ReferenceCitation: Popat S, Liu G, Lu S, Song G, Ma X, Yang JC. Brigatinib vs alectinib in crizotinib-resistant advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALTA-3). Future Oncol. 2021 Nov;17(32):4237-4247. doi: 10.2217/fon-2021-0608. Epub 2021 Aug 23.

name: The Royal Marsden Hospital & The Institute of Cancer Research, 203 Fulham Road, Chelsea, London SW3 6JJ, England

family: Popat

full_name: Sanjay Popat

given: Sanjay

name: Ontario Cancer Institute, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON M5G 2M9, Canada

family: Liu

full_name: Geoffrey Liu

given: Geoffrey

name: Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai, China

family: Lu

full_name: Shun Lu

given: Shun

family: Song

full_name: Gregory Song

given: Gregory

family: Ma

full_name: Xin Ma

given: Xin

name: Department of Medical Oncology, National Taiwan University Cancer Center, No. 57, Ln. 155, Sec. 3, Keelung Road, Da’an District, Taipei City, Taiwan

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

journal_name: Future Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

title: Brigatinib vs Alectinib in Crizotinib-Resistant Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer (ALTA-3)

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

lead_sponsor: Takeda

location_country:
Italy
Austria
United States
Chile
Sweden
Hong Kong
Mexico
Spain
Germany
Croatia
France
Greece
Thailand
Romania
Argentina
Russian Federation
China
Canada
Korea, Republic of
Taiwan

location_facility: Peking Union Medical College Hospital - East

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Omsk Regional Clinical Oncologic Dispensary

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Hospital Teresa Herrera - Materno Infantil

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: New York Oncology Hematology - Albany Medical Center

location_facility: Saint Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Aid

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The 307th Hospital of Chinese Peoples Liberation Army

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Sotiria General Hospital for Respiratory Diseases of Attica

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

location_facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti

location_facility: Peking University Cancer Hospital/Beijing Cancer Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Oncology Institute of Hope and Innovation

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: General Oncology Hospital of Kifisia Oi Agioi Anargiroi

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: State Budget Institution National Medical Research Center of Radiology of the Ministry of Heal

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricu

location_facility: Klinicki bolnicki centar Sestre milosrdnice

location_facility: The Catholic University of Korea - Seoul St. Mary's Hospital

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Affiliated Tumor Hospital of Harbin Medical University - The 3rd Affiliated Hospital of HMU

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)

location_facility: University General Hospital of Athens Attikon

location_facility: State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Centro Para la Atencion Integral del Paciente Oncologico

title: A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

summary:
Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib.

At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance:

Brigatinib tablets
Alectinib capsules

All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped.

After stopping treatment, participants will visit the study clinic for a check-up 30 days later.


ReferenceType: derived

ReferenceCitation: Swisher EM, Kwan TT, Oza AM, Tinker AV, Ray-Coquard I, Oaknin A, Coleman RL, Aghajanian C, Konecny GE, O'Malley DM, Leary A, Provencher D, Welch S, Chen LM, Wahner Hendrickson AE, Ma L, Ghatage P, Kristeleit RS, Dorigo O, Musafer A, Kaufmann SH, Elvin JA, Lin DI, Chambers SK, Dominy E, Vo LT, Goble S, Maloney L, Giordano H, Harding T, Dobrovic A, Scott CL, Lin KK, McNeish IA. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun. 2021 May 3;12(1):2487. doi: 10.1038/s41467-021-22582-6.

family: Swisher

full_name: Elizabeth M. Swisher

given: Elizabeth M.

sequence: first

family: Kwan

full_name: Tanya T. Kwan

given: Tanya T.

sequence: additional

family: Oza

full_name: Amit M. Oza

given: Amit M.

family: Tinker

full_name: Anna V. Tinker

given: Anna V.

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Coleman

full_name: Robert L. Coleman

given: Robert L.

family: Aghajanian

full_name: Carol Aghajanian

given: Carol

family: Konecny

full_name: Gottfried E. Konecny

given: Gottfried E.

family: O’Malley

full_name: David M. O’Malley

given: David M.

family: Leary

full_name: Alexandra Leary

given: Alexandra

family: Provencher

full_name: Diane Provencher

given: Diane

family: Welch

full_name: Stephen Welch

given: Stephen

family: Chen

full_name: Lee-may Chen

given: Lee-may

family: Wahner Hendrickson

full_name: Andrea E. Wahner Hendrickson

given: Andrea E.

full_name: Ling Ma

given: Ling

family: Ghatage

full_name: Prafull Ghatage

given: Prafull

family: Kristeleit

full_name: Rebecca S. Kristeleit

given: Rebecca S.

family: Dorigo

full_name: Oliver Dorigo

given: Oliver

family: Musafer

full_name: Ashan Musafer

given: Ashan

family: Kaufmann

full_name: Scott H. Kaufmann

given: Scott H.

family: Elvin

full_name: Julia A. Elvin

given: Julia A.

family: Lin

full_name: Douglas I. Lin

given: Douglas I.

family: Chambers

full_name: Setsuko K. Chambers

given: Setsuko K.

family: Dominy

full_name: Erin Dominy

given: Erin

repository_institution: University of Melbourne - Minerva Access

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmaña J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623.

journal_name: International Journal of Gynecologic Cancer

repository_institution: University College London - UCL Discovery

ReferenceCitation: Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29.

evidence: open (via crossref license, author manuscript)

repository_institution: The University of Glasgow - Enlighten: Publications

location_country:
United States
France
Australia
Spain
Canada
United Kingdom

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: University of Cincinnati Physicians Company

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Crown Princess Mary Cancer Centre (Westmead Hospital)

location_facility: Washington University School of Medicine

location_facility: Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: New York University Langone Medical Center

location_facility: Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Flinders Cancer Clinic - Flinders Medical Centre (FMC)

location_facility: University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center

title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


title: Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceCitation: Bécouarn Y, Cany L, Pulido M, Beyssac R, Texereau P, Le Morvan V, Béchade D, Brunet R, Aitouferoukh S, Lalet C, Mathoulin-Pélissier S, Fonck M, Robert J. FOLFIRI® and bevacizumab in first-line treatment for colorectal cancer patients: safety, efficacy and genetic polymorphisms. BMC Res Notes. 2014 Apr 23;7:260. doi: 10.1186/1756-0500-7-260.

family: Bécouarn

full_name: Yves Bécouarn

given: Yves

family: Cany

full_name: Laurent Cany

given: Laurent

family: Pulido

full_name: Marina Pulido

given: Marina

family: Beyssac

full_name: Richard Beyssac

given: Richard

family: Texereau

full_name: Patrick Texereau

given: Patrick

family: Le Morvan

full_name: Valérie Le Morvan

given: Valérie

family: Béchade

full_name: Dominique Béchade

given: Dominique

family: Brunet

full_name: René Brunet

given: René

family: Aitouferoukh

full_name: Sofiane Aitouferoukh

given: Sofiane

family: Lalet

full_name: Caroline Lalet

given: Caroline

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

family: Fonck

full_name: Marianne Fonck

given: Marianne

family: Robert

full_name: Jacques Robert

given: Jacques

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Research Notes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: FOLFIRI® and Bevacizumab in first-line treatment for colorectal cancer patients: safety, efficacy and genetic polymorphisms


ReferenceCitation: Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.

name: Department of Neurology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA

family: Lassman

full_name: Andrew B Lassman

given: Andrew B

name: Erasmus MC Cancer Institute, Rotterdam, Netherlands

family: van den Bent

full_name: Martin J van den Bent

given: Martin J

name: School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia

name: Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia

family: Gan

full_name: Hui K Gan

given: Hui K

name: Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

family: Reardon

full_name: David A Reardon

given: David A

name: Northwestern University, Chicago, Illinois, USA

family: Kumthekar

full_name: Priya Kumthekar

given: Priya

name: Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA

family: Butowski

full_name: Nicholas Butowski

given: Nicholas

name: Department of Medical Oncology, University of Queensland School of Medicine, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia

family: Lwin

full_name: Zarnie Lwin

given: Zarnie

name: Henry Ford Health System, Detroit, Michigan, USA

family: Mikkelsen

full_name: Tom Mikkelsen

given: Tom

name: University of Alabama at Birmingham, Birmingham, Alabama, USA

family: Nabors

full_name: Louis B Nabors

given: Louis B

name: South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, USA

family: Papadopoulos

full_name: Kyriakos P Papadopoulos

given: Kyriakos P

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

family: Penas-Prado

full_name: Marta Penas-Prado

given: Marta

name: NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

family: Simes

full_name: John Simes

given: John

name: Medical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia

family: Wheeler

full_name: Helen Wheeler

given: Helen

family: Walbert

full_name: Tobias Walbert

given: Tobias

family: Scott

full_name: Andrew M Scott

given: Andrew M

name: AbbVie Inc., North Chicago, Illinois, USA

family: Gomez

full_name: Erica Gomez

given: Erica

family: Lee

full_name: Ho-Jin Lee

given: Ho-Jin

family: Roberts-Rapp

full_name: Lisa Roberts-Rapp

given: Lisa

family: Xiong

full_name: Hao Xiong

given: Hao

family: Ansell

full_name: Peter J Ansell

given: Peter J

family: Bain

full_name: Earle Bain

given: Earle

family: Holen

full_name: Kyle D Holen

given: Kyle D

family: Maag

full_name: David Maag

given: David

name: NorthShore University Health System, Evanston, Illinois, USA

family: Merrell

full_name: Ryan Merrell

given: Ryan

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

title: Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients withEGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial

ReferenceCitation: Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.

name: Department of Medical Oncology, Austin Health and Olivia Newton-John Cancer Research Institute, Melbourne, Victoria, Australia

name: School of Cancer Medicine, La Trobe University School of Cancer Medicine, Melbourne, Victoria, Australia

name: Department of Neurology & Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, USA

name: Department of Neurology, NorthShore University HealthSystem, Evanston, Illinois, USA

name: Neuro-Oncology Unit, Erasmus MC Cancer Center, Rotterdam, the Netherlands

name: Department of Neurological Surgery, University of California, San Francisco, California, USA

name: South Texas Accelerated Research Therapeutics, San Antonio, Texas, USA

name: Department of Neurology, Northwestern University, Chicago, Illinois, USA

ReferenceCitation: Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Australia
Belgium
Russian Federation
Taiwan
France
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Netherlands
Switzerland
Singapore
Ireland
Portugal
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Liga Norte Rigrandese Contra o /ID# 143878

location_facility: Centro Medico Imbanaco de Cali /ID# 143882

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983

location_facility: Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 141984

location_facility: Canterbury District Health Boa /ID# 143861

location_facility: Montreal General Hospital - McGill University Health Center /ID# 144187

location_facility: The First Affiliated Hospital of Soochow University /ID# 165596

location_facility: St. James University Hospital /ID# 141653

location_facility: Netcare Oncology Intervent Ctr /ID# 143951

location_facility: Virginia Mason - Seattle Orthapedics /ID# 144022

location_facility: St Vincent's Hospital Melbourne /ID# 143858

location_facility: Princess Margaret Cancer Centre /ID# 166277

location_facility: Inst Med Alta Tec Onc (IMAT) /ID# 147223

location_facility: Univ California, San Francisco /ID# 145889

location_facility: University of Pennsylvania Medical Center - Shadyside /ID# 144159

location_facility: Boca Raton Regional Hospital /ID# 163659

location_facility: Univ Kansas Cancer Ctr - Overl /ID# 145895

location_facility: Southern Medical Day Care Centre /ID# 143868

location_facility: Winship Cancer Institute of Emory University /ID# 144015

location_facility: The Prince of Wales Hospital /ID# 144882

location_facility: Inselspital, Universitaetsklinik /ID# 141886

location_facility: Universitair Medisch Centrum Groningen /ID# 141408

location_facility: MD Anderson Cancer Center at Cooper - Camden /ID# 145891

location_facility: GEMC - European Medical Center /ID# 141703

location_facility: Sun Yat-Sen Uni Cancer Center /ID# 143919

location_facility: Sanatorio Parque S.A. - Grupo /ID# 142825

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 148472

location_facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 154592

location_facility: Hospital Clinico Universitario San Carlos /ID# 143901

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 147525

location_facility: 'The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 165593

location_facility: Massachusetts General Hospital /ID# 144145

location_facility: Fourth Military Medical University Tangdu Hospital, PLA /ID# 143920

location_facility: Maastricht Universitair Medisch Centrum /ID# 143585

location_facility: Tianjin Med Univ General Hosp /ID# 143923

location_facility: Northwestern Medicine Cancer Center - Warrenville /ID# 148476

location_facility: Calvary North Adelaide Hospita /ID# 143866

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 143877

location_facility: Tongji Hosp Tongji Med College /ID# 163820

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 141999

location_facility: Medizinische Universitat Wien /ID# 141981

location_facility: Linkou Chang Gung Memorial Ho /ID# 143941

location_facility: GVI Rondebosch Oncology Centre /ID# 143949

location_facility: Universitair Ziekenhuis Leuven /ID# 143872

location_facility: Interregional clin.diagnostic cntr /ID# 141702

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941

location_facility: Scott and White Medical Center /ID# 160743

location_facility: Froedtert Memorial Lutheran Hospital /ID# 144139

location_facility: University of Texas MD Anderson Cancer Center /ID# 144018

location_facility: CHU de Quebec-Universite Laval /ID# 144189

location_facility: Shengjing Hospital of China Medical University /ID# 167016

location_facility: University College Hospitals /ID# 142658

location_facility: Universitaetsklinikum Leipzig /ID# 143962

location_facility: Medizinische Universität Graz /ID# 141982

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 149014

location_facility: Sanbo Brain Hospital Capital M /ID# 166422

location_facility: Intermountain Medical Center /ID# 144142

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 143915

location_facility: Krajska nemocnice Liberec, a.s. /ID# 142024

location_facility: Cleveland Clinic Main Campus /ID# 144023

location_facility: Christiana Care Health Service /ID# 144127

location_facility: Hospital Maisonneuve-Rosemont /ID# 149315

location_facility: Taipei Veterans General Hosp /ID# 143955

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844

location_facility: Regina Elena National Cancer I /ID# 141795

location_facility: Washington University-School of Medicine /ID# 144174

location_facility: Rutgers Cancer Institute of NJ /ID# 148190

location_facility: Universitaetsklinik Heidelberg /ID# 143927

location_facility: National University Hospital /ID# 143933

location_facility: Scientific and Research Inst. /ID# 141701

location_facility: University of California, Los Angeles /ID# 149239

location_facility: Xiangya Hospital Central South University /ID# 166791

location_facility: Universitaetsklinikum Tuebingen /ID# 143926

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 141707

location_facility: Hospital Universitario 12 de Octubre /ID# 143930

location_facility: Hospital General Universitario de Valencia /ID# 143903

location_facility: Centro Hospitalar Universitário de São João, EPE /ID# 142830

location_facility: Institut de Cancer de l'Ouest /ID# 143914

location_facility: Associated Neurologists of Sou /ID# 147701

location_facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064

location_facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 141700

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876

location_facility: Dana-Farber Cancer Institute /ID# 148475

location_facility: Universtiy of Southern California /ID# 147543

location_facility: St. Josephs Hosp and Med Ctr /ID# 144149

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 144167

location_facility: Medical University of South Carolina /ID# 144141

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 144017

location_facility: St John Of God Subiaco Hospital /ID# 143869

location_facility: 1st Affiliated Hosp Fujian Med /ID# 159166

location_facility: Hospital Clinic de Barcelona /ID# 143906

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939

location_facility: Hospital Universitario HM Sanchinarro /ID# 143496

location_facility: Levine Cancer Ins, Carolina Me /ID# 144124

location_facility: Hospital Santa Creu i Sant Pau /ID# 143900

location_facility: Baylor Sammons Cancer Center /ID# 155542

location_facility: Guy's and St Thomas' NHS Found /ID# 142652

location_facility: Tel Aviv Sourasky Medical Center /ID# 143956

location_facility: Maine Medical Partners Neurolo /ID# 160864

location_facility: Huashan Hospital of Fudan University /ID# 159999

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 143890

location_facility: CCA Braga - Hospital de Braga /ID# 141940

location_facility: The University of Texas Health Science Center at Houston /ID# 144013

location_facility: State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706

location_facility: The University of Chicago Medical Center /ID# 144158

location_facility: AOU Citta della Salute Scienza /ID# 141801

location_facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961

location_facility: Federal State Treatment and rehabilitation center /ID# 141704

location_facility: Seoul National University Hospital /ID# 143886

location_facility: Administradora del Country_S.A-Clinica Del Country /ID# 143881

location_facility: Vrije Universiteit Medisch Centrum /ID# 143889

location_facility: Universitair Medisch Centrum Utrecht /ID# 141406

location_facility: National Cancer Ctr Singapore /ID# 143932

location_facility: Gastroenterology Institute, Division of Medicine /ID# 143958

location_facility: Peking Union Medical College H /ID# 157430

location_facility: Northwestern University Feinberg School of Medicine /ID# 147895

location_facility: Columbia University Medical Center /ID# 144020

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800

location_facility: Univ of Colorado Cancer Center /ID# 148194

title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

summary:
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


title: Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.

summary: Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

acronym: ALLELE

summary: The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Atara Biotherapeutics

location_country:
Italy
Austria
United States
France
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: University of Miami/Jackson Memorial Hospital (Adults only)

location_facility: Children's Hospital of Philadelphia (Pediatrics only)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli (Adults only)

location_facility: Washington University School of Medicine (Adults only)

location_facility: University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)

location_facility: Universitair Ziekenhuis Leuven (Adults and Pediatrics)

location_facility: Montefiore Medical Center (Pediatrics only)

location_facility: Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)

location_facility: Saint Jude Children's Research Hospital (Pediatrics only)

location_facility: Medizinische Universitat Wien (Adults only)

location_facility: Columbia University Medical Center (Adults and Pediatrics)

location_facility: Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)

location_facility: Alberta Children's Hospital (Adults and Pediatrics)

location_facility: Princess Margaret Cancer Centre (Adults only)

location_facility: University Hospitals Birmingham NHS Foundation Trust (Adults only)

location_facility: The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)

location_facility: University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)

location_facility: Medical University of South Carolina (Adults and Pediatrics)

location_facility: MD Anderson Cancer Center (Adults and Pediatrics)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)

location_facility: Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)

location_facility: Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)

location_facility: Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)

location_facility: Children's Healthcare of Atlanta at Egleston (Pediatrics)

location_facility: Nationwide Children's Hospital (Pediatrics only)

location_facility: The Royal Children's Hospital Melbourne (Pediatrics only)

location_facility: The Children's Hospital at Westmead (Pediatrics only)

location_facility: Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)

location_facility: Loma Linda University Cancer Center (Adults only)

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)

location_facility: Hôpital Necker-Enfants Malades (Pediatrics only)

location_facility: University Hospital Virgen del Rocio (Adults and Pediatrics)

location_facility: Groupe Hospitalier du Haut Leveque (Adults only)

location_facility: Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)

location_facility: University of Maryland School of Medicine (Adults only)

location_facility: Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)

location_facility: Baylor Scott and White Research Institute (Adults only)

location_facility: Loyola University Medical Center (Adults and Pediatrics)

location_facility: University of California Davis Comprehensive Cancer Center (Adults only)

location_facility: Cleveland Clinic Foundation (Adults and Pediatrics)

location_facility: Winship Cancer Institute of Emory University (Adults only)

location_facility: University of Florida (Adults and Pediatrics)

location_facility: University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)

location_facility: Froedtert Hospital & the Medical College of Wisconsin (Adults only)

location_facility: The Prince Charles Hospital (Adults only)

location_facility: University of California San Diego Moores Cancer Center (Adults only)

location_facility: University of Pennsylvania (Adults only)

location_facility: UCLA Medical Center (Adults and Pediatrics)

location_facility: Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)

location_facility: University of Pittsburgh Medical Center (Adults only)

location_facility: Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)

location_facility: MedStar Georgetown University Hospital (Adults and Pediatrics)

location_facility: Hôpital Universitaire Pitié Salpêtrière (Adults only)

location_facility: Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)

location_facility: Imperial College Healthcare NHS Trust (Adults only)

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)

location_facility: Hospital Universitario La Fe (Adults and Pediatrics)

location_facility: Ospedale Pediatrico Bambino Gesu (Adults and Pediatrics)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Fentanyl Ultra Low Doses Effects on Human Volunteer's Nociceptive Threshold. Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability, Post Operative Hyperalgesia Development Risk?

acronym: FENTANULD

summary: Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the first demonstration that a drug can induce opposite effect depending on individual history. We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main aim of this study is to measure the dose effect response to fentanyl "ultra low doses" on human volunteer's nociceptive threshold, to determine if such an opposite response profile can be revealed.

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8.

ReferenceCitation: Kalkman JC, Visser K, Moen J, Bonsel JG, Grobbee ED, Moons MKG. Preoperative prediction of severe postoperative pain. Pain. 2003 Oct;105(3):415-423. doi: 10.1016/S0304-3959(03)00252-5.

ReferenceCitation: Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review.

ReferenceCitation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review.

ReferenceCitation: Célèrier E, Laulin JP, Corcuff JB, Le Moal M, Simonnet G. Progressive enhancement of delayed hyperalgesia induced by repeated heroin administration: a sensitization process. J Neurosci. 2001 Jun 1;21(11):4074-80.

ReferenceCitation: Coderre TJ, Katz J, Vaccarino AL, Melzack R. Contribution of central neuroplasticity to pathological pain: review of clinical and experimental evidence. Pain. 1993 Mar;52(3):259-285. doi: 10.1016/0304-3959(93)90161-H. Review.

ReferenceCitation: Shen KF, Crain SM. Cholera toxin-B subunit blocks excitatory effects of opioids on sensory neuron action potentials indicating that GM1 ganglioside may regulate Gs-linked opioid receptor functions. Brain Res. 1990 Oct 29;531(1-2):1-7.

ReferenceCitation: Crain SM, Shen KF. Modulation of opioid analgesia, tolerance and dependence by Gs-coupled, GM1 ganglioside-regulated opioid receptor functions. Trends Pharmacol Sci. 1998 Sep;19(9):358-65.

ReferenceCitation: Richebé P, Rivat C, Laulin JP, Maurette P, Simonnet G. Ketamine improves the management of exaggerated postoperative pain observed in perioperative fentanyl-treated rats. Anesthesiology. 2005 Feb;102(2):421-8.

ReferenceCitation: Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review.

ReferenceCitation: Rivat C, Laulin JP, Corcuff JB, Célèrier E, Pain L, Simonnet G. Fentanyl enhancement of carrageenan-induced long-lasting hyperalgesia in rats: prevention by the N-methyl-D-aspartate receptor antagonist ketamine. Anesthesiology. 2002 Feb;96(2):381-91.

ReferenceCitation: Simonnet G, Rivat C. Opioid-induced hyperalgesia: abnormal or normal pain? Neuroreport. 2003 Jan 20;14(1):1-7. Review.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux Département d'Anesthésie-Réanimation II

intervention_type: Drug

status_simplified: Completed


title: Long Term, Double Blind, Randomized, Placebo Controlled Multi-center Study of FRE.M.S.- Frequency Modulated Neural Stimulation Lorenz Therapy™ in Symptomatic Diabetic Neuropathy

summary: Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.

ReferenceCitation: Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.

ReferenceCitation: Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. Epub 2005 Apr 15.

ReferenceCitation: Bosi E, Bax G, Scionti L, Spallone V, Tesfaye S, Valensi P, Ziegler D; FREMS European Trial Study Group. Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia. 2013 Mar;56(3):467-75. doi: 10.1007/s00125-012-2795-7. Epub 2012 Dec 13.

family: Bosi

full_name: E. Bosi

given: E.

name: on behalf of the FREMS European Trial Study Group

family: Bax

full_name: G. Bax

given: G.

family: Scionti

full_name: L. Scionti

given: L.

family: Spallone

full_name: V. Spallone

given: V.

family: Tesfaye

full_name: S. Tesfaye

given: S.

family: Valensi

full_name: P. Valensi

given: P.

family: Ziegler

full_name: D. Ziegler

given: D.

journal_name: Diabetologia

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

version: acceptedVersion

repository_institution: Tor Vergata University - Cineca Institutional Research Information System

version: submittedVersion

lead_sponsor: Lorenz Biotech S.p.A.

location_country: Italy Germany France

location_facility: San Raffaele Hospital & Scientific Institute


title: Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome

summary:
Clinical Objective : To improve the growth of these children
Genetic objective : A study of the genetics of the syndrome

lead_sponsor: Sanofi


title: A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation

summary:
To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
To specify the best period of treatment
To assess the efficacy of treatment based on final adult height of these children


title: Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study

summary:
Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11 betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS following cardiopulmonary bypass.

A previous observational study found more adrenal insufficiency and need for vasopressive support therapy in the etomidate group versus another propofol induced group.

The aim of our work is to compare hemodynamic dysfunction following induction with etomidate for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients would be included.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

summary:
As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.

Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.

It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves.

The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising.

The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain.

Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.

primary_purpose: Supportive Care

ReferenceCitation: Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.

ReferenceCitation: Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS©® yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.

ReferenceCitation: Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83.

ReferenceCitation: Lyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline. J Clin Oncol. 2018 Sep 1;36(25):2647-2655. doi: 10.1200/JCO.2018.79.2721. Epub 2018 Jun 11.

ReferenceCitation: Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.

ReferenceCitation: Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.

ReferenceCitation: Sharma M, Lingam VC, Nahar VK. A systematic review of yoga interventions as integrative treatment in breast cancer. J Cancer Res Clin Oncol. 2016 Dec;142(12):2523-2540. Epub 2016 Sep 15. Review.

ReferenceCitation: Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1:CD010802. doi: 10.1002/14651858.CD010802.pub2. Review.

ReferenceCitation: Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.

ReferenceCitation: Chandwani KD, Perkins G, Nagendra HR, Raghuram NV, Spelman A, Nagarathna R, Johnson K, Fortier A, Arun B, Wei Q, Kirschbaum C, Haddad R, Morris GS, Scheetz J, Chaoul A, Cohen L. Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy. J Clin Oncol. 2014 Apr 1;32(10):1058-65. doi: 10.1200/JCO.2012.48.2752. Epub 2014 Mar 3.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
Institut du sein Basque
Institut de Cancérologie de l'Ouest
Insitut de Cancérologie de Lorraine
institut Curie
Icm Val D'Aurelle
centre léon Bérard

intervention_type: Other


title: Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial

acronym: OMAGE

summary: A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.

ReferenceType: result

ReferenceCitation: Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2017-28. doi: 10.1111/j.1532-5415.2011.03628.x. Epub 2011 Sep 27.

family: Legrain

full_name: Sylvie Legrain

given: Sylvie

family: Tubach

full_name: Florence Tubach

given: Florence

family: Bonnet-Zamponi

full_name: Dominique Bonnet-Zamponi

given: Dominique

name: Geriatric Unit; L'Assistance Publique-Hôpitaux de Paris; Hôpital Pitié-Salpêtrière; Paris; France

family: Lemaire

full_name: Aurélie Lemaire

given: Aurélie

name: Geriatric Unit; Clinique de la Porte Verte; Versailles; France

family: Aquino

full_name: Jean-Pierre Aquino

given: Jean-Pierre

family: Paillaud

full_name: Elena Paillaud

given: Elena

name: Department of Geriatrics and Internal Medicine; L'Assistance Publique-Hôpitaux de Paris; Hôpital Albert Chenevier;

family: Taillandier-Heriche

full_name: Elodie Taillandier-Heriche

given: Elodie

name: Geriatric Unit; L'Assistance Publique-Hôpitaux de Paris; Hôpital Saint-Antoine;

family: Thomas

full_name: Caroline Thomas

given: Caroline

family: Verny

full_name: Marc Verny

given: Marc

name: Department of Epidemiology, Biostatistics, and Clinical Research; L'Assistance Publique-Hôpitaux de Paris; Hôpital Bichat;

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

name: Patient Education Unit for Chronic Patients; Hôpitaux Universitaires de Genève; Geneva; Switzerland

family: Moutet

full_name: Aline Lasserre Moutet

given: Aline Lasserre

family: Lieberherr

full_name: Déborah Lieberherr

given: Déborah

name: Geriatric Unit; L'Assistance Publique-Hôpitaux de Paris; Hôpital Bichat;

family: Lacaille

full_name: Sophie Lacaille

given: Sophie

journal_name: Journal of the American Geriatrics Society

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A New Multimodal Geriatric Discharge-Planning Intervention to Prevent Emergency Visits and Rehospitalizations of Older Adults: The Optimization of Medication in AGEd Multicenter Randomized Controlled Trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity

summary: The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.

primary_purpose: Prevention

lead_sponsor: PiLeJe


ReferenceCitation: Shavadia J, Welsh R, Gershlick A, Zheng Y, Huber K, Halvorsen S, Steg PG, Van de Werf F, Armstrong PW. Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study. J Am Heart Assoc. 2016 Jun 13;5(6). pii: e003559. doi: 10.1161/JAHA.116.003559.

name: Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada

family: Shavadia

full_name: Jay Shavadia

given: Jay

family: Welsh

full_name: Robert Welsh

given: Robert

name: Department of Academic Cardiology, University Hospitals of Leicester, United Kingdom

family: Gershlick

full_name: Anthony Gershlick

given: Anthony

family: Zheng

full_name: Yinggan Zheng

given: Yinggan

name: Department of Cardiology, University of Vienna, Austria

family: Huber

full_name: Kurt Huber

given: Kurt

name: Department of Cardiology, Oslo University Hospital HF Ullevål, Oslo, Norway

family: Halvorsen

full_name: Sigrun Halvorsen

given: Sigrun

name: Sorbonne Paris‐Cité, INSERM Unité 1148, Hôpital Bichat, Assistance Publique‐Hôpitaux de Paris, Université Paris–Diderot, Paris, France

family: Steg

full_name: Phillipe G. Steg

given: Phillipe G.

name: Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

family: Armstrong

full_name: Paul W. Armstrong

given: Paul W.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (semantic scholar lookup)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Relationship Between Arterial Access and Outcomes in ST‐Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study

ReferenceCitation: Bainey KR, Fresco C, Zheng Y, Halvorsen S, Carvalho A, Ostojic M, Goldstein P, Gershlick AH, Westerhout CM, Van de Werf F, Armstrong PW; STREAM Investigators. Implications of ischaemic area at risk and mode of reperfusion in ST-elevation myocardial infarction. Heart. 2016 Apr;102(7):527-33. doi: 10.1136/heartjnl-2015-308075. Epub 2016 Jan 18.

family: Bainey

full_name: Kevin R Bainey

given: Kevin R

family: Fresco

full_name: Claudio Fresco

given: Claudio

family: Carvalho

full_name: Antonio Carvalho

given: Antonio

ReferenceCitation: Shavadia J, Zheng Y, Dianati Maleki N, Huber K, Halvorsen S, Goldstein P, Gershlick AH, Wilcox R, Van de Werf F, Armstrong PW. Infarct Size, Shock, and Heart Failure: Does Reperfusion Strategy Matter in Early Presenting Patients With ST-Segment Elevation Myocardial Infarction? J Am Heart Assoc. 2015 Aug 24;4(8):e002049. doi: 10.1161/JAHA.115.002049.

name: Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada

name: Centre Hospitalier Régional et Universitaire, Lille Cedex, France

name: Department of Academic Cardiology, University Hospitals of Leicester, Leicester, United Kingdom

name: Department Cardiovascular Medicine, University Hospital, Nottingham, United Kingdom

title: Infarct Size, Shock, and Heart Failure: Does Reperfusion Strategy Matter in Early Presenting Patients With ST‐Segment Elevation Myocardial Infarction?

ReferenceCitation: Gershlick AH, Westerhout CM, Armstrong PW, Huber K, Halvorsen S, Steg PG, Ostojic M, Goldstein P, Carvalho AC, Van de Werf F, Wilcox RG. Impact of a pharmacoinvasive strategy when delays to primary PCI are prolonged. Heart. 2015 May;101(9):692-8. doi: 10.1136/heartjnl-2014-306686. Epub 2015 Feb 17.

ReferenceCitation: Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.

name: From the Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium (P.R.S., K.V., F.V.d.W.); The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (Canadian VIGOUR Centre), University of Alberta, Edmonton, Canada (P.W.A); NIHR, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, Leicester, United Kingdom (A.H.G.); Emergency Department and SAMU, Lille University Hospital, Lille, France (P.G.); the Department of...

title: ST–Segment-Elevation Myocardial Infarction Patients Randomized to a Pharmaco-Invasive Strategy or Primary Percutaneous Coronary Intervention

ReferenceCitation: Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.

ReferenceCitation: Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

title: Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007.

location_country:
Italy
Austria
Chile
Brazil
Peru
Serbia
Germany
France
Poland
Greece
Norway
Belgium
Russian Federation
Spain
Canada
United Kingdom

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title: STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within 6-24 Hours or Rescue Coronary Intervention Versus a Strategy of Standard Primary PCI in Patients With Acute Myocardial Infarction Within 3 Hours of Onset of Symptoms

summary:
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.


title: Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity

acronym: KETASED

summary: The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.

ReferenceCitation: Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

family: Jabre

full_name: Patricia Jabre

given: Patricia

family: Combes

full_name: Xavier Combes

given: Xavier

family: Lapostolle

full_name: Frederic Lapostolle

given: Frederic

family: Dhaouadi

full_name: Mohamed Dhaouadi

given: Mohamed

family: Ricard-Hibon

full_name: Agnes Ricard-Hibon

given: Agnes

family: Vivien

full_name: Benoit Vivien

given: Benoit

family: Bertrand

full_name: Lionel Bertrand

given: Lionel

family: Beltramini

full_name: Alexandra Beltramini

given: Alexandra

family: Gamand

full_name: Pascale Gamand

given: Pascale

family: Albizzati

full_name: Stephane Albizzati

given: Stephane

family: Perdrizet

full_name: Deborah Perdrizet

given: Deborah

family: Lebail

full_name: Gaelle Lebail

given: Gaelle

family: Chollet-Xemard

full_name: Charlotte Chollet-Xemard

given: Charlotte

family: Maxime

full_name: Virginie Maxime

given: Virginie

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Bollaert

full_name: Pierre-Edouard Bollaert

given: Pierre-Edouard

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Anguel

full_name: Nadia Anguel

given: Nadia

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Adnet

full_name: Frederic Adnet

ReferenceCitation: Wenzel V, Lindner KH. Best pharmacological practice in prehospital intubation. Lancet. 2009 Jul 25;374(9686):267-8. doi: 10.1016/S0140-6736(09)61071-0. Epub 2009 Jul 1.


title: Validation of a Prognostic Score to Identify Heart Failure Patients Who Might Need an Implantable Cardioverter Defibrillator Using Muscle Sympathetic Nerve Activity and Autonomic Testing

summary: The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Toulouse


title: Comparative Effect of 2 Different Sources of Trans Fatty Acid (Milk Fat vs Hydrogenated Oil)on Cardiovascular Risk Factors in Healthy Humans

summary:
Background:

Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects.

Methodology:

To compare the effects of industrial and natural dietary sources of TFA, two specific test fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in TFA has been produced by modification of the cow's diet and selection of cows with the highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily energy (based on 2000 kcal/day). These two test fats have been incorporated into food items and will be provided to 46 healthy subjects under a randomised, double blind, controlled, cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated.

ReferenceCitation: Chardigny JM, Malpuech-Brugère C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sébédio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. Epub 2006 Apr 24.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine

intervention_type: Dietary Supplement


title: Randomised Controlled Comparison of Continuous Positive Airway Pressure (CPAP) With Standard Treatment in Out-of-hospital Patients With Acute Cardiogenic Pulmonary Edema.

summary: Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.

ReferenceCitation: Crane SD, Elliott MW, Gilligan P, Richards K, Gray AJ. Randomised controlled comparison of continuous positive airways pressure, bilevel non-invasive ventilation, and standard treatment in emergency department patients with acute cardiogenic pulmonary oedema. Emerg Med J. 2004 Mar;21(2):155-61.

ReferenceCitation: Bellone A, Monari A, Cortellaro F, Vettorello M, Arlati S, Coen D. Myocardial infarction rate in acute pulmonary edema: noninvasive pressure support ventilation versus continuous positive airway pressure. Crit Care Med. 2004 Sep;32(9):1860-5.

ReferenceCitation: Mehta S, Jay GD, Woolard RH, Hipona RA, Connolly EM, Cimini DM, Drinkwine JH, Hill NS. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Crit Care Med. 1997 Apr;25(4):620-8.

ReferenceCitation: L'Her E, Duquesne F, Paris A, Mouline J, Renault A, Garo B, Boles JM. [Spontaneous positive end-expiratory pressure ventilation in elderly patients with cardiogenic pulmonary edema. Assessment in an emergency admissions unit]. Presse Med. 1998 Jun 20;27(22):1089-94. French.

ReferenceCitation: Evans TW. International Consensus Conferences in Intensive Care Medicine: non-invasive positive pressure ventilation in acute respiratory failure. Organised jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Société de Réanimation de Langue Française, and approved by the ATS Board of Directors, December 2000. Intensive Care Med. 2001 Jan;27(1):166-78. Review.

ReferenceCitation: Pang D, Keenan SP, Cook DJ, Sibbald WJ. The effect of positive pressure airway support on mortality and the need for intubation in cardiogenic pulmonary edema: a systematic review. Chest. 1998 Oct;114(4):1185-92. Review.

ReferenceCitation: Lenique F, Habis M, Lofaso F, Dubois-Randé JL, Harf A, Brochard L. Ventilatory and hemodynamic effects of continuous positive airway pressure in left heart failure. Am J Respir Crit Care Med. 1997 Feb;155(2):500-5.

ReferenceCitation: The treatment of heart failure. Task Force of the Working Group on Heart Failure of the European Society of Cardiology. Eur Heart J. 1997 May;18(5):736-53.

ReferenceCitation: Frontin P, Bounes V, Houzé-Cerfon CH, Charpentier S, Houzé-Cerfon V, Ducassé JL. Continuous positive airway pressure for cardiogenic pulmonary edema: a randomized study. Am J Emerg Med. 2011 Sep;29(7):775-81. doi: 10.1016/j.ajem.2010.03.007. Epub 2010 May 1.

family: Frontin

full_name: Philippe Frontin

given: Philippe

family: Bounes

full_name: Vincent Bounes

given: Vincent

family: Houzé-Cerfon

full_name: Charles Henri Houzé-Cerfon

given: Charles Henri

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

full_name: Vanessa Houzé-Cerfon

given: Vanessa

family: Ducassé

full_name: Jean Louis Ducassé

given: Jean Louis

journal_name: The American Journal of Emergency Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Randomized Phase II Trial Evaluating the Feasibility and Tolerance of the Combination of FOLFOX With Cetuximab and the Combination of FOLFOX With Cetuximab and Bevacizumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without bevacizumab in treating patients with resectable liver metastases from colorectal cancer.

status: Unknown status

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


title: Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery

summary: Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.


title: Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals

acronym: ECG-Spectral

summary: Postoperative pain stimulates the autonomic nervous system, induces the production of pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To our knowledge, the correlation between the sympathovagal activity quantified by a non invasive method and the postoperative pain, has not been studied before.

primary_purpose: Diagnostic

ReferenceCitation: Sesay M, Vignes JR, Liguoro D, Crozat P, Boulard G, Guerin J, Barat M, Maurette P. [Autonomic hyperreflexia induced by sacral root stimulation is detected by spectral analysis of the EEG]. Can J Anaesth. 2002 Nov;49(9):936-41. French.

ReferenceCitation: Sesay M, Robin G, Tauzin-Fin P, Sacko O, Gimbert E, Vignes JR, Liguoro D, Nouette-Gaulain K. Responses of heart rate variability to acute pain after minor spinal surgery: optimal thresholds and correlation with the numeric rating scale. J Neurosurg Anesthesiol. 2015 Apr;27(2):148-54. doi: 10.1097/ANA.0000000000000102.

family: Sesay

full_name: Musa Sesay

given: Musa

family: Robin

full_name: Georges Robin

given: Georges

family: Tauzin-Fin

full_name: Patrick Tauzin-Fin

given: Patrick

family: Sacko

full_name: Oumar Sacko

given: Oumar

family: Gimbert

full_name: Edouard Gimbert

given: Edouard

family: Vignes

full_name: Jean-Rodolphe Vignes

given: Jean-Rodolphe

family: Liguoro

full_name: Dominique Liguoro

given: Dominique

family: Nouette-Gaulain

full_name: Karine Nouette-Gaulain

given: Karine

journal_name: Journal of Neurosurgical Anesthesiology

title: Responses of Heart Rate Variability to Acute Pain After Minor Spinal Surgery

location_facility: Service de Neurochirurgie A, hôpital Pellegrin


title: Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo

acronym: TBA

summary: Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.

location_facility: Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.


title: Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study

summary: This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

ReferenceCitation: Vidal M, Forestier C, Charbonnel N, Henard S, Rabaud C, Lesens O. Probiotics and intestinal colonization by vancomycin-resistant enterococci in mice and humans. J Clin Microbiol. 2010 Jul;48(7):2595-8. doi: 10.1128/JCM.00473-10. Epub 2010 Apr 26.

name: Service des maladies infectieuses et tropicales, CHU Clermont-Ferrand, Clermont-Ferrand, France

name: Laboratoire de bactériologie, UFR Pharmacie, Université d'Auvergne-Clermont 1, Clermont-Ferrand, France

family: Vidal

full_name: Magali Vidal

given: Magali

family: Forestier

full_name: Christiane Forestier

given: Christiane

family: Charbonnel

full_name: Nicolas Charbonnel

given: Nicolas

name: CCLIN-Est, hôpitaux de Brabois, Vandoeuvre-les-Nancy, France

family: Henard

full_name: Sandrine Henard

family: Rabaud

full_name: Christian Rabaud

given: Christian

name: Université d'Auvergne-Clermont 1, UFR de Médecine, Clermont-Ferrand, France

family: Lesens

full_name: Olivier Lesens

given: Olivier

journal_name: Journal of Clinical Microbiology

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Probiotics and Intestinal Colonization by Vancomycin-Resistant Enterococci in Mice and Humans

location_facility: Service des Maladies infectieuses et tropicales


title: Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level

summary: Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem cells graft are based on genotypical analyses of the KIR receptors and on genotypic incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of issues non resolved: Are KIR really expressed and how occur their expression during time when hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed, what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells? Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and elimination of leukemia during hematopoietic stem cells grafts?

lead_sponsor: Nantes University Hospital


title: Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study

summary: The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.

lead_sponsor: Hospices Civils de Lyon


title: Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.

summary: Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric oral suspension in children weighing between 3 and 26 kg including limits


title: Therapeutic Intensification for HIV-associated Non-Hodgkin's Lymphoma by Autologous Transplantation of Either Unselected or CD34+-Selected Peripheral Blood Stem Cells, in Patients in First or Second Complete Remission. ANRS 131

summary:
Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high incidence in HAART era, more intensive therapy is required in patients with initially severe stage of NHL or relapsing after first-line chemotherapy.

The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by peripheral blood cell transplantation in these patients.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis

summary: The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.

primary_purpose: Screening

lead_sponsor: Laboratoire Régional de Nutrition Humaine

intervention_type: Behavioral


title: Discovery of New Circulating Biomarkers of Coronary Atherosclerosis Using Differential Proteomics: the BIOmarkers of CORonary Events (BIOCORE) Study

summary: The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery disease (either stable or unstable) who will be compared to a group of patients without coronary artery disease

ReferenceCitation: Duran MC, Mas S, Martin-Ventura JL, Meilhac O, Michel JB, Gallego-Delgado J, Lázaro A, Tuñon J, Egido J, Vivanco F. Proteomic analysis of human vessels: application to atherosclerotic plaques. Proteomics. 2003 Jun;3(6):973-8.

ReferenceCitation: Martin-Ventura JL, Duran MC, Blanco-Colio LM, Meilhac O, Leclercq A, Michel JB, Jensen ON, Hernandez-Merida S, Tuñón J, Vivanco F, Egido J. Identification by a differential proteomic approach of heat shock protein 27 as a potential marker of atherosclerosis. Circulation. 2004 Oct 12;110(15):2216-9. Epub 2004 Jul 12.

ReferenceCitation: Vivanco F, Martín-Ventura JL, Duran MC, Barderas MG, Blanco-Colio L, Dardé VM, Mas S, Meilhac O, Michel JB, Tuñón J, Egido J. Quest for novel cardiovascular biomarkers by proteomic analysis. J Proteome Res. 2005 Jul-Aug;4(4):1181-91. Review.

ReferenceCitation: Blanco-Colio LM, Martín-Ventura JL, Vivanco F, Michel JB, Meilhac O, Egido J. Biology of atherosclerotic plaques: what we are learning from proteomic analysis. Cardiovasc Res. 2006 Oct 1;72(1):18-29. Epub 2006 May 24. Review.

ReferenceCitation: Ramos-Mozo P, Madrigal-Matute J, Vega de Ceniga M, Blanco-Colio LM, Meilhac O, Feldman L, Michel JB, Clancy P, Golledge J, Norman PE, Egido J, Martin-Ventura JL. Increased plasma levels of NGAL, a marker of neutrophil activation, in patients with abdominal aortic aneurysm. Atherosclerosis. 2012 Feb;220(2):552-6. doi: 10.1016/j.atherosclerosis.2011.11.023. Epub 2011 Nov 25.

family: Ramos-Mozo

full_name: Priscila Ramos-Mozo

given: Priscila

family: Madrigal-Matute

full_name: Julio Madrigal-Matute

given: Julio

family: Vega de Ceniga

full_name: Melina Vega de Ceniga

given: Melina

family: Blanco-Colio

full_name: Luis Miguel Blanco-Colio

given: Luis Miguel

family: Meilhac

full_name: Olivier Meilhac

family: Feldman

full_name: Laurent Feldman

given: Laurent

family: Michel

full_name: Jean-Baptiste Michel

given: Jean-Baptiste

family: Clancy

full_name: Paula Clancy

given: Paula

family: Golledge

full_name: Jonathan Golledge

given: Jonathan

family: Norman

full_name: Paul E. Norman

given: Paul E.

family: Egido

full_name: Jesus Egido

given: Jesus

family: Martin-Ventura

full_name: José Luis Martin-Ventura

given: José Luis

journal_name: Atherosclerosis

location_facility: Department of Cardiology, Hopital Bichat, APHP