ReferenceCitation: French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15.

family: French

full_name: J. A. French

given: J. A.

family: Gil-Nagel

full_name: A. Gil-Nagel

given: A.

family: Malerba

full_name: S. Malerba

given: S.

family: Kramer

full_name: L. Kramer

family: Kumar

full_name: D. Kumar

given: D.

family: Bagiella

full_name: E. Bagiella

journal_name: Neurology

ReferenceCitation: Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

family: Rosenfeld

full_name: William Rosenfeld

given: William

family: Conry

full_name: Joan Conry

given: Joan

family: Lagae

full_name: Lieven Lagae

given: Lieven

family: Rozentals

full_name: Guntis Rozentals

given: Guntis

family: Yang

full_name: Haichen Yang

given: Haichen

family: Fain

full_name: Randi Fain

given: Randi

family: Williams

full_name: Betsy Williams

given: Betsy

full_name: Dinesh Kumar

given: Dinesh

family: Zhu

full_name: Jin Zhu

given: Jin

family: Laurenza

full_name: Antonio Laurenza

given: Antonio

journal_name: European Journal of Paediatric Neurology

ReferenceCitation: Steinhoff BJ, Ben-Menachem E, Ryvlin P, Shorvon S, Kramer L, Satlin A, Squillacote D, Yang H, Zhu J, Laurenza A. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013 Aug;54(8):1481-9. doi: 10.1111/epi.12212. Epub 2013 May 10.

name: UCL Institute of Neurology; London United Kingdom

name: Eisai Neuroscience Product Creation Unit; Woodcliff Lake New Jersey U.S.A

name: Eisai Global Medical Affairs; Woodcliff Lake New Jersey U.S.A

title: Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: A pooled analysis of three phase III studies

ReferenceCitation: French JA, Krauss GL, Steinhoff BJ, Squillacote D, Yang H, Kumar D, Laurenza A. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia. 2013 Jan;54(1):117-25. doi: 10.1111/j.1528-1167.2012.03638.x. Epub 2012 Aug 20.

title: Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305

location_country:
Italy
Austria
South Africa
Sweden
India
Netherlands
Germany
Finland
France
Israel
Belgium
Russian Federation
United States
United Kingdom

location_facility: Neurological Research Center at Hattiesburg Clinic

location_facility: Dean Foundation for Health, Research and Education, Inc.

location_facility: Neurology Associates of Northern Colorado

location_facility: The Comprehensive Care Center for Children And Adults

location_facility: North Alabama Neuroscience Research Associates

location_facility: Saint Luke's Comprehensive Epilepsy Center

title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Novartis Pharmaceuticals

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
Austria
Brazil
Sweden
Germany
France
Poland
Israel
Norway
Singapore
Argentina
Belgium
Spain
United States
United Kingdom
Canada

location_facility: MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)

location_facility: Mount Sinai School of Medicine Study Coordinator

location_facility: Duke University Medical Center Dept. of Duke Cancer Center(2)

location_facility: University of Arizona / Arizona Cancer Center

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: Loma Linda University Dept. of Loma Linda CancerCent

location_facility: H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.

summary: The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

acronym: FINDER

summary: The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

lead_sponsor: Bayer

location_country:
Finland
France
Belgium
Spain
Denmark
Germany
United Kingdom


title: Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

summary: The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

name: Department of Renal Medicine; Royal Infirmary of Edinburgh; Edinburgh UK

family: Pugh

full_name: Dan Pugh

given: Dan

sequence: additional

name: Centre for Inflammation Research; Royal Infirmary of Edinburgh; Edinburgh UK

family: O'Sullivan

full_name: Eoin D O'Sullivan

given: Eoin D

family: Duthie

full_name: Fiona AI Duthie

given: Fiona AI

name: Department of Renal Medicine; Royal Free London NHS Foundation Trust; London UK

family: Masson

full_name: Philip Masson

given: Philip

name: Renal Department; Newcastle University/Freeman Hospital; Newcastle Upon Tyne UK

family: Kavanagh

full_name: David Kavanagh

given: David

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Gäckler A, Schönermarck U, Dobronravov V, La Manna G, Denker A, Liu P, Vinogradova M, Yoon SS, Praga M. Efficacy and safety of the long-acting C5 inhibitor ravulizumab in patients with atypical hemolytic uremic syndrome triggered by pregnancy: a subgroup analysis. BMC Nephrol. 2021 Jan 6;22(1):5. doi: 10.1186/s12882-020-02190-0. Erratum in: BMC Nephrol. 2021 Feb 2;22(1):49.

family: Gäckler

full_name: Anja Gäckler

given: Anja

sequence: first

family: Schönermarck

full_name: Ulf Schönermarck

given: Ulf

family: Dobronravov

full_name: Vladimir Dobronravov

given: Vladimir

family: La Manna

full_name: Gaetano La Manna

given: Gaetano

family: Denker

full_name: Andrew Denker

given: Andrew

family: Liu

full_name: Peng Liu

given: Peng

family: Vinogradova

full_name: Maria Vinogradova

given: Maria

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

family: Praga

full_name: Manuel Praga

given: Manuel

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

endpoint_id: fhisxppmrqpajgzqkvft

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

host_type: repository

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via page says license)

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

repositories:
PubMed Central
Research Square
cris.unibo.it

location_country:
Italy
Austria
United States
Germany
France
Japan
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan


ReferenceCitation: Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Keller B, Jack D, Vermersch P. Long-Term Disease Stability Assessed by the Expanded Disability Status Scale in Patients Treated with Cladribine Tablets 3.5 mg/kg for Relapsing Multiple Sclerosis: An Exploratory Post Hoc Analysis of the CLARITY and CLARITY Extension Studies. Adv Ther. 2021 Sep;38(9):4975-4985. doi: 10.1007/s12325-021-01865-w. Epub 2021 Aug 9.

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Rammohan

full_name: Kottil Rammohan

given: Kottil

family: Rieckmann

full_name: Peter Rieckmann

given: Peter

family: Dangond

full_name: Fernando Dangond

given: Fernando

family: Keller

full_name: Birgit Keller

given: Birgit

family: Jack

full_name: Dominic Jack

given: Dominic

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: De Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist T, Coyle PK, Dangond F, Keller B, Alexandri N, Galazka A. Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies. Mult Scler. 2021 May 10:13524585211010294. doi: 10.1177/13524585211010294. [Epub ahead of print]

name: Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy/Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy

family: De Stefano

full_name: Nicola De Stefano

given: Nicola

name: Department of Health Sciences, University of Genoa and Ospedale Policlinico San Martino IRCCS, Genoa, Italy

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

name: Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK

name: Department of Neurology, University of Miami School of Medicine, MS Research Center, Miami, FL, USA

name: Division of Clinical Neuroimmunology, Jefferson University, Comprehensive MS Center, Philadelphia, PA, USA

family: Leist

full_name: Thomas Leist

given: Thomas

name: Department of Neurology, Stony Brook University, Stony Brook, NY, USA

family: Coyle

full_name: Patricia K Coyle

given: Patricia K

name: EMD Serono Research & Development Institute, Inc., Billerica, MA, USA

family: Alexandri

full_name: Nektaria Alexandri

given: Nektaria

family: Galazka

full_name: Andrew Galazka

journal_name: Multiple Sclerosis Journal

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

ReferenceCitation: Comi G, Cook S, Rammohan K, Soelberg Sorensen P, Vermersch P, Adeniji AK, Dangond F, Giovannoni G. Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing-remitting multiple sclerosis: the CLARITY Extension study. Ther Adv Neurol Disord. 2018 Jan 23;11:1756285617753365. doi: 10.1177/1756285617753365. eCollection 2018.

name: Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan 20132, Italy

name: Rutgers, The State University of New Jersey, New Jersey Medical School, Newark, NJ, USA

name: Depatment of Neurology, University of Miami School of Medicine, Miami, FL, USA

name: Department of Neurology, University of Copenhagen, Copenhagen, Denmark

name: Queen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK

journal_name: Therapeutic Advances in Neurological Disorders

repository_institution: University of Copenhagen - Research at the University of Copenhagen

title: Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing–remitting multiple sclerosis: the CLARITY Extension study

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Ukraine
Morocco
Croatia
France
Lithuania
Poland
Canada
Turkey
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Lebanon
Czechia
Tunisia
Estonia
Latvia

acronym: Extension trial to Trial 25643: Oral Cladribine in MS

title: A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

summary: The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.


title: A Randomized, Open-Label, Multi-Center, International Phase 2 Study of TAS-114 in Combination With S-1 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary:
This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC.

The study will be conducted internationally in 2 regions: Asian [Japan] and Western [Europe and US]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.

ReferenceCitation: Yamamoto N, Hayashi H, Planchard D, Morán T, Gregorc V, Dowell J, Sakai H, Yoh K, Nishio M, Cortot AB, Benhadji KA, Soni N, Huang J, Makris L, Cedres S. A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer. Invest New Drugs. 2020 Oct;38(5):1588-1597. doi: 10.1007/s10637-020-00930-5. Epub 2020 Apr 3.

family: Yamamoto

full_name: Nobuyuki Yamamoto

given: Nobuyuki

family: Hayashi

full_name: Hidetoshi Hayashi

given: Hidetoshi

family: Planchard

full_name: David Planchard

given: David

family: Morán

full_name: Teresa Morán

given: Teresa

family: Gregorc

full_name: Vanesa Gregorc

given: Vanesa

family: Dowell

full_name: Jonathan Dowell

given: Jonathan

family: Sakai

full_name: Hiroshi Sakai

given: Hiroshi

family: Yoh

full_name: Kiyotaka Yoh

given: Kiyotaka

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: Cortot

full_name: Alexis B. Cortot

given: Alexis B.

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

family: Soni

full_name: Nital Soni

given: Nital

family: Huang

full_name: Jinhong Huang

given: Jinhong

family: Makris

full_name: Lukas Makris

given: Lukas

family: Cedres

full_name: Susana Cedres

given: Susana

journal_name: Investigational New Drugs

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo
ddd.uab.cat

location_country:
Italy
France
Japan
Poland
Spain
United States


ReferenceType: background

ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum in: Lancet. 2018 Nov 28;:.

lead_sponsor: ViiV Healthcare

location_country:
Italy
United States
South Africa
Mexico
Netherlands
Germany
Spain
France
Romania
Belgium
Argentina
Australia
Portugal
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Gemini I

title: A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults

summary: This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.

status_simplified: Ongoing


title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Nov 2;93:154-159. doi: 10.1016/j.seizure.2021.10.024. [Epub ahead of print]

family: Cross

full_name: J. Helen Cross

given: J. Helen

family: Galer

full_name: Bradley S. Galer

given: Bradley S.

family: Gil-Nagel

full_name: Antonio Gil-Nagel

given: Antonio

family: Devinsky

full_name: Orrin Devinsky

given: Orrin

family: Ceulemans

full_name: Berten Ceulemans

given: Berten

family: Lagae

full_name: Lieven Lagae

given: Lieven

family: Schoonjans

full_name: An-Sofie Schoonjans

given: An-Sofie

family: Donner

full_name: Elizabeth Donner

given: Elizabeth

family: Wirrell

full_name: Elaine Wirrell

given: Elaine

family: Kothare

full_name: Sanjeev Kothare

given: Sanjeev

family: Agarwal

full_name: Anupam Agarwal

given: Anupam

family: Lock

full_name: Michael Lock

given: Michael

family: Gammaitoni

full_name: Arnold R. Gammaitoni

given: Arnold R.

journal_name: Seizure

oa_host_type: publisher

evidence: open (via page says license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Schoen Klinik Vogtareuth Neuropaediatrie und Neurologische Rehabilitation, Epilepsiezentrum fuer Kinder und Jugendlische, Tagesklinik fuer Neuropaediatrie

location_facility: Hôpital Robert Debré Pôle: Pédiatrie Médicale Service: Neurologie Et Maladies Métaboliques

location_facility: Universitaetsklinikum Freiburg Zentrum fuer Kinder- und Jugendmedizin

location_facility: DRK Kliniken Berlin - Westend Epilepsiezentrum / Neuropaediatrie

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel Klinik fuer Neuropaediatrie

location_facility: National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: HOPITAL DEL LA TIMONE - HOPITAL HENRI GASTAUT Hôpital De La Timone Neurologie Pédiatrique Pneumologie Pédiatrique Et Médecine Infantile

location_facility: Kleinwachau Saechsisches Epilepsiezentrum Radeberg gemeinnuetzige GmbH

location_facility: CHRU Lille Antenne Pédiatrique Du CIC - Hôpital Jeanne De Flandre

location_facility: MultiCare Institute for Research & Innovation

location_facility: Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique Centre de référence épilepsies rares (CReER)

location_facility: Institute of Neurosciences Queen Elizabeth University Hospital

location_facility: Hospital Ruber Internacional Primera Planta Servicio de Neurologia

location_facility: University Hospitals Cleveland Medical Center

location_facility: Birmingham Children Hospital NHS Foundation Trust

location_facility: Miami Children's Hospital Brain Institute

location_facility: Ospedale Civile Maggiore di Borgo Trento - Ospedale della Donna e del Bambino

location_facility: Universitaetsklinik fuer Kinder- und Jugendmedizin Abteilung III

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: The Children's Hospital Westmead Dept. of Neurology and Neurosurgery

location_facility: Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia

location_facility: CHU De Bordeaux Service De Pédiatrie Médicale

location_facility: AOU Anna Meyer Clinica di Neurologia Pediatrica

location_facility: CHU Amiens-Picardie Service De Neurologie Pediatrique

location_facility: Institute of Neurology and Neurosurgery at St. Barnabus

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: Tokyo Women's Medical University Hospital

location_facility: Krankenhaus Mara Epilepsie-Zentrum Bethel

location_facility: Clinica Universitaria de Navarra Fase 4. Segunda planta, Consulta de Pediatria

location_facility: U.O. Neurologia Dipartimento di Neuroscienze Ospedale Pediatrico Bambino Gesù

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology


title: A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis

acronym: SEGMENT

summary: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

status: Terminated

ipd_sharing: Undecided

lead_sponsor: PPM Services S.A.

location_country:
Italy
France
Bulgaria
Poland
Slovakia
Hungary
United States
Latvia
Canada
Ukraine

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office

location_facility: Cabinet Médical de Gastroentérologie Dr. Ben Ali

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

location_facility: Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche

location_facility: Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille

location_facility: CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Center for Advanced Gastroenterology, PLLC

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC

location_facility: Pauls Stradins Clinical University Hospital SLLC

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif

location_facility: B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova

location_facility: CI Odesa Regional Clinical Hospital, Center of Gastroenterology

location_facility: Cabinet Médical de Gastroentérologie Dr. Bismuth

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU

location_facility: Cabinet Médical de Gastro-entérologie Dr.Lesage

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE

status_simplified: Unknown


title: A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis

summary: This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Brazil
United Arab Emirates
France
Greece
Turkey
Indonesia


title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

summary: The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Hájek R, Minařík J, Straub J, Pour L, Jungova A, Berdeja JG, Boccadoro M, Brozova L, Spencer A, van Rhee F, Vela-Ojeda J, Thompson MA, Abonour R, Chari A, Cook G, Costello CL, Davies FE, Hungria VT, Lee HC, Leleu X, Puig N, Rifkin RM, Terpos E, Usmani SZ, Weisel KC, Zonder JA, Bařinová M, Kuhn M, Šilar J, Čápková L, Galvez K, Lu J, Elliott J, Stull DM, Ren K, Maisnar V. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. Future Oncol. 2021 Jul;17(19):2499-2512. doi: 10.2217/fon-2020-1225. Epub 2021 Mar 26.

name: University Hospital Ostrava & Faculty of Medicine, University of Ostrava, Ostrava, 703 00, Czech Republic

family: Hájek

full_name: Roman Hájek

given: Roman

name: Palacky University & University Hospital Olomouc, Olomouc, 771 47, Czech Republic

family: Minařík

full_name: Jiří Minařík

given: Jiří

name: General Teaching Hospital, Prague, 128 08, Czech Republic

family: Straub

full_name: Jan Straub

given: Jan

name: University Hospital, Brno, 625 00, Czech Republic

family: Pour

full_name: Luděk Pour

given: Luděk

name: Faculty Hospital Pilsen, Pilsen, 301 00, Czech Republic

family: Jungova

full_name: Alexandra Jungova

given: Alexandra

family: Berdeja

full_name: Jesus G Berdeja

given: Jesus G

name: University of Torino, Torino, 10124, Italy

family: Boccadoro

full_name: Mario Boccadoro

given: Mario

name: Institute of Biostatistics & Analyses, Ltd, Brno, 602 00, Czech Republic

family: Brozova

full_name: Lucie Brozova

given: Lucie

name: Alfred Health-Monash University, Melbourne, 3004, Australia

family: Spencer

full_name: Andrew Spencer

given: Andrew

name: University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA

family: van Rhee

full_name: Frits van Rhee

given: Frits

name: UMAE Especialidades Centro Medico La Raza IMSS, Ciudad de México, 02990, Mexico

family: Vela-Ojeda

full_name: Jorge Vela-Ojeda

given: Jorge

name: Advocate Aurora Research Institute, Advocate Aurora Health, Milwaukee, WI 53227, USA

family: Thompson

full_name: Michael A Thompson

given: Michael A

name: Indiana University School of Medicine, Indianapolis, IN 46202, USA

family: Abonour

full_name: Rafat Abonour

given: Rafat

name: Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA

family: Chari

full_name: Ajai Chari

given: Ajai

name: Leeds Teaching Hospital, Leeds, LS1 3EX, UK

family: Cook

full_name: Gordon Cook

given: Gordon

name: Moores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA

family: Costello

full_name: Caitlin L Costello

given: Caitlin L

name: Perlmutter Cancer Center, NYU Langone, New York, NY 10016, USA

family: Davies

full_name: Faith E Davies

given: Faith E

name: Clinica São Germano & Santa Casa Medical School, São Paulo, 04537-081, Brazil

family: Hungria

full_name: Vania TM Hungria

given: Vania TM

name: M.D. Anderson Cancer Center, Houston, TX 77030, USA

family: Lee

full_name: Hans C Lee

given: Hans C

name: Pôle Régional de Cancérologie, CHU de Poitiers, Poitiers, 86000, France

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Department of Hematology, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC (CB16/12/00233), Salamanca, 37007, Spain

family: Puig

full_name: Noemi Puig

given: Noemi

name: Rocky Mountain Cancer Centers US Oncology Research, Denver, CO 80218, USA

family: Rifkin

full_name: Robert M Rifkin

given: Robert M

name: National & Kapodistrian University of Athens, School of Medicine, Athens, 115 27, Greece

family: Terpos

full_name: Evangelos Terpos

given: Evangelos

name: Levine Cancer Institute, Charlotte, NC 115 27, USA

family: Usmani

name: University Medical Center Hamburg-Eppendorf, Hamburg, 20251, Germany

name: Barbara Ann Karmanos Cancer Institute / Wayne State University School of Medicine, Detroit, MI 48201, USA

name: Hospital Pablo Tobón Uribe, Medellin, 11001, Colombia

name: Peking University People's Hospital, National Clinical Research Center for Hematologic Disease, Beijing, 100044, China

name: Millennium Pharmaceuticals, Inc., Cambridge, MA 02139, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

name: Charles University Hospital & Faculty of Medicine, Hradec Králové, 121 08, Czech Republic

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, Hungria V. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma. Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.

name: Department of Medicine, Division of Blood and Marrow Transplantation, Moores Cancer Center, University of California San Diego, La Jolla, CA 92093, USA

name: Myeloma Institute, University of Arkansas for Medical Sciences (UAMS), Little Rock, AR 72205, USA

name: Department of Haematology, Leeds Cancer Centre, St James's University Hospital, Leeds, UK

name: Hematology Department, La Raza Medical Center, IMSS, México City, México

name: The Central Nebraska Myeloma Support Group, Grand Island, NE 68801, USA

name: Department of Hematology Research, US Oncology Research/Rocky Mountain Cancer Centers, Denver, CO 80218, USA

name: Department of Hematology, Sarah Cannon Research Institute, Nashville, TN 37203, USA

name: Department of Hematology, Hospital Universitario de Salamanca, Salamanca, Spain

name: Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Charlotte, NC 28204, USA

name: Department of Hematology, University of Tuebingen, Tuebingen, Germany

name: Department of Oncology, Hematology & Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

name: Department of Oncology, Barbara Ann Karmanos Cancer Institute/Wayne State University School of Medicine, Detroit, MI 48201, USA

name: Department of Clinical Therapeutics, National & Kapodistrian University of Athens, School of Medicine, Athens, Greece

name: Department of Clinical Haematology, Alfred Health-Monash University, Melbourne, Australia

name: Pôle Régional de Cancérologie and CIC1402 INSERM, CHU de Poitiers, France

name: Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy

name: Aurora Cancer Care, Advocate Aurora Health, Milwaukee, WI 53215, USA

name: Global Outcomes Research, Millennium Pharmaceuticals, Inc., Cambridge, MA 02139, USA

name: Global Medical Affairs, Millenium Pharmaceuticals, Inc., Cambridge, MA 02139, USA

name: Department of Hematology, Clinica São Germano and Santa Casa Medical School, São Paulo, Brazil

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Italy
Brazil
Mexico
Spain
Germany
France
Greece
Israel
Belgium
China
Turkey
United States
United Kingdom
Taiwan
Colombia

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Yakima Valley Memorial Hospital North Star Lodge - USOR

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Northwest Cancer Specialists (Broadway) - USOR

location_facility: Johns Hopkins Medicine - Anadolu Saglik Merkezi

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Illinois Cancer Specialists (Niles) - USOR

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Unicamp Universidade Estadual de Campinas

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Maryland Oncology Hematology (Columbia) - USOR

location_facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

location_facility: Greenville Health System Cancer Institute

location_facility: Institut fur Versorgungsforschung in der Onkologie GbR

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Fundacion Oftalmologica de Santander Foscal

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Gefos - Gesellschaft fur onkologische Studien mbH

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Internistisch Hamatologische und Internistische Praxis

location_facility: First Affiliated Hospital of Soochow University

location_facility: CEHON - Centro de Hematologia e Oncologia da Bahia Ltda

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Hospital Das Clinicas Da Universidade Federal de Goias

location_facility: University of Arkansas For Medical Sciences

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University


ReferenceCitation: Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Théroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

family: Belzeaux

full_name: Raoul Belzeaux

given: Raoul

family: Gorgievski

full_name: Victor Gorgievski

given: Victor

family: Fiori

full_name: Laura M. Fiori

given: Laura M.

family: Lopez

full_name: Juan Pablo Lopez

given: Juan Pablo

family: Grenier

full_name: Julien Grenier

given: Julien

family: Lin

full_name: Rixing Lin

given: Rixing

family: Nagy

full_name: Corina Nagy

given: Corina

family: Ibrahim

full_name: El Chérif Ibrahim

given: El Chérif

family: Gascon

full_name: Eduardo Gascon

given: Eduardo

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Richard-Devantoy

full_name: Stéphane Richard-Devantoy

given: Stéphane

family: Berlim

full_name: Marcelo Berlim

given: Marcelo

family: Chachamovich

full_name: Eduardo Chachamovich

family: Théroux

full_name: Jean-François Théroux

given: Jean-François

family: Dumas

full_name: Sylvie Dumas

given: Sylvie

family: Giros

full_name: Bruno Giros

given: Bruno

family: Rotzinger

full_name: Susan Rotzinger

given: Susan

family: Soares

full_name: Claudio N. Soares

given: Claudio N.

family: Foster

full_name: Jane A. Foster

given: Jane A.

family: Mechawar

full_name: Naguib Mechawar

given: Naguib

family: Tall

full_name: Gregory G. Tall

given: Gregory G.

family: Tzavara

full_name: Eleni T. Tzavara

given: Eleni T.

family: Kennedy

full_name: Sidney H. Kennedy

given: Sidney H.

family: Turecki

full_name: Gustavo Turecki

given: Gustavo

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

ReferenceCitation: Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Müller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3). pii: 18m12556. doi: 10.4088/JCP.18m12556.

location_country:
Austria
Sweden
India
Serbia
Philippines
Finland
France
Malaysia
Lithuania
Norway
Australia
Belgium
Russian Federation
Canada
Czech Republic
Korea, Republic of
Ukraine

title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

summary: The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo


title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

lead_sponsor: Novartis

location_country: Italy Germany France Belgium Australia Spain Turkey Canada

location_facility:
Novartis Investigator site
Novartis Investigator Site
Novartis investigator site


type: Other Identifier

title: A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

family: Rimsky

full_name: Laurence Rimsky

given: Laurence

family: Van Eygen

full_name: Veerle Van Eygen

given: Veerle

family: Hoogstoel

full_name: Annemie Hoogstoel

given: Annemie

family: Stevens

full_name: Marita Stevens

given: Marita

family: Boven

full_name: Katia Boven

given: Katia

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Vingerhoets

full_name: Johan Vingerhoets

given: Johan

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: 96-week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

family: Nelson

full_name: M. Nelson

given: M.

family: Amaya

full_name: G. Amaya

given: G.

family: Clumeck

full_name: N. Clumeck

given: N.

family: Arns da Cunha

full_name: C. Arns da Cunha

given: C.

family: Jayaweera

full_name: D. Jayaweera

given: D.

family: Junod

full_name: P. Junod

given: P.

family: Li

full_name: T. Li

given: T.

family: Tebas

full_name: P. Tebas

full_name: M. Stevens

family: Buelens

full_name: A. Buelens

given: A.

family: Vanveggel

full_name: S. Vanveggel

given: S.

full_name: K. Boven

given: K.

name: on behalf of the ECHO and THRIVE Study Groups

journal_name: Journal of Antimicrobial Chemotherapy

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

ReferenceCitation: Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.

location_country:
Austria
Brazil
South Africa
Sweden
Mexico
Netherlands
Spain
France
Thailand
Romania
Argentina
Australia
Puerto Rico
Portugal
Russian Federation
Denmark
United States
United Kingdom
Canada
Taiwan


ReferenceCitation: Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0.

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

family: Mehta

full_name: Rashmi Mehta

given: Rashmi

family: Farrell

full_name: Colm Farrell

given: Colm

family: Hayes

full_name: Siobhán Hayes

given: Siobhán

family: Birk

full_name: Ruby Birk

given: Ruby

family: Okour

full_name: Malek Okour

given: Malek

family: Lipson

full_name: David A. Lipson

given: David A.

journal_name: Clinical Pharmacokinetics

repository_institution: PubMed Central - Europe PMC

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Mexico
France
Japan
Poland
Romania
Argentina
Australia
Russian Federation
Spain
Germany
Korea, Republic of

ipd_sharing: Yes

title: A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary: This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.


title: A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

summary: The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

ReferenceCitation: Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.

family: Elgadi

full_name: Mabrouk M. Elgadi

given: Mabrouk M.

family: Piliero

full_name: Peter J. Piliero

given: Peter J.

journal_name: Drugs in R&D

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Springer

publisher_group: Springer

title: Boosted Tipranavir versus Darunavir in Treatment-Experienced Patients

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Spain
Germany
France
Thailand
Greece
Belgium
Puerto Rico
Bahamas
Canada
Portugal

location_facility: 1182.71.6602 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3405 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3919 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1124 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3301A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3504 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1108 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6606 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3303A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1116 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3908 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1126 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1006 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3305A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4902 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1010 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3310A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3206 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1129 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3203 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6605 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3402 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3407 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6604 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3205 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6601 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1101 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3401 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1104 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1118 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1115 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3503 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3308A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1016 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3403 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3408 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3312A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6603 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4903 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3502 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3306A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1109 Boehringer Ingelheim Investigational Site


title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

summary: A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

design_allocation: Non-Randomized

lead_sponsor: Astellas Pharma Inc

location_country:
United States
Canada
France
Spain


ReferenceCitation: Deodhar AA, Mease PJ, Rahman P, Navarro-Compán V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.

family: Deodhar

full_name: Atul A. Deodhar

given: Atul A.

family: Mease

full_name: Philip J. Mease

given: Philip J.

family: Rahman

full_name: Proton Rahman

given: Proton

family: Navarro-Compán

full_name: Victoria Navarro-Compán

given: Victoria

family: Strand

full_name: Vibeke Strand

given: Vibeke

family: Hunter

full_name: Theresa Hunter

given: Theresa

family: Bolce

full_name: Rebecca Bolce

given: Rebecca

family: Leon

full_name: Luis Leon

given: Luis

family: Lauzon

full_name: Steve Lauzon

given: Steve

family: Marzo-Ortega

full_name: Helena Marzo-Ortega

given: Helena

journal_name: BMC Rheumatology

ReferenceCitation: Dougados M, Wei JC, Landewé R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4. Erratum in: Ann Rheum Dis. 2020 Jun;79(6):e75.

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Wei

full_name: James Cheng-Chung Wei

given: James Cheng-Chung

family: Landewé

full_name: Robert Landewé

given: Robert

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Maksymowych

full_name: Walter P Maksymowych

given: Walter P

family: Ermann

full_name: Joerg Ermann

given: Joerg

family: Walsh

full_name: Jessica A Walsh

given: Jessica A

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.

ReferenceCitation: Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Järvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.

name: Oregon Health & Science University Portland

name: Universitätsmedizin Berlin and German Rheumatism Research Centre Berlin Germany

name: Universidad Autónoma de Chihuahua Chihuahua Deodhar Mexico

name: Azienda USL‐IRCCS di Reggio Emilia and Universita’ di Modena e Reggio Emilia Reggio Emilia Italy

name: Memorial University St. John’s Newfoundland Canada

name: Kiljava Medical Research Hyvinkää Finland

name: Norfolk and Norwich Hospital NHS Foundation Trust and University of East Anglia Norwich UK

name: Seoul National University College of Medicine Seoul Republic of Korea

name: Eli Lilly and Company Indianapolis Indiana

name: University of Texas‐McGovern Medical School Houston

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: University of East Anglia - UEA Digital Repository

title: Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen‐Week Results From a Phase III Randomized, Double‐Blind, Placebo‐Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Italy
Brazil
United States
Mexico
Netherlands
Germany
Finland
France
Japan
Poland
Israel
Argentina
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Center for Arthritis and Rheumatic Diseases, PC

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

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

location_facility: Univ of Texas Health Science Center - Houston

title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis

summary: The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).


title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

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

lead_sponsor: Pfizer

location_country:
United States
France
Japan
Spain
Germany
Canada

location_facility: Vero Beach Neurology and Research Institute

location_facility: Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute

location_facility: Duke University/Duke Neurology/Department of Neurology

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: Medical Corporation Abe Neurology Clinic

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Rhode Island Hospital/ Brown University Medical School

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Montreal Neurological Institute and Hospital

location_facility: Indiana University Health Neuroscience Center

location_facility: Hospital Universitario y Politecnico la Fe

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie


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
Brazil
Sweden
Switzerland
Netherlands
Spain
Germany
Finland
France
Czechia
Japan
Israel
Belgium
Argentina
Australia
Russian Federation
Denmark
United States
United Kingdom
Canada

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Johns Hopkins University IDS Pharmacy John Hopkins Hospital

location_facility: Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst.

location_facility: Washington University School of Medicine SC

location_facility: Texas Children s Hospital Baylor College of Medicine

title: Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

summary: The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.


title: A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

summary: The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

ipd_sharing: No

lead_sponsor: Shield Therapeutics

location_country:
United States
France
Hungary
Belgium
Spain
Germany


title: Sorin Universal REgistry on Aortic Valve Replacement

acronym: SURE-AVR

summary:
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

status: Recruiting

lead_sponsor: LivaNova

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Bulgaria
Czechia
Israel
Slovakia
Singapore
Australia
Belgium
Spain
United States
United Kingdom
Canada

location_facility: Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Baylor Scott and White Research Institute

location_facility: Foothill Medical Centre - Calgary, Alberta

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

location_facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

location_facility: Center of Cardiovascular Surgery and Transplantation Brno

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne


title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease

acronym: PERSIST-AVR

summary:
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available.

The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

ReferenceCitation: Lorusso R, Jiritano F, Roselli E, Shrestha M, Folliguet T, Meuris B, Pollari F, Fischlein T. Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial. Eur J Cardiothorac Surg. 2021 Jun 12. pii: ezab175. doi: 10.1093/ejcts/ezab175. [Epub ahead of print]

name: Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Maastricht, Netherlands

name: Cardiovascular Research Institute Maastricht (CARIM), Maastricht, Netherlands

family: Lorusso

full_name: Roberto Lorusso

given: Roberto

name: Cardiac Surgery Unit, Department of Experimental and Clinical Medicine, University “Magna Graecia” of Catanzaro, Catanzaro, Italy

family: Jiritano

full_name: Federica Jiritano

given: Federica

name: Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA

family: Roselli

full_name: Eric Roselli

given: Eric

name: Hannover Medical School, Hannover, Germany

family: Shrestha

full_name: Malakh Shrestha

given: Malakh

name: Department of Cardiac Surgery, Hôpital Henri Mondor, Université Paris 12, Créteil, Paris, France

family: Folliguet

full_name: Thierry Folliguet

given: Thierry

name: Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven, Leuven, Belgium

family: Meuris

full_name: Bart Meuris

given: Bart

name: Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany

family: Pollari

full_name: Francesco Pollari

given: Francesco

family: Fischlein

full_name: Theodor Fischlein

given: Theodor

journal_name: European Journal of Cardio-Thoracic Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_country:
Italy
Austria
Netherlands
Germany
France
Israel
Romania
Hungary
Australia
Belgium
Spain
Turkey
Canada
United Kingdom

location_facility: Complejo Hospitalario Universitario De A Coruña

location_facility: Hospital University Germans Trias I Pujol

location_facility: Ankara University Cebeci Education and Research Hospitals

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: lstituto Clinico Sant'Ambrogio e San Siro

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

location_facility: Gottsegen Hungarian Institute os Cardiology

location_facility: Hospital Clinico Universitario Virgen De La Arrixaca

intervention_type: Device


title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

summary:
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response.

The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

ReferenceCitation: Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.

family: Houssiau

full_name: Frederic A Houssiau

given: Frederic A

family: Thanou

full_name: Aikaterini Thanou

given: Aikaterini

family: Mazur

full_name: Minodora Mazur

given: Minodora

family: Ramiterre

full_name: Edgar Ramiterre

given: Edgar

family: Gomez Mora

full_name: Danny Alexis Gomez Mora

given: Danny Alexis

family: Misterska-Skora

full_name: Maria Misterska-Skora

given: Maria

family: Perich-Campos

full_name: Risto Alfredo Perich-Campos

given: Risto Alfredo

family: Smakotina

full_name: Svetlana A Smakotina

given: Svetlana A

family: Cerpa Cruz

full_name: Sergio Cerpa Cruz

given: Sergio

family: Louzir

full_name: Bassem Louzir

given: Bassem

family: Croughs

full_name: Thérèse Croughs

given: Thérèse

family: Tee

full_name: Michael Lucas Tee

given: Michael Lucas

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Neovacs

location_country:
Peru
Belgium
Russian Federation
Taiwan
Croatia
France
Poland
Thailand
Argentina
Moldova, Republic of
Korea, Republic of
Colombia
Chile
Switzerland
Philippines
Germany
United States
Italy
Mexico
Tunisia
Georgia

location_facility:
Research site
Research Site

intervention_type: Other


title: An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

summary: The primary purpose of the study is to evaluate objective response rate ([ORR]: complete response [CR] and partial response [PR]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.

ReferenceCitation: Wirth LJ, Brose MS, Sherman EJ, Licitra L, Schlumberger M, Sherman SI, Bible KC, Robinson B, Rodien P, Godbert Y, De La Fouchardiere C, Newbold K, Nutting C, Misir S, Xie R, Almonte A, Ye W, Cabanillas ME. Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. J Clin Oncol. 2021 Jul 20;39(21):2359-2366. doi: 10.1200/JCO.20.03093. Epub 2021 May 7.

name: Harvard Medical School, Massachusetts General Hospital, Boston, MA

family: Wirth

full_name: Lori J. Wirth

given: Lori J.

name: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

family: Brose

full_name: Marcia S. Brose

given: Marcia S.

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Sherman

full_name: Eric J. Sherman

given: Eric J.

name: Istituto Nazionale dei Tumori and University of Milan, Milan, Italy

family: Licitra

full_name: Lisa Licitra

given: Lisa

name: Institut Gustave-Roussy and University Paris Saclay, Villejuif, France

family: Schlumberger

full_name: Martin Schlumberger

given: Martin

name: The University of Texas MD Anderson Cancer Center, Houston, TX

full_name: Steven I. Sherman

given: Steven I.

family: Bible

full_name: Keith C. Bible

given: Keith C.

name: University of Sydney, Royal North Shore Hospital, St Leonards, NSW, Australia

family: Robinson

full_name: Bruce Robinson

given: Bruce

family: Rodien

full_name: Patrice Rodien

given: Patrice

family: Godbert

full_name: Yann Godbert

given: Yann

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

name: Royal Marsden Hospital, London, United Kingdom

family: Newbold

full_name: Kate Newbold

given: Kate

family: Nutting

full_name: Christopher Nutting

given: Christopher

name: Formerly of Eisai Inc, Woodcliff Lake, NJ

family: Misir

full_name: Soamnauth Misir

given: Soamnauth

family: Xie

full_name: Ran Xie

given: Ran

family: Almonte

full_name: Ana Almonte

given: Ana

family: Ye

full_name: Weifei Ye

given: Weifei

family: Cabanillas

full_name: Maria E. Cabanillas

given: Maria E.

journal_name: Journal of Clinical Oncology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher: American Society of Clinical Oncology (ASCO)

full_name: Maria E Cabanillas

title: Thyroid cancer

ipd_sharing_description: Eisai IPD sharing statement: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Italy
France
Australia
United States
United Kingdom


title: A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency

summary:
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.

The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.

ReferenceCitation: Sävendahl L, Battelino T, Brod M, Højby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4). pii: dgz310. doi: 10.1210/clinem/dgz310. Erratum in: J Clin Endocrinol Metab. 2020 Dec 1;105(12):.

name: Department of Women’s and Children’s Health, Karolinska Institute and Pediatric Endocrinology Unit, Karolinska University Hospital, Stockholm, Sweden

family: Sävendahl

full_name: Lars Sävendahl

given: Lars

name: UMC–University Children’s Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

family: Battelino

full_name: Tadej Battelino

given: Tadej

name: The Brod Group, Mill Valley, California, US

family: Brod

full_name: Meryl Brod

given: Meryl

name: Novo Nordisk, Global Development, Søborg, Denmark

family: Højby Rasmussen

full_name: Michael Højby Rasmussen

given: Michael

name: National Center for Child Health and Development, Tokyo, Japan

family: Horikawa

full_name: Reiko Horikawa

given: Reiko

family: Juul

full_name: Rasmus Vestergaard Juul

given: Rasmus Vestergaard

name: University Hospital, Mineola, New York, US

family: Saenger

full_name: Paul Saenger

given: Paul

family: Furthner

full_name: Dieter Furthner

given: Dieter

family: Piringer

full_name: Bettina Piringer

given: Bettina

family: Auer-Hackenberg

full_name: Lorenz Auer-Hackenberg

given: Lorenz

family: Schmitt

full_name: Klaus Schmitt

given: Klaus

family: Reitmayr

full_name: Marlene Reitmayr

given: Marlene

family: Bronstein

full_name: Marcello Delano Bronstein

given: Marcello Delano

family: Lima

full_name: Francisco Samuel Magalhães Lima

given: Francisco Samuel Magalhães

family: Wabitsch

full_name: Martin Wabitsch

family: Posovszky

full_name: Carsten Posovszky

given: Carsten

family: Böttcher

full_name: Volker Böttcher

given: Volker

family: Mann

full_name: Alexander Mann

given: Alexander

family: Hershkovitz

full_name: Eli Hershkovitz

given: Eli

family: Haim

full_name: Alon Haim

given: Alon

family: Lowenthal

full_name: Neta Lowenthal

given: Neta

family: Hamiel

full_name: Orit Hamiel

given: Orit

family: Levin

full_name: Sharon Sheinvald Levin

journal_name: The Journal of Clinical Endocrinology & Metabolism

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Austria
Brazil
Sweden
India
Germany
France
Japan
Israel
Belgium
Turkey
United States
Slovenia
Ukraine


title: A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors

summary:
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS[Progression Free Survival] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

ReferenceCitation: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

family: Fazio

full_name: Nicola Fazio

given: Nicola

family: Kulke

full_name: Matthew Kulke

given: Matthew

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Fernandez

full_name: Kathrine Fernandez

given: Kathrine

family: Raymond

full_name: Eric Raymond

given: Eric

journal_name: Targeted Oncology

ReferenceCitation: Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.

family: Lamarca

full_name: Angela Lamarca

given: Angela

family: Barriuso

full_name: Jorge Barriuso

given: Jorge

family: Borbath

full_name: Ivan Borbath

given: Ivan

family: Lenz

full_name: Heinz-Josef Lenz

given: Heinz-Josef

family: Raoul

full_name: Jean Luc Raoul

given: Jean Luc

family: Meropol

full_name: Neal J Meropol

given: Neal J

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Posey

full_name: James Posey

given: James

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

family: Valle

full_name: Juan W Valle

given: Juan W

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Hörsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial. Target Oncol. 2016 Dec;11(6):815-824.

ReferenceCitation: Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. doi: 10.1093/annonc/mdw561.

ReferenceCitation: Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825. Erratum in: N Engl J Med. 2011 Mar 17;364(11):1082.

title: Sunitinib Malate for the Treatment of Pancreatic Neuroendocrine Tumors

location_country:
Italy
United States
Germany
France
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan


title: The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

summary: To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

ReferenceType: result

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foà R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. Erratum in: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.

family: San-Miguel

full_name: Jesús F. San-Miguel

given: Jesús F.

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

family: Stadtmauer

full_name: Edward A. Stadtmauer

given: Edward A.

family: Rajkumar

full_name: S. Vincent Rajkumar

given: S. Vincent

family: Siegel

full_name: David Siegel

given: David

family: Bravo

full_name: Marie-Laure Bravo

given: Marie-Laure

family: Olesnyckyj

full_name: Marta Olesnyckyj

given: Marta

family: Knight

full_name: Robert D. Knight

given: Robert D.

family: Zeldis

full_name: Jerome B. Zeldis

given: Jerome B.

family: Harousseau

full_name: Jean-Luc Harousseau

given: Jean-Luc

family: Weber

full_name: Donna M. Weber

given: Donna M.

journal_name: Clinical Lymphoma Myeloma and Leukemia

title: Effects of Lenalidomide and Dexamethasone Treatment Duration on Survival in Patients With Relapsed or Refractory Multiple Myeloma Treated With Lenalidomide and Dexamethasone

ReferenceCitation: Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.

name: From the Division of Hematology, Blood/Marrow Transplant and Myeloma Program, University of Utah, Salt Lake City, UT; Celgene, Summit, NJ; The University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Athens School of Medicine, Athens, Greece; Cornell University, New York Presbyterian Hospital, New York, NY; and Laboratory Medicine, Nevada Cancer Institute, Las Vegas, NV.

family: Zangari

full_name: Maurizio Zangari

given: Maurizio

family: Tricot

full_name: Guido Tricot

given: Guido

family: Polavaram

full_name: Latha Polavaram

given: Latha

family: Zhan

full_name: Fenghuang Zhan

given: Fenghuang

family: Finlayson

full_name: Ashlie Finlayson

given: Ashlie

full_name: Robert Knight

given: Robert

family: Fu

full_name: Tommy Fu

given: Tommy

full_name: Donna Weber

given: Donna

family: Niesvizky

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Survival Effect of Venous Thromboembolism in Patients With Multiple Myeloma Treated With Lenalidomide and High-Dose Dexamethasone

ReferenceCitation: Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.

name: Department of Lymphoma and Myeloma, M. D. Anderson Cancer Center, Houston, TX;

name: Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece;

name: Department of Medicine, Princess Margaret Hospital, Toronto, ON;

name: Hematology Department, Institute of Hematology and Oncology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain;

name: Division of Hematology, Centre Hospitalier Université de Purpan, Toulouse, France;

name: Department of Malignant Hematology and Stem Cell Transplantation Service, The Alfred Hospital, Melbourne, Australia;

name: Mayo Clinic Cancer Center, Rochester, MN; and

location_country:
Italy
Austria
Sweden
Switzerland
France
Poland
Greece
Israel
Ireland
Australia
Belgium
Spain
Germany
United Kingdom
Ukraine

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Dnepropetrovsk City Clinical Hospital #4

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Kiev Bone Marrow Transplantation Center Bone Marrow Department

location_facility: Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

location_facility: Sahlgrenska University Hospital Department of Hematology and Coagulation

location_facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department

location_facility: Policlinico Universitario a Gesttione diretta di Udine

location_facility: University Hospital GalwayHaematology Department

location_facility: Haematology Dept, 4th Floor Thomas Guy House

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Institute of Haematology and Blood Transfusion

location_facility: Universitatsklinik Muenster Medizinische Klinik A

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Institute of Internal Diseases University of Medicine

location_facility: Hope Directorate Haematology Oncology Service St. James Hospital

location_facility: University Hospital of Salzburg St Johanns Spital

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Belfast City HospitalHaematology Department

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

ReferenceCitation: Bennett RM, Benson B, Choy EH, Hackshaw KV, Alvarez-Horine S, Wang, YG, Spaeth M. Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. [AAPM abstract 186]. Pain Med. 2010;11(2):317.

ReferenceCitation: Swick TJ, Spaeth M, Choy EH, Alvarez-Horine S, Wang YG, Benson B, Bennett R. Sodium Oxybate Reduces Pain and Improves Function and PGIC in Fibromyalgia: Results From an International, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial [AAN abstract P03.293]. Neurology. 2010;74(suppl 2):A280.

ReferenceCitation: Bennett RM, Rosenthal N, Lai C, Benson B, Wang YG, Alegre C, Perrot S.. Functionality and Quality of Life Are Improved in Fibromyalgia Patients Treated With Sodium Oxybate: Results From a Phase 3 International Trial. In: American Psychiatric Association New Research Abstracts to the 2010 Annual Meeting; May 22-26, 2010; New Orleans, LA. Abstract NR7-49.

ReferenceCitation: Swick TJ, Curtis C, Benson B, Lai C, Wang YG, Rothman J, Sarzi-Puttini P. Fibromyalgia Patients Have Impaired Sleep and Daytime Functioning at Baseline: Data From an International Phase 3 Trial of Sodium Oxybate [APSS abstract 0882]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Swick TJ, Lai C, Benson B, Wang YG, Sarzi-Puttini P. Fibromyalgia Pain, Fatigue, and Sleep Improve With Sodium Oxybate Treatment: A 14-Week Randomized, Double-Blind, Placebo-Controlled International Trial [APSS abstract 0883]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Choy E, Alegre C, Sarzi-Puttini P, van Seventer R, Wang YG, Guinta D, Lai C, Bennett R and the Oxybate in Fibromyalgia 06-009 Study Group. The Effects of Sodium Oxybate on Sleep Disturbance, Fatigue, and Functioning in Fibromyalgia: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Trial [FRI10411]. Ann Rheum Dis. 2010;69(suppl 3):449.

ReferenceCitation: Spaeth M, Perrot S, Samborski W, Bazzichi L, van de Laar M, Guinta D, Wang YG, Lai C, Bennett R and Sodium Oxybate in Fibromyalgia 06-009 Study Group. Sodium Oxybate Treatment Improves Pain, Function, and Patient Global Impression of Change (PGIC) in Fibromyalgia Patients: Results From an International, Randomized, Double-Blind, Placebo-Controlled Trial. Ann Rheum Dis. 2010;69(suppl 3):449

lead_sponsor: Jazz Pharmaceuticals

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

location_facility: University of Texas Health Science Center

location_facility: Barnsley District General Hospital, Rheumatology Department

location_facility: North Orange County Research Institute, Inc.

location_facility: Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU

location_facility: Ohio State U, Immunology/Rheumatology William Davis Medical Research Center

location_facility: Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny

location_facility: Center for Musculoskeletal Pain Research

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Florida Medical Clinic, P.A., Clinical Research Division

location_facility: Hopital Hotel Dieu service de medecine interne

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord

location_facility: Praxis fur Innere Medizin und Rheumatologie

location_facility: Arthritis and Osteoporosis Clinic, Research Center of Central Texas

location_facility: Royal National Hospital for Rheumatic Diseases NHS

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hopital Claude Huriez Service de medecine Interne

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Professional Clinical Research at Cyrstal Lake Health Center

location_facility: Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis

location_facility: Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara

location_facility: Oregon Health Sciences University School of Medicine

location_facility: Central Kentucky Research Associates,Inc.

location_facility: Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie

location_facility: Cleveland Neuro-Sleep Research Institute Inc.

location_facility: Professional Clinical Research at Crystal Lake Health Center

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Rheumazentrum am Krankenhaus Bad Doberan

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: North Shore University Hospital, North Shore Pain Services

location_facility: Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny