title: French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)

summary: This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.

ReferenceCitation: Bachy E, Le Gouill S, Di Blasi R, Sesques P, Manson G, Cartron G, Beauvais D, Roulin L, Gros FX, Rubio MT, Bories P, Bay JO, Llorente CC, Choquet S, Casasnovas RO, Mohty M, Guidez S, Joris M, Loschi M, Carras S, Abraham J, Chauchet A, Drieu La Rochelle L, Deau-Fischer B, Hermine O, Gastinne T, Tudesq JJ, Gat E, Broussais F, Thieblemont C, Houot R, Morschhauser F. A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma. Nat Med. 2022 Oct;28(10):2145-2154. doi: 10.1038/s41591-022-01969-y. Epub 2022 Sep 22.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: LillOA (Lille Open Archive);PubMed Central

lead_sponsor: The Lymphoma Academic Research Organisation

collaborators:
Gilead Sciences
Novartis

location_facility: ICANS (Institut de Cancérologie Strasbourg Europe)

location_facility: Hôpital de la Milétrie - CHU de Poitiers

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Institut de Cancérologie Hématologie Universitaire de Saint Etienne

location_facility: APHP - Hôpital Universitaire Robert Debré

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)


study_start_date_type: Actual

acronym: HYCOVID

intervention_type: Drug

lead_sponsor: University Hospital, Angers

summary:
A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated.

Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening.

The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

ReferenceType: derived

ReferenceCitation: Dubee V, Roy PM, Vielle B, Parot-Schinkel E, Blanchet O, Darsonval A, Lefeuvre C, Abbara C, Boucher S, Devaud E, Robineau O, Rispal P, Guimard T, d'Anglejean E, Diamantis S, Custaud MA, Pellier I, Mercat A; HYCOVID study group; HYCOVID investigators; Angers University Hospital; Cholet Hospital; Laval Hospital; Le Mans Hospital; Tours University Hospital; Quimper Hospital; La Roche sur Yon Hospital; Tourcoing Hospital; Orleans Hospital; Nantes University Hospital; Niort Hospital; Lorient Hospital; Brest University Hospital; Cherbourg Hospital; Saint-Brieuc Hospital; Creteil - APHP University Hospital; Saint-Antoine - APHP University Hospital; Saint-Etienne University Hospital; Toulouse University Hospital; Melun Hospital; Dijon University Hospital; Princesse Grace - Monaco Hospital; Versailles Hospital; Colmar Hospital; Agen-Nerac Hospital; Caen University Hospital; Saint-Nazaire Hospital; Nantes - Confluent Hospital; Limoges University Hospital; Poitiers University Hospital; Amiens University Hospital; Bobigny - APHP University Hospital; Cergy-Pontoise Hospital; Valencienne Hospital; Valencienne - Clinique Tessier Hospital; Henri-Mondor - APHP University Hospital; Chalon-sur-Saone Hospital; Marseille European Hospital; Auxerre Hospital; Diaconnesses Croix-Saint-Simon Hospital; Marseille - Saint Joseph Hospital; HYCOVID management team: Steering committee (authors); HYCOVID management team: Independant data safety and monitoring board; HYCOVID management team: Independent adjudication of clinical events committee; Study management: Coordination; Study management: Data management. Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial. Clin Microbiol Infect. 2021 Aug;27(8):1124-1130. doi: 10.1016/j.cmi.2021.03.005. Epub 2021 Apr 1.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

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

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via page says license)

repository_normalized: medRxiv

version: submittedVersion

repositories:
HAL
PubMed Central
medRxiv

repositories_concat: HAL;PubMed Central;medRxiv

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility:
CH Niort
La Pitié-Salpétrière
CHU Toulouse
CH Pointoise
Hôpital Européen - Marseille
GH Croix Saint Simon
CHU Brest
CHU Limoges
CH Quimper
CHU Tours
CHU Amiens
CH Cherbroug
CH Melun
CHR Orléans
Clinique Tessier Valenciennes
CH Auxerre
CH Intercommunal Créteil
CHU Saint-Etienne
APHP Henri Mondor
Hôpital Privé du Confluent
CHU Dijon
CH Valenciennes
CHU Angers
CH Le Mans
CHU Nantes
CH Compiègne
Hôpital Saint-Joseph
CH Versailles
CHU Caen
CH Agen
CH Colmar
APHP Saint-Antoine
CH Lorient
CH Saint-Nazaire
CH Princesse Grace
APHP Emile ROUX
APHP Avicenne
CHD Vendée
CH Laval
CH Cholet
CH Tourcoing
CH Vannes
CH Emile Roux
CHU Poitiers
CH Chalon Sur Saône
CH Saint-Brieuc
APHP Joffre Dupuytren

status: Terminated

title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country: Monaco France

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Unknown


title: Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma

summary:
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.

After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).

Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).

Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:

Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy).
Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.

A total of 250 patients will have to be randomized with 125 patients in each arm.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Filleron T, Le Guellec S, Chevreau C, Cabarrou B, Lesluyes T, Lodin S, Massoubre A, Mounier M, Poublanc M, Chibon F, Valentin T. Value of peri-operative chemotherapy in patients with CINSARC high-risk localized grade 1 or 2 soft tissue sarcoma: study protocol of the target selection phase III CHIC-STS trial. BMC Cancer. 2020 Jul 31;20(1):716. doi: 10.1186/s12885-020-07207-3.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

lead_sponsor_type: industriel

status_simplified: Ongoing

appel_a_projets: PHRCK

region: Occitanie

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

type_etablissement: CLCC

acronyme: CHICSTS 01

titre: Essai CHIC  STS 01-Intérêt de la chimiothérapie péri-opératoire chez les patients porteurs de sarcomes des tissus mous localisés de grade 1 ou 2, définis à HAUT RISQUE par la signature CINSARC

discipline_principale: cancer

nom_porteur: VALENTIN

prenom_porteur: Thibaud


type: Other Identifier

title: EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)

acronym: HIFI

summary:
to compare the efficacy of HIFU treatment with standard treatment in two situations:

as first-line cancer treatment, HIFU is compared to radical prostatectomy.
for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

status: Completed

design_allocation: Non-Randomized

lead_sponsor: Association Francaise d'Urologie

location_country: Guadeloupe France

location_facility: Fondation St Jean de Dieu - Clinique Oudinot

intervention_type: Procedure

status_simplified: Completed


title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy

acronym: INTERMEDIATE

summary: This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

ipd_sharing: No

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
French cancer Institute INCa

location_facility: Institu de Cancérologie de l'Ouest - Site Angers

location_facility: Institu de Cancérologie de l'Ouest - Site St Herblain

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

titre: INTERMEDIATE-01_Essai multicentrique de phase III comparant 2 stratégies chez des patients présentant un cancer différencié de la thyroïde et un risque intermédiaire de maladie résiduelle : Traitement à l'I131 systématique (3.7 GBq sous rhTSH) versus décision de traitement à l'I131 guidée par le taux sérique de Tg post-opératoire et une scintigraphie diagnostique à l'I131

nom_porteur: BARDET

prenom_porteur: Stéphane


acronym: SWIFT

lead_sponsor: Novartis Pharmaceuticals

summary:
Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.

The safety and efficacy of brolucizumab were assessed in 2 randomized, multicenter, double-masked, active treatment-controlled Phase 3 studies in nAMD patients (the HAWK study (RTH258-C001 [NCT02307682]) and the HARRIER study (RTH258-C002 [NCT02434328]). Accordingly, a new Phase 3b study (TALON, CRTH258A2303) is being conducted to evaluate the efficacy and safety of brolucizumab in a Treat-to-Control (TtC) regimen for the treatment of naïve patients with nAMD. In this TtC regimen, patients receive 3 consecutive injections every 4 weeks and then the injection interval is extended by 4 weeks up to a maximum of a 16-week interval. The decision to extend or reduce the injection interval is taken by the Investigator at each visit based on his/her judgment of disease activity, according to the patient visual and/or anatomic outcomes. If there is no disease activity, the injection interval can be extended by 4 weeks ; if disease activity occurs or recurs, the injection interval should be shortened accordingly by 4 weeks at a time or to a minimal interval of 8 weeks. The injection interval can also be maintained if the Investigator deems that the patient do not benefit from injection interval adjustment.

Since all these studies were conducted in a naïve nAMD patient population, no data are available on the efficacy and safety of brolucizumab in pretreated nAMD patients who still present active exudation.

title: A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)

type: EudraCT Number

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

ipd_sharing: Yes


title: Pembrolizumab in Combination With Xelox Bevacizumab in Patients With Microsatellite Stable Mestatic Colorectal Cancer and a High Immune Infiltrate : a Proof of Concept Study

acronym: POCHI

summary:
About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are "microsatellite unstable" (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX.

Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI.

The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC.

Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a "high" or "low" immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype.

Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.

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oa_host_type: repository

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version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Springer

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ReferenceCitation: Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, Chmielowski B, Spasic M, Henry G, Ciobanu V, West AN, Carmona M, Kivork C, Seja E, Cherry G, Gutierrez AJ, Grogan TR, Mateus C, Tomasic G, Glaspy JA, Emerson RO, Robins H, Pierce RH, Elashoff DA, Robert C, Ribas A. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27;515(7528):568-71. doi: 10.1038/nature13954.

ReferenceCitation: Viaud S, Saccheri F, Mignot G, Yamazaki T, Daillere R, Hannani D, Enot DP, Pfirschke C, Engblom C, Pittet MJ, Schlitzer A, Ginhoux F, Apetoh L, Chachaty E, Woerther PL, Eberl G, Berard M, Ecobichon C, Clermont D, Bizet C, Gaboriau-Routhiau V, Cerf-Bensussan N, Opolon P, Yessaad N, Vivier E, Ryffel B, Elson CO, Dore J, Kroemer G, Lepage P, Boneca IG, Ghiringhelli F, Zitvogel L. The intestinal microbiota modulates the anticancer immune effects of cyclophosphamide. Science. 2013 Nov 22;342(6161):971-6. doi: 10.1126/science.1240537.

ReferenceCitation: Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie

location_facility: Chu - Hôpital Morvan - Institut de Cancérologie

location_facility: Privé - Cac - Institut de Cancerologie de Lorraine

location_facility: Ch - Centre Hospitalier de La Côte Basque

location_facility: Chu - Centre Hospitalier Universitaire de Saint Etienne - Hôpital Nord - Service Hge

location_facility: Prive - Institut Du Cancer Avignon Provence

location_facility: Chu - Centre Hospitalier Universitaire Robert Debre

location_facility: Privé - Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Chu - Centre Hospitalier Universitaire Pontchaillou

location_facility: CH - GROUPE HOSPITALIER DE La Rochelle RE AUNIS

location_facility: Privé - Cac - Ico - Site René Gauducheau

location_facility: Privé - Cac - Centre Georges-Francois Leclerc

location_facility: Ch - Ghi - Groupe Hospitalier de L'Est Francilien - Site de Meaux

location_facility: Chu - Hôpital Ambroise Paré - Service Anatomie Pathologique

location_facility: Privé - Polyclinique de Blois - 3Eme Etage

location_facility: Privé - Cac - Paul Strauss / Institut de Cancérologie de Strasbourg Europe


title: Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial

acronym: SESAR

summary:
This study evaluates whether a sedation with inhaled sevoflurane will decrease mortality and increase time off the ventilator at 28 days in patients with acute respiratory distress syndrome (ARDS).

Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation with propofol.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Cavale Blanche Hospital - University Hospital

location_facility: Saint-Louis University Hospital - Assistance Publique-Hôpitaux

location_facility: Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux

location_facility: Saint-Antoine University Hospital - Assistance Publique-Hôpitaux

location_facility: Hotel Dieu Hospital - University Hospital

location_facility: Timone Hospital - Assistance Publique-Hôpitaux

location_facility: Hautepierre Hospital, University Hospitals

location_facility: Pasteur 2 Hospital - University Hospital

location_facility: Saint-Eloi Hospital - University Hospital

location_facility: Lapeyronie Hospital - University Hospital

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: SESAR

titre: Sédation par sevoflurane dans le syndrome de détresse respiratoire aiguë: étude prospective, randomisée, multicentrique

discipline_principale: anesthesiology / resuscitation

nom_porteur: JABAUDON

prenom_porteur: Matthieu


type: Other Grant/Funding Number

title: Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial

acronym: eo-Drive

summary:
The primary objective of this study is to compare treatment failure rates between a group of eosinophilic (eosinophilia > 2% on day 1 of hospitalization) patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo.

Secondarily, treatment failure rates will also be compared between a group of non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Study arms will also be compared for additional aspects of efficacy and safety:

speed of recovery during the initial hospitalization;
corticosteroid side effects / induced comorbidities;
changes in symptoms and episodes of exacerbation;
pulmonary function, oxygen use and ventilation;
patient trajectories and resource use (e.g. survival, consults, episodes of hospitalization, medications);
drug consumption (especially as relates to COPD management, exacerbations and induced comorbidities);
health status, quality of life, activity/disability;
patient safety / adverse events in general.

Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD outcomes will be re-evaluated. The relationships between corticosteroid response and key biomarkers (e.g. infectious groups) will be thoroughly explored, including within eosinophil strata. Potential gender subgroups differences will also be evaluated.

Finally, in prevision of further exploratory studies, a biological collection and an imaging library will be created in association with this protocol. The biological collection will be used to explore the genetic basis and physiology linked with treatment response, gender and patient trajectories. The image library will be used as a platform for the exploration of new imaging markers developed, for example, via machine learning and affiliated techniques.

ReferenceCitation: Suehs CM, Zysman M, Chenivesse C, Burgel PR, Couturaud F, Deslee G, Berger P, Raherison C, Devouassoux G, Brousse C, Roche N, Molimard M, Chinet T, Devillier P, Chanez P, Kessler R, Didier A, Martinat Y, Le Rouzic O, Bourdin A. Prioritising outcomes for evaluating eosinophil-guided corticosteroid therapy among patients with acute COPD exacerbations requiring hospitalisation: a Delphi consensus study. BMJ Open. 2020 Jul 1;10(7):e035811. doi: 10.1136/bmjopen-2019-035811.

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable dataset request to the sponsor coordinating team (c/o Dr Carey Suehs, Department of Medical Information, Hôpital La Colombière, 39 avenue Charles Flahault, 34295 Montpellier Cedex 5, France).

In accordance with French law, dataset usage requests must by approved by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel) prior to access.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: APHP - Hôpital Universitaire Pitié-Salpétrière

location_facility: APHP - Hopital Européen Georges Pompidou

nom_etablissement: CHU MONTPELLIER

acronyme: eo-Drive

titre: Intérêt de la corticothérapie guidé par l'éosinophilie sanguine chez les patients hospitalisés pour exacerbation de BPCO: essai contrôlé, randomisé en double aveugle

discipline_principale: pneumology

nom_porteur: BOURDIN

prenom_porteur: Arnaud


title: A Phase II, Multi-centre Study, to Evaluate the Efficacy and Safety of Osimertinib Treatment for Patients With EGFR-mutated Non-small Cell Lung Cancer (NSCLC) With Brain or Leptomeningeal Metastases

acronym: ORBITAL

summary:
Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment.

In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication.

Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Centre Hospitalier Régional - Hôpital de la Source

location_facility: Lyon - URCOT Centre Hospitalier Universitaire

location_facility: Centre Hospitalier de Villefranche-sur-Saône

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

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


title: Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP

acronym: TEC-ADHERE

summary:
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively.

The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;

For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_facility: Centre Hospitalier Intercommunal JURA-SUD

location_facility: Cabinet des Drs Lorenzi Pernot et Guilloton

location_facility: Cabinet des Drs Chanel-Soulier et Cheron

location_facility: Hôpital Pellegrin / Service : Neurologie

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Assessment of Quitting Versus Using Aspirin Therapy In Patients Treated With Oral Anticoagulation for Atrial Fibrillation or Other Indication With Stabilized Coronary Artery Disease

acronym: AQUATIC

summary:
Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A).
Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A).
During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing.
At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD.
However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice.
The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events.
The coordinating investigators therefore designed a double blind placebo controlled trial in order to assess the optimal antithrombotic regimen that should be pursued long-life in this subset of patients.

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Bayer

location_facility: Hôpital Haut Lévêque -CHU Bordeaux-Pessac

location_facility: CH Louis Pasteur - Chartres - Le Coudray

location_facility: Centre Hospitalier René Dubos - Cergy Pontoise

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: AQUATIC

titre: Evaluation de l'arrêt versus de la poursuite de l'aspirine chez les patients présentant une maladie coronaire stabilisée recevant une anticoagulation pour une fibrillation auriculaire

discipline_principale: cardiology

nom_porteur: GILARD

prenom_porteur: Martine


title: A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study

summary:
There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.

The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.

In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien

location_facility: Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP

location_facility: Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord

location_facility: Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2

location_facility: Service de Médecine Vasculaire - Hôpital de la Côte de Nacre

location_facility: Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle

location_facility: Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing

location_facility: Unité de Génétique médicale, CHU de Rennes, Hôpital Sud

location_facility: Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Service de Neuroradiologie Interventionnelle - Hôpital Foch

location_facility: Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC

location_facility: Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille

location_facility: Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers

location_facility: Service de Cardiologie _ Hôpital des Enfants (Purpan)

location_facility: Service de Génétique Médicale, Hôpital de Hautepierre

location_facility: Service de Lymphologie - Hôpital Cognacq-Jay - Paris

location_facility: Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL

location_facility: Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL

location_facility: Service Pneumologie + Service de Dermatologie _ Hôpital Bretonneau Centre Hospitalier Régional Universitaire de TOURS

location_facility: Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré

location_facility: Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux

location_facility: Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez

location_facility: Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL

location_facility: Service de Cardiologie - Hôpital Bichat, AP-HP

location_facility: Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild

location_facility: Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

location_facility: Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)

location_facility: Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou

intervention_type: Other


title: Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation

acronym: OXYOP 2

summary:
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).

The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.

Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.

In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.

The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.

primary_purpose: Other

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Caen
Clermont-Ferrand
La Réunion
Angers
Marseille
Bordeaux
Rouen
Rennes
Besançon
Amiens
Lille
Association Hopital Foch
APHP Bicêtre
APHP Henri Mondor
Lyon
CHRU de Brest
APHP Saint-Louis
APHP Necker
Toulouse
Poitiers
Nancy
Montpellier
Limoges
Grenoble
Nice
Saint-Etienne
Dijon
Reims
Nantes
Tours
Paris La Salpétrière
Strasbourg

titre: Evaluation d'un transporteur d'oxygène d'origine marine pour la préservation des organes : une étude multicentrique randomisée évaluant l'efficacité d'HEMO2Life® versus traitement conventionnel en transplantation rénale.

discipline_principale: nephrology

nom_porteur: LE MEUR

prenom_porteur: Yannick


title: Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms

acronym: MPN-BIOCLOT

summary: Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Européen Georges Pompidou - APHP

location_facility: CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire

intervention_type: Biological


title: LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

acronym: LONGBOARD

summary: Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique Bordeaux Nord
centre Pierre Curie
CHRU Jean Minjoz
Groupe Hospitalier Pitié Sapêtrière
Hôpital Nord Franche Comté
CHU Amiens
Institut de cancérologie de l'Ouest
Hôpital Layne
Hôpital Privé Jean Mermoz
CHU Robert Debré
Centre Georges François Leclerc
Clinique de Flandre
Hôpital Franco-Britannique
Polyclinique Sainte Côme
Hôpital Cochin
Hôpital Européen
Hôpital Saint Antoine
Hôpital Henri Mondor
CHD Vendée
CHU Poitiers
Hôpital Haut Lévêque
Centre hospitalier de Chauny


title: Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial

acronym: ADAPT

summary:
Sepsis induces both a systolic and diastolic cardiac dysfunction. The prevalence of this septic cardiomyopathy ranges between 30 and 60% according to the timing of assessment and definition used. Although the prognostic role of septic cardiomyopathy remains debated, sepsis-induced left ventricular (LV) systolic dysfunction may be severe and associated with tissue hypoperfusion, while it appears to fully recover in survivors. Accordingly, optimization of therapeutic management of septic cardiomyopathy may contribute to improve tissue hypoperfusion in increasing oxygen delivery, and to reduce related organ dysfunctions in septic shock patients.

Echocardiography is currently the recommended first-line modality to assess patients with acute circulatory failure.

Current Surviving Sepsis Campaign strongly recommends Norepinephrine as the first-choice vasopressor in fluid-filled patients with septic shock. In contrast, the use of Dobutamine is only suggested (weak recommendation, low quality of evidence) in patients with persistent tissue hypoperfusion despite adequate fluid resuscitation and vasopressor support. Levosimendan, an alternative inodilator, has failed preventing acute organ dysfunction in septic patients and has induced more supraventricular tachyarrhythmias than in the control group. Data supporting Dobutamine in this setting are scarce and primarily physiologic and based on monitored effects of this drug on hemodynamics and indices of tissue perfusion.

No randomized controlled trials have yet compared the effects of Dobutamine versus placebo on clinical outcomes. In open-labelled, small sample trials, the ability of septic patients to increase their oxygen delivery during Dobutamine administration appears to be associated with lower mortality.

The tested hypothesis in the ADAPT trial is that Dobutamine will reduce tissue hypoperfusion and associated organ dysfunctions in patients with septic shock and associated septic cardiomyopathy. In doing so, it may participate in improving clinical outcomes.

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Centre d'Investigation Clinique 1415

location_facility:
HCL
Poitiers University Hospital
Lille University Hospital
CH d'Haguenau
University Hospital
Montpellier University Hospital
CHU de Nancy
CHU Strasbourg - service de Réanimation
CHU Orléans - service de Réanimation
Aphp - Ambroise Paré
CH de Bethune
CH de Cannes
CH de Toulon
Dijon university hospital
Hôpital Cochin - service de Réanimation
CH de Brive
CHU de Grenoble-Alpes
CH de Versailles
Aphp - Henri Mondor
CHU Tours - Service de Réanimation
Le Mans Hospital
Limoges University Hospital
Argenteuil Hospital
CH de Vendée
Nice University Hospital
Angouleme Hospital

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: ADAPT

titre: Traitement adjuvant par Dobutamine de la cardiomyopathie septique avec hypoperfusion tissulaire : essai multicentrique randomisé contrôlé.

nom_porteur: VIGNON

prenom_porteur: Philippe


title: Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial

acronym: Corticop

summary: The main objective of this study is to determine if the systemic (intravenous) administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.

lead_sponsor: Versailles Hospital

location_facility: André Mignot Hospital, Intensive care unit

region: Île-de-France

nom_etablissement: CENTRE HOSPITALIER  DE VERSAILLES

acronyme: CORTICOP

titre: Comparaison de la corticothérapie au placebo sur la durée de ventilation mécanique lors des exacerbations aiguës sévères de BPCO en Réanimation : une étude multicentrique, randomisée-contrôlée.

nom_porteur: FERRE

prenom_porteur: Alexis


title: Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy

acronym: RETROLA

summary: This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.

time_perspective: Retrospective

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
AstraZeneca

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire


acronym: DAISY

lead_sponsor: UNICANCER

summary: Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.

sponsor_collaborators: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

location_facility: Institut Régional du Cancer Montpellier (ICM)

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

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

title: Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy


title: Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema

acronym: LOADEX

summary:
Nowadays, steroids and anti-VEGF are the first line treatment for diabetic macular edema. Ozurdex is the most frequently used steroid and has label for both first and second line treatment. Ozurdex treatment paradigm for patients with diabetic macular edema is to inject patient only in case of huge recurrence. The risk of this scheme is a progressive loss of vision due to photoreceptors loss. A more pro-active regimen, as it already exists for anti-VEGF treatment, would allow a better patient management. A new treatment paradigm consisting in a loading dose of 2 injections within 12 weeks, followed by a PRN (Pro Re Nata) regimen with strict retreatment criteria and minimal time limit of 12 weeks between two injections should result in a better visual acuity gain and a limited augmentation of the number of injections (which will remain lower than the number observed for anti-VEGF treatment).

The investigators have therefore chosen a pilot study to investigate the impact on efficacy and on the number of intravitreal injections (IVI) of such a scheme.

location_facility: CHU Toulouse - Hôpital Pierre Paul Riquet

location_facility: Centre Hospitalier National d'Ophtalmologie des XV XX

location_facility: Centre Monticelli Paradis d'ophtalmologie

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse

location_facility: Hôpital d'instruction des armées Desgenettes


title: A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

acronym: ORAKLE

summary: Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Créteil - CHI
Caen - CHU Côte de Nacre
Dijon - CRLCC
Montpellier - CHU
Paris - APHP - Hopital Tenon
Marseille - Institut Paoli Calmette
Boulogne - Ambroise Paré
Bayonne - CH
Lyon - CRLCC
Besançon - CHU
Strasbourg - Nouvel Hôpital Civil
Bordeaux - CHU Hôpital Haut-Lévèque
Marseille - AP-HM Hôpital Nord
Lille - Hôpital Calmette
Nantes - CRLCC
Vandoeuvre-lès-Nancy - CRLCC
Colmar - CH
Paris - APHP Bichat
Le Mans - CHG
Toulon - CHI
Lyon - URCOT
Mulhouse - GHRMSA
Montpellier - Clinique
Paris - Curie
Toulouse - CHU
Saint Quentin - CH
Annecy - CH
Orléans - CHR
Paris - Hôpital Cochin
Suresnes - Hopital Foch
Grenoble - CHU
Angers - CHU


title: Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits

acronym: Memento-Plus

summary:
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive.

Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial.

To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers).

This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.

location_facility: APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal


title: Double-blind, Randomised, Parallel-group, Three-arm, Dose Range, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy, Tolerability and Safety of a Combination of Cypropheptadine and Prazosin on Alcohol Consumption in Patients With Severe Alcohol Use Disorder

acronym: COCKTAIL

summary:
Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients.

180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).

lead_sponsor: Kinnov Therapeutics

sponsor_collaborators:
Kinnov Therapeutics
ECSOR

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse

location_facility: Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia

location_facility: Centre hospitalier Esquirol - Pôle d'addictologie en Limousin

location_facility: Centre Hospitalier de la Côte Basque - Service d'addictologie

location_facility: Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie

location_facility: Association Hospitalière de Bourgogne Franche-Comté

location_facility: Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie

location_facility: Centre Hospitalier universitaire de Nice - Hôpital Archet II

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif

location_facility: Centre Hospitalier de Pau - Unité d'addictologie

location_facility: CHU Provences-Alpes Côte d'Azur Hôpital Publique

location_facility: Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques

location_facility: Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier

location_facility: Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive

location_facility: Centre Hospitalier Universitaire de Dijon - Service d'addictologie


title: A Phase II Single-arm Trial Evaluating Safety and Efficacy of Durvalumab in ECOG Performance Status 2-3, Treatment-naive, Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) and High PD-L1 Tumor Expression

acronym: SAVIMMUNE

summary:
Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

location_facility: Nancy - Institut de Cancérologie de Lorraine


title: Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

acronym: Biper

summary: The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

primary_purpose: Supportive Care

collaborators: Direction Générale de l'Offre de Soin (DGOS)

location_facility: Pasteur 2 Hospital - University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

appel_a_projets: PHRCI

acronyme: BIPER

titre: Extubation des patients neurolésés en réanimation à l'aide d'un score: essai randomisé multicentrique en grappes avec permutation séquentielle (Brain Injured Patients Extubation Readiness study)

discipline_principale: hors cancer

nom_porteur: CHABANNE

prenom_porteur: Russell


acronym: BEPCOME-MB

summary: This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib + encorafenib + pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases (MBM).

sponsor_collaborators: European Association of Dermato Oncology

location_facility: CLCC - Institut de Cancerologie de Montpellier

location_facility: CLCC - Institut de Cancerologie de l'Ouest - Nantes

location_facility: CLCC - IUCT-0 / Institut Claudius Regaud

location_facility: APHP - L'hôpital de la Pitié-Salpêtrière

title: Randomised Phase 2 Trial Testing the Addition of Upfront Stereotactic Radiosurgery to Binimetinib Encorafenib Pembrolizumab Compared to Binimetinib Encorafenib Pembrolizumab Alone in BRAFV600 Mutation-positive Melanoma With Brain Metastasis

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.


title: A Multicentre, Open-label Phase II Trial Evaluating the Safety and Efficacy of Ponatinib Induction Followed by Imatinib Maintenance in Adult Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) ≤ 65 Years

acronym: TIPI

summary:
The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment.

The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Nîmes Caremeau - Institut de Cancérologie du Gard

location_facility: Institut D'Hematologie de Basse Normandie

location_facility: Institut de cancérologie Strasbourg Europe


title: Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial

acronym: SMART ANGEL 2

summary: The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre hospitalier universitaire Amiens-Picardie


title: A Multicentre Phase II, Open-label, Non-randomized Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/- Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies

summary: The objective of this study is to assess the efficacy of the combination of Platinum (carboplatin or cisplatin), Pemetrexed, Atezolizumab+/- Bevacizumab if eligible, in stage IIIB/IV non-squamous non-small cell lung cancer patients with progression-enhancing mutations following targeted therapies.

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
GFPC

location_facility: Hôpital Haut Lévêque,Centre François Magendie


title: Cohort Study to Evaluate the Clinical Features of Patients With Epithelial Ovarian Cancer Depending on Tumoral Mutation of BRCA or Beyond BRCA Genomic Molecular Abnormalities

acronym: GREAT

summary: This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancérologie du Gard - ONCOGARD

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Groupe Hospitalier public du Sud de l'Oise (GHPSO)

location_facility: Centre de Cancérologe du Grand Montpellier

location_facility: Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG)

location_facility: Hôpitaux Drôme Nord - Centre Hospitalier Romans

location_facility: Centre Hospitalier Intercommunal de Fréjus Saint Raphael

location_facility: CHU Saint-Etienne - Pôle de Cancérologie

location_facility: Groupe Hospitalier Bretagne Sud - Hôpital du Scorff

location_facility: Clinique Pasteur - Groupe Oncorad Garonne

location_facility: Centre Hospitalier Sud Francilien (Site Gilles de Corbeil)

location_facility: Centre d'Oncologie et de Radiothérapie 37

location_facility: Polyclinique de Limoges - Clinique Chenieux

location_facility: Centre Hospitalier Général d'Aix-en-Provence

location_facility: CHU Grenoble Alpes - Site Nord (La Tronche)

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: Institut de Cancérologie de Lorraine (ICL) - Centre Alexis Vautrin

location_facility: Centre Médicale Sainte Feyre Alfred Leune

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi

location_facility: Hôpital d'Instruction des Armées Saint-Anne

location_facility: Clinique du Mousseau (CMCO) - Ramsay Santé

location_facility: Institut de Cancérologie de Bourgogne - GRReCC

location_facility: Institut de Cancérologie de l'Ouest - ICO

location_facility: Centre Hospitalier Départemental de Vendée


title: Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia: a Randomized Phase II Trial Comparing FCR and a Chemo-free Combination of Venetoclax and Ibrutinib

acronym: ERADIC

summary:
The aim of this study is to test the potential benefit of an innovative combination of targeted therapy over the standard the immunochemotherapy (FCR). The interest in this study resides in an MRD driven discontinuation of the novel agents, and a fixed maximum duration of these agents. This design allows a true comparison of the efficacy of IV with the immuno-chemotherapy at 2 years of treatment and later.

Finally, other trials propose to include to all risk categories of patients, and we are developing here a stratification preventing the dilution of the results. The intermediate risk patients are the ones for which alternative to chemotherapy is critical, as chemotherapy is likely to alter the clonal evolution of their disease, whereas the low risk patients are already doing well with standard treatment and are likely to benefit from other therapies as well. The high risk patients, id est patients with 17p deletion and or TP 53 mutational status responded very well to new drugs as BTK inhibitors or BLC2 inhibitors.

ipd_sharing_description: At the end of the study, the participant data (DPI) collected in this study may be made available to other researchers who request it from the sponsor and if the rationale is the improvement of knowledge in the CLL. The provision will be evaluated by the sponsor.

lead_sponsor: French Innovative Leukemia Organisation

collaborators:
AbbVie
Janssen-Cilag Ltd.

sponsor_collaborators:
French Innovative Leukemia Organisation
AbbVie
Janssen-Cilag Ltd.

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique


lead_sponsor: University Hospital, Lille

summary: This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

location_facility:
Chu de Grenoble
Chu Dijon Bourgogne
Chru Brest Site Hopital Morvan
Hopital Prive Sevigne - Cesson
Chu de Nantes Site Hotel Dieu Hme
Chu de Tours
Centre Hospitalier Saint-Malo
Chu de Nice Hopital de L'Archet
Chru Rennes Site Pontchaillou
Centre Hospitalier de Saint Quentin
Chi Mont de Marsan Et Pays Des Sources
Ch Chartres Louis Pasteur-Le Coudray
Ch Blois Simone Veil
Chru Jean Minjoz
Gpe Hospitalier La Rochelle-Re-Aunis
Centre Hospitalier de Perigueux
Oncopole Chu Toulouse
Institut Paoli Calmettes
Hôpital Claude Huriez, CHU
Ch Fleyriat
Chu Montpellier
Hopital Haut-Leveque - Chu
Chu de Caen Normandie

title: A Phase III Study Comparing Lenalidomide and Subcutaneous Daratumumab (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy


title: Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year

acronym: PTSD-REA

summary:
Reducing discomfort in the intensive care unit (ICU) should be beneficial to longterm outcomes. This study assesses whether a tailored multicomponent program for discomfort reduction may be effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1-year in general ICU survivors.

The psychiatric morbidity may be increased by the COVID-19 epidemic and its consequences on the healthcare system (patient care, reorganization of French ICUs). The main objective of PTSD-REA_COVID cohort is to assess this psychiatric morbidity 6 months after an ICU stay during the epidemic period.

ReferenceType: result

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oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.

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publisher_dissemination: Cambridge University Press

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publisher_dissemination: American Thoracic Society

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ReferenceCitation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

ReferenceCitation: Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.

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ReferenceCitation: Jehel L, Brunet A, Paterniti S, Guelfi JD. [Validation of the Peritraumatic Distress Inventory's French translation]. Can J Psychiatry. 2005 Jan;50(1):67-71. doi: 10.1177/070674370505000112. French.

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location_facility: Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: Hôpital de Hautepierre_CHU de Strasbourg


title: Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury

acronym: TRUST

summary: The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.

primary_purpose: Prevention

ReferenceCitation: Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.

ReferenceCitation: Tagliaferri F, Compagnone C, Korsic M, Servadei F, Kraus J. A systematic review of brain injury epidemiology in Europe. Acta Neurochir (Wien). 2006 Mar;148(3):255-68; discussion 268. doi: 10.1007/s00701-005-0651-y.

ReferenceCitation: Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81. doi: 10.1097/TA.0b013e31802ef4a3.

ReferenceCitation: af Geijerstam JL, Britton M. Mild head injury: reliability of early computed tomographic findings in triage for admission. Emerg Med J. 2005 Feb;22(2):103-7. doi: 10.1136/emj.2004.015396.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Toulouse
AP-HP Lariboisière
CHU Grenoble Alpes
AP-HP - Avicenne
CH Melun
CHU Nîmes
Chu Reunion
CHU Nantes
CH Monaco
AP-HP Pitié Salpetrière
CHU Clermont-Ferrand
CHRU Lille
CHRU Montpellier
CH Bourg-en-bresse
HCL - Edouard Herriot
CHU Réunion
CHU Poitiers
HCL - Lyon Sud
AP-HM Timone

nom_etablissement: CHU GRENOBLE ALPES

acronyme: TRUST

titre: Intérêt du doppler transcrânien pour la gestion des patients traumatisés crâniens légers

discipline_principale: emergency medicine

nom_porteur: BOUZAT

prenom_porteur: Pierre


title: Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial

summary: The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

ReferenceCitation: Khaled L, Godet T, Jaber S, Chanques G, Asehnoune K, Bourdier J, Araujo L, Futier E, Pereira B. Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol. BMJ Open. 2022 May 6;12(5):e054823. doi: 10.1136/bmjopen-2021-054823.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

publisher_dissemination: British Medical Journal

ipd_sharing_description:
The French National Data Safety Authority (CNIL) forbids making data freely available without prior agreement. Thus, the data underlying study findings cannot be made freely available because of ethical and legal restrictions. However, individual participant data underlying the results reported in the manuscript (text, tables, figures, and appendices) can be obtained after deidentification. Data can be obtained upon request from the IMPROVE-2 steering committee. Readers may contact: efutier@chu-clermontferrand.fr to request the data.

The data cannot be freely available for the reasons mentioned above. Data access can be only possible after scientific assessment and data sharing agreement, detailing the type of data requested. This data sharing agreement has to be signed between applicants and the sponsor, Clermont-Ferrand University Hospital.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique-Hôpitaux de Marseille

acronyme: IMPROVE 2

titre: Ventilation mécanique protectrice pour chirurgie abdominale urgente: étude multicentrique prospective randomisée

discipline_principale: anesthésiologie / réanimation

nom_porteur: FUTIER

prenom_porteur: Emmanuel


title: IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.

summary:
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.

Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.

As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Centre Hospitalier des Deux Vallees Juvisy

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro

location_facility: Centre Hospitalier Departemental Vendee Les Oudairies

location_facility: Centre Hospitalier Universitaire Saint Etienne Hopital Nord

location_facility: Centre Hospitalier Annecy Genevois Site Annecy

location_facility: Centre Hospitalier de Bigorre Site La Gespe

location_facility: Centre Hospitalier Orleans-Hopital La Source

location_facility: Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri

location_facility: Clinique de La Sauvegarde / Cabinet Le Trait D Union


title: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

acronym: PAF-ICU

summary: The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.

collaborators: French Society of Anesthesia and Intensive Care Medecine

location_facility: Institut Régional du Cancer de Montpellier