ReferenceCitation: Sullivan RJ, Weber J, Patel S, Dummer R, Carlino MS, Tan DSW, Lebbé C, Siena S, Elez E, Wollenberg L, Pickard MD, Sandor V, Ascierto PA. A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. Clin Cancer Res. 2020 Oct 1;26(19):5102-5112. doi: 10.1158/1078-0432.CCR-19-3550. Epub 2020 Jul 15.

family: Sullivan

full_name: Ryan J. Sullivan

given: Ryan J.

family: Weber

full_name: Jeffrey Weber

given: Jeffrey

family: Patel

full_name: Sapna Patel

given: Sapna

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Carlino

full_name: Matteo S. Carlino

given: Matteo S.

family: Tan

full_name: Daniel S.W. Tan

given: Daniel S.W.

family: Lebbé

full_name: Celeste Lebbé

given: Celeste

family: Siena

full_name: Salvatore Siena

given: Salvatore

family: Elez

full_name: Elena Elez

given: Elena

family: Wollenberg

full_name: Lance Wollenberg

given: Lance

family: Pickard

full_name: Michael D. Pickard

given: Michael D.

family: Sandor

full_name: Victor Sandor

given: Victor

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K-mutant Solid Tumors

status: Active, not recruiting

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

primary_purpose: Other

location_country:
Italy
United States
Switzerland
France
Singapore
Belgium
Australia
Spain
Canada

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: H. Lee Moffitt Cancer Center & Research Institute, Inc.

location_facility: Ophthalmic Consultants of Boston Inc (OCB)

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: Hospital Universitario HM Sanchinarro ? CIOCC

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

study_completion_date_type: Anticipated

title: A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors

summary: This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.


title: A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

summary:
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of ERCP procedures during 24 months.

Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Püspöek A, Tribl B, Dolak W, Devière J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.

family: Ramchandani

full_name: Mohan Ramchandani

given: Mohan

sequence: first

family: Lakhtakia

full_name: Sundeep Lakhtakia

given: Sundeep

sequence: additional

family: Costamagna

full_name: Guido Costamagna

given: Guido

family: Tringali

full_name: Andrea Tringali

given: Andrea

family: Püspöek

full_name: Andreas Püspöek

given: Andreas

family: Tribl

full_name: Barbara Tribl

given: Barbara

family: Dolak

full_name: Werner Dolak

given: Werner

family: Devière

full_name: Jacques Devière

given: Jacques

family: Arvanitakis

full_name: Marianna Arvanitakis

given: Marianna

family: van der Merwe

full_name: Schalk van der Merwe

given: Schalk

family: Laleman

full_name: Wim Laleman

given: Wim

family: Ponchon

full_name: Thierry Ponchon

given: Thierry

family: Lepilliez

full_name: Vincent Lepilliez

given: Vincent

family: Gabbrielli

full_name: Armando Gabbrielli

given: Armando

family: Bernardoni

full_name: Laura Bernardoni

given: Laura

family: Bruno

full_name: Marco J. Bruno

given: Marco J.

family: Poley

full_name: Jan-Werner Poley

given: Jan-Werner

family: Arnelo

full_name: Urban Arnelo

given: Urban

family: Lau

full_name: James Lau

given: James

family: Roy

full_name: André Roy

given: André

family: Bourke

full_name: Michael Bourke

given: Michael

family: Kaffes

full_name: Arthur Kaffes

given: Arthur

family: Neuhaus

full_name: Horst Neuhaus

given: Horst

location_country:
Italy
Austria
Sweden
India
Hong Kong
Netherlands
Germany
France
Australia
Belgium
Canada

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona


title: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

summary: The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Zimmer Biomet

location_country:
Italy
Germany
France
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Klinik fur Endoprothetik und gelenkchirurgie

location_facility: OrthoVirginia West End Orthopedic Clinic

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: An Observational Study of the Clinical Characteristics and Disease Progression of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype

summary: This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).

time_perspective: Retrospective

ReferenceCitation: Burton BK, Silliman N, Marulkar S. Progression of liver disease in children and adults with lysosomal acid lipase deficiency. Curr Med Res Opin. 2017 Jul;33(7):1211-1214. doi: 10.1080/03007995.2017.1309371. Epub 2017 Apr 3.

name: Northwestern University Feinberg School of Medicine and the Ann & Robert H. Lurie Children’s Hospital, Chicago, IL, USA;

family: Burton

full_name: Barbara K. Burton

given: Barbara K.

name: Alexion Pharmaceuticals Inc., New Haven, CT, USA

family: Silliman

full_name: Nancy Silliman

given: Nancy

family: Marulkar

full_name: Sachin Marulkar

given: Sachin

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Burton BK, Deegan PB, Enns GM, Guardamagna O, Horslen S, Hovingh GK, Lobritto SJ, Malinova V, McLin VA, Raiman J, Di Rocco M, Santra S, Sharma R, Sykut-Cegielska J, Whitley CB, Eckert S, Valayannopoulos V, Quinn AG. Clinical Features of Lysosomal Acid Lipase Deficiency. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):619-25. doi: 10.1097/MPG.0000000000000935.

family: Deegan

full_name: Patrick B. Deegan

given: Patrick B.

family: Enns

full_name: Gregory M. Enns

given: Gregory M.

family: Guardamagna

full_name: Ornella Guardamagna

given: Ornella

family: Horslen

full_name: Simon Horslen

given: Simon

family: Hovingh

full_name: Gerard K. Hovingh

given: Gerard K.

family: Lobritto

full_name: Steve J. Lobritto

given: Steve J.

family: Malinova

full_name: Vera Malinova

given: Vera

family: McLin

full_name: Valerie A. McLin

given: Valerie A.

family: Raiman

full_name: Julian Raiman

given: Julian

family: Di Rocco

full_name: Maja Di Rocco

given: Maja

family: Santra

full_name: Saikat Santra

given: Saikat

family: Sharma

full_name: Reena Sharma

given: Reena

family: Sykut-Cegielska

full_name: Jolanta Sykut-Cegielska

given: Jolanta

family: Whitley

full_name: Chester B. Whitley

given: Chester B.

family: Eckert

full_name: Stephen Eckert

given: Stephen

family: Valayannopoulos

full_name: Vassili Valayannopoulos

given: Vassili

family: Quinn

full_name: Anthony G. Quinn

given: Anthony G.

journal_name: Journal of Pediatric Gastroenterology & Nutrition

repository_institution: University of Geneva - Archive ouverte UNIGE

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Italy
Switzerland
United Kingdom
France
Poland
United States
Czech Republic
Canada

location_facility: Morgan Stanley Children's Hospital of New York-Presbyterian

location_facility: 1st Faculty of Medicine Charles University


type: EudraCT Number

title: A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS

summary: The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

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

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Yes

location_country:
Italy
South Africa
India
Spain
France
Czechia
Japan
Slovakia
Norway
Hungary
Belgium
Australia
Romania
China
United States

location_facility: Barwon Health - University Hospital Geelong

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: IEO Istituto Europeo di Oncologia, IRCCS

location_facility: Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika

location_facility: Cliniques Universitaires Saint-Luc, Gastroenterologie

location_facility: Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)

intervention_type: Drug

status_simplified: Completed


title: A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
United Kingdom
Mexico
Netherlands
Spain
France
Poland
Hungary
Australia
China
Denmark
Canada
Czech Republic

intervention_type: Other


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Long Lesion Sub-trial

acronym: PLATINUM LL

summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.

ReferenceCitation: Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

name: Scripps Clinic; Division of Cardiovascular Diseases; La Jolla California

family: Teirstein

full_name: Paul S. Teirstein

given: Paul S.

name: MonashHEART; Southern Health, Monash Medical Centre; Clayton Victoria Australia

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

name: Munroe Regional Medical Center; Ocala Florida

family: Feldman

full_name: Robert L. Feldman

given: Robert L.

name: TexSan Heart Hospital; San Antonio Texas

family: Rabinowitz

full_name: A. Charles Rabinowitz

given: A. Charles

name: The Cardiac & Vascular Research Center; McLaren Northern Michigan; Petoskey Michigan

family: Cannon

full_name: Louis A. Cannon

given: Louis A.

name: Bakersfield Memorial Hospital; Bakersfield California

family: Lee

full_name: Tommy C. Lee

given: Tommy C.

family: Dens

full_name: Joseph Dens

given: Joseph

name: Department of Cardiovascular Diseases; University Hospitals Leuven; Belgium

name: Department of Cardiovascular Sciences; University of Leuven; Belgium

family: Dubois

full_name: Christophe L. Dubois

given: Christophe L.

name: Minneapolis Heart Institute Foundation; Minneapolis Minnesota

family: Mooney

full_name: Michael R. Mooney

given: Michael R.

name: Ohio State University Medical Center; Columbus Ohio

family: Pompili

full_name: Vincent J. Pompili

given: Vincent J.

name: Shonan Kamakura General Hospital; Kanagawa Japan

family: Saito

full_name: Shigeru Saito

given: Shigeru

name: Boston Scientific Corporation; Marlborough Massachusetts

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

name: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation; New York New York

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: Catheterization and Cardiovascular Interventions

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing: Undecided

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

lead_sponsor: Boston Scientific Corporation

location_country:
France
Japan
Belgium
Australia
New Zealand
United States
Latvia

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: MediQuest Research Group Inc. at Munroe Regional Medical Center

location_facility: Ohio Health Research and Innovation Institute

location_facility: Providence Health & Services - Washington

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation


title: A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

summary: The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

ReferenceCitation: Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2021 Nov 6. doi: 10.1007/s40121-021-00557-w. [Epub ahead of print]

family: Wilcox

full_name: Mark Wilcox

given: Mark

family: Yan

full_name: Jean Li Yan

given: Jean Li

family: Gonzalez

full_name: Pedro L. Gonzalez

given: Pedro L.

family: Dryden

full_name: Matthew Dryden

given: Matthew

full_name: Gregory G. Stone

given: Gregory G.

family: Kantecki

full_name: Michal Kantecki

given: Michal

journal_name: Infectious Diseases and Therapy

oa_host_type: publisher

evidence: oa journal (via doaj)

ReferenceCitation: Sánchez-García M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.

family: Sánchez-García

full_name: Miguel Sánchez-García

given: Miguel

family: Hammond

full_name: Jennifer Hammond

given: Jennifer

family: Ansari

full_name: Wajeeha Ansari

given: Wajeeha

oa_colors: green gold

ReferenceCitation: Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.

family: Corey

full_name: G. Ralph Corey

given: G. Ralph

full_name: Mark H. Wilcox

given: Mark H.

journal_name: International Journal of Antimicrobial Agents

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

ReferenceCitation: Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

ReferenceCitation: Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.

name: AstraZeneca, Alderley Park, Macclesfield, Cheshire, UK

name: AstraZeneca, 35 Gatehouse Drive, Waltham, MA, USA

name: Pfizer, 235 E 42nd St, New York, NY, USA

name: Allergan Inc., 5 Giralda Farms, Madison, NJ, USA

title: Ceftaroline fosamil doses and breakpoints forStaphylococcus aureusin complicated skin and soft tissue infections

ReferenceCitation: Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. Epub 2016 Sep 1.

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Croatia
France
Poland
Argentina
Korea, Republic of
South Africa
Chile
Hong Kong
Philippines
Bulgaria
China
Germany
United States
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey


title: A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Cobitolimod as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients

acronym: COLLECT

summary: The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.

ReferenceCitation: Atreya R, Reinisch W, Peyrin-Biroulet L, Scaldaferri F, Admyre C, Knittel T, Kowalski J, Neurath MF, Hawkey C. Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. Dig Liver Dis. 2018 Oct;50(10):1019-1029. doi: 10.1016/j.dld.2018.06.010. Epub 2018 Jun 22.

family: Atreya

full_name: Raja Atreya

given: Raja

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Scaldaferri

full_name: Franco Scaldaferri

given: Franco

family: Admyre

full_name: Charlotte Admyre

given: Charlotte

family: Knittel

full_name: Thomas Knittel

given: Thomas

family: Kowalski

full_name: Jan Kowalski

given: Jan

family: Neurath

full_name: Markus Friedrich Neurath

given: Markus Friedrich

family: Hawkey

full_name: Christopher Hawkey

given: Christopher

journal_name: Digestive and Liver Disease

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: InDex Pharmaceuticals

location_country:
Italy
France
Czechia
Poland
Hungary
Germany
United Kingdom

location_facility:
Site 603
Site 407
Site 402
Site 606
Site 403
Site 101
Site 204
Site 406
Site 103
Site 205
Site 514
Site 604
Site 404
Site 607
Site 602
Site 509
Site 513
Site 207
Site 302
Site 304
Site 605
Site 502
Site 405
Site 102
Site 508
Site 702
Site 203
Site 501
Site 503
Site 510
Site 511
Site 202
Site 601
Site 104
Site 507
Site 409
Site 504


title: Imagerie moléculaire de l’activation microgliale dans l’infarctus cérébral: validation d’un nouveau radiopharmaceutique le [18F]-DPA-714.

source: euctr

lead_sponsor: CHRU de Tours

status: Ongoing

status_simplified: Ongoing


title: Etude prospective, randomisée, en ouvert évaluant le bénéfice clinique sur les hypoglycémies après 6 mois de l’addition de la vildagliptine versus celle d’un autre antidiabétique oral, chez des patients âgés diabétiques de type 2, insuffisamment contrôlés par la metformine en monothérapie.

acronym: GLYCEMIA

lead_sponsor: Novartis Pharma S.A.S


title: A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose

summary: The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

status: Terminated

ReferenceCitation: Gupta SK, McComsey GA, Lombaard J, Echevarría J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12.

family: Gupta

full_name: Samir K Gupta

given: Samir K

family: McComsey

full_name: Grace A McComsey

given: Grace A

family: Lombaard

full_name: John Lombaard

given: John

family: Echevarría

full_name: Juan Echevarría

given: Juan

family: Orrell

full_name: Catherine Orrell

given: Catherine

family: Avihingsanon

full_name: Anchalee Avihingsanon

given: Anchalee

family: Osiyemi

full_name: Olayemi Osiyemi

given: Olayemi

family: Santoscoy

full_name: Mario Santoscoy

given: Mario

family: Ray

full_name: Neelanjana Ray

given: Neelanjana

family: Stock

full_name: David A Stock

given: David A

family: Joshi

full_name: Samit R Joshi

given: Samit R

family: Hanna

full_name: George J Hanna

given: George J

family: Lataillade

full_name: Max Lataillade

given: Max

journal_name: The Lancet HIV

oa_host_type: repository

repository_institution: Indiana University - IUScholarWorks

version: submittedVersion

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Chile
Peru
South Africa
Mexico
France
Thailand
Hungary
Argentina
Australia
Spain
Canada
Colombia

location_facility: Clinic 42 And International Travel Clinic

location_facility: Tarrant County Infectious Disease Associates

location_facility: North Texas Infectious Disease Consultants


title: Interaction médicamenteuse entre la Colchicine et les inhibiteurs de calcineurine chez les patients transplantés rénaux

acronym: COLCHINCAL

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

lead_sponsor_type: academique


title: Traitement Ciblé et Précoce du Canal  Artériel du Prématuré par Ibuprofène (TRIOCAPI)

acronym:
TRIOCAPI

 TRIOCAPI

lead_sponsor: CHU Nantes


title: Etude du rizatriptan comme prémédication antalgique lors d’une pulpite irréversible.

lead_sponsor: CHU de Clermont-Ferrand


title: Douleur aiguë modérée en préhospitalier : Etude prospective randomisée en double aveugle comparant le mélange équimolaire oxygène protoxyde d’azote au placebo

lead_sponsor: CHU TOULOUSE


title: Validation de l’effet antiviral du Midodrine identifié par l’analyse de la signature transcriptomique cellulaire de l’infection par les virus influenza A

acronym: FLUMED

lead_sponsor: Hospices Civils de Lyon


title: Prévention par une héparine de bas poids moléculaire, l'enoxaparine, des complications maternelles et périnatale chez les patientes ayant un antécédent de prééclampsie sévère avant 34 semaines d'aménorrhée: Essai contrôlé randomisé multicentrique.

acronym: HEPEPE


title: Comparaison de l’effet antisécrétoire d’une dose unique de rabeprazole 20 mg et d’omeprazole 20 mg chez des sujets obèses

acronym: Oberab

lead_sponsor: CHU de Nantes


title: ETUDE CLINIQUE COMPARANT L’EFFICACITE DU PARACETAMOL PERMUQUEUX BUCCAL 125 MG VERSUS CELLE DU PARACETAMOL INJECTABLE 1 G, EN PERFUSION LENTE IV CHEZ DES PATIENTS SOUFFRANT DE DOULEUR AIGUË.

acronym: ParaJug


title: Traitement de la Progéria de Hutchinson-Gilford par l’association de pravastatine (Vasten®) et d’acide zolédronique (Zométa®)

lead_sponsor: Assistance Publique Hopitaux de marseille


title: OPTIMISATION DE L’EVALUATION DE LA FONCTION  SURRENALIENNE APRES ARRET D’UNE CORTICOTHERAPIE PROLONGEE

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: METAFORE : Maladie de Rendu-Osler :  Etude de l’Efficacité et de la tolérance du Bevacizumab utilisé pour le traitement des formes hépatiques sévères. Etude de phase II

acronym: METAFORE

lead_sponsor: HOSPICES CIVILS DE LYON


title: Impact du remplissage vasculaire sur l’œdème pulmonaire mesuré par la clairance alvéolaire chez des patients atteints de SDRA.

acronym: IROCA

lead_sponsor: CHU Clermont-Ferrand


title: Neoadjuvant phase II trial combining [3 FEC 100 followed by 3 docetaxel associated with trastuzumab plus pertuzumab] or [6 docetaxel, carboplatin associated with trastuzumab plus pertuzumab] according to TOP2A status in patients with T1c operable, HER2-positive breast cancer. Identification of pathological Complete Response (pCR) predictive factors.

lead_sponsor: UNICANCER


title: Héparinothérapie pour la circulation extracorporelle en chirurgie cardiaque chez les patients obèses : étude prospective évaluant une posologie basée sur le poids idéal au C.H.U. de Strasbourg

acronym:
HEPOIRINE

 HEPOIRINE

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title:
A PHASE II PROSPECTIVE IMMUNE NEOADJUVANT THERAPY STUDY OF DURVALUMAB (MEDI4736) IN EARLY STAGE NON-SMALL CELL LUNG CANCER

 Etude de phase II évaluant une immunothérapie néoadjuvante, le durvalumab, chez les patients présentant un Cancer du Poumon Non à Petites cellules de stade limité

lead_sponsor: IFCT


title:
PHASE I/II DE RADIOCHIMIOTHERAPIE DANS LES CANCERS DE L’ŒSOPHAGE DU SUJET AGE. OSAGE

 PHASE I/II DE RADIOCHIMIOTHERAPIE DANS LES CANCERS DE L’ŒSOPHAGE DU SUJET AGE. OSAGE

acronym:
OSAGE

 OSAGE

lead_sponsor: Centre Hospitalier Régional Universitaire de Besançon


title:
Lévétiracétam pour le traitement en première intention des convulsions du nouveau-né : étude de phase II

 Lévétiracétam pour le traitement en première intention des convulsions du nouveau-né : étude de phase II

lead_sponsor: CHRU TOURS


title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

summary: This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
United States
France
Poland
Slovakia
Australia
New Zealand
Canada


title: A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

acronym: POISE

summary: The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).

ReferenceType: background

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906.

ReferenceType: result

ReferenceCitation: Nevens F, Andreone P, Mazzella G, Strasser SI, Bowlus C, Invernizzi P, Drenth JP, Pockros PJ, Regula J, Beuers U, Trauner M, Jones DE, Floreani A, Hohenester S, Luketic V, Shiffman M, van Erpecum KJ, Vargas V, Vincent C, Hirschfield GM, Shah H, Hansen B, Lindor KD, Marschall HU, Kowdley KV, Hooshmand-Rad R, Marmon T, Sheeron S, Pencek R, MacConell L, Pruzanski M, Shapiro D; POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med. 2016 Aug 18;375(7):631-43. doi: 10.1056/NEJMoa1509840.

family: Nevens

full_name: Frederik Nevens

given: Frederik

family: Andreone

full_name: Pietro Andreone

given: Pietro

family: Mazzella

full_name: Giuseppe Mazzella

given: Giuseppe

family: Strasser

full_name: Simone I. Strasser

given: Simone I.

family: Bowlus

full_name: Christopher Bowlus

family: Invernizzi

full_name: Pietro Invernizzi

family: Drenth

full_name: Joost P.H. Drenth

given: Joost P.H.

family: Pockros

full_name: Paul J. Pockros

given: Paul J.

family: Regula

full_name: Jaroslaw Regula

given: Jaroslaw

family: Beuers

full_name: Ulrich Beuers

given: Ulrich

family: Trauner

full_name: Michael Trauner

given: Michael

family: Jones

full_name: David E. Jones

given: David E.

family: Floreani

full_name: Annarosa Floreani

given: Annarosa

family: Hohenester

full_name: Simon Hohenester

given: Simon

family: Luketic

full_name: Velimir Luketic

given: Velimir

family: Shiffman

full_name: Mitchell Shiffman

given: Mitchell

family: van Erpecum

full_name: Karel J. van Erpecum

given: Karel J.

family: Vargas

full_name: Victor Vargas

given: Victor

family: Vincent

full_name: Catherine Vincent

family: Hirschfield

full_name: Gideon M. Hirschfield

given: Gideon M.

family: Shah

full_name: Hemant Shah

given: Hemant

family: Hansen

full_name: Bettina Hansen

given: Bettina

family: Lindor

full_name: Keith D. Lindor

given: Keith D.

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

repository_institution: University of Birmingham - University of Birmingham Research Portal

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Trauner M, Nevens F, Shiffman ML, Drenth JPH, Bowlus CL, Vargas V, Andreone P, Hirschfield GM, Pencek R, Malecha ES, MacConell L, Shapiro D. Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):445-453. doi: 10.1016/S2468-1253(19)30094-9. Epub 2019 Mar 26.

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Harms MH, Hirschfield GM, Floreani A, Mayo MJ, Parés A, Liberman A, Malecha ES, Pencek R, MacConell L, Hansen BE. Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis. JHEP Rep. 2020 Sep 29;3(1):100191. doi: 10.1016/j.jhepr.2020.100191. eCollection 2021 Feb.

ReferenceCitation: Bowlus CL, Pockros PJ, Kremer AE, Parés A, Forman LM, Drenth JPH, Ryder SD, Terracciano L, Jin Y, Liberman A, Pencek R, Iloeje U, MacConell L, Bedossa P. Long-Term Obeticholic Acid Therapy Improves Histological Endpoints in Patients With Primary Biliary Cholangitis. Clin Gastroenterol Hepatol. 2020 May;18(5):1170-1178.e6. doi: 10.1016/j.cgh.2019.09.050. Epub 2019 Oct 10.

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29. Review.

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Poland
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Klinika Gastroenterologii i Hepatologii SP CSK im. prof. K. Gibinskiego SUM

location_facility: Dip. Medicina Clinica - Università di Bologna

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii

location_facility: Gastroenterologische Gemeinschaftspraxis, Dres. Felten / Hartmann / Hüppe

location_facility: Dip. Medicina Clinica- Università di Bologna

location_facility: Azienda Ospedaliera di Padova - Gastroenterologia

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "SONOMED"

location_facility: Virginia Commonwealth University/McGuire DVAMC

location_facility: Klinikum der Johann-Wolfgang Goethe Universität Frankfurt am Main

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Texas Southwestern Medical Center


title:
Impact of dexmedetomidine on preventive noninvasive ventilation in thoracic trauma

 Impact de la dexmedetomidine sur la ventilation non invasive préventive chez le traumatisé thoracique

acronym:
VENDETTA

 VENDETTA

lead_sponsor: University Hospital Grenoble


title:
Effet pharmacométabolomique des statines : Etude METASTATINE

 Effet pharmacométabolomique des statines : Etude METASTATINE

acronym:
METASTATINE

 METASTATINE

lead_sponsor: Societe Francaise de Cardiologie


title:
A prospective, multicenter, randomized, open-label study of 12 week duration to evaluate the effect of VILDagliptin added to insulin on glycaemic control in haemoDIALyzed patients with type 2 diabetes: probe analysis of CGM

 Etude prospective randomisée multicentrique d’évaluation de la VILDagliptine associée à l’insuline sur le contrôle glycémique chez les patients hémoDIALysés diabétiques de type 2 : étude VILDDIAL

acronym:
VILDDIAL

 VILDDIAL


title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.

summary: Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).

lead_sponsor: UCB BIOSCIENCES GmbH

location_country:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Thailand
Canada
Korea, Republic of
Sweden
Switzerland
Philippines
Bulgaria
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Spain
Latvia


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

summary: This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.

ReferenceCitation: Germain DP, Hughes DA, Nicholls K, Bichet DG, Giugliani R, Wilcox WR, Feliciani C, Shankar SP, Ezgu F, Amartino H, Bratkovic D, Feldt-Rasmussen U, Nedd K, Sharaf El Din U, Lourenco CM, Banikazemi M, Charrow J, Dasouki M, Finegold D, Giraldo P, Goker-Alpan O, Longo N, Scott CR, Torra R, Tuffaha A, Jovanovic A, Waldek S, Packman S, Ludington E, Viereck C, Kirk J, Yu J, Benjamin ER, Johnson F, Lockhart DJ, Skuban N, Castelli J, Barth J, Barlow C, Schiffmann R. Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat. N Engl J Med. 2016 Aug 11;375(6):545-55. doi: 10.1056/NEJMoa1510198.

family: Germain

full_name: Dominique P. Germain

given: Dominique P.

family: Hughes

full_name: Derralynn A. Hughes

given: Derralynn A.

family: Nicholls

full_name: Kathleen Nicholls

given: Kathleen

family: Bichet

full_name: Daniel G. Bichet

given: Daniel G.

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Wilcox

full_name: William R. Wilcox

given: William R.

family: Feliciani

full_name: Claudio Feliciani

given: Claudio

family: Shankar

full_name: Suma P. Shankar

given: Suma P.

family: Ezgu

full_name: Fatih Ezgu

given: Fatih

family: Amartino

full_name: Hernan Amartino

given: Hernan

family: Bratkovic

full_name: Drago Bratkovic

given: Drago

family: Feldt-Rasmussen

full_name: Ulla Feldt-Rasmussen

given: Ulla

family: Nedd

full_name: Khan Nedd

given: Khan

family: Sharaf El Din

full_name: Usama Sharaf El Din

given: Usama

family: Lourenco

full_name: Charles M. Lourenco

given: Charles M.

family: Banikazemi

full_name: Maryam Banikazemi

given: Maryam

family: Charrow

full_name: Joel Charrow

given: Joel

family: Dasouki

full_name: Majed Dasouki

given: Majed

family: Finegold

full_name: David Finegold

given: David

family: Giraldo

full_name: Pilar Giraldo

given: Pilar

family: Goker-Alpan

full_name: Ozlem Goker-Alpan

given: Ozlem

family: Longo

full_name: Nicola Longo

given: Nicola

family: Scott

full_name: C. Ronald Scott

given: C. Ronald

repositories_institution: University College London - UCL Discovery

title: Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat

location_country:
Italy
Brazil
Spain
France
Belgium
Argentina
Australia
Egypt
Turkey
Denmark
United States
United Kingdom
Canada


title: A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer

summary:
The human body has a natural stress response to surgery, including the formation of blood clots. This response to surgery has been shown to increase metastases (the spread of cancer cells to other organs in the body). These metastases cannot be seen at the time of surgery but when they grow into new tumors, the cancer has recurred (come back). A blood thinner called "low molecular weight heparin" (LMWH) can suppress the development of metastases after surgery in animal experiments. The investigators want to see if giving patients with colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance of their cancer spreading to other organs (metastases) and coming back (recurrence).

The investigators need 1075 patients to answer our scientific question. Patients who give informed consent will be randomly put into one of two groups, the experimental group and the control group. The patients in the control group will be treated with LMWH starting a few hours after surgery and every day until they leave the hospital. This is how most patients are treated after colon cancer surgery (standard care). The patients in the experimental group will be treated with LMWH for a longer period of time, starting on the day they agree to have surgery and continuing for two months after surgery. All the patients will be followed for at least three years after surgery to find out if their cancer has recurred (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in patients with colorectal cancer, it would improve the health and quality of life for these patients.

primary_purpose: Prevention

lead_sponsor: Ottawa Hospital Research Institute

location_country: Canada Belgium France

location_facility:
CHRU Brest
Humber River Hospital
Kingston General Hospital
Queensway Carleton Hospital
Hamilton Health Sciences Corporation
Montfort Hospital
Mount Sinai Hospital
St. Joseph's Health Centre
Sunnybrook Health Science Centre
Sault Area Hospital
Health Sciences North
Jewish General Hospital
London Health Research Institute
Ghent University Hospital
North York General Hospital
The Ottawa Hospital


title:
Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis

 Etude de l’intérêt d’un traitement précoce par un inhibiteur de l’endothéline  (Bosentan) chez des patients présentant une cécité brutale secondaire à une artérite à cellules géantes

acronym:
CECIBO

 CECIBO

lead_sponsor: CHU de Nice


title:
Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients

 Optimisation de la préparation cutanée pour réduire la colonisation à Cutibacterium acnes dans des prélèvements superficiels et profonds lors de la chirurgie prothétique de l'épaule chez l'homme

acronym: OPRICA


title:
/

 Kétamine et douleur neuropathique

acronym:
/

 KETAPAIN

lead_sponsor: CHU CLERMONT-FERRAND


title: A Multicenter Prospective Cohort Management Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound

acronym: SSPE

summary:
Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological test called computed tomography (CT scan). As technology advances, the CT scans are able to detect smaller and smaller blood clots. Over time, the frequency of blood clots in the pulmonary arteries has increased significantly (CT scan are now detecting very small blood clots that the investigators could not see before). As a result, more and more people are on blood thinners to treat these small blood clots but their true clinical significance is unknown.

The management of blood thinners is costly and also utilizes scarce healthcare resources. These blood thinners need to be monitored with frequent blood work. Furthermore, every year, approximately 3 percent of patients on blood thinners will have a major bleeding event requiring medical attention.

The investigators don't think that treating these small blood clots in the pulmonary arteries detected on CT scan is worth the risk of bleeding from the blood thinners.

The main goal of this study is to find out if it is safe to not treat very small blood clots in the pulmonary arteries.

The investigators plan to follow 300 patients with small blood clots in their lungs for 90 days. These patients will not be treated with blood thinners but will be followed closely with other non-invasive tests to avoid progression or recurrence of blood clots.

ReferenceCitation: Le Gal G, Kovacs MJ, Bertoletti L, Couturaud F, Dennie C, Hirsch AM, Huisman MV, Klok FA, Kraaijpoel N, Mallick R, Pecarskie A, Pena E, Phillips P, Pichon I, Ramsay T, Righini M, Rodger MA, Roy PM, Sanchez O, Schmidt J, Schulman S, Shivakumar S, Trinh-Duc A, Verdet R, Vinsonneau U, Wells P, Wu C, Yeo E, Carrier M; SSPE Investigators*. Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation : A Multicenter Prospective Cohort Study. Ann Intern Med. 2021 Nov 23. doi: 10.7326/M21-2981. [Epub ahead of print]

name: Centre d’Investigation Clinique, Centre Hospitalier Régional et Universitaire de Brest, Brest, France, and Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (G.L.)

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

name: Division of Hematology, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada (M.J.K.)

family: Kovacs

full_name: Michael J. Kovacs

given: Michael J.

name: Service de Médecine Vasculaire et Thérapeutique, Hôpital Nord, CHU de St-Etienne, INSERM, SAINBIOSE, U1059, Dysfonction Vasculaire et Hémostase et Université Jean-Monnet, CIC1408, F- 42055 Saint-Etienne, Réseau français F-CRIN INNOVTE, Saint-Etienne, France (L.B.)

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

name: Centre d’Investigation Clinique, Centre Hospitalier Régional et Universitaire de Brest, and Département de médecine interne, médecine vasculaire et pneumologie, Hôpital de la Cavale Blanche, EA3878-GETBO, Univ Brest, Réseau français F-CRIN INNOVTE, CHRU Brest, Brest, France (F.C.)

family: Couturaud

full_name: Francis Couturaud

given: Francis

name: Department of Radiology, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (C.D., E.P.)

family: Dennie

full_name: Carole Dennie

given: Carole

name: Department of Medicine, McGill University, Jewish General Hospital, Montreal, Quebec, Canada (A.M.H.)

family: Hirsch

full_name: Andrew M. Hirsch

given: Andrew M.

name: Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Dutch Thrombosis Network, Leiden, the Netherlands (M.V.H., F.A.K.)

family: Huisman

full_name: Menno V. Huisman

given: Menno V.

family: Klok

full_name: Frederikus A. Klok

given: Frederikus A.

name: Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands (N.K.)

family: Kraaijpoel

full_name: Noémie Kraaijpoel

given: Noémie

name: Ottawa Methods Center, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (R.M.)

family: Mallick

full_name: Ranjeeta Mallick

given: Ranjeeta

name: Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (A.P., P.P., P.W., M.C.)

family: Pecarskie

full_name: Amanda Pecarskie

given: Amanda

family: Pena

full_name: Elena Pena

given: Elena

family: Phillips

full_name: Penny Phillips

given: Penny

name: Service de Recherche Clinique, Hôpital d’Instruction des Armées, Brest, France (I.P.)

family: Pichon

full_name: Isabelle Pichon

given: Isabelle

name: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (T.R.)

family: Ramsay

full_name: Tim Ramsay

given: Tim

name: Division of Angiology and Hemostasis, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland (M.R.)

family: Righini

full_name: Marc Righini

given: Marc

name: Department of Medicine, McGill University, McGill University Health Center, Montreal, Quebec, Canada (M.A.R.)

family: Rodger

full_name: Marc A. Rodger

given: Marc A.

name: Univ Angers, MITOVASC, Equipe CarMe, Département de Médecine d’Urgence, Centre Hospitalier Universitaire d’Angers, Réseau français F-CRIN INNOVTE, Angers, France (P.R.)

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: Université de Paris, Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges Pompidou, AP-HP.Centre – Université de Paris, INSERM UMR S 1140 Innovative therapies in hemostasis, Réseau français F-CRIN INNOVTE, Paris, France (O.S.)

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Département de Médecine d’Urgence, Centre Hospitalier Universitaire Gabriel Montpied, Réseau français F-CRIN INNOVTE, Clermont-Ferrand, France (J.S.)

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

name: Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada, and Department of Obstetrics and Gynecology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia (S.S.)

family: Schulman

full_name: Sam Schulman

given: Sam

name: Department of Medicine, Dalhousie University, Nova Scotia Health, Halifax, Nova Scotia, Canada (S.S.)

family: Shivakumar

full_name: Sudeep Shivakumar

given: Sudeep

name: Centre Hospitalier d’Agen-Nérac, Agen, France (A.T.)

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

name: Direction de la Recherche et de l’Innovation, Centre Hospitalier Régional Universitaire de Brest, Brest, France (R.V.)

family: Verdet

name: Department of Cardiology, Clermont Tonnerre Hospital of Military Training, Brest, France (U.V.)

name: Department of Medicine, University of Alberta Hospital, Edmonton, Alberta, Canada (C.W.)

name: Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada (E.Y.).

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Sir Mortimer B. Davis Jewish General Hospital


title:
"STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19

 « ETUDE DE L’EFFICACITE DES IMMUNOGLOBULINES HUMAINES NORMALES (IGIV) CHEZ LES PATIENTS AGES DE 75 ANS ET PLUS COVID-19 PRESENTANT UNE INSUFFISANCE RESPIRATOIRE AIGUE SEVERE » GERONIMO 19

lead_sponsor: CH Versailles


title:
A  Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2

 Essai multicentrique, randomisé contre placebo, de l’utilisation du Nintedanib dans le traitement de la bronchiolite obliterante/dysfonction chronique du greffon chez les patients transplantés pulmonaires.

acronym: INFINITX BOS

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


title: Assessment of Endothelial VAsomotricity after treatment by Nicotinic Acid in Patients presenting a recent Acute Coronary Syndrome

acronym: EVAN ACS

lead_sponsor: French Society of Cardiology


title: Etude de la réduction des poussées de lupus érythémateux systémique par adaptation de la posologie de l'hydroxychloroquine à sa concentration sanguine. Etude randomisée multicentrique nationale.

acronym: PLUS


title: Etude de phase III randomisée comparant deux modes d’administration des facteurs de croissance (G-CSF) non pégylés dans la prévention secondaire des neutropénies sévères

acronym: G-CSF 3/7

lead_sponsor: CENTRE ANTOINE LACASSAGNE


title: L’administration d’ondansetron dans le cadre d’une prophylaxie des nausées et vomissements postopératoires réduirait-il l’effet analgésique du paracétamol ?

lead_sponsor: Centre Hospitalier Universitaire de Nancy


title: An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects with Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone

lead_sponsor: Amgen Inc


title: Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus


title: Efficacité d’un traitement par l’association amlodipine et valsartan en monoprise vespérale ou matinale, chez des Patients présentant une HTA Essentielle moyenne à modérée, non contRôlée par amlodipine 5mg en mesure ambulatoire de la pression arTérielle: Etude ExPERT

acronym: ExPERT

lead_sponsor: Novartis Pharma S.A.S.


title: Exploration de l'influence du polymorphisme *2 du gène codant pour le cytochrome 2C19 sur la réponse au clopidogrel chez le jeune coronarien

acronym: CLOVIS 2


title: A phase II study evaluating the efficacy and safety of the farnesyltransferase inhibitor ZARNESTRA® (R115777, tipifarnib) in patients with relapsed , refractory or progressive mantle cell lymphoma not appropriate for autologous bone marrow transplantation

acronym: Zarnestra® (tipifarnib) for oral administration

lead_sponsor: GELA


title: Durée de Traitement des Pyélonéphrites aiguës - Etude multicentrique, de non infériorité, randomisée évaluant deux durées de traitement antibiotique (5 versus 10 jours) dans les pyélonéphrites aiguës (PNA) communautaires non compliquées de la femme jeune. Etude DTP

acronym: DTP


title: Etude de phase II, multicentrique, en ouvert, évaluant l'efficacité d'un traitement par Sutent (sunitinib) chez des patients porteurs de métastases cérébrales d'origine rénale non traitées antérieurement ou en reprise évolutive après radiothérapie ou chirurgie

acronym: Sutent Métastases cérébrales

lead_sponsor: Institut Claudius Regaud


title: Influence du traitement par glitazones sur les Phospholipases A2 et sur l'effet des Lipoprotéines de haute densité (HDL) sur la réactivité artérielle, au cours du diabète de type 2

lead_sponsor: CHU DIJON


title: Efficacité du levetiracetam intra-veineux en association avec le clonazepam versus clonazepam seul dans la prise en charge pré-hospitalière de l'état de mal épileptique généralisé tonico-clonique

acronym: SAMUKEPPRA


title: Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept.

acronym: RAINBOW

lead_sponsor: Wyeth Pharmaceuticals France


title: A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

summary: This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.

lead_sponsor: Array BioPharma

location_country:
Italy
Switzerland
France
Australia
Spain
United States
United Kingdom

location_facility: University of Texas/MD Anderson Cancer Center Dept. of Onc.

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

location_facility: University of Utah / Huntsman Cancer Institute Huntsman (3)

location_facility: Memorial Sloan Kettering Cancer Center Onc. Dept

location_facility: University of California San Diego - Moores Cancer Center Dept Onc


title: A Non-Randomized, Within Subject Placebo-Controlled Exploratory Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal EEG Response in Subjects with Photosensitive Epilepsy

lead_sponsor: Janssen-Cilag International N.V


type: Other Identifier

title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

summary: This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

ReferenceCitation: Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Jun;17(6):811-821. doi: 10.1016/S1470-2045(16)00106-6. Epub 2016 May 4.

family: Krop

full_name: Ian E Krop

given: Ian E

family: Mayer

full_name: Ingrid A Mayer

given: Ingrid A

family: Ganju

full_name: Vinod Ganju

given: Vinod

family: Dickler

full_name: Maura Dickler

given: Maura

family: Johnston

full_name: Stephen Johnston

given: Stephen

family: Morales

full_name: Serafin Morales

given: Serafin

family: Yardley

full_name: Denise A Yardley

given: Denise A

family: Melichar

full_name: Bohuslav Melichar

given: Bohuslav

family: Forero-Torres

full_name: Andres Forero-Torres

given: Andres

family: Lee

full_name: Soo Chin Lee

given: Soo Chin

family: de Boer

full_name: Richard de Boer

given: Richard

family: Petrakova

full_name: Katarina Petrakova

given: Katarina

family: Vallentin

full_name: Susanne Vallentin

given: Susanne

family: Perez

full_name: Edith A Perez

given: Edith A

family: Piccart

full_name: Martine Piccart

given: Martine

family: Ellis

full_name: Matthew Ellis

given: Matthew

family: Winer

full_name: Eric Winer

given: Eric

family: Gendreau

full_name: Steven Gendreau

given: Steven

family: Derynck

full_name: Mika Derynck

given: Mika

family: Lackner

full_name: Mark Lackner

given: Mark

family: Levy

full_name: Gallia Levy

given: Gallia

family: Qiu

full_name: Jiaheng Qiu

given: Jiaheng

family: He

full_name: Jing He

given: Jing

location_country:
Peru
Malaysia
Belgium
Australia
Russian Federation
Denmark
Czech Republic
France
Thailand
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Singapore
United States
Germany
United Kingdom
Italy
Mexico
Israel
New Zealand
Spain


title: Etude clinique de phase II, monocentrique, en simple aveugle comparant l'efficacité et la tolérance de l'administration intraveineuse de dipyridamole et d'adénosine donnés séquentiellement ou de façon concomitante à faible doses, à l'adénosine seule donnée à la dose standard usuelle, dans l'évaluation de l'ischémie myocardique par scintigraphie au technetium sestamibi.

acronym: non applicable

lead_sponsor: ADENOBIO N.V.


title: Evaluation médico-économique de l'échographie de contraste pour l'appréciation précoce de l'effet du bevacizumab sur les métastases hépatiques de cancer colorectal

acronym: stic avastin

lead_sponsor: CHRU TOURS


title: Impact de l'analgésie péridurale thoracique sur la récupération fonctionnelle des patients participant à un programme de réhabilitation précoce en chirurgie colo-rectale, Essai multicentrique, randomisé en simple aveugle. Analgésie Péridurale Thoracique (APT) versus Analgésie MultiModale Intraveineuse (AMMI)


title: A randomized, double-blind, vehicle controlled, single center, intra-individual comparative study of the efficacy and safety of diclofenac sodium 1 mg/g (0.1%) gel in subjects with painful UV-induced erythema

acronym: Diclofenac sodium 1 mg/g (0.1%) gel

lead_sponsor: Novartis Consumer Health SA


title: A Phase 2, Open-Label, Non-Comparative Study of Doripenem in the Treatment of Nosocomial and Ventilator-Associated Pneumonia in Hospitals where Pseudomonas aeruginosa may be a Prevalent Pathogen.

lead_sponsor: ORTHO MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC


title: Phase II study of pegylated liposomal doxorubicin (Caelyxâ) in breast cancer patients with brain metastases and not candidate for an antiHER2 therapy

acronym: AROBASE

lead_sponsor: APREC


title: Intérêt de l’administration intra-coronaire d’une dose unique d’EPO lors de la reperfusion chez des patients hospitalisés pour un primo infarctus avec sus-décalage persistant du segment ST

lead_sponsor: CHRU Montpellier - Direction de la Recherche, Partenariats et Réseaux, Relations avec l'Université


title: Efficacy and Safety of two doses regimens of Octaplex in patients with cerebral haemorrhage related to oral anticoagulant therapy: A phase IV, prospective, randomised, open-label study.

lead_sponsor: OCTAPHARMA AG


title: An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B

acronym: B-YOND

summary:
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B.

The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

ReferenceCitation: Shapiro AD, Pasi KJ, Ozelo MC, Kulkarni R, Barnowski C, Winding B, Szamosi J, Lethagen S. Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B. Res Pract Thromb Haemost. 2018 Nov 29;3(1):109-113. doi: 10.1002/rth2.12163. eCollection 2019 Jan.

name: Indiana Hemophilia & Thrombosis Center; Indianapolis Indiana

family: Shapiro

full_name: Amy D. Shapiro

given: Amy D.

name: Royal London Haemophilia Centre; Barts and The London School of Medicine and Dentistry; London UK

family: Pasi

full_name: K. John Pasi

given: K. John

name: INCT do Sangue Hemocentro UNICAMP; University of Campinas; Campinas Brazil

family: Ozelo

full_name: Margareth C. Ozelo

given: Margareth C.

name: Department of Pediatrics and Human Development; Michigan State University; East Lansing Michigan

family: Kulkarni

full_name: Roshni Kulkarni

given: Roshni

name: Bioverativ, a Sanofi Company; Waltham Massachusetts

family: Barnowski

full_name: Christopher Barnowski

given: Christopher

family: Winding

full_name: Bent Winding

given: Bent

family: Szamosi

full_name: Johan Szamosi

given: Johan

name: University of Copenhagen; Copenhagen Denmark

family: Lethagen

full_name: Stefan Lethagen

given: Stefan

currency_apc_doaj: USD

journal_name: Research and Practice in Thrombosis and Haemostasis

repository_institution: PubMed Central - Europe PMC

license: cc-by

license_normalized: cc-by

repository_institution: Queen Mary University of London - Queen Mary Research Online

lead_sponsor: Bioverativ Therapeutics Inc.

location_country:
Italy
United States
Brazil
South Africa
India
Sweden
Hong Kong
Netherlands
Germany
France
Japan
Poland
Ireland
Belgium
Australia
China
Canada
United Kingdom

location_facility:
Research site
Research Site

intervention_type: Biological


title: Etude pilote multicentrique randomisée en double aveugle des effets de la toxine botulique dans le traitement des vestibulodynies

acronym: VESTIBULE

lead_sponsor: Centre Hospitalier Universitaire de Besançon


ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Italy
Austria
Brazil
Peru
South Africa
Spain
France
Czechia
Japan
Israel
Lithuania
Panama
Hungary
Argentina
Belgium
Poland
Russian Federation
Latvia
Ukraine

title: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

summary: This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.


title: Effets cliniques de VALDOXAN® (25 ou 50mg) à long terme chez des patients déprimés - Etude clinique, nationale, interventionnelle de phase IV, multicentrique, réalisée en ouvert. Etude Valdoxan D - EXTENSION

lead_sponsor: EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier


title: A Phase 2a Study of BMS-790052 in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects with Chronic Hepatitis C Virus Genotype 1 Infection

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Cysteamine Hydrochloride for nephropathic Cystinosis, open-label Phase III pivotal study

acronym: CYSTADROPS CHOC study

lead_sponsor: Orphan Europe SARL


title: Efficacité de la Fluoxétine dans la prévention des apnées centrales compliquant les crises d’épilepsie. Etude randomisée en double aveugle contre placebo

lead_sponsor: Hospices Civils de Lyon


title: Randomised, Openlabel Study Evaluating Efficacy and Safety of Maraviroc as a Switch for Either NRTI or PI/r in HIV-1 Infected Individuals With Stable, Well-Controlled Plasma HIV-RNA While Taking Their First N(t)RTI + PI/r Regimen of cART

acronym: MARCH

summary:
MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r.

The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.

ReferenceCitation: Pett SL, Amin J, Horban A, Andrade-Villanueva J, Losso M, Porteiro N, Sierra Madero J, Belloso W, Tu E, Silk D, Kelleher A, Harrigan R, Clark A, Sugiura W, Wolff M, Gill J, Gatell J, Fisher M, Clarke A, Ruxrungtham K, Prazuck T, Kaiser R, Woolley I, Arnaiz JA, Cooper D, Rockstroh JK, Mallon P, Emery S; Maraviroc Switch (MARCH) Study Group. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016 Jul 1;63(1):122-32. doi: 10.1093/cid/ciw207. Epub 2016 Apr 5.

family: Pett

full_name: Sarah Lilian Pett

given: Sarah Lilian

family: Amin

full_name: Janaki Amin

given: Janaki

family: Horban

full_name: Andrejz Horban

given: Andrejz

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

family: Losso

full_name: Marcelo Losso

given: Marcelo

family: Porteiro

full_name: Norma Porteiro

given: Norma

family: Sierra Madero

full_name: Juan Sierra Madero

given: Juan

family: Belloso

full_name: Waldo Belloso

given: Waldo

family: Tu

full_name: Elise Tu

given: Elise

family: Silk

full_name: David Silk

given: David

family: Kelleher

full_name: Anthony Kelleher

given: Anthony

family: Harrigan

full_name: Richard Harrigan

given: Richard

family: Clark

full_name: Andrew Clark

given: Andrew

family: Sugiura

full_name: Wataru Sugiura

given: Wataru

family: Wolff

full_name: Marcelo Wolff

family: Gill

full_name: John Gill

given: John

family: Gatell

full_name: Jose Gatell

given: Jose

family: Fisher

full_name: Martin Fisher

given: Martin

family: Clarke

full_name: Amanda Clarke

given: Amanda

family: Ruxrungtham

full_name: Kiat Ruxrungtham

given: Kiat

family: Prazuck

full_name: Thierry Prazuck

given: Thierry

family: Kaiser

full_name: Rolf Kaiser

given: Rolf

family: Woolley

full_name: Ian Woolley

given: Ian

title: Maraviroc, as a Switch Option, in HIV-1–infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study

ReferenceCitation: Tu E, Swenson LC, Land S, Pett S, Emery S, Marks K, Kelleher AD, Kaye S, Kaiser R, Schuelter E, Harrigan R; MARCH Laboratory Group and the MARCH Study Group. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013 Jul;51(7):2063-71. doi: 10.1128/JCM.00510-13. Epub 2013 Apr 17.

name: on behalf of the MARCH Laboratory Group and the MARCH Study Group

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

repository_institution: The Pennsylvania State University - CiteSeer X

repositories:
CiteSeerX
PubMed Central
espace.library.uq.edu.au

title: Results of External Quality Assessment for Proviral DNA Testing of HIV Tropism in the Maraviroc Switch Collaborative Study

location_country:
Chile
Mexico
Germany
France
Japan
Poland
Thailand
Ireland
Argentina
Australia
Spain
Canada
United Kingdom

location_facility: Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE

location_facility: University of Bonn, Med J. Immunologische Siudienzenirale

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)

location_facility: Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb

location_facility: University Health Network/Toronto General Hospital

location_facility: Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Nacional Prof Alejandro Posadas

location_facility: Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover

location_facility: Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS

location_facility: Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)

location_facility: Coventry and Warwickshire Partnership Trust

location_facility: Brisbane Sexual Health and HIV Service (formerly AMU)


title: Un placebo peut il améliorer l'apprentissage d'une habileté motrice manuelle du sujet sain? Comparaison avec la paroxétine.

acronym: Placebo, paroxétine et apprentissage

lead_sponsor: INSERM


title: A phase II - III double-blind study of oral vinflunine plus best supportive care versus placebo plus best supportive care in patients with malignant pleural mesothelioma previously treated with systemic chemotherapy.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: EVALUATION DE L’ASSOCIATION RADIOTHERAPIE DE CONFORMATION ET CHEMOEMBOLISATION INTRA-ARTERIELLE HEPATIQUE EN NEOADJUVANT DE LA RESECTION CHIRURGICALE DES CARCINOMES HEPATOCELLULAIRES DE GRANDE TAILLE


title: ETUDE DE L’EFFICACITE D’UN TRAITEMENT PAR BUMETANIDE DANS UNE POPULATION D’ENFANTS AUTISTES

lead_sponsor: CHU de BREST


title: Etude de l’efficacité et de la tolérance du traitement par la culture totale lyophilisée de lactobacillus casei variété rhamnosus (Lcr35 Lc) administré par voie vaginale  dans la prévention de récidives dans une population de patientes présentant des vaginoses bactériennes récidivantes. Essai de supériorité, randomisé de phase III, en double aveugle versus placebo, multicentrique et international.

acronym: Lcr35 Lc (Gynophilus®) dans la prévention de la vaginose bactérienne récidivante

lead_sponsor: LYOCENTRE


title: Intérêt de l’administration continue de ropivacaïne à l’aide du Pain – Buster™  dans la chirurgie des lambeaux microanastomosés de latissimus dorsi et de serratus

acronym: Protocole Pain Buster ™ lambeaux libres

lead_sponsor: Centre Hospitalier Universitaire de Nantes


title: Evaluation de l'efficacité d'une corticothérapie à faible dose, associée à l'acide mycophénolique (Myfortic) dans le traitement d'attaque du syndrome néphrotique à lésions glomérulaires minimes de l'adulte

acronym: MSN

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


title: Proteomic and genetic analysis of neurotoxicity predicting markers in oxaliplatine treated patients with colorectal carcinoma.

acronym: NEUROTOXALI

lead_sponsor: CENTRE PAUL PAPIN - IRCAM


title: Imagerie moléculaire in vivo des transmissions cholinergique et dopaminergique dans les démences à corps de Lewy par tomographie d’émission monophotonique : Applications au diagnostic et à l’identification de sous-types pathologiques.

acronym: IBVM/DATSCAN

lead_sponsor: CHU de Bordeaux


title: Etude d’efficacité et d’acceptabilité du méthylphénidate dans les troubles de la marche de la maladie de Parkinson : Etude multicentrique en double aveugle versus placebo.

acronym: PARGKAIT II

lead_sponsor: Centre Hospitalier Régional et Universitaire de Lille


title: A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with advanced solid tumors

lead_sponsor: F.Hoffmann-La Roche Ltd.


title:
Phase II study: individualization of dosage of irinotecan in the FOLFIRI according to the genetic polymorphism of UGT1A1 in the first line treatment of metastatic colorectal cancer

 Etude de phase II : individualisation de la posologie d'irinotécan dans le protocole FOLFIRI selon le polymorphisme génétique de l’UGT1A1 en première ligne de traitement du cancer colorectal métastatique

acronym: IriGen

lead_sponsor: Centre Jean Perrin


title: A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors

summary:
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of ipatasertib administered in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1, approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to further characterize the safety and tolerability of ipatasertib in these combinations and to confirm a potential recommended Phase II dose of ipatasertib for each regimen.

NOTE: Arms A, B, and C are closed.

ReferenceCitation: Isakoff SJ, Tabernero J, Molife LR, Soria JC, Cervantes A, Vogelzang NJ, Patel MR, Hussain M, Baron A, Argilés G, Conkling PR, Sampath D, Maslyar D, Patel P, Chan W, Gendreau S, Musib L, Xu N, Ma H, Lin K, Bendell J. Antitumor activity of ipatasertib combined with chemotherapy: results from a phase Ib study in solid tumors. Ann Oncol. 2020 May;31(5):626-633. doi: 10.1016/j.annonc.2020.02.007. Epub 2020 Feb 20.

family: Isakoff

full_name: S.J. Isakoff

family: Tabernero

full_name: J. Tabernero

given: J.

family: Molife

full_name: L.R. Molife

family: Soria

full_name: J.-C. Soria

family: Cervantes

full_name: A. Cervantes

given: A.

family: Vogelzang

full_name: N.J. Vogelzang

family: Patel

full_name: M.R. Patel

family: Hussain

full_name: M. Hussain

given: M.

family: Baron

full_name: A. Baron

family: Argilés

full_name: G. Argilés

given: G.

family: Conkling

full_name: P.R. Conkling

family: Sampath

full_name: D. Sampath

given: D.

family: Maslyar

full_name: D. Maslyar

full_name: P. Patel

given: P.

family: Chan

full_name: W. Chan

given: W.

family: Gendreau

full_name: S. Gendreau

given: S.

family: Musib

full_name: L. Musib

given: L.

family: Xu

full_name: N. Xu

given: N.

family: Ma

full_name: H. Ma

given: H.

family: Lin

full_name: K. Lin

given: K.

family: Bendell

full_name: J. Bendell

journal_name: Annals of Oncology

location_country:
United States
United Kingdom
France
Spain

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hospital Clinico Universitario de Valencia


title: An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

summary: The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

primary_purpose: Basic Science

ReferenceCitation: Ross-Macdonald P, Walsh AM, Chasalow SD, Ammar R, Papillon-Cavanagh S, Szabo PM, Choueiri TK, Sznol M, Wind-Rotolo M. Molecular correlates of response to nivolumab at baseline and on treatment in patients with RCC. J Immunother Cancer. 2021 Mar;9(3). pii: e001506. doi: 10.1136/jitc-2020-001506.

family: Ross-Macdonald

full_name: Petra Ross-Macdonald

given: Petra

family: Walsh

full_name: Alice M Walsh

given: Alice M

family: Chasalow

full_name: Scott D Chasalow

given: Scott D

family: Ammar

full_name: Ron Ammar

given: Ron

family: Papillon-Cavanagh

full_name: Simon Papillon-Cavanagh

given: Simon

family: Szabo

full_name: Peter M Szabo

given: Peter M

family: Choueiri

full_name: Toni K Choueiri

given: Toni K

family: Sznol

full_name: Mario Sznol

given: Mario

family: Wind-Rotolo

full_name: Megan Wind-Rotolo

given: Megan

journal_name: Journal for ImmunoTherapy of Cancer

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Zhou Q, Qi Y, Wang Z, Zeng H, Zhang H, Liu Z, Huang Q, Xiong Y, Wang J, Chang Y, Bai Q, Xia Y, Wang Y, Liu L, Xu L, Dai B, Guo J, Zhu Y, Zhang W, Xu J. CCR5 blockade inflames antitumor immunity in BAP1-mutant clear cell renal cell carcinoma. J Immunother Cancer. 2020 Apr;8(1). pii: e000228. doi: 10.1136/jitc-2019-000228.

family: Zhou

full_name: Quan Zhou

given: Quan

family: Qi

full_name: Yangyang Qi

given: Yangyang

family: Wang

full_name: Zewei Wang

given: Zewei

family: Zeng

full_name: Han Zeng

given: Han

family: Zhang

full_name: Hongyu Zhang

given: Hongyu

family: Liu

full_name: Zhaopei Liu

given: Zhaopei

family: Huang

full_name: Qiuren Huang

given: Qiuren

family: Xiong

full_name: Ying Xiong

given: Ying

location_facility: University Of Wisconsin Carbone Cancer Center

location_facility: The Bunting-Blaustein Cancer Research Building

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center


title: Etude randomisée en double aveugle de l’efficacité du topiramate sur les symptômes d’irritabilité - impulsivité, d’hyperphagie et d’automutilation dans une population de patients atteints du Syndrome de Prader Willi sur 8 semaines.

acronym: TOPRADER


title: A phase II trial of SGI-110 in patients with ipss high and int 2 myelodysplastic syndrome, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to azacitidine or decitabine after at least 6 courses or relapsing after a response

lead_sponsor: Groupe Francophone des Myélodysplasies (GFM)


title:
Comparison of motor blockade duration in the context of scheduled caesarean section with spinal anaesthesia : hyperbaric  Prilocaïne versus hyperbaric Bupivacaïne.

 Comparaison de la durée du bloc moteur au cours de césariennes programmées sous rachianesthésie : Prilocaïne Hyperbare versus Bupivacaïne Hyperbare

acronym:
Césarcaïne

 Césarcaïne

lead_sponsor: University hospital of Montpellier


title:
A randomized phase III trial evaluating two strategies of rituximab administration for the treatment of first line/low tumor burden follicular lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)

 Etude randomisée de phase III visant à évaluer deux stratégies d'administration du rituximab (SC versus IV) chez des patients atteints d'un lymphome folliculaire de faible masse tumorale non antérieurement traité

acronym: FLIRT

lead_sponsor: LYSARC


title: Nintedanib for the treatment of SARS-Cov-2 induced pulmonary fibrosis

acronym: NINTECOR

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Clairance de l'Acétate et du gluconate au cours du Remplissage vasculaire des brûlés graves:CARE  Clearance of Acetate during fluid REsuscitation in critically ill patients: The CARE trial

acronym: CARE


title: ETUDE MULTICENTRIQUE D’EQUIVALENCE, CONTROLEE RANDOMISEE, OUVERTE, COMPARANT L’EFFICACITE DE LA COLCHICINE ET DE LA PREDNISONE DANS LA POUSSEE DE RHUMATISME A DEPOTS DE PYROPHOSPHATE DE CALCIUM DIHYDRATE

acronym:
COLCHICORT

 COLCHICORT

lead_sponsor: Groupement des Hôpitaux de l’Institut Catholique de Lille


title:
LENVAGIST - A multicentre, comparative, placebo-controlled, double-blinded, phase II study of the efficacy of lenvatinib in patients with  locally advanced or metastatic GIST after failure of imatinib and sunitinib

 LENVAGIST – Etude de phase II, multicentrique, comparative, contrôlée contre placebo, en double-insu, de l’efficacité du Lenvatinib chez des patients présentant un GIST localement avancé ou métastatique après échec de l’imatinib et du sunitinib.

acronym:
LENVAGIST

 LENVAGIST

lead_sponsor: Centre Léon Bérard


title: Etude de phase IV, de non infériorité, multicentrique, randomisée, en double aveugle, comparant la pristinamycine (2g x 2 par jour pendant 2 jours puis 1g x 3 par jour pendant 5 à 7 jours) à l’amoxicilline (1g x 3 par jour) pendant 7 à 9 jours chez des adultes présentant une pneumonie aiguë communautaire avec un score PORT de II ou III

lead_sponsor: sanofi-aventis France


title:
Impact of the administration of Fludrocortisone the fluid and electrolyte balance in great premature. Pilot study.

 Impact de l’administration de Fludrocortisone sur la balance hydro-électrolytique chez le grand prématuré. Etude pilote.

acronym: MINIPREM


title:
Etude préliminaire de l’efficacité d’un α1 bloquant (la prazosine) en prévention de la survenue d’un état de stress post-traumatique chez des patients présentant un état de stress aigu.

 Etude préliminaire de l’efficacité d’un α1 bloquant (la prazosine) en prévention de la survenue d’un état de stress post-traumatique chez des patients présentant un état de stress aigu.

acronym:
PRAZOSTRESS

 PRAZOSTRESS

lead_sponsor: Hospices Civils de Lyon


title:
Norepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study

 Etude noradrénaline seule ou en assiation avec la dobutamine dans le choc cardiogénique : étude randomisée, ouverte, en cross over  de phase IV.

acronym: HEARTSCHOCK-NORDOB

lead_sponsor: CHRU NANCY


title: Essai randomisé de phase II d’évaluation immunologique d’une stratégie vaccinale de « prime-boost »  anti-pneumococcique associant un vaccin conjugué (Prevenar) et le vaccin polysaccharidique (Pneumo23) chez des patients adultes drépanocytaires

acronym: DREVAC


title:
EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.

 Evaluation de l'efficacité d'un traitement par bumétanide chez les enfants autistes avec une étiologie connue : étude multicentrique randomisée en groupes parallèles et double aveugle contre placebo.

acronym:
BUMAUTEP

 BUMAUTEP

lead_sponsor: Limoges Hospital


title:
Predictive Signature of Benralizumab Response

 Signature prédictive de la réponse au Benralizumab

acronym: BENRAPRED

lead_sponsor: CHU of Nantes


title:
IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS

 Impact des anti-TNF, du vedolizumab et du tofacitinib sur la rigidité aortique, l'épaisseur de l'intima-média carotidienne et le risque cardiovasculaire des patients atteints de rectocolite hémorragique

acronym:
VASC-UC

 VASC-UC

lead_sponsor: CHU Amiens-Picardie


title:
Comparison of an inhaled sedation strategy to an intravenous sedation strategy in ICU patients treated with invasive mechanical ventilation

 Comparaison d’une stratégie de sédation inhalée à une stratégie de sédation intra-veineuse chez les patients de réanimation traités par ventilation mécanique invasive

acronym: INASED

lead_sponsor: CHRU de Brest


title:
Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?

 Y a-t-il un interet à répéter l’administration de dinoprostone vaginal (Propess®), pour favoriser la maturation cervicale des patientes à terme ?

acronym: RE-DINO

lead_sponsor: CHU de LIMOGES


title:
CAMOVID: A multicenter randomized trial to evaluate the efficacy and safety of camostat mesylate for the treatment of SARS-CoV-2 infection in ambulatory adult patients.

 CAMOVID: Etude multicentrique randomisée, pour évaluer l'efficacité et la tolérance du camostat mesylate pour le traitement de l'infection à SARSCoV-2 chez des patients adultes ambulatoires

lead_sponsor: Assitance Publique-Hopiaux de Paris


title: Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable high grade gliomas patients

lead_sponsor: Centre François baclesse


title:
Target-controled infusion with propofol in the Emergency Department : a prospective study on 50 adult patients

 Sédation Intraveineuse à Objectif de Concentration (SIVOC) au propofol à l’accueil des urgences : étude prospective pilote sur 50 patients consécutifs

acronym:
SIVOC

 SIVOC

lead_sponsor: CHU DE NICE


type: Registry Identifier

title: An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Formulation of MLN9708 Administered Weekly in Adult Patients With Relapsed or Refractory Light-Chain (AL) Amyloidosis Who Require Further Treatment

summary: This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.

ReferenceCitation: Sanchorawala V, Comenzo R, Zonder J, Kukreti V, Cohen A, Dispenzieri A, et al. MLN9708, an investigational oral proteasome inhibitor (PI), in relapsed or refractory lightchain (AL) amyloidosis. Clinical Lymphoma Myeloma and Leukemia 2013;13(suppl 1):S153-4; abstr P-229.

ReferenceCitation: Sanchorawala V, Zonder J, Comenzo R, Schönland S, Dispenzieri A, Berg D, et al. Poster Presentation: Phase 1 study of MLN9708, a novel, investigational oral proteasome inhibitor, in patients with relapsed or refractory light-chain amyloidosis. XIII International Symposium on Amyloidosis, Groningen, The Netherlands 2012.

ReferenceCitation: Merlini G, Sanchorawala V, Zonder J, Kukreti V, Schonland S, Jaccard A, et al. MLN9708, a novel, investigational oral proteasome inhibitor, in patients with relapsed or refractory light-chain amyloidosis (AL): results of a phase 1 study. In: 54th ASH Annual Meeting and Exposition; 2012 8-11 December; Atlanta, GA; p. abstr 731.

ReferenceCitation: Sanchorawala V, Palladini G, Kukreti V, Zonder JA, Cohen AD, Seldin DC, Dispenzieri A, Jaccard A, Schönland SO, Berg D, Yang H, Gupta N, Hui AM, Comenzo RL, Merlini G. A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis. Blood. 2017 Aug 3;130(5):597-605. doi: 10.1182/blood-2017-03-771220. Epub 2017 May 26. Erratum in: Blood. 2020 Mar 26;135(13):1071.

name: Amyloidosis Center, Boston University School of Medicine, Boston, MA;

family: Sanchorawala

full_name: Vaishali Sanchorawala

given: Vaishali

name: Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;

name: Department of Molecular Medicine, University of Pavia, Pavia, Italy;

family: Palladini

full_name: Giovanni Palladini

given: Giovanni

name: Princess Margaret Hospital, Toronto, ON, Canada;

family: Kukreti

full_name: Vishal Kukreti

given: Vishal

name: Barbara Ann Karmanos Cancer Institute, Detroit, MI;

family: Zonder

full_name: Jeffrey A. Zonder

given: Jeffrey A.

name: Fox Chase Cancer Center, Philadelphia, PA;

family: Cohen

full_name: Adam D. Cohen

given: Adam D.

family: Seldin

full_name: David C. Seldin

given: David C.

family: Dispenzieri

full_name: Angela Dispenzieri

given: Angela

name: Centre Hospitalier Universitaire, Limoges, France;

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

name: Medical Department V, Amyloidosis Center, University Hospital of Heidelberg, Heidelberg, Germany;

family: Schönland

full_name: Stefan O. Schönland

given: Stefan O.

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

family: Berg

full_name: Deborah Berg

given: Deborah

family: Yang

full_name: Huyuan Yang

given: Huyuan

family: Gupta

full_name: Neeraj Gupta

given: Neeraj

family: Hui

full_name: Ai-Min Hui

given: Ai-Min

family: Comenzo

full_name: Raymond L. Comenzo

given: Raymond L.

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Italy
United States
France
Germany
Canada

location_facility: Universitatsklinikum Heidelberg Innere Medizin V; Hamatologie, Onkologie und Rheumatologie

location_facility: CHU Limoges, Department of Hematology and Cell Therapy, Reference Center for AL amyloidosis

location_facility: Amyloidosis Research & Treatment Center, Fondazione IRCCS Policlinico San Matteo


title:
Interest of Intra-nodal injection of gentamicin for the treatment of suppurated cat scratch disease’s lymphadenitis: a randomized controlled study.
 "BIGG" : Bartonellosis and intra-nodal injection of gentamicin

 Intérêt d’une injection intra-ganglionnaire de gentamicine dans le traitement des formes ganglionnaires suppurées de maladie des griffes du chat : étude contrôlée randomisée en double aveugle.
 « BIGG » : Bartonellose et Injection intra-Ganglionnaire de Gentamicine

acronym:
BIGG

 BIGG

lead_sponsor: CHU TOULOUSE