ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
Germany
France
Hungary
Belgium
Australia
Spain
Canada
United Kingdom

acronym: FINESSE

location_facility: Cliniques Universitaires St. Luc Oncology - Breast Clinic

location_facility: H. Ramón y Cajal Servicio de Oncología Médica

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: Institut Claudius Regaud Dpt d'Oncologie Médicale

location_facility: UZ Leuven Campus Gasthuisberg Dept. of General Medical

location_facility: Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

location_facility: Institut Gustave Roussy Dépt d'oncologie - Cancer du sein

location_facility: Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.

location_facility: The Royal Marsden NHS Trust Dpt of Medicine-Oncology

location_facility: University Health Network - Princess Margaret Hospital

location_facility: McGill University Department of Oncologie - Clinical Reserach Program

location_facility: Nottingham University Hospitals NHS Trust Department of Clinical Oncology

location_facility: Western General Hospital Edinburgh Cancer Centre

location_facility: Grand Hôpital de Charleroi Oncologie-Hématologie

location_facility: Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum

location_facility: KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe

location_facility: Clinique Sainte-Elisabeth Médecine Interne - Oncologie

location_facility: MD Anderson Cancer Center Unidad de Investigación Clínica

location_facility: H. Clínico de Valencia Servicio de Hematología y oncología Médica

location_facility: H. Valle de Hebrón Servicio de Oncología

ipd_sharing: Yes

title: An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


title: A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

summary:
This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD.

Subjects can continue to an optional open-label extension period for one year; To contact US site near you should go to: www.BouNDless-Study.com

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: NeuroDerm Ltd.

location_country:
Italy
Austria
Serbia
Netherlands
Spain
France
Czechia
Poland
Israel
Slovakia
Hungary
Belgium
Russian Federation
Portugal
United States
United Kingdom
Ukraine

location_facility: University of Arkansas for Medical Sciences

location_facility: The Research Center of Southern California

location_facility: Hospital Policlinica de Guipuzkoax Policlinica Guipuzcoa

location_facility: Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy

location_facility: Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust

location_facility: Institute of Gerontolgoy - Parkinsons disease Treatment Centre

location_facility: Azienda Ospedaliero Universitaria - PO Santa Chiara

location_facility: Hospital General Universitario de Elche, Edificio principal

location_facility: Policlinico Tor Vergata - UOSD Parkinson

location_facility: Federal Siberian Scientic Clinical Center of FMBA

location_facility: University of Florida Norman Fixel Institute for Neurological Diseases

location_facility: The first Saint-Petersburg State Medical University named after IP Pavlov

location_facility: Cedar- Sinai Medical Center Department of Neurology

location_facility: Hospital Universitario Virgen del Rocío, Laboratorio 104.

location_facility: Centro Ricerca Parkinson San Raffaele Cassino

location_facility: Hospital Universitario y Politcnico de La Fe

location_facility: University of Kentucky, Neurology and Movement Disorder

location_facility: Krakowska Akademia Neurologii Sp. z o. o

location_facility: Hospital Universitari General de Catalunya

location_facility: Parkinsons Disease and Movement Disorders Center of Boca Raton

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council

location_facility: Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34

location_facility: Hospital Universitari de la Vall d'Hebron

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Oddział Neurologii ul. L. Kondratowicza 8

location_facility: Ospedale di Grosseto, Azienda USL Toscana Sud Est

location_facility: Mount Sinai Medical center Movement Disorders Center

location_facility: NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

location_facility: University Chieti CeSI MET Clinical research center-CRC

location_facility: Hartford Healthcare Chase Family Movement Disorders Center

location_facility: New York-Presbyterian Brooklyn Methodist Hospital

location_facility: Neurologicka klinika Fakutni nemocnice sv. Anny v Brne

location_facility: AOU University of Campania "Luigi Vanvitelli"

intervention_type: Combination Product

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

title: A Randomized Double-blind Phase II Study Evaluating the Role of Maintenance Therapy With Cabozantinib in High Grade Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment

summary:
This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread.

Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.

All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753. Review.

family: Hanvic

full_name: Brunhilde Hanvic

given: Brunhilde

sequence: first

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Current Opinion in Oncology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Ray-Coquard I, Hatcher H, Bompas E, Casado A, Westermann A, Isambert N, Casali PG, Pratap S, Stark D, Valverde C, Anand A, Huizing M, Floquet A, Lindner L, Hermes B, Seddon B, Coens C, Jones R, Reed N. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113). Int J Gynecol Cancer. 2020 Oct;30(10):1633-1637. doi: 10.1136/ijgc-2020-001519. Epub 2020 Jun 15.

family: Hatcher

full_name: Helen Hatcher

given: Helen

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Casado

full_name: Antonio Casado

given: Antonio

family: Westermann

full_name: Annekke Westermann

given: Annekke

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Casali

full_name: Paolo Giovanni Casali

given: Paolo Giovanni

family: Pratap

full_name: Sarah Pratap

given: Sarah

family: Stark

full_name: Daniel Stark

given: Daniel

family: Valverde

full_name: Claudia Valverde

given: Claudia

family: Anand

full_name: Anjana Anand

given: Anjana

family: Huizing

full_name: Manon Huizing

given: Manon

family: Floquet

full_name: Anne Floquet

given: Anne

family: Lindner

full_name: Lars Lindner

given: Lars

family: Hermes

full_name: Barbara Hermes

given: Barbara

family: Seddon

full_name: Beatrice Seddon

given: Beatrice

family: Coens

full_name: Corneel Coens

given: Corneel

family: Jones

full_name: Robin Jones

given: Robin

family: Reed

full_name: Nick Reed

journal_name: International Journal of Gynecologic Cancer

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

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

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

location_country:
Italy
Netherlands
France
Belgium
Spain
United Kingdom

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau


title: Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study

acronym: PRERIES

summary:
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

status: Unknown status

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Donner EJ, Waddell B, Osland K, Leach JP, Duncan S, Nashef L, Picot MC. After sudden unexpected death in epilepsy: Lessons learned and the road forward. Epilepsia. 2016 Jan;57 Suppl 1:46-53. doi: 10.1111/epi.13235.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: A Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)

acronym: PREMIER

summary: The purpose of this study is to determine whether PXT3003 is effective and safe in the treatment of Charcot-Marie-Tooth disease - Type 1A. This double-blind study will assess in parallel groups 1 dose of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.

ipd_sharing: No

lead_sponsor: Pharnext SA

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Belgium
Spain
Denmark
Canada

location_facility: University Hospital GB Rossi UOC Neurologia B, AOUI Verona Department of Neuroscience, Biomedicine and Movement Sciences

location_facility: Rigshospitalet, University of Copenhagen Copenhagen Neuromuscular Center

location_facility: Azienda Ospedaliera Universitaria San Martino Universita Degli Studi di Genova Clinica Neurologica

location_facility: UC Davis Health Department of Physical Medicine and Rehabilitation

location_facility: Service de Neurologie et Maladies Neuromusculaires, CHU de Marseille - Hopital La Timone

location_facility: Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik Ludwig-Maximilians-Universität

location_facility: Universitätsklinikum Tübingen Crona Kliniken Neuromuskuläres Zentrum

location_facility: University of Florida Clinical Research Center

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: Montreal Neurological Institute and Hospital-Clinical Research Unit

location_facility: Hackensack Meridian Health Hackensack University Medical Center

location_facility: Centre de Reference des Maladies Neuromusculaires AOC Service de Neurologie, CHU d'Angers

location_facility: CHU de Quebec-Universite Laval- Hopital Enfant-Jesus

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Providence St. Luke's Rehabilitation Medical Center

location_facility: Colombia University Department of Neurology

location_facility: Hadassah Ein Kerem University Medical Center Department of Neurology

location_facility: Centre de reference des maladies neuromusculaires AOC Hopital Pellegrin CHU de Bordeaux

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: UNC Department of Neurology Peripheral Neuropathy Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: UCLA Department of Psychiatry and Biobehavioral Sciences

location_facility: CIUSS de Saguenay-Lac-Saint-Jean Centre d'etudes Cliniques

location_facility: Hospital Universitario y Politécnico La Fé

location_facility: Massachusetts General Hospital Neuromuscular Diagnostic Center

location_facility: University Hospital RWTH Aachen, Department of Neurology and Institute for Neuropathology

location_facility: Centre d'investigation Clinique CHU de Strasbourg Hopital de Hautepierre

location_facility: University Hospital Muenster UKM Department of Neurology

location_facility: MU Health Care Neurology and Sleep Disorders Clinic

location_facility: University of Kansas Medical Center Research Institute

location_facility: Advent Health Medical Group Neurology Orlando

location_facility: Association lnstitut de Myologie Hopital Pitie-Salpetriere Service de Neuro-Myologie

location_facility: University Medical Centre Goettingen, Dept. of Clinical Neurology

location_facility: Ottawa Hospital Research Institute- Neuromuscular Research Centre

location_facility: Neurology Clinic at University of Washington Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino" di Messina

location_facility: UHN Toronto General Hospital Krembil Neuroscience Centre

intervention_type: Drug


title: A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP

acronym: SELINDA

summary:
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation phase will be followed by an exploratory expansion phase in the same population with 12 patients enrolled in each group, who will receive selinexor at the RP2D.

The "3+3" design will be applied for dose escalation. The escalation will be performed independently in two distinct groups:

Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)
Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)

The choice of the conventional immunotherapy regimen which will be administered to each patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before patient's inclusion. Different dose levels for selinexor administration will be examined sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per 3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will continue until the MTD is exceeded or until the highest dose level defined in the study (DL3) is reached.

Dose escalation to the next planned dose level will be decided by the DEC based on the number of DLTs observed during the DLT assessment period.

The dose escalation phase will be followed by an exploratory expansion phase in the same two groups (Groups A and B), depending on the decision of the Independent Data Monitoring Committee (IDMC) after review of safety data at the end of dose escalation part.

Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the investigator's choice).

status: Completed

study_completion_date_type: Actual

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility:
CHU Nancy - Hôpital de Brabois
CHRU de Lille - Hôpital Claude Huriez
CHU Montpellier - Hôpital Saint Eloi
Institut Jules Bordet
CHU Dijon
CHU Bordeaux - Centre François Magendie
Centre Henri Becquerel
Hôpital Saint-Louis

status_simplified: Completed


title: A Single-arm Dose Finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

summary: This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Saint-Louis - Service d'hématologie AJA

location_facility: Hôpital Saint Louis - Service Hématologie Sénior


title: Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

summary:
PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.

SECONDARY OBJECTIVE(S):

PSA evolution
Evaluation of testosterone level
Specific survival
Overall survival
Tolerance
Quality of life (QLQ-C30 questionnaires)

lead_sponsor: UNICANCER

location_facility: Centre Hopsitalier Prive - Polyclinique Du Littoral


title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

acronym: TOUCH

summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

ReferenceCitation: Biganzoli L, Wildiers H, Oakman C, Marotti L, Loibl S, Kunkler I, Reed M, Ciatto S, Voogd AC, Brain E, Cutuli B, Terret C, Gosney M, Aapro M, Audisio R. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol. 2012 Apr;13(4):e148-60. doi: 10.1016/S1470-2045(11)70383-7. Epub 2012 Mar 30. Review.

ReferenceCitation: Biganzoli L, Aapro M, Loibl S, Wildiers H, Brain E. Taxanes in the treatment of breast cancer: Have we better defined their role in older patients? A position paper from a SIOG Task Force. Cancer Treat Rev. 2016 Feb;43:19-26. doi: 10.1016/j.ctrv.2015.11.009. Epub 2015 Dec 15. Review.

ReferenceCitation: Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.

ReferenceCitation: Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum in: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.

ReferenceCitation: Herschkowitz JI, He X, Fan C, Perou CM. The functional loss of the retinoblastoma tumour suppressor is a common event in basal-like and luminal B breast carcinomas. Breast Cancer Res. 2008;10(5):R75. doi: 10.1186/bcr2142. Epub 2008 Sep 9.

ReferenceCitation: Jenkins EO, Deal AM, Anders CK, Prat A, Perou CM, Carey LA, Muss HB. Age-specific changes in intrinsic breast cancer subtypes: a focus on older women. Oncologist. 2014 Oct;19(10):1076-83. doi: 10.1634/theoncologist.2014-0184. Epub 2014 Aug 20.

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009 Nov 20;27(33):5529-37. doi: 10.1200/JCO.2008.20.6847. Epub 2009 Sep 28.

ReferenceCitation: Malorni L, Piazza S, Ciani Y, Guarducci C, Bonechi M, Biagioni C, Hart CD, Verardo R, Di Leo A, Migliaccio I. A gene expression signature of retinoblastoma loss-of-function is a predictive biomarker of resistance to palbociclib in breast cancer cell lines and is prognostic in patients with ER positive early breast cancer. Oncotarget. 2016 Sep 13;7(42):68012-68022. doi: 10.18632/oncotarget.12010.

ReferenceCitation: Miles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.

family: Miles

full_name: David Miles

given: David

family: Baselga

full_name: José Baselga

given: José

family: Amadori

full_name: Dino Amadori

given: Dino

family: Sunpaweravong

full_name: Patrapim Sunpaweravong

given: Patrapim

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

family: Knott

full_name: Adam Knott

given: Adam

family: Clark

full_name: Emma Clark

given: Emma

family: Ross

full_name: Graham Ross

given: Graham

family: Swain

full_name: Sandra M. Swain

given: Sandra M.

journal_name: Breast Cancer Research and Treatment

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Witkiewicz AK, Ertel A, McFalls J, Valsecchi ME, Schwartz G, Knudsen ES. RB-pathway disruption is associated with improved response to neoadjuvant chemotherapy in breast cancer. Clin Cancer Res. 2012 Sep 15;18(18):5110-22. doi: 10.1158/1078-0432.CCR-12-0903. Epub 2012 Jul 18.

lead_sponsor: International Breast Cancer Study Group

location_country: Italy Belgium France Switzerland

location_facility: ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16

location_facility: Kantonsspital St. Gallen, Rorschacher Strasse 95

location_facility: Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI

location_facility: Universitatsspital Basel, Petersgraben 4

location_facility: Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15

location_facility: CHR de la Citadelle, Boulevard du XIIe de Ligne, 1

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10

location_facility: Hospital of Prato, Via Dolce dei Mazzamuti, 7

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57

location_facility: Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40

location_facility: A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67

location_facility: Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,

location_facility: Oncologia Medica Fano Italy,V.le Vittorio Veneto 2

location_facility: E.O. Ospedali Galliera, Mura delle Cappuccine, 14

location_facility: ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1

location_facility: Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5

location_facility: Ospedale Policlinico San Martino,Largo Rosanna Benzi,10

location_facility: UO Oncologia, Rimini Hospital, Via Settembrini 2

location_facility: Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18

location_facility: Clinique Saint- Joseph, Rue de Hesbaye 75

location_facility: Santa Maria delle Croci Hospital, Viale Randi 5

location_facility: Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2

location_facility: Ospedale Civile di Lecco,Via della Filanda 14

location_facility: University Hospital Zurich, Frauenklinikstrasse 10

location_facility: Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14

location_facility: U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Clinique Saint Elizabeth, Place Louise Godin 15

location_facility: Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4


title: REACTION: A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer

acronym: REACTION

summary: This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in Extensive Disease (ED)-SCLC.

location_country:
Italy
United Kingdom
France
Egypt

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Avicenne

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Centre Hospitalier d'Avignon - Hopital Duffaut

location_facility: Ain Shams University Faculty of Medicine - Ain Shams University Hospital

location_facility: Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

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

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital


title: A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months

summary:
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.

The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.

This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.


title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

summary: A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

ReferenceCitation: Oudard S, Culine S, Vano Y, Goldwasser F, Théodore C, Nguyen T, Voog E, Banu E, Vieillefond A, Priou F, Deplanque G, Gravis G, Ravaud A, Vannetzel JM, Machiels JP, Muracciole X, Pichon MF, Bay JO, Elaidi R, Teghom C, Radvanyi F, Beuzeboc P. Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2. Eur J Cancer. 2015 Jan;51(1):45-54. doi: 10.1016/j.ejca.2014.10.009. Epub 2014 Nov 15.

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Culine

full_name: Stéphane Culine

family: Vano

full_name: Yann Vano

given: Yann

family: Goldwasser

full_name: François Goldwasser

given: François

family: Théodore

full_name: Christine Théodore

given: Christine

family: Nguyen

full_name: Thierry Nguyen

given: Thierry

family: Voog

full_name: Eric Voog

given: Eric

family: Banu

full_name: Eugeniu Banu

given: Eugeniu

family: Vieillefond

full_name: Annick Vieillefond

given: Annick

family: Priou

full_name: Franck Priou

given: Franck

family: Deplanque

full_name: Gaël Deplanque

given: Gaël

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Vannetzel

full_name: Jean Michel Vannetzel

given: Jean Michel

family: Machiels

full_name: Jean-Pascal Machiels

given: Jean-Pascal

family: Muracciole

full_name: Xavier Muracciole

given: Xavier

family: Pichon

full_name: Marie-France Pichon

given: Marie-France

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: Elaidi

full_name: Reza Elaidi

given: Reza

family: Teghom

full_name: Corine Teghom

given: Corine

family: Radvanyi

full_name: François Radvanyi

family: Beuzeboc

full_name: Philippe Beuzeboc

given: Philippe

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Centre Hospitalier Départemental de la Vendée

location_facility: Cliniques saint Luc - Université Catholique de Louvain


title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

acronym: ETHAP

summary:
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.

This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.

The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.

ReferenceCitation: Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

family: Chaumais

full_name: Marie-Camille Chaumais

given: Marie-Camille

family: Chapuis

full_name: Claire Chapuis

given: Claire

family: Gairard-Dory

full_name: Anne Gairard-Dory

given: Anne

family: Hadjadj

full_name: Caroline Hadjadj

given: Caroline

family: Chanoine

full_name: Sébastien Chanoine

given: Sébastien

family: Allenet

full_name: Benoît Allenet

given: Benoît

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Pison

full_name: Christophe Pison

given: Christophe

family: Bedouch

full_name: Pierrick Bedouch

given: Pierrick

family: Dromer

full_name: Claire Dromer

family: Duconge

full_name: Séverine Duconge

given: Séverine

family: Glavieux

full_name: Alan Glavieux

given: Alan

family: Saux

full_name: Marie-Claude Saux

given: Marie-Claude

family: Yeni

full_name: Sami Yeni

given: Sami

family: Demeyer

full_name: Christelle Demeyer

given: Christelle

family: Frachon

full_name: Irène Frachon

given: Irène

family: Lorillon

full_name: Philippe Lorillon

family: Bastin

full_name: Anne Bastin

family: Bouvaist

full_name: Hélène Bouvaist

given: Hélène

family: Camara

full_name: Boubou Camara

given: Boubou

family: Chat

full_name: Céline Chat

given: Céline

family: Coste

full_name: Marie Coste

given: Marie

family: Delamare

journal_name: International Journal of Clinical Pharmacy

location_facility: Clinical Research Center Inserm CIC03 - Grenoble University Hospital


title: Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

summary: Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

ReferenceCitation: Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamié D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12). pii: e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

name: From the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., F.J.S., T.H.); Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands (P.C.S., A.O.K., G.J.V.); Department of Cardiology, CHU Rangueil, Toulouse, France (D.C.); Department of Cardiology, Munich University Clinic, LMU Munich and Munich Heart Alliance, DZHK, Germany (J.M.); Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (A.J.V.B.);...

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Smits

full_name: Pieter C. Smits

given: Pieter C.

family: Carrié

full_name: Didier Carrié

given: Didier

family: Mehilli

full_name: Julinda Mehilli

given: Julinda

family: Van Boven

full_name: Ad J. Van Boven

given: Ad J.

family: Regar

full_name: Evelyn Regar

given: Evelyn

family: Sawaya

full_name: Fadi J. Sawaya

given: Fadi J.

family: Chamié

full_name: Daniel Chamié

given: Daniel

family: Kraaijeveld

full_name: Adriaan O. Kraaijeveld

given: Adriaan O.

family: Hovasse

full_name: Thomas Hovasse

given: Thomas

family: Vlachojannis

full_name: Georgios J. Vlachojannis

given: Georgios J.

evidence: open (via free pdf)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

lead_sponsor: Terumo Europe N.V.

location_country: Germany France Netherlands

location_facility: Cardiovascular Institute Paris Sud (ICPS)

intervention_type: Device


title: The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?

acronym: SYNCOMOT

summary:
Stroke is the leading cause of severe disability in adults. The first cause of alterations in the quality of life and autonomy in these patients are disorders of walking and the balance. They are the leading cause of falls responsible for important medical, surgical and economic complications as well as a reactionary social isolation.

The techniques of rehabilitation of walking to the subacute phase of a stroke are usually based on automatic walking.Off walking is a complex activity usually performed in everyday life in association with multiple tasks. It is therefore interesting to re-educate walking in dual task or even in multitasking.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN)

acronym: TRIGTOX

summary: Peripheral painful traumatic trigeminal neuropathy (PPTTN) are poorly relieved by existing treatments which in addition induce many adverse effects. BTX, which blocks the exocytosis of neurotransmitters, can be captured by axonal retrograde transport in primary nociceptive neurons. Injected in the painful area, it might therefore inhibit the release of algogenic neurotransmitters, at both the peripheral and central levels and thus reduce pain. One study reported such an effect in neuropathic spinal pain. A recent study reported an analgesic effect in trigeminal neuralgia.

ReferenceCitation: Moreau N, Dieb W, Descroix V, Svensson P, Ernberg M, Boucher Y. Topical Review: Potential Use of Botulinum Toxin in the Management of Painful Posttraumatic Trigeminal Neuropathy. J Oral Facial Pain Headache. 2017 Winter;31(1):7-18. doi: 10.11607/ofph.1753. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors

acronym: ProTool

summary: The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Grenoble

location_facility:
Sainte-Anne Hospital
Grenoble University Hospital
Angers University Hospital
Henri Mondor University Hospital
CLINATEC


title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

summary:
Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

primary_purpose: Prevention

ReferenceCitation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Mørkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5:CD007471. doi: 10.1002/14651858.CD007471.pub4.

name: Department of Anatomy; University of Otago; Dunedin New Zealand

family: Woodley

full_name: Stephanie J Woodley

given: Stephanie J

family: Lawrenson

full_name: Peter Lawrenson

given: Peter

name: Academic Urology Unit; University of Aberdeen; Aberdeen UK

family: Boyle

full_name: Rhianon Boyle

given: Rhianon

name: c/o Cochrane Incontinence, Population Health Sciences Institute; Newcastle University; Newcastle upon Tyne UK

family: Cody

full_name: June D Cody

given: June D

name: Clinical Service; St. Olavs Hospital, Trondheim University Hospital; Trondheim Norway

family: Mørkved

full_name: Siv Mørkved

given: Siv

family: Kernohan

full_name: Ashleigh Kernohan

given: Ashleigh

name: Rehabilitation Teaching and Research Unit, Department of Medicine; University of Otago; Wellington New Zealand

family: Hay-Smith

full_name: E Jean C Hay-Smith

given: E Jean C

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972.

family: Fritel

full_name: Xavier Fritel

given: Xavier

family: de Tayrac

full_name: Renaud de Tayrac

given: Renaud

family: Bader

full_name: Georges Bader

given: Georges

family: Savary

full_name: Denis Savary

given: Denis

family: Gueye

full_name: Ameth Gueye

given: Ameth

family: Deffieux

full_name: Xavier Deffieux

family: Fernandez

full_name: Hervé Fernandez

given: Hervé

family: Richet

full_name: Claude Richet

given: Claude

family: Guilhot

full_name: Joëlle Guilhot

given: Joëlle

family: Fauconnier

full_name: Arnaud Fauconnier

given: Arnaud

journal_name: Obstetrics & Gynecology

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

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

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
CHU Clermont
CHR Réunion, CH Félix-Guyon
CHU Caremeau
CHU Antoine-Béclère
CH Poissy-Saint-Germain


title: Randomized Phase III Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cells Non Hodgkin's Lymphoma CD 20+

summary:
In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

This is an open randomized study.

The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non inferiority of the experimental arm in comparison to standard arm:

In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account of PET scan results after 2 cycles.

In experimental arm, early good responder patients (defined as having a negative PET scan after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam is needed to confirm the failure and an intensive chemotherapy is then recommended.

All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan will be reviewed by a group of expert according to Deauville criteria defined by Meignan et al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for all patients. The final evaluation of response will be made according to 2007 Cheson's criteria.

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: CH de Saint-Brieuc - Hôpital Yves Le Foll

location_facility: Hôpital Saint Antoine, Service d'hématologie du Pr Marie

location_facility: Université Catholique de Louvain Saint Luc


title: Conservative Treatments of Retinoblastoma

summary:
Conservative treatments of retinoblastoma (RETINO 2011)

-Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
-Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
- Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.

design_allocation: Non-Randomized

lead_sponsor: Institut Curie


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Généreux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5). pii: e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

name: From the Columbia University Medical Center, New York, NY (P.G., G.W.S.); Cardiovascular Research Foundation, New York, NY (P.G., G.W.S.); Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada (P.G.); Abbott Vascular, Santa Clara, CA (D.R.R., J.W., J.J.-M., K.S., C.A.S.); Istituto di Cardiologia, University of Bologna, Italy (T.P.); Escola Paulista de Medicina, Universidade Federal de São Paulo and Hospital Israelita Albert Einstein, São Paolo, Brazil (A.C.); Isala...

family: Généreux

full_name: Philippe Généreux

given: Philippe

family: Rutledge

full_name: David R. Rutledge

given: David R.

family: Palmerini

full_name: Tullio Palmerini

given: Tullio

family: Caixeta

full_name: Adriano Caixeta

given: Adriano

family: Kedhi

full_name: Elvin Kedhi

given: Elvin

family: Hermiller

full_name: James B. Hermiller

given: James B.

family: Wang

full_name: Jin Wang

given: Jin

family: Krucoff

full_name: Mitchell W. Krucoff

given: Mitchell W.

family: Jones-McMeans

full_name: Jennifer Jones-McMeans

given: Jennifer

family: Sudhir

full_name: Krishnankutty Sudhir

given: Krishnankutty

family: Simonton

full_name: Charles A. Simonton

given: Charles A.

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

oa_host_type: publisher

lead_sponsor: Abbott Medical Devices

location_country:
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
India
France
Poland
Norway
Argentina
South Africa
Switzerland
Netherlands
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Venezuela
Israel
Spain
Latvia

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Cardiology Clinic of Papageorgiou Hospital

location_facility: A.O. Universitaria Tor Vergata, Cardiologia

location_facility: Hospital Moinhos de Ventos-Centro de Cardiologia

location_facility: Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik

location_facility: China People Liberation Army (PLA) General Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum

location_facility: L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli

location_facility: Polsko Amerykanskie-Kliniki Serca American Heart

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences

location_facility: H. Miguel Servet. Zaragoza, Cardiology Service

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: University of Pécs/Medical School/Heart Institute

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: Universitäres Herzzentrum, Medizinische Klinik III

location_facility: Escorts Heart Institute & Research Centre

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Hospital Clinico San Carlos, Hemodynamics Department

location_facility: Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie

location_facility: Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: Semmelweis University, Department of Cardiovascular Surgery

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

location_facility: Max Devki Devi Heart & Vascular Insititute, Department of Cardiology


title: First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

acronym: FIRSTMAPPP

summary: The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).

ReferenceCitation: Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spöttl G, Rank P, Knösel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nölting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

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

family: Fankhauser

full_name: Maria Fankhauser

given: Maria

name: Institute for Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany

family: Bechmann

full_name: Nicole Bechmann

given: Nicole

name: Institute for Medical Information Sciences, Biometry, and Epidemiology, Campus Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany

family: Lauseker

full_name: Michael Lauseker

given: Michael

name: Institut National de la Santé et de la Recherche Médicale, UMR970, Paris-Cardiovascular Research Center, Equipe Labellisée par la Ligue contre le Cancer, Paris, France

name: Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France

name: Université Paris Diderot, Sorbonne Paris Cité, Paris, France

family: Goncalves

full_name: Judith Goncalves

given: Judith

family: Favier

full_name: Judith Favier

name: Institute for Clinical Genetics, Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany

name: National Center of Genetics, Laboratoire National de Santé, Dudelange, Luxembourg

name: German Cancer Consortium, Dresden, Germany

family: Klink

full_name: Barbara Klink

given: Barbara

family: William

full_name: Doreen William

given: Doreen

name: German Cancer Research Center, Heidelberg, Germany

name: Core Unit for Molecular Tumor Diagnostics, National Center for Tumor Diseases, Heidelberg, Germany

family: Gieldon

full_name: Laura Gieldon

given: Laura

family: Maurer

full_name: Julian Maurer

given: Julian

family: Spöttl

full_name: Gerald Spöttl

given: Gerald

family: Rank

full_name: Petra Rank

given: Petra

name: Institute of Pathology, Ludwig-Maximilians-University, Munich, Germany

family: Knösel

full_name: Thomas Knösel

given: Thomas

name: Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany

family: Orth

full_name: Michael Orth

name: Department of Medicine III, University Hospital Carl Gustav Carus Dresden, Dresden, Germany

family: Ziegler

full_name: Christian G Ziegler

given: Christian G

family: Aristizabal Prada

full_name: Elke Tatjana Aristizabal Prada

given: Elke Tatjana

family: Rubinstein

full_name: German Rubinstein

given: German

name: Department of Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany

family: Fassnacht

full_name: Martin Fassnacht

given: Martin

family: Spitzweg

full_name: Christine Spitzweg

given: Christine

name: Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom

name: Royal Free Hospital ENETS Centre of Excellence, London, United Kingdom

family: Grossman

full_name: Ashley B Grossman

given: Ashley B

name: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland

family: Pacak

full_name: Karel Pacak

given: Karel

name: Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich, Zurich, Switzerland

family: Beuschlein

full_name: Felix Beuschlein

given: Felix

family: Bornstein

full_name: Stefan R Bornstein

given: Stefan R

family: Eisenhofer

full_name: Graeme Eisenhofer

repositories_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Radboud University Nijmegen Medical Centre


title: Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

acronym: ROUTE

summary: This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

time_perspective: Prospective

ReferenceCitation: Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.

name: Department of Cardiothoracic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

family: Cocchieri

full_name: Riccardo Cocchieri

given: Riccardo

name: Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, Kiel, Germany

family: Petzina

full_name: Rainer Petzina

given: Rainer

name: Department of Thoracic and Cardiovascular Surgery, Institut Hospitalier Jacques Cartier, Massy, France

family: Romano

full_name: Mauro Romano

given: Mauro

name: Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, Poland

family: Jagielak

full_name: Dariusz Jagielak

given: Dariusz

name: Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria

family: Bonaros

full_name: Nikolaos Bonaros

given: Nikolaos

name: Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S. Matteo, Pavia University School of Medicine, Pavia, Italy

family: Aiello

full_name: Marco Aiello

given: Marco

name: Department of Cardiovascular Surgery, Hospital Louis Pradel, Lyon, France

family: Lapeze

full_name: Joel Lapeze

given: Joel

name: Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland

family: Laine

full_name: Mika Laine

given: Mika

name: Department of Cardiac Surgery, Hospital Jean Minjoz, University Hospital of Besancon, Besancon, France

family: Chocron

full_name: Sidney Chocron

given: Sidney

name: Department of Cardiothoracic Surgery, James Cook Hospital, Middlesbrough, UK

family: Muir

full_name: Douglas Muir

given: Douglas

name: Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany

family: Eichinger

full_name: Walter Eichinger

given: Walter

name: Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Hospital Essen, Essen, Germany

family: Thielmann

full_name: Matthias Thielmann

given: Matthias

name: Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, Bordeaux, France

family: Labrousse

full_name: Louis Labrousse

given: Louis

name: Department of Cardiothoracic Surgery, Rikshospital Oslo, Oslo, Norway

family: Rein

full_name: Kjell Arne Rein

given: Kjell Arne

name: Department of Cardiovascular Surgery, CHU Rennes, Rennes, France

family: Verhoye

full_name: Jean-Philippe Verhoye

given: Jean-Philippe

name: Department of Cardiac Surgery, University of Padova, Padova, Italy

family: Gerosa

full_name: Gino Gerosa

given: Gino

name: Department of Cardiac Surgery, St. Thomas‘Hospital, London, UK

family: Bapat

full_name: Vinayak Bapat

given: Vinayak

name: Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany

family: Baumbach

full_name: Hardy Baumbach

given: Hardy

name: Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany

family: Sims

full_name: Helen Sims

given: Helen

family: Deutsch

full_name: Cornelia Deutsch

given: Cornelia

family: Bramlage

full_name: Peter Bramlage

given: Peter

name: Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland

family: Kurucova

full_name: Jana Kurucova

given: Jana

family: Thoenes

full_name: Martin Thoenes

journal_name: European Journal of Cardio-Thoracic Surgery

ReferenceCitation: Romano M, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Deutsch C, Bramlage P, Thoenes M, Bapat V. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. Interact Cardiovasc Thorac Surg. 2017 Nov 1;25(5):757-764. doi: 10.1093/icvts/ivx159.

journal_name: Interactive CardioVascular and Thoracic Surgery

title: Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry†

ReferenceCitation: Bonaros N, Petzina R, Cocchieri R, Jagielak D, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Bapat V, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Kofler M, Bramlage P, Deutsch C, Thoenes M, Frank D, Romano M. Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. Eur J Cardiothorac Surg. 2017 May 1;51(5):919-926. doi: 10.1093/ejcts/ezw406.

repository_normalized: HELDA - Digital Repository of the University of Helsinki

title: Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry†

ReferenceCitation: Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Baumbach H, Bramlage P, Deutsch C, Thoenes M, Romano M. Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1815-22. doi: 10.1016/j.jcin.2016.06.031.

ReferenceCitation: Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V. Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry. BMC Cardiovasc Disord. 2014 Nov 1;14:152. doi: 10.1186/1471-2261-14-152.

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Italy
Austria
Netherlands
Finland
France
Poland
Norway
Germany
United Kingdom

location_facility: Universitätsklinikum Kiel - Kardiologie u. Angiologie

location_facility: Städt. Klinikum München GmbH Herzchirurgie Bogenhausen

location_facility: St. Thomas Hospital Cardiothoracic surgery dept

location_facility: Cardiac Surgery dpt., Innsbruck Medical University Hospital

location_facility: Westdeutsches Herzzentrum Essen - Uniklinikum -

location_facility: Policlinico San Matteo/Department of Cardiac Surgery

location_facility: Hopital Cardio-Vasculaire et Pneumologie Louis Pradel

location_facility: James Cook Hospital - Cardiothoracic Division

location_facility: Univ. Padova, Azienda Ospedaliera di Padova


title: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study

acronym: CARVASAXe

summary: The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

primary_purpose: Screening

lead_sponsor: Air Liquide Santé International

location_facility: Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre

location_facility: CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577

location_facility: CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc


title: A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents. PECATI.

acronym: PECATI

summary: This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: MedSIR

location_country: Italy France Spain

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hôpitaux Universitaires de Marseille - Hôpital Nord


title: Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults

summary: The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.

status: Withdrawn

location_facility:
Hôpital Necker-Enfants Malades
Hôpital Tenon
Hôpital Bichat
Hôpital Pitié Salpêtrière
Hôpital Armand Trousseau
HEGP
Hôpital Bicêtre
Hôpital Mondor
Hôpital Lariboisière


title: Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

summary: The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

ReferenceType: result

ReferenceCitation: Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.

family: Denis

full_name: P. Denis

given: P.

family: Aptel

full_name: F. Aptel

given: F.

family: Rouland

full_name: J.-F. Rouland

family: Nordmann

full_name: J.-P. Nordmann

family: Lachkar

full_name: Y. Lachkar

given: Y.

family: Renard

full_name: J.-P. Renard

family: Sellem

full_name: E. Sellem

given: E.

family: Baudouin

full_name: C. Baudouin

given: C.

family: Bron

full_name: A. Bron

given: A.

journal_name: Investigative Ophthalmology & Visual Science

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Cyclocoagulation of the Ciliary Bodies by High-Intensity Focused Ultrasound: A 12-Month Multicenter Study

lead_sponsor: EyeTechCare

location_facility:
University Hospital - Cl Huriez
Croix Rousse Hospital
Saint-Joseph Hospital
Clinique du Parc - Private Hospital
XV-XX National Ophthalmologic Hospital
XV-XX Ophthalmologic Hospital
University Hospital
Val de Grace Hospital


ReferenceCitation: Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5. Review.

family: Davis

full_name: Janet L. Davis

given: Janet L.

journal_name: American Journal of Ophthalmology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Parker MA, Choi D, Erker LR, Pennesi ME, Yang P, Chegarnov EN, Steinkamp PN, Schlechter CL, Dhaenens CM, Mohand-Said S, Audo I, Sahel J, Weleber RG, Wilson DJ. Test-Retest Variability of Functional and Structural Parameters in Patients with Stargardt Disease Participating in the SAR422459 Gene Therapy Trial. Transl Vis Sci Technol. 2016 Oct 1;5(5):10. eCollection 2016 Oct.

status: Terminated

ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
United States
France

location_facility:
Investigational Site Number 840004
Investigational Site Number 840001
Investigational Site Number 840005
Investigational Site Number 840002
Investigational Site Number 250001

source: euctr

title: A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular Degeneration

summary:
Primary Objective:

To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD).

Secondary Objective:

To evaluate for possible biological activity of SAR422459.


title: Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis

acronym: GiAnT

summary:
SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50 years. Despite recent progress and physiopathogenic, corticosteroids remains the standard treatment for decades with a very good initial clinical efficacy but a high relapse rate (nearly 40% to 6,5 months) during its decay. This sensible population is particularly exposed to the side effects of corticosteroids, leading to think about savings strategies. But the association of immunosuppressive therapy and/or anti- TNFα has not demonstrated benefits in terms of efficiency or long-term tolerance to cumulative doses of prednisone. The responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been studied in the pathogenesis of GCA in temporal artery walls and in mouse models. The primary pathogenic role of IL- 1 is based on the increase in serum or nuclear protein itself or that of its mRNA. The study of temporal artery biopsies has shown increased local production of IL- 1β mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL 2 (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β, in three cases GCA refractory to conventional treatments.

Here investigators propose a randomized, multicenter, controlled, double-blind study of anakinra against placebo in addition to corticosteroids in the treatment of GCA.

This study will include 70 patients randomized equally in both arms: reference treatment (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on day 1, followed by a progressive decrease in the dose pattern depending on the weight. In the experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by subcutaneous injection from day 1 until the end of week 16 (S16). In the reference arm of the treatment, a placebo anakinra is associated with corticosteroid in the same packaging, duration and respecting the double-blind.

Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed, the challenge of corticosteroid therapy in this disease is not so much a problem of initial effectiveness, than the adverse events related to relapses and steroid dependence.

ipd_sharing: Undecided

ipd_sharing_description: It will be planify

lead_sponsor: University Hospital, Caen


lead_sponsor: Redar

type: Registry Identifier

title: Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial

summary:
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.

Study design: Interventional randomized placebo-controlled clinical trial.

￼Main goals:

To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.


title: ANRS HIV CONTROLLERS NATIONAL OBSERVATORY

acronym: ANRS CO18

summary: The investigators have previously described a limited group of HIV-1-infected patients, we called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral replication is spontaneously controlled without any treatment. These patients are defined according to virological criteria: more than 90% of the quantifications of plasma viral load should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize these patients.

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

intervention_type: Biological


title: Beta Testing of a New Assessment Protocol for Assessment of Complex Therapies in Huntington's Disease (HD)

acronym: CAPIT-HD Beta

summary:
Huntington's disease (HD) is an inherited neurodegenerative disease for which there are no existing disease-modifying treatments.

Repair-HD is an EU FP7 consortium that aims to establish all the preclinical requirements for transplantation of stem cell-derived neurons in HD in order to replace those lost to the disease process. These requirements include the generation of new clinical assessments for detailed monitoring of patients with HD who have undergone cell replacement therapy.

This protocol describes the beta testing of a new clinical assessment battery: Core Assessment Protocol for Intrastriatal Transplantation in HD version 2 (CAPIT-HD beta / CAPIT-HD2). CAPIT-HD beta represents a substantial revision of a previous CAPIT-HD battery published over 20 years ago, which is in need of updating in order to accommodate knowledge from clinical transplant studies over this time and to take advantage of technological advances in patient assessment.

HD is a complex disorder in which there is relentless deterioration of motor, cognitive and behavioural functions, usually from mid-life onwards. The original CAPIT battery aimed to capture elements of change in all three domains, but was based predominantly on subjective semi-quantitative assessment tools that have poor inter-rater reliability. Moreover, a number of deficits, such as impairments in social cognition, were not recognised when the original CAPIT-HD battery was constructed, so we have developed novel assessments of these deficits, some of which are included in CAPIT-HD beta. The beta testing will take place in established HD clinical centres in Cardiff, Manchester, Paris, and Munster by teams of researchers who are experienced in leading clinic research in HD. Patients with early to moderate HD will be assessed at baseline, and at one and twelve months later, to assess the reliability and sensitivity of the CAPIT-HD beta battery. Arrangements for data storage and analysis are in place.

primary_purpose: Other


title: Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa

summary: The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.

ReferenceCitation: Köhler T, Perron GG, Buckling A, van Delden C. Quorum sensing inhibition selects for virulence and cooperation in Pseudomonas aeruginosa. PLoS Pathog. 2010 May 6;6(5):e1000883. doi: 10.1371/journal.ppat.1000883.

family: Köhler

full_name: Thilo Köhler

given: Thilo

family: Perron

full_name: Gabriel G. Perron

given: Gabriel G.

family: Buckling

full_name: Angus Buckling

given: Angus

family: van Delden

full_name: Christian van Delden

given: Christian

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS Pathogens

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Geneva - Archive ouverte UNIGE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Quorum Sensing Inhibition Selects for Virulence and Cooperation in Pseudomonas aeruginosa

lead_sponsor: Anbics Management-Services Ag

location_country:
Former Serbia and Montenegro
Switzerland
France
Poland
Belgium
Spain

location_facility: Intensive Car Unit, Calmette University Hospital of Lille

location_facility: Internal Medicine, Vall d'Hebron Hospital

location_facility: Intensive Care Unit, Joan XXIII University Hospital

location_facility: Intensive Care Unit, Jean Minjoz University Hospital

location_facility: General Intensive Care Unit, Montauban City Hospital

location_facility: Medical Intensive Care Unit, Cochin Hospital

location_facility: Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery

location_facility: Surgical and Medical Intensive Care Units, University Hospital Lausanne

location_facility: Medical Intensive Car Unit, Hospital Bichat

location_facility: Intensive Care Unit, Wojewodzki Hospital

location_facility: General Intensive Care Unit, Hospital Saint-Joseph

location_facility: Surgical Intensive Car Unit; University Hospital Bichat

location_facility: Intensive Care Unit, San Dureta University Hospital

location_facility: Intensive Care Unit, Clinique Saint-Pierre

location_facility: General Intensive Car Unit, Centre Hospitalier Universitaire de Liège

location_facility: Medical-surgical intensive car unit, Dupuytren Teaching Hospital


title: Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care

acronym: REVEH

summary:
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.

However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment.

Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.

lead_sponsor: Weprom

location_facility: Centre Jean Bernard - Clinique Victor Hugo


title: Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease

summary:
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.

Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.

Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.

Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.

The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.

lead_sponsor: ADIR Association

location_facility: Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil


title: Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis

acronym: REFLATE TB2

summary: Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.

ReferenceCitation: De Castro N, Marcy O, Chazallon C, Messou E, Eholié S, N'takpe JB, Bhatt N, Khosa C, Timana Massango I, Laureillard D, Chau GD, Domergue A, Veloso V, Escada R, Wagner Cardoso S, Delaugerre C, Anglaret X, Molina JM, Grinsztejn B; ANRS 12300 Reflate TB2 study group. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial. Lancet Infect Dis. 2021 Jun;21(6):813-822. doi: 10.1016/S1473-3099(20)30869-0. Epub 2021 Mar 2.

family: De Castro

full_name: Nathalie De Castro

given: Nathalie

family: Marcy

full_name: Olivier Marcy

given: Olivier

family: Chazallon

full_name: Corine Chazallon

given: Corine

family: Messou

full_name: Eugène Messou

given: Eugène

family: Eholié

full_name: Serge Eholié

given: Serge

family: N'takpe

full_name: Jean-Baptiste N'takpe

given: Jean-Baptiste

family: Bhatt

full_name: Nilesh Bhatt

given: Nilesh

family: Khosa

full_name: Celso Khosa

given: Celso

family: Timana Massango

full_name: Isabel Timana Massango

given: Isabel

family: Laureillard

full_name: Didier Laureillard

given: Didier

family: Chau

full_name: Giang Do Chau

given: Giang Do

family: Domergue

full_name: Anaïs Domergue

given: Anaïs

family: Veloso

full_name: Valdilea Veloso

given: Valdilea

family: Escada

full_name: Rodrigo Escada

given: Rodrigo

family: Wagner Cardoso

full_name: Sandra Wagner Cardoso

given: Sandra

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

family: Anglaret

full_name: Xavier Anglaret

given: Xavier

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Grinsztejn

full_name: Beatriz Grinsztejn

given: Beatriz

family: Irmine

full_name: Ahyi Irmine

given: Ahyi

family: Kakou

full_name: Aka Kakou

given: Aka

family: Ana cláudia

full_name: Alves Ana cláudia

given: Alves

family: Jacqueline

full_name: Amani Jacqueline

given: Amani

location_country:
Brazil
Côte D'Ivoire
Vietnam
Mozambique
France

location_facility: Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ

location_facility: PACCI / CePReF Centre de Prise en charge de Recherche et de Formation

location_facility: Instituto Nacional de Saude / Hospital Geral de Machava


title: Phase II Trial in Inoperable œsophageal Cancer Evaluating the Feasibility of the Combination of Definitive Chemoradiation With the Immune Checkpoint Blockers Nivolumab +/- Ipilimumab

acronym: CRUCIAL

summary:
The main objective of the trial is to assess the feasibility and the safety of the addition of immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant chemoradiation therapy (CRT) in inoperable patients with early or locally advanced oesophageal cancer and to select the more promising experimental arm among the two possible combinations in terms of activity (based on progression free survival (PFS) at 12 months according to RECIST 1.1) for further evaluation in a phase III trial.

The secondary objectives will aim to evaluate progression-free survival, failure-free survival and overall survival and pattern of progression (including incidence of distance metastasis).

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

location_country: France Spain

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)


title: BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

acronym: BIOFLOW-II

summary: The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

ReferenceCitation: Lefèvre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabaté M, Goicolea J, Barragan P, Cook S, Macia JC, Windecker S. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial. JACC Cardiovasc Interv. 2018 May 28;11(10):995-1002. doi: 10.1016/j.jcin.2018.04.014.

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Haude

full_name: Michael Haude

given: Michael

family: Neumann

full_name: Franz-Josef Neumann

given: Franz-Josef

family: Stangl

full_name: Karl Stangl

given: Karl

family: Skurk

full_name: Carsten Skurk

given: Carsten

family: Slagboom

full_name: Ton Slagboom

given: Ton

family: Sabaté

full_name: Manel Sabaté

given: Manel

family: Goicolea

full_name: Javier Goicolea

given: Javier

family: Barragan

full_name: Paul Barragan

given: Paul

family: Cook

full_name: Stéphane Cook

given: Stéphane

family: Macia

full_name: Jean-Christophe Macia

given: Jean-Christophe

family: Windecker

full_name: Stephan Windecker

given: Stephan

journal_name: JACC: Cardiovascular Interventions

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

ReferenceCitation: Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefèvre T, Saito S, Slagboom T, Kandzari D, Koolen J, Waksman R, Richardt G. Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents. J Am Heart Assoc. 2021 Jun 15;10(12):e019815. doi: 10.1161/JAHA.120.019815. Epub 2021 May 29.

name: Heart Center Bad Segeberg Segeberger Kliniken GmbH Bad Segeberg Germany

family: Hemetsberger

full_name: Rayyan Hemetsberger

given: Rayyan

name: Cardiology Department Al‐Azhar University Cairo Egypt

name: Cardiology Department Amsterdam University Medical CenterUniversity of Amsterdam the Netherlands

family: Abdelghani

full_name: Mohammad Abdelghani

given: Mohammad

family: Toelg

full_name: Ralph Toelg

given: Ralph

family: Mankerious

full_name: Nader Mankerious

given: Nader

family: Allali

full_name: Abdelhakim Allali

given: Abdelhakim

name: Medstar Washington Hospital Center Washington DC

family: Garcia‐Garcia

full_name: Hector M. Garcia‐Garcia

name: Inselspital (University Hospital) Bern Switzerland

name: Hospital Privé Jaques Cartier Massy France

name: Onze Lieve Vrouwe Gasthuis Amsterdam the Netherlands

name: Catharina Hospital Eindhoven the Netherlands

journal_name: Journal of the American Heart Association

title: Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer‐Generation Drug‐Eluting Stents

ReferenceCitation: Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.

name: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).

name: Department of Cardiology, Bern University Hospital, Switzerland (S.W.).

name: Department of Cardiology, Shonan Kamakura General Hospital, Japan (S.S.).

name: Piedmont Heart Institute, Atlanta, GA (D.E.K.).

ReferenceCitation: Toelg R, Slagboom T, Waltenberger J, Lefèvre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

name: HerzzentrumSegeberger Kliniken GmbH Bad Segeberg Germany

name: HeartcenterOLVG Amsterdam The Netherlands

name: Klinik für Innere Med. ISRH Zentralklinikum Suhl gGmbH Suhl Germany

name: Hospital Privé Jacques Cartier Massy France

name: Department of CardiologyOkinawa Tokushukai Shonan Kamakura General Hospital Kamakura Japan

name: Piedmont Heart Institute Atlanta Georgia USA

name: Catharina Hospital Eindhoven The Netherlands

journal_name: Catheterization and Cardiovascular Interventions

ReferenceCitation: Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabaté M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Jüni P, Lefèvre T. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001441. doi: 10.1161/CIRCINTERVENTIONS.114.001441.

name: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany (F.-J.N.); Charité-Campus Mitte, Berlin, Germany (K.S.); Charité Campus Benjamin Franklin, Berlin, Germany (B.W.); Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (T.S.); Hospital Clínic, Thorax Institute, Barcelona, Spain (M.S.); IDIBAPS, University of Barcelona,...

location_country: Austria Switzerland Netherlands France Hungary Spain Germany Latvia

location_facility: University Hospital of Bern (Inselspital)

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Hospital Clínico y Provincial de Barcelona


title: Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

acronym: DETECT

summary:
The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine.

This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

lead_sponsor: Nantes University Hospital

location_facility:
Chu Rennes
Chd Vendee
Chu Angers
Chu Nantes