title: A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

summary: The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Brunner

full_name: Hermine I. Brunner

given: Hermine I.

family: Tzaribachev

full_name: Nikolay Tzaribachev

given: Nikolay

family: Vega-Cornejo

full_name: Gabriel Vega-Cornejo

given: Gabriel

family: Louw

full_name: Ingrid Louw

given: Ingrid

family: Cimaz

full_name: Rolando Cimaz

given: Rolando

family: Dare

full_name: Jason Dare

given: Jason

family: Espada

full_name: Graciela Espada

given: Graciela

family: Faugier

full_name: Enrique Faugier

given: Enrique

family: Ferrandiz

full_name: Manuel Ferrandiz

given: Manuel

family: Gerloni

full_name: Valeria Gerloni

given: Valeria

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Silva

full_name: Clovis Artur Silva

given: Clovis Artur

family: Wagner-Weiner

full_name: Linda Wagner-Weiner

given: Linda

family: Gandhi

full_name: Yash Gandhi

given: Yash

family: Passarell

full_name: Julie Passarell

given: Julie

family: Nys

full_name: Marleen Nys

given: Marleen

family: Wong

full_name: Robert Wong

given: Robert

family: Martini

full_name: Alberto Martini

given: Alberto

family: Lovell

full_name: Daniel J. Lovell

given: Daniel J.

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

ReferenceCitation: Lovell DJ, Ruperto N, Mouy R, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Huppertz HI, Job Deslandre C, Minden K, Punaro M, Block AJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

name: Cincinnati Children's Hospital Medical CenterCincinnati Ohio

name: Hôpital Necker‐Enfants Malades, AP‐HPParis France

name: Hospital Universitario Dr. J. E. GonzalezMonterrey Mexico

name: Children's Institute, Hospital das Clinicas, and Faculdade de Medicina da Universidade de São PauloSão Paulo Brazil

name: Hospital Central Dr. Ignacio Morones Prieto y Facultad de Medicina and Universidad Autonoma de San Luis PotosiSan Luis Potosi Mexico

name: Hospital General de Mexico and Universidad Nacional Autonoma de MexicoMexico City Mexico

name: Istituto Ortopedico Gaetano PiniMilan Italy

name: Instituto Portugues de ReumatologiaLisbon Portugal

name: Universidade Estadual PaulistaBotucatu Brazil

name: Hospital Nacional Edgardo RebagliatiLima Peru

name: Altoona Arthritis and Osteoporosis CenterDuncansville Pennsylvania

name: Hospital Universitario A CoruñaA Coruña Spain

name: Hamburger Zentrum für Kinder und JugendrheumatologieHamburg Germany

name: Centre Multisite Romand de Rhumatologie PédiatriqueLausanne Switzerland

name: Professor Hess KinderklinikBremen Germany

name: Hôpital St. Vincent de Paul, AP‐HPParis France

name: Charité University Hospital BerlinBerlin Germany

name: Bristol‐Myers SquibbPrinceton New Jersey

name: IRCCS G. Gaslini and Università degli Studi di GenovaGenoa Italy

name: for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation

repositories_institution:
PubMed Central - Europe PMC
Universidade Da Coruña - RUC

title: Long‐Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years

ReferenceCitation: Ruperto N, Lovell DJ, Li T, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Alcala JO, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace C, Alessio M, Quartier P, Cortis E, Eberhard A, Simonini G, Lemelle I, Chalom EC, Sigal LH, Block A, Covucci A, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1542-51. doi: 10.1002/acr.20283. Epub 2010 Jul 1.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Horneff G, Huppertz HI, Job-Deslandre C, Loy A, Minden K, Punaro M, Nunez AF, Sigal LH, Block AJ, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010 Jun;62(6):1792-802. doi: 10.1002/art.27431.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH; Paediatric Rheumatology INternational Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. doi: 10.1016/S0140-6736(08)60998-8. Epub 2008 Jul 14.

location_country:
Italy
Austria
Brazil
Peru
Switzerland
Mexico
Spain
Germany
France
Portugal
United States


type: Other Identifier

title: A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

summary: The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
South Africa
Serbia
United Kingdom
Netherlands
Spain
France
Bulgaria
Lithuania
Israel
Poland
Romania
Hungary
Russian Federation
Portugal
Estonia
United States
Latvia
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

summary: This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Mexico
Germany
France
Australia
Spain
Canada


title: A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES

summary:
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.

HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.

Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Roufosse F, de Lavareille A, Schandené L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.

family: Roufosse

full_name: Florence Roufosse

given: Florence

sequence: first

family: de Lavareille

full_name: Aurore de Lavareille

given: Aurore

sequence: additional

family: Schandené

full_name: Liliane Schandené

given: Liliane

family: Cogan

full_name: Elie Cogan

given: Elie

family: Georgelas

full_name: Ann Georgelas

given: Ann

family: Wagner

full_name: Lori Wagner

given: Lori

family: Xi

full_name: Liqiang Xi

given: Liqiang

family: Raffeld

full_name: Mark Raffeld

given: Mark

family: Goldman

full_name: Michel Goldman

given: Michel

family: Gleich

full_name: Gerald J. Gleich

given: Gerald J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Allergy and Clinical Immunology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16. Erratum in: N Engl J Med. 2008 Jun 5;358(23): 2530.

family: Rothenberg

full_name: Marc E. Rothenberg

given: Marc E.

family: Klion

full_name: Amy D. Klion

given: Amy D.

full_name: Florence E. Roufosse

given: Florence E.

family: Kahn

full_name: Jean Emmanuel Kahn

given: Jean Emmanuel

family: Weller

full_name: Peter F. Weller

given: Peter F.

family: Simon

full_name: Hans-Uwe Simon

given: Hans-Uwe

family: Schwartz

full_name: Lawrence B. Schwartz

given: Lawrence B.

family: Rosenwasser

full_name: Lanny J. Rosenwasser

given: Lanny J.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

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

title: Treatment of Patients with the Hypereosinophilic Syndrome with Mepolizumab

location_country:
Italy
United States
Switzerland
Germany
France
Belgium
Australia
Canada


title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis

summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

ReferenceType: result

ReferenceCitation: Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.

family: Mikol

full_name: Daniel D Mikol

given: Daniel D

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Chang

full_name: Peter Chang

given: Peter

family: Coyle

full_name: Patricia K Coyle

given: Patricia K

family: Jeffery

full_name: Douglas R Jeffery

given: Douglas R

family: Schwid

full_name: Steven R Schwid

given: Steven R

family: Stubinski

full_name: Bettina Stubinski

given: Bettina

family: Uitdehaag

full_name: Bernard MJ Uitdehaag

given: Bernard MJ

journal_name: The Lancet Neurology

lead_sponsor: EMD Serono

location_country:
Italy
Austria
Brazil
Switzerland
Netherlands
Germany
France
Argentina
Russian Federation
Spain
United States
United Kingdom

location_facility: Thomas Jefferson University Physicians Dept of Neurology

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Dept of Neurosciences Oftamology and Genetics Univ of Genoa

location_facility: Dept of Neurological and Psychiatric Sciences University of Bari

location_facility: University of Minnesota Medical School, Dept of Neurology

location_facility: Dept Of Neurology and Neurosurgery, Russian State Med Univ

location_facility: Dept of Neurological Sciences University La Sapienza Rome

location_facility: Dept of Neurology Universitatsklinikum Munster

location_facility: Department of Neurology City Hospital #33

location_facility: Division of Clinical Neurology Medical School Universtity Hopsital

location_facility: SUNY At Stony Brook U Hospital - Department of Neurology

location_facility: State Instituion Central Clinical Milatary Hospital

location_facility: Dept of Neurology Medical Clinic of Russian MoH

location_facility: Neurology Health Care Service / Fletcher Allen Health Care

location_facility: Unidad de EM Neurologia Hospital Virgen Macarena

location_facility: Department Of Neurology Royal London Hospital

location_facility: Chair of Nuerological Diseases and Medical Genetics

location_facility: Dept of Neurology Johannes Gutenberg University

location_facility: Dept Neurologia Sanatorio Britanico de Rosario

location_facility: The MS Treatment Center at Griffin Hospital

location_facility: Scientific Research Center of Neurology Russian MOH

location_facility: Albany Medical College Dept of Neurology MC-70

location_facility: Div of Clinical Neurology B Floor Medical School Univ Hospital

location_facility: Dept of MS Institute for Human Brain of R.A.Sci

location_facility: SUNY Upstate Medical University Dept of Neurology

location_facility: Academisch Ziekenhuis Vrije Universiteit

location_facility: Servicio de Neurologia Departmento Enfermedades Desmielinizantes

location_facility: Neuroinmunologia Clinica Hospital Vall d'Hebron

location_facility: Servicio de Neurologia Hospital Bellvitge

location_facility: Dept of Neurology St Petersburg State Medical University

location_facility: Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo


title: A Multi-center, Open-Label Extension Study of the Safety and Efficacy of Recombinant Human a-Galactosidase A (r-haGAL) Replacement in Patients With Fabry Disease

summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globatriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.

ReferenceCitation: Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

family: Germain

full_name: Dominique P Germain

given: Dominique P

family: Charrow

full_name: Joel Charrow

given: Joel

family: Desnick

full_name: Robert J Desnick

given: Robert J

family: Guffon

full_name: Nathalie Guffon

given: Nathalie

family: Kempf

full_name: Judy Kempf

given: Judy

family: Lachmann

full_name: Robin H Lachmann

given: Robin H

family: Lemay

full_name: Roberta Lemay

given: Roberta

family: Linthorst

full_name: Gabor E Linthorst

given: Gabor E

family: Packman

full_name: Seymour Packman

given: Seymour

family: Scott

full_name: C Ronald Scott

given: C Ronald

family: Waldek

full_name: Stephen Waldek

given: Stephen

family: Warnock

full_name: David G Warnock

given: David G

family: Weinreb

full_name: Neal J Weinreb

given: Neal J

family: Wilcox

full_name: William R Wilcox

given: William R

journal_name: Journal of Medical Genetics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

repository_institution: University of California - eScholarship University of California

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Netherlands
France
Puerto Rico
United States
United Kingdom

location_facility: Northwest Oncology & Hematology Associates

location_facility: University of Washington School of Medicine

location_facility: Hematology/Oncology Associates of South Texas

location_facility: University of Rochester School of Medicine

location_facility: National Hospital for Neurology and Neurosurgery


title: Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

summary:
RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.

ReferenceCitation: Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, Delforge M, Thyss A, Selleslag D, Indrak K, Ossenkoppele G, de Witte T. Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group. Haematologica. 2012 Apr;97(4):529-33. doi: 10.3324/haematol.2011.044347. Epub 2011 Nov 18.

family: Baron

full_name: F. Baron

given: F.

family: Suciu

full_name: S. Suciu

given: S.

family: Amadori

full_name: S. Amadori

family: Muus

full_name: P. Muus

given: P.

family: Zwierzina

full_name: H. Zwierzina

given: H.

family: Denzlinger

full_name: C. Denzlinger

given: C.

family: Delforge

full_name: M. Delforge

given: M.

family: Thyss

full_name: A. Thyss

given: A.

family: Selleslag

full_name: D. Selleslag

given: D.

family: Indrak

full_name: K. Indrak

given: K.

family: Ossenkoppele

full_name: G. Ossenkoppele

given: G.

family: de Witte

full_name: T. de Witte

given: T.

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

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

repository_institution: Radboud University - Radboud Repository

publisher: Ferrata Storti Foundation (Haematologica)

title: Value of infliximab (Remicade(R)) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group

ReferenceCitation: Baila L, Suciu S, Muus P, et al.: Assessment of two doses of infliximab in patients with low/intermediate risk IPSS myelodysplastic syndrome (MDS): an EORTC leukemia group (LG) randomized phase II trial (06023). [Abstract] Blood 110 (11): A-1456, 2007.

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

location_country:
Italy
Netherlands
France
Belgium
Germany
Czech Republic

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Institute of Hematology and Blood Transfusion

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

intervention_type: Biological


title: A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma

summary: To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

lead_sponsor: Pfizer

location_country:
United States
Switzerland
France
Belgium
Spain
Germany
United Kingdom

location_facility: University of Alabama at Birmingham Kirklin Clinic

location_facility: Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitaet Muenchen Klinikum Grosshadern

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet


title: A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy

summary: The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.

location_country:
Italy
Austria
United States
South Africa
India
Germany
Croatia
France
Australia
Russian Federation
Spain
Canada
Czech Republic


title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

summary: The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

location_country:
Italy
Brazil
United States
Sweden
Germany
France
Greece
Norway
Ireland
Australia
Spain
Canada
United Kingdom


title: A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

summary: The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

location_country:
Italy
Brazil
United States
Mexico
Netherlands
Germany
France
Norway
Australia
Spain
Canada
United Kingdom


lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
France
Ireland
Spain
United States
United Kingdom
Ukraine

acronym: DIONE

type: EudraCT Number

source: euctr

title: A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years

summary: The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to <18 years and weighing at least 40 kg.


status: Terminated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Sweden
Netherlands
France
United States

location_facility: Seattle Children's Hospital CPKC412A2114

title: A Phase I/II, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia

summary: This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

status_simplified: Unknown


title: A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

summary: The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.

family: Milani

full_name: Alfredo L. Milani

given: Alfredo L.

family: Hinoul

full_name: Piet Hinoul

given: Piet

family: Gauld

full_name: Judi M. Gauld

given: Judi M.

family: Sikirica

full_name: Vanja Sikirica

given: Vanja

family: van Drie

full_name: Douglas van Drie

given: Douglas

family: Cosson

full_name: Michel Cosson

given: Michel

journal_name: American Journal of Obstetrics and Gynecology

lead_sponsor: Ethicon, Inc.

location_country: Germany Belgium France Netherlands

location_facility:
CHRU de Lille
St. Marien-Hospital
Kreiskrankenhaus
Martin Luther University
Reinier de Graaf Gasthuis
Universitatsklinik Tubingen
DRT Krankenhaus
Sint Lodewijkstraat 78

intervention_type: Device


status: Active, not recruiting

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

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

location_country: Italy Germany Finland France

ipd_sharing: Yes

study_completion_date_type: Anticipated

title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

summary: The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors

status_simplified: Ongoing


title: Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

summary: This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
South Africa
India
Hong Kong
Philippines
France
Poland
Greece
Thailand
Singapore
Russian Federation
Turkey
Indonesia
United States
United Kingdom
Canada
Taiwan

location_facility: Columbia Presbyterian Medical Center (Cpmc)


title: A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide

summary: The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

location_country:
United States
Germany
France
Belgium
Australia
Russian Federation
Spain
Canada


title: A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease

summary: The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

ReferenceType: background

ReferenceCitation: Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37.

ReferenceCitation: Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. Review.

ReferenceCitation: Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11. Erratum in: Blood. 2009 Apr 30;113(18):4478.

name: Division of Clinical Research, Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle;

family: Flowers

full_name: Mary E. D. Flowers

given: Mary E. D.

name: Division of Investigative Science, Royal Hammersmith Hospital, Imperial College of London, London, United Kingdom;

family: Apperley

full_name: Jane F. Apperley

given: Jane F.

name: Section of Hematology/Oncology, University of Chicago Pritzker School of Medicine, IL;

family: van Besien

full_name: Koen van Besien

given: Koen

name: Klinik und Poliklinik fur Knochenmarktransplantation, Universitäts-Klinikum Essen, Essen, Germany;

family: Elmaagacli

full_name: Ahmet Elmaagacli

given: Ahmet

name: Clinical Haematology and Medical Oncology, Royal Melbourne Hospital, Parkville, Australia;

family: Grigg

full_name: Andrew Grigg

given: Andrew

name: Division of Hematology Oncology, University of Florida, Gainesville;

family: Reddy

full_name: Vijay Reddy

given: Vijay

family: Bacigalupo

full_name: Andrea Bacigalupo

given: Andrea

family: Kolb

full_name: Hans-Jochem Kolb

given: Hans-Jochem

name: National Cancer Institute (CEMO), Rio de Janeiro, Brazil;

family: Bouzas

full_name: Luis Bouzas

given: Luis

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

name: Peter MacCallum Cancer Centre, Melbourne, Australia;

family: Prince

full_name: H. Miles Prince

given: H. Miles

name: Department of Dermatology, Medical University of Vienna, Vienna, Austria;

family: Knobler

full_name: Robert Knobler

given: Robert

family: Parenti

full_name: Dennis Parenti

given: Dennis

family: Gallo

full_name: Jose Gallo

given: Jose

name: Department of Internal Medicine I, Bone Marrow Transplant Unit, Medical University of Vienna, Vienna, Austria

family: Greinix

full_name: Hildegard T. Greinix

given: Hildegard T.

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Mallinckrodt

location_country:
Italy
Austria
Switzerland
Spain
Germany
France
Slovakia
Australia
Portugal
Turkey
United States
United Kingdom

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Rush Presbyterian - St. Lukes Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Klinika hematologie a transfuziologie FN

location_facility: Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona

intervention_type: Procedure


title: Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

location_country:
Italy
Austria
Netherlands
Spain
France
Belgium
Portugal
United Kingdom

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Centro di Riferimento Oncologico - Aviano


title: A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

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

PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

ReferenceCitation: Shustik C, Turner AR, Desjardins P, Fernandez L, Rubin S, Larratt L, Duncan AM, Rizi D, Sadura A, Shepherd L, Li D, Rassenti L, Kipps T. Oral fludarabine in untreated patients with B-cell chronic lymphocytic leukemia. Leukemia. 2010 Jan;24(1):237-9. doi: 10.1038/leu.2009.205. Epub 2009 Oct 8.

family: Shustik

full_name: C Shustik

given: C

family: Turner

full_name: A R Turner

given: A R

family: Desjardins

full_name: P Desjardins

given: P

family: Fernandez

full_name: L Fernandez

given: L

family: Rubin

full_name: S Rubin

given: S

family: Larratt

full_name: L Larratt

family: Duncan

full_name: A M V Duncan

given: A M V

family: Rizi

full_name: D Rizi

given: D

family: Sadura

full_name: A Sadura

given: A

family: Shepherd

full_name: L Shepherd

family: Li

full_name: D Li

family: Rassenti

full_name: L Rassenti

family: Kipps

full_name: T Kipps

given: T

journal_name: Leukemia

evidence: open (via free pdf)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

location_country: Canada France

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Durham Regional Cancer Centre at Lakeridge Health Oshawa

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Northeastern Ontario Regional Cancer Centre, Sudbury

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Algoma Reginal Cancer Program at Sault Area Hospital

location_facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay


summary: The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.

location_country:
Brazil
United States
Switzerland
Germany
France
Poland
Thailand
Israel
Singapore
Australia
Puerto Rico
New Zealand
China
Canada
United Kingdom
Korea, Republic of
Taiwan


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis

summary: This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.

ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Seyger

full_name: Marieke M.B. Seyger

given: Marieke M.B.

family: Arikan

full_name: Dilek Arikan

given: Dilek

family: Kalabic

full_name: Jasmina Kalabic

given: Jasmina

family: Anderson

full_name: Jaclyn K. Anderson

given: Jaclyn K.

family: Lazar

full_name: Andreas Lazar

given: Andreas

family: Williams

full_name: David A. Williams

given: David A.

family: Wang

full_name: Chen Wang

given: Chen

family: Tarzynski-Potempa

full_name: Rita Tarzynski-Potempa

given: Rita

family: Hyams

full_name: Jeffrey S. Hyams

given: Jeffrey S.

journal_name: The Journal of Pediatrics

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

ReferenceCitation: Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008 Aug 21;359(8):810-20. doi: 10.1056/NEJMoa0706290.

family: Lovell

full_name: Daniel J. Lovell

given: Daniel J.

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Goodman

full_name: Steven Goodman

given: Steven

family: Reiff

full_name: Andreas Reiff

family: Jung

full_name: Lawrence Jung

given: Lawrence

family: Jarosova

full_name: Katerina Jarosova

given: Katerina

family: Nemcova

full_name: Dana Nemcova

given: Dana

family: Mouy

full_name: Richard Mouy

given: Richard

title: Adalimumab with or without Methotrexate in Juvenile Rheumatoid Arthritis

location_country:
Italy
United States
France
Slovakia
Belgium
Spain
Germany
Czech Republic

location_facility:
Site Reference ID/Investigator# 2538
Site Reference ID/Investigator# 631
Site Reference ID/Investigator# 644
Site Ref # / Investigator 45522
Site Reference ID/Investigator# 622
Site Reference ID/Investigator# 638
Site Reference ID/Investigator# 45545
Site Reference ID/Investigator# 386
Site Ref # / Investigator 45524
Site Ref # / Investigator 45542
Site Ref # / Investigator 45523
Site Ref # / Investigator 45525
Site Reference ID/Investigator# 625
Site Ref # / Investigator 45544
Site Reference ID/Investigator# 640
Site Reference ID/Investigator# 2235
Site Reference ID/Investigator# 406
Site Reference ID/Investigator# 3425
Site Ref # / Investigator 45543
Site Reference ID/Investigator# 518
Site Reference ID/Investigator# 627
Site Reference ID/Investigator# 628
Site Reference ID/Investigator# 636
Site Reference ID/Investigator# 621
Site Reference ID/Investigator# 645
Site Reference ID/Investigator# 2501
Site Reference ID/Investigator# 641
Site Reference ID/Investigator# 642
Site Reference ID/Investigator# 516
Site Reference ID/Investigator# 3713
Site Reference ID/Investigator# 519


title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

acronym: LEADERS

summary: The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Serruys

full_name: Patrick W Serruys

given: Patrick W

family: Wandel

full_name: Simon Wandel

given: Simon

family: Buszman

full_name: Pawel Buszman

given: Pawel

family: Trznadel

full_name: Stanislaw Trznadel

given: Stanislaw

family: Linke

full_name: Axel Linke

given: Axel

family: Lenk

full_name: Karsten Lenk

given: Karsten

family: Ischinger

full_name: Thomas Ischinger

given: Thomas

family: Klauss

full_name: Volker Klauss

given: Volker

family: Eberli

full_name: Franz Eberli

given: Franz

family: Corti

full_name: Roberto Corti

given: Roberto

family: Wijns

full_name: William Wijns

given: William

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: di Mario

full_name: Carlo di Mario

given: Carlo

family: Davies

full_name: Simon Davies

family: van Geuns

full_name: Robert-Jan van Geuns

given: Robert-Jan

family: Eerdmans

full_name: Pedro Eerdmans

given: Pedro

family: van Es

full_name: Gerrit-Anne van Es

given: Gerrit-Anne

family: Meier

full_name: Bernhard Meier

given: Bernhard

family: Jüni

full_name: Peter Jüni

given: Peter

journal_name: The Lancet

ReferenceCitation: Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9. doi: 10.4244/.

ReferenceCitation: Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Jüni P, Meier B, Windecker S, Serruys P. The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.

family: Sarno

title: The Impact of Body Mass Index on the One Year Outcomes of Patients Treated by Percutaneous Coronary Intervention With Biolimus- and Sirolimus-Eluting Stents (from the LEADERS Trial)

ReferenceCitation: Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70. doi: 10.1016/j.jcin.2009.05.024.

repository_institution: University of Florence - Florence Research

repositories_institution: University of Florence - Florence Research

title: Impact of Vessel Size on Angiographic and Clinical Outcomes of Revascularization With Biolimus-Eluting Stent With Biodegradable Polymer and Sirolimus-Eluting Stent With Durable Polymer

ReferenceCitation: Wykrzykowska JJ, Räber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Jüni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7.

ReferenceCitation: Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Räber L, Heg D, Jüni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

name: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London,...

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Jüni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.

name: Heartcenter; Academic Medical Center; Amsterdam The Netherlands

name: Thoraxcenter; Erasmus Medical Center; Rotterdam The Netherlands

name: East Lancashire Hospitals NHS Trust; Blackburn United Kingdom

name: Cardialysis BV; Rotterdam The Netherlands

name: Department of Cardiology; Triemli Spital, Zurich; Switzerland

name: University Hospital Zurich; Zurich Switzerland

name: Department of Cardiology; Onze Lieve Vrouw Ziekenhuis; Aalst Belgium

name: Institut Hospitalier Jacques-Cartier; Institut Cardiovasculaire Paris-Sud; Massy France

name: Royal Brompton Hospital; London United Kingdom

name: Department of Cardiology; University of Bern; Bern Switzerland

name: Department of Cardiology/University of Bern; CTU Bern and Institute of Social and Preventive Medicine; Bern Switzerland

name: Biosensors Europe SA; Morges Switzerland

name: International Centre for Circulatory Health, NHLI, Imperial College London; London the United Kingdom

journal_name: Catheterization and Cardiovascular Interventions

ReferenceCitation: Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

ReferenceCitation: Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Jüni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.

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

ReferenceCitation: Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Jüni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.

title: Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

ReferenceCitation: Gutiérrez-Chico JL, Räber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

title: Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: In vivo assessment with optical coherence tomography

ReferenceCitation: Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.

title: Impact of Sex on Clinical and Angiographic Outcomes Among Patients Undergoing Revascularization With Drug-Eluting Stents

ReferenceCitation: Gutiérrez-Chico JL, Jüni P, García-García HM, Regar E, Nüesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. doi: 10.1016/j.ahj.2011.09.005. Epub 2011 Oct 7.

title: Long-term tissue coverage of a biodegradable polylactide polymer–coated biolimus-eluting stent: Comparative sequential assessment with optical coherence tomography until complete resorption of the polymer

ReferenceCitation: Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. doi: 10.1016/S0140-6736(11)61672-3. Epub 2011 Nov 8.

ReferenceCitation: Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95. doi: 10.1016/j.jcin.2011.03.017.

title: 2-Year Clinical Follow-Up From the Randomized Comparison of Biolimus-Eluting Stents With Biodegradable Polymer and Sirolimus-Eluting Stents With Durable Polymer in Routine Clinical Practice

ReferenceCitation: Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.

name: From the Erasmus Medical Centre, Thoraxcentre, Rotterdam, Netherlands (J.L.G.-C., E.R., T.O., J.W., P.W.S.); Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland (E.N., P.J.); CTU Bern, Bern University Hospital, Bern, Switzerland (E.N., P.J.); Royal Brompton Hospital, London, UK (C.d.M.); Schweizerisches HerzzentrumûInselspital, Bern, Switzerland (S.W.); and Cardialysis BV, Rotterdam, Netherlands (G.v.E., P.G.).

title: Delayed Coverage in Malapposed and Side-Branch Struts With Respect to Well-Apposed Struts in Drug-Eluting Stents

ReferenceCitation: Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. doi: 10.1161/CIRCINTERVENTIONS.110.958389. Epub 2011 Jan 4.

name: From the Department of Interventional Cardiology (J.J.W., S.G., Y.O., R.J.v.G., P.W.S.), Thoraxcenter, Erasmus MC, and Cardialysis BV (T.v.D., D.G., M.-A.M., G.-A.v.E.), Rotterdam, Netherlands; Medical University of Silesia (P.B.), Katowice, Poland; Herzzentrum Leipzig (A.L.), Leipzig, Germany; Department of Cardiology (T.I.), Hospital Bogenhausen, and Department of Cardiology (V.K.), University Hospital Munich (Innenstadt), Munich, Germany; Department of Cardiology (R.C., F.E.), University Hospital...

title: Value of Age, Creatinine, and Ejection Fraction (ACEF Score) in Assessing Risk in Patients Undergoing Percutaneous Coronary Interventions in the ‘All-Comers' LEADERS Trial

ReferenceCitation: Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7. doi: 10.1016/j.jacc.2010.03.044.

journal_name: Journal of the American College of Cardiology

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Value of the SYNTAX Score for Risk Assessment in the All-Comers Population of the Randomized Multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) Trial

location_country:
Switzerland
Netherlands
Poland
France
Belgium
Germany
United Kingdom

location_facility: Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital

location_facility: Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39

location_facility: University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100

location_facility: Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164

location_facility: Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1

location_facility: Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77

location_facility: L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert

location_facility: University Medical Center Rotterdam Erasmus, Thoraxcentrum


title: Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

acronym: OSIRIS

summary:
Primary objectives :

To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.

Secondary objectives :

To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

lead_sponsor: Sanofi

location_country:
Italy
Sweden
Mexico
Netherlands
France
Poland
Greece
Lithuania
Hungary
Belgium
Ireland
Russian Federation
Spain
Turkey
Germany
United Kingdom
Korea, Republic of
Taiwan


title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

summary:
Primary objective:

Pathological complete response (ypT0N0) rate

Secondary objectives:

Histopathological R0 resection rate
Pathological downstaging (ypT0-T2N0) rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival

location_country:
Italy
Netherlands
France
Belgium
Spain
Germany
United Kingdom


title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment

acronym: CAESAR

summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

ReferenceCitation: Alcorn HG, Wolfson SK Jr, Sutton-Tyrrell K, Kuller LH, O'Leary D. Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):963-70.

ReferenceCitation: Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6.

ReferenceCitation: United Kingdom Small Aneurysm Trial Participants, Powell JT, Brady AR, Brown LC, Fowkes FG, Greenhalgh RM, Ruckley CV, Thompson SG. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1445-52.

ReferenceCitation: Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants. Lancet. 1998 Nov 21;352(9141):1649-55.

ReferenceCitation: Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1437-44.

ReferenceCitation: EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005 Jun 25-Jul 1;365(9478):2179-86.

ReferenceCitation: De Rango P, Verzini F, Parlani G, Cieri E, Romano L, Loschi D, Cao P; Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair (CAESAR) Investigators. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):324-31. doi: 10.1016/j.ejvs.2010.11.005. Epub 2010 Dec 9.

family: De Rango

full_name: P. De Rango

given: P.

family: Verzini

full_name: F. Verzini

given: F.

family: Parlani

full_name: G. Parlani

given: G.

family: Cieri

full_name: E. Cieri

given: E.

family: Romano

full_name: L. Romano

given: L.

family: Loschi

full_name: D. Loschi

given: D.

family: Cao

full_name: P. Cao

journal_name: European Journal of Vascular and Endovascular Surgery

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Quality of Life in Patients with Small Abdominal Aortic Aneurysm: The Effect of Early Endovascular Repair Versus Surveillance in the CAESAR Trial

ReferenceCitation: Cao P, De Rango P, Verzini F, Parlani G, Romano L, Cieri E; CAESAR Trial Group. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):13-25. doi: 10.1016/j.ejvs.2010.08.026. Epub 2010 Sep 25.

title: Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR): Results from a Randomised Trial

lead_sponsor: University Of Perugia

location_country:
Italy
United Kingdom
Netherlands
France
Poland
Israel
Spain
Germany
Czech Republic

location_facility: Institute of Cardiovascular Disease Hospital Clinic University of Barcelona

location_facility: S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova

location_facility: Naczyniowej i Transplantacyjnej Akademii Medycznej

location_facility: Klinik Fuer Gefasschirurgie st.Franziskus Hospital

location_facility: Chirurgia Vascolare Ospedale San Giovanni di Dio

location_facility: Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw

location_facility: Chirurgia Vascolare, Ospedale San Donato

location_facility: Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

location_facility: S.C. Chirurgia Vascolare - Università di Perugia

location_facility: Azienda Ospedaliera "Antonio Cardarelli"

location_facility: Policlinico Le Scotte - U.O. Chirurgia Vascolare

lead_sponsor_type: academique


title: Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

ReferenceCitation: Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marréaud S, Oliver RDT; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-1307. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.

family: Theodore

full_name: C. Theodore

given: C.

family: Skoneczna

full_name: I. Skoneczna

given: I.

family: Bodrogi

full_name: I. Bodrogi

family: Leahy

full_name: M. Leahy

given: M.

family: Kerst

full_name: J.M. Kerst

family: Collette

full_name: L. Collette

family: Ven

full_name: K. Ven

given: K.

family: Marréaud

full_name: S. Marréaud

given: S.

family: Oliver

full_name: R.D.T. Oliver

journal_name: Annals of Oncology

location_country:
Netherlands
Poland
France
Hungary
Belgium
United Kingdom

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital


title: Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

status: Unknown status

enrollment_type: Anticipated

location_country: Italy Netherlands Croatia France Belgium Portugal Turkey

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

ReferenceCitation: du Bois A, Herrstedt J, Hardy-Bessard AC, Müller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.

name: From the Dr Horst Schmidt Klinik (HSK), Wiesbaden; Coordinating Center for Clinical Trials, Philipps-Universität, Marburg; University Hospital Tuebingen, Tuebingen; University Hospital Ulm, Ulm; Klinikum Großhadern, München; University Hospital Schleswig-Holstein, Campus Kiel, Kiel; Evangelisches Krankenhaus, Duesseldorf; St Vincentius Kliniken, Karlsruhe; University Hospital Essen, Essen; Klinikum Offenbach, Offenbach; Charité, Campus Virchow-Klinikum, Berlin, Germany; Odense University Hospital, Odense...

family: du Bois

full_name: Andreas du Bois

given: Andreas

family: Herrstedt

full_name: Jørn Herrstedt

given: Jørn

family: Hardy-Bessard

full_name: Anne-Claire Hardy-Bessard

given: Anne-Claire

family: Müller

full_name: Hans-Helge Müller

given: Hans-Helge

family: Harter

full_name: Philipp Harter

given: Philipp

family: Kristensen

full_name: Gunnar Kristensen

given: Gunnar

family: Joly

full_name: Florence Joly

given: Florence

family: Huober

full_name: Jens Huober

given: Jens

family: Åvall-Lundqvist

full_name: Elisabeth Åvall-Lundqvist

given: Elisabeth

family: Weber

full_name: Béatrice Weber

given: Béatrice

family: Kurzeder

full_name: Christian Kurzeder

given: Christian

family: Jelic

full_name: Svetislav Jelic

given: Svetislav

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

family: Burges

full_name: Alexander Burges

given: Alexander

family: Pfisterer

full_name: Jacobus Pfisterer

given: Jacobus

family: Gropp

full_name: Martina Gropp

given: Martina

family: Staehle

full_name: Anne Staehle

given: Anne

family: Wimberger

full_name: Pauline Wimberger

given: Pauline

family: Jackisch

full_name: Christian Jackisch

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer

ReferenceCitation: Machelon V, Gaudin F, Camilleri-Broët S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prévot S, Broët P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.

family: Machelon

full_name: Véronique Machelon

given: Véronique

family: Gaudin

full_name: Françoise Gaudin

given: Françoise

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

location_facility: University Hospital Schleswig-Holstein - Kiel Campus


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

summary: The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

lead_sponsor: Gilead Sciences

location_country:
United States
France
Germany
United Kingdom
Canada

location_facility: Centre hospitalier de l'Universite de Montreal (CHUM)

location_facility: Univ of Texas Southwestern Med Ctr of Dallas

location_facility: San Francisco Gen Hosp / UCSF AIDS Program

location_facility: Univ of Utah Med School / Clinical Trials Ctr

location_facility: Indiana Univ Infectious Disease Research Clinic

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Rush Presbyterian - Saint Luke's Med Ctr

location_facility: Ctr for AIDS Research / Education and Service (CARES)


title: Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.

ReferenceCitation: Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.

family: Baumert

full_name: Brigitta G. Baumert

given: Brigitta G.

family: Brada

full_name: Michael Brada

given: Michael

family: Bernier

full_name: Jacques Bernier

given: Jacques

family: Kortmann

full_name: Rolf D. Kortmann

given: Rolf D.

family: Dehing-Oberije

full_name: Cary Dehing-Oberije

given: Cary

family: Collette

full_name: Laurence Collette

given: Laurence

family: Davis

full_name: J. Bernard Davis

given: J. Bernard

journal_name: Radiotherapy and Oncology

title: EORTC 22972–26991/MRC BR10 trial: Fractionated stereotactic boost following conventional radiotherapy of high grade gliomas

ReferenceCitation: Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3.

location_country:
Switzerland
Netherlands
France
Australia
Spain
Germany
United Kingdom

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

intervention_type: Radiation


title: Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.

ReferenceCitation: Harder H, Holtel H, Bromberg JE, Poortmans P, Haaxma-Reiche H, Kluin-Nelemans HC, Menten J, van den Bent MJ. Cognitive status and quality of life after treatment for primary CNS lymphoma. Neurology. 2004 Feb 24;62(4):544-7.

ReferenceCitation: Poortmans PM, Kluin-Nelemans HC, Haaxma-Reiche H, Van't Veer M, Hansen M, Soubeyran P, Taphoorn M, Thomas J, Van den Bent M, Fickers M, Van Imhoff G, Rozewicz C, Teodorovic I, van Glabbeke M; European Organization for Research and Treatment of Cancer Lymphoma Group. High-dose methotrexate-based chemotherapy followed by consolidating radiotherapy in non-AIDS-related primary central nervous system lymphoma: European Organization for Research and Treatment of Cancer Lymphoma Group Phase II Trial 20962. J Clin Oncol. 2003 Dec 15;21(24):4483-8. Epub 2003 Nov 3.

ReferenceCitation: Kluin-Nelemans JC, Poortmans P, Haaxma-Reicher H, et al.: Final results of the EORTC phase II trial 20962 evaluating high-dose MTX-based chemotherapy followed by consolidating radiotherapy in non-Aids related primary central nervous system lymphoma. [Abstract] Blood 100 (11 pt 1): A-3071, 776a, 2002.

location_country: Belgium France Netherlands

location_facility:
Dr. Bernard Verbeeten Instituut
Academisch Ziekenhuis Utrecht
U.Z. Gasthuisberg
Academisch Ziekenhuis Maastricht
Atrium Medical Centre
Rotterdam Cancer Institute
Institut Gustave Roussy


title: Clinical and Radiological Outcomes of Medacta Shoulder System

summary: This is a post-marketing surveillance on Medacta Shoulder System

status: Recruiting

lead_sponsor: Medacta International SA

location_country: Germany France Switzerland

location_facility: Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation

location_facility: Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,

location_facility: Clinique du Sport et de Chirurgie Orthopédique


title: A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System

summary: The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System.

lead_sponsor: Hologic, Inc.

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Centro de Patalogia de la Mama-Fundacion Tejerina

location_facility: Institut régional du Cancer de Montpellier


title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

acronym: LOCALIZE

summary: The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
United Kingdom
France
Spain

location_facility:
Universitäres Herzzentrum Hamburg
CHU de Bordeaux
Southampton General Hospital
Clinica Universitaria de Navarra
Stadtisches Klinikum Karlsruhe
Freeman Hospital


title: A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds

acronym: ASOLO-CW

summary: The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

lead_sponsor: Molnlycke Health Care AB

location_country: Italy France Ireland Belgium Portugal Germany

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin

location_facility: Unidade de Cuidados Continuados António Francisco Guimarães

location_facility: Trofa Saúde Hospital Central Hospital da Trofa

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista


title: Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.

acronym: COMBOMESA

summary:
The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation.

The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
Italy
Serbia
France
Greece
Israel
Korea, Republic of

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

location_facility: Institute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

location_facility: Zvezdara University Clinical Center, Gastroenterology Department


title: An Open-label Study to Evaluate the Efficacy and Safety of Revusiran in Patients With Transthyretin-mediated Familial Amyloidotic Polyneuropathy With Disease Progression Post-Orthotopic Liver Transplant

summary: The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation. Dosing has been discontinued; patients are being followed-up for safety.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Sweden
France
Spain
Germany
United Kingdom
Portugal

location_facility:
Clinical Trial Site
Clinical Trial SIte


title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

family: Warden

full_name: Bruce A. Warden

given: Bruce A.

family: Duell

full_name: Paul Barton Duell

given: Paul Barton

journal_name: Journal of Cardiovascular Pharmacology

evidence: open (via free article)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Inclisiran: A Novel Agent for Lowering Apolipoprotein B–containing Lipoproteins

location_country:
Switzerland
Lebanon
Netherlands
France
Greece
Turkey
United States
Slovenia
Canada

location_facility:
Metropolitan Hospital
Novartis Investigative Site
Excel Medical Clinical Trials LLC


title: Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)

acronym: METABREC

summary:
Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.

Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.

There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.

The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.

time_perspective: Retrospective

lead_sponsor: Universitaire Ziekenhuizen Leuven

location_country:
Sweden
Netherlands
France
Ireland
Belgium
United States

location_facility: Centre Hospitalier régional Universitaire de Lille


lead_sponsor: Glycostem Therapeutics BV

location_country: Switzerland Netherlands France Belgium Germany

location_facility: University Medical Center Hamburg-Eppendorf

title: A Phase I/IIa Trial to Evaluate the Safety and Efficacy of an Off-the-shelf ex Vivo Cultured Allogeneic NK Cell Preparation in Subjects With Acute Myeloid Leukemia in Complete Morphologic Remission With Measurable Residual Disease and no Strong Indication for Stem Cell Transplantation

summary: WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.


title: Myeloproliferative Neoplasms (MPN) and COVID-19

acronym: MPN-COVID

summary: An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

time_perspective: Other

ipd_sharing_description: Each participant can visualize its own data on eCRF after the completion patient's electronic data form.

lead_sponsor: Fondazione per la Ricerca Ospedale Maggiore

location_country:
Italy
United States
Croatia
France
Poland
Spain
Germany
United Kingdom

location_facility: FEA Hematología Hospital Universitario de Móstoles

location_facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

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

location_facility: ICO Girona Hospital Josep Trueta Servei d'hematologia

location_facility: ICO L'Hospitalet - Hospital Moisès Broggi

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

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria

location_facility: Institut Català d' Oncologia - Hospital Germans Trias i Pujol

location_facility: Servicio de Hematología Hospital General Universitario de Albacete

location_facility: Policlinico Universitario Fondazione Agostino Gemelli

location_facility: University hospital Dubrava-School of Medicine University of Zagreb

location_facility: University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità

location_facility: New York-Presbyterian/Weill Cornell Medical Center


type: Other Grant/Funding Number

title: Phenotypes, Biomarkers and Pathophysiology in Spastic Ataxias

acronym: SPAX-PBP

summary: The aim of this study is to determine the clinical spectrum and natural progression of Spastic Ataxias (SPAX) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

ipd_sharing: Undecided

lead_sponsor: Dr. Rebecca Schule

location_country:
Italy
Netherlands
France
Turkey
Germany
United Kingdom
Canada

location_facility: Département d'information médicale (DIM); Département de Biostatistique, Santn 3emé Publique et Information Médicale (BIOSPIM)- Bâtiment Mazarie étage; Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Radboud University Medical Center; Department of Neurology & Donders Institute for Brain, Cognition, and Behaviour

location_facility: Montreal Neurological Institute of McGill University, Department of Neurology and Neurosurgery and Human Genetics

location_facility: Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

location_facility: Department of Clinical Neurosciences, University of Cambridge; John Van Geest Cambridge Centre for Brain Repair

intervention_type: Other


title: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

acronym: MPN-DOACs

summary:
Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events).

While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known.

The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of:

cardioembolic stroke in patients with MPN with AF
recurrent thrombosis in patients with MPN with VTE
major bleeding in all patients with MPN.

The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Fondazione IRCCS Policlinico San Matteo S.C Ematologia

location_facility: Ospedale San Bortolo di Vicenza - U.O.C di Ematologia

location_facility: Divisione Ematologia, Ospedale Borgo Roma

location_facility: ASST MONZA Ospedale San Gerardo Clinica Ematologica

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

location_facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia


title: Prospective Epidemiological Study to Estimate the O-serotype Distribution of Extraintestinal Pathogenic Escherichia Coli (ExPEC) Isolated From Hospitalized Patients Aged 60 Years or Older With Invasive ExPEC Disease (IED) and to Evaluate the Clinical Case Definition and Risk Factors.

summary:
The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC). This information will be used to support the development of a new vaccine to prevent Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of serious infections. Especially adults older than 60 years have a higher risk of developing such infections. To date, there is no vaccine available to prevent E. coli infections. To support the development of a vaccine, more information about E. coli infections is first needed. This information will be collected in the current study, such as:

Medical information such as medical history, diagnosis, duration of hospitalization
Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC)
Laboratory information

lead_sponsor: UMC Utrecht

location_country:
Italy
United States
France
Japan
Spain
Germany
United Kingdom
Canada

location_facility: Andalusian Public Foundation for Health Research Management in Seville (FISEVI)


title: Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health

summary: The purpose of this study is to collect information from study participants who develop an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC) during a period of 12 months. This information will be used to support the development of a new vaccine to prevent ExPEC infections.

lead_sponsor: MJM Bonten

location_facility: - Andalusian Public Foundation for Health Research Management in Seville (FISEVI)


title: A Phase 1/2 Trial on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of DYN101 in Patients ≥ 16 Years of Age With Centronuclear Myopathies Caused by Mutations in DNM2 or MTM1.

acronym: Unite-CNM

summary:
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, PK and PD/preliminary efficacy of a new medicine called DYN101 in patients ≥ 16 years of age with CNM caused by mutations in DNM2 or MTM1.

The trial will consist of a consent, a screening period, a run-in period (if applicable), a Single dose treatment part (SAD) with 4 weeks of follow-up after the drug administration and a washout period of at least 12 weeks (followed by follow-up phone calls), a Multiple dose treatment part (MAD) of 12 weeks of weekly dosing, and a Multiple dose extension part of 12 weeks. All subjects will participate in the SAD, MAD, and MAD extension parts, unless they withdraw. During this time, multiple test will be performed in order to better understand how the drug is distributed and then later removed from the body and whether there any signs of an effect.

As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

lead_sponsor: Dynacure

location_country:
Netherlands
France
Belgium
Denmark
Germany
United Kingdom

location_facility: Rigshospitalet, Copenhagen Neuromuscular Center, Neurocentret

location_facility: Friedrich Baur Institut - Neurologische Klinik LMV, Klinikum Innenstadt

location_facility: MRC centre for Neuromuscular Disease, National Hospital for Neurology and Neurosurgery

location_facility: universitätsklinikum Essen, Kinderklinik I, Sozialpädiatrisches Zentrum


title: Post-Market Clinical Follow Up of Rotarex®S Catheter

summary: Post-Market Clinical Follow Up of the Rotarex®S Catheter

lead_sponsor: Straub Medical AG

location_country: Italy France Czechia Estonia Germany

location_facility: Kreiskrankenhaus Torgau "Johann Kentmann"

location_facility: Ospedale P. Pederzoli - Casa di Cura Privata Spa

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen