acronym: BRADYKID

summary:
In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care.

The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

ReferenceCitation: Boccon-Gibod I, Bouillet L. [Angioedema and urticaria]. Ann Dermatol Venereol. 2014 Nov;141 Suppl 3:S586-95. doi: 10.1016/S0151-9638(14)70162-0. French.

ReferenceCitation: Pagnier A. [Hereditary angioedema in childhood. Diagnosis and therapeutic challenges]. Presse Med. 2015 Jan;44(1):89-95. doi: 10.1016/j.lpm.2014.07.018. Epub 2014 Dec 12. French.

ReferenceCitation: Dinkel HP, Maroske J, Schrod L. Sonographic appearances of the abdominal manifestations of hereditary angioedema. Pediatr Radiol. 2001 Apr;31(4):296-8. doi: 10.1007/s002470000409.

ReferenceCitation: Bygum A. Hereditary angio-oedema in Denmark: a nationwide survey. Br J Dermatol. 2009 Nov;161(5):1153-8. doi: 10.1111/j.1365-2133.2009.09366.x. Epub 2009 Jun 22.

ReferenceCitation: Farkas H. Pediatric hereditary angioedema due to C1-inhibitor deficiency. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):18. doi: 10.1186/1710-1492-6-18.

ReferenceCitation: El-Hachem C, Amiour M, Guillot M, Laurent J. [Hereditary angioneurotic edema: a case report in a 3-year-old child]. Arch Pediatr. 2005 Aug;12(8):1232-6. doi: 10.1016/j.arcped.2005.03.052. French.

ReferenceCitation: Farkas H. Management of upper airway edema caused by hereditary angioedema. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):19. doi: 10.1186/1710-1492-6-19.

ReferenceCitation: Sanchez A, Ecochard A, Maestracci M, Rodiere M. [Hereditary angioedema causing colocolic intussusception]. Arch Pediatr. 2008 Mar;15(3):271-4. doi: 10.1016/j.arcped.2007.12.004. Epub 2008 Mar 10. French.

ReferenceCitation: Pritzker HA, Levin TL, Weinberg G. Recurrent colocolic intussusception in a child with hereditary angioneurotic edema: reduction by air enema. J Pediatr Surg. 2004 Jul;39(7):1144-6. doi: 10.1016/j.jpedsurg.2004.03.075.

ReferenceCitation: Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27

ReferenceCitation: MacGinnitie AJ. Pediatric hereditary angioedema. Pediatr Allergy Immunol. 2014 Aug;25(5):420-7. doi: 10.1111/pai.12168. Epub 2013 Dec 9.

ReferenceCitation: Deroux A, Vilgrain I, Dumestre-Perard C, Boccon-Gibod I, Bouillet L. Towards a specific marker for acute bradykinin-mediated angioedema attacks: a literature review. Eur J Dermatol. 2015 Jul-Aug;25(4):290-5. doi: 10.1684/ejd.2015.2547.

ReferenceCitation: Cugno M, Zanichelli A, Bellatorre AG, Griffini S, Cicardi M. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy. 2009 Feb;64(2):254-7. doi: 10.1111/j.1398-9995.2008.01859.x. Epub 2008 Dec 4.

ReferenceCitation: Hogan AD, Schwartz LB. Markers of mast cell degranulation. Methods. 1997 Sep;13(1):43-52. doi: 10.1006/meth.1997.0494.

ReferenceCitation: Brickman CM, Frank MM, Kaliner M. Urine-histamine levels in patients with hereditary angioedema (HAE). J Allergy Clin Immunol. 1988 Sep;82(3 Pt 1):403-6. doi: 10.1016/0091-6749(88)90012-7.

ReferenceCitation: Payne V, Kam PC. Mast cell tryptase: a review of its physiology and clinical significance. Anaesthesia. 2004 Jul;59(7):695-703. doi: 10.1111/j.1365-2044.2004.03757.x.

ReferenceCitation: Kasperska-Zajac A, Grzanka A, Czecior E, Misiolek M, Rogala B, Machura E. Acute phase inflammatory markers in patients with non-steroidal anti-inflammatory drugs (NSAIDs)-induced acute urticaria/angioedema and after aspirin challenge. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1048-52. doi: 10.1111/j.1468-3083.2012.04486.x. Epub 2012 Feb 21.

ReferenceCitation: Fujii K, Konishi K, Kanno Y, Ohgou N. Acute urticaria with elevated circulating interleukin-6 is resistant to anti-histamine treatment. J Dermatol. 2001 May;28(5):248-50. doi: 10.1111/j.1346-8138.2001.tb00126.x.

ReferenceCitation: Kasperska-Zajac A, Brzoza Z. Increased D-dimer concentration in plasma of patients with severe acute urticaria. Br J Dermatol. 2009 Dec;161(6):1409-10. doi: 10.1111/j.1365-2133.2009.09466.x. Epub 2009 Sep 15. No abstract available.

ReferenceCitation: Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

ReferenceCitation: Bouillet L, Sidibe A, Polena H, Mannic T, Deroux A, Stidder B, Vittecoq O, Vilgrain I. [Endothelial junctions: exploiting their instability in the development of biomarkers for vascular remodelling]. Med Sci (Paris). 2014 Jun-Jul;30(6-7):633-5. doi: 10.1051/medsci/20143006012. Epub 2014 Jul 11. No abstract available. French.

ReferenceCitation: Bouillet L, Vilgrain I. VE-cadherin, a potential marker for endothelial cell activation during hereditary angioedema attacks. J Allergy Clin Immunol. 2014 Jul;134(1):241. doi: 10.1016/j.jaci.2014.04.016. Epub 2014 May 27. No abstract available.

ReferenceCitation: Sidibe A, Polena H, Pernet-Gallay K, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Marechal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. VE-cadherin Y685F knock-in mouse is sensitive to vascular permeability in recurrent angiogenic organs. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H455-63. doi: 10.1152/ajpheart.00774.2013. Epub 2014 May 23.

ReferenceCitation: Sidibe A, Polena H, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Marechal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. Dynamic phosphorylation of VE-cadherin Y685 throughout mouse estrous cycle in ovary and uterus. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H448-54. doi: 10.1152/ajpheart.00773.2013. Epub 2014 May 23.

ReferenceCitation: Bouillet L, Mannic T, Arboleas M, Subileau M, Massot C, Drouet C, Huber P, Vilgrain I. Hereditary angioedema: key role for kallikrein and bradykinin in vascular endothelial-cadherin cleavage and edema formation. J Allergy Clin Immunol. 2011 Jul;128(1):232-4. doi: 10.1016/j.jaci.2011.02.017. Epub 2011 Mar 24. No abstract available.

ReferenceCitation: Suffritti C, Zanichelli A, Maggioni L, Bonanni E, Cugno M, Cicardi M. High-molecular-weight kininogen cleavage correlates with disease states in the bradykinin-mediated angioedema due to hereditary C1-inhibitor deficiency. Clin Exp Allergy. 2014 Dec;44(12):1503-14. doi: 10.1111/cea.12293.

ReferenceCitation: Kahn R, Herwald H, Muller-Esterl W, Schmitt R, Sjogren AC, Truedsson L, Karpman D. Contact-system activation in children with vasculitis. Lancet. 2002 Aug 17;360(9332):535-41. doi: 10.1016/S0140-6736(02)09743-X.

ReferenceCitation: Ghannam A, Sellier P, Defendi F, Favier B, Charignon D, Lopez-Lera A, Lopez-Trascasa M, Ponard D, Drouet C. C1 inhibitor function using contact-phase proteases as target: evaluation of an innovative assay. Allergy. 2015 Sep;70(9):1103-11. doi: 10.1111/all.12657. Epub 2015 Jun 9.

ReferenceCitation: Adam SS, Key NS, Greenberg CS. D-dimer antigen: current concepts and future prospects. Blood. 2009 Mar 26;113(13):2878-87. doi: 10.1182/blood-2008-06-165845. Epub 2008 Nov 13.

ReferenceCitation: Blohme G. Treatment of hereditary angioneurotic oedema with tranexamic acid. A random double-blind cross-over study. Acta Med Scand. 1972 Oct;192(4):293-8. doi: 10.1111/j.0954-6820.1972.tb04818.x. No abstract available.

ReferenceCitation: Brown NJ, Gainer JV, Stein CM, Vaughan DE. Bradykinin stimulates tissue plasminogen activator release in human vasculature. Hypertension. 1999 Jun;33(6):1431-5. doi: 10.1161/01.hyp.33.6.1431.

ReferenceCitation: Cugno M, Hack CE, de Boer JP, Eerenberg AJ, Agostoni A, Cicardi M. Generation of plasmin during acute attacks of hereditary angioedema. J Lab Clin Med. 1993 Jan;121(1):38-43.

ReferenceCitation: Frank MM, Sergent JS, Kane MA, Alling DW. Epsilon aminocaproic acid therapy of hereditary angioneurotic edema. A double-blind study. N Engl J Med. 1972 Apr 13;286(15):808-12. doi: 10.1056/NEJM197204132861503. No abstract available.

ReferenceCitation: Joseph K, Tholanikunnel BG, Wolf B, Bork K, Kaplan AP. Deficiency of plasminogen activator inhibitor 2 in plasma of patients with hereditary angioedema with normal C1 inhibitor levels. J Allergy Clin Immunol. 2016 Jun;137(6):1822-1829.e1. doi: 10.1016/j.jaci.2015.07.041. Epub 2015 Sep 26.

ReferenceCitation: Kaplan AP, Austen KF. A prealbumin activator of prekallikrein. II. Derivation of activators of prekallikrein from active Hageman factor by digestion with plasmin. J Exp Med. 1971 Apr 1;133(4):696-712. doi: 10.1084/jem.133.4.696.

ReferenceCitation: Kleniewski J, Blankenship DT, Cardin AD, Donaldson V. Mechanism of enhanced kinin release from high molecular weight kininogen by plasma kallikrein after its exposure to plasmin. J Lab Clin Med. 1992 Jul;120(1):129-39.

ReferenceCitation: Kluft C, Trumpi-Kalshoven MM, Jie AF, Veldhuyzen-Stolk EC. Factor XII-dependent fibrinolysis: a double function of plasma kallikrein and the occurrence of a previously undescribed factor XII- and kallikrein-dependent plasminogen proactivator. Thromb Haemost. 1979 Jun 30;41(4):756-73.

ReferenceCitation: Nielsen EW, Johansen HT, Hogasen K, Wuillemin W, Hack CE, Mollnes TE. Activation of the complement, coagulation, fibrinolytic and kallikrein-kinin systems during attacks of hereditary angioedema. Scand J Immunol. 1996 Aug;44(2):185-92. doi: 10.1046/j.1365-3083.1996.d01-298.x.

ReferenceCitation: Reshef A, Zanichelli A, Longhurst H, Relan A, Hack CE. Elevated D-dimers in attacks of hereditary angioedema are not associated with increased thrombotic risk. Allergy. 2015 May;70(5):506-13. doi: 10.1111/all.12587. Epub 2015 Feb 23.

location_facility: university hospital Saint-Antoine (AP-HP)


title: Nivolumab in Combination With High Dose Radiotherapy at Varied Tumor Sites in Advanced Melanoma and no Prior Antitumoral Treatment

acronym: NIRVANA

summary:
Combining nivolumab with conventional multisite high dose radiotherapy seems to be an interesting approach that could increase the antitumoral effect of nivolumab by increasing the diversity and quantity of tumoral antigen presentation thanks to radiotherapy. Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire of intratumoral T cells.

The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other).

The investigators hypothesize that combining nivolumab with multisite, multifractionated HR increases the overall survival rate at 1 year compared to published data with nivolumab alone.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gerard A, Doyen J, Cremoni M, Bailly L, Zorzi K, Ruetsch-Chelli C, Brglez V, Picard-Gauci A, Troin L, Esnault VLM, Passeron T, Montaudie H, Seitz-Polski B. Baseline and early functional immune response is associated with subsequent clinical outcomes of PD-1 inhibition therapy in metastatic melanoma patients. J Immunother Cancer. 2021 Jun;9(6):e002512. doi: 10.1136/jitc-2021-002512.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU d'Amiens
Hôpital Ambroise Paré
Hôpital Avicenne
CHU Hôpital Clemenceau
CHRU de Besançon
Hôpital St Louis
CHRU de Lille
Hôpital Dupuytren
CHU La Timone
Hospices civiles de Lyon
CHU de NIce
CH d'Annecy
CHU de Rouen
CHU de Clermont Ferrand

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


title: NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

acronym: NSE-HYPERION

summary:
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.

design_allocation: Randomized

primary_purpose: Diagnostic

ReferenceCitation: Lascarrou JB, Miailhe AF, le Gouge A, Cariou A, Dequin PF, Reignier J, Coupez E, Quenot JP, Legriel S, Pichon N, Thevenin D, Boulain T, Frat JP, Vimeux S, Colin G, Desroys du Roure F. NSE as a predictor of death or poor neurological outcome after non-shockable cardiac arrest due to any cause: Ancillary study of HYPERION trial data. Resuscitation. 2021 Jan;158:193-200. doi: 10.1016/j.resuscitation.2020.11.035. Epub 2020 Dec 8.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Medical Surgical Intensive Care Unit
Medical Intensive Care Unit


title: InterLeukine Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

acronym: IL-HYPERION

summary:
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.

location_facility:
Centre hospitalier d'Annecy
Medical Intensive Care Unit
CHU Orleans
CHU Dijon
Medical Surgical Intensive Care Unit
CHU Tours


title: L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial

acronym: CarniSave

summary: The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Drug

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU NIMES

type_etablissement: CH

acronyme: CarniSave

titre: L-carnitine comme traitement complémentaire pour les patients en choc septique avec insuffisance rénale aïgue: une étude de supériorité, multi-centrique, randomisée, à deux groupes parallèles

discipline_principale: néphrologie

nom_porteur: REBOUL

prenom_porteur: Pascal


summary:
Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative procedure for hematological malignancies. It is now well known that this property is related to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in or generating from the donor graft. For years, however, and despite this unique antitumoral activity, Allo-HSCT has been restricted to a limited number of patients due to two major limitations: the toxicity of the procedure and the absence of a donor for every single patients. More recently the stage has dramatically changed with respect to these two restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT in older patients but the availability of MRD is even less frequent in elderlies, likely related to medical contraindication for graft donation or sibling deaths. UD are routinely used but associated with a high incidence of GVHD. As compared to younger populations, unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with age due to the feared risk of supposed increased lethal infectious complications related to the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative donors allowing for a safe and efficient transplantation is still unmet. In consequence, overall, despite the fact that Allo-HSCT feasibility has been established in the oldest patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT performed in a population with the higher incidence of hematologic malignancies that usually present with the poorest prognosis.

Thus it is critical developing innovative efficient therapeutic strategies answering this unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in this aged population. It offers the potential advantage to offer a rapid donor determination for virtually every single patient. In addition, our data suggest that in elderlies haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower costs (no graft purchase and low post-transplant complications rate) and better QOL likely related to low cGVHD-rate. In addition the conduct of such trial at a time when the diffusion of the strategy in this population is just starting is really crucial before widespread uncontrolled dissemination.

The investigators propose to address this question by prospectively comparing these 2 strategies in elderly patients without MRD, in terms of efficacy, safety and including the prospective evaluation study of quality-of-life (QOL). They will conduct a national, multicenter, open-label, comparative, randomized phase III trial in patients with hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has not been identified.

When MRD search is recognized to be a failure, patients will be included in the clinical trial after informed consent and randomized in the two strategies based on donor search:

Reference group: Unrelated Donor group
Investigational group: Haplo Donor Group

Investigators will use a composite end-point embracing the three main causes of failure: death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT usual objectives as GHVD, NRM, relapse and survival. A specific study of patients' health related quality of life will also be conducted using the FACT-BMT questionnaire. In addition, the success of the two strategies in term of transplant completion (donor determination, transplant realization and time to do so) will be compared.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Institut de Cancérologie Lucien Neuwirth


title: RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer: Concordance With the "Standard" Testing Method From Tumor Tissue and Review of Associated Timelines and Costs

acronym: RASANC

summary: This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).

status: Unknown status

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Bachet JB, Bouche O, Taieb J, Dubreuil O, Garcia ML, Meurisse A, Normand C, Gornet JM, Artru P, Louafi S, Bonnetain F, Thirot-Bidault A, Baumgaertner I, Coriat R, Tougeron D, Lecomte T, Mary F, Aparicio T, Marthey L, Taly V, Blons H, Vernerey D, Laurent-Puig P. RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study. Ann Oncol. 2018 May 1;29(5):1211-1219. doi: 10.1093/annonc/mdy061.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Association des Gastroentérologues Oncologues

location_facility:
Hôpital Avicenne
Hôpital Européen Georges Pompidou
Hopital Saint-Antoine
Hopital Saint-Louis
Hopital Béclère
Hopital Kremlin-Bicêtre
Hopital Mermoz
Hôpital Pitié Salpêtrière
Hôpital Trousseau
CHU Poitiers
Hopital Cochin
Hopital Henri Mondor
CHU Robert Debré
CH Longjumeau et Sud

lead_sponsor_type: industriel

status_simplified: Unknown


title: Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant

summary: Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

lead_sponsor: Poitiers University Hospital

location_facility:
Reims University Hospital
Clermont Ferrand University Hospital
Georges Pompidou European Hospital
Limoges University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Rouen University Hospital
Brest University Hospital
Rennes University Hospital
Amiens University Hospital
Strasbourg University Hospital
Caen University Hospital
Necker Hospital


title: Assessment of Incidence of Adverse Events in a Naive Pediatric Population Treated With an (Typical and Atypical) Antipsychotic Drug Over 12 Months Follow-up

summary:
We propose a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population. Its purpose is to evaluate the incidence of adverse events related to the use of l antipsychotic drugs in children and adolescents with no history of taking such drugs.

The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years, (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days without taking antipsychotic before or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months.

Therapeutic monitoring during the 12 month study period will include clinical assessments and laboratory testing. These assessments will be performed before treatment (at inclusion), and at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.

primary_purpose: Other

ReferenceCitation: Menard ML, Thummler S, Giannitelli M, Olliac B, Bonnot O, Cohen D, Askenazy F; ETAPE Study group. Incidence of adverse events in antipsychotic-naive children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE). BMJ Open. 2016 Apr 6;6(4):e011020. doi: 10.1136/bmjopen-2015-011020.

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

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

endpoint_id: HAL

repository_institution: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Service de psychiatrie de l'enfant et de l'adolescent

intervention_type: Other


type: Other Identifier

title: Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)

acronym: APERCU

summary:
This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :

Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

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

lead_sponsor: Pfizer

location_facility: Institut Paoli-Calmettes / Hôpital de jour

location_facility: Clinique Chirurgicale de l'Orangerie, Chiliotherapie


title: Non Interventional Study Dealing With the Use of Bevacizumab (Avastin®) in Patients With Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal and Treated in First-line Therapy

acronym: ENCOURAGE

summary: The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of bevacizumab (Avastin ®)

ReferenceCitation: Berton D, Floquet A, Lescaut W, Baron G, Kaminsky MC, Toussaint P, Largillier R, Savoye AM, Alexandre J, Delbaldo C, Malaurie E, Barletta H, Bosacki C, Garnier-Tixidre C, Follana P, Laharie-Mineur H, Briac Levache C, Valenza B, Dechartres A, Mollon-Grange D, Selle F. Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients. Front Pharmacol. 2021 Sep 20;12:711813. doi: 10.3389/fphar.2021.711813. eCollection 2021.

license: cc-by

license_normalized: cc-by

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

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

publisher_dissemination: Frontiers

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Roche Pharma AG

location_facility:
Institut Bergonié
Hôpital Civil
Clinique Tivoli
Clinique Valdegour
Clinique Armoricaine de Radiologie
ICO René Gauducheau
Centre Hospitalier Lyon-sud
Centre Hospitalier Régional
institut Paoli Calmette
Centre Hospitalier Intercommunal
Arcagy-Gineco
Centre Paul Papin
Institut Jean Godinot
Centre jean Perrin


title: A Phase II Study of Chlorambucil in Combination With Subcutaneous Rituximab Followed by Maintenance Therapy With Subcutaneous Rituximab in Patients With Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)

summary: Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).

status: Active, not recruiting

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Italy Switzerland France

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Torino Università, Ematologia 1, AO Città della Salute e della Scienza

location_facility: IOSI - Oncology Institute of Southern Switzerland

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

location_facility: Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia

location_facility: Centro di Riferimento Oncologico di Aviano


title: Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality: Tools for Evaluating Sexuality in Patients With From Urinary Incontinence or Pelvic Organ Prolapse

summary: The primary objective of this study is the psychometric validation of two questionnaires (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (FSFI).

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Groupe Hospitalier Dioconesses - Site Reuilly

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre


acronym: SIMCER

lead_sponsor: Novartis Pharmaceuticals

summary:
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.

The renal function was estimated by glomerular filtration rate.

title: A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients

type: EudraCT Number

source: euctr


title: Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

acronym: Fimbriectomy

summary: Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

primary_purpose: Prevention

lead_sponsor: Centre Oscar Lambret

collaborators:
CTD-CNO
Laboratoire PRISM

sponsor_collaborators:
Centre Oscar Lambret
CTD-CNO
Laboratoire PRISM

location_facility:
Institut Bergonié
Centre Antoine Lacassagne
Centre Henri Becquerel
Clinique du Bois - Bourgogne Center
Polyclinique du Parc Rambot
Hospices Civils de Lyon
Institut Curie
IUCT-O Toulouse
Centre Oscar Lambret
Institut Gustave Roussy
Hôpital Privé VA
Institut Paoli Calmettes
Centre Jean Perrin
CHR-U

intervention_type: Procedure


title: Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus.

acronym: ATCF

summary: Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Gangneux JP, Godet C, Denning DW. Allergic diseases and fungal exposome: Prevention is better than cure. Allergy. 2022 Nov;77(11):3182-3184. doi: 10.1111/all.15436. No abstract available.

oa_host_type: repository

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

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

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

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

repository_institution: Authorea - Authorea

repository_normalized: Authorea - Authorea

repositories:
Authorea - Authorea
HAL

repositories_concat: Authorea - Authorea;HAL

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Guegan H, Prat E, Robert-Gangneux F, Gangneux JP. Azole Resistance in Aspergillus fumigatus: A Five-Year Follow Up Experience in a Tertiary Hospital With a Special Focus on Cystic Fibrosis. Front Cell Infect Microbiol. 2021 Feb 18;10:613774. doi: 10.3389/fcimb.2020.613774. eCollection 2020.

ReferenceCitation: Guegan H, Poirier W, Ravenel K, Dion S, Delabarre A, Desvillechabrol D, Pinson X, Sergent O, Gallais I, Gangneux JP, Giraud S, Gastebois A. Deciphering the Role of PIG1 and DHN-Melanin in Scedosporium apiospermum Conidia. J Fungi (Basel). 2023 Jan 18;9(2):134. doi: 10.3390/jof9020134.

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

location_facility: Service de Pneumologie-Immuno-Allergologie / Hôpital Calmette

location_facility: Pediatric penumologic - Groupe hospitalier de Pellegrin

location_facility: Pneumology pediatric - Hôpital Femme-Mère-Enfants

location_facility: Pédiatrie - Pneumologie, Allergologie - Hôpital des enfants

location_facility: Pneumologie Infantile - Hôpital des enfants

location_facility: Manchester Adult Cystic Fibrosis Centre - University Hospital of South Manchester

location_facility: CRCM Pédiatrique - Hôpital de Hautepierre


type: Registry Identifier

title: National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency

summary: The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Merck Sharp & Dohme LLC

location_facility: Hopital Saint Louis, Service de Néphrologie

location_facility: Hôpital Necker, Service de Néphrologie adulte

location_facility: Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale

location_facility: CHU de Nantes, Service de Néphrologie et Immunologie Clinique

location_facility: Hôpital Henri Mondor, Service de Néphrologie Transplantation

location_facility: Hôpital Bretonneau, Service de Néphrologie

location_facility: CHU De Caen, Service de Néphrologie Hémodialyse

location_facility: Hôpital Foch, Service de Néphrologie Transplantation

location_facility: Hôpital civil, Service de Néphrologie et Transplantation

location_facility: Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation

location_facility: Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse

location_facility: Hôpital Kremlin Bicêtre, Service de Néphrologie

location_facility: Hôpital Pasteur, Service de Néphrologie - Transplantation


title: Influence of Iron Depletion by Phlebotomy on the Risk of Hepatocellular Carcinoma Occurrence in Patients With Compensated Alcoholic Cirrhosis. Prospective, Multicentre, Randomized Trial

acronym: CIRROX

summary: The main objective of the study is to assess in patients with compensated alcoholic cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during follow-up.

status: Terminated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU
Antoine Béclère
Amiens University Hospital :
Jean Verdier
CHU Bordeaux univerity hospital 1
CHU Bordeaux University hospital 2
Avicenne


title: Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

acronym: TELESAS

summary: The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.

ReferenceCitation: Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. Sleep. 2014 Nov 1;37(11):1863-70. doi: 10.5665/sleep.4186.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Mendelson M, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, de Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea. Respir Care. 2014 Aug;59(8):1218-27. doi: 10.4187/respcare.02948.

publisher_dissemination: Daedalus Enterprises

lead_sponsor: Initiative Pour la Sante

location_facility:
Hospitalor Hospital
Montier Polyclinic
Cornouaille Hospital
Clermont Tonerre military hospital
Liberal Office
University Hospital

intervention_type: Device


title: Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial

acronym: MSA-Fluox

summary:
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 15 centers and 88 patients of both sexes.

The primary objective of the trial is to evaluate the effect of a selective inhibitor of serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for depressed patients, after three months in patients suffering from an atypical Parkinson's disease called Multiple System Atrophy, compared to the placebo effect.

Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the effects on mortality, quality of life, autonomic disorders, particularly orthostatic hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Clinical Research Center, Toulouse

location_facility:
hospital center of Aix enProvence
Hospital
Hospital Pontchaillou
University Hospital Henri Mondor
Hospital Gabriel Montpied
Hopital
University Hospital La Miletrie
Hospital R Salengro
civil hospital of Strasbourg
university hospital Dupuytren
university hospital Timone
hospital Pitié Salpêtrière
University Hospital


acronym: APPROCHE ORL

summary: The purpose of this study is to determine if there is a correlation between tumor response after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional modifications.

ReferenceCitation: Labadie RF, Yarbrough WG, Weissler MC, Pillsbury HC, Mukherji SK. Nodal volume reduction after concurrent chemo- and radiotherapy: correlation between initial CT and histopathologic findings. AJNR Am J Neuroradiol. 2000 Feb;21(2):310-4.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André

location_facility: Centre de Lutte Contre le Cancer - Institut Claudius Regaud

location_facility: Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Centre de Lutte Contre le Cancer - Centre Oscar Lambret

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque

title: Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers


title: Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo

summary: Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.

location_country:
French Polynesia
France

location_facility: CH de Colmar - Hôpitaux Civils de Colmar

location_facility: Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon

location_facility: CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu

location_facility: Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut

location_facility: CH Pontoise - Centre Hospitalier René Dubos


title: Phase I-II Trial of Erlotinib in Higher Risk Myelodysplastic Syndrome

summary: The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent.

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Roche Pharma AG

location_facility:
Hôpital Avicenne
CHU Nantes
Centre Hospitalier Lyon Sud
Institut Paoli-Calmettes
Hopital Purpan-Medecine interne
Hopital Purpan
CHRU Huriez
CHU d'Angers
Hopital Cochin
Institut Gustave Roussy
Centre Hospitalier du Mans
CHRU de Limoges
Hopital St Louis
CHU Caremeau


title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses

acronym: COPOUSEP

summary: The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.

ReferenceCitation: Le Page E, Veillard D, Laplaud DA, Hamonic S, Wardi R, Lebrun C, Zagnoli F, Wiertlewski S, Deburghgraeve V, Coustans M, Edan G; COPOUSEP investigators; West Network for Excellence in Neuroscience. Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial. Lancet. 2015 Sep 5;386(9997):974-81. doi: 10.1016/S0140-6736(15)61137-0. Epub 2015 Jun 28. Erratum In: Lancet. 2016 Jan 23;387(10016):340.

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

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

repositories_concat: HAL

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

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital de Cornouaille
Centre Hospitalier de Lannion
Hopital Yves Le Foll
CHU Cavale Blanche
Centre hospitalier Bretagne Sud
Centre Hospitalier de Pontivy
Centre Hospitalier Bretagne Atlantique
CHU Laennec
CH Saint Malo
Hôpital des Armées
Rennes University Hospital
CH de Cornouaille
Hôpital La pitié Salpétriere
Centre Hospitalier de Vendée


title: A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

acronym: IMURELPOST

summary: To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Hopital Beaujon
Hopital Lariboisiere
Hopital Saint Louis
Chu Toulouse
CHU CAEN
Chu Reims
Chu Tours
Hopital Haut Leveque
Chu Rennes
Hopital Cochin
Hopital St Antoine
Chu Besancon
Chru Lille


title: An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Transesophageal Echocardiography

summary: The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).

lead_sponsor: GlaxoSmithKline

location_country: Germany France


title: A Phase I/II Study of Vorinostat in Combination With Low Dose Ara-C for Patients With Intermediate-2 or High Risk Myelodysplastic Syndromes

summary: The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes.

ReferenceCitation: Prebet T, Braun T, Beyne-Rauzy O, Dreyfus F, Stammatoullas A, Wattel E, Ame S, Raffoux E, Delaunay J, Charbonnier A, Ades L, Fenaux P, Vey N. Combination of vorinostat and low dose cytarabine for patients with azacitidine-refractory/relapsed high risk myelodysplastic syndromes. Leuk Res. 2014 Jan;38(1):29-33. doi: 10.1016/j.leukres.2013.07.023. Epub 2013 Aug 13.

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Merck Sharp & Dohme LLC

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Hematology Dpt, Institut Paoli Calmettes


title: Eighteen Months of Oral Anticoagulant Therapy Versus Placebo After 6 Six Months of Anticoagulation for a First Episode of Idiopathic Proximal Deep Vein Thrombosis: a Multicentre Double-Blind Randomized Controlled Trial. "PADIS-TVP" Study.

acronym: PADIS TVP

summary: In a French multicenter double blind randomized controlled trial, the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic proximal deep vein thrombosis, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.

ReferenceCitation: Couturaud F, Pernod G, Presles E, Duhamel E, Jego P, Provost K, Pan-Petesch B, Sollier CBD, Tromeur C, Hoffmann C, Bressollette L, Lorillon P, Girard P, Le Moigne E, Le Hir A, Guegan M, Laporte S, Mismetti P, Lacut K, Bosson JL, Bertoletti L, Sanchez O, Meyer G, Leroyer C, Mottier D; "PADIS-DVT" investigators. Six months versus two years of oral anticoagulation after a first episode of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial. Haematologica. 2019 Jul;104(7):1493-1501. doi: 10.3324/haematol.2018.210971. Epub 2019 Jan 3.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Universitaire de Nantes


title: Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction

summary: Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion

ReferenceCitation: Zeymer U, Margenet A, Haude M, Bode C, Lablanche JM, Heuer H, Schroder R, Kropff S, Bourkaib R, Banik N, Zahn R, Teiger E. Randomized comparison of eptifibatide versus abciximab in primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results of the EVA-AMI Trial. J Am Coll Cardiol. 2010 Aug 3;56(6):463-9. doi: 10.1016/j.jacc.2009.08.093.


title: Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm

summary: This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic axillary node clearance can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50

ReferenceCitation: Avril A, Le Bouedec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pelissier S, Mauriac L; AXIL95 Group. Phase III randomized equivalence trial of early breast cancer treatments with or without axillary clearance in post-menopausal patients results after 5 years of follow-up. Eur J Surg Oncol. 2011 Jul;37(7):563-70. doi: 10.1016/j.ejso.2011.04.008. Epub 2011 Jun 12.

lead_sponsor: Institut Bergonié

location_facility: Centre Régional de Luttre Contre le Cancer de Strasbourg

location_facility: Centre Régional de Lutte Contre le Cancer d'Anger

location_facility: Centre Hospitalier Intercommunal de Marmande

location_facility: Centre Régional de Luttre Contre le Cancer de Dijon

location_facility: Centre Régional de Luttre Contre le Cancer de Lille

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Régional de Luttre Contre le Cancer de Clermont Ferrand

location_facility: Centre Régional de Luttre Contre le Cancer de Nantes

location_facility: Centre Hospitalier Universitaire de Saint Nazaire

location_facility: Centre Régional de Luttre Contre le Cancer de Montpellier

location_facility: Centre Regional de Lutte Contre le Cancer de Toulouse

location_facility: Centre Régional de Lutte Contre le Cancer de Lyon


title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

summary: Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

ReferenceCitation: Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.

ReferenceCitation: Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Clinique Ste - Marie
Polyclinique De Courlancy
Hopital Andre Mignot
CHR de Grenoble - La Tronche
Hopital Saint-Louis
Clinique Fleming
Hopital Laennec
CMC Les Ormeaux
Clinique Saint Vincent
Hopital Tenon
Clinique Saint - Jean
Centre Jean Bernard
C.H. Senlis
Hopital Saint Antoine


title: Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial

acronym: RADIOLIGA

summary:
Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years.

Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate < 5%.

To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids.

The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier Départemental de Vendée


title: Efficacy and Safety After Failure of a First POEM

acronym: redoPOEM

summary: observational study, measurement of efficacy in the cohort.

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

location_facility: Hôpitaux Universitaires de Marseille Nord


title: Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy

acronym: TPN-RAD

summary: This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)

lead_sponsor: Centre Leon Berard

location_facility:
IUCT Oncopole
Institut Bergonié
CHU Nantes
Institut du Cancer de Montpellier
Centre Oscar Lambert
Centre Leon Berard
CHRU Tours Hôpital Trousseau
APHP Hôpital Cochin
CHU Rennes
CHU Limoges
Centre Georges François Leclerc
Centre Jean Perrin
Institut Curie


title: PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "

acronym: PSYCARE

summary:
Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.

Pioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency/hyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy.

Cognitive remediation improves quality of life (QoL) and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live.

Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.

The study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Eldorado - Maison des Adolescents de Meurthe et Moselle


title: A Phase II Double-blind Multi-center, Placebo-controlled Trial, to Assess the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)

acronym: SESAM

summary: This study is a two periods multi-center Phase II trial, with a 6 months double-blind, placebo-controlled period followed by open label period, to assess the efficacy and safety of alpelisib (BYL719) in pediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP)

ReferenceCitation: Sparrow SSC, D.V.; Saulnier, C.A. Vineland-3: Vineland Adaptive Behavior Scales. 3rd ed. Pearson Assessments; Minneapolis, MN, USA. 2016.

ReferenceCitation: Curie A, Brun A, Cheylus A, Reboul A, Nazir T, Bussy G, et al. A Novel Analog Reasoning Paradigm: New Insights in Intellectually Disabled Patients. PLoS One. 2016;11(2):e0149717.

ipd_sharing: Yes

ipd_sharing_description: All requests for the study's data will be considered by the SESAM trial steering committee.

lead_sponsor: Centre Hospitalier Universitaire Dijon

sponsor_collaborators:
Centre Hospitalier Universitaire Dijon
Novartis Pharmaceuticals

location_facility: AP-HP Hôpital Necker-Enfants Malades - CIC

location_facility: HCL - Groupement Hospitalier Est Hôpital Femme-Mère-Enfant


acronym: MYOCIT

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.

ReferenceCitation: Ruperto N, Ravelli A, Pistorio A, Ferriani V, Calvo I, Ganser G, Brunner J, Dannecker G, Silva CA, Stanevicha V, Cate RT, van Suijlekom-Smit LW, Voygioyka O, Fischbach M, Foeldvari I, Hilario O, Modesto C, Saurenmann RK, Sauvain MJ, Scheibel I, Sommelet D, Tambic-Bukovac L, Barcellona R, Brik R, Ehl S, Jovanovic M, Rovensky J, Bagnasco F, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). The provisional Paediatric Rheumatology International Trials Organisation/American College of Rheumatology/European League Against Rheumatism Disease activity core set for the evaluation of response to therapy in juvenile dermatomyositis: a prospective validation study. Arthritis Rheum. 2008 Jan 15;59(1):4-13. doi: 10.1002/art.23248.

ReferenceCitation: Lazarevic D, Pistorio A, Palmisani E, Miettunen P, Ravelli A, Pilkington C, Wulffraat NM, Malattia C, Garay SM, Hofer M, Quartier P, Dolezalova P, Penades IC, Ferriani VP, Ganser G, Kasapcopur O, Melo-Gomes JA, Reed AM, Wierzbowska M, Rider LG, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO criteria for clinically inactive disease in juvenile dermatomyositis. Ann Rheum Dis. 2013 May;72(5):686-93. doi: 10.1136/annrheumdis-2012-201483. Epub 2012 Jun 26.

ReferenceCitation: Bode RK, Klein-Gitelman MS, Miller ML, Lechman TS, Pachman LM. Disease activity score for children with juvenile dermatomyositis: reliability and validity evidence. Arthritis Rheum. 2003 Feb 15;49(1):7-15. doi: 10.1002/art.10924.

ReferenceCitation: Giancane G, Lavarello C, Pistorio A, Oliveira SK, Zulian F, Cuttica R, Fischbach M, Magnusson B, Pastore S, Marini R, Martino S, Pagnier A, Soler C, Stanevicha V, Ten Cate R, Uziel Y, Vojinovic J, Fueri E, Ravelli A, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO evidence-based proposal for glucocorticoids tapering/discontinuation in new onset juvenile dermatomyositis patients. Pediatr Rheumatol Online J. 2019 May 22;17(1):24. doi: 10.1186/s12969-019-0326-5.

ReferenceCitation: Mammen AL, Allenbach Y, Stenzel W, Benveniste O; ENMC 239th Workshop Study Group. 239th ENMC International Workshop: Classification of dermatomyositis, Amsterdam, the Netherlands, 14-16 December 2018. Neuromuscul Disord. 2020 Jan;30(1):70-92. doi: 10.1016/j.nmd.2019.10.005. Epub 2019 Oct 25. No abstract available.

ReferenceCitation: Singh G, Athreya BH, Fries JF, Goldsmith DP. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 1994 Dec;37(12):1761-9. doi: 10.1002/art.1780371209.

location_facility: Hôpital Necker - Enfants malades : service de dermatologie

location_facility: Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie

title: Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis


title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

acronym: BIOMEDE 2

summary:
The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol).

It is a multicenter, randomized open-label phase-3 controlled trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls.

Two treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until disease progression, unacceptable toxicity or consent withdrawal.

The final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Innovative Therapies For Children with Cancer Consortium

location_facility: CHU de Bordeaux - Groupe hospitalier Saint André - Hôpital Saint André

location_facility: CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: INSTITUT GUSTAVE ROUSSY

type_etablissement: CLCC

titre: BIOMEDE 2.0 -  Essai randomisé multicentrique de combinaison d'une thérapeutique ciblée avec la radiothérapie dans les gliomes diffus de la ligne médiane

discipline_principale: cancer

nom_porteur: GRILL

prenom_porteur: Jacques


title: Induction Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin Followed by Chemotherapy in Second Line Metastatic Colorectal Cancer Carcinoma An Open-label Randomized Phase II-III Study

summary: This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Groupe hospitalier de la région de Mulhouse et Sud Alsace


title: Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study

acronym: METRO

summary: Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

location_facility: Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière

location_facility: Médecine interne et maladies infectieuses - GH Sud Haut Lévêque

location_facility: Médecine interne et immunologie clinique - Dijon


title: Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.

acronym: TRANS'ITION

summary:
Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams.

The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence

Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.

lead_sponsor: University Hospital, Lille

location_facility:
Maison de Santé Lille Sud
CHU de Caen
Maison de Santé Lille Moulins
CHU de Lyon
CHU de Lille
CHU de Nice
Centre Hospitalier Maison Blanche
CHU de Brest
G..R.E.T.T.I.S
Hopital de la Conception - Marseille
Centre Hospitalier de Béziers
Centre Hospitalier Sainte-Anne
CHU de Bordeaux


title: Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia

acronym: RAVEN

summary: The purpose of this study is to collect medical informations and samples from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU d'Amiens
Hopital AVICENNE
IUCT Oncopole
CHU Grenoble
CHU de Reims
Hopital Haut LEVEQUE
CHRU de Lille
CHU de Montpellier
CHU de Besançon
Centre LEON BERARD
Hopital Pitié Salpetrière
CHU Nancy
CHU clermont-ferrand


title: Pharmaco-epidemiological Study of COVID 19 Vaccines in Patients Undergoing Immunotherapy for Cancer. A Retrospective Open Cohort Study.

acronym: IVACOV

summary: The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

ReferenceCitation: Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

ReferenceCitation: Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. No abstract available.

ReferenceCitation: Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum In: Lancet. 2021 Jan 9;397(10269):98.

ReferenceCitation: Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

ReferenceCitation: Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

ReferenceCitation: Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438. doi: 10.1056/NEJMoa2028436. Epub 2020 Sep 29.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

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

collaborators: Centre Hospitalier Intercommunal de Castres

collaborators: Clinique La Croix du Sud Quint-Fonsegrives

location_facility:
Centre Hospitalier d'Albi
Clinique des Cèdres - Capio
Centre Hospitalier du bassin de Thau
Centre Hospitalier de Toulouse
Centre Hospitalier d'Alès
Clinique Claude Bernard
CH de Bagnols sur Cèze
Institut de Cancer de Montpellier
Centre Hospitalier COMMINGES PYRENEES
CH de Bigorre
CH d'Auch
Clinique La Croix du Sud
CH de Cahors


title: Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced/Metastatic Gastrointestinal Stromal Tumors (GISTs)

summary:
This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST.

In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.

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

location_facility: Institut de Cancérologie Lucien NEUWIRTH


title: Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination

summary: To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre hospitalier universitaire de Montpellier


title: A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line

acronym: AxiPRO

summary:
With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients.

In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management.

In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.

lead_sponsor: Weprom

collaborators: Pfizer FLGXPL

sponsor_collaborators: Weprom Pfizer FLGXPL

location_facility: Clinique Victor Hugo / Centre Jean Bernard


title: Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

summary:
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents:

a risk for the patient who could be usually exposed to potential side effects,
a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions
a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars.

Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD [11]. Thus exploration of a new approach is totally in purpose.

The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Clinique de l'Infirmerie Protestante deLyon

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand


title: A Randomised, Comparative, Prospective, Multicentre Study of the Efficacy of Nivolumab + Ipilimumab Versus Pazopanib Alone in Patients With Metastatic or Unresectable Advanced Sarcoma of Rare Subtype (RAR-Immune)

acronym: RAR-Immune

summary:
This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator.

In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone.

The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.

location_facility: Institut Claudius Regaud - IUCT Oncopole

location_facility: Institut de cancérologie Strasbourg Europe


title: Impact of Early Haemodynamic Assessment by Echocardiography on Organ Dysfunction of Patients Admitted in the Emergency Department for Sepsis or Septic Shock

acronym: GENESIS

summary: Acute circulatory failure that combines hypovolemia, vasoplegia and cardiac dysfunction plays a major role in the development of sepsis-related organ dysfunction. Pathophysiological mechanisms are multiple and complex. The objective of the GENESIS study is to determine the impact of early haemodynamic assessment using echocardiography in association with a therapeutic algorithm (intervention arm), when compared with standard of care based on the current Surviving Sepsis Campaign (SSC) recommendations (control arm), on the development of organ dysfunctions in patients admitted to the Emergency Department for sepsis or septic shock.

lead_sponsor: University Hospital, Limoges

location_facility:
Limgoes university hospital
Nantes university hospital
CH d'Albi
Nice university hospital
Poitiers university hospital
La réunion university hospital
Bordeaux university hospital
Toulouse university hospital
Hopital de Versailles
Hopital lariboisière
Hospices civils de Lyon
Grenoble university hospital
CH d'Eaubonne - Montmorency

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: GENESIS

titre: Impact de l'évaluation hémodynamique précoce par échocardiographie ciblée sur l'évolution des patients admis au Service d'Urgences avec un sepsis

discipline_principale: sepsis,  / choc septique,  / médecine d'urgence,  / echographie cardiaque

nom_porteur: LAFON

prenom_porteur: Thomas


title: Constitution of a Prospective Cohort of Patients With Acute Suppurative Hidrosadenitis Followed in the Great West: the COVER Cohort (Verneuil Cohort)

acronym: COVER

summary: Our primary objective with this cohort will be to define the different phenotypes of acute hidrosadenitis, the characterization of which is essential to define suitable therapeutic approaches. Indeed, our recent data allow us to note that there would be different phenotypes of acute hidrosadenitis and therefore different pathologies inducing different follow-ups and care.

lead_sponsor: Nantes University Hospital

location_facility:
Ch Saint-Brieuc
Chru Brest
CH La Rochelle
CH bretagne sud
CH
CHD Vendée
Chr D'Orléans
Ch de Cornouaille
CHU de Nantes - Dermatologie
CHU Pontchaillou
CHU Milétrie
CHRU Tours
CHU Angers


title: Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy

acronym: PHRASAL

summary:
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients.

This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage.

Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: Phrasal

titre: Analyse coût-utilité de la réhabilitation vocale avec prothèse phonatoire inter-trachéo-oesophagienne renforcée versus prothèse phonatoire standard en cas de fuites intra-prothétiques répétées chez les patients laryngectomisés totaux

discipline_principale: orl

nom_porteur: Malard

prenom_porteur: Olivier


title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method With Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.

acronym: PROLISA

summary: The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.

ReferenceCitation: Dekker J, Lopriore E, Rijken M, Rijntjes-Jacobs E, Smits-Wintjens V, Te Pas A. Sedation during Minimal Invasive Surfactant Therapy in Preterm Infants. Neonatology. 2016;109(4):308-13. doi: 10.1159/000443823. Epub 2016 Feb 24.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: S. Karger AG

ReferenceCitation: Dargaville PA, Kamlin CO, De Paoli AG, Carlin JB, Orsini F, Soll RF, Davis PG. The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation. BMC Pediatr. 2014 Aug 27;14:213. doi: 10.1186/1471-2431-14-213.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Tasmania - eCite Digital Repository

version: acceptedVersion

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;ecite.utas.edu.au;figshare.com

publisher_dissemination: Springer

ReferenceCitation: Gopel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Siegel J, Avenarius S, von der Wense A, Vochem M, Groneck P, Weller U, Moller J, Hartel C, Haller S, Roth B, Herting E; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011 Nov 5;378(9803):1627-34. doi: 10.1016/S0140-6736(11)60986-0. Epub 2011 Sep 29.

ReferenceCitation: Dekker J, Lopriore E, van Zanten HA, Tan RNGB, Hooper SB, Te Pas AB. Sedation during minimal invasive surfactant therapy: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F378-F383. doi: 10.1136/archdischild-2018-315015. Epub 2018 Aug 1.

ReferenceCitation: Berde CB, Walco GA, Krane EJ, Anand KJ, Aranda JV, Craig KD, Dampier CD, Finkel JC, Grabois M, Johnston C, Lantos J, Lebel A, Maxwell LG, McGrath P, Oberlander TF, Schanberg LE, Stevens B, Taddio A, von Baeyer CL, Yaster M, Zempsky WT. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop. Pediatrics. 2012 Feb;129(2):354-64. doi: 10.1542/peds.2010-3591. Epub 2012 Jan 16.

ReferenceCitation: Bourgoin L, Caeymaex L, Decobert F, Jung C, Danan C, Durrmeyer X. Administering atropine and ketamine before less invasive surfactant administration resulted in low pain scores in a prospective study of premature neonates. Acta Paediatr. 2018 Jul;107(7):1184-1190. doi: 10.1111/apa.14317. Epub 2018 Apr 16.

ReferenceCitation: Ghanta S, Abdel-Latif ME, Lui K, Ravindranathan H, Awad J, Oei J. Propofol compared with the morphine, atropine, and suxamethonium regimen as induction agents for neonatal endotracheal intubation: a randomized, controlled trial. Pediatrics. 2007 Jun;119(6):e1248-55. doi: 10.1542/peds.2006-2708. Epub 2007 May 7.

ReferenceCitation: Owen LS, Manley BJ. Nasal intermittent positive pressure ventilation in preterm infants: Equipment, evidence, and synchronization. Semin Fetal Neonatal Med. 2016 Jun;21(3):146-53. doi: 10.1016/j.siny.2016.01.003. Epub 2016 Feb 26.

ReferenceCitation: Durrmeyer X, Daoud P, Decobert F, Boileau P, Renolleau S, Zana-Taieb E, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Nicloux M, de Saint Blanquat L, Shankland R, Boelle PY, Carbajal R. Premedication for neonatal endotracheal intubation: results from the epidemiology of procedural pain in neonates study. Pediatr Crit Care Med. 2013 May;14(4):e169-75. doi: 10.1097/PCC.0b013e3182720616.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

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

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013 Feb;131(2):e502-9. doi: 10.1542/peds.2012-0603. Epub 2013 Jan 28.

publisher_dissemination: American Academy of Pediatrics (AAP)

ReferenceCitation: Descamps CS, Chevallier M, Ego A, Pin I, Epiard C, Debillon T. Propofol for sedation during less invasive surfactant administration in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F465. doi: 10.1136/archdischild-2017-312791. Epub 2017 May 8. No abstract available.

ReferenceCitation: Klotz D, Porcaro U, Fleck T, Fuchs H. European perspective on less invasive surfactant administration-a survey. Eur J Pediatr. 2017 Feb;176(2):147-154. doi: 10.1007/s00431-016-2812-9. Epub 2016 Dec 9.

ReferenceCitation: Chevallier M, Durrmeyer X, Ego A, Debillon T; PROLISA Study Group. Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA). BMC Pediatr. 2020 May 8;20(1):199. doi: 10.1186/s12887-020-02112-x.

location_facility:
Chu Amiens
Chu Nantes
Chu Angers
Chu Chambery
Chi Creteil
Chu Brest
centre hospitalier deTroyes
Ap-H Marseille
CHU Grenoble Alpes
Chu Limoges
Chu Nimes
Ch Rennes
Chi Poissy St Germain

titre: Evaluation d'une sédation par Propofol au cours d'une administration intra trachéale de surfactant par méthode LISA (Less Invasive Surfactant Administration)


title: Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I

acronym: THYGRET

summary:
This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

time_perspective: Other

lead_sponsor: University Hospital, Brest

location_facility: Hopitaux Universitaires de Strasbourg - Hopital civil


acronym: REMICRUSH

summary: REMICrush is a French multicentric non inferiority simple blind randomized clinical trial that will compare the use of Remifentanil to muscle relaxant (reference treatment) for anesthetic rapid sequence intubation in terms of major complications (difficult intubation, gastric liquid aspiration, desaturation, hemodynamics reaction, ventricular arrhythmia, anaphylactic reaction).

ReferenceCitation: Grillot N, Garot M, Lasocki S, Huet O, Bouzat P, Le Moal C, Oudot M, Chatel-Josse N, El Amine Y, Danguy des Deserts M, Bruneau N, Cinotti R, David JS, Langeron O, Minville V, Tching-Sin M, Faurel-Paul E, Lerebourg C, Flattres-Duchaussoy D, Jobert A, Asehnoune K, Feuillet F, Roquilly A. Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study). Trials. 2021 Mar 30;22(1):237. doi: 10.1186/s13063-021-05192-x.

publisher_dissemination: Springer-Nature

location_facility:
Hospital
University Hospital Lyon Sud
Toulouse University Hospital
University hospital (SALENGRO hospital)
CHD Vendée
Le Confluent
Military Hospital
University Hospital

title: Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial

acronyme: REMICRUSH

titre: Évaluation de l'utilisation du rémifentanil en remplacement du curare pour l'induction anesthésique en séquence rapide  - Étude multicentrique, prospective, contrôlée, randomisée, en simple aveugle, de non infériorité

discipline_principale: autre

nom_porteur: GRILLOT

prenom_porteur: Nicolas