title: Study of Genetic Factors Influencing the Factor VIII Response to Desmopressin in Carriers of Hemophilia A: the GIDEHAC Study

acronym: GIDEHAC

summary:
Hemophilia A (HA) is a rare X-linked bleeding disorder caused by a deficiency in factor VIII (FVIII) affecting 1/5,000 males1. Carriers of HA are females carrying the pathogenic variant responsible for the familial HA at a heterozygous status. About 30% of HA carriers have low FVIII levels and can therefore have abnormal bleeding symptoms2,3. Such as males with moderate/mild HA, bleeding can be treated or prevented with either FVIII concentrates or desmopressin4,5. This drug acts as a vasopressin type 2-receptor (V2R) agonist that causes endothelial cells to rapidly secrete von Willebrand factor (VWF) and FVIII from Weibel-Palade bodies into the bloodstream6,7. However, the mechanism of action of post-DDAVP FVIII increase remains poorly understood in hemophilia A. One advantage of DDAVP is that it increases the level of endogenous FVIII, thus avoiding the need for potentially immunogenic exogenous FVIII. It is also cheaper than FVIII concentrates. Finally, it is more widely available in pharmacies in all hospitals with emergency rooms and surgical facilities.

The FVIII response profile to DDAVP in carriers appears quite similar to that seen in men with mild/moderate HA8-11. A post-DDAVP increase in the FVIII level of 2-4 fold the basal level is usually observed. This FVIII response presents an important inter-individual variation making it necessary to carry out a therapeutic test before its use for the anti-hemorrhagic treatment. The basal FVIII level logically conditions the intensity of the post-DDAVP FVIII peak. However, other factors influencing the post-DDAVP FVIII response are very likely. Unfortunately, few series describing the FVIII response to DDAVP in HA carriers have been reported to date and they included too small numbers of patients to precisely analyze the factors of variation in the post-DDAVP FVIII pharmacokinetics (PK). Candy et al did not find any difference depending on the severity of the pathogenic variants for HA or on the age11. However, this study was carried out in a cohort including only 17 patients, therefore too small for a reliable statistical analysis.

The GIDEHAC study (Genetic Influence of Desmopressin Efficacy in Hemophilia A Carriers) is a French study with the following objectives: the description of the post-DDAVP FVIII PK in a large retrospective cohort of HA carriers, the research of patients-related factors influencing this FVIII PK, and the building of predictive population- and Bayesian-based models.

ReferenceCitation: Seaman CD, Xavier F, Ragni MV. Hemophilia A (Factor VIII Deficiency). Hematol Oncol Clin North Am. 2021 Dec;35(6):1117-1129. doi: 10.1016/j.hoc.2021.07.006. Epub 2021 Aug 10.

ReferenceCitation: Plug I, Mauser-Bunschoten EP, Brocker-Vriends AH, van Amstel HK, van der Bom JG, van Diemen-Homan JE, Willemse J, Rosendaal FR. Bleeding in carriers of hemophilia. Blood. 2006 Jul 1;108(1):52-6. doi: 10.1182/blood-2005-09-3879. Epub 2006 Mar 21.

ReferenceCitation: Mannucci PM, Vicente V, Alberca I, Sacchi E, Longo G, Harris AS, Lindquist A. Intravenous and subcutaneous administration of desmopressin (DDAVP) to hemophiliacs: pharmacokinetics and factor VIII responses. Thromb Haemost. 1987 Dec 18;58(4):1037-9.

ReferenceCitation: Leissinger C, Carcao M, Gill JC, Journeycake J, Singleton T, Valentino L. Desmopressin (DDAVP) in the management of patients with congenital bleeding disorders. Haemophilia. 2014 Mar;20(2):158-67. doi: 10.1111/hae.12254. Epub 2013 Aug 12.

ReferenceCitation: van Galen KPM, d'Oiron R, James P, Abdul-Kadir R, Kouides PA, Kulkarni R, Mahlangu JN, Othman M, Peyvandi F, Rotellini D, Winikoff R, Sidonio RF. A new hemophilia carrier nomenclature to define hemophilia in women and girls: Communication from the SSC of the ISTH. J Thromb Haemost. 2021 Aug;19(8):1883-1887. doi: 10.1111/jth.15397.

ReferenceCitation: Kaufmann JE, Vischer UM. Cellular mechanisms of the hemostatic effects of desmopressin (DDAVP). J Thromb Haemost. 2003 Apr;1(4):682-9. doi: 10.1046/j.1538-7836.2003.00190.x.

ReferenceCitation: Kaufmann JE, Oksche A, Wollheim CB, Gunther G, Rosenthal W, Vischer UM. Vasopressin-induced von Willebrand factor secretion from endothelial cells involves V2 receptors and cAMP. J Clin Invest. 2000 Jul;106(1):107-16. doi: 10.1172/JCI9516.

ReferenceCitation: Hews-Girard J, Rydz N, Lee A, Goodyear MD, Poon MC. Desmopressin in non-severe haemophilia A: Test-response and clinical outcomes in a single Canadian centre review. Haemophilia. 2018 Sep;24(5):720-725. doi: 10.1111/hae.13586. Epub 2018 Jul 13.

ReferenceCitation: Kobrinsky NL, Watson CM, Cheang MS, Bishop AJ. Improved hemophilia A carrier detection by DDAVP stimulation of factor VIII. J Pediatr. 1984 May;104(5):718-24. doi: 10.1016/s0022-3476(84)80951-8.

ReferenceCitation: Casonato A, Dannhauser D, Pontara E, Bertomoro A, Orazi B, Santarossa L, Zerbinati P, Girolami A. DDAVP infusion in haemophilia A carriers: different behaviour of plasma factor VIII and von Willebrand factor. Blood Coagul Fibrinolysis. 1996 Jul;7(5):549-53.

ipd_sharing_description: It is not yet known if there will be a plan to make IPD available

lead_sponsor: Groupe Maladies hémorragiques de Bretagne

location_facility: Assistance publique hôpitaux de Marseille


title: REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma

acronym: REVERT

summary: The aim of this protocol is to perform a first randomized controlled trial evaluating how Tezepelumab affects the bronchial morphology (and computed tomographic variables in general) of asthmatic patients. In parallel, the investigators also hope to reproduce clinical benefits and perform a transcriptomic study that will juxtapose changes in genetic expression with changes in bronchial morphology and inflammatory signatures. The general hypothesis is that tezepelumab treatment is capable of at least partially reversing bronchial remodelling as detected on computed-tomographic (CT) scans. The investigators also expect such reversal to occur within a unique physiological repair environment that will be reflected by transcriptomic profiles

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU de Montpelier
CHU Toulouse
Hôpital Foch
Hôpital de la Croix Rousse
CHU Grenoble Alpes La Tronche
APHP Bicêtre
CHRU Lille
CHRU Strasbourg
CHU Dijon
APHP Bichat
Hôpital Haut-Lévêque
Hôpital Nord Marseille

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

summary: The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Dr. Schär AG / SPA

sponsor_collaborators:
Dr. Schär AG / SPA
Slb Pharma

location_facility:
CH Le Mans
Hôpital Nord-Ouest
CH Chalon
CHU Gabriel Montpied
CHU Besançon
Tenon hospital -APHP
AURA Paris
Cabinet médical du Dr Magnant
Maison du Rein
Hospices Civiles de Lyon
CH Mâcon
Hôpital la conception

intervention_type: Other

lead_sponsor_type: industriel


title: Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial

acronym: pc-ASTER

summary:
Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis.

Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population .

Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).

First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome.

Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients .

However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT.

In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.

lead_sponsor: Hopital Foch

location_facility:
Hôpital FOCH
Chu Nantes
CHU Montpellier
CHU de Reims
CHU de Tours
CHU Rennes
CHU Caen
CHU Limoges
APHP - Pitié Salpêtrière
Chru Nancy
Chu Bordeaux
Fondation Adolphe de Rothschild

intervention_type: Procedure

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: HOPITAL FOCH

type_etablissement: EBNL

acronyme: pc-ASTER

titre: Comparaison de l'efficacité de l'aspiration distale versus le stent retriever dans la recanalisation des patients victimes d'un AVC aigu avec une occlusion de l'artère basilaire : protocole ASTER circulation postérieure

discipline_principale: neurologie

nom_porteur: CONSOLI

prenom_porteur: Arturo


title: Validation of Ultrasonic Positive Diagnosis Criteria of Ipsilateral Deep Vein Thrombosis Recurrence of the Lower Limbs Based on Thrombosis Evolution at a 3-month Follow-up Under Anticoagulation: The ULTREC Project Ancillary Study

acronym: ULTRECAncillar

summary:
The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.

The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.

In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.

The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

ReferenceCitation: Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.

ReferenceCitation: Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.

ReferenceCitation: Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.

ReferenceCitation: Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

status_simplified: Completed


type: Other Identifier

title: Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

acronym: PAXIPEM

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancerologie de Lorraine - Alexis Vautrin


title: Outcomes of Adjuvant "Polymer Cerclage System "OrthoLoop" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.

acronym: SERRE

summary:
The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population.

Whether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip/shoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.

The "Sterile Self Locking Polymer Cerclage System" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications.

Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care.

SERRE is a 36 months follow up study in two arms :

Experimental group: "OrthoLoop cercalge"
Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.

The main objective of this study is to assess the role of "OrthoLoop cerclage" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.

ReferenceType: result

ReferenceCitation: Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. doi: 10.1016/j.injury.2007.02.048. Epub 2007 May 2.

ReferenceCitation: Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. doi: 10.1177/112070001002000402.

ReferenceCitation: Tsiridis E, Pavlou G, Venkatesh R, Bobak P, Gie G. Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management. Hip Int. 2009 Apr-Jun;19(2):75-86. doi: 10.1177/112070000901900201.

ReferenceCitation: Ferbert T, Jaber A, Gress N, Schmidmaier G, Gotterbarm T, Merle C. Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up. Hip Int. 2020 Sep;30(5):544-551. doi: 10.1177/1120700019849911. Epub 2019 May 17.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: SAGE Publications

ReferenceCitation: Ebraheim NA, Sochacki KR, Liu X, Hirschfeld AG, Liu J. Locking plate fixation of periprosthetic femur fractures with and without cerclage wires. Orthop Surg. 2013 Aug;5(3):183-7. doi: 10.1111/os.12052.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says Open Access)

host_type: publisher

license: unspecified-oa

license_normalized: unspecified-oa

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Angelini A, Battiato C. Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures. Eur J Orthop Surg Traumatol. 2016 May;26(4):397-406. doi: 10.1007/s00590-016-1761-3. Epub 2016 Mar 17.

publisher_dissemination: Springer-Nature

ReferenceCitation: Gordon K, Winkler M, Hofstadter T, Dorn U, Augat P. Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study. Injury. 2016 Jun;47 Suppl 2:S51-7. doi: 10.1016/S0020-1383(16)47009-9.

publisher_dissemination: Elsevier

ReferenceCitation: Angelini A, Battiato C. Past and present of the use of cerclage wires in orthopedics. Eur J Orthop Surg Traumatol. 2015 May;25(4):623-35. doi: 10.1007/s00590-014-1520-2. Epub 2014 Sep 4.

publisher_dissemination: Springer

ReferenceCitation: Altenburg AJ, Callaghan JJ, Yehyawi TM, Pedersen DR, Liu SS, Leinen JA, Dahl KA, Goetz DD, Brown TD, Johnston RC. Cemented total hip replacement cable debris and acetabular construct durability. J Bone Joint Surg Am. 2009 Jul;91(7):1664-70. doi: 10.2106/JBJS.G.00428.

ReferenceCitation: Silverton CD, Jacobs JJ, Rosenberg AG, Kull L, Conley A, Galante JO. Complications of a cable grip system. J Arthroplasty. 1996 Jun;11(4):400-4. doi: 10.1016/s0883-5403(96)80029-5.

ReferenceCitation: Peeters I, Depover A, Van Tongel A, De Wilde L. A review of metallic and non-metallic cerclage in orthopaedic surgery: Is there still a place for metallic cerclage? Injury. 2019 Oct;50(10):1627-1633. doi: 10.1016/j.injury.2019.06.034. Epub 2019 Jul 13.

lead_sponsor: Quanta Medical

sponsor_collaborators:
Quanta Medical
Cousin Biotech

location_facility:
CH Le Mans
CHU Toulouse
CH Libourne
Ch Metz - Thionville
CHU Nimes
CHRU Nancy
CH Agen
CH Arcachon
CHU Lille
Clinique de Saint Omer
Polyclinique Du Parc
CH Valenciennes

intervention_type: Device


title: Evaluation of Treatment PERSOnalization Based on Its Therapeutic Monitoring in Patients With Metastatic Colorectal Cancer Treated With REgorafenib

acronym: RePERSO

summary:
Regorafenib has demonstrated a significant benefit in overall survival in metastatic colorectal cancer (mCRC) patients. However, more than 50% of patients had severe adverse events (grade 3-4), leading to temporary or definitive discontinuation of treatment.

The RePERSO study proposes to adapt the regorafenib dose regimen taking into account firstly the measurement of sum of metabolites M-2 and M-5 and secondly the occurrence of toxicity during treatment. This treatment personalization through therapeutic drug monitoring pharmacological dosing optimization strategy aims at validating the proof of concept of regorafenib therapeutic drug monitoring and at improving the benefit in OS in patients, using the previously defined Csum therapeutic range.

lead_sponsor: Rennes University Hospital

location_facility: Institut Daniel Hollard, Groupe Hospitalier Mutualiste de Grenoble


title: A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia

acronym: ENDOBARRETT

summary:
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.

A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

lead_sponsor: University Hospital, Angers

location_facility:
Georges Pompidou European Hospital
University Hospital of Rennes
University Hospital of Nantes
Edouard Herriot Hospital
University Hospital of Bordeaux
University Hospital of Lille
University Hospital of Tours
University Hospital of Brest
University Hospital of Nice
Cochin Hospital
University Hospital of Poitiers
University Hospital of Limoges

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: ENDOBARRETT

titre: Etude prospective, multicentrique randomisée contrôlée, comparant l'efficacité de l'Endorotor (nouvelle technique thérapeutique) versus la radiofréquence (technique de référence) dans le traitement de l'endobrachy-oesophage compliqué de dysplasie

discipline_principale: gastro-entérologie

nom_porteur: CESBRON-METIVIER

prenom_porteur: Elodie


title: Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO

acronym: DISCO-SET

summary:
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.

Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.

Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.

The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.

The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.

time_perspective: Cross-Sectional

location_facility:
Laurent LENOBLE
Hoël CHARBONNEL
Marie BROSSET
Lucie MURGALE
Antoine MOUTEL
Lucie DELATTE
Emmanuelle FOURE-AMELOT
Jean-Philippe DUGUEY
Béatrice NEGARET
Romain NIFENECKER
Marieke SALACROUP
Anna JARNO-JOSSE


title: Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis

acronym: Quali-SAT

summary: Patients in maintenance treatment for HFE hemochromatosis since at least one year will be included in a two year study period and randomized in two groups experimental and control group. Because proton pump inhibitors are widely used as chronic medication, and because they can significantly modify iron absorption, patients will be stratified according to the use of proton pump inhibitors and gender. A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients. Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group (patients treated with bloodletting according to current guidelines "ferritin alone" versus patients treated with bloodletting according to "transferrin saturation and serum ferritin").Blood count and iron metabolism parameters will be performed at each bloodletting and follow-up visits. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit. Volume and schedule for bloodlettings will be determined according to guidelines specifically designed for this study to assure harmonization of treatment management, and centrally validated through the recording of the biological tests in the electronic Case Report Form which will provide the investigator with the volume and schedule of the next bloodletting. There will be two ways of treatment modification: either change of schedule or volume of bloodletting. Patients will undergo follow-up visit every six months with clinical examination, questionnaires at J0, M12 and M24 (SF-36; AIMS2-SF, WOMAC, EQ-5D-5L), and biological test. For health economics analysis, data will be obtained thanks to a dedicated extraction from SNDS database SNDS database will allow to gather hospital stays, visits, and other healthcare-related costs as well as vital status (date (month/year) of death) and cause of death. A de-identified copy of the clinical database, restricted to the relevant variables, will be sent for semideterministic matching purpose with SNDS extraction using four key variables: gender, same date (month/year) of birth, same date (day/month/year) of visit for bloodletting; pending, of course, regulatory authorization.

location_facility:
Hôpital Européen Georges Pompidou
CHU Dupuytren
Hôpital Rangueil
Hôpital Paul Brousse
CHR Orléans
CH Yves le Foll
Centre hospitalier Bretagne Atlantique
CHU Rennes
Hopital Avicenne
CH de St Malo
GHRMSA - Hôpital Emile Muller
GHBS site du Scorff

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: Quali-SAT

titre: Impact sur la qualité de vie de la prise en compte de la saturation de la transferrine dans la conduite du traitement d'entretien de l'hémochromatose HFE

discipline_principale: hépatologie

nom_porteur: BARDOU-JACQUET

prenom_porteur: Edouard


title: Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease

acronym: PREPCOV

summary: There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

oa_colors: green other

evidence: open (via free pdf)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: bronze

ReferenceCitation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: University Hospital, Toulouse

location_facility: Haut-Lévêque Hospital - Médecine interne

location_facility: Toulouse University Hospital - Rhumatologie

location_facility: Toulouse university Hospital - Larrey Dermatologie

location_facility: Haut-Lévêque Hospital - Gastro-entérologie

location_facility: University hospital Toulouse - Purpan Médecine interne

location_facility: Pitié Salpêtrière Hospital - Hépatologie

location_facility: Pitié Salpêtrière Hospital - Médecine interne

location_facility: University Hospital of Toulouse - Rangueil Médecine interne

location_facility: Joseph Ducuing Hospital - Médecine interne

intervention_type: Diagnostic Test

status_simplified: Unknown


title: KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

acronym: KETACANCER

summary:
The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication).

The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression.

In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin


title: Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

acronym: DOCTORS-LM

summary: The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

status: Active, not recruiting

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

oa_host_type: publisher

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier de Chartres - Hôpital Louis Pasteur


title: Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

summary:
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.

In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.

In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalo-Universitaire de Grenoble


title: Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial

acronym: EMPROTECT

summary: Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital d'instruction des armées de Percy

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: EMPROTECT

titre: Embolisation de l'artère méningée moyenne en prévention de la récidive des hématomes sous-duraux chroniques chez les patients à haut risque de récidive

discipline_principale: autre

nom_porteur: SHOTAR

prenom_porteur: Eimad


acronym: IMMUNONCOVID

summary:
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit.

According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts:

COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1).
COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

title: A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

type: EudraCT Number

source: euctr


type: Registry Identifier

title: Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.

acronym: GREPH

summary: The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salame E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w. Erratum In: Trials. 2022 May 24;23(1):438.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

lead_sponsor: University Hospital, Tours

collaborators: Unité d'Epidémiologie des Données cliniques en Centre-Val de Loire (EpiDcliC)

collaborators: Unité d'Evaluation Médico-Economique (UEME)

location_facility: CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique

location_facility: APHM - Service de Pharmacie Clinique; Hôpital de la Timone

location_facility: CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre

location_facility: CHU-BREST - Pharmacie clinique La Cavale Blanche

location_facility: CHU-REIMS Service de Pharmacie -Robert Debré

location_facility: CHU-Montpellier Service Pharmacie Lapeyronie

location_facility: APHM Service Pharmacie- Hôpital de la Conception

intervention_type: Behavioral

appel_a_projets: PREPS

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: GRePH

titre: Mise en place d'un Plan Pharmaceutique Personnalisé chez les patients transplantés rénaux et/ou hépatiques

discipline_principale: pharmacologie

nom_porteur: POURRAT

prenom_porteur: Xavier


title: Ocular Surface in Patients With Soft Contact Lenses

summary:
Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact

location_facility: Centre hospitalier national d'ophtalmologie des Quinze-Vingts


title: Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

acronym: SPLEEN

summary: Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.

ReferenceCitation: Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014 Feb;99(2):392-8. doi: 10.3324/haematol.2013.092460. Epub 2013 Sep 20.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.

ReferenceCitation: Aiolfi A, Inaba K, Strumwasser A, Matsushima K, Grabo D, Benjamin E, Lam L, Demetriades D. Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes. J Trauma Acute Care Surg. 2017 Sep;83(3):356-360. doi: 10.1097/TA.0000000000001550.

lead_sponsor: Poitiers University Hospital

collaborators: Pr Pierre BUFFET Institut National de la Transfusion Sanguine

collaborators: Pr Sophie CANDON Laboratoire d'immunologie et biothérapies CHU de Rouen

collaborators: Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier

location_facility:
C.H.U. de Poitiers
C.H.U. de Montpellier
Hôpitaux de Chartres
C.H. de Tourcoing
C.H. de Béthune
C.H. Victor Dupouy
C.H. d'Angoulême
C.H. de Valenciennes
C.H.U. de Lille
C.H.U. de Toulouse
C.H.U. de Rouen
Hôtel-Dieu - CHU de Nantes


title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

acronym: BRAINI

summary: Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

ReferenceCitation: Richard M, Lagares A, Bondanese V, de la Cruz J, Mejan O, Pavlov V, Payen JF; BRAINI investigators. Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Grenoble

location_country: Spain France

location_facility: Hôpital Nord Ouest de Villefranche sur Saône


title: "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases

acronym: CEREMET-LR

summary: The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

ReferenceCitation: Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.

ReferenceCitation: Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007.

ReferenceCitation: Smedby KE, Brandt L, Backlund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.

ReferenceCitation: Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

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

location_facility: Centre hospitalier régional et universitaire de Montpellier

location_facility: Centre hospitalier régional et universitaire de Nîmes

location_facility: Laboratoire d'anatomo-pathologie de Nîmes

location_facility: Centre d'Anatomie et Cytologie Pathologiques de Grabels


title: CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

acronym: CABRAMET

summary: This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).

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

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


title: MELROSE: Phase 2 Study Evaluating MEchanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtinib Until and Beyond Radiological Progression : the MELROSE Trial

acronym: MELROSE

summary:
Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer.

The AURA 3 study (T790M-positive advanced non-small-cell lung cancer in progression after first-line EGFR-TKI therapy, shown that the median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months p<0.001).

In addition, clinical data show that patients with mutated EGFR NSCLC receiving osimertinib in first line, presented an objective response rate of 77 % with a disease control rate of 98 % and a median PFS was 19.3 months.

Finally, The FLAURA study randomized phase 3 study clearly demonstrated the superiority of osimertinib compared with erlotinib or gefitinib in EGFR mutated nonpretreated NSCLC (median PFS of 18.9 months versus 10.2 months).

However, several issues remain unknown or debated :

What are the mechanisms of resistance to osimertinib prescribed in first-line?
What are the consequences of prolonged exposure to osimertinib on the expression of markers of response to immunotherapy?
Is there an association between kinetic parameters of ctDNA (circulating tumor DNA) and prediction of response to osimertinib and/ or and prediction of therapeutic escape under osimertinib? In order to respond to all these questions, this phase II trial will be the first to systemically analyze the mechanisms of resistance to Osimertinib based on the analysis of biopsy, and collection of plasma from all patients during the course of treatment.

ReferenceCitation: Bennouna J, Girard N, Audigier-Valette C, le Thuaut A, Gervais R, Masson P, Marcq M, Molinier O, Cortot A, Debieuvre D, Cadranel J, Lena H, Moro-Sibilot D, Chouaid C, Mennecier B, Urban T, Sagan C, Perrier L, Barlesi F, Denis MG. Phase II Study Evaluating the Mechanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR-mutated Non-pretreated Advanced Lung Cancer Receiving Osimertinib Until and Beyond Radiologic Progression: The MELROSE Trial. Clin Lung Cancer. 2020 Jan;21(1):e10-e14. doi: 10.1016/j.cllc.2019.09.007. Epub 2019 Oct 1.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
AstraZeneca

location_facility: CH DU MOENCHSBERG - Hôpital Emile Muller


title: Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial

summary: The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

ReferenceCitation: Deshayes E, Piron L, Bouvier A, Lapuyade B, Lermite E, Vervueren L, Laurent C, Pinaquy JB, Chevallier P, Dohan A, Rode A, Sengel C, Guillot C, Quenet F, Guiu B. Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases. BMC Cancer. 2020 Jun 19;20(1):574. doi: 10.1186/s12885-020-07065-z.

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: University Hospital, Montpellier

collaborators: Federation Francophone de Cancerologie Digestive

location_facility:
Centre Léon Berard
Hôpital Paul Brousse
CHU de Poitiers
CHU de Nice
CHU de Dijon
CHU de Montpellier
CHU d'Angers
CHU de Grenoble
Hospices Civils de Lyon
APHP - Cochin hospital
Institut Gustave Roussy
Bordeaux University Hospital

appel_a_projets: PHRCK

region: Occitanie

nom_etablissement: CHU MONTPELLIER

titre: EMBOLISATION SIMULTANEE PORTALE ET SUS-HEPATIQUE VERSUS EMBOLISATION PORTALE SEULE POUR HYPERTROPHIER LE FUTUR FOIE RESTANT AVANT RESECTION HEPATIQUE MAJEURE SUR FOIE NON CIRRHOTIQUE : ESSAI MULTICENTRIQUE RANDOMISE COMPARATIF DE PHASE II

discipline_principale: cancer

nom_porteur: GUIU

prenom_porteur: Boris


title: Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care

acronym: AdoDesP

summary:
Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care.

In children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. It is regularly reported that 30% of adolescents of depressed parents have depression themselves. General Practitioners (GP) have significant access to the depression of adults, potentially parents of teenagers. In fact, 20% of patients in the regular active file of one GP have depression. The primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents.

The difficulties of articulation between primary care (PC) and mental health devices are demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and may even disturb early detection of depression. An organized joint between the PC and a specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in PC.

In addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. They vary by age and sex of the child but also the sex of the parent. A concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors.

AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group of adolescent with PC articulated with mental health service (MDA) and an other group without articulation (routine cares).

A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.

status: Terminated

primary_purpose: Diagnostic

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Dr NABBE
Dr Ac'h
Dr Phan
Dr Volant-Le-Berre
Dr AUGUSTIN
Dr Coat-Gourio
Dr Wauters
Dr Le Grignou
Dr CONNAN
Dr PITMAN
Dr CHIRON
Dr Cazuguel

nom_etablissement: CHRU BREST

acronyme: AdoDeSP

titre: Dépression de l'adolescent associée à la dépression parentale : dépistage, prévalence,et prévention en soins primaires à partir de la rencontre de parents déprimés

discipline_principale: médecine générale

nom_porteur: Bronsard

prenom_porteur: Guillaume


title: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.

acronym: DISCO

summary:
The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy.

This is a 3 years medico-economics study with 1 year follow-up period involving patients with 1 or 2 depression treatment(s) failed.

Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).

ReferenceCitation: Sauvaget A, Lagalice L, Schirr-Bonnans S, Volteau C, Pere M, Dert C, Rivalland A, Tessier F, Lepage A, Tostivint A, Deschamps T, Thomas-Ollivier V, Robin A, Pineau N, Cabelguen C, Bukowski N, Guitteny M, Beslot A, Simons L, Network H, Vanelle JM, D'Urso G, Bulteau S, Riche VP; DISCO investigators group. Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol. BMJ Open. 2020 Jan 13;10(1):e033376. doi: 10.1136/bmjopen-2019-033376.

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

location_facility: Centre hospitalier Guillaume Regnier Rennes

appel_a_projets: PRME

nom_etablissement: CHU DE NANTES

acronyme: DiSCo

titre: Analyse coût-utilité de la stimulation transcrânienne à courant continu (tDCS) dans la prise en charge de l'épisode dépressif caractérisé en échec d'un traitement médicamenteux

discipline_principale: psychiatrie / addictologie

nom_porteur: Sauvaget

prenom_porteur: Anne


title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study

summary: This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

lead_sponsor: Theraclion

location_facility:
Hopital Saint Louis
CHU Strasbourg
Hopital TENON
Centre Hospitalier
Clinique Mutualiste LA SAGESSE
Groupe Hospitaliler Diaconesses
CHU de Montpellier
American Hospital of Paris
Hopital Pitié-salpêtrière
Polyclinique de l'Atlantique
Hopital Européen
Polyclinique Majorelle


title: Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?

acronym: TCAP

summary:
At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner.

However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

location_facility:
CH Le Mans
CHU de Poitiers
CH Bretagne Atlantique
CH Chartres
CHU d'Angers
CHU Brest
CH de Saint Brieuc
CHU de Rennes
CH de Saint Malo
CHU de Nantes
CH Bretagne Sud, Lorient
CH Bretagne Sud - Quimperlé

intervention_type: Radiation

titre: Traumatisme crânien léger sous antiagrégant plaquettaire sans signes cliniques d'hémorragie intracrânienne (critères NICE): peut-on ne pas faire de scanner cérébral?

nom_porteur: BONENFANT

prenom_porteur: Jeremie


title: Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM)

summary:
The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.

For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.

location_facility:
CHRU de Nancy
CHU de Caen
CHU de Dijon
CHU de Tours
CHRU de Lille
CHU de Grenoble
Hospices Civils de Lyon
CHU Bordeaux
University Hosptial Toulouse
CHU de Rennes
CHU de Nantes
Institut Paoli Calmettes


title: An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients: a Phase II Study of the Intergroupe Francophone du Myélome "IFM 2018-04"

summary: According to international guidelines, upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent, autologous stem cell transplant, PI+Imid based triplet consolidation and lenalidomide maintenance. Despite this approach, virtually all MM patients experience disease relapse, especially those with High Risk disease defined by adverse cytogenetic abnormalities (i.e. del(17p), or t(14;16) or t(4;14)) detected by FISH and/or SNP arrays. Indeed, HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients. The primary objective of this prospective multicenter, open label, interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation, tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic. Quadruplet induction and consolidation include carfilzomib, lenalidomide, dexamethasone and daratumumab. Maintenance will include lenalidomide and daratumumab. Secondary objectives will include efficacy parameters (i.e. response rate, minimal residual disease, safety, progression free survival, overall survival).

ReferenceCitation: Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available.

location_facility:
CHRU - Hôpital A.Michallon
CHRU - Hôpitaux de Brabois
CHRU - Hôpital Claude Huriez
CHU Toulouse
CHRU - Hôpital de Pontchaillou
CHRU Dijon
CH de Lyon Sud
CHD Vendée
CHRU Bretonneau
CHU Caen
CHRU Hôpital du Haut Lévêque
CHU de Nantes


title: Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

acronym: POCA

summary:
Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available.

Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.

ReferenceCitation: Trang-Poisson C, Kerdreux E, Poinas A, Planche L, Sokol H, Bemer P, Cabanas K, Hivernaud E, Biron L, Flet L, Montassier E, Le Garcasson G, Chiffoleau A, Jobert A, Lepelletier D, Caillon J, Le Pape P, Imbert BM, Bourreille A. Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2020 Jun 3;21(1):455. doi: 10.1186/s13063-020-04330-1.

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

location_facility: Groupe Hospitalier Sud- Hopital Haut-lévêque

acronyme: POCA

titre: Etude prospective multicentrique, contrôlée, randomisée, en double aveugle évaluant la transplantation fécale en prévention de la rechute de pochite chronique récidivante chez des patients atteints de RCH avec anastomose iléoanale.

nom_porteur: TRANG POISSON

prenom_porteur: Caroline


title: Guadecitabine SGI-110 and Donor Lymphocyte Infusions (Dli) After Allogeneic Stem Cell Transplantation (Allo Sct) in Very High Risk MDS or AML Patients

summary: High risk MDS (Myelodysplastic Syndrome) patients will be treated with SGI-110 after Allogeneic Stem Cell Transplantation in the hypothesis that SGI-110 maintenance given early after HSCT can prevent relapse without increasing non-relapse mortality translating in an improved disease-free survival.

study_start_date_type: Anticipated

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Nantes
CHU Estaing
Hôpital Archet 1
CHU Brabois
Hôpital St Louis
Hôpital Pitié-Salpêtrière
CHU d'Angers
CHU Toulouse - IUCT Oncopole
Centre Hospitalier Lyon-Sud
CHU de Haut-Lévèque
Hôpital St Vincent de Paul
Hôpital Necker


title: Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

summary: The aim of this study is to assess the benefit of 3D models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of 3D reconstruction.

ReferenceCitation: Gauss T, Merckx P, Brasher C, Kavafyan J, Le Bihan E, Aussilhou B, Belghiti J, Mantz J. Deviation from a preoperative surgical and anaesthetic care plan is associated with increased risk of adverse intraoperative events in major abdominal surgery. Langenbecks Arch Surg. 2013 Feb;398(2):277-85. doi: 10.1007/s00423-012-1028-3. Epub 2012 Nov 13.

ReferenceCitation: Couinaud C. [Errors in the topographic diagnosis of liver diseases]. Ann Chir. 2002 Jun;127(6):418-30. doi: 10.1016/s0003-3944(02)00802-7. French.

ReferenceCitation: Mutter D, Dallemagne B, Bailey Ch, Soler L, Marescaux J. 3D virtual reality and selective vascular control for laparoscopic left hepatic lobectomy. Surg Endosc. 2009 Feb;23(2):432-5. doi: 10.1007/s00464-008-9931-y. Epub 2008 Apr 29.

ReferenceCitation: Mutter D, Soler L, Marescaux J. Recent advances in liver imaging. Expert Rev Gastroenterol Hepatol. 2010 Oct;4(5):613-21. doi: 10.1586/egh.10.57.

lead_sponsor: IHU Strasbourg

location_facility: Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière

location_facility: Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen

location_facility: Service de Chirurgie Digestive - CH Emile Muller

location_facility: Service de Chirurgie Digestive - Hôpital Beaujon

location_facility: Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse

location_facility: Chirurgie Viscérale et Digestive - Polyclinique de Gentilly

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

location_facility: Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez

location_facility: Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -

location_facility: Institut de Chirurgie Viscérale - Clinique de l'Orangerie

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Service de Chirurgie Digestive - CHU Robert Debré


title: Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer

acronym: HERACLES

summary: Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

lead_sponsor: MaaT Pharma

location_country: Italy Poland France

location_facility:
IUCT Oncopole
Public Clinic Hospital
CHU Nantes
Gemelli Hospital
Hôpital Saint Antoine
Hôpital Henri Mondor
Centre Hospitalier Lyon Sud
Klinika Hematologii i Transplantologii
Institut de Cancérologie de la Loire
University Clinical hospital
CHRU Lille
CHU Limoges
CHRU Besançon
CHU Strasbourg
CHU Angers
CHU Amiens


title: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial

acronym: KETAMORPH

summary: This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.

ReferenceCitation: Le Cornec C, Lariby S, Brenckmann V, Hardouin JB, Ecoffey C, Le Pottier M, Fradin P, Broch H, Kabbaj A, Auffret Y, Deciron F, Longo C, Javaudin F, Le Bastard Q, Jenvrin J, Montassier E. Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):260. doi: 10.1186/s13063-018-2634-3.

location_facility:
La Roche sur Yon Hospital
Le Mans University Hospital
University Hospital of Bordeaux
Nantes University Hospital
Hospital of Chateaubriant
Tours University Hospital
Angers University Hospital
Grenoble University Hospital
Rennes University Hospital
Hospital of Saint Nazaire
CH de Gonesse
Quimper Hospital

acronyme: KETAMORPH

titre: Kétamine versus morphine pour la prise en charge de la douleur aiguë en préhospitalier: essai randomisé contrôlé

nom_porteur: JENVRIN

prenom_porteur: Joel


title: Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU

acronym: VPP-ImPRoVE

summary:
The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.

In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.

Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of ideal body weight).

Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.

ReferenceCitation: Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.

ReferenceCitation: Cherpanath TG, Hirsch A, Geerts BF, Lagrand WK, Leeflang MM, Schultz MJ, Groeneveld AB. Predicting Fluid Responsiveness by Passive Leg Raising: A Systematic Review and Meta-Analysis of 23 Clinical Trials. Crit Care Med. 2016 May;44(5):981-91. doi: 10.1097/CCM.0000000000001556.

ReferenceCitation: Mallat J, Meddour M, Durville E, Lemyze M, Pepy F, Temime J, Vangrunderbeeck N, Tronchon L, Thevenin D, Tavernier B. Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsivenessdagger. Br J Anaesth. 2015 Sep;115(3):449-56. doi: 10.1093/bja/aev222. Epub 2015 Jul 6.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Mallat J, Fischer MO, Granier M, Vinsonneau C, Jonard M, Mahjoub Y, Baghdadi FA, Preau S, Poher F, Rebet O, Bouhemad B, Lemyze M, Marzouk M, Besnier E, Hamed F, Rahman N, Abou-Arab O, Guinot PG. Passive leg raising-induced changes in pulse pressure variation to assess fluid responsiveness in mechanically ventilated patients: a multicentre prospective observational study. Br J Anaesth. 2022 Sep;129(3):308-316. doi: 10.1016/j.bja.2022.04.031. Epub 2022 Jul 14.

lead_sponsor: Centre Hospitalier Arras

location_facility: Centre Hospitalier de Lens - Anesthésie-Réanimation

location_facility: CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire

location_facility: Centre Hospitalier de Lens - Réanimation


title: Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

acronym: PROCOAG

summary:
Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP.

To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion.

ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion.

Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.

ReferenceCitation: Bouzat P, Bosson JL, David JS, Riou B, Duranteau J, Payen JF; PROCOAG study group. Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study. Trials. 2021 Sep 16;22(1):634. doi: 10.1186/s13063-021-05524-x.

location_facility:
Montpellier University Hospital
AP-HM - Marseille Nord
HCL - Hôpital Edouard Herriot
Nantes University Hospital
AP-HP Pitié Salpetrière
Grenoble University Hospital
Lille University Hospital
Strasbourg University Hospital
AP-HP Kremlin Bicêtre
Annecy University Hospital
HCL - Lyon Sud
AP-HP Beaujon

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: ProCoag

titre: Impact clinique et médico-économique de l'administration précoce de concentrés de complexe prothrombique chez les patients présentant une hémorragie post-traumatique grave

nom_porteur: BOUZAT

prenom_porteur: Pierre


title: Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology

acronym: PRE-TRANS

summary: Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal dominant inherited disease resulting in the abnormal multi-system deposition of amyloid proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years after onset of symptoms if untreated. The prevalence of the disease remains still poorly understood and usually the search for this pathology is done in a third line of investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as possible. With this study, investigator decided to test for TTR mutation all patients presented with neuropathy of unknown etiology at the first line of investigation. The goal of this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best strategy to test this population for TTR mutations.

sponsor_collaborators:
Nantes University Hospital
Pfizer

location_facility: CHP Saint-Grégoire - Cabinet de Neurologie ENMG

intervention_type: Genetic


title: Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion

acronym: SCENE

summary: The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.

location_facility: Services Neurologie et Médecine d'urgence, CH de Villefranche sur Saône

location_facility: Services Médecine d'urgence et Neurologie, CH de Vienne

location_facility: Médecine d'urgence, Clinique de la Sauvegarde

location_facility: Médecine d'urgence, Hôpital Mutualiste Médipôle

location_facility: Médecine d'urgence, Hôpital Saint Joseph Saint Luc

location_facility: Médecine d'urgence, Hôpital de la Croix-Rousse - HCL


title: Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR Monoclonal Antibody

acronym: OPTIMAG

summary:
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.

Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.

There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.

These food supplements rich in magnesium are sold without proof of effectiveness. Moreover, the prescription of oral magnesium supplementation adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance.

The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.

Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.

lead_sponsor: Weprom

sponsor_collaborators: Weprom Neptune

location_facility:
Centre Maurice TUBIANA
Centre Hospitalier Centre Bretagne
CORT 37
Centre Hospitalier
Polyclinique de Gentilly
Centre Hospitalier Départemental
Centre Jean Bernard
GHBS Lorient
CHRU Tours
CARIO-HPCA Plérin
Centre d'Oncolgie Saint Yves


title: Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

summary:
The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

ReferenceCitation: Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291. No abstract available.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.

ReferenceCitation: Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier Universitaire Jean Minjoz


title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study

summary: This study assessed the feasibility and effects of an early integrative supportive care program in patient with Advanced pancreatic adenocarcinoma (aPDAC).

primary_purpose: Health Services Research

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CH Layne
Centre Léon Bérard
Hôpital Henri Mondor
Hôpital Cochin
Hopitaux du Léman
CHU Tours - Hôpital Trousseau
Institut Mutualiste Montsouris
Hôpital Pitié Salpêtrière
Grope Hospitalier Paris Saint Joseph
Hôpital Beaujon
Institut Hospitalier Franco-Britannique
Institut Sainte Catherine


title: Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

acronym: ARCOL

summary: This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.

ipd_sharing_description: Not authorized in France

lead_sponsor: Center Eugene Marquis

location_facility:
Centre rené Gauducheau
Centre Léon Bérard
Gustave Roussy
CHU de Tours
CHU Poitiers
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Centre Eugène Marquis
Centre François Baclesse
CLCC Georges François Leclerc
Centre Henri Becquerel
Centre Alexis Vautrin


title: Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate

acronym: BOUST

summary: Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

status: Not yet recruiting

ReferenceCitation: Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye

location_facility: Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat

location_facility: Centre hospitalier Intercommunal de Créteil

acronyme: BOUST

titre: Etude prospective randomisée multicentrique évaluant l'effet du diamètre du tube de calibration utilisé au cours des sleeve gastrectomies laparoscopiques sur le taux de fistule post-opératoire sur la ligne d'agrafage

discipline_principale: nutrition et obésité

nom_porteur: TRANCHART

prenom_porteur: Hadrien


title: Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses

acronym: PEG-MF

summary:
Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news.

A non-opposition consent form need to be signed before entering this study.

ReferenceCitation: Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.

location_facility:
Hopital du genevois
CHRU de Brest
Institut Paoli Calmette
CHU de Nancy
CH des pays de Morlaix
Centre Hospitalier de Lens
Centre Hospitalier de Nice
CHU d'Angers
Centre Hospitalier de Tours
CHIC de Cornouaille
Centre Hospitalier du Mans
AP-HP Hôpital Saint Louis


title: Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study

acronym: SACHA

summary: Prospective, multicenter, observational study with a three-year inclusion period (from January 1, 2012 to December 31, 2015) and a 6-month follow-up

ReferenceCitation: Bouget J, Balusson F, Kerbrat S, Roy PM, Viglino D, Lacut K, Pavageau L, Oger E. Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system. Eur J Clin Pharmacol. 2022 Jul;78(7):1137-1144. doi: 10.1007/s00228-022-03318-x. Epub 2022 Apr 6.

ReferenceCitation: Bouget J, Balusson F, Viglino D, Roy PM, Lacut K, Pavageau L, Oger E. Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study. PLoS One. 2020 Aug 7;15(8):e0237022. doi: 10.1371/journal.pone.0237022. eCollection 2020.

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

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

publisher_dissemination: Public Library of Science

ReferenceCitation: Bouget J, Balusson F, Maignan M, Pavageau L, Roy PM, Lacut K, Scailteux LM, Nowak E, Oger E. Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3-year period population-based prospective cohort study. Br J Clin Pharmacol. 2020 Dec;86(12):2519-2529. doi: 10.1111/bcp.14362. Epub 2020 Jun 1.

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

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

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

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital Privé Sévigné
Nouvelles Cliniques Nantaises
Centre Hospitalier Privé
Clinique des Cèdres
Clinique de l'Anjou
CHU de Brest
CHU d'Angers
CHU de Grenoble
CHU de Rennes
CHU de Nantes
Hôpital Inter-Armées
Groupe Hospitalier Mutualiste


title: Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma. The International Extranodal Lymphoma Study Group (IELSG) 36 Phase II Prospective Study

summary:
Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the disease pursues an aggressive course and most patients die of lymphoma progression within 3-4 years.

Retrospective studies have indicated that purine analogous achieved very high response rates in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in combination with chemotherapy has been reported to be very effective in producing a rapid clearance of neoplastic cells.

location_country: Italy France

location_facility: Lille cedex (CHRU Lille - Hôpital Claude Huriez)

location_facility: Ospedale S. Maria Delle Croci Di Di Ravenna

location_facility: Irccs Istituto Dermatologico S. Gallicano (Ifo)

location_facility: Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Sede Di Meldola (Fc)

location_facility: Nantes cedex 01 (CHU de Nantes - Hôtel Dieu)

location_facility: Dijon (CHU de Dijon - Hôpital d'Enfants)

location_facility: Irccs Fondazione Centro S. Raffaele Del Monte Tabor

location_facility: Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)

location_facility: A.O. Universitaria Policlinico Di Modena

location_facility: A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

location_facility: Vandoeuvre-les-Nancy cedex (CHU Brabois)


title: Impact of the PRISM-care Multidisciplinary Oncology Program Versus Usual Care on Secured Drug Intake of Patients With Kidney Cancer, Through Self-management of Adverse Events Related to Oral Targeted Therapies, Control of Drug Interactions, and Sharing of the Information Between Ambulatory and Hospital Settings.

acronym: PRISM care

summary:
The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.

Adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). This results in a decrease in the dose taken and a risk of loss of efficacy.

In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss of efficacy.

The investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. This program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals.

The hypothesis of the study is that the PRISM care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet

location_facility: ICL Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Centre de Lutte Contre le Cancer Jean Perrin