title: Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units

acronym: DELIREA

summary:
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment.

The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.

ReferenceCitation: Aïssaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.

ReferenceCitation: Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x. Review.

ReferenceCitation: Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.

ReferenceCitation: Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cissé M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.

ReferenceCitation: Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002. Review.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

ReferenceCitation: Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71.

ReferenceCitation: Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3:S3. doi: 10.1186/cc6149. Epub 2008 May 14. Review.

ReferenceCitation: Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.

ReferenceCitation: McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.

lead_sponsor: University Hospital, Toulouse

location_facility:
Saint-André Hospital
Saint-Joseph Hospital
Nord Hospital
Montauban Hospital
Hospital
Oncologic Hospital
University Hospital Toulouse
Jacques Puel Hospital
Estaing Hospital
Gabriel Montpied
Rangueil Hospital
Caremeau Hospital
Perpignan Hospital
Hospital Castres-Mazamet


title: Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study

acronym: QUALIOR

summary: This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Joly F, Lefeuvre-Plesse C, Garnier-Tixidre C, Helissey C, Menneveau N, Zannetti A, Salas S, Houede N, Abadie-Lacourtoisie S, Stefani L, Nenan S, Rieger I, Durand-Zaleski I, Descotes JM, Anota A. Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial. BMC Cancer. 2020 Oct 9;20(1):975. doi: 10.1186/s12885-020-07381-4.

family: Joly

full_name: Florence Joly

given: Florence

sequence: first

family: Lefeuvre-Plesse

full_name: Claudia Lefeuvre-Plesse

given: Claudia

sequence: additional

family: Garnier-Tixidre

full_name: Claire Garnier-Tixidre

given: Claire

family: Helissey

full_name: Carole Helissey

given: Carole

family: Menneveau

full_name: Nathalie Menneveau

given: Nathalie

family: Zannetti

full_name: Alain Zannetti

given: Alain

family: Salas

full_name: Sebastien Salas

given: Sebastien

family: Houede

full_name: Nadine Houede

given: Nadine

family: Abadie-Lacourtoisie

full_name: Sophie Abadie-Lacourtoisie

given: Sophie

family: Stefani

full_name: Laetitia Stefani

given: Laetitia

family: Nenan

full_name: Soazig Nenan

given: Soazig

family: Rieger

full_name: Isabelle Rieger

given: Isabelle

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

family: Descotes

full_name: Jean-Marc Descotes

given: Jean-Marc

family: Anota

full_name: Amélie Anota

given: Amélie

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: CH Nimes - Institut de Cancérologie du Gard

location_facility: INSTITUT CURIE - Site René Huguenin St Cloud

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.

acronym: PROFILER 02

summary:
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.

This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).

status: Active, not recruiting

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie Lucien NEUWIRTH

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Ongoing


title: Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study

acronym: TERIS

summary:
Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults, resulting from an autoimmune interruption of both myelin and axons within the central nervous system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the requisite number of lesions within the brain or spinal cord, along with criteria for time, by demonstrating a history of at least a second clinical attack or the development of a new MS lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals who do not exhibit signs of neurological dysfunction commonly have brain MRI studies performed for a reason other than an evaluation for MS that reveal unexpected anomalies highly suggestive of demyelinating plaques given their size, location, and morphology. These healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the phenotype of at-risk individuals for future demyelinating events. The discovery of such anomalies creates intersecting neuro-ethical, legal, social, and practical medical management quandaries and is, therefore, of both immediate and long-term clinical significance. Despite advancements in the characterization of RIS subjects, and in our understanding of risk factors for initial symptom development, the effect of treatment on such cases remain unclear.

The purpose of this investigation is to systematically study the efficacy of Teriflunomide in those individuals who possess incidental white matter anomalies within the brain and following a MRI study that is performed for a reason other than for the evaluation of MS.

RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.

The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.

This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Turkey France Switzerland

location_facility: Ondokuz Mayis University, Faculty of Medicine

intervention_type: Drug


title: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)

summary:
The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients.

The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: CHU de Poitiers - Hôpital de la Miletrie

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: Six Years of Follow-up After Extended Duration of Oral Anticoagulant Therapy for a First Episode of Idiopathic Pulmonary Embolism or Proximal Deep Vein Thrombosis.

acronym: Padis-Ext

summary: Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations. Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial).

ipd_sharing: Undecided

lead_sponsor: University Hospital, Brest

location_facility:
CH de Lorient
CHU de St Etienne
CHU de Nantes
AP-HP Kremlin Bicetre
CHU de Clermont-Ferrand
Hotel Dieu
CHIC Quimper
CH St Brieuc
CHU de Grenoble
CHU de Tours
CHRU de Brest
Hôpital Européen Georges Pompidou
CH de Lannion
CHU de Toulouse
CHU de Rennes


title: Observational Study of Interventional Cardiology in Centre Region

summary:
Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.

lead_sponsor: Club Régional des Angioplasticiens de la région Centre

location_facility: CHU Gabriel-Montpied de Clermont-Ferrand

location_facility: Centre Hospitalier Jacques Coeur de Bourges

location_facility: Pôle Santé Oréliance - Clinique de la Reine Blanche

location_facility: Centre Hospitalier Henri Mondor d'Aurillac

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

location_facility: Research Cardiology Unit / Les hopitaux de Chartres


title: Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.

acronym: CASTA-DIVA

summary: The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.

ReferenceCitation: Planquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahé I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Riviere A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P; CASTA DIVA Trial Investigators. Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial. Chest. 2021 Oct 8. pii: S0012-3692(21)04079-4. doi: 10.1016/j.chest.2021.09.037. [Epub ahead of print]

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

family: Charles-Nelson

full_name: Anaïs Charles-Nelson

given: Anaïs

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Grange

full_name: Claire Grange

family: Mahé

full_name: Isabelle Mahé

family: Pernod

full_name: Gilles Pernod

given: Gilles

family: Elias

full_name: Antoine Elias

given: Antoine

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Falvo

full_name: Nicolas Falvo

given: Nicolas

family: Sevestre

full_name: Marie Antoinette Sevestre

given: Marie Antoinette

family: Ray

full_name: Valérie Ray

given: Valérie

family: Burnod

full_name: Alexis Burnod

given: Alexis

family: Brebion

full_name: Nicolas Brebion

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Timar-David

full_name: Miruna Timar-David

given: Miruna

family: Aquilanti

full_name: Sandro Aquilanti

given: Sandro

family: Constans

full_name: Joel Constans

given: Joel

family: Bura-Riviere

full_name: Alessandra Bura-Riviere

given: Alessandra

family: Brisot

full_name: Dominique Brisot

given: Dominique

family: Chatellier

full_name: Gilles Chatellier

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Meyer

full_name: Guy Meyer

given: Guy

title: Rivaroxaban versus Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial

location_facility: CHU Saint Etienne - Medecin vasculaire et therapeutique (006)

location_facility: CHU Brest - Departement de medecin interne et pneumologie (008)

location_facility: Institut Curie - Soins de support en Cancerologie (020)

location_facility: Hopital Saint Andre - Medecine vasculaire (015)

location_facility: CHU Le Bocage - Medecine interne 1 (014)

location_facility: CHU Grenoble - Medecine vasculaire (007)

location_facility: HEGP - Pneumologie et soins intensifs (001)

location_facility: Hopital Saine Musse - Service de Medecine Vasculaire (010)

location_facility: Centre hospitalier Lyon Sud - Medecine interne (011)


title: Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.

acronym: INTACT

summary: The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

status: Unknown status

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: University Hospital of Bordeaux - Hospital Pellegrin

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Hôpital Européen Georges Pompidou - AP-HP de Paris

intervention_type: Device

status_simplified: Unknown


type: Other Identifier

title: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

acronym: NIGA-RA

summary:
The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a prognostic value (which could increase the risk of Renal Absolute), the longitudinal monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3) in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in therapeutic trials IgA nephropathy.

This research project constitutes the first step in validating these antibodies biomarker of IgA nephropathy and its main objective is to study the performance of the blood levels of anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA nephropathy as defined by the Renal Risk Absolute.

The secondary objectives of this project are to establish a bio-collection that will allow us to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new international histological classification.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH d'ANNECY
CH d'ANNONAY
CHU de GRENOBLE
CHU de SAINT-ETIENNE
Hôpital Edouard. HERRIOT
Centre Hospitalier de Lyon Sud
CH du PUY EN VELAY
CH de CHAMBERY
CH de VALENCE
Hôpitaux Drome Nord
CHU de DIJON
CH de BOURG EN BRESSE
CH de ROANNE
Clinique du TONKIN
CHU de CLERMONT-FERRAND

intervention_type: Biological


status: Terminated

acronym: PIRAT

location_facility:
CHU de BESANCON
CHU de NANTES
Chu Kremlin Bicetre
Hopital LYON Sud
CHU de STRASBOURG
CHU de TOULOUSE
Hopital Edouard HERRIOT
Hopital Pitie Salpetriere
CHU de SAINT-ETIENNE
CHRU de TOURS
CHU de MONTPELLIER
CHU de NANCY
Hopital Tenon
CHU de BORDEAUX
CHU de NICE

type: EudraCT Number

source: euctr

title: Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment

summary:
IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years post-transplant.

The primary immunosuppressive induction regimens currently used in kidney transplantation are the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal) and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may prevent or delay the recurrence on renal transplant.

The aim of this study was to evaluate the influence of induction therapy (ATG versus Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney transplant.

This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years old.

Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4 post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of 4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4 after the graft. The maintenance immunosuppressive therapy is left to the discretion of the center.

The primary endpoint will be the clinical and histological recurrence of IgAN defined by the presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg / day.


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).

ReferenceType: background

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. Review. 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. Review. 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.

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. 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.

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. Review.

ReferenceCitation: Deroux A, Vilgrain I, Dumestre-Pérard 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. Review.

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.

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.

ReferenceCitation: Payne V, Kam PC. Mast cell tryptase: a review of its physiology and clinical significance. Anaesthesia. 2004 Jul;59(7):695-703. Review.

ReferenceCitation: Kasperska-Zając 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.

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.

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, Sidibé 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. 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.

ReferenceCitation: Sidibé A, Polena H, Pernet-Gallay K, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal 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: Sidibé A, Polena H, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal 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.

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, Müller-Esterl W, Schmitt R, Sjögren AC, Truedsson L, Karpman D. Contact-system activation in children with vasculitis. Lancet. 2002 Aug 17;360(9332):535-41.

ReferenceCitation: Ghannam A, Sellier P, Defendi F, Favier B, Charignon D, López-Lera A, López-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. Review.

ReferenceCitation: Blohmé 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.

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.

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.

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.

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, Høgåsen 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.

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.

lead_sponsor: University Hospital, Grenoble

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

intervention_type: Other


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.

ReferenceCitation: Gérard A, Doyen J, Cremoni M, Bailly L, Zorzi K, Ruetsch-Chelli C, Brglez V, Picard-Gauci A, Troin L, Esnault VLM, Passeron T, Montaudié 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). pii: e002512. doi: 10.1136/jitc-2021-002512.

family: Gérard

full_name: Alexandre Gérard

given: Alexandre

family: Doyen

full_name: Jerome Doyen

given: Jerome

family: Cremoni

full_name: Marion Cremoni

given: Marion

family: Bailly

full_name: Laurent Bailly

given: Laurent

family: Zorzi

full_name: Kevin Zorzi

given: Kevin

family: Ruetsch-Chelli

full_name: Caroline Ruetsch-Chelli

given: Caroline

family: Brglez

full_name: Vesna Brglez

given: Vesna

family: Picard-Gauci

full_name: Alexandra Picard-Gauci

given: Alexandra

family: Troin

full_name: Laura Troin

given: Laura

family: Esnault

full_name: Vincent L.M. Esnault

given: Vincent L.M.

family: Passeron

full_name: Thierry Passeron

given: Thierry

family: Montaudié

full_name: Henri Montaudié

given: Henri

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

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

intervention_type: Radiation


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.

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.

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Miailhe

full_name: Arnaud-Félix Miailhe

given: Arnaud-Félix

family: le Gouge

full_name: Amélie le Gouge

given: Amélie

family: Cariou

full_name: Alain Cariou

given: Alain

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Reignier

full_name: Jean Reignier

given: Jean

family: Coupez

full_name: Elisabeth Coupez

given: Elisabeth

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Legriel

full_name: Stephane Legriel

given: Stephane

family: Pichon

full_name: Nicolas Pichon

given: Nicolas

family: Thevenin

full_name: Didier Thevenin

given: Didier

family: Boulain

full_name: Thierry Boulain

family: Frat

full_name: Jean-Pierre Frat

family: Vimeux

full_name: Sylvie Vimeux

given: Sylvie

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Desroys du Roure

full_name: François Desroys du Roure

given: François

journal_name: Resuscitation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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 Surgical Intensive Care Unit
CHU Orleans
Medical Intensive Care Unit
CHU Tours
CHU Dijon


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).

ReferenceCitation: Bachet JB, Bouché 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.

family: Bachet

full_name: J.B. Bachet

family: Bouché

full_name: O. Bouché

given: O.

family: Taieb

full_name: J. Taieb

given: J.

family: Dubreuil

full_name: O. Dubreuil

family: Garcia

full_name: M.L. Garcia

family: Meurisse

full_name: A. Meurisse

given: A.

family: Normand

full_name: C. Normand

given: C.

family: Gornet

full_name: J.M. Gornet

family: Artru

full_name: P. Artru

given: P.

family: Louafi

full_name: S. Louafi

given: S.

family: Bonnetain

full_name: F. Bonnetain

given: F.

family: Thirot-Bidault

full_name: A. Thirot-Bidault

family: Baumgaertner

full_name: I. Baumgaertner

given: I.

family: Coriat

full_name: R. Coriat

given: R.

family: Tougeron

full_name: D. Tougeron

given: D.

family: Lecomte

full_name: T. Lecomte

given: T.

family: Mary

full_name: F. Mary

family: Aparicio

full_name: T. Aparicio

family: Marthey

full_name: L. Marthey

given: L.

family: Taly

full_name: V. Taly

given: V.

family: Blons

full_name: H. Blons

given: H.

family: Vernerey

full_name: D. Vernerey

family: Laurent-Puig

full_name: P. Laurent-Puig

lead_sponsor: Association des Gastroentérologues Oncologues

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


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:
Strasbourg University Hospital
Brest University Hospital
Rennes University Hospital
Georges Pompidou European Hospital
Rouen University Hospital
Necker Hospital
Amiens University Hospital
Limoges University Hospital
Tours University Hospital
Caen University Hospital
Angers University Hospital
Poitiers University Hospital
Reims University Hospital
Clermont Ferrand University 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, Thümmler S, Giannitelli M, Olliac B, Bonnot O, Cohen D, Askenazy F; ETAPE Study group. Incidence of adverse events in antipsychotic-naïve 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.

family: Menard

full_name: Marie-Line Menard

given: Marie-Line

family: Thümmler

full_name: Susanne Thümmler

given: Susanne

family: Giannitelli

full_name: Marianna Giannitelli

given: Marianna

family: Olliac

full_name: Bertrand Olliac

given: Bertrand

family: Bonnot

full_name: Olivier Bonnot

given: Olivier

family: Cohen

full_name: David Cohen

given: David

family: Askenazy

full_name: Florence Askenazy

given: Florence

journal_name: BMJ Open

repository_institution: PubMed Central - Europe PMC

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

endpoint_id: HAL

repository_institution: HAL

version: submittedVersion

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


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: Clinique Chirurgicale de l'Orangerie, Chiliotherapie

location_facility: Institut Paoli-Calmettes / Hôpital de jour


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.

family: Berton

full_name: Dominique Berton

given: Dominique

family: Floquet

full_name: Anne Floquet

given: Anne

family: Lescaut

full_name: Willy Lescaut

given: Willy

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Toussaint

full_name: Philippe Toussaint

given: Philippe

family: Largillier

full_name: Rémy Largillier

given: Rémy

family: Savoye

full_name: Aude-Marie Savoye

given: Aude-Marie

family: Alexandre

full_name: Jérôme Alexandre

given: Jérôme

family: Delbaldo

full_name: Catherine Delbaldo

given: Catherine

family: Malaurie

full_name: Emmanuelle Malaurie

given: Emmanuelle

family: Barletta

full_name: Hugues Barletta

given: Hugues

family: Bosacki

full_name: Claire Bosacki

given: Claire

family: Garnier-Tixidre

full_name: Claire Garnier-Tixidre

family: Follana

full_name: Philippe Follana

family: Laharie-Mineur

full_name: Hortense Laharie-Mineur

given: Hortense

family: Briac Levache

full_name: Charles Briac Levache

given: Charles

family: Valenza

full_name: Bruno Valenza

given: Bruno

family: Dechartres

full_name: Agnès Dechartres

given: Agnès

family: Mollon-Grange

full_name: Delphine Mollon-Grange

given: Delphine

family: Selle

full_name: Frédéric Selle

given: Frédéric

journal_name: Frontiers in Pharmacology

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

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

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


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).

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Italy France Switzerland

location_facility: Azienda Ospedaliero-Universitaria di Parma

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

location_facility: Centro di Riferimento Oncologico di Aviano

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

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

location_facility: IOSI - Oncology Institute of Southern Switzerland


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).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Groupe Hospitalier Dioconesses - Site Reuilly

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

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre


lead_sponsor: Novartis Pharmaceuticals

acronym: SIMCER

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

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: 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

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


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

lead_sponsor: Rennes University Hospital

location_country:
United Kingdom
France

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

location_facility: Pédiatrie - Pneumologie, Allergologie - Hôpital des enfants

location_facility: CRCM Pédiatrique - Hôpital de Hautepierre

location_facility: Pneumologie Infantile - Hôpital des enfants

location_facility: Pneumology pediatric - Hôpital Femme-Mère-Enfants

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

location_facility: Pediatric penumologic - Groupe hospitalier de Pellegrin


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

location_facility: Hôpital Necker, Service de Néphrologie adulte

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

location_facility: Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale

location_facility: Hôpital Bretonneau, Service de Néphrologie

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

location_facility: Hôpital Pasteur, Service de Néphrologie - Transplantation

location_facility: Hôpital Foch, Service de Néphrologie Transplantation

location_facility: Hopital Saint Louis, Service de Néphrologie

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

location_facility: Hôpital Henri Mondor, Service de Néphrologie Transplantation

location_facility: Hôpital Kremlin Bicêtre, Service de Néphrologie

location_facility: CHU De Caen, Service de Néphrologie Hémodialyse

location_facility: Hôpital civil, Service de Néphrologie et 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.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Bordeaux University hospital 2
Amiens University Hospital :
CHU Bordeaux univerity hospital 1
Jean Verdier
Antoine Béclère
CHU
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, Pépin 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.

name: Univ Grenoble Alpes, HP2 laboratory, Grenoble, France

family: Mendelson

full_name: Monique Mendelson

given: Monique

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Laplaud

full_name: David Laplaud

given: David

family: Dias-Domingos

full_name: Sonia Dias-Domingos

given: Sonia

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Moreau

full_name: Laurent Moreau

given: Laurent

name: Service de Pneumologie, Saint Avold, France

family: Koltes

full_name: Christian Koltes

given: Christian

family: Chavez

full_name: Léonidas Chavez

given: Léonidas

family: De Lamberterie

full_name: Gilles De Lamberterie

given: Gilles

name: Dieulefit Santé, Domaine Chamonix, Dieulefit, France

family: Herengt

full_name: Frédéric Herengt

family: Levy

full_name: Patrick Levy

given: Patrick

family: Flore

full_name: Patrice Flore

given: Patrice

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Sleep

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: CPAP Treatment Supported by Telemedicine Does Not Improve Blood Pressure in High Cardiovascular Risk OSA Patients: A Randomized, Controlled Trial

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, Pépin 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.

lead_sponsor: Initiative Pour la Sante

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


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.

lead_sponsor: University Hospital, Toulouse

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


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.

acronym: APPROCHE ORL

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

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

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

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin

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

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

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

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

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.


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 Pontoise - Centre Hospitalier René Dubos

location_facility: CH de Colmar - Hôpitaux Civils de Colmar

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut

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

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

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

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


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

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


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.

family: Le Page

full_name: Emmanuelle Le Page

given: Emmanuelle

family: Veillard

full_name: David Veillard

full_name: David A Laplaud

given: David A

family: Hamonic

full_name: Stéphanie Hamonic

given: Stéphanie

family: Wardi

full_name: Rasha Wardi

given: Rasha

family: Lebrun

full_name: Christine Lebrun

given: Christine

family: Zagnoli

full_name: Fabien Zagnoli

given: Fabien

family: Wiertlewski

full_name: Sandrine Wiertlewski

given: Sandrine

family: Deburghgraeve

full_name: Véronique Deburghgraeve

given: Véronique

family: Coustans

full_name: Marc Coustans

given: Marc

family: Edan

full_name: Gilles Edan

journal_name: The Lancet

oa_host_type: repository

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

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

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


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 Rennes
Chu Besancon
Hopital Saint Louis
Hopital Haut Leveque
CHU CAEN
Hopital Cochin
Hopital Lariboisiere
Hopital St Antoine
Chu Amiens
Chu Reims
Hopital Beaujon
Chu Tours
Chu Toulouse
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, Adès 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.

family: Prebet

full_name: Thomas Prebet

given: Thomas

family: Braun

full_name: Thorsten Braun

given: Thorsten

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

family: Dreyfus

full_name: Francois Dreyfus

given: Francois

family: Stammatoullas

full_name: Aspasia Stammatoullas

given: Aspasia

family: Wattel

full_name: Eric Wattel

given: Eric

family: Ame

full_name: Shanti Ame

given: Shanti

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

family: Adès

full_name: Lionel Adès

given: Lionel

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Vey

full_name: Norbert Vey

given: Norbert

journal_name: Leukemia Research

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, Guégan 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.

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Pernod

full_name: Gilles Pernod

given: Gilles

family: Presles

full_name: Emilie Presles

given: Emilie

family: Duhamel

full_name: Elisabeth Duhamel

given: Elisabeth

family: Jego

full_name: Patrick Jego

given: Patrick

family: Provost

full_name: Karine Provost

given: Karine

family: Pan-Petesch

full_name: Brigitte Pan-Petesch

given: Brigitte

family: Sollier

full_name: Claire Bal dit Sollier

given: Claire Bal dit

family: Tromeur

full_name: Cécile Tromeur

given: Cécile

family: Hoffmann

full_name: Clément Hoffmann

given: Clément

family: Bressollette

full_name: Luc Bressollette

given: Luc

family: Lorillon

full_name: Philippe Lorillon

given: Philippe

family: Girard

full_name: Philippe Girard

family: Le Moigne

full_name: Emmanuelle Le Moigne

given: Emmanuelle

family: Le Hir

full_name: Aurelia Le Hir

given: Aurelia

family: Guégan

full_name: Marie Guégan

given: Marie

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Mismetti

full_name: Patrick Mismetti

family: Lacut

full_name: Karine Lacut

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

family: Sanchez

full_name: Oliver Sanchez

given: Oliver

family: Meyer

full_name: Guy Meyer

given: Guy

publisher: Ferrata Storti Foundation (Haematologica)

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, Schröder 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.

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

family: Margenet

full_name: Alain Margenet

given: Alain

family: Haude

full_name: Michael Haude

given: Michael

family: Bode

full_name: Christoph Bode

given: Christoph

family: Lablanche

full_name: Jean-Marc Lablanche

given: Jean-Marc

family: Heuer

full_name: Hubertus Heuer

given: Hubertus

family: Schröder

full_name: Rolf Schröder

given: Rolf

family: Kropff

full_name: Stefan Kropff

given: Stefan

family: Bourkaib

full_name: Ryad Bourkaib

given: Ryad

family: Banik

full_name: Norbert Banik

given: Norbert

family: Zahn

full_name: Ralf Zahn

given: Ralf

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Randomized Comparison of Eptifibatide Versus Abciximab in Primary Percutaneous Coronary Intervention in Patients With Acute ST-Segment Elevation Myocardial Infarction


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 Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer


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 Bouëdec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pélissier 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.

family: Avril

full_name: A. Avril

given: A.

family: Le Bouëdec

full_name: G. Le Bouëdec

given: G.

family: Lorimier

full_name: G. Lorimier

family: Classe

full_name: J.M. Classe

family: Tunon-de-Lara

full_name: C. Tunon-de-Lara

given: C.

family: Giard

full_name: S. Giard

given: S.

family: MacGrogan

full_name: G. MacGrogan

family: Debled

full_name: M. Debled

given: M.

family: Mathoulin-Pélissier

full_name: S. Mathoulin-Pélissier

family: Mauriac

full_name: L. Mauriac

given: L.

journal_name: European Journal of Surgical Oncology (EJSO)

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

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

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Saint Nazaire

location_facility: Centre Régional de Luttre Contre le Cancer de Strasbourg

location_facility: Centre Régional de Luttre Contre le Cancer de Lille

location_facility: Centre Régional de Lutte Contre le Cancer de Lyon

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 Dijon

location_facility: Centre Régional de Luttre Contre le Cancer de Montpellier

location_facility: Centre Hospitalier Intercommunal de Marmande

location_facility: Centre Regional de Lutte Contre le Cancer de Toulouse

location_facility: Centre Régional de Luttre Contre le Cancer de Nantes

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

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


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.

family: Geier

full_name: Jamie L. Geier

given: Jamie L.

family: Karayal

full_name: Onur N. Karayal

given: Onur N.

family: Lewis

full_name: Michael Lewis

family: Camm

full_name: John A. Camm

given: John A.

name: University of Pennsylvania School of Medicine; Philadelphia PA USA

family: Keane

full_name: Martin Keane

given: Martin

family: Kremer

full_name: Charlotte ME. Kremer

given: Charlotte ME.

family: Kolluri

full_name: Sheela Kolluri

given: Sheela

family: Reynolds

full_name: Robert Reynolds

given: Robert

family: Eng

full_name: Sybil Eng

given: Sybil

family: Strom

full_name: Brian L. Strom

given: Brian L.

journal_name: Pharmacoepidemiology and Drug Safety

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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.

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.

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


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

location_facility: Centre Hospitalier General de Saint Nazaire


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

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 National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer

summary:
INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer.

METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application.

DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

ReferenceCitation: Delrieu L, Anota A, Trédan O, Freyssenet D, Maire A, Canada B, Fournier B, Febvey-Combes O, Pilleul F, Bouhamama A, Caux C, Joly F, Fervers B, Pialoux V, Pérol D, Pérol O. Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial. BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.

family: Delrieu

full_name: Lidia Delrieu

given: Lidia

family: Anota

full_name: Amélie Anota

given: Amélie

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Freyssenet

full_name: Damien Freyssenet

given: Damien

family: Maire

full_name: Aurélia Maire

given: Aurélia

family: Canada

full_name: Brice Canada

given: Brice

family: Fournier

full_name: Baptiste Fournier

given: Baptiste

family: Febvey-Combes

full_name: Olivia Febvey-Combes

given: Olivia

family: Pilleul

full_name: Frank Pilleul

given: Frank

family: Bouhamama

full_name: Amine Bouhamama

given: Amine

family: Caux

full_name: Christophe Caux

given: Christophe

family: Joly

full_name: Florence Joly

given: Florence

family: Fervers

full_name: Béatrice Fervers

given: Béatrice

family: Pialoux

full_name: Vincent Pialoux

given: Vincent

family: Pérol

full_name: David Pérol

given: David

full_name: Olivia Pérol

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: Institut de Cancérologie de l'Ouest (ICO)


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.

study_start_date_type: Anticipated

lead_sponsor: Nantes University Hospital

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


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