title: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

acronym: PRIMUS

summary: Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.

lead_sponsor: HiberCell, Inc.

location_country:
Germany
United States
Puerto Rico
France

location_facility: Ãrzteforum Henningsdorf Darmzentrum Oberhavel

location_facility: Hematology and Oncology Associates of Central NY

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Toledo Community Oncology Program- Toledo Community Hospital

location_facility: Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care

location_facility: Medizinisches Versorgungszentrum Ãrzteforum Seestrabe

location_facility: Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie

location_facility: Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: Ellis Fischel Cancer Center at University of Missouri- Columbia

location_facility: University of Louisville/James Brown Cancer Center


title:
Efficacy study of the quadrivalent Human Papilloma Virus (HPV) vaccine to prevent recurrence of External Genital Warts (EGW) in patients who were cured in the first place

 Étude de l’efficacité de la vaccination anti-PVH (Papilloma Virus Humain) quadrivalente sur la prévention secondaire de la récidive des condylomes ano-génitaux externes chez des patients cliniquement guéris en premier lieu

acronym: CONDYVAC

source: euctr

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

study_type: Interventional

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title: Préparation colique et antibiotiques oraux avant chirurgie du cancer colique: un essai randomisé multicentrique en double aveugle

acronym: COLONPREP


title: DOuleurs chroniques et VItamine D : une étude pilote en médecine de ville.

acronym: DOVID

lead_sponsor: Hospices Civils de Lyon


title:
Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in children: a multicenter European randomized controlled trial

 Efficacité des immunoglobulines humaines normales (IGHN) dans les chocs toxiques (staphylococciques et streptococciques) chez l’enfant : un essai clinique randomisé multicentrique européen

status: Not Authorised

status_simplified: Unknown


type: EudraCT Number

title: A PHASE 1 STUDY OF PF-05082566 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED CANCER, AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA (NHL)

summary: A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gopal AK, Levy R, Houot R, Patel SP, Popplewell L, Jacobson C, Mu XJ, Deng S, Ching KA, Chen Y, Davis CB, Huang B, Fly KD, Thall A, Woolfson A, Bartlett NL. First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20(+) Non-Hodgkin Lymphomas. Clin Cancer Res. 2020 Jun 1;26(11):2524-2534. doi: 10.1158/1078-0432.CCR-19-2973. Epub 2020 Mar 6.

family: Gopal

full_name: Ajay K. Gopal

given: Ajay K.

sequence: first

family: Levy

full_name: Ronald Levy

given: Ronald

sequence: additional

family: Houot

full_name: Roch Houot

given: Roch

family: Patel

full_name: Sandip P. Patel

given: Sandip P.

family: Popplewell

full_name: Leslie Popplewell

given: Leslie

family: Jacobson

full_name: Caron Jacobson

given: Caron

family: Mu

full_name: Xinmeng J. Mu

given: Xinmeng J.

family: Deng

full_name: Shibing Deng

given: Shibing

family: Ching

full_name: Keith A. Ching

given: Keith A.

family: Chen

full_name: Ying Chen

given: Ying

family: Davis

full_name: Craig B. Davis

given: Craig B.

family: Huang

full_name: Bo Huang

given: Bo

family: Fly

full_name: Kolette D. Fly

given: Kolette D.

family: Thall

full_name: Aron Thall

given: Aron

family: Woolfson

full_name: Adrian Woolfson

given: Adrian

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Association for Cancer Research (AACR)

title: First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20+ Non-Hodgkin Lymphomas

ReferenceCitation: Segal NH, He AR, Doi T, Levy R, Bhatia S, Pishvaian MJ, Cesari R, Chen Y, Davis CB, Huang B, Thall AD, Gopal AK. Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer. Clin Cancer Res. 2018 Apr 15;24(8):1816-1823. doi: 10.1158/1078-0432.CCR-17-1922. Epub 2018 Mar 16.

family: Segal

full_name: Neil H. Segal

given: Neil H.

family: He

full_name: Aiwu R. He

given: Aiwu R.

family: Doi

full_name: Toshihiko Doi

given: Toshihiko

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Italy
France
Japan
Australia
United States

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Santa Monica UCLA Hematology & Oncology Clinic

location_facility: Georgetown University Medical Center Department of Pharmacy, Research

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Washington University School of Medicine

location_facility: UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)

location_facility: Research Administration Office: Clinical Research Unit

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: The University of Texas - M.D. Anderson Cancer Center

location_facility: UC San Diego Moores Cancer Center-Investigational Drug Services

location_facility: Az. Ospedaliera-Univer. di Bologna Policlinico S. Orsola Malpighi

location_facility: Washington University Infusion Center Pharmacy


title:
Place de la scintigraphie au 99mTc-Leukoscan® dans la prise en charge diagnostique des suspicions d’endocardite infectieuse sur matériels

 Place de la scintigraphie au 99mTc-Leukoscan® dans la prise en charge diagnostique des suspicions d’endocardite infectieuse sur matériels

acronym: PLEIM


title: A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma

summary: This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
France

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Hackensack University Medical Center Multiple Myeloma Division

location_facility: H. Lee Moffitt Cancer Center & Research Institute SC - 3

location_facility: Washington University School of Medicine Dept. of WUSTL

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: Fred Hutchinson Cancer Research Center Fred Hutchinson

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Genentech, Inc.

location_country:
United States
Canada
France
Spain

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Vanderbilt Breast Center; Vanderbilt Health Pharmacy

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: University of California Irvine Medical Center

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Washington University; Division of Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Hospital Clinico Universitario de Valencia

type: Other Identifier

title: An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

summary: This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.


title: A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab

acronym: LIFT

summary: This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

location_country:
Italy
United States
France
Belgium
Australia
Spain
Canada

location_facility: Duke University Medical Center Duke Hem & Onc

location_facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)


title: International Observational Retrospective Case Review of Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement in Males and Females With Anderson-Fabry Disease

acronym: SWITCH

summary: The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been commercially available in Europe for almost 10 years, yet little information is available about the clinical and safety profile of patients who switch from one therapy to the other. An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of these patients received a reduced dosage of Fabrazyme® for an extended period before transitioning to treatment with Replagal®.

study_type: Observational

time_perspective: Other

ReferenceType: background

ReferenceCitation: Rolfs A, Böttcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Löhr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. Erratum in: Lancet. 2006 Dec 23;368(9554):2210.

ReferenceCitation: Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Böttcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

ReferenceCitation: Kint JA. Fabry's disease: alpha-galactosidase deficiency. Science. 1970 Feb 27;167(3922):1268-9.

ReferenceCitation: Mehta A, Ricci R, Widmer U, Dehout F, Garcia de Lorenzo A, Kampmann C, Linhart A, Sunder-Plassmann G, Ries M, Beck M. Fabry disease defined: baseline clinical manifestations of 366 patients in the Fabry Outcome Survey. Eur J Clin Invest. 2004 Mar;34(3):236-42.

ReferenceCitation: MacDermot KD, Holmes A, Miners AH. Anderson-Fabry disease: clinical manifestations and impact of disease in a cohort of 98 hemizygous males. J Med Genet. 2001 Nov;38(11):750-60.

ReferenceCitation: Eng CM, Banikazemi M, Gordon RE, Goldman M, Phelps R, Kim L, Gass A, Winston J, Dikman S, Fallon JT, Brodie S, Stacy CB, Mehta D, Parsons R, Norton K, O'Callaghan M, Desnick RJ. A phase 1/2 clinical trial of enzyme replacement in fabry disease: pharmacokinetic, substrate clearance, and safety studies. Am J Hum Genet. 2001 Mar;68(3):711-22. Epub 2001 Feb 1.

ReferenceCitation: Schiffmann R, Kopp JB, Austin HA 3rd, Sabnis S, Moore DF, Weibel T, Balow JE, Brady RO. Enzyme replacement therapy in Fabry disease: a randomized controlled trial. JAMA. 2001 Jun 6;285(21):2743-9.

ReferenceCitation: Moore DF, Altarescu G, Herscovitch P, Schiffmann R. Enzyme replacement reverses abnormal cerebrovascular responses in Fabry disease. BMC Neurol. 2002 Jun 18;2:4.

ReferenceCitation: Schiffmann R, Floeter MK, Dambrosia JM, Gupta S, Moore DF, Sharabi Y, Khurana RK, Brady RO. Enzyme replacement therapy improves peripheral nerve and sweat function in Fabry disease. Muscle Nerve. 2003 Dec;28(6):703-10.

ReferenceCitation: Hoffmann B, Reinhardt D, Koletzko B. Effect of enzyme-replacement therapy on gastrointestinal symptoms in Fabry disease. Eur J Gastroenterol Hepatol. 2004 Oct;16(10):1067-9.

ReferenceCitation: Hajioff D, Goodwin S, Quiney R, Zuckerman J, MacDermot KD, Mehta A. Hearing improvement in patients with Fabry disease treated with agalsidase alfa. Acta Paediatr Suppl. 2003 Dec;92(443):28-30; discussion 27.

ReferenceCitation: Hoffmann B, Garcia de Lorenzo A, Mehta A, Beck M, Widmer U, Ricci R; FOS European Investigators. Effects of enzyme replacement therapy on pain and health related quality of life in patients with Fabry disease: data from FOS (Fabry Outcome Survey). J Med Genet. 2005 Mar;42(3):247-52.

ReferenceCitation: Beck M, Ricci R, Widmer U, Dehout F, de Lorenzo AG, Kampmann C, Linhart A, Sunder-Plassmann G, Houge G, Ramaswami U, Gal A, Mehta A. Fabry disease: overall effects of agalsidase alfa treatment. Eur J Clin Invest. 2004 Dec;34(12):838-44.

ReferenceCitation: Banikazemi M, Ullman T, Desnick RJ. Gastrointestinal manifestations of Fabry disease: clinical response to enzyme replacement therapy. Mol Genet Metab. 2005 Aug;85(4):255-9.

ReferenceCitation: Banikazemi M, Bultas J, Waldek S, Wilcox WR, Whitley CB, McDonald M, Finkel R, Packman S, Bichet DG, Warnock DG, Desnick RJ; Fabry Disease Clinical Trial Study Group. Agalsidase-beta therapy for advanced Fabry disease: a randomized trial. Ann Intern Med. 2007 Jan 16;146(2):77-86. Epub 2006 Dec 18.

ReferenceCitation: Ramaswami U, Wendt S, Pintos-Morell G, Parini R, Whybra C, Leon Leal JA, Santus F, Beck M. Enzyme replacement therapy with agalsidase alfa in children with Fabry disease. Acta Paediatr. 2007 Jan;96(1):122-7.

ReferenceCitation: Ries M, Clarke JT, Whybra C, Timmons M, Robinson C, Schlaggar BL, Pastores G, Lien YH, Kampmann C, Brady RO, Beck M, Schiffmann R. Enzyme-replacement therapy with agalsidase alfa in children with Fabry disease. Pediatrics. 2006 Sep;118(3):924-32.

ipd_sharing: Undecided

lead_sponsor: CENTOGENE GmbH Rostock

location_country:
Croatia
Czechia
France
Belgium
Argentina
Denmark
Germany
United Kingdom

location_facility: Kinderklinik München-Schwabing Städt. Klinikum GmbH

location_facility: Unidad Renal Corrientes SRL, Medicina Interna Nefrólogo

location_facility: Juan Fernandez Hospital, Department of Neurology

location_facility: Miroslava Hajkova, 2nd Dept of Cardiology&Angiology, Fakultni poliklinika

location_facility: National University Hosoital Rigshospitalet, Endokrinologisk ward

location_facility: Université de Versailles - Saint Quentin en YvelinesService de Génétique Médicale

location_facility: University Hospital "Sestre Milosrdnice" Department of neuroimmunology and neurogenetic

location_facility: Royal Free Hospital, Dep. of Academic Haematology, Lysosomal Storage Disorders Unit


title: A randomized double-blinded pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome

acronym: NS-Dupi

lead_sponsor: CHU de Toulouse


title: A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

status: Terminated

design_allocation: Randomized

lead_sponsor: MedImmune LLC

location_country:
United States
France
Japan
Poland
Hungary
Germany
Canada


title:
Proactive Management of Outpatient Covid-19 Patients : a randomised controlled trial

 Prise en charge proactive des Patients Covid-19 en Ambulatoire
 Un essai randomisé ouvert

acronym:
AMBUCOVID

 AMBUCOVID

lead_sponsor: CHU Amiens Picardie


title: A randomised trial to compare ASPIRIN versus HYDROXYUREA/ASPIRIN in 'intermediate risk' primary thrombocythaemia and ASPIRIN only with observation in 'Low risk' primary thrombocythaemia.


title: A randomized, stratified on age, parallel group design study to investigate the safety, tolerability and pharmacokinetics after a 60 minutes application of 4% lidocaine cream compared to EMLA® cream for local anaesthesia in 40 children in need of scheduled surgery.

lead_sponsor: Merck Sante France


title: Etude multicentrique, randomisée , de phase II évaluant l'association méthotrexate et témozolomide (MT) à l'association méthotrexate, procarbazine, vincristine et cytarabine (MPV-A) dans le traitement du lymphome primitif du système nerveux central chez le sujet âgé


title: Effet du mazindol sur le Trouble Déficit de l'Attention/Hyperactivité chez l'enfant : étude prospective pilote (phase II) d'efficacité, de tolérance et de pharmacocinétique

acronym: MAZDAH


title: A phase III randomised study comparing concomitant radiochemotherapy with cisplatin and docetaxel as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer

lead_sponsor: CHRU de Lille

status: Prematurely Ended


title: Impact d'un traitement par le rituximab sur l'évolution des rejets aigus humoraux après transplantation rénale

acronym: MabThera

lead_sponsor: CHRU-Tours


intervention_type: Biological

lead_sponsor: Ipsen

location_country:
Chile
Mexico
Poland
France
Turkey
United States

location_facility: Yildirim Beyazit Training and Research Hospital

location_facility: Non-public Healthcare Unit - Grunwaldzka Clinic

location_facility: Texas Scottish Rite - Hospital for Children

location_facility: Gillette Children's Speciality Healthcare

location_facility: Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU

location_facility: Neurorehabilitation Laboratory, Pontifical Catholic University

location_facility: Non-public Healthcare Unit Mazovian Neurorehabilitatio

location_facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi

location_facility: Centro de Rehabilitacion Integral de Queretaro (CRIQ)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Ghulane Military Medical Academy and School of Medicine

location_facility: Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas

title: A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

summary: The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.


title: Essai de phase II multicentrique sur le traitement préventif de la folliculite induite par les anti-EGFR chez des patients atteints de cancer colorectal métastatique sous Cetuximab ou atteints de cancer bronchique non à petites cellules sous Erlotinib

acronym: DIPROCOL

lead_sponsor: Centre Oscar Lambret


location_facility: Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas

location_facility: Hospital Central Dr Ignacio Morones Prieto

title: A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

summary: The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.


title: Existe t-il une sensibilité accrue à l’hormone de croissance chez les enfants présentant un syndrome de Prader-Willi ?

lead_sponsor: CHU TOULOUSE


title: Open, non-controlled, multicentre, first-in-man study using escalating doses of LFB-R603 in patients with advanced stage B-Chronic lymphocytic leukemia

lead_sponsor: LFB BIOTECHNOLOGIES


title: INTERNATIONAL NON -CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF FIBRINOGENE T-I IN ADOLESCENTS AND ADULTS WITH AFIBRINOGENAEMIA OR SEVERE HYPOFIBRINOGENAEMIA UNDERGOING SURGERY

acronym: FGT1 surgery adults

lead_sponsor: LFB SA


title: Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques

acronym: CORTICOFLASH


title: A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated with One Dose of Smallpox Vaccine (LISTER Strain).

lead_sponsor: Sanofi Pasteur SA


title: Etude pilote de comparaison de la méthode EMIT et de la chromotographie liquide couplée à la spectométrie de masse pour l'étude de la pharmacocinétique du mycophénolate mofétil chez des patients transplantés hépatiques de novo.

lead_sponsor: Centre Hospitalier Universitaire de Montpellier


title: Traitement in utero de l’infection congénitale à cytomegalovirus (CMV) par valaciclovir : essai prospectif randomisé contre placebo

acronym: CYMEVAL

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: « Etude contrôlée randomisée versus placebo évaluant l’efficacité de Gelsemium sempervirens (5CH et 15CH) sur l’anxiété anticipatoire provoquée, chez des volontaires sains. »

acronym: ANXIHOMEV

lead_sponsor: CHU de GRENOBLE


title: Evaluation de l'intérêt de la loxapine dans le contrôle de l'agitation au cours du sevrage de la ventilation mécanique. Etude randomisée, contrôlée.

acronym: SEVRALOX


title: Optimization of Treatment and Management of Schizophrenia in Europe

acronym: OPTIMISE

summary: The purpose of the study is optimising current treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The study intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, and will identify potential mechanisms for new drug development.

ReferenceCitation: Fraguas D, Díaz-Caneja CM, Pina-Camacho L, Winter van Rossum I, Baandrup L, Sommer IE, Glenthøj B, Kahn RS, Leucht S, Arango C. The role of depression in the prediction of a "late" remission in first-episode psychosis: An analysis of the OPTiMiSE study. Schizophr Res. 2021 May;231:100-107. doi: 10.1016/j.schres.2021.03.010. Epub 2021 Apr 7.

family: Fraguas

full_name: David Fraguas

given: David

family: Díaz-Caneja

full_name: Covadonga M. Díaz-Caneja

given: Covadonga M.

family: Pina-Camacho

full_name: Laura Pina-Camacho

given: Laura

family: Winter van Rossum

full_name: Inge Winter van Rossum

given: Inge

family: Baandrup

full_name: Lone Baandrup

given: Lone

family: Sommer

full_name: Iris E. Sommer

given: Iris E.

family: Glenthøj

full_name: Birte Glenthøj

given: Birte

family: Kahn

full_name: René S. Kahn

given: René S.

family: Leucht

full_name: Stefan Leucht

given: Stefan

family: Arango

full_name: Celso Arango

given: Celso

bso_classification: Social sciences

journal_name: Schizophrenia Research

oa_host_type: repository

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

host_type: repository

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The role of depression in the prediction of a “late” remission in first-episode psychosis: An analysis of the OPTiMiSE study

ReferenceCitation: Pollak TA, Vincent A, Iyegbe C, Coutinho E, Jacobson L, Rujescu D, Stone J, Jezequel J, Rogemond V, Jamain S, Groc L, David A, Egerton A, Kahn RS, Honnorat J, Dazzan P, Leboyer M, McGuire P. Relationship Between Serum NMDA Receptor Antibodies and Response to Antipsychotic Treatment in First-Episode Psychosis. Biol Psychiatry. 2021 Jul 1;90(1):9-15. doi: 10.1016/j.biopsych.2020.11.014. Epub 2020 Nov 24. Erratum in: Biol Psychiatry. 2021 Jul 1;90(1):69.

family: Pollak

full_name: Thomas A. Pollak

given: Thomas A.

family: Vincent

full_name: Angela Vincent

given: Angela

family: Iyegbe

full_name: Conrad Iyegbe

given: Conrad

family: Coutinho

full_name: Ester Coutinho

given: Ester

full_name: Leslie Jacobson

family: Rujescu

full_name: Dan Rujescu

given: Dan

family: Stone

full_name: James Stone

given: James

family: Jezequel

full_name: Julie Jezequel

given: Julie

family: Rogemond

full_name: Veronique Rogemond

given: Veronique

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

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

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Kahn RS, Winter van Rossum I, Leucht S, McGuire P, Lewis SW, Leboyer M, Arango C, Dazzan P, Drake R, Heres S, Díaz-Caneja CM, Rujescu D, Weiser M, Galderisi S, Glenthøj B, Eijkemans MJC, Fleischhacker WW, Kapur S, Sommer IE; OPTiMiSE study group. Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study. Lancet Psychiatry. 2018 Oct;5(10):797-807. doi: 10.1016/S2215-0366(18)30252-9. Epub 2018 Aug 13.

repositories_institution:
KU Leuven - Lirias
King's College London - Research Portal

location_country:
Italy
Austria
Switzerland
Netherlands
France
Czechia
Bulgaria
Israel
Poland
Romania
Australia
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Instituto de Investigación Hospital 12 de Octubre

location_facility: Martin-Luther-University (MLU) of Halle-Wittenberg

location_facility: Psychiatrická klinika LF UK, Fakultní nemocnice

location_facility: University Specialised Hospital for Active Treatment in Neurology and Psychiatry "St. Naum"

location_facility: Clienia Schlössli AG, Privatklinik für Psychiatrie und Psychotherapie

location_facility: Institut National de la Santé et de la Reserche Médicale (INSERM)

location_facility: Katholieke Universiteit Leuven (KU Leuven)

location_facility: Department of Psychiatry University of Naples

location_facility: King's College London, Departments of Psychological Medicine, Psychiatry & Cognitive Neuroscience

location_facility: Sheba Medical Centre Department of Psychiatry

location_facility: Department of Adult Psychiatry, University of Medical Sciences

location_facility: Deprtment of Psychiatry, University of Heidelberg

location_facility: Department of Biological Psychiatry, Innsbruck University Clinics


title: GIANT Study - Genotyping Infarct patients to Adjust and Normalize Thienopyridine treatment

acronym: GIANT

lead_sponsor: BIOTRONIK France


title: Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ®

lead_sponsor: Erempharma SAS


title: Etude des effets d’une infiltration continue péristernale de ropivacaïne sur l’hypersensibilité à la douleur consécutive à une sternotomie en chirurgie cardiaque

acronym: CARDIODOLAL

lead_sponsor: CHU de Bordeaux


title: Effet du néfopam sur la montée laiteuse après césarienne ( étude randomisée en double insu)

lead_sponsor: Maternté Régionale Universitaire de Nancy


title: A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®)-Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects with Choroidal Neovasularization (CNV) Associated with Age-Related Macular Degeneration (AMD)

lead_sponsor: Steba Biotech S.A.


title: "Essai multicentrique de phase II randomisé évaluant la tolérance et l'efficacité du tamoxifène seul versus association Tamoxifène-RAD001 (Everolimus), chez les patientes atteintes de cancer du sein métastatique résistant aux anti-aromatases"

acronym: TAMRAD

lead_sponsor: ARCAGY


title: Essai de phase II de preuve du concept : Evaluation de l’activité anti-cellules souches cancéreuses du bevacizumab administré en combinaison à la chimiothérapie néoadjuvante dans les cancers du sein

lead_sponsor: Institut Paoli-Calmettes


title: Étude sur la relation  dose-effet de la néostigmine pour l’antagonisation des faibles niveaux de curarisations résiduelles induites par l’atracurium

acronym: NEOSTIGMINE

lead_sponsor: Centre Hospitalier Universitaire  DE NANCY


title: Etude de phase III randomisée comparant une chimiothérapie adjuvante par Fotémustine à une surveillance chez des patients présentant un mélanome de la choroïde à haut risque de rechute.

acronym: FOTE ADJ

lead_sponsor: INSTITUT CURIE


title: Etude pilote de la pharmacocinétique, de la tolérance et de l’efficacité du raltégravir associé à deux molécules actives parmi les analogues nucléosi(ti)diques et l’enfuvirtide, avant et après transplantation hépatique chez des patients VIH+ en insuffisance hépatique sévère.

acronym: LIVERAL

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales. ANRS.


title: Essai multicentrique randomisé ouvert évaluant l'apport du CCNU dans le traitement des leucémies aigues myéloïdes (LAM) des sujets de plus de 60 ans à cytogénétique non défavorable et la faisabilité de l'allogreffe à conditionnement atténué chez les sujets de 60 à 65 ans.

acronym: LAM-SA 2007


title: Reconnaissance des expressons faciales émotionnelles chez les patients présentant un épisode dépressif magnétique transcranienne répétée du cortex préfrontal dorsolatéral droit à basse fréquence et/ou venlafaxine

lead_sponsor: CHU Clermont-Ferrand


title: Etude de phase I / II de l’association carboplatine et topotecan oral  hebdomadaire chez des patientes atteintes de cancer du col de l’utérus métastatique ou en rechute.

acronym: HYCAR


title: Multicenter Study on Use and Interpretation of Adrenal Vein Sampling

acronym: AVIS

summary:
The AVIS Study is a retrospective multicenter international study that aims to answer a series of questions on the use and performance of adrenal venous catheterization (AVS) for the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among the centres that are internationally recognized and have published in the field of AVS and have agreed to participate in the study.

The first aim of the AVIS study is to collect summary data on how AVS is being performed throughout the world to answer the following questions:

How many AVS studies haw been performed yearly from 2005 to 2010 at each center?
How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of adrenal vein rupture been steady or has it changed over the 5 years?
How many centers use bilaterally simultaneous and how many use sequential AVS catheterization?
How many radiologists perform AVS at each center?
How many centers use a cosyntropin stimulation during AVS?
What is the percentage of PA patients in whom AVS is performed?
How many centres calculate the selectivity index? What is the minimum cutoff used?
How many centers calculate the lateralization index? What is the minimum cutoff used?
Are the AVS studies that are not bilaterally selective used for diagnosis?
How many centers calculate the controlateral suppression index and what is the minimum cutoff used?
What is the cost of AVS for the National Health System or Insurance and for patients? The second aim of the study is to calculate the rate of AVS studies that are selective and show lateralization of aldosterone excess at each center by applying predefined set of criteria for defining selectivity and lateralization. Data on the final diagnosis of the PA subtype will be gathered and used as reference to assess the performance of AVS using receiver operating characteristic curves analysis and the Youden index to determine the optimal cutoffs. A worksheet will need to be completed providing information on the following: Demography; Date of AVS;Baseline blood pressure (BP) values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol concentration in the infra-adrenal inferior vena cava and in the right and left adrenal vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy); post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or RM) and AVS.

time_perspective: Retrospective

ReferenceCitation: Funder J, Carey R, Fardella C, Gomez-Sanchez C, Mantero F, Stowasser M, Young W, Montori VM. Withdrawn: Case detection, diagnosis, and treatment of patients with primary aldosteronism: an Endocrine Society clinical practice guideline. Eur J Endocrinol. 2009 Sep 30. [Epub ahead of print]

ReferenceCitation: Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21.

ReferenceCitation: Seccia TM, Miotto D, De Toni R, Pitter G, Mantero F, Pessina AC, Rossi GP. Adrenocorticotropic hormone stimulation during adrenal vein sampling for identifying surgically curable subtypes of primary aldosteronism: comparison of 3 different protocols. Hypertension. 2009 May;53(5):761-6. doi: 10.1161/HYPERTENSIONAHA.108.128553. Epub 2009 Apr 6.

ReferenceCitation: Rossi GP, Pitter G, Bernante P, Motta R, Feltrin G, Miotto D. Adrenal vein sampling for primary aldosteronism: the assessment of selectivity and lateralization of aldosterone excess baseline and after adrenocorticotropic hormone (ACTH) stimulation. J Hypertens. 2008 May;26(5):989-97. doi: 10.1097/HJH.0b013e3282f9e66a.

ReferenceCitation: Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1.

ReferenceCitation: Auchus RJ, Wians FH Jr, Anderson ME, Dolmatch BL, Trimmer CK, Josephs SC, Chan D, Toomay S, Nwariaku FE. What we still do not know about adrenal vein sampling for primary aldosteronism. Horm Metab Res. 2010 Jun;42(6):411-5. doi: 10.1055/s-0030-1252060. Epub 2010 Apr 21. Review.

ReferenceCitation: Nishikawa T, Saito J, Omura M. Adrenal venous sampling is absolutely requisite for definitively diagnosing primary aldosteronism as well as for detecting laterality of the adrenal lesion. Hypertens Res. 2007 Nov;30(11):1009-10. doi: 10.1291/hypres.30.1009.

ReferenceCitation: Rossi GP, Crimì F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Cent Wu V, Kratka Z, Barbiero G, Seccia TM, Battistel M. Identification of Surgically Curable Primary Aldosteronism by Imaging in a Large, Multiethnic International Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4340-e4349. doi: 10.1210/clinem/dgab482.

name: University of Padova, Department of Medicine-DIMED, International PhD Program in Arterial Hypertension and Vascular Biology (ARHYVAB), University Hospital, Padova, Italy

family: Rossi

full_name: Gian Paolo Rossi

given: Gian Paolo

name: University of Padova, Department of Medicine-DIMED, Institute of Radiology, University Hospital, Padova, Italy

family: Crimì

full_name: Filippo Crimì

given: Filippo

family: Rossitto

full_name: Giacomo Rossitto

given: Giacomo

name: AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France

name: Université de Paris, INSERM, CIC1418 and UMR 970, Paris, France

family: Amar

full_name: Laurence Amar

given: Laurence

family: Azizi

full_name: Michel Azizi

given: Michel

name: Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, LMU München, Munich, Germany

family: Riester

full_name: Anna Riester

given: Anna

family: Reincke

full_name: Martin Reincke

given: Martin

family: Degenhart

full_name: Christoph Degenhart

given: Christoph

name: 3rd Department of Medicine, Charles University, General Faculty Hospital, Prague, Czech Republic

family: Widimsky

full_name: Jiri Widimsky

given: Jiri

name: Department of Endocrinology, Clinical Research Institute, NHO Kyoto Medical Center and Endocrine Center, Ijinkai Takeda General Hospital, Kyoto, Japan

family: Naruse

full_name: Mitsuhide Naruse

given: Mitsuhide

name: Department of Internal Medicine, Radboud University Medical Center, HB Nijmegen, the Netherlands

family: Deinum

full_name: Jaap Deinum

given: Jaap

name: Department of Radiology, Radboud University Medical Center, HB Nijmegen, the Netherlands

family: Schultze Kool

full_name: Leo Schultze Kool

given: Leo

name: Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

name: Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

family: Kocjan

full_name: Tomaz Kocjan

given: Tomaz

family: Negro

full_name: Aurelio Negro

given: Aurelio

full_name: Ermanno Rossi

given: Ermanno

name: Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada

family: Kline

full_name: Gregory Kline

given: Gregory

name: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine, Tokyo, Japan

family: Tanabe

full_name: Akiyo Tanabe

given: Akiyo

name: Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Hospital, Sendai, Japan

family: Satoh

full_name: Fumitoshi Satoh

given: Fumitoshi

name: Heinrich Heine University Düsseldorf, Nephrologie, 40225 Düsseldorf, Germany

family: Christian Rump

full_name: Lars Christian Rump

given: Lars

family: Vonend

full_name: Oliver Vonend

given: Oliver

name: Division of Endocrinology and Metabolism, Rostock University Medical Center, Rostock, Germany

family: Willenberg

full_name: Holger S Willenberg

given: Holger S

name: Endocrinology Unit, Monash Health, Clayton, Victoria, Australia

name: Centre for Endocrinology and Metabolism, Hudson Institute of Medical Research, Clayton, Victoria, Australia

family: Fuller

full_name: Peter J Fuller

name: Department of Medicine, Monash University, Clayton, 3168, Victoria, Australia

name: Medical College of Wisconsin, Endocrinology Center, North Hills Health Center, Menomonee Falls, Wisconsin, USA

name: Department of Endocrinology, North-Western Medical University named after I. I. Mechnikov, Saint Petersburg, Russia

name: Endocrinology in Charlottenburg, 10627 Berlin, Germany

name: Department of Nephrology, Hypertension Unit, Hospital del Mar; Universitat Pompeu Fabra; IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain

name: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultzekool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller P, Yang J, Nian Chee NY, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Chang CC, Wu VC, Somloova Z, Maiolino G, Barbiero G, Battistel M, Lenzini L, Quaia E, Pessina AC, Rossi GP. Subtyping of Primary Aldosteronism in the AVIS-2 Study: Assessment of Selectivity and Lateralization. J Clin Endocrinol Metab. 2020 Jun 1;105(6). pii: dgz017. doi: 10.1210/clinem/dgz017.

name: Department of Medicine-DIMED, University Hospital, Padova, Italy

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK

name: Hypertension unit, Université de Paris, Inserm UMR970 and CIC1418, Hôpital Européen Georges Pompidou, Paris, France

name: Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, LMU München, München, Germany

name: 3rd Department of Medicine, Charles University Prague, General Hospital, Prague, Czech Republic

name: Departments of Internal Medicine and Radiology, Radboud University Nijmegen, Nijmegen, The Netherlands

name: Department of Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

name: Department of Internal Medicine, Azienda Unità Sanitaria Locale, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy

name: University of Calgary, Foothills Medical Centre, Calgary, Canada

name: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine (NCGHM), Tokyo, Japan

name: Department of Nephrology, Tohoku University Hospital, Endocrinology and Vascular Medicine, Sendai, Japan

name: Department of Nephrology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany

name: Department of Endocrinology, Monash Health, Clayton, Australia

name: Endocrinology in Charlottenburg, Berlin, Germany

name: Nephrology Department, Hospital del Mar Universitat Autònoma de Barcelona, Barcelona, Spain

name: Institute of Radiology, University of Padova, Padova, Italy

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

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: The University of Glasgow - Enlighten: Publications

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

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

repositories_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

ReferenceCitation: Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J Jr, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Dun Wu K, Wu VC, Kratka Z, Barbiero G, Battistel M, Chang CC, Vanderriele PE, Pessina AC. Clinical Outcomes of 1625 Patients With Primary Aldosteronism Subtyped With Adrenal Vein Sampling. Hypertension. 2019 Oct;74(4):800-808. doi: 10.1161/HYPERTENSIONAHA.119.13463. Epub 2019 Sep 3.

name: From the Department of Medicine-DIMED, University of Padova, Hypertension Unit, University Hospital, Padova, Italy (G.P.R., G.R., P.-E.V., A.C.P.)

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (G.R.).

name: AP-HP, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (L.A., M.A.)

name: Faculty of Medicine, Université de Paris, INSERM, UMR970, Paris-Cardiovascular Research Center, France (L.A.)

name: INSERM, CIC1418, F-75015, Paris, France (M.A.)

name: Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, LMU München (A.R., M.R., C.D.)

name: 3rd Department of Medicine, Charles University Prague, General Hospital, Czech Republic (J.W., Z.K.)

name: Department of Endocrinology, National Hospital Organization Kyoto Medical Center, Clinical Research Institute, Japan (M.N.)

name: Radboud University Medical Center, Nijmegen, Netherlands (L.S.)

name: University Medical Centre Ljubljana (T.K.)

name: Department of Internal Medicine, Azienda Unità Sanitaria Locale, IRCCS Arcispedale S. Maria Nuova, Hypertension Unit, Reggio Emilia, Italy (A.N., E.R.)

name: Foothills Medical Centre, University of Calgary, Canada (G.K.)

name: Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine (A.T.)

name: Department of Nephrology, Tohoku University Hospital, Endocrinology and Vascular Medicine, Sendai (F.S.)

name: Heinrich Heine University Düsseldorf, Nephrologie, Germany (L.C.R., O.V.)

name: Division of Endocrinology and Metabolism, Rostock University Medical Center, Germany (H.S.W.)

name: Endocrinology Unit, Monash Health, Clayton, VIC, Australia (P.J.F., J.Y., N.Y.N.C.)

name: Medical College of Wisconsin, Endocrinology Center, North Hills Health Center, Menomonee Falls (S.B.M.)

name: Endocrinology in Charlottenburg, Berlin, Germany (M.Q.)

name: Department of Nephrology, Hypertension Unit, Hosp. del Mar Universitat Autònoma de Barcelona, Spain (A.O.)

name: Department of Internal Medicine, National Taiwan University Hospital, Taipei (K.D.W., V-C.W.)

name: Department of Endocrinology, North-Western State Medical University named after I.I. Mechnikov, St. Petersburg, Russia (Z.K.)

name: Institute of Radiology, University of Padova, Italy (G.B., M.B.)

name: Department of Medical Imaging, National Taiwan University Hospital, Taipei (C.-C.C.)

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Rossi GP, Barisa M, Allolio B, Auchus RJ, Amar L, Cohen D, Degenhart C, Deinum J, Fischer E, Gordon R, Kickuth R, Kline G, Lacroix A, Magill S, Miotto D, Naruse M, Nishikawa T, Omura M, Pimenta E, Plouin PF, Quinkler M, Reincke M, Rossi E, Rump LC, Satoh F, Schultze Kool L, Seccia TM, Stowasser M, Tanabe A, Trerotola S, Vonend O, Widimsky J Jr, Wu KD, Wu VC, Pessina AC. The Adrenal Vein Sampling International Study (AVIS) for identifying the major subtypes of primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1606-14. doi: 10.1210/jc.2011-2830. Epub 2012 Mar 7.

title: The Adrenal Vein Sampling International Study (AVIS) for Identifying the Major Subtypes of Primary Aldosteronism

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Australia
Canada
Czech Republic
Taiwan

location_facility: National Hospital Organizatio, Kyoto Medical Center

location_facility: Hospital of The University of Pennsylvania, Philadelphia

location_facility: University of Paris, Hopital Européen Georges Pompidou

location_facility: Institute of Clinical Endocrinology, Tokyo Women's Medical University

location_facility: Foothills Medical Centre, University of Calgary

location_facility: Centre Hospitalier de l'Université de Montreal (CHUM)

location_facility: Medicina 2, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliera Santa Maria Nuova

location_facility: Radboud University Nijmegen Medical Center

location_facility: Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy

location_facility: Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital


title: Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis

acronym: TEFRA

lead_sponsor: CHU de Clermont Ferrand


title: A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors

summary: This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Germany
France
Poland
Australia
Spain
Canada
United Kingdom


title: Comparison of the protective effect of two cardioplegic solutions Custodiol versus St Thomas on the cardiac metabolism assessed by microdialysis in coronary surgery

lead_sponsor: CHU de Saint-Etienne


title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)

summary: This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

lead_sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

location_country:
Germany
United States
United Kingdom
France

location_facility: Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin

location_facility: Hôpital Saint Jacques Service de Dermatologie


title: Etude pilote d'évaluation du test du freination de la sécrétion de l'hormone parathyroïdienne par le Cinacalcet (MIMPARA). Comparaisons : 1/ avec les résultats du test de charge calcique intra-veineux chez l'homme sain, 2/ entre le témoin sain et le patient atteint d'hyperparathyroïdie primaire

acronym: Cinacalcet: test freination de PTH

lead_sponsor: CHU de Rouen


title: Randomized, double-blind, placebo and active controlled study of the activity of SAR407899A single-dose on the ability to increase duration of penile rigidity, under experimental condition, in patients with mild to moderate erectile dysfunction

acronym: RHOKET

lead_sponsor: sanofi-aventis recherche et développement


title: Intérêt des inhibiteurs de l'enzyme de conversion dans l'atteinte rénale précoce des enfants drépanocytaires : Etude randomisée en double aveugle énalapril versus placebo.

acronym: MADREPIEC

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Analgésie post-opératoire pour prothèse totale de genou par cathéter péri-nerveux fémoral: Etude comparative de la levobupivacaine 0,125% versus ropivacaine 0, 2%. Protocole LPTG

acronym: LPTG

lead_sponsor: CHU de Caen


title: Essai clinique multicentrique, randomisé et contrôlé comparant l’efficacité de la pioglitazone versus placebo chez les patients avec hépatite virale chronique C de génotype non-2, non-3, insulinorésistance et traités par bithérapie interféron pégylé ribavirine.

acronym: PEGLIST

lead_sponsor: ANRS


title: Multicenter, phase II trial assessing the efficacy and safety of bevacizumab (Avastin®) combined to trastuzumab (Herceptin®) based chemotherapy in patients with primary inflammatory HER2+ breast cancer

acronym: BEVERLY 2

lead_sponsor: ROCHE SAS


title: Réversion de l'effet anticoagulant des nouveaux antithrombotiques anti Xa et anti IIa par des médicaments hémostatiques spécifiques ou non spécifiques : étude ex vivo chez le volontaire sain.

acronym: ReversNewAnticoag

lead_sponsor: University Hospital of Grenoble


title: Confirmation de l'efficacité et de la tolérance du LBC 45 dans la dermite séborrhéique du cuir chevelu

lead_sponsor: Laboratoire LABCATAL


title: A plaque test comparing 4 steroids with Daivobet® ointment and a vehicle control for the treatment of psoriasis vulgaris

lead_sponsor: LEO Pharma A/S


title: A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL

summary: This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
France
Bulgaria
Poland
Hungary
Russian Federation
Spain
Estonia
Latvia
Ukraine

location_facility:
Teva Investigational Site 31005
Teva Investigational Site 50017
Teva Investigational Site 31006
Teva Investigational Site 58012
Teva Investigational Site 31001
Teva Investigational Site 53010
Teva Investigational Site 51026
Teva Investigational Site 30001
Teva Investigational Site 31004
Teva Investigational Site 50001
Teva Investigational Site 50010
Teva Investigational Site 59002
Teva Investigational Site 50009
Teva Investigational Site 50005
Teva Investigational Site 55001
Teva Investigational Site 58015
Teva Investigational Site 50015
Teva Investigational Site 58017
Teva Investigational Site 58010
Teva Investigational Site 50012
Teva Investigational Site 59004
Teva Investigational Site 59005
Teva Investigational Site 58011
Teva Investigational Site 30002
Teva Investigational Site 50011
Teva Investigational Site 50003
Teva Investigational Site 58014
Teva Investigational Site 50014
Teva Investigational Site 50006
Teva Investigational Site 59001
Teva Investigational Site 56003
Teva Investigational Site 35066
Teva Investigational Site 56001
Teva Investigational Site 31002
Teva Investigational Site 55002
Teva Investigational Site 31003
Teva Investigational Site 50004
Teva Investigational Site 58016
Teva Investigational Site 56002
Teva Investigational Site 59003
Teva Investigational Site 58013


title: Diagnostic clinique et mécanismes physiopathologiques de l'allergie à l'insuline.

acronym: ALLERDIAB


title: Evaluation de la non-infériorité de l’efficacité d’Helicidine® versus Sirop à base de dextromethorphane sur la toux sèche des patients pris en charge en médecine générale.

lead_sponsor: THERABEL LUCIEN PHARMA


title: Etude prospective de la prescripion d'anidulafungine pour infections intra-abdominales graves hospitalisées en réanimation

lead_sponsor: ADRFARCP


title: CLOFARABINE/ARA-C TREATMENT COMBINED WITH REDUCED-INTENSITY CONDITIONING ALLOGENEIC STEM CELL TRANSPLANTATION FOR ACUTEMYELOID LEUKEMIA IN PRIMARY TREATMENT FAILURE

acronym: SET-RIC

lead_sponsor: CHU de Nantes


title:
Evaluation of the Immune Response against Neisseria meningitidis B:14, P1-7,16 in subjects inoculated by MenBVac ® vaccine.

 Evaluation de la réponse Immunitaire contre la souche de Neisseria meningitidis B:14,P1-7,16 chez les sujets amenés à être vaccinés par MenBVac®

acronym:
Effivac clinical trial extension

 extension de l'étude Effivac

lead_sponsor: CHU - Hôpitaux de Rouen


title:
Evaluation of the Immune Response against Neisseria meningitidis B:14,P1-7,16 in subjects inoculated by MenBVac (R) vaccine.

 Evaluation de la réponse immunitaire contre la souche de Neisseria Meningitidis B:14,P1.7,16 chez les sujets vaccinés par MenBVac®.

acronym:
MenBVac clinical trial extension

 Extension de l'étude MenBVac

lead_sponsor: CHU  - Hôpitaux de Rouen


title: A multicenter phase II pilot open label study  to evaluate the efficacy and safety of BKM120 in the treatment of patients with advanced or metastatic differentiated thyroid cancers

acronym: BKM 120

lead_sponsor: HOSPICES CIVILS DE LYON


title:
Evaluation of cardiac uptake during a PET examination 18F Flutematamol (Vizamyl®) in cardiac damage amyloid.

 Evaluation de la fixation cardiaque lors d’un examen TEP au 18F Flutematamol (Vizamyl®) dans les atteintes cardiaques amyloïdes.

acronym: AMYLCAR

lead_sponsor: CHU Toulouse


title: Comparison of neuromuscular blockade’s monitoring and clinical assessment during cisatracurium paralysis in critically ill patients

acronym: MONITOR

lead_sponsor: CHU DE POITIERS


title: Modalities of vitamin D supplementation and the risk of hypercalcemia in children aged 2 to 6 years

acronym: DonneDvit

lead_sponsor: uh Montpellier


title:
Randomized double-blind study on the benefit of spironolactone for treating acne of adult woman

 Etude randomisée en double-aveugle sur l'intérêt de la spironolactone dans le traitement de l'acné de la femme adulte

acronym: FASCE


title:
INTRANASAL KETAMINE IN THE REDUCTION OF THE ISOLATED FRACTURES OF THE HIGHER MEMBER OF THE CHILD TO PEDIATRIC EMERGENCIES

 KETAMINE PAR VOIE INTRANASALE DANS LA REDUCTION DES FRACTURES ISOLEES DU MEMBRE SUPERIEUR DE L’ENFANT AUX URGENCES PEDIATRIQUES

acronym:
KETA PED

 KETA PED

lead_sponsor: Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL


title:
Efficacy and safety of Passiflora Compose in patients newly diagnosed with adjustment disorder with anxiety, as first-line treatment, compared to alprazolam

 Efficacité et tolérance de Passiflora composé dans l’anxiété réactionnelle récente, en première intention, en comparaison de l’alprazolam.

acronym:
PASSIANCE

 PASSIANCE

lead_sponsor: BOIRON


title:
Adjunction of daptomycin for the treatment of pneumococcal meningitis AddaMAP study

 Daptomycine en traitement adjuvant des méningites à pneumocoque.  Etude ADDAMAP

acronym: ADDAMAP Study

lead_sponsor: CHU Dijon Bourgogne


title:
Active surveillance with or without a 6 months Apalutamide treatment in low risk prostate cancer: a phase II randomized multicenter trial

 Surveillance active avec ou sans traitement de 6 mois par Apalutamide dans le cancer de la prostate de bas risque : une étude multicentrique de phase 2 randomisée.

lead_sponsor: Institut Paoli Calmettes


title:
Study of the role of local treatments on the modulation of the microbiome in psoriatic skin

 Etude du rôle des traitements locaux  sur la modulation du microbiome dans la peau psoriasique

acronym:
Microbiome & Psoriasis Study

 Etude microbiome & psoriasis

lead_sponsor: CHU de Nice


title:
Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study

 Injection de cellules souches mésenchymateuses autologues issues de tissu adipeux dans la prise en charge des ulcères digitaux de la sclérodermie systémique. Essai multicentrique, randomisé, contrôlé versus placebo de phase 2

acronym:
ADUSE

 ADUSE

lead_sponsor: CHU de Toulouse


title:
Randomized, open-label and multicentric trial evaluating the non-inferiority of antiretroviral treatment taken 4 consecutive days per week versus continuous therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral therapy

 Essai multicentrique, en ouvert, randomisé en 2 groupes parallèles, évaluant la non-infériorité d’un traitement de maintenance à 4 jours consécutifs sur 7 versus la poursuite du traitement antirétroviral en continu, chez des patients en succès thérapeutique sous ARV.

acronym:
QUATUOR

 QUATUOR

lead_sponsor: Inserm-ANRS


title:
NEOADUVANT ATEZOLIZUMAB AND ADJUVANT ATEZOLIZUMAB + BEVACIZUMAB IN COMBINATION WITH PERCUTANEOUS RADIOFREQUENCY ABLATION OF SMALL HCC: A MULTICENTER RANDOMIZED PHASE II TRIAL

 ATEZOLIZUMAB NEOADJUVANT ET ATEZOLIZUMAB + BEVACIZUMAB EN ADJUVANT APRES ABLATION PERCUTANEE PAR RADIOFREQUENCE DE CHC DE PETITE TAILLE : ESSAI DE PHASE II RANDOMISE MULTICENTRIQUE

acronym:
AB-LATE02

 AB-LATE02

lead_sponsor: University Hospital of Montpellier


title:
Intérêt de la curarisation lors de la chirurgie laparoscopique et recherche de facteurs associés à une compliance abdominale diminuée.

 Intérêt de la curarisation lors de la chirurgie laparoscopique et recherche de facteurs associés à une compliance abdominale diminuée.

acronym:
Coeliocur

 Coeliocur

lead_sponsor: Centre Hospitalier Universitaire de Reims


title:
Randomised phase III multicentric study comparing efficacy of doxorubicin with trabectedin followed by trabectedin in non-progressive patients versus doxorubicine alone as first-line therapy in patients with metastatic or unresectable leiomyosarcoma (uterine or soft tissue)

 Étude de phase III multicentrique randomisée comparant l’efficacité de l’association doxorubicine et trabectédine, suivie de trabectédine seule en l’absence de progression, à celle de la doxorubicine seule, en traitement de première ligne des patients qui présentent un léiomyosarcome (utérin et des tissus mous) métastatique et/ou localement avancé

lead_sponsor: GUSTAVE ROUSSY


title:
A RANDOMIZED PHASE III MULTICENTER TRIAL COMPARING THE EFFICACY AND SAFETY OF ANAKINRA VERSUS INTRAVENOUS IMMUNOGLOBULIN (IVIG) RETREATMENT, IN PATIENTS WITH KAWASAKI DISEASE WHO FAILED TO RESPOND TO INITIAL STANDARD IVIG TREATMENT (ANACOMP)

 Essai multicentrique randomisé de phase III comparant l'efficacité et la sécurité de l'anakinra au retraitement par immunoglobulines intraveineuses (IVIG), chez des patients atteints de la maladie de Kawasaki qui n'ont pas répondu au traitement initial standard par IVIG

acronym: ANACOMP

lead_sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)


lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
Finland
France

location_facility: Rush-Presbyterian St. Lukes Medical Center

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: San Diego Arthritis & Osteoporosis Medical Clinic

location_facility: Cotton O'Neil Clinical Research Institute

title: A Randomized, Double Blind, Placebo and Naproxen Controlled, Multi-center, Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

summary: The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.


title: A Phase II, Single-blind, Randomized, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired Thrombotic Thrombocytopenic Purpura

acronym: TITAN

summary:
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.

Patients received either placebo or anti-vWF Nanobody as adjunctive therapy to plasma exchange (PE).

ReferenceCitation: Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.

name: Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;

name: Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy;

family: Peyvandi

full_name: Flora Peyvandi

given: Flora

name: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH;

family: Cataland

full_name: Spero Cataland

given: Spero

name: Department of Haematology, University College London Hospital National Health Service Trust, London, United Kingdom;

family: Scully

full_name: Marie Scully

given: Marie

name: Department of Hematology, Reference Center for Thrombotic Microangiopathies, Saint-Antoine University Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France;

family: Coppo

full_name: Paul Coppo

given: Paul

name: Department of Medicine 1, Division of Hematology and Hemostasis, Medical University of Vienna, Vienna, Austria;

family: Knoebl

full_name: Paul Knoebl

name: Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland;

family: Kremer Hovinga

full_name: Johanna A. Kremer Hovinga

given: Johanna A.

name: Department of Medicine, Duke University School of Medicine, Durham, NC;

family: Metjian

full_name: Ara Metjian

given: Ara

name: Hematology Department, Internal Medicine, School of Medicine and Dentistry, Catholic University of Valencia and Hospital Doctor Peset, Valencia, Spain;

family: de la Rubia

full_name: Javier de la Rubia

given: Javier

name: Departments of Laboratory Medicine and Medicine, St. Michael’s Hospital, Toronto, Canada;

name: Departments of Laboratory Medicine and Pathobiology and Medicine, University of Toronto, Toronto, Canada;

family: Pavenski

full_name: Katerina Pavenski

given: Katerina

name: Clinical Development, Ablynx, a Sanofi company, Ghent, Belgium; and

family: Minkue Mi Edou

full_name: Jessica Minkue Mi Edou

given: Jessica

family: De Winter

full_name: Hilde De Winter

given: Hilde

name: Medical Affairs, Sanofi, Diegem, Belgium

family: Callewaert

full_name: Filip Callewaert

given: Filip

journal_name: Blood Advances

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via free article)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Peyvandi F, Scully M, Kremer Hovinga JA, Cataland S, Knöbl P, Wu H, Artoni A, Westwood JP, Mansouri Taleghani M, Jilma B, Callewaert F, Ulrichts H, Duby C, Tersago D; TITAN Investigators. Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2016 Feb 11;374(6):511-22. doi: 10.1056/NEJMoa1505533.

family: Knöbl

full_name: Paul Knöbl

family: Wu

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

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

ReferenceCitation: Holz JB. The TITAN trial--assessing the efficacy and safety of an anti-von Willebrand factor Nanobody in patients with acquired thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2012 Jun;46(3):343-6. doi: 10.1016/j.transci.2012.03.027. Epub 2012 Apr 3.

title: The TITAN trial – Assessing the efficacy and safety of an anti-von Willebrand factor Nanobody in patients with acquired thrombotic thrombocytopenic purpura

location_country:
Italy
Austria
Switzerland
Germany
France
Bulgaria
Israel
Romania
Australia
Belgium
Spain
United States
United Kingdom


ReferenceType: result

ReferenceCitation: Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbüchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsányi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14. Erratum in: N Engl J Med. 2012 Feb 16;366(7):672.

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Camm

full_name: A. John Camm

given: A. John

family: Halperin

full_name: Jonathan L. Halperin

given: Jonathan L.

family: Joyner

full_name: Campbell Joyner

given: Campbell

family: Alings

full_name: Marco Alings

given: Marco

family: Amerena

full_name: John Amerena

given: John

family: Atar

full_name: Dan Atar

given: Dan

family: Avezum

full_name: Álvaro Avezum

given: Álvaro

family: Blomström

full_name: Per Blomström

given: Per

family: Borggrefe

full_name: Martin Borggrefe

given: Martin

family: Budaj

full_name: Andrzej Budaj

given: Andrzej

family: Chen

full_name: Shih-Ann Chen

given: Shih-Ann

family: Ching

full_name: Chi Keong Ching

given: Chi Keong

family: Commerford

full_name: Patrick Commerford

given: Patrick

family: Dans

full_name: Antonio Dans

given: Antonio

family: Davy

full_name: Jean-Marc Davy

given: Jean-Marc

family: Delacrétaz

full_name: Etienne Delacrétaz

given: Etienne

family: Di Pasquale

full_name: Giuseppe Di Pasquale

given: Giuseppe

family: Diaz

full_name: Rafael Diaz

given: Rafael

family: Dorian

full_name: Paul Dorian

family: Flaker

full_name: Greg Flaker

given: Greg

family: Golitsyn

full_name: Sergey Golitsyn

given: Sergey

family: Gonzalez-Hermosillo

full_name: Antonio Gonzalez-Hermosillo

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Heidbüchel

full_name: Hein Heidbüchel

given: Hein

repository_institution: The University of Queensland - Queensland's institutional digital repository

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

title: Dronedarone in High-Risk Permanent Atrial Fibrillation

ReferenceCitation: Hohnloser SH, Halperin JL, Camm AJ, Gao P, Radzik D, Connolly SJ; PALLAS investigators. Interaction between digoxin and dronedarone in the PALLAS trial. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1019-25. doi: 10.1161/CIRCEP.114.002046. Epub 2014 Nov 6.

name: From the Division of Clinical Electrophysiology, J.W. Goethe University, Frankfurt, Germany (S.H.H.); Population Health Research Institute, McMaster University, Hamilton, ON, Canada (P.G., S.J.C.); Department of Clinical Sciences, St George’s University of London, London, United Kingdom (A.J.C.); The Cardiovascular Institute, Mount Sinai Medical Center, New York, NY (J.L.H.); and Sanofi Recherche, Paris, France (D.R.).

journal_name: Circulation: Arrhythmia and Electrophysiology

title: Interaction Between Digoxin and Dronedarone in the PALLAS Trial

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
France
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain

title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors

summary:
Primary Objective:

Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors

Secondary Objective:

Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).


title: AN OPEN-LABEL, SINGLE ARM, MONOCENTRIC, PHASE I/II CLINICAL STUDY OF INTRACEREBRAL ADMINISTRATION OF ADENO-ASSOCIATED VIRAL VECTORS SEROTYPE 10 CARRYING THE HUMAN SGSH AND SUMF1 cDNAS FOR THE TREATMENT OF SANFILIPPO TYPE A SYNDROME

acronym: Intracerebral Gene therapy for Sanfilippo type A syndrome

lead_sponsor: SANFILIPPO Therapeutics SAS


title: Etude multicentrique française, ouverte, non-comparative, évaluant la tolérance clinique et biologique de l’utilisation de l'epoetin beta (NeoRecormon®) chez des patients présentant une anémie au cours d’une hépatite chronique virale C traitée par bithérapie peginterferon alfa plus ribavirine

acronym: NEOS

lead_sponsor: ROCHE


title: EFFICACY OF AN EARLY ADMINISTRATION OF L0013CP 10 MG/DAY VERSUS PLACEBO DURING 4 WEEKS IN THE TREATMENT OF INFECTIOUS DISEASES INDUCED ARTHRITIS PAINFUL SYMPTOMS. A MULTICENTER, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED CLINICAL TRIAL IN ADULT PATIENTS SUFFERING FROM CHIKUNGUNYA FEVER.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Evaluation de l’efficacité du temsirolimus chez des patients récidivant d’un cancer de la vessie après une première ligne de chimiothérapie. Essai clinique de phase II multicentrique.

acronym: VESTOR

lead_sponsor: Institut Bergonié - Département d’Oncologie Médicale


title: Prospective Collection of Data in Pts With Peripheral T-Cell Lymphoma: PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type; Hepatosplenic γ-δ; Subcutaneous Panniculitis-like; ALCL,Primary Systemic Type. By the Intl. T-Cell Lymphoma Project

summary:
The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project).

It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49.

ReferenceCitation: Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.

ReferenceCitation: Picker LJ, Weiss LM, Medeiros LJ, Wood GS, Warnke RA. Immunophenotypic criteria for the diagnosis of non-Hodgkin's lymphoma. Am J Pathol. 1987 Jul;128(1):181-201. Review.

ReferenceCitation: Cooke CB, Krenacs L, Stetler-Stevenson M, Greiner TC, Raffeld M, Kingma DW, Abruzzo L, Frantz C, Kaviani M, Jaffe ES. Hepatosplenic T-cell lymphoma: a distinct clinicopathologic entity of cytotoxic gamma delta T-cell origin. Blood. 1996 Dec 1;88(11):4265-74.

ReferenceCitation: Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.

ReferenceCitation: Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95.

ReferenceCitation: Ascani S, Zinzani PL, Gherlinzoni F, Sabattini E, Briskomatis A, de Vivo A, Piccioli M, Fraternali Orcioni G, Pieri F, Goldoni A, Piccaluga PP, Zallocco D, Burnelli R, Leoncini L, Falini B, Tura S, Pileri SA. Peripheral T-cell lymphomas. Clinico-pathologic study of 168 cases diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1997 Jun;8(6):583-92.

ReferenceCitation: López-Guillermo A, Cid J, Salar A, López A, Montalbán C, Castrillo JM, González M, Ribera JM, Brunet S, García-Conde J, Fernández de Sevilla A, Bosch F, Montserrat E. Peripheral T-cell lymphomas: initial features, natural history, and prognostic factors in a series of 174 patients diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1998 Aug;9(8):849-55. Review.

ReferenceCitation: Savage KJ, Chhanabhai M, Gascoyne RD, Connors JM. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol. 2004 Oct;15(10):1467-75.

ReferenceCitation: Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S, Rigacci L, Devizzi L, Todeschini G, Santini G, Brugiatelli M, Federico M; Intergruppo Italiano Linfomi. Peripheral T-cell lymphoma unspecified (PTCL-U): a new prognostic model from a retrospective multicentric clinical study. Blood. 2004 Apr 1;103(7):2474-9. Epub 2003 Nov 26.

ReferenceCitation: Zaja F, Russo D, Silvestri F, Fanin R, Damiani D, Infanti L, Salmaso F, Mariuzzi L, Di Loreto C, Baccarani M. Retrospective analysis of 23 cases with peripheral T-cell lymphoma, unspecified: clinical characteristics and outcome. Haematologica. 1997 Mar-Apr;82(2):171-7.

ReferenceCitation: Tsuchiya T, Ohshima K, Karube K, Yamaguchi T, Suefuji H, Hamasaki M, Kawasaki C, Suzumiya J, Tomonaga M, Kikuchi M. Th1, Th2, and activated T-cell marker and clinical prognosis in peripheral T-cell lymphoma, unspecified: comparison with AILD, ALCL, lymphoblastic lymphoma, and ATLL. Blood. 2004 Jan 1;103(1):236-41. Epub 2003 Sep 4.

ReferenceCitation: Federico M, Bellei M, Pesce, E, Zucca E, Pileri S, Montoto S, Weisenburger DD, Ruediger T, KO YH, Liang R, Zinzani PL, Connors JM, Foss FM, Horwitz SM, Polliack A, Vose JM. T-Cell Project: an international, longitudinal, observational study of patients with aggressive peripheral T-cell lymphoma. Revista Brasileira de Hematologia e Hemoterapia 31(suppl 2):21-25,2009.

ReferenceCitation: Federico M, Bellei M, Pesce EA, Zucca E, Pielri S, Montoto S, Weisenburger D, Rugiger T, Ko Y, Liang R, Zinzani PL, Connors J, Foss F, Horwitz S, Polliack A, Vose J. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral T-cell Lymphoma. Analysis of the first 524 patients. 11 ICML, Lugano (Switzerland), 15-18 June 2011. Abs 241. Ann Oncol 22 (suppl 4), 2011

ReferenceCitation: Bellei M, Chiattone CS, Luminari S, Pesce EA, Cabrera ME, de Souza CA, Gabús R, Zoppegno L, Zoppegno L, Milone J, Pavlovsky A, Connors JM, Foss FM, Horwitz SM, Liang R, Montoto S, Pileri SA, Polliack A, Vose JM, Zinzani PL, Zucca E, Federico M. T-cell lymphomas in South america and europe. Rev Bras Hematol Hemoter. 2012;34(1):42-7. doi: 10.5581/1516-8484.20120013.

family: Bellei

full_name: Monica Bellei

given: Monica

family: Chiattone

full_name: Carlos Sergio Chiattone

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family: Luminari

full_name: Stefano Luminari

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family: Pesce

full_name: Emanuela Anna Pesce

given: Emanuela Anna

family: Cabrera

full_name: Maria Elena Cabrera

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family: Souza

full_name: Carmino Antonio de Souza

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family: Gabús

full_name: Raul Gabús

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family: Zoppegno

full_name: Lucia Zoppegno

given: Lucia

family: Milone

full_name: Jorge Milone

given: Jorge

family: Pavlovsky

full_name: Astrid Pavlovsky

given: Astrid

family: Connors

full_name: Joseph Michael Connors

given: Joseph Michael

family: Foss

full_name: Francine Mary Foss

given: Francine Mary

family: Horwitz

full_name: Steven Michael Horwitz

given: Steven Michael

family: Liang

full_name: Raymond Liang

given: Raymond

family: Montoto

full_name: Silvia Montoto

given: Silvia

family: Pileri

full_name: Stefano Aldo Pileri

given: Stefano Aldo

family: Polliack

full_name: Aaron Polliack

given: Aaron

family: Vose

full_name: Julie Marie Vose

given: Julie Marie

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Zucca

full_name: Emanuele Zucca

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journal_name: Revista Brasileira de Hematologia e Hemoterapia

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

publisher: Revista Brasileira de Hematologia e Hemoterapia (RBHH)

publisher_dissemination: Revista Brasileira de Hematologia e Hemoterapia (RBHH)

publisher_group: Revista Brasileira de Hematologia e Hemoterapia (RBHH)

publisher_normalized: Revista Brasileira de Hematologia e Hemoterapia (RBHH)

title: T-Cell Lymphomas in South America and Europe

ReferenceCitation: Federico M, Bellei M, Luminari S, Horwitz SM, Montoto S, Zucca E, Pileri SA, Ko YH, Zinzani PL, Connors JM, Foss FM, Polliack A, Cabrera ME, Kim WS, Spina M, De Souza CA, Bobillo Varela S, Dlouhy I, Advani RH, Vose J and T-Cell Project. CD30+ expression in Peripheral T-cell lymphomas (PTCLs): A subset analysis from the international, prospective T-Cell Project. Journal of Clinical Oncology, 2015 ASCO Annual Meeting (May 29 - June 2, 2015).Vol 33, No 15_suppl (May 20 Supplement), 2015: 8552

ReferenceCitation: Federico M, Bellei M, Pesce EA, et al. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral NK/T-Cell Lymphoma: Lesson from the first 1308 patients. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 070. Hematol Oncol 2015; 33(Suppl1):100-180

ReferenceCitation: Bellei M, Marcheselli L, Pesce EA, et al. Clinical Characteristics and Patterns of Care of Patients (pts) with Peripheral T-cell Lymphoma (PTCLs) according to age at time of diagnosis: A T-Cell Project snapshot. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 231. Hematol Oncol 2015; 33(Suppl1):181-243

ReferenceCitation: Horwitz SM, Bellei M, Marcheselli L, et al. The role of transplant in the treatment of Peripheral T-cell Lymphomas (PTCLs): an analysis from the T-cell Project database. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 247. Hematol Oncol 2015; 33(Suppl1):181-243

ReferenceCitation: Bellei M, Sabattini E, Pesce EA, Ko YH, Kim WS, Cabrera ME, Martinez V, Dlouhy I, Paes RP, Barrese T, Vassallo J, Tarantino V, Vose J, Weisenburger D, Rüdiger T, Federico M, Pileri S. Pitfalls and major issues in the histologic diagnosis of peripheral T-cell lymphomas: results of the central review of 573 cases from the T-Cell Project, an international, cooperative study. Hematol Oncol. 2017 Dec;35(4):630-636. doi: 10.1002/hon.2316. Epub 2016 Jun 3.

name: Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica; Università di Modena e Reggio Emilia; Modena Italy

name: Policlinico Sant′Orsola - Malpighi; Unità di Emolinfopatologia; Bologna Italy

name: Samsung General Center, Department of Pathology; Sungkyunkwan University School of Medicine; Seoul Korea

name: Samsung General Center, Division of Hematology - Oncology, Department of Medicine; Sungkyunkwan University School of Medicine; Seoul Korea

name: Sección Hematología, Hospedal del Salvator; Universidad de Chile; Santiago de Chile Chile

name: Instituto de Anatomía Patologica; Santiago de Chile Chile

name: Hematology Department; Hospital Clinic de Barcelona; Barcelona Spain

name: Irmandade da Santa Casa de Misericordia de São Paulo; São Paulo Brazil

name: Laboratory of Molecular and Investigative Pathology; University of Campinas; Campinas Brazil

name: UNMC, Internal Medicine; Nebraska Medical Center; Omaha NE USA

name: City of Hope National Medical Center; Duarte CA USA

name: Stadtisches Klinikum Karlsruhe gGmbH; Institute of Pathology; Karlsruhe Baden - Württemberg Germany

name: Unità di Diagnosi Emolinfopatologica; IEO - Istituto Europeo di Oncologia; Milano Italy

name: Alma mater Professor of Pathology; Università degli Studi di Bologna, Scuola di Medicina e Chirurgia; Bologna Italy

ReferenceCitation: Advani RH, Skrypets T, Civallero M, Spinner MA, Manni M, Kim WS, Shustov AR, Horwitz SM, Hitz F, Cabrera ME, Dlouhy I, Vassallo J, Pileri SA, Inghirami G, Montoto S, Vitolo U, Radford J, Vose JM, Federico M. Outcomes and prognostic factors in angioimmunoblastic T-cell lymphoma: final report from the international T-cell Project. Blood. 2021 Jul 22;138(3):213-220. doi: 10.1182/blood.2020010387.

name: Stanford University, Stanford, California, United States

name: University of Modena and Reggio Emilia, Modena, Italy

name: Samsung Medical Center, SEOUL, Korea, Republic of

name: University of Washington, Seattle, Washington, United States

name: Memorial Sloan Kettering Cancer Center, New York, New York, United States

name: Hospital del Salvador, Universidad de Chile, Santiago, Chile

name: Hospital Clinic Barcelona, Barcelona, Spain

name: State University of Campinas-UNICAMP, Campinas-SP, Brazil

name: IEO - European Institute of Oncology IRCCS (Milan) & Bologna University School of Medicine, Milano, Italy

name: Weill Cornell Medical College, New York, New York, United States

name: Barts Health NHS Trust, London, United Kingdom

name: Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo (Torino), Italy

name: University of Manchester and the Christie NHS Foundation Trust, Manchester, United Kingdom

name: University of Nebraska Medical Center, Omaha, Nebraska, United States

title: Outcomes and Prognostic Factors in Angioimmunoblastic T cell Lymphoma: Final Report from the International TCell Project

ReferenceCitation: Shustov A, Cabrera ME, Civallero M, Bellei M, Ko YH, Manni M, Skrypets T, Horwitz SM, De Souza CA, Radford JA, Bobillo S, Prates MV, Ferreri AJM, Chiattone C, Spina M, Vose JM, Chiappella A, Laszlo D, Marino D, Stelitano C, Federico M. ALK-negative anaplastic large cell lymphoma: features and outcomes of 235 patients from the International T-Cell Project. Blood Adv. 2021 Feb 9;5(3):640-648. doi: 10.1182/bloodadvances.2020001581.

name: Division of Hematology, University of Washington, Seattle, WA;

name: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

name: Seccion Hematologia, Hospital del Salvador, Universidad de Chile, Santiago, Chile;

name: Fondazione Italiana Linformi (FIL) onlus, University of Modena and Reggio Emilia, Modena, Italy;

name: Department of Pathology, Sungkyunkwan University, Seoul, Republic of Korea;

name: Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY;

name: Centro de Hematologia e Hemoterapia, Universidale Estadual de Campinas, Campinas, Brazil;

name: University of Manchester and the Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom;

name: University Hospital Vall d'Hebron, Barcelona, Spain;

name: Gatla, Laboratorio Varifarma Sa, Buenos Aires, Argentina;

name: Lymphoma Unit, Department of Onco-Hematology, IRCCS San Raffaele Scientific Institute, Milan, Italy;

name: Departamento de Clinica Medica, FCM da Santa Casa de Sao Paulo and Centro de Linfomas Nucleo de Oncologia Hospital Samaritano, São Paulo, Brazil;

name: Medical Oncology A, Aviano National Cancer Institute, Aviano, Italy;

name: Division of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE;

name: Fondazione Italiana Linfomi, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Turin, Italy;

name: Division of Haemato-Oncology, Istituto Europeodi Oncologia, Milan, Italy;

name: Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS Padua, Padua, Italy; and

name: Department of Haematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy

ReferenceCitation: Fox CP, Civallero M, Ko YH, Manni M, Skrypets T, Pileri S, Kim SJ, Cabrera ME, Shustov AR, Chiattone CS, Horwitz SM, Dlouhy I, Spina M, Hitz F, Montoto S, Nagler A, Martinez V, De Souza CA, Fernandez-Alvarez R, Ballova V, Gabús R, Inghirami G, Federico M, Kim WS. Survival outcomes of patients with extranodal natural-killer T-cell lymphoma: a prospective cohort study from the international T-cell Project. Lancet Haematol. 2020 Apr;7(4):e284-e294. doi: 10.1016/S2352-3026(19)30283-2. Epub 2020 Feb 24.

ReferenceCitation: Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M; International T-cell Project Network. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica. 2018 Jul;103(7):1191-1197. doi: 10.3324/haematol.2017.186577. Epub 2018 Mar 29.

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ipd_sharing_description: Preliminary analysis results will be made available during the study on the single population and separately for each subtype. Final results will be made available 6-12 months after the end of the study

lead_sponsor: Associazione Angela Serra per la ricerca sul cancro

location_country:
Italy
Brazil
Chile
Switzerland
Spain
Uruguay
France
Israel
Slovakia
Argentina
China
United States
United Kingdom
Korea, Republic of

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Franda

location_facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

location_facility: University of Southampton School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Maggiore della Carità

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliera Universitaria Pisana

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

location_facility: Azienda Ospedaliera S. Giovanni Battista

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS