A, Pearce R, Linch DC, Goldstone AH. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol. 1995 Mar;13(3):588-95. doi: 10.1200/JCO.1995.13.3.588.

ReferenceCitation: Witzig TE, White CA, Gordon LI, Wiseman GA, Emmanouilides C, Murray JL, Lister J, Multani PS. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-hodgkin's lymphoma. J Clin Oncol. 2003 Apr 1;21(7):1263-70. doi: 10.1200/JCO.2003.08.043.

ReferenceCitation: Fung HC, Forman SJ, Nademanee A, Molina A, Yamauchi D, Speilberger R, Kogut N, Sahebi F, Parker P, Rodriguez R, Krishnan A, Popplewell L, Wong J, and Raubitschek A. A new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high-dose BEAM followed by autologous hematopoietic cell transplantation (AHCT) : targeted intensification without increased transplant-related toxicity. Blood 2003, forty-fifth annual meeting of the American Society of Hematology, abstract 870.

ReferenceCitation: Nademanee A, Forman SJ, Molina A, Kogut N, Fung HC, Yamauchi D, Anderson A-L, Smith D, Liu AN, and Raubitschek A. High-dose radioimmunotherapy with yttrium 90 (90Y) ibritumomab tiuxetan with high-dose etoposide (VP-16) and cyclophosphamide (CY) followed by autologous hematopoietic cell transplantation (AHCT) for poor-risk or relapsed B-cell non-Hodgkin's lymphoma (NHL): update of a phase I/II trial. J Clin Oncol 2004, fortieth annual meeting of the American Society of Clinical Oncology, abstract 6504.

location_country: Switzerland Belgium France

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

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have glioblastoma multiforme.

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

location_country: Italy Netherlands Switzerland Belgium Spain France

location_facility: Academisch Ziekenhuis der Vrije Universiteit

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


title: A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis

summary: A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.

lead_sponsor: Wellspect HealthCare

location_country:
United Kingdom
Denmark
Switzerland
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales


title: Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)

summary: This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners & Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

primary_purpose: Basic Science

lead_sponsor: University of Leeds

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_country:
Denmark
United Kingdom
Spain
France

location_facility:
University of Liverpool
University of Leeds
University of Navarra
CRNH-RA
University of Copenhagen


title: Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes

acronym: DWELL

summary: This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 800 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

status: Unknown status

ipd_sharing: Yes

ipd_sharing_description: Anonymous participant data relating to results in publications with regards to primary and secondary outcome measures will be shared through publishing platforms. Anonymised individual participant datasets may be shared via a suitable public data repository. A final report of the evaluation study will be made available via the Canterbury Christ Church University DWELL Project web page.

lead_sponsor: Canterbury Christ Church University

sponsor_collaborators:
Canterbury Christ Church University
Interreg 2 Seas Mers Zeeen
Medway Community Healthcare
Blackthorn Trust
Arteveldehogeschool
Kinetic Analysis
Centre Hospitalier de Douai

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility:
Medway Community Healthcare
Arteveldehogeschool
Blackthorn Trust
Centre Hosptalier Douai
Kinetic Analysis

intervention_type: Behavioral


title: Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

summary: The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.

lead_sponsor: Zimmer Biomet

location_country: Germany Spain Austria France

location_facility: Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"

location_facility: Medizinische Universität Wien, Universitätsklinik für Orhopädie

location_facility: Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela


lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary: Relapses after perioperative chemotherapy and surgery

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Chambray Les Tours - Clinique Léonard de Vinci

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

title: Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.


title: Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)

summary: The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.

time_perspective: Retrospective

lead_sponsor: Wissenschaftliches Institut Bethanien e.V

location_country: Germany Denmark France

location_facility: Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin

location_facility: Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice

location_facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V.

location_facility: Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg


title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis

summary:
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.

There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.

lead_sponsor: Gilead Sciences

location_country:
Germany
United Kingdom
Australia
Spain
France


title: An Observational, Prospective, Multi-center, Natural History Study of Patients With Mucopolysaccharidosis Type IIIA (MPS IIIA)

summary: Evaluate the clinical progression in patients with MPS IIIA who are untreated with any investigational product and to obtain standardized assessments: neurocognitive, behavioral, sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their families.

ipd_sharing: Undecided

lead_sponsor: LYSOGENE

location_country:
Germany
United Kingdom
Brazil
Netherlands
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Great Ormond Street Hospital NHS Foundation Trust

location_facility: Academic Medical Center, Emma Children's Hospital


title: A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

summary: A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.

ReferenceCitation: HEIDELBERGER C, CHAUDHURI NK, DANNEBERG P, MOOREN D, GRIESBACH L, DUSCHINSKY R, SCHNITZER RJ, PLEVEN E, SCHEINER J. Fluorinated pyrimidines, a new class of tumour-inhibitory compounds. Nature. 1957 Mar 30;179(4561):663-6. doi: 10.1038/179663a0. No abstract available.

ReferenceCitation: Longley DB, Harkin DP, Johnston PG. 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer. 2003 May;3(5):330-8. doi: 10.1038/nrc1074.

ReferenceCitation: Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3.

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ReferenceCitation: Fukushima M, Satake H, Uchida J, Shimamoto Y, Kato T, Takechi T, Okabe H, Fujioka A, Nakano K, Ohshimo H, Takeda S, Shirasaka T. Preclinical antitumor efficacy of S-1: a new oral formulation of 5-fluorouracil on human tumor xenografts. Int J Oncol. 1998 Oct;13(4):693-8. doi: 10.3892/ijo.13.4.693.

ReferenceCitation: Shirasaka T, Shimamoto Y, Fukushima M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res. 1993 Sep 1;53(17):4004-9.

ReferenceCitation: Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.

ReferenceCitation: Johnston PG, Fisher ER, Rockette HE, Fisher B, Wolmark N, Drake JC, Chabner BA, Allegra CJ. The role of thymidylate synthase expression in prognosis and outcome of adjuvant chemotherapy in patients with rectal cancer. J Clin Oncol. 1994 Dec;12(12):2640-7. doi: 10.1200/JCO.1994.12.12.2640.

ReferenceCitation: Johnston PG, Lenz HJ, Leichman CG, Danenberg KD, Allegra CJ, Danenberg PV, Leichman L. Thymidylate synthase gene and protein expression correlate and are associated with response to 5-fluorouracil in human colorectal and gastric tumors. Cancer Res. 1995 Apr 1;55(7):1407-12.

ReferenceCitation: Lenz HJ, Leichman CG, Danenberg KD, Danenberg PV, Groshen S, Cohen H, Laine L, Crookes P, Silberman H, Baranda J, Garcia Y, Li J, Leichman L. Thymidylate synthase mRNA level in adenocarcinoma of the stomach: a predictor for primary tumor response and overall survival. J Clin Oncol. 1996 Jan;14(1):176-82. doi: 10.1200/JCO.1996.14.1.176.

ReferenceCitation: Peters GJ, van der Wilt CL, van Groeningen CJ, Smid K, Meijer S, Pinedo HM. Thymidylate synthase inhibition after administration of fluorouracil with or without leucovorin in colon cancer patients: implications for treatment with fluorouracil. J Clin Oncol. 1994 Oct;12(10):2035-42. doi: 10.1200/JCO.1994.12.10.2035.

ReferenceCitation: Aschele C, Debernardis D, Casazza S, Antonelli G, Tunesi G, Baldo C, Lionetto R, Maley F, Sobrero A. Immunohistochemical quantitation of thymidylate synthase expression in colorectal cancer metastases predicts for clinical outcome to fluorouracil-based chemotherapy. J Clin Oncol. 1999 Jun;17(6):1760-70. doi: 10.1200/JCO.1999.17.6.1760.

ReferenceCitation: Ichikawa W, Takahashi T, Suto K, Yamashita T, Nihei Z, Shirota Y, Shimizu M, Sasaki Y, Hirayama R. Thymidylate synthase predictive power is overcome by irinotecan combination therapy with S-1 for gastric cancer. Br J Cancer. 2004 Oct 4;91(7):1245-50. doi: 10.1038/sj.bjc.6602139.

ReferenceCitation: Ladner RD. The role of dUTPase and uracil-DNA repair in cancer chemotherapy. Curr Protein Pept Sci. 2001 Dec;2(4):361-70. doi: 10.2174/1389203013380991.

ReferenceCitation: Quesada-Soriano I, Casas-Solvas JM, Recio E, Ruiz-Perez LM, Vargas-Berenguel A, Gonzalez-Pacanowska D, Garcia-Fuentes L. Kinetic properties and specificity of trimeric Plasmodium falciparum and human dUTPases. Biochimie. 2010 Feb;92(2):178-86. doi: 10.1016/j.biochi.2009.10.008. Epub 2009 Oct 29.

ReferenceCitation: Canman CE, Radany EH, Parsels LA, Davis MA, Lawrence TS, Maybaum J. Induction of resistance to fluorodeoxyuridine cytotoxicity and DNA damage in human tumor cells by expression of Escherichia coli deoxyuridinetriphosphatase. Cancer Res. 1994 May 1;54(9):2296-8.

ReferenceCitation: Koehler SE, Ladner RD. Small interfering RNA-mediated suppression of dUTPase sensitizes cancer cell lines to thymidylate synthase inhibition. Mol Pharmacol. 2004 Sep;66(3):620-6. doi: 10.1124/mol.66.3..

ReferenceCitation: Ladner RD, Lynch FJ, Groshen S, Xiong YP, Sherrod A, Caradonna SJ, Stoehlmacher J, Lenz HJ. dUTP nucleotidohydrolase isoform expression in normal and neoplastic tissues: association with survival and response to 5-fluorouracil in colorectal cancer. Cancer Res. 2000 Jul 1;60(13):3493-503.

ReferenceCitation: Nobili S, Napoli C, Landini I, Morganti M, Cianchi F, Valanzano R, Tonelli F, Cortesini C, Mazzei T, Mini E. Identification of potential pharmacogenomic markers of clinical efficacy of 5-fluorouracil in colorectal cancer. Int J Cancer. 2011 Apr 15;128(8):1935-45. doi: 10.1002/ijc.25514.

ReferenceCitation: Takatori H, Yamashita T, Honda M, Nishino R, Arai K, Yamashita T, Takamura H, Ohta T, Zen Y, Kaneko S. dUTP pyrophosphatase expression correlates with a poor prognosis in hepatocellular carcinoma. Liver Int. 2010 Mar;30(3):438-46. doi: 10.1111/j.1478-3231.2009.02177.x. Epub 2009 Nov 30.

ReferenceCitation: McIntosh EM, Haynes RH. dUTP pyrophosphatase as a potential target for chemotherapeutic drug development. Acta Biochim Pol. 1997;44(2):159-71.

ReferenceCitation: Wilson PM, Fazzone W, LaBonte MJ, Deng J, Neamati N, Ladner RD. Novel opportunities for thymidylate metabolism as a therapeutic target. Mol Cancer Ther. 2008 Sep;7(9):3029-37. doi: 10.1158/1535-7163.MCT-08-0280.

ReferenceCitation: Hayashi T, Yamaguchi S, Kito S, Tanaka G, Kurokawa K, Hirota T. [An oral repeated dose toxicity study of a new antineoplastic agent S-1 in dogs. I. A 13-week repeated dose toxicity study. II. An ophthalmologic toxicity recovery study]. J Toxicol Sci. 1996 Nov;21 Suppl 3:527-44. doi: 10.2131/jts.21.supplementiii_527. Japanese.

ReferenceCitation: Zhu AX, Clark JW, Ryan DP, Meyerhardt JA, Enzinger PC, Earle CC, Fuchs CS, Regan E, Anbe H, Houghton M, Zhang J, Urrea P, Kulke MH. Phase I and pharmacokinetic study of S-1 administered for 14 days in a 21-day cycle in patients with advanced upper gastrointestinal cancer. Cancer Chemother Pharmacol. 2007 Feb;59(3):285-93. doi: 10.1007/s00280-006-0265-y. Epub 2006 Jun 20.

ReferenceCitation: Benson AB 3rd, Ajani JA, Catalano RB, Engelking C, Kornblau SM, Martenson JA Jr, McCallum R, Mitchell EP, O'Dorisio TM, Vokes EE, Wadler S. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol. 2004 Jul 15;22(14):2918-26. doi: 10.1200/JCO.2004.04.132.

ReferenceCitation: American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22. Erratum In: J Clin Oncol. 2006 Nov 20;24(33):5341-2.

ReferenceCitation: Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989 Sep-Oct;5(5):303-11; discussion 312-3. No abstract available.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Saito K, Nagashima H, Noguchi K, Yoshisue K, Yokogawa T, Matsushima E, Tahara T, Takagi S. First-in-human, phase I dose-escalation study of single and multiple doses of a first-in-class enhancer of fluoropyrimidines, a dUTPase inhibitor (TAS-114) in healthy male volunteers. Cancer Chemother Pharmacol. 2014 Mar;73(3):577-83. doi: 10.1007/s00280-014-2383-2. Epub 2014 Jan 23.

ReferenceCitation: Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V, Vynnychenko I, Garin A, Lang I, Falcon S. Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol. 2010 Mar 20;28(9):1547-53. doi: 10.1200/JCO.2009.25.4706. Epub 2010 Feb 16.

lead_sponsor: Taiho Oncology, Inc.

location_country: Italy Switzerland Belgium France

location_facility: IOSI Istituto Oncologico della Svizzera Italiana


acronym: CRYSTMAS

lead_sponsor: Fresenius Kabi

summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.

ReferenceCitation: Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

location_facility: Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente

location_facility: Hôpital de la Source, Réanimation Polyvalente

location_facility: CHI Poissy - St Germain en Laye, Site de St Germain en Laye

location_facility: Hôpital Saint-Joseph, Service de Réanimation Polyvalente

location_facility: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR

location_facility: CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale

location_facility: CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.

location_facility: CH Manchester, Service de Réanimation Polyvalente

location_facility: Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation

location_facility: Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale

location_facility: Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU

location_facility: CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,

location_facility: CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente

location_facility: Hôpital St Antoine, Réanimation Médicale

location_facility: Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität

location_facility: Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort

location_facility: Centre Hospitalier de Metz, Réa Polyvalente

location_facility: Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

location_facility: Hôpital Sud, Unité de Réanimation Médicale

location_facility: Hôpital Civil de Strasbourg, Service de Réanimation Médicale

location_facility: Hôpital Avicenne, Service de Réanimation

location_facility: Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente

title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

location_country: Germany France


title: Interruption of the Calcineurine Inhibitors (ICN) and Introduction of Mycophenolate Mofetil (MMF) in Liver Transplant Patients With Side Effects Due to ICN: Study of the Reduction of the Risks of Rejection by Mycophenolate Mofetil Therapeutic Drug Monitoring

acronym: MONOCEPT

summary:
The aim of this project is to determine whether, in liver transplant patients with side effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase IV trial with direct individual benefit.

A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included and randomised 1:1 in two arms:

Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l, followed by MMF monotherapy with dose adjustment based on the AUC of MPA,
Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.

The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6 months. The secondary judgment criterion will be the evaluation of the benefit of stopping ICN on the side effects caused by these drugs.

lead_sponsor: University Hospital, Limoges

location_facility:
Hôpital Paul Brousse
Hôpital Saint Antoine
Hôpital Henri Mondor
CHU de Caen
Hôpital Cochin
CHU de Nice
CHU de Lille
CHU de Toulouse
CHU de Strasbourg
CHU de Montpellier
CHU de Grenoble
CHU de Besançon
Hôpital Beaujon
Hôpital Edouard Herriot
CHU de Rennes
CHU de Marseille
CHU de Bordeaux


title: Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes

summary:
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement, mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low doses and between 4 and 8 weeks.

The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.

ReferenceCitation: Bouscary D, Legros L, Tulliez M, Dubois S, Mahe B, Beyne-Rauzy O, Quarre MC, Vassilief D, Varet B, Aouba A, Gardembas M, Giraudier S, Guerci A, Rousselot P, Gaillard F, Moreau A, Rousselet MC, Ifrah N, Fenaux P, Dreyfus F; Groupe Francais des Myelodysplasies (GFM). A non-randomised dose-escalating phase II study of thalidomide for the treatment of patients with low-risk myelodysplastic syndromes: the Thal-SMD-2000 trial of the Groupe Francais des Myelodysplasies. Br J Haematol. 2005 Dec;131(5):609-18. doi: 10.1111/j.1365-2141.2005.05817.x.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hopital Saint Antoine
CHU de Brest - Hopital Morvan
CH Joffre
Centre Henry Becquerel
CHU d'Angers
CHRU de Lille - Hopital C. Huriez
Hopital Cochin
CHU Dijon
Hopital Necker
CHU de Nantes
Hotel Dieu
Institut Paoli Calmette
CH d'Avignon
Hopital Avicenne
CHU de Nice - Hopital de l'Archet 1
CHU Nancy-Brabois
CHU Purpan
CH de la Cote Basque
CHU Albert Michallon
CHU de Limoges


title: BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem

acronym: BEAUTY

summary: The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e. without IHM) during a 6 months intensive treatment program.

ReferenceCitation: Fadl Elmula FE, Rebora P, Talvik A, Salerno S, Miszkowska-Nagorna E, Liu X, Heinpalu-Kuum M, Comotti T, Larstorp AC, Rostrup M, Swierblewska E, Valsecchi MG, Kjeldsen SE, Viigimaa M, Narkiewicz K, Parati G, Laurent S; BEtter control of blood pressure in hypertensive pAtients monitored Using the HOTMAN sYstem (BEAUTY) Study Investigators. A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients. J Hypertens. 2015 Dec;33(12):2534-45. doi: 10.1097/HJH.0000000000000749.

lead_sponsor: Hemo Sapiens, Inc.

location_country: Italy Poland Norway Estonia France

location_facility: Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk


title: Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study

acronym: TROFI

summary: The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

ReferenceCitation: Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.

ReferenceCitation: Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.

ReferenceCitation: Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.

ReferenceCitation: Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg RT, Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients with ST-elevation myocardial infarction and large thrombus burden: the Thoraxcenter experience. J Invasive Cardiol. 2006 Jul;18 Suppl C:3C-7C.

ReferenceCitation: Haeck JD, Koch KT, Bilodeau L, Van der Schaaf RJ, Henriques JP, Vis MM, Baan J Jr, Van der Wal AC, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ. Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study. JACC Cardiovasc Interv. 2009 Oct;2(10):934-43. doi: 10.1016/j.jcin.2009.07.013.

ReferenceCitation: Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.

ReferenceCitation: Vlaar PJ, Svilaas T, Vogelzang M, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan E, Suurmeijer AJ, Zijlstra F. A comparison of 2 thrombus aspiration devices with histopathological analysis of retrieved material in patients presenting with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2008 Jun;1(3):258-64. doi: 10.1016/j.jcin.2008.03.014.

ReferenceCitation: Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

ReferenceCitation: Sardella G, Mancone M, Nguyen BL, De Luca L, Di Roma A, Colantonio R, Petrolini A, Conti G, Fedele F. The effect of thrombectomy on myocardial blush in primary angioplasty: the Randomized Evaluation of Thrombus Aspiration by two thrombectomy devices in acute Myocardial Infarction (RETAMI) trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):84-91. doi: 10.1002/ccd.21312.

ReferenceCitation: Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. doi: 10.1016/j.jacc.2006.03.068. Epub 2006 Sep 26.

ReferenceCitation: Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design. Am Heart J. 2006 Mar;151(3):597.e1-597.e7. doi: 10.1016/j.ahj.2005.11.010.

ReferenceCitation: Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6. doi: 10.1016/j.jacc.2005.04.057.

ReferenceCitation: De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J. 2008 Dec;29(24):3002-10. doi: 10.1093/eurheartj/ehn389. Epub 2008 Sep 5.

ReferenceCitation: Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrie D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8. doi: 10.4244/eijv4i2a40.

ReferenceCitation: Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.

ReferenceCitation: Kubo T, Imanishi T, Takarada S, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Kitabata H, Tsuda K, Tomobuchi Y, Akasaka T. Assessment of culprit lesion morphology in acute myocardial infarction: ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. J Am Coll Cardiol. 2007 Sep 4;50(10):933-9. doi: 10.1016/j.jacc.2007.04.082. Epub 2007 Aug 20.

ReferenceCitation: Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.

ReferenceCitation: Hara H, Nakamura M, Komatsu H, Ikeda N, Shinji H, Makino K, Itaya H, Yamamoto M, Itou N, Tsunoda T, Sugi K. Comparison of the in vitro performance of 6 and 7 French aspiration catheters. EuroIntervention. 2007 Feb;2(4):487-92.

ReferenceCitation: Grayson AD, Moore RK, Jackson M, Rathore S, Sastry S, Gray TP, Schofield I, Chauhan A, Ordoubadi FF, Prendergast B, Stables RH; North West Quality Improvement Programme in Cardiac Interventions. Multivariate prediction of major adverse cardiac events after 9914 percutaneous coronary interventions in the north west of England. Heart. 2006 May;92(5):658-63. doi: 10.1136/hrt.2005.066415. Epub 2005 Sep 13.

ReferenceCitation: Guedes A, Keller PF, L'Allier PL, Lesperance J, Gregoire J, Tardif JC. Long-term safety of intravascular ultrasound in nontransplant, nonintervened, atherosclerotic coronary arteries. J Am Coll Cardiol. 2005 Feb 15;45(4):559-64. doi: 10.1016/j.jacc.2004.10.063.

ReferenceCitation: Johansson P, Lunden M, Ekstrom L, Grip L, Wennerblom B. Intensive use of intravascular ultrasound during coronary angioplasty. A six-month campaign. Scand Cardiovasc J. 2001 Mar;35(2):75-9. doi: 10.1080/140174301750164655.

ReferenceCitation: Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S, Serruys PW. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010 Feb;5(7):871-4. doi: 10.4244/eijv5i7a146. No abstract available.

ReferenceCitation: Muramatsu T, Garcia-Garcia HM, Onuma Y, Zhang YJ, Bourantas CV, Diletti R, Iqbal J, Radu MD, Ozaki Y, Serruys PW; TROFI investigators. Intimal flaps detected by optical frequency domain imaging in the proximal segments of native coronary arteries: an innocent bystander? Insights from the TROFI Trial. Circ J. 2013;77(9):2327-33. doi: 10.1253/circj.cj-13-0357. Epub 2013 Jun 15.

oa_host_type: publisher

publisher_dissemination: Japanese Circulation Society

ReferenceCitation: Muramatsu T, Garcia-Garcia HM, Onuma Y, Zhang YJ, Bourantas CV, Diletti R, Iqbal J, Radu MD, Ozaki Y, Serruys PW; on behalf of the TROFI investigators. Intimal Flaps Detected by Optical Frequency Domain Imaging in the Proximal Segments of Native Coronary Arteries. Circ J. 2013 Jun 15. Online ahead of print.

ReferenceCitation: Muramatsu T, Garcia-Garcia HM, Lee IS, Bruining N, Onuma Y, Serruys PW. Quantitative optical frequency domain imaging assessment of in-stent structures in patients with ST-segment elevation myocardial infarction: impact of imaging sampling rate. Circ J. 2012;76(12):2822-31. doi: 10.1253/circj.cj-12-0536. Epub 2012 Aug 29.

lead_sponsor: Terumo Europe N.V.

location_country: Germany Denmark Netherlands France

location_facility:
Erasmus Medical Center
Maastad Hospital
Aarhus University Hospital Skejby
Clinique Pasteur
Universität Leipzig - Herzzentrum


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.

summary: Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
Japan
France

location_facility:
Baylor College of Medicine
Keio University Hospital
Osaka University Hospital
Hopital Antoine Beclere
National Cardiovascular Center


title: Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen

acronym: PORTREAT

summary:
Primary Objective:

Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

Describe treatment patterns
Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
Describe economic and patient-reported outcomes

lead_sponsor: Sanofi

location_country:
Germany
United Kingdom
United States
Spain
France


title: A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer

acronym: PARAGON-II

summary: The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.

ReferenceCitation: Jones RP, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Stremitzer S, Gruenberger T, Rees M, Plant G, Figueras J, Albiol M, Adam R, Awad S, Poston GJ. PARAGON II - A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer. Eur J Surg Oncol. 2016 Dec;42(12):1866-1872. doi: 10.1016/j.ejso.2016.07.142. Epub 2016 Aug 10.

ReferenceCitation: Jones RP, Dunne D, Sutton P, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Koelblinger C, Stattner S, Stremitzer S, Gruenberger T, Poston GJ. Segmental and lobar administration of drug-eluting beads delivering irinotecan leads to tumour destruction: a case-control series. HPB (Oxford). 2013 Jan;15(1):71-7. doi: 10.1111/j.1477-2574.2012.00587.x. Epub 2012 Oct 16.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Biocompatibles UK Ltd

location_country:
United Kingdom
Austria
France

location_facility: Centre Hépato-Biliaire, Hôpital Paul Brousse

location_facility: Basingstoke and North Hampshire NHS Foundation Trust


title: Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke

summary: The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) is a safe treatment for patients who have suffered an acute ischemic stroke.

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
United Kingdom
Singapore
Netherlands
France


acronym: Curpap

lead_sponsor: Chiesi Farmaceutici S.p.A.

summary:
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

Early stabilization on nCPAP
Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.

ReferenceCitation: Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.

location_facility:
General Faculty Hospital
Maternidade Alfredo da Costa
Hopital De La Conception
Hospital De Cruces
Ospedale Maggiore

title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome

location_country: Italy Portugal Spain Czechia France


title: Phase II Study for Repeated Dosing of the Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab in Patients With HER-2/Neu 1+ or 2+/FISH Negative Expressing Advanced or Metastatic Breast Cancer (Stage IIIb/IV) Progressing After Endocrine Treatment

summary:
The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed after endocrine therapy.

Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.

ReferenceCitation: Kiewe P, Hasmuller S, Kahlert S, Heinrigs M, Rack B, Marme A, Korfel A, Jager M, Lindhofer H, Sommer H, Thiel E, Untch M. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res. 2006 May 15;12(10):3085-91. doi: 10.1158/1078-0432.CCR-05-2436.

ReferenceCitation: Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.

ReferenceCitation: Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

ReferenceCitation: Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.

lead_sponsor: Neovii Biotech

location_country: Germany Italy Austria Spain France

intervention_type: Biological


title: Fungemia Survey in Cancer Patients

summary:
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.

PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.

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

location_country: Germany Italy Switzerland Belgium France

location_facility: Hopital Cantonal Universitaire de Geneve


title: A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease

summary:
Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).

Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

location_country:
France
Italy
Netherlands
United States
Sweden


title: A Phase II, Randomized, Placebo-controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

acronym: MANON 02

summary: Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.

ReferenceCitation: Autran B, Debre P, Walker B, Katlama C. Therapeutic vaccines against HIV need international partnerships. Nat Rev Immunol. 2003 Jun;3(6):503-8. doi: 10.1038/nri1107.

ReferenceCitation: Autran B, Costagliola D, Murphy R, Katlama C. Evaluating therapeutic vaccines in patients infected with HIV. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S169-77. doi: 10.1586/14760584.3.4.s169.

ReferenceCitation: Autran B, Murphy RL, Costagliola D, Tubiana R, Clotet B, Gatell J, Staszewski S, Wincker N, Assoumou L, El-Habib R, Calvez V, Walker B, Katlama C; ORVACS Study Group. Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AIDS. 2008 Jul 11;22(11):1313-22. doi: 10.1097/QAD.0b013e3282fdce94.

lead_sponsor: Objectif Recherche Vaccins SIDA

location_country:
United States
Spain
Germany
France

location_facility: Servicios de Infecciosos, Hospital y clinic Provincial

location_facility: Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans

location_facility: Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin

location_facility: Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran


title: A 3-Month, Open, Randomised Trial Comparing the Efficacy and Safety of the Association Valproate-Amisulpride to the Association Valproate-Haloperidol in Bipolar I Patients Suffering From a Manic Episode

summary:
The primary objective is:

To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period.

The secondary objectives are:

To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol;
To assess the patient status 3 weeks and 3 months after inclusion; and
To assess patient satisfaction at 3 months.

location_country:
Poland
Slovakia
Spain
Czech Republic
France


title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

acronym: APOLLO-EU

summary: Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

lead_sponsor: Medtronic Cardiovascular

location_country:
Germany
United Kingdom
Denmark
Netherlands
Switzerland
France

location_facility: University Hospitals Sussex NHS Foundation Trust


title: Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment

acronym: SEALANT

summary: This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure

lead_sponsor: Microvention-Terumo, Inc.

location_country:
Germany
Italy
United Kingdom
Belgium
France

location_facility: Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona


title: A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

summary: The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

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

lead_sponsor: Janssen Research & Development, LLC

location_country: Denmark Poland Sweden France

location_facility: Universitetssjukhuset Lund, Onkologiska Kliniken, Lund