acronym: TRIALS study

lead_sponsor: InFlectis BioScience

summary:
Prospective, international, randomised, double-blind, placebo controlled, multicentre, parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either IFB-088 + riluzole 100 mg or placebo + riluzole 100 mg. This clinical trial is an exploratory study, designed to show a signal of efficacy of IFB-088 through ALSFRS-R, MITOS and King's College. Respiratory function will be followed through SVC. Biomarkers and quality of life will also be evaluated throughout the study.

Patients will be treated over a 6-month period. After a screening/consent visit, patients will undergo clinic visits at randomisation (V0), at 2 weeks (V1), and at months 1 (V2), 3 (V3) and 6 (V4). One week after V0, the patient will undergo urine analysis (dipstick)and blood sampling for measurement of creatinine

, as well as blood sampling for measurement of creatinine and calculation of eGFR at months 2, 4 and 5. At the V2 visit, in addition to other assessments, patients will undergo blood sampling for PK measurements and urine sampling for crystalluria examination. Blood and urine chemistry, as well as physical examination and vital signs assessment to assess safety will be performed at each visit for safety purpose and crystalluria examination will be repeated at the follow-up visit, performed one month ± one week after V4.

location_facility: Centro Clinico NeMO per le Malattie Neuromuscolari

location_facility: Clinica Neurologica Amaducci (tertiary motor neuron Centre)

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: CHU de Toulouse - Hôpital Pierre-Paul Riquet

location_facility: Sant'Andrea Hospital Unit of Neuromuscular Disorders

location_facility: Centro Regionale Esperto per la Sclerosi Laterale Amiotrofica (C.R.E.S.L.A.)

location_facility: APHM Hôpital La Timone Adultes SCE Maladies Neuromusculaires / SLA

location_facility: CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

title: A Double-blind, Placebo-controlled, Exploratory Randomised Clinical Trial to Assess the Safety and Efficacy of IFB-088 Plus Riluzole 100 mg vs Placebo Plus Riluzole 100 mg in Patients With Bulbar-onset Amyotrophic Lateral Sclerosis.

location_country: Italy France


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.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

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 ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

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.

evidence: open (via free pdf)

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.

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

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.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

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

location_facility: Städt. Klinikum München GmbH Herzchirurgie Bogenhausen

location_facility: Westdeutsches Herzzentrum Essen - Uniklinikum -

location_facility: Policlinico San Matteo/Department of Cardiac Surgery

location_facility: Universitätsklinikum Kiel - Kardiologie u. Angiologie

location_facility: Division of Cardiology, Helsinki University Central Hospital

location_facility: Hopital Cardio-Vasculaire et Pneumologie Louis Pradel

location_facility: Cardiac Surgery dpt., Innsbruck Medical University Hospital

location_facility: St. Thomas Hospital Cardiothoracic surgery dept

location_facility: Univ. Padova, Azienda Ospedaliera di Padova

location_facility: James Cook Hospital - Cardiothoracic Division

lead_sponsor_type: industriel

status_simplified: Completed


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.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Screening

lead_sponsor: Air Liquide Santé International

sponsor_collaborators:
Air Liquide Santé International
Eurofins Biomnis
Monitoring Force Group
Inferential

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

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

intervention_type: Drug


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.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: MedSIR

sponsor_collaborators:
MedSIR
Merck Sharp & Dohme LLC

location_country: Italy Spain France

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Hôpitaux Universitaires de Marseille - Hôpital Nord

status_simplified: Ongoing


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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

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.

design_allocation: Non-Randomized

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.

oa_host_type: repository

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

repository_normalized: HAL

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

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

repositories_concat: HAL

unpaywall_oa_status: green

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

lead_sponsor: EyeTechCare

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

intervention_type: Device


type: EudraCT Number

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, Spottl G, Rank P, Knosel 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, Nolting 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.

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repositories_concat: PubMed Central;www.zora.uzh.ch

publisher_dissemination: The Endocrine Society

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: European Network for the Study of Adrenal Tumours

location_country: Germany Italy Netherlands France

location_facility: Radboud University Nijmegen Medical Centre


lead_sponsor: Sanofi

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.

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.

oa_host_type: closed

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. doi: 10.1167/tvst.5.5.10. eCollection 2016 Oct.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

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

status: Terminated

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

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient 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. Patient 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://vivli.org

location_country:
United States
France

ipd_sharing: Yes


type: Other Grant/Funding Number

title: Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users

acronym: RVCOC

summary: Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).

primary_purpose: Basic Science

collaborators: The French Institute for Public Health Research

location_facility: Laboratoire de Psychologie des Cognitions (Strasbourg University)


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.

primary_purpose: Prevention

ReferenceCitation: Kohler 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.

lead_sponsor: Anbics Management-Services Ag

sponsor_collaborators:
Anbics Management-Services Ag
Swiss National Science Foundation

location_country:
Poland
Switzerland
Belgium
Spain
Former Serbia and Montenegro
France

location_facility: Intensive Care Unit, Jean Minjoz University Hospital

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

location_facility: Intensive Care Unit, San Dureta University Hospital

location_facility: Intensive Car Unit, Calmette University Hospital of Lille

location_facility: Intensive Care Unit, Clinique Saint-Pierre

location_facility: Intensive Care Unit, Joan XXIII University Hospital

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

location_facility: Surgical Intensive Car Unit; University Hospital Bichat

location_facility: General Intensive Care Unit, Montauban City Hospital

location_facility: General Intensive Care Unit, Hospital Saint-Joseph

location_facility: Internal Medicine, Vall d'Hebron Hospital

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

location_facility: Medical Intensive Car Unit, Hospital Bichat

location_facility: Intensive Care Unit, Wojewodzki Hospital

location_facility: Medical Intensive Care Unit, Cochin Hospital

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


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.

status: Unknown status

ipd_sharing: Undecided

ipd_sharing_description: It will be planify

lead_sponsor: University Hospital, Caen

collaborators: Valenciennes Hospital, Valenciennes, FRANCE


lead_sponsor: Redar

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.

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

sponsor_collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

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

type: Registry Identifier


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: 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: Spain France

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

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

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

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


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, Eholie 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.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Merck Sharp & Dohme LLC
Ministry of Health, Brazil

location_country:
Côte D'Ivoire
Brazil
Vietnam
Mozambique
France

location_facility: Instituto Nacional de Saude / Hospital Geral de Machava

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

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


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: Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabate 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.

oa_colors: green hybrid

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

ReferenceCitation: Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, Farhan S, Mankerious N, Elbasha K, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.

publisher_dissemination: Springer-Nature

ReferenceCitation: Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefevre 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.

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

repositories_concat: PubMed Central;boris.unibe.ch

publisher_dissemination: Wolters Kluwer Health

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.

ReferenceCitation: Toelg R, Slagboom T, Waltenberger J, Lefevre 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.

publisher_dissemination: Wiley

ReferenceCitation: Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Juni P, Lefevre 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.

lead_sponsor: Biotronik AG

location_country: Germany Hungary Netherlands Austria Switzerland Latvia Spain France

location_facility: Hospital Clínico y Provincial de Barcelona

location_facility: University Hospital of Bern (Inselspital)

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH


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

collaborators: School of Biosciences - Cardiff University

collaborators: National Reference Center for Huntington's disease Cognitive Neurology Unit

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

collaborators: Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester


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: 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

sponsor_collaborators:
Weprom
L'effet Papillon

location_facility: Centre Jean Bernard - Clinique Victor Hugo


title: Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)

summary: The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.

primary_purpose: Diagnostic

ReferenceType: background

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lead_sponsor: Medtronic BRC

location_country:
Italy
Slovakia
United Kingdom
Netherlands
Serbia
Czech Republic
France

location_facility: Fakultní Nemocnice S Poliklinikou Ostrava

location_facility: Slovenský Ústav Srdcových A Cievnych Chorôb

location_facility: Institut Klinické A Experimentální Medicíny

location_facility: Hôpital Cardiologique Du Haut-Levêque - Chu


title: A Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic Sclerosis

acronym: FASST

summary: Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences. IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms , either IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment.

lead_sponsor: Inventiva Pharma

location_country:
Germany
Italy
Poland
Slovenia
United Kingdom
Netherlands
Switzerland
Spain
Bulgaria
France

location_facility: Multiprofile Hospital for Active Treatment Plovdiv

location_facility: CIRI GmbH Centrum für Innovative Diagnostik und Therapie

location_facility: Istituto di Clinica Medica Generale Polo Didattico

location_facility: Erasmus MC Universitair Medisch Centrum Rotterdam

location_facility: Ospedale di Alta Specializzazione "San Camillo"

location_facility: University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski

location_facility: University Multiprofile Hospital for Active Treatment - "Sveti Ivan Rilski"

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Leeds Institut of Rheumatic and Musculoskeletal Medicine

location_facility: Klinik fur Dermatologie und Venerologie der Universitat zu Köln

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University Multiprofile Hospital for Active Treatment -Kaspela

location_facility: Azienda Ospedalaria Spedali Civili di Brescia


title: A Phase Ib/II Trial Evaluating the Efficacy of MK-3475 and Trastuzumab in Patients With Trastuzumab-resistant, HER2-positive Metastatic Breast Cancers

acronym: PANACEA

summary: Panacea is a phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2- positive metastatic breast cancers

ReferenceCitation: Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.

ReferenceCitation: Hurvitz SA, Betting DJ, Stern HM, Quinaux E, Stinson J, Seshagiri S, Zhao Y, Buyse M, Mackey J, Driga A, Damaraju S, Sliwkowski MX, Robert NJ, Valero V, Crown J, Falkson C, Brufsky A, Pienkowski T, Eiermann W, Martin M, Bee V, Marathe O, Slamon DJ, Timmerman JM. Analysis of Fcgamma receptor IIIa and IIa polymorphisms: lack of correlation with outcome in trastuzumab-treated breast cancer patients. Clin Cancer Res. 2012 Jun 15;18(12):3478-86. doi: 10.1158/1078-0432.CCR-11-2294. Epub 2012 Apr 13.

ReferenceCitation: Denkert C, Loibl S, Noske A, Roller M, Muller BM, Komor M, Budczies J, Darb-Esfahani S, Kronenwett R, Hanusch C, von Torne C, Weichert W, Engels K, Solbach C, Schrader I, Dietel M, von Minckwitz G. Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer. J Clin Oncol. 2010 Jan 1;28(1):105-13. doi: 10.1200/JCO.2009.23.7370. Epub 2009 Nov 16. Erratum In: J Clin Oncol. 2010 Feb 1;28(4):708.

ReferenceCitation: Loi S, Sirtaine N, Piette F, Salgado R, Viale G, Van Eenoo F, Rouas G, Francis P, Crown JP, Hitre E, de Azambuja E, Quinaux E, Di Leo A, Michiels S, Piccart MJ, Sotiriou C. Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin-based chemotherapy: BIG 02-98. J Clin Oncol. 2013 Mar 1;31(7):860-7. doi: 10.1200/JCO.2011.41.0902. Epub 2013 Jan 22.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Loi S, Giobbie-Hurder A, Gombos A, Bachelot T, Hui R, Curigliano G, Campone M, Biganzoli L, Bonnefoi H, Jerusalem G, Bartsch R, Rabaglio-Poretti M, Kammler R, Maibach R, Smyth MJ, Di Leo A, Colleoni M, Viale G, Regan MM, Andre F; International Breast Cancer Study Group and the Breast International Group. Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial. Lancet Oncol. 2019 Mar;20(3):371-382. doi: 10.1016/S1470-2045(18)30812-X. Epub 2019 Feb 11.

lead_sponsor: ETOP IBCSG Partners Foundation

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Breast International Group

location_country: Italy Australia Austria Belgium France

location_facility:
Istituto Europeo di Oncologia
Azienda USL4 Prato
Institut Bergonie
Medical University of Vienna
Centre Leon Berard
Westmead Hospital
CHU Sart Tilman
Institut Gustave Roussy
Jules Bordet Institute
Peter MacCallum Cancer Centre
Institut de Cacérologie de l'OUEST


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:
Chd Vendee
Chu Nantes
Chu Angers
Chu Rennes


title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

acronym: ESMART

summary:
This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019).

The aims of the trial are:

To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and
To explore first signals of activity in a molecularly enriched study population.

ReferenceCitation: Berlanga P, Pierron G, Lacroix L, Chicard M, Adam de Beaumais T, Marchais A, Harttrampf AC, Iddir Y, Larive A, Soriano Fernandez A, Hezam I, Chevassus C, Bernard V, Cotteret S, Scoazec JY, Gauthier A, Abbou S, Corradini N, Andre N, Aerts I, Thebaud E, Casanova M, Owens C, Hladun-Alvaro R, Michiels S, Delattre O, Vassal G, Schleiermacher G, Geoerger B. The European MAPPYACTS Trial: Precision Medicine Program in Pediatric and Adolescent Patients with Recurrent Malignancies. Cancer Discov. 2022 May 2;12(5):1266-1281. doi: 10.1158/2159-8290.CD-21-1136.

evidence: oa repository (via page says license)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Morscher RJ, Brard C, Berlanga P, Marshall LV, Andre N, Rubino J, Aerts I, De Carli E, Corradini N, Nebchi S, Paoletti X, Mortimer P, Lacroix L, Pierron G, Schleiermacher G, Vassal G, Geoerger B. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSe-ESMART trial. Eur J Cancer. 2021 Nov;157:268-277. doi: 10.1016/j.ejca.2021.08.010. Epub 2021 Sep 17.

evidence: open (via crossref license, author manuscript)

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Bautista F, Paoletti X, Rubino J, Brard C, Rezai K, Nebchi S, Andre N, Aerts I, De Carli E, van Eijkelenburg N, Thebaud E, Corradini N, Defachelles AS, Ducassou S, Morscher RJ, Vassal G, Geoerger B. Phase I or II Study of Ribociclib in Combination With Topotecan-Temozolomide or Everolimus in Children With Advanced Malignancies: Arms A and B of the AcSe-ESMART Trial. J Clin Oncol. 2021 Nov 10;39(32):3546-3560. doi: 10.1200/JCO.21.01152. Epub 2021 Aug 4.

ReferenceCitation: Pasqualini C, Rubino J, Brard C, Cassard L, Andre N, Rondof W, Scoazec JY, Marchais A, Nebchi S, Boselli L, Grivel J, Aerts I, Thebaud E, Paoletti X, Minard-Colin V, Vassal G, Geoerger B. Phase II and biomarker study of programmed cell death protein 1 inhibitor nivolumab and metronomic cyclophosphamide in paediatric relapsed/refractory solid tumours: Arm G of AcSe-ESMART, a trial of the European Innovative Therapies for Children With Cancer Consortium. Eur J Cancer. 2021 Jun;150:53-62. doi: 10.1016/j.ejca.2021.03.032. Epub 2021 Apr 20.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Rossoni C, Bardet A, Geoerger B, Paoletti X. Sequential or combined designs for Phase I/II clinical trials? A simulation study. Clin Trials. 2019 Dec;16(6):635-644. doi: 10.1177/1740774519872702. Epub 2019 Sep 20.

publisher_dissemination: SAGE Publications

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
Spain
France

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Pediatric and Adolescent Oncology The Royal Marsden Hospital

location_facility: Unidad de Oncología Pediátrica Hospital Niño Jesús


lead_sponsor: The Lymphoma Academic Research Organisation

summary:
This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :

In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.

location_facility: Centre Hospitalier Annecy-Genevois - Site d'Annecy

location_facility: Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Centre François Magendie - Hôpital du Haut Lévêque

title: A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.

location_country: Belgium France


acronym: ADAGIO Follow-Up

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary: Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).

location_facility:
Teva Investigational Site 7019
Teva Investigational Site 7606
Teva Investigational Site 7205
Teva Investigational Site 7306
Teva Investigational Site 7607
Teva Investigational Site 7604
Teva Investigational Site 7161
Teva Investigational Site 7163
Teva Investigational Site 7611
Teva Investigational Site 7615
Teva Investigational Site 7104
Teva Investigational Site 7044
Teva Investigational Site 7302
Teva Investigational Site 7051
Teva Investigational Site 7056
Teva Investigational Site 7024
Teva Investigational Site 7013
Teva Investigational Site 7052
Teva Investigational Site 7088
Teva Investigational Site 7101
Teva Investigational Site 7039
Teva Investigational Site 7201
Teva Investigational Site 7806
Teva Investigational Site 7802
Teva Investigational Site 7400
Teva Investigational Site 7404
Teva Investigational Site 7085
Teva Investigational Site 7083
Teva Investigational Site 7100
Teva Investigational Site 7504
Teva Investigational Site 7015
Teva Investigational Site 7501
Teva Investigational Site 7164
Teva Investigational Site 7037
Teva Investigational Site 7500
Teva Investigational Site 7081
Teva Investigational Site 7009
Teva Investigational Site 7900
Teva Investigational Site 7160
Teva Investigational Site 7017
Teva Investigational Site 7053
Teva Investigational Site 7054
Teva Investigational Site 7502
Teva Investigational Site 7803
Teva Investigational Site 7304
Teva Investigational Site 7046
Teva Investigational Site 7602
Teva Investigational Site 7022
Teva Investigational Site 7704
Teva Investigational Site 7026
Teva Investigational Site 7004
Teva Investigational Site 7800
Teva Investigational Site 7001
Teva Investigational Site 7082
Teva Investigational Site 7010
Teva Investigational Site 7303
Teva Investigational Site 7045
Teva Investigational Site 7086
Teva Investigational Site 7035
Teva Investigational Site 7006
Teva Investigational Site 7150
Teva Investigational Site 7034
Teva Investigational Site 7307
Teva Investigational Site 7801
Teva Investigational Site 7805
Teva Investigational Site 7506
Teva Investigational Site 7020
Teva Investigational Site 7204
Teva Investigational Site 7507
Teva Investigational Site 7023
Teva Investigational Site 7804
Teva Investigational Site 7002
Teva Investigational Site 7102
Teva Investigational Site 7029
Teva Investigational Site 7902
Teva Investigational Site 7087
Teva Investigational Site 7503
Teva Investigational Site 7200
Teva Investigational Site 7206
Teva Investigational Site 7055
Teva Investigational Site 7610
Teva Investigational Site 7025
Teva Investigational Site 7162
Teva Investigational Site 7300
Teva Investigational Site 7308
Teva Investigational Site 7203
Teva Investigational Site 7011
Teva Investigational Site 7103
Teva Investigational Site 7202
Teva Investigational Site 7080
Teva Investigational Site 7018
Teva Investigational Site 7309
Teva Investigational Site 7601
Teva Investigational Site 7050
Teva Investigational Site 7600
Teva Investigational Site 7089
Teva Investigational Site 7008
Teva Investigational Site 7016
Teva Investigational Site 7048
Teva Investigational Site 7401
Teva Investigational Site 7043
Teva Investigational Site 7505

title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study

location_country:
Germany
Italy
Portugal
Hungary
Argentina
Israel
Romania
United Kingdom
Netherlands
United States
Spain
Canada
France

collaborators:
Teva Neuroscience, Inc.
H. Lundbeck A/S


title: Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

acronym: PEMBROCABOSARC

summary: Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

lead_sponsor: Institut Bergonié

collaborators:
Ipsen
MSD France

sponsor_collaborators:
Institut Bergonié
Ipsen
MSD France

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: PEMBROCABOSARC

titre: Combination of pembrolizumab and cabozantinib in patients with advanced sarcomas

discipline_principale: oncologie,  / sarcomes

nom_porteur: COUSIN

prenom_porteur: Sophie


title: Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)

acronym: ETERNITY

summary: The purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%) and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in chronic hemodialysis patients

ReferenceCitation: Aniort J, Piraud A, Adda M, Perreira B, Bouiller M, Fourcade J, Guerraoui A, Kalbacher E, Krumel T, Moragues HL, Thibaudin D, Vela CG, Vernin G, Weclawiak H, Bernard L, Heng AE, Souweine B. Evaluation of the efficacy of an interdialytic "ethanol 40% v/v - enoxaparin 1000 U/mL" lock solution to prevent tunnelled catheter infections in chronic hemodialysis patients: a multi-centre, randomized, single blind, parallel group study. BMC Nephrol. 2019 Apr 30;20(1):149. doi: 10.1186/s12882-019-1338-6.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex

collaborators: Centre de néphrologie Polyclinique Médipôle Saint-Roch, Rue Ambroise Croizat

collaborators: CHU Hôpital Maison Blanche, 45 Rue Cognacq-Jay 51092 REIMS Cedex

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: ETERNITY

titre: Evaluation de l'efficacité d'un verrou interdialytique à base d'une solution "Ethanol 40% - Enoxaparine 1000 U/mL" pour prévenir les infections de cathéters tunnelisés de dialyse chez les patients hémodialysés chroniques : étude multicentrique randomisée contrôlée en simple aveugle

discipline_principale: néphrologie

nom_porteur: ANIORT

prenom_porteur: Julien


acronym: PELICAN

lead_sponsor: Institut Paoli-Calmettes

summary: This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.

ReferenceCitation: Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Binder-Foucard F, Rasamimanana Cerf N, Belot A, Bossard N. Estimation nationale de l'incidence et de la mortalité par cancer en France entre 1980 et 2012. Étude à partir des registres des cancers du réseau Francim. Partie 1 - Tumeurs solides-Synthèse. In: http://www.invs.sante.fr. 2013.

ReferenceCitation: Chang S, Parker SL, Pham T, Buzdar AU, Hursting SD. Inflammatory breast carcinoma incidence and survival: the surveillance, epidemiology, and end results program of the National Cancer Institute, 1975-1992. Cancer. 1998 Jun 15;82(12):2366-72.

ReferenceCitation: Dawood S, Merajver SD, Viens P, Vermeulen PB, Swain SM, Buchholz TA, Dirix LY, Levine PH, Lucci A, Krishnamurthy S, Robertson FM, Woodward WA, Yang WT, Ueno NT, Cristofanilli M. International expert panel on inflammatory breast cancer: consensus statement for standardized diagnosis and treatment. Ann Oncol. 2011 Mar;22(3):515-523. doi: 10.1093/annonc/mdq345. Epub 2010 Jul 5.

ReferenceCitation: Cristofanilli M, Valero V, Buzdar AU, Kau SW, Broglio KR, Gonzalez-Angulo AM, Sneige N, Islam R, Ueno NT, Buchholz TA, Singletary SE, Hortobagyi GN. Inflammatory breast cancer (IBC) and patterns of recurrence: understanding the biology of a unique disease. Cancer. 2007 Oct 1;110(7):1436-44. doi: 10.1002/cncr.22927.

ReferenceCitation: McCarthy NJ, Yang X, Linnoila IR, Merino MJ, Hewitt SM, Parr AL, Paik S, Steinberg SM, Hartmann DP, Mourali N, Levine PH, Swain SM. Microvessel density, expression of estrogen receptor alpha, MIB-1, p53, and c-erbB-2 in inflammatory breast cancer. Clin Cancer Res. 2002 Dec;8(12):3857-62.

ReferenceCitation: Lerebours F, Bieche I, Lidereau R. Update on inflammatory breast cancer. Breast Cancer Res. 2005;7(2):52-8. doi: 10.1186/bcr997. Epub 2005 Jan 20.

ReferenceCitation: Chevallier B, Bastit P, Graic Y, Menard JF, Dauce JP, Julien JP, Clavier B, Kunlin A, D'Anjou J. The Centre H. Becquerel studies in inflammatory non metastatic breast cancer. Combined modality approach in 178 patients. Br J Cancer. 1993 Mar;67(3):594-601. doi: 10.1038/bjc.1993.109.

ReferenceCitation: Rouesse J, Friedman S, Sarrazin D, Mouriesse H, Le Chevalier T, Arriagada R, Spielmann M, Papacharalambous A, May-Levin F. Primary chemotherapy in the treatment of inflammatory breast carcinoma: a study of 230 cases from the Institut Gustave-Roussy. J Clin Oncol. 1986 Dec;4(12):1765-71. doi: 10.1200/JCO.1986.4.12.1765.

ReferenceCitation: Brun B, Otmezguine Y, Feuilhade F, Julien M, Lebourgeois JP, Calitchi E, Roucayrol AM, Ganem G, Huart J, Pierquin B. Treatment of inflammatory breast cancer with combination chemotherapy and mastectomy versus breast conservation. Cancer. 1988 Mar 15;61(6):1096-103. doi: 10.1002/1097-0142(19880315)61:63.0.co;2-y.

ReferenceCitation: Jaiyesimi IA, Buzdar AU, Hortobagyi G. Inflammatory breast cancer: a review. J Clin Oncol. 1992 Jun;10(6):1014-24. doi: 10.1200/JCO.1992.10.6.1014.

ReferenceCitation: Cristofanilli M, Buzdar AU, Sneige N, Smith T, Wasaff B, Ibrahim N, Booser D, Rivera E, Murray JL, Valero V, Ueno N, Singletary ES, Hunt K, Strom E, McNeese M, Stelling C, Hortobagyi GN. Paclitaxel in the multimodality treatment for inflammatory breast carcinoma. Cancer. 2001 Oct 1;92(7):1775-82. doi: 10.1002/1097-0142(20011001)92:73.0.co;2-e.

ReferenceCitation: Cristofanilli M, Gonzalez-Angulo AM, Buzdar AU, Kau SW, Frye DK, Hortobagyi GN. Paclitaxel improves the prognosis in estrogen receptor negative inflammatory breast cancer: the M. D. Anderson Cancer Center experience. Clin Breast Cancer. 2004 Feb;4(6):415-9. doi: 10.3816/cbc.2004.n.004.

ReferenceCitation: de Matteis A, Nuzzo F, D'Aiuto G, Labonia V, Landi G, Rossi E, Mastro AA, Botti G, De Maio E, Perrone F. Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast: a single-center, phase II study. Cancer. 2002 Feb 15;94(4):895-901. doi: 10.1002/cncr.20335.abs.

ReferenceCitation: Gradishar WJ, Wedam SB, Jahanzeb M, Erban J, Limentani SA, Tsai KT, Olsen SR, Swain SM. Neoadjuvant docetaxel followed by adjuvant doxorubicin and cyclophosphamide in patients with stage III breast cancer. Ann Oncol. 2005 Aug;16(8):1297-304. doi: 10.1093/annonc/mdi254. Epub 2005 May 19.

ReferenceCitation: Espinosa E, Morales S, Borrega P, Casas A, Madronal C, Machengs I, Illarramendi JA, Lizon J, Moreno JA, Belon J, Janariz J, de la Puente M, Checa T, Mel JR, Gonzalez Baron M. Docetaxel and high-dose epirubicin as neoadjuvant chemotherapy in locally advanced breast cancer. Cancer Chemother Pharmacol. 2004 Dec;54(6):546-52. doi: 10.1007/s00280-004-0830-1. Epub 2004 Aug 17.

ReferenceCitation: Reitsamer R, Peintinger F, Prokop E, Hitzl W. Pathological complete response rates comparing 3 versus 6 cycles of epidoxorubicin and docetaxel in the neoadjuvant setting of patients with stage II and III breast cancer. Anticancer Drugs. 2005 Sep;16(8):867-70. doi: 10.1097/01.cad.0000173475.59616.b4. Erratum In: Anticancer Drugs. 2006 Mar;17(3):363.

ReferenceCitation: Smith IC, Heys SD, Hutcheon AW, Miller ID, Payne S, Gilbert FJ, Ah-See AK, Eremin O, Walker LG, Sarkar TK, Eggleton SP, Ogston KN. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol. 2002 Mar 15;20(6):1456-66. doi: 10.1200/JCO.2002.20.6.1456.

ReferenceCitation: Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.

ReferenceCitation: Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. Erratum In: J Clin Oncol. 2008 Jun 1;26(16):2793.

ReferenceCitation: Goncalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.

ReferenceCitation: Masuda H, Brewer TM, Liu DD, Iwamoto T, Shen Y, Hsu L, Willey JS, Gonzalez-Angulo AM, Chavez-MacGregor M, Fouad TM, Woodward WA, Reuben JM, Valero V, Alvarez RH, Hortobagyi GN, Ueno NT. Long-term treatment efficacy in primary inflammatory breast cancer by hormonal receptor- and HER2-defined subtypes. Ann Oncol. 2014 Feb;25(2):384-91. doi: 10.1093/annonc/mdt525. Epub 2013 Dec 18.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.

ReferenceCitation: Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32. doi: 10.1016/S1470-2045(11)70336-9. Epub 2011 Dec 6.

ReferenceCitation: Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gomez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horvath Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. Erratum In: Lancet. 2012 Feb 18;379(9816):616. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

ReferenceCitation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.

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repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

sponsor_collaborators:
Institut Paoli-Calmettes
MSD France
Oncodistinct

location_facility:
Institut de cancérologie de la loire
Centre Paul Strauss
IUCT-Oncopole Institut Claudius Rigaud
UCL
Grand Hôpital de Charleroi
CHU Ambroise Pare
Clinique de L'Europe
Sint-Augustinus Hospital
Centre Leon Berard
Saint Elisabeth
Institut Curie hopital rene huguenin
CENTRE Francois Baclesse
Institut Sainte Catherine
Jules Bordet
Institut BERGONIE
UZ Gand
Centre Henri Becquerel
Institut Curie

title: A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.


title: A Phase II, Double-blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 (Zibotentan) in Combination With Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients With Non-small Cell Lung Cancer Who Have Failed One Prior Platinum-based Chemotherapy Regimen

summary: The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone

lead_sponsor: AstraZeneca

location_country:
Romania
Bulgaria
Ukraine
Czech Republic
France

location_facility:
research Site
Research Site


title: Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest

acronym: HEAVENwARd

summary:
Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state.

Early prognostication in comatose patients after ROSC remains challenging. Recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after ROSC, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent N20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (NSE) > 60 µg/L, a diffuse and extensive anoxic injury on brain CT/MRI), but with a low sensitivity due to frequent confounding factors.

The heart rate variability (HRV) is a simple and non-invasive technique for assessing the autonomic nervous system function. In patients with a recent myocardial infarction, reduced HRV is associated with an increased risk for malignant arrhythmias or death. In neurology, reduced HRV is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke.

A reduced HRV could be a sensitive, specific and early indicator of diffuse anoxic brain injury after CA.

This multicenter prospective cohort study assesses the added value of early HRV (within 24h of ICU admission) for neuroprognostication after cardiac arrest.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: CMC Ambroise Paré

location_facility: Ambroise Paré - Hartmann Private Hospital Group