title: Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

summary:
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

lead_sponsor: Galderma R&D

location_country: Germany France Netherlands Spain Sweden

location_facility:
Investigative site
Investigational site


type: EudraCT Number

title: Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive.

acronym: LIZ-BONE

summary: The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours

collaborators: International Clinical Trials Association

location_country: Italy Spain France

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Opedaliera Universitaria San Maria della Misericordia

location_facility: Centre de Chirurgie Orthopédique et de la Main

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


type: Registry Identifier

title: Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

summary:
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:

Repair of root or furcation perforations.
Repair of root resorptions (internal and external).
Root-end filling in endodontic surgery (retrograde filling).
Apexification (tooth with open apex).
Revitalization procedure by means of revascularization.

Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Other

ipd_sharing: No

lead_sponsor: Septodont

collaborators: EndoData ReCOL QualityStat

sponsor_collaborators: Septodont EndoData ReCOL QualityStat

location_facility:
AP-HP, Hôpital Louis Mourier
CHU de Reims
HCL de Lyon
CHU de Toulouse
Private dental care office
CHU de Nantes

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

summary: Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012 Sep;51(9):1687-96. doi: 10.1093/rheumatology/kes125. Epub 2012 May 30.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis. Arthritis Care Res (Hoboken). 2012 Feb;64(2):290-4. doi: 10.1002/acr.20671.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Elbaz M, Geher P, Thabut G, Leblanc V, Logeart I. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE). Ann Rheum Dis. 2011 May;70(5):799-804. doi: 10.1136/ard.2010.139261. Epub 2011 Feb 13. Erratum In: Ann Rheum Dis. 2011 Jul;70(7):1349.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Germany Hungary Netherlands France

status_simplified: Completed


title: Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome

acronym: MILESTONE

summary: The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.

ReferenceType: background

ReferenceCitation: Stel VS, van de Luijtgaarden MW, Wanner C, Jager KJ; on behalf of the European Renal Registry Investigators. The 2008 ERA-EDTA Registry Annual Report-a precis. NDT Plus. 2011 Feb;4(1):1-13. doi: 10.1093/ndtplus/sfq191. Epub 2010 Nov 19.

ReferenceCitation: Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Levesque R, Nube MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

ReferenceCitation: Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.1038/sj.ki.5000447.

ReferenceCitation: Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R; Membrane Permeability Outcome (MPO) Study Group. Effect of membrane permeability on survival of hemodialysis patients. J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

lead_sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_country: Italy Spain Belgium France


title: International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer

summary: This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

status: Terminated

lead_sponsor: Accuray Incorporated

sponsor_collaborators:
Accuray Incorporated
Centre Oscar Lambret

location_country:
Germany
United Kingdom
France

intervention_type: Radiation


title: Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

acronym: CHANGE

summary: The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.

time_perspective: Prospective

lead_sponsor: Robocath

sponsor_collaborators:
Robocath
European Cardiovascular Research Center

location_country:
Germany
Italy
Poland
Belgium
South Africa
France

location_facility: Netcare Christiaan Barnard Memorial Hospital


title: Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

summary: Management of participants with low-level persistent viremia

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Janssen-Cilag Ltd.

location_facility:
Hôpital pitié Salpetrière
Hôpital Avicenne
Hôpital Européen Georges Pompidou
Hôpital Purpan
Hôpital Jean Verdier
Hôpital Pellegrin
Hôpital de la côte de Nacre
Hôpital Necker
Hôpital Hôtel Dieu
Hôpital Tenon
Hôpital de l'Hôtel Dieu
Hôpital Bichat
Hôpital Saint André
Hôpital Henry Mondor
Hôpital Cochin
Hôpital Pontchaillou
Hôpital Saint Louis
Hôpital Lariboisière
Hôpital Charles Nicoll
Hôpital de Bicêtre


lead_sponsor: Centre Oscar Lambret

summary: This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma.

ReferenceCitation: Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators:
Centre Oscar Lambret
SFCE

location_facility: Hôpital des Enfants, Groupe Hospitalier Pellegrin

title: International Randomized Phase II Trial of the Combination of Vincristine and Irinotecan With or Without Temozolomide (VI or VIT) in Children and Adults With Refractory or Relapsed Rhabdomyosarcoma

source: euctr

appel_a_projets: PHRCK

region: Hauts-de-France

nom_etablissement: CLCC OSCAR LAMBRET LILLE

type_etablissement: CLCC

titre: Etude internationale de phase II randomisée évaluant l'association Vincristine-Irinotecan avec ou sans Temozolomide (VI ou VIT) chez les enfants et adultes présentant un rhabdomyosarcome réfractaire ou en rechute

discipline_principale: oncologie / oncologie pédiatrique / oncology / pediatric oncology

nom_porteur: DEFACHELLES

prenom_porteur: Anne-Sophie


acronym: SeaSTAR

lead_sponsor: Kubota Vision Inc.

summary:
The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease.

Funding Source -- FDA OOPD

sponsor_collaborators:
Kubota Vision Inc.
Food and Drug Administration (FDA)

location_facility: Università Cattolica del Sacro Cuore - Fondazione Policlinico Gemelli

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: University of Utah John Moran Eye Center

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: UOC Oculistica Asst Fatebene Pratelli Sacco Universita delgi Studi di Milano

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Oxford Eye Hospital,Oxford University Hospitals NHS Foundation Trust

location_facility: University of Michigan Kellogg Eye Center

location_facility: The Wilmer Eye Institute Johns Hopkins University

location_facility: Medical College of Wisconsin-Eye Institute

location_facility: AOU Università della Campania Luigi Vanvitelli

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Universitätsklinikum Tübingen, Department für Augenheilkunde

title: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

type: U.S. FDA Grant/Contract

location_country:
Germany
Italy
United Kingdom
Denmark
Brazil
Netherlands
United States
Spain
South Africa
Canada
France

ipd_sharing: Undecided


lead_sponsor: Tiziana Life Sciences LTD

summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.

location_facility: TGen Clinical Research Services at Scottsdale Healthcare

location_facility: NIH, Center for Cancer Research, Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

location_country:
United States
Italy
France


acronym: TEMO-CARB

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.

sponsor_collaborators: French National Network of Clinical Research in Infectious Diseases (RENARCI)

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: APHP - Georges Pompidou European Hospital

title: Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: TEMO CARB

titre: Témocilline versus carbapénèmes dans le traitement des infections urinaires à entérobactéries productrices de bêta-lactamase à spectre étendu, étude de non inferiorité.

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: PILMIS

prenom_porteur: Benoit


title: Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.

summary: Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

ReferenceCitation: de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

publisher_dissemination: Oxford University Press

location_facility:
Hôpital Avicenne
Hôpital Gui de Chauliac
Hôpital Européen Georges Pompidou
Hôpital Purpan
Hôpital Tenon
Hôpital Meynard
Hôpital Foch
Hôpital Raymond Poincaré
Hôpital Pitié-Salpêtrière
Hôpital Bichat
Centre Hospitalier Sud Francilien
Hôpital Le Bocage
Hôpital Bicêtre
CHU Côte de Nacre
Hôpital Bretonneau
Hôpital Saint-Antoine
Hôpital Necker


title: A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL.

acronym: DATA

summary: A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

ReferenceCitation: Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabie A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital L'Archet
Hopital Lariboisiere
Hopital Civil
Hopital Bretonneau
Hopital Bichat
Hopital Dupuytren
Centre Hospitalier de Melun
Hopital Saint Antoine
Hopital Louis Mourier
Hopital Raymond Poincare
Hopital Zobda Quitman
C.H.D de Vendee
Centre Hospitalier D'Argenteuil
Hopital Cochin
Hopital Necker
Hopital Rene Dubos
Hopital Le Bocage
Hopital Avicenne
Hopital Saint-Andre
Hopital Sainte-Marguerite
Hopital Saint-Jacques
Hopital Tenon
C.H.R.A
Hopital Saint-Jean Roussillon
Hopital Europeen Georges Pompidou
Hopital Jean Verdier
Hopital Pitie-Salpetriere
Hopital Gustave Dron
Chu Cote de Nacre


acronym: PLEO-CMT-FU

lead_sponsor: Pharnext S.C.A.

summary:
All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary study CLN-PXT3003-02, i.e. treatment with PXT3003 or placebo, are eligible to continue in the extension study CLN-PXT3003-03.

Period 1: Patients randomised to PXT3003 dose 1 or placebo in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 1 (5 mL). Patients randomised to PXT3003 dose 2 (5 mL) in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 2 or PXT3003 twice dose 1 (2x5 mL).

Period 2: All patients continue on twice dose 1 (2X5mL).

sponsor_collaborators:
Pharnext S.C.A.
SynteractHCR
Syneos Health
Premier Research Group plc

location_facility: Department of Neurology, University of Minnesota

location_facility: Cntre de Reference des Maladies Neuromusculaires, Hopital Swynghedauwl, CHU Lille

location_facility: Department of Neurology, Salford Royal NHS Foundation Trust

location_facility: Centre de Reference des Neuropathies Peripheriques Rare, Hopital Dupuytren, CHU Limoges

location_facility: Service de Neurologie, Hopital Kremlin Bicetre

location_facility: Peripheral Neuropathy Center, Neurological Institue Building, Columbia University Medical Center

location_facility: Centre de Reference des Maladie Neuromusculaires, CHU la Timone

location_facility: Servicio de Neurologia, Hospital Universitario La Paz

location_facility: Centro de Diagnostico y Tratamiento, Hospital Universitario Virgen del Rocio

location_facility: Servicio de Neurologia, Hospital Universitario i Politécnic La Fe

location_facility: Department of Neurology, McKnight Brain Institute

location_facility: Department of Neurology, Cedars-Sinai Medical Center

location_facility: Department of neurology, Hospital Univesitario de Bellvitge

location_facility: Department of Neurology and Psichiatry, Saint Louis University

location_facility: Service de Neurologie et du Sommeil, CHU Lyon Sud

location_facility: Departement of Neurology, Academic Medical Center

location_facility: Centre de Reference des Maladie Neuromusculaires, Hotel Dieu, CHU de Nantes

status: Active, not recruiting

title: International, Multi-center, Open Label, Follow-up Extension Study Assessing the Long-term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

design_allocation: Non-Randomized

location_country:
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
France


title: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

summary: Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Angers
Centre Hospitalier le Mans
University Hospital, Limoges
Central Hospital, Nancy, France
Pitié-Salpêtrière Hospital

location_facility:
Centre Hospitalier Le Mans
CHU Nantes
AP-HP La Pitié Salpétrière
CHU Limoges
CHU Nancy
CHU Angers

intervention_type: Other


title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT

acronym: PAIN-OUT

summary:
This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

What is the incidence of chronic post surgical pain (CPSP) in Europe?
What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
What are the difference in incidence and risk factors in different European countries?

ReferenceCitation: Fletcher D, Pogatzki-Zahn E, Zaslansky R, Meissner W; Pain Out Group. euCPSP: European observational study on chronic post-surgical pain. Eur J Anaesthesiol. 2011 Jun;28(6):461-2. doi: 10.1097/EJA.0b013e328344b4cd. No abstract available.

ReferenceCitation: Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206. Erratum In: Eur J Anaesthesiol. 2015 Mar;32(3):222.

evidence: open (via free article)

lead_sponsor: European Society of Anaesthesiology

sponsor_collaborators:
European Society of Anaesthesiology
University of Jena

location_country:
Germany
Ireland
Italy
United Kingdom
Romania
Switzerland
Belgium
Spain
Moldova, Republic of
Ukraine
France

location_facility: Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''

location_facility: Ensemble Hospitalier de la Cote in Morges

location_facility: University College Hospital NHS Foundation Trust

location_facility: Central Universitty and Emergency Military Hospital "Dr. Carol Davila"


title: Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Treatment Taken 4 Consecutive Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Therapy

acronym: QUATUOR

summary: The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.

ReferenceCitation: Landman R, de Truchis P, Assoumou L, Lambert S, Bellet J, Amat K, Lefebvre B, Allavena C, Katlama C, Yazdanpanah Y, Molina JM, Petrov-Sanchez V, Gibowski S, Alvarez JC, Leibowitch J, Capeau J, Fellahi S, Duracinsky M, Morand-Joubert L, Costagliola D, Alvarez JC, Girard PM; ANRS 170 QUATUOR study group. A 4-days-on and 3-days-off maintenance treatment strategy for adults with HIV-1 (ANRS 170 QUATUOR): a randomised, open-label, multicentre, parallel, non-inferiority trial. Lancet HIV. 2022 Feb;9(2):e79-e90. doi: 10.1016/S2352-3018(21)00300-3. Erratum In: Lancet HIV. 2022 Feb 22;:

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

collaborators: Unit 1136 INSERM, Faculty of medecine, University Pierre and Marie Curie

location_facility: Centre Hospitalier Général de Saint Nazaire


title: A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)

acronym: HALO

summary: Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

lead_sponsor: Debiopharm International SA

sponsor_collaborators:
Debiopharm International SA
Syneos Health

location_country:
Spain
United Kingdom
France

location_facility: Institut de Cancérologie de l'Ouest- Institut René Gauduchau


acronym: PDOne

lead_sponsor: Fresenius Medical Care Deutschland GmbH

summary: The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.

location_facility: University of North Staffordshire - Renal Medicine - Royal Infirmary

location_facility: KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

location_facility: KfH-Nierenzentrum am Krankenhaus Oststadt

title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis

location_country:
Germany
France
United Kingdom
Denmark
Sweden


acronym: TREAT-CTC

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

summary:
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.

Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.

ReferenceCitation: Ignatiadis M, Rack B, Rothe F, Riethdorf S, Decraene C, Bonnefoi H, Dittrich C, Messina C, Beauvois M, Trapp E, Goulioti T, Tryfonidis K, Pantel K, Repollet M, Janni W, Piccart M, Sotiriou C, Litiere S, Pierga JY. Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial. Eur J Cancer. 2016 Aug;63:97-104. doi: 10.1016/j.ejca.2016.04.024. Epub 2016 Jun 10.

location_facility: Gemeinschaftspraxis Lorenz / Hecker / Wesche

location_facility: Staedtische Kliniken Frankfurt Am Main-Hoechst

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG

location_facility: Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

location_facility: Gemeinschaftspraxis Prof. Salat / Dr. Stötzer

location_facility: HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt

location_facility: Gesellschaft für onkologische Studien, Praxismanagement und -Logistik

location_facility: HELIOS Kliniken - HELIOS Klinik Rottweil

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

location_country:
Germany
United Kingdom
Belgium
France

collaborators:
Hoffmann-La Roche
Janssen Diagnostics, LLC
SUCCESS
UNICANCER


title: Performance Study of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis

summary: The management of rheumatoid arthritis is based on the prescription of disease-modifying anti-rheumatic drugs (DMARDs) to induce clinical and biological remission. If the first line of treatment (methotrexate) fails, a biotherapy may be prescribed. In daily practice, the initiation of a targeted therapy must therefore be based on the prescriber's expertise or qualification in terms of his or her level of experience in the diagnosis and management of chronic inflammatory rheumatic diseases such as rheumatoid arthritis. As the therapeutic arsenal has expanded, so has the question of choosing the right treatment for the right patient at the right time. At present, in daily practice, there is no tool to help clinicians predict treatment efficacy. The choice of biotherapy based on efficacy carries relatively little weight, firstly because this choice is made in relation to other biotherapies, and secondly because there are no superiority studies that have actually demonstrated greater efficacy in favor of one of the targeted therapies. In the age of Big Data, artificial intelligence can be used to develop algorithms for predicting treatment response. mYXpression has developed medical decision support software based on the integration of transcriptomic markers to assess the probability of response and/or non-response to biotherapies for each patient. The algorithm's performance was theoretically tested by retrospectively collecting transcriptomic data and clinical responses to 6 biotherapies from 992 patients included in 17 clinical trials or cohorts. The aim of this observational study is to demonstrate the value of PEAR 2.0 medical decision support software in the management of rheumatoid arthritis patients who are candidates for biotherapy.

ipd_sharing_description: The study protocol and report will be shared if the results are not published.

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
MYEXPRESION

location_facility: Hôpital Roger Salengro University Hospital of Lille


title: HRD Tests for Ovarian cancER

acronym: HERO

summary:
The study concerns patients with Invasive epithelial ovarian cancer, primary Fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy.

To determine HRD status, 2 separate tests will be performed in the study:

Giscar assay : developed by the sponsor
myChoice assay

If one or two tests identifies a HRD status :

a PARP inhibitor treatment may be initiated according to current recommendations

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Oscar Lambret
Chu Amiens
Centre Henri Becquerel
Centre Francois Baclesse

intervention_type: Genetic


type: Other Identifier

title: Characterisation of TLR4+ Blood Cells in Patients With Solid Cancer

acronym: ODYSSEE

summary:
The potential of immunotherapy in the treatment of cancer is now well documented. While excessive activation of the immune system may be associated with severe reactions and/or auto-immune syndromes, it is now clearly established that controlled activation of the adaptive immune system constitutes a major contribution to the treatment of cancer. Antigen-independent activation of the adaptative immune system with " immune checkpoint inhibitors " (ICI) has allowed prolonged survival in a minority of patients with previously intractable disease. However, a variety of tumor indications are still presently inaccessible to immunotherapeutic approaches or poorly responsive to these therapies.

The immune system is a highly reactive complex comprising antigen-specific cells (adaptive immune system) and antigen-agnostic cells (innate immune system) which interact closely in a complex network. The adaptive immune response is mediated by B and T cells upon antigen-specific recognition. The innate response is mediated by macrophages, dendritic cells, Natural Killer cells and assume the immediate defense of the organism against infectious agents. The innate immune system plays a key role in antigen processing and presentation, production of key cytokines and as anti-tumor effector cells. The role of the innate immune system in the control of cancer progression and in cancer therapy is well documented. Natural Killer cells, involved in antibody-dependent cellular cytotoxicity, and cells performing phagocytosis such as macrophages and neutrophils, participate in tumor destruction after intervention of adaptive immune cells and in combination with certain tumor-targeting therapies, such as antibodies recognizing tumor-specific antigens.

The Odyssey project aims to harness the next generation paradigm of cancer immunotherapy : systemic stimulation of the innate immune system.

To achieve this endeavour the investigator will exploit a well-known yet poorly documented phenomenon, i.e. the rare occurrence of cure in cancer patients who have presented a simultaneous severe septic episode at the time of diagnosis.

Several clinical studies have been realized in order to demonstrate the effect of the innate immune response activation by the bacterial LPS (lipopolysaccharides) in cancer therapy. However, severe toxicities have been described even at very low dose of LPS. The LPS-activated immune response is mediated by TLR4 (Toll Like Receptor 4), a transmembrane receptor expressed by several cell types including monocytes and macrophages. The interaction of TLR4 with LPS mainly induces the release of proinflammatory cytokines (so called " canonical pathway "). TLR4-signalling cascade can also induce the release of type I interferon (so called " alternative pathway "), a class of cytokines known to promote antitumoral activity. LPS tolerance is presumed to be rather associated with the activation of the alternative pathway. Therefore, managing this LPS tolerance is a key mechanism that could limit the systemic toxicity of LPS while stimulating the innate immune system.

Héphaïstos-Pharma biotech and the CRCL Onco-Pharmacology lab (Centre de Recherche en Cancérologie de Lyon) have set up a modified formulation of the LPS that improves its pharmacokinetic properties, reduces its toxicity, and preferentially activates TLR4-alternative signalling pathway. Before investigating the effect of this new immunostimulant in a future phase I/II clinical trial, a translational study is required to further characterize the TLR4 positive cells population as well as the innate immune system in patients with solid cancer.

primary_purpose: Screening

lead_sponsor: Hospices Civils de Lyon

location_facility: Oncological and Gynecological Surgery Unit,

location_facility: Oncology Unit, Hospices Civils de Lyon Sud

intervention_type: Biological


title: Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

summary:
Acute respiratory distress syndrome remains a deadly disease with hospital mortality remaining between 40 to 50%. ARDS mortality risk factors have been identified from patient history, common clinical and biological variables in the lung SAFE study. Part of ARDS mortality is attributable to ventilator-induced lung injury (VILI), in relation with inappropriate settings on the ventilator. Tidal hyperinflation and recruitment/derecruitment during lung inflation are 2 identified mechanisms leading to VILI, that may be identified on computed tomography while poorly identified with variables collected at the bedside.

The aim of this study is to identify whether tidal hyperinflation identified on computed tomography is a risk factor for ARDS mortality, independently from know bio-clinical risk factors.

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation

location_facility: Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes


title: A Pilot Single-Arm, Multicenter, Prospective, Post-Market 6 Months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINT™ (HOLOBLUEPRINT™).

acronym: BLUEMR

summary: A pilot Single-Arm, Multicenter, Prospective, Post-Market 6 months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINT™ (HOLOBLUEPRINT™).

lead_sponsor: Stryker Trauma GmbH

sponsor_collaborators:
Stryker Trauma GmbH
ClinSearch

location_facility:
Centre Orthopédique Santy
CHU de Brest
CHU de Tours
APHP Ambroise Paré


title: DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study

acronym: DOR

summary: The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.

ipd_sharing: Yes

ipd_sharing_description: Contact principal investigator

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
Merck Sharp & Dohme LLC

location_facility:
CHU Rouen
CHU Orléans
CH Tourcoing
CHU de Caen


title: Etude du rôle Des microARNs Dans la Physiopathologie de la fièvre méditerranéenne Familiale

acronym: miRinFMF

summary:
Familial Mediterranean Fever (FMF) genetic diagnosis is well established for homozygous patients. On the other hand, although heterozygous individuals are theoretically healthy carriers, 1/3 of them will develop clinical symptoms of FMF and could benefit from prophylactic treatment. This suggests that the disorder expression mechanisms are not fully elucidated to date. The preliminary results obtained at the Institute for Regenerative Medicine and Biotherapy (IRMB) suggest the involvement of an epigenetic mechanism in FMF pathogenesis, and our laboratory has strong arguments as to the involvement of microRNAs (in particular miR-326) which are negative regulators of gene expression.

This study is exploratory and aims to validate the role of miRNAs in the clinical expression of FMF in patients, thus to explore the epigenetic mechanisms that may explain the variability of expression of this disorder.

primary_purpose: Other

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Paris Kremlin Bicêtre

location_facility: Robert Debré University Hospital of Paris


title: GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.

summary: Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.

lead_sponsor: CardioRenal

location_facility:
Biogroup
CHU Grenoble-Alpes
Centre d'Investigation Clinique
Agduc La Tronche


title: Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double Blind Prospective, Non Comparative Proof of Concept Phase II Study

acronym: VITANI

summary: The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of ANIFROLUMAB in combination with phototherapy in adult participants with non-segmental progressive vitiligo

ReferenceCitation: Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.

ReferenceCitation: Picardo M, Dell'Anna ML, Ezzedine K, Hamzavi I, Harris JE, Parsad D, Taieb A. Vitiligo. Nat Rev Dis Primers. 2015 Jun 4;1:15011. doi: 10.1038/nrdp.2015.11.

ReferenceCitation: Whitton ME, Pinart M, Batchelor J, Leonardi-Bee J, Gonzalez U, Jiyad Z, Eleftheriadou V, Ezzedine K. Interventions for vitiligo. Cochrane Database Syst Rev. 2015 Feb 24;(2):CD003263. doi: 10.1002/14651858.CD003263.pub5.

ReferenceCitation: Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.

ReferenceCitation: Boniface K, Seneschal J, Picardo M, Taieb A. Vitiligo: Focus on Clinical Aspects, Immunopathogenesis, and Therapy. Clin Rev Allergy Immunol. 2018 Feb;54(1):52-67. doi: 10.1007/s12016-017-8622-7.

ReferenceCitation: Bertolotti A, Boniface K, Vergier B, Mossalayi D, Taieb A, Ezzedine K, Seneschal J. Type I interferon signature in the initiation of the immune response in vitiligo. Pigment Cell Melanoma Res. 2014 May;27(3):398-407. doi: 10.1111/pcmr.12219. Epub 2014 Feb 21.

ReferenceCitation: Jacquemin C, Rambert J, Guillet S, Thiolat D, Boukhedouni N, Doutre MS, Darrigade AS, Ezzedine K, Blanco P, Taieb A, Boniface K, Seneschal J. Heat shock protein 70 potentiates interferon alpha production by plasmacytoid dendritic cells: relevance for cutaneous lupus and vitiligo pathogenesis. Br J Dermatol. 2017 Nov;177(5):1367-1375. doi: 10.1111/bjd.15550. Epub 2017 Oct 25.

ReferenceCitation: Boukhedouni N, Martins C, Darrigade AS, Drullion C, Rambert J, Barrault C, Garnier J, Jacquemin C, Thiolat D, Lucchese F, Morel F, Ezzedine K, Taieb A, Bernard FX, Seneschal J, Boniface K. Type-1 cytokines regulate MMP-9 production and E-cadherin disruption to promote melanocyte loss in vitiligo. JCI Insight. 2020 Jun 4;5(11):e133772. doi: 10.1172/jci.insight.133772.

ReferenceCitation: Boniface K, Jacquemin C, Darrigade AS, Dessarthe B, Martins C, Boukhedouni N, Vernisse C, Grasseau A, Thiolat D, Rambert J, Lucchese F, Bertolotti A, Ezzedine K, Taieb A, Seneschal J. Vitiligo Skin Is Imprinted with Resident Memory CD8 T Cells Expressing CXCR3. J Invest Dermatol. 2018 Feb;138(2):355-364. doi: 10.1016/j.jid.2017.08.038. Epub 2017 Sep 18.

ReferenceCitation: Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories:
LIRIAS (KU Leuven)
Pure (Denmark)

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Brown SR, Gregory WM, Twelves CJ, Buyse M, Collinson F, Parmar M, Seymour MT, Brown JM. Designing phase II trials in cancer: a systematic review and guidance. Br J Cancer. 2011 Jul 12;105(2):194-9. doi: 10.1038/bjc.2011.235. Epub 2011 Jun 28.

ReferenceCitation: Ratain MJ, Humphrey RW, Gordon GB, Fyfe G, Adamson PC, Fleming TR, Stadler WM, Berry DA, Peck CC. Recommended changes to oncology clinical trial design: revolution or evolution? Eur J Cancer. 2008 Jan;44(1):8-11. doi: 10.1016/j.ejca.2007.09.011. Epub 2007 Nov 5. No abstract available.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
AstraZeneca

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Nice


title: Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial

acronym: IPPOEM

summary: Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
AP-HM
CHU de Nîmes
Clinique mutualiste Beausoleil


title: Controlled Randomized Non-comparative Trial Assessing Active Transcranial Direct Current Stimulation [tDCS] on Left Dorsoleteral Prefrontal Cortex Versus Active tDCS Active on Right Orbitofrontal Cortex to Treat Unipolar Depression

acronym: DEPIMPULSE

summary: The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Chenevier, GH Henri Mondor
CHU de Montpellier
CHU de Clermont-Ferrand
CHU de Besançon


title: Comparison of the Two-year Efficacy of Three Exercise Rehabilitation Strategies on Dyspnea in Patients Who Presented With Secondary Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia

summary:
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management.

Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death.

In patients surviving the initial condition, dyspnea persists and can be found months or even years later, despite the initial rehabilitation. It is strongly associated with anxiety or even the fear of dying and contributes to the occurrence of post-traumatic stress syndromes. This persistent sensation of respiratory discomfort, limiting the patient's autonomy in his activities of daily living, seems to be able to reduce his quality of life. In addition, the perpetuation of this dyspnea could favor a spiral of deconditioning causing a progressive deterioration of the cardio-respiratory system justifying new hospitalizations.

In patients with chronic respiratory failure, exercise rehabilitation supervised by hysiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnoea, thus increasing the quality of life of these patients.

The main objective of this study is to evaluate the effect at 2 years of 3 modes of management of dyspnea: exercise rehabilitation, standard physiotherapy and "usual care" on post-resuscitation dyspnea in patients with presented with severe COVID-19.

ReferenceCitation: Romanet C, Wormser J, Fels A, Lucas P, Prudat C, Sacco E, Bruel C, Plantefeve G, Pene F, Chatellier G, Philippart F. Effectiveness of exercise training on the dyspnoea of individuals with long COVID: A randomised controlled multicentre trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101765. doi: 10.1016/j.rehab.2023.101765. Epub 2023 Jun 2.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

ReferenceCitation: Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

ReferenceCitation: Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

ReferenceCitation: Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.

ReferenceCitation: Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.

ReferenceCitation: Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Centre Hospitalier André Mignot
Centre Hospitalier Victor Dupouy
Fondation Hôpital Saint-Joseph
Hôpital Cochin


title: An Open-label, Phase 0 Clinical Study in Parkinson's Disease Patients and Healthy Volunteers for the Establishment of Biomarker Analytical Methods and ex Vivo Assessment of the Potency of LRRK2 Inhibitors Using Human Biological Samples.

summary: This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.

ipd_sharing_description:
Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Servier

location_facility: Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences

location_facility: Centre Hospitalo-Universitaire Grenoble Alpes


title: APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.

acronym: APAS

summary: Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.

collaborators:
University Hospital, Lille
Kremlin-Bicetre Hospital, Paris
Clinique Sainte-Anne, Strasbourg
Centre Hospitalier de La Rochelle

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility:
Lille University Hospital
Clinique Sainte-Anne
Kremlin-Bicêtre Hospital
La Rochelle General Hospital


title: Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).

acronym: RECIDREAM

summary:
Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients.

Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares.

The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare.

Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.

location_facility: CHU Grenoble Hôpital Michallon-Site Nord


title: A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 as Monotherapy and in Combination Therapy in Patients With Selected Hematological Malignancies and Solid Tumors

summary: This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.

lead_sponsor: Onward Therapeutics

location_facility:
Saint-Eloi Hospital - Montpellier (CHU)
Centre Eugène Marquis
ICM - Montpellier
Saint-Joseph Hospital - Paris


title: Hysteroscopy Versus Endouterine Aspiration in the Management of Trophoblastic Retention: A Prospective Randomized Multicenter Study

acronym: HARET

summary:
Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists.

Aim: The main objective is to compare the efficacy of management by endo-uterine aspiration vs. management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound.

Methods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage.

Patients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation:

Arm A: 110 patients treated by operative hysteroscopy
Arm B: 110 patients treated by endo-uterine aspiration

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

intervention_type: Procedure


title: Effect of a Health Pathway for People With Persistent Symptoms Covid-19

acronym: SPACO+

summary: People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. By proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Urps Medecins Libéraux Auvergne-Rhône-Alpes


title: Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.

acronym: PEDIALOCK

summary:
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology.

Multicentric, controlled, randomized and double-blind label study.

primary_purpose: Prevention

lead_sponsor: Institut Curie

location_facility:
Gustave Roussy
Robert Debre
Saint Louis
Armand Trousseau


title: An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

summary: The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.

lead_sponsor: Smart Immune SAS

location_facility: CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole

location_facility: Centre hospitalier universitaire de Nantes


title: Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae

acronym: LAMBEAU STEPA

summary:
This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the external pudendal free flap in two groups of patients.

A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A phase study.

Stage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female).

Stage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations.

Each patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment).

A complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)


title: Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.

acronym: ESTES

summary: The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread. The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.

lead_sponsor: 1st SurgiConcept

sponsor_collaborators:
1st SurgiConcept
EVAMED

location_facility:
Centre Massilien de la Face
Hôpital Pierre Paul Riquet
Hôpital Henri Mondor


title: Multicentric Before/After Study to Assess the Efficacy and Safety of DBL-4pen Mobile Application on Glycemic Control in Patients With Type 2 Diabetes

summary:
This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.

After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection), the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps, in addition to the Dexcom G6 CGM. An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application.

The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes.

Data related to efficacy of DBL-4pen, global safety of DBL-4pen, compliance with recommended insulin injections, satisfaction with the system and quality of life will be collected.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

lead_sponsor: Diabeloop

sponsor_collaborators: Diabeloop Icadom

location_facility:
CHRU de Strasbourg - Hôpital Civil
CHU Toulouse - Hôpital de Rangueil
CHU Grenoble
CH Sud Francilien


title: Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

acronym: NeckTAR

summary:
Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.

18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET/CT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.

Circulating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.

This is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.

lead_sponsor: Centre Jean Perrin

collaborators: Groupement Inter-Régional de Recherche Clinique et d'Innovation Auvergne Rhône-Alpes

location_facility:
CHU de Saint-Étienne
Hôpital de la Croix-Rousse
CHU de Grenoble Alpes
Centre Jean PERRIN

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LUTTE CONTRE LE CANCER J.PERRIN

acronyme: NeckTAR

titre: Prédiction d'une maladie résiduelle par détection de l'ADN circulant après radiothérapie potentialisée pour un cancer de la tête et du cou localement avancé

discipline_principale: cancer

nom_porteur: BERNADACH

prenom_porteur: Maureen


title: Clinical Investigation Evaluating Safety and Efficacy of Selective Intra-arterial 166Holmium Radiation Therapy in Combination With Atezolizumab and Bevacizumab for Non Resectable Hepatocellular Carcinoma

acronym: HOLMBRAVE

summary:
The goal of this clinical trial is to evaluate the added value of 166Holmium SIRT to Atezolizumab-Bevacizumab in patients with non resectable HCC. The primary endpoint is the Best Objective Response Rate at 6 months after 166Holmium SIRT according to mRECIST.

Participants will be treated by :

Approved first line systemic therapy: Atezolizumab (1200mg Q3W, IV) with Bevacizumab (15mg/kg Q3W, IV)
In combination with 166Holmium selective internal intra-arterial radiation therapy (Quirem Spheres®, the investigational medical device) after a work-up phase considered as "favorable".

Participants will be followed up to 12 months after the first cycle of Atezolizumab and Bevacizumab therapy.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hôpital Saint Eloi
Gustave Roussy
CHU Nantes
AP-HP Hôpital Beaujon


title: Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers

acronym: AJILITT

summary: JIA patients, their parents, and the health care professionals experience the complexity of the initial care pathway. The aim of the study is to explore the referral pathway to access pediatric rheumatology centers for JIA patients. The exploration will aim to identify the barriers and facilitators of referral, based on the conceptual framework of the health literacy. The investigators will conduct a qualitative study using semi-structured interviews. The perspectives of parents/children/health care professionals will be crossed to enrich the data.

ReferenceCitation: Chausset A, Pereira B, Echaubard S, Merlin E, Freychet C. Access to paediatric rheumatology care in juvenile idiopathic arthritis: what do we know? A systematic review. Rheumatology (Oxford). 2020 Dec 1;59(12):3633-3644. doi: 10.1093/rheumatology/keaa438.

ReferenceCitation: Davies K, Cleary G, Foster H, Hutchinson E, Baildam E; British Society of Paediatric and Adolescent Rheumatology. BSPAR Standards of Care for children and young people with juvenile idiopathic arthritis. Rheumatology (Oxford). 2010 Jul;49(7):1406-8. doi: 10.1093/rheumatology/kep460. Epub 2010 Feb 19. No abstract available.

ReferenceCitation: Scott C, Chan M, Slamang W, Okong'o L, Petty R, Laxer RM, Katsicas MM, Fredrick F, Chipeta J, Faller G, Pileggi G, Saad-Magalhaes C, Wouters C, Foster HE, Kubchandani R, Ruperto N, Russo R. Juvenile arthritis management in less resourced countries (JAMLess): consensus recommendations from the Cradle of Humankind. Clin Rheumatol. 2019 Feb;38(2):563-575. doi: 10.1007/s10067-018-4304-y. Epub 2018 Sep 28.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Research on Healthcare Performance Lab U1290

location_facility:
CHU de Clermont-Ferrand
Hopital Nord Franche-Comté
APHP
Hospices Civils de Lyon


title: Impact of a Joint Practice of a Tai Chi Inspired Gymnastics Program on the Relationship Between Family Caregivers and Residents in Nursing Homes

summary:
The goal of this multicentre cluster randomised controlled trial is to evaluate the effects of a joint practice of a Tai Chi inspired gymnastics programme in nursing home on the relationship between family caregivers and residents living with mild to moderate dementia. The intervention consists of 24 sessions of Tai Chi inspired gymnastics programme for two one-hour sessions per week in a family caregiver-resident pair. The researchers will compare the practice of the intervention in pairs with a separate practice and with the absence of intervention to see if any effects are observed on the family caregiver-resident relationship. The hypotheses are as follows:

Hypothesis 1: the relationship between family caregiver and resident will be judged better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.
Hypothesis 2: signs of anxiety and depression in the family caregiver and resident should be lower after joint practice of a Tai Chi inspired gymnastics programme compared to separate practice and compared to no intervention.
Hypothesis 3: the family caregivers' feeling of competence will be higher after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.
Hypothesis 4: the quality of life of the residents will be better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.

lead_sponsor: Fondation Mederic Alzheimer

collaborators:
Malakoff-Humanis
Siel Bleu

sponsor_collaborators:
Fondation Mederic Alzheimer
Malakoff-Humanis
Siel Bleu

location_facility:
EHPAD Korian Samara
EHPAD Afeji Edilys
EHPAD Afeji Les Tilleuls
Résidence Les Terrasses de la Scarpe


title: An Interventional and Translational Study Investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

acronym: CODEBREAK-IGR

summary: This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
AP-HM Hôpital Nord
AP-HP Hôpital Tenon
Centre Léon Bérard


title: Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound: Cluster Randomized Controlled Prospective Multicenter Study in Two Parallel Groups 1:1 in Open-label

acronym: DACEP

summary:
Abdominal aortic aneurysm (AAA) is a localized dilatation of a segment of the aorta artery in its abdominal portion. It affects 1.7% of men aged 65 years and older. In the high-risk population (male smokers aged 65-75 years), its prevalence is estimated to be between 2.8 and 9%. Mortality of ruptured AAAs is high (80% of deaths before hospitalization or perioperatively), whereas mortality of scheduled procedures for unruptured AAAs is less than 5%. AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term. The French National Authority for Health (HAS) recommends targeted screening for AAA by ultrasound at the radiologist. The target population is male smokers or former smokers aged 65 to 75 years, as well as all persons aged 50 to 75 years with a family history of AAA. Despite recommendations, the rate of access to targeted screening appears low. Ultrasound screening for AAA is a rapid, noninvasive, and reproducible test. It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section. It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists.

In addition, new ultra-portable ultrasound devices, inexpensive and with validated performances have appeared on the market in the last few years, making it possible to equip general practitioners (GPs). We propose a simplified care pathway for AAA screening, by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure, which will be performed in the office or at the patient's home, during a usual consultation of general medicine. Our hypothesis is that this new organization will allow better access to screening for the target population, at a lower cost, compared to the current screening method recommended by the HAS (referral of the patient to the radiologist).

primary_purpose: Health Services Research

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Cabinet IPSO Ourcq
Cabinet IPSO Saint Martin
Cabinet IPSO Nation
Cabinet IPSO Italie


title: A Multicenter, Open-label, Proof of Concept Phase II Aiming to Assess the Clinical and Biological Activity of Anti-netrin-1 (NP137) as Add on Therapy in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Immunotherapies

acronym: IMMUNONET

summary:
This study is a multicenter, open-label, proof-of-concept study aiming to assess the clinical and biological impact of NP137 when added to standard PD-1/PD-L1 blockade therapy in 3 independent cohorts of advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1:

Cohort 1 [Stable Disease]: Patients with a radiological documentation of SD according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy.
Cohort 2 [primary refractory]: Patients with documented radiological PD according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy.
Cohort 3 [secondary refractory]: Patients with documented radiological PD following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
NETRIS Pharma

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: Institut Claudius Regaud (IUCT Oncopole)


title: Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility

acronym: APREVIO

summary:
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence.

Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions.

Translated with www.DeepL.com/Translator (free version)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Pascal PERNEY
Gaëlle SULTAN-TIHLL
Nicolas FRANCHITTO
Hélène DONNADIEU


title: Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer

acronym: SMALLHAN

summary:
The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head & neck cancer.

To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head & neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head & neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).

lead_sponsor: Hospices Civils de Lyon

collaborators: Centre international de Recherche sur le Cancer (CIRC)

location_facility: Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale


title: Disease Burden of RSV in Young Children in Primary Care

acronym: RSV ComNet III

summary:
Respiratory diseases are one of the leading causes of morbidity and mortality among young children, and respiratory syncytial virus (RSV) is the most common pathogen causing these respiratory diseases in this age group. RSV can present in the form of a variety of clinical syndromes, including upper respiratory tract infections, bronchiolitis, pneumonia, exacerbations of asthma and viral-induced wheeze. RSV is highly seasonal and occurs mostly during winter seasons in temperate climates. Sixty to seventy percent of all children experience an RSV infection before the age of one, and nearly all do so before the age of two.(

'Burden of disease' is a general term without a universally accepted definition and refers to the human and economic costs that result from poor health. RSV 'burden of disease' studies in young children (aged 0-4 years), have mostly been focused on the morbidity and mortality rates of RSV infections. The socio-economic burden of RSV infections in young children has been studied, however, a meta-analysis showed that of the 365,828 RSV disease episodes included in cost-analysis studies, only 27,286 (7.4%) focused on outpatient and emergency cases. To our knowledge, only two outpatient studies have prospectively investigated the clinical and socio-economic burden of laboratory confirmed RSV infections in young children; and both studies collected data in the early 2000s. More recently, one study has investigated the health care use, duration of illness and complications associated with RSV in a cohort of newborn infants. There is therefore a lack of knowledge on the clinical and socio-economic disease burden of RSV infections in young children in primary care.

Current treatment options for RSV infections are limited to supportive care. The only available antiviral monoclonal antibody (mAb) 'Palivizumab' is considered cost-effective for certain high-risk group infants and requires monthly injections during winter. New candidate RSV vaccines and mAbs (with longer half-life times) are in late-stage clinical trials. Therefore, accurate estimates of the burden of RSV infections, including in primary care, are crucial to better assess the overall impact RSV infections may have on the society.

location_facility: Centre d'Investigation Clinique de Lyon- Groupement Hospitalier Est- Hospices Civils de Lyon

intervention_type: Diagnostic Test


title: A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors

summary: The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

lead_sponsor: Genmab

sponsor_collaborators:
Genmab
BioNTech SE

location_facility:
Centre Leon Berard
Institut Bergonie
Institut Gustave Roussy
Oscar Lambret Center


title: Étude Clinique Des Biomarqueurs de la résilience au Stress: rôle d'ELK1 et GPR56

acronym: GeBra-clin

summary:
70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment.

Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit.

We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHRU de Tours
CHU Montpellier
Hopital Sainte Marguerite
Hopital de la Conception


title: Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy

acronym: CharACTPET-MR

summary:
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.

Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).

Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.

Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Brest
University Hospital, Paris
University Hospital, Angers

location_facility:
CHU de Nantes
CHU Brest
AP-HP La Salpêtrière
CHU Angers


title: Efficacy and Auditory Biomarker Analysis of Fronto-Temporal Transcranial Direct Current Stimulation (tDCS) in Targeting Cognitive Impairment Associated With Recent-onset Schizophrenia: A Randomized Double-blind Sham-controlled Trial

acronym: STICOG

summary:
Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.

Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.

Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.

ipd_sharing_description: The data will be available from the principal investigator to other study investigators or scientists upon reasonable request.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Direction Générale de l'Offre de Soins

location_facility:
CHU Grenoble Alpes
CH Le Vinatier
CH Alpes-Isère
CHU Saint-Etienne

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: STICOG

titre: Efficacité et tolérance de la stimulation électrique transcrânienne fronto-temporale gauche à courant continu (tDCS) comme traitement du déficit cognitif chez les sujets atteints de schizophrénie débutante : essai multicentrique, randomisé, contrôlé.

discipline_principale: psychiatrie

nom_porteur: DONDE

prenom_porteur: Clément


title: Correction of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events

acronym: PECA

summary:
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.

The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.

The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.

lead_sponsor: Novastep

location_facility:
Toulouse University Hospital
Policlinic Bordeaux North Aquitaine
Saint-Charles Clinic
New Clinic Bel Air


title: Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

acronym: PROLIFE

summary:
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.

Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.

Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.

Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.

location_facility:
Centre Hospitalier Dubois Brive
CHU de Nîmes
Institut cancerologie du Gard
Chic Castres-Mazamet


title: Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network

acronym: OUTMEDIC-FR

summary: The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.

ReferenceCitation: Roux B, Sirois C, Niquille A, Spinewine A, Ouellet N, Petein C, Sibille FX, Csajka C, Reeve E, Villeneuve C, Laroche ML. Cross-cultural adaptation and psychometric validation of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in French. Res Social Adm Pharm. 2021 Aug;17(8):1453-1462. doi: 10.1016/j.sapharm.2020.11.004. Epub 2020 Nov 10.

lead_sponsor: Hôpital NOVO

location_facility: Short stay Geriatric department - Hospital Simone Veil

location_facility: Short stay Geriatric department - Hospital René Dubos

location_facility: SSR Geriatric department - Hospital Simone Veil

location_facility: SSR Geriatric department - Hospital René Dubos


title: Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study.

acronym: HospiFlow

summary:
High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.

There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.

Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.

The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CH Bretagne Atlantique vannes-Auray
Hospital Center of DAX
CH de Martigues
CHR d'ORLEANS


title: Effect of Intranasal Oxytocin on Dysphagia Related to Oropharyngo-oesophageal Dysmotility in Children and Adolescents With Prader-Willi Syndrome: a Phase 2B Study

acronym: DYSMOT

summary:
This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS).

This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.

lead_sponsor: University Hospital, Toulouse

location_facility: Hôpital Femme-Mère-enfant Groupement hospitalier Est


title: Prospective, Multicenter Study Assessing a Screening Campaign for Cardiovascular Diseases Risk Factors During SARS-CoV-2 Epidemic

acronym: VACCIPREV

summary:
The goal of this prospective study is to evaluate the impact of an innovative screening campagn (using the medical device "CONSULT STATION®" on french population healthcare . The main aims of this study are:

To determine whether a screening campaign for cardiovascular disease risk factor has a greater impact on the population who is not monitored by a primary care physician
To determine whether people who are not monitored by a primary care physician have greater cardiovascular risk
To determine whether the screening campaign offered to the general population has strengthened the relationship between community medecine and healthcare circuit coordination

Data of patients from vaccination center who agreed to participate to the screening campaign by using the medical device "CONSULT STATION®" will be analyzed.

Patients will also be called at least 3 months after their visit in the vaccination center in order to assess the impact of the screening campaign on their medical monitoring

time_perspective: Retrospective

lead_sponsor: Elsan

location_facility:
Clinique Vauban
Clinique de Saint Omer
Hôpital Privé Saint Claude
Hôpital privé du Hainaut


title: Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part I: Identification of Effusion and Detection of Basilic Vein

acronym: CLIN-ECHO-I

summary:
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.

This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.

The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.

The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators:
ECHOPEN
EIT Health

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ECHOPEN
EIT Health

location_facility: Cochin Hospital - APHP - Pneumology department

location_facility: Avicenne Hospital - APHP - Hepatology Department

location_facility: Paul Brousse Hospital - APHP - Hepatobiliary Center

location_facility: Cochin Hospital - APHP - Emergency Department


title: A Phase II, Prospective, Multicenter Study Assessing the Contribution and Tolerance of a Multi-targeted Microbiotherapy in Addition to Venlafaxine, After Failure of a First-line Antidepressant Treatment in Depressed Patients

acronym: PROMOOD

summary: The study aims to evaluate the contribution of a multi-targeted microbiotherapy at 12 weeks in depressed-patients in a situation of failure of a 1st line of antidepressant treatment and treated in add-on with a 2nd antidepressant, venlafaxine.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
Fondation FondaMental
GYNOV

location_facility: Centre Hospitalier Spécialisé Charles Perrens