title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria

acronym: SPIDAC

summary: Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Lille

location_facility:
Ch Cambrai
CHRU,
CH ARRAS
Ch Armentieres
Ch Boulogne-Sur-Mer
Ch Denain
Ch Bethune
CH DOUAI
Hopital Saint Vincent - Saint Antoine
Groupe Hospitalier Seclin Carvin
Ch Dunkerque
Ch Arrondissement de Montreuil
C.H de Roubaix
Clinique Teissier
Ch de Valenciennes
Ch Region de St-Omer
Hopital Prive La Louviere
Ch Tourcoing
CH LENS

intervention_type: Biological


title: Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study

acronym: PREV-ONM

summary:
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).

Data are collected during the usual follow-up of patients during the first 3 months following surgery.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7.

ReferenceCitation: Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76.

ReferenceCitation: Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5. Erratum in: J Oral Maxillofac Surg. 2015 Jul;73(7):1440. J Oral Maxillofac Surg. 2015 Sep;73(9):1879.

family: Ruggiero

full_name: Salvatore L. Ruggiero

given: Salvatore L.

sequence: first

family: Dodson

full_name: Thomas B. Dodson

given: Thomas B.

sequence: additional

family: Fantasia

full_name: John Fantasia

given: John

family: Goodday

full_name: Reginald Goodday

given: Reginald

family: Aghaloo

full_name: Tara Aghaloo

given: Tara

family: Mehrotra

full_name: Bhoomi Mehrotra

given: Bhoomi

family: O'Ryan

full_name: Felice O'Ryan

given: Felice

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Oral and Maxillofacial Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: American Association of Oral and Maxillofacial Surgeons Position Paper on Medication-Related Osteonecrosis of the Jaw—2014 Update

ReferenceCitation: Qi WX, Tang LN, He AN, Yao Y, Shen Z. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 2013 Apr 20.

family: Qi

full_name: Wei-Xiang Qi

given: Wei-Xiang

family: Tang

full_name: Li-Na Tang

given: Li-Na

family: He

full_name: Ai-Na He

given: Ai-Na

family: Yao

full_name: Yang Yao

given: Yang

family: Shen

full_name: Zan Shen

given: Zan

journal_name: International Journal of Clinical Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009 May;67(5 Suppl):61-70. doi: 10.1016/j.joms.2009.01.007. Review.

family: Allen

full_name: Matthew R. Allen

given: Matthew R.

family: Burr

full_name: David B. Burr

given: David B.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Indiana University - IUScholarWorks

version: submittedVersion

title: The Pathogenesis of Bisphosphonate-Related Osteonecrosis of the Jaw: So Many Hypotheses, So Few Data

ReferenceCitation: Gaudin E, Seidel L, Bacevic M, Rompen E, Lambert F. Occurrence and risk indicators of medication-related osteonecrosis of the jaw after dental extraction: a systematic review and meta-analysis. J Clin Periodontol. 2015 Oct;42(10):922-32. doi: 10.1111/jcpe.12455. Epub 2015 Nov 3. Review.

name: Department of Periodontology and Oral Surgery; Faculty of Medicine; University of Liège; Liège Belgium

family: Gaudin

name: Biostatistics; University Hospital of Liège; University of Liege; Liège Belgium

name: Dental Biomaterials Research Unit (d-BRU); Faculty of Medicine; University of Liege; Liège Belgium

name: Clinic of Oral Surgery; School of Dental Medicine; University of Belgrade; Belgrade Serbia

ReferenceCitation: Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Feb;39(1):97-104. doi: 10.1016/j.ctrv.2012.07.002. Epub 2012 Aug 13. Review.

title: Denosumab in patients with cancer and skeletal metastases: A systematic review and meta-analysis

ReferenceCitation: Landesberg R, Woo V, Cremers S, Cozin M, Marolt D, Vunjak-Novakovic G, Kousteni S, Raghavan S. Potential pathophysiological mechanisms in osteonecrosis of the jaw. Ann N Y Acad Sci. 2011 Feb;1218:62-79. doi: 10.1111/j.1749-6632.2010.05835.x. Review.

journal_name: Annals of the New York Academy of Sciences

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

ReferenceCitation: Reich W, Bilkenroth U, Schubert J, Wickenhauser C, Eckert AW. Surgical treatment of bisphosphonate-associated osteonecrosis: Prognostic score and long-term results. J Craniomaxillofac Surg. 2015 Nov;43(9):1809-22. doi: 10.1016/j.jcms.2015.07.035. Epub 2015 Aug 6.

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Intercommunal Robert Ballanger


ReferenceType: derived

ReferenceCitation: Bouhassira D, Perrot S, Riant T, Martiné-Fabre G, Pickering G, Maindet C, Attal N, Ranque Garnier S, Nguyen JP, Kuhn E, Viel E, Kieffert P, Tölle T, Delorme C, Deleens R, Giniès P, Corand-Dousset V, Dal-Col C, Serrie A, Chevrillon E, Gov C, Ramirez-Gil JF, Delval C, Schaller M, Bessière B, Houéto P, Sommer C; ProtoTOP group. Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain. Pain. 2021 Apr 1;162(4):1104-1115. doi: 10.1097/j.pain.0000000000002109.

family: Bouhassira

full_name: Didier Bouhassira

given: Didier

family: Perrot

full_name: Serge Perrot

given: Serge

family: Riant

full_name: Thibault Riant

given: Thibault

family: Martiné-Fabre

full_name: Gaelle Martiné-Fabre

given: Gaelle

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

family: Maindet

full_name: Caroline Maindet

given: Caroline

family: Attal

full_name: Nadine Attal

given: Nadine

family: Ranque Garnier

full_name: Stéphanie Ranque Garnier

given: Stéphanie

family: Nguyen

full_name: Jean-Paul Nguyen

given: Jean-Paul

family: Kuhn

full_name: Emmanuelle Kuhn

given: Emmanuelle

family: Viel

full_name: Eric Viel

given: Eric

family: Kieffert

full_name: Patrick Kieffert

given: Patrick

family: Tölle

full_name: Thomas Tölle

given: Thomas

family: Delorme

full_name: Claire Delorme

given: Claire

family: Deleens

full_name: Rodrigue Deleens

given: Rodrigue

family: Giniès

full_name: Patrick Giniès

family: Corand-Dousset

full_name: Virginie Corand-Dousset

given: Virginie

family: Dal-Col

full_name: Clémence Dal-Col

given: Clémence

family: Serrie

full_name: Alain Serrie

given: Alain

family: Chevrillon

full_name: Emmanuel Chevrillon

given: Emmanuel

family: Gov

full_name: Christian Gov

given: Christian

family: Ramirez-Gil

full_name: Juan Fernando Ramirez-Gil

given: Juan Fernando

family: Delval

full_name: Cécile Delval

given: Cécile

family: Schaller

full_name: Manuella Schaller

given: Manuella

family: Bessière

full_name: Baptiste Bessière

given: Baptiste

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre Hospitalier Régional de Metz-Thionville

location_facility: Neurologische Klinik Klinikum rechts der Isar

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz

title: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study

summary: To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments


title: Score of Echogenicity and Pancreatic Echo-endoscopy

acronym: OBELIX

summary:
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.

The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility:
Clinique du Trocadéro
Clinique des Portes du Sud
Clinique du Val d'Ouest
Polyclinique du Beaujolais
Hôpital privé Jean Mermoz

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis

acronym: StomaPed

summary:
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.

The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.

It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

study_start_date_type: Anticipated

status: Unknown status

time_perspective: Retrospective

ReferenceCitation: BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4.

ReferenceCitation: SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154:939-48.

ReferenceCitation: Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.

family: Sehgal

full_name: Sona Sehgal

given: Sona

family: Sandler

full_name: Anthony D. Sandler

given: Anthony D.

family: Alfred Chahine

full_name: A Alfred Chahine

given: A

family: Mohan

full_name: Parvati Mohan

given: Parvati

family: Torres

full_name: Clarivet Torres

given: Clarivet

journal_name: Journal of Pediatric Surgery

lead_sponsor: University Hospital, Angers

location_facility:
Necker Enfants Malades Hospital
University Hospital of Brest
University Hospital of Rennes
University Hospital of Tours
University Hospital of Nantes

status_simplified: Unknown


title: Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQol-MDS)

summary:
Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The only available treatment for severe thrombocytopenia, in the presence of bleeding, is platelet transfusion.

Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.

The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia and low- or intermediate-1 IPSS risk (Index Prognostic Score System).

Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients become refractory in the long term. The availability of a treatment that induces the increase of platelet count is extremely important, either in terms of quality of life, and in overall survival.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Associazione Qol-one

location_country: Italy Germany Slovenia France

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: A.O.U. San Giovanni di Dio e Ruggì D'Aragona

location_facility: U.O. Citta' della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: A.O. Citta' della Salute e della Scienza di Torino

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Pisana

intervention_type: Other

lead_sponsor_type: industriel


title: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

acronym: CP-GARO

summary: Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

ipd_sharing: No

lead_sponsor: Rennes University Hospital

location_facility: Groupement Coopération Sanitaire Pui Cite Sanitaire

location_facility: Communauté Hospitalière de Territoire Rance Emeraude


title: Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

acronym: FIBROTHERME

summary: This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.

primary_purpose: Supportive Care

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Clinique du Parc de Charleville-Mézières

location_facility: Centre d'Oncologie et de Radiothérapie du Parc

location_facility: CH de Belfort-Montbéliard Site du Mittan


title: A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate (Glivec®) Plasmatic Through Level in Patients Newly Diagnosed With Chronic Phase Chronic Myelogenous Leukaemia (CP-CML).

acronym: OPTIMIMATINIB

summary:
Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.

lead_sponsor: Versailles Hospital

location_facility:
Hopital Necker
CHU Rennes
Hopital Bon secours
CH Dunkerque
CHU CAEN
Hopital Purpan
CHU angers
CHU Lille
CHU Lyon
CHU Bordeaux
CH d'Annecy
CH de Dieppe
CH argenteuil
CH Versailles
CH Meaux
Institut Bergonié
CHU Nice
CH Boulogne
Hopital La Source


intervention_type: Drug

lead_sponsor: Institut Bergonié

acronym: CONGRATS

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

type: EudraCT Number

type: Other Identifier

source: euctr

title: Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study.

summary: This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.

status_simplified: Ongoing


title: Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance

summary: This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance

status: Active, not recruiting

ReferenceCitation: Le Gouill S, Beldi-Ferchiou A, Alcantara M, Cacheux V, Safar V, Burroni B, Guidez S, Gastinne T, Canioni D, Thieblemont C, Maisonneuve H, Bodet-Milin C, Houot R, Oberic L, Bouabdallah K, Bescond C, Damaj G, Jaccard A, Daguindau N, Moreau A, Tilly H, Ribrag V, Delfau-Larue MH, Hermine O, Macintyre E. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group. Lancet Haematol. 2020 Nov;7(11):e798-e807. doi: 10.1016/S2352-3026(20)30291-X. Epub 2020 Sep 21.

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Beldi-Ferchiou

full_name: Asma Beldi-Ferchiou

given: Asma

family: Alcantara

full_name: Marion Alcantara

given: Marion

family: Cacheux

full_name: Victoria Cacheux

given: Victoria

family: Safar

full_name: Violaine Safar

given: Violaine

family: Burroni

full_name: Barbara Burroni

given: Barbara

family: Guidez

full_name: Stéphanie Guidez

given: Stéphanie

family: Gastinne

full_name: Thomas Gastinne

given: Thomas

family: Canioni

full_name: Danielle Canioni

given: Danielle

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Houot

full_name: Roch Houot

given: Roch

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Bescond

full_name: Charles Bescond

given: Charles

family: Damaj

full_name: Ghandi Damaj

given: Ghandi

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

family: Daguindau

full_name: Nicolas Daguindau

given: Nicolas

family: Moreau

full_name: Anne Moreau

given: Anne

family: Tilly

full_name: Hervé Tilly

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Delfau-Larue

full_name: Marie-Hélène Delfau-Larue

given: Marie-Hélène

family: Hermine

ReferenceCitation: Bailly C, Carlier T, Berriolo-Riedinger A, Casasnovas O, Gyan E, Meignan M, Moreau A, Burroni B, Djaileb L, Gressin R, Devillers A, Lamy T, Thieblemont C, Hermine O, Kraeber-Bodéré F, Le Gouill S, Bodet-Milin C. Prognostic value of FDG-PET in patients with mantle cell lymphoma: results from the LyMa-PET Project. Haematologica. 2020 Jan;105(1):e33-e36. doi: 10.3324/haematol.2019.223016. Epub 2019 Aug 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU de Strasbourg
CHU d'Angers
CHU d'Amiens
Hopital Henri Mondor
CHU Montpellier
CHU Nantes
Centre Henri Becquerel
CHU de Brabois
CH Perpignan
I.U.C.T Oncopole
CHU de Poitiers
CHU de Grenoble
CHU de Haut Leveque
CH d'Avignon
CHU de Caen
CHU Limoges
CHU de Clermont Ferrand
CHU Robert Debré
CHRU Lille - Hôpital Claude Huriez
CHU Pontchaillou
Institut de Cancérologie de Loire
Gustave Roussy Cancer Campus
CHD Vendée
Clinique Victor Hugo
CHU de Dijon - Hôpital le Bocage
CHRU Bretonneau
APHP - Hopital Necker
Hôpital Saint Louis
CHU Lyon Sud
Centre Hospitalier Annecy-Genevois


title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

acronym: RORC

summary:
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.

The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.

The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).

location_facility:
Strasbourg University Hospital
Lyon University Hospital
Brest University Hospital
Le Mans Hospital
Tenon Hospital
Centre Antoine Lacassagne
Clermont-Ferrand University Hospital
Rennes University Hospital
Tours University Hospital
Bretagne Atlantique Hospital
Marseille University Hospital
Bretagne Sud Hospital
Poitiers University Hospital
Nantes University Hospital
Institut Gustave Roussy
Toulouse University Hospital
Centre Alexis Vautrin
Centre François Baclesse
Lille University Hospital
Caen University Hospital
Clinique La Sagesse


title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

acronym: EARS

summary:
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.

Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")

EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. Review.

ReferenceCitation: Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26. Review.

ReferenceCitation: Bocéréan C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.

ReferenceCitation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. Review.

ReferenceCitation: Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6. Review.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU de Lille
CHU de Clermont-Ferrand
CHU de Montpellier
CHU de nîmes
Hôpital COCHIN


title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

summary: To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

status: Not yet recruiting

ReferenceCitation: Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouvière O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21. Review.

ReferenceCitation: N. Mottet JB, E. Briers, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel. Guidelines on prostate cancer. European Association of Urology Web site https://uroweborg/guideline/prostate-cancer/. Accessed May 17, 2016.

ReferenceCitation: Schoots IG, Petrides N, Giganti F, Bokhorst LP, Rannikko A, Klotz L, Villers A, Hugosson J, Moore CM. Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Eur Urol. 2015 Apr;67(4):627-36. doi: 10.1016/j.eururo.2014.10.050. Epub 2014 Nov 15. Review.

ReferenceCitation: Le JD, Tan N, Shkolyar E, Lu DY, Kwan L, Marks LS, Huang J, Margolis DJ, Raman SS, Reiter RE. Multifocality and prostate cancer detection by multiparametric magnetic resonance imaging: correlation with whole-mount histopathology. Eur Urol. 2015 Mar;67(3):569-76. doi: 10.1016/j.eururo.2014.08.079. Epub 2014 Sep 23.

ReferenceCitation: Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.

ReferenceCitation: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

ReferenceCitation: Robertson NL, Hu Y, Ahmed HU, Freeman A, Barratt D, Emberton M. Prostate cancer risk inflation as a consequence of image-targeted biopsy of the prostate: a computer simulation study. Eur Urol. 2014 Mar;65(3):628-34. doi: 10.1016/j.eururo.2012.12.057. Epub 2013 Jan 3.

ReferenceCitation: Wetterauer C, Weibel M, Gsponer JR, Vlajnic T, Zellweger T, Bütikofer S, Müller G, Püschel H, Bachmann A, Gasser TC, Bubendorf L, Rentsch CA. Incidental prostate cancer prevalence at radical cystoprostatectomy--importance of the histopathological work-up. Virchows Arch. 2014 Dec;465(6):629-36. doi: 10.1007/s00428-014-1656-9. Epub 2014 Oct 1.

ReferenceCitation: Bains LJ, Studer UE, Froehlich JM, Giannarini G, Triantafyllou M, Fleischmann A, Thoeny HC. Diffusion-weighted magnetic resonance imaging detects significant prostate cancer with high probability. J Urol. 2014 Sep;192(3):737-42. doi: 10.1016/j.juro.2014.03.039. Epub 2014 Mar 15.

ReferenceCitation: Steinberg DM, Fine J, Chappell R. Sample size for positive and negative predictive value in diagnostic research using case-control designs. Biostatistics. 2009 Jan;10(1):94-105. doi: 10.1093/biostatistics/kxn018. Epub 2008 Jun 12.

ReferenceCitation: DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
CHRU Hopital Edouard Herriot
Chu Saint Etienne
Institut Paoli Calmettes
Hopital Nord
Institut Mutualiste Montsouris

intervention_type: Device


title: A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation

acronym: SILK BM

summary:
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation.

Fifty patients will have to be enrolled in this phase II trial.

Total duration of treatment will be 12 months.

Patients will be followed for a maximum of 2 years following the date of inclusion.

lead_sponsor: Institut Claudius Regaud

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Combination Product


title: Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer

summary: This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced

lead_sponsor: Institut Cancerologie de l'Ouest

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


title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

acronym: COATS-VEGF

summary:
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.

The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hôpital Universitaire Necker Enfants Malades, APHP

location_facility: Centre hospitalier René Dubos (Pontoise)

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS

acronym: COPP-MS

summary:
Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.

In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.

The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

time_perspective: Other

location_facility:
CHU Strasbourg
Hôpital LAENNEC
CHU Lyon
Hôpital Pasteur 2 - CHU Nice
CHU Rennes


title: Feasibility and Efficacy of a New Ovarian Stimulation Regimen With RANDom Start, Use of Corifollitropin Alpha and Progestin Protocol for Oocyte donorS

acronym: RANDOS

summary: Oocyte donation is a cumbersome and demanding procedure, involving an injectable hormonal treatment for an average duration of 12 days, according to the protocols, 1 to several daily injections. The objective of this study is to show that treatments can be simplified without reducing the number of oocytes that have been punctured, by blocking the luteinizing hormone (LH) surge by using oral progesterone and by limiting the number of injections of gonadotropins using corifollitropin alpha, regardless of the start date of the pacing protocol during a natural cycle.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHU Marseille
CHRU Lille
Clinique de la Sagesse
CHU Tenon
CHU Bondy


title: Phase Ib Study Evaluating the Safety and Efficacy of Intratumoral Agonistic Anti-CD40 (Selicrelumab) in Combination With Anti-PDL1 (Atezolizumab) in Patients With Refractory or Relapsed B Cell Lymphoma

summary: This is a multicenter, open, dose escalation phase Ib trial of intratumoral agonistic anti-CD40 Ab (Selicrelumab intratumoral every 3 weeks for 3 cycles) in combination with anti-PDL1 Ab (Atezolizumab 1200mg intravenous every 3 weeks) in patients with refractory or relapsed B cell lymphoma

status: Terminated

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


title: Regional Anticoagulation of Dialysis Extra-corporeal Circuits With a Calcium-free Citrate-containing Dialysate : Efficiency and Tolerance

summary: Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the dialysis circuit is required. In a non-comparative study, heparin-free regional citrate anticoagulation of the dialysis circuit using a calcium-free citrate-containing dialysate, with calcium reinjected according to ionic dialysance, was considered as safe and efficient. The aim of this study is to confirm the superiority of this approach compared to a anticoagulation based on heparin-grafted membrane.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse
Tenon Hospital
Marseille Hospital
Pellegrin Hospital
Montpellier Hospital


title: Microvesicles and Monocytes to Predict Mortality of Patients With Cirrhosis

acronym: PROMICE

summary:
Chronic liver diseases related to viral hepatitis, metabolic syndrome or excessive alcohol consumption can evolve towards cirrhosis. Cirrhosis is responsible for 170 000 deaths per year in Europe. Initially asymptomatic and called "compensated" it can become "decompensated" with the developement of acute complications such as infections, ascites or variceal bleeding. The transition from compensated to decompensated cirrhosis is associated with a reduction in survival from 95 to 55% at 1 year.

The only curative treatment for cirrhosis is liver transplantation (LT). Liver transplants are allocated according to the severity of the patients. Despite a modest prognostic value (area under the ROC curve = 0.7 to predict the risk of death), graft allocation is based on the MELD (Model for End-Stage Liver Disease) score including INR, bilirubin and serum creatinine. In 2014, 11.5% of registered patients died on the liver transplant waiting list, illustrating the need for biomarkers that predict death and improve MELD-based prediction.

Microvesicles are membrane vesicles released in extracellular space during cell activation or apoptosis. Our team showed that circulating levels of hepatocyte microvesicles increase with the severity of cirrhosis and predict survival at 6 months independently of MELD score in a cohort of 242 patients with cirrhosis.

Type 1 interferons (IFN-1) are mediators of inflammation, which is excessively activated in cirrhosis. Our team has shown that a gene signature (IFN score) measured in the immune cells of 101 patients with cirrhosis is able to predict 6 month-survival independently of the MELD score.

Thus, the investigators hypothesize that a composite score combining the level of circulating hepatocyte microvesicles, the IFN score and the MELD score could improve the prediction of survival in patients with severe cirrhosis.

The aim of this study is to compare the prognostic performance for the cumulative incidence of death at 6 months of a composite score including MELD, hepatocyte microvesicle level and IFN score with that of the MELD score alone, in patients with Child B or C cirrhosis, considering liver transplantation as a competitive risk.

To address this question, peripheral blood from 335 patients with Child B or C cirrhosis will be obtained and hepatocyte microvesicle levels and IFN score will be measured using ELISA/filtration and Real Time-quantitative PCR.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
De La Fontaine hospital
La Pitié Salpêtrière hospital
Beaujon hospital
Foch hospital
Avicenne Hospital


title: Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening

acronym: RUC EHPAD

summary: The goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (CUR) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.

location_facility: EHPAD du Centre Local Hospitalier de Saint-Joseph

intervention_type: Diagnostic Test


title: Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis

acronym: DIANE

summary: The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .

lead_sponsor: University Hospital, Montpellier

location_facility: CHU Toulouse - Pediatric infectious diseases

location_facility: Hospices Civils de Lyon - pediatric rheumatology


title: Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

acronym: PAAF

summary: Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Angers
Centre Hospitalier Départemental Vendée
CH Cholet
CH La Rochelle
CH Saint Malo


title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

acronym: COCTAEyl

summary: The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

location_facility: Centre Ophtalmologique d'Imagerie et de Laser,


title: National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients

acronym: Loreline

summary:
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.

Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.

An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.

According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).

In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.

According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.

For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.

In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

summary: Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility:
Hopital D'Enfants La Timone
Chu de Rouen
Chu Saint Etienne
Hopital Nord Chu Amiens
Institut Curie
Centre Leon Berard
Chu de Grenoble
Chu Bocage
Chur de Reims
Chu Angers
Chu Nantes
Chr Felix Guyon
Hoptial Hautepierre
Chu Limoges
Chu Tours
Hopital Jean Minioz
Chu Estaing
Chu de Rennes
Chu de Poitiers
Chu de Nice
Chu R; Pellegrin
Chu Nancy
Centre Oscar Lambret
CHU CAEN
Hopital Arnaud de Villeneuve
Chu Toulouse
Chu Morvan


title: Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients

acronym: MAINTAIN

summary: Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Behavioral


title: Apomorphine Pump in Early Stage of Parkinson's Disease

acronym: EARLY-PUMP

summary: The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.

lead_sponsor: Rennes University Hospital

location_facility: Groupe Hospitalier Régional de Mulhouse et Sud Alsace


title: Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse

acronym: FIGARO

summary:
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.

Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.

There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.

Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.

In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.

Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.

In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.

The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.

location_facility: CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN

location_facility: INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle


title: " Endarterectomy Combined With Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "

acronym: ACTRIS

summary: The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre Hospitalier régional de Besançon, Hôpital Jean Minjoz

location_facility: CHU Bordeaux, Groupe Hospitalier Pellegrin

location_facility: CHU de Strasbourg, Hôpital de Hautpierre

location_facility: Centre Hospitalier Bichat-Claude Bernard

location_facility: CHU de Toulouse Hôpital Pierre-Paul Riquet

location_facility: Hôpital Neurologique Pierre Wertheimer GHE


title: Observational Multicenter Cohort Study of French Patients With a Central or Combined Syndrome of Sleep Apnea With a Predominant Central SAS Treated by Adaptive Servo-Ventilation

acronym: FACIL-VAA

summary: The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.

ipd_sharing: Yes

ipd_sharing_description: oversight committee

lead_sponsor: Société Française de Recherche et de Médecine du Sommeil

location_facility: Centre Hospitalier Intercommunal Compiègne-Noyon

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Hôpital Arnaud de Villeneuve CHU de Montpellier

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: Groupe Hospitalier Public du Sud de l'Oise


title: NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis

summary: This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.

lead_sponsor: Hoffmann-La Roche


title: Clinical and Genetic Analyzes of Age-related Macular Degeneration

acronym: COLDMLA

summary: The purpose of this collection is to search for susceptibility genes for age-related macular degeneration (AMD) alone or in combination with environmental factors and to look for genes that modulate the AMD phenotype (particularly the response to treatment).

location_facility: Centre ophtalmologique d'imagerie et de laser

intervention_type: Genetic


title: Biological Bank for Studies Related to Atrial Fibrillation and Stroke

acronym: BAFA

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service neurologie Centre hospitalier Fleyriat

location_facility: Service de médecine gériatrique Centre hospitalier Lyon Sud, Groupement hospitalier Sud

location_facility: Service de rythmologie, hôpital cardiologique Louis Pradel

location_facility: Service d'urgences Neurovasculaires - service de neurologie vasculaire , Hôpital Pierre Wertheimer


title: Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Gambling Disorder. A Multicenter Randomized Controlled Trial (AjusT)

acronym: AjusT

summary: The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.

location_facility: Centre Hospitalier Universitaire La Réunion

location_facility: Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA


title: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

acronym: ADNCirc

summary:
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

ipd_sharing_description: the data are anonymized

lead_sponsor: University Hospital, Limoges

location_facility:
Montpellier University Hospital
Cahors Hospital
Vichy Hospital
Limoges Hospital
Saint Antoine AP-HP
Aurillac Hospital
Moulins Hospital
Sainte feyre Hospital
Montpellier Institute
Brive Hospital
Gueret Hospital
La marche clinical
Périgueux Hospital
Perigueux clinical
Les Cèdres clinical
Bergonie institute
Saint Junien Hospital
Bordeaux University Hospital
Clermont Ferrand University Hospital


title: Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

acronym: ITS-PILOT

summary:
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important.

Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.

We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).

location_facility:
ApHp - hôpital Lariboisière
CHU de Limoges
ApHp - Hôpital Bicêtre
CHU de MONTPELLIER
CHU de BORDEAUX


title: Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction After Pooling Pharyngeal, Anorectal and Urinary Samples, in Men Who Have Sex With Men

acronym: ISTPOOL

summary: This study aims to compare the sensitivity of detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time multiplex PCR in a pooled analysis (i.e. gathering pharyngeal, anorectal and urinary samples) versus the standard of care (where a real-time multiplex PCR is made in each of the three samples).

ReferenceCitation: Kacena KA, Quinn SB, Howell MR, Madico GE, Quinn TC, Gaydos CA. Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women. J Clin Microbiol. 1998 Feb;36(2):481-5.

ReferenceCitation: La Ruche G, Le Strat Y, Fromage M, Berçot B, Goubard A, de Barbeyrac B, Sednaoui P, Cambau E, Lot F. Incidence of gonococcal and chlamydial infections and coverage of two laboratory surveillance networks, France, 2012. Euro Surveill. 2015 Aug 13;20(32):6-15.

ReferenceCitation: Lewis JL, Lockary VM, Kobic S. Cost savings and increased efficiency using a stratified specimen pooling strategy for Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2012 Jan;39(1):46-8. doi: 10.1097/OLQ.0b013e318231cd4a.

ReferenceCitation: Kacena KA, Quinn SB, Hartman SC, Quinn TC, Gaydos CA. Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application. J Clin Microbiol. 1998 Dec;36(12):3624-8.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHR d'Orleans
CHU de Tours
CHU de Poitiers
CH de Niort
CH Laennec


title: Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury

acronym: OXY-TC

summary:
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU).

The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.

ReferenceCitation: Cunningham AS, Salvador R, Coles JP, Chatfield DA, Bradley PG, Johnston AJ, Steiner LA, Fryer TD, Aigbirhio FI, Smielewski P, Williams GB, Carpenter TA, Gillard JH, Pickard JD, Menon DK. Physiological thresholds for irreversible tissue damage in contusional regions following traumatic brain injury. Brain. 2005 Aug;128(Pt 8):1931-42. Epub 2005 May 11.

ReferenceCitation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS, Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.

ReferenceCitation: Oddo M, Levine JM, Mackenzie L, Frangos S, Feihl F, Kasner SE, Katsnelson M, Pukenas B, Macmurtrie E, Maloney-Wilensky E, Kofke WA, LeRoux PD. Brain hypoxia is associated with short-term outcome after severe traumatic brain injury independently of intracranial hypertension and low cerebral perfusion pressure. Neurosurgery. 2011 Nov;69(5):1037-45; discussion 1045. doi: 10.1227/NEU.0b013e3182287ca7.

ReferenceCitation: van den Brink WA, van Santbrink H, Steyerberg EW, Avezaat CJ, Suazo JA, Hogesteeger C, Jansen WJ, Kloos LM, Vermeulen J, Maas AI. Brain oxygen tension in severe head injury. Neurosurgery. 2000 Apr;46(4):868-76; discussion 876-8.

ReferenceCitation: Stiefel MF, Spiotta A, Gracias VH, Garuffe AM, Guillamondegui O, Maloney-Wilensky E, Bloom S, Grady MS, LeRoux PD. Reduced mortality rate in patients with severe traumatic brain injury treated with brain tissue oxygen monitoring. J Neurosurg. 2005 Nov;103(5):805-11.

ReferenceCitation: Narotam PK, Morrison JF, Nathoo N. Brain tissue oxygen monitoring in traumatic brain injury and major trauma: outcome analysis of a brain tissue oxygen-directed therapy. J Neurosurg. 2009 Oct;111(4):672-82. doi: 10.3171/2009.4.JNS081150.

ReferenceCitation: Payen JF, Richard M, Francony G, Audibert G, Barbier EL, Bruder N, Dahyot-Fizelier C, Geeraerts T, Gergele L, Puybasset L, Vigue B, Skaare K, Bosson JL, Bouzat P. Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol. BMJ Open. 2020 Aug 20;10(8):e040550. doi: 10.1136/bmjopen-2020-040550.

family: Payen

full_name: Jean-Francois Payen

given: Jean-Francois

family: Richard

full_name: Marion Richard

given: Marion

family: Francony

full_name: Gilles Francony

given: Gilles

family: Audibert

full_name: Gérard Audibert

given: Gérard

family: Barbier

full_name: Emmanuel L Barbier

given: Emmanuel L

family: Bruder

full_name: Nicolas Bruder

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Geeraerts

full_name: Thomas Geeraerts

family: Gergele

full_name: Laurent Gergele

given: Laurent

family: Puybasset

full_name: Louis Puybasset

given: Louis

family: Vigue

full_name: Bernard Vigue

given: Bernard

family: Skaare

full_name: Kristina Skaare

given: Kristina

family: Bosson

full_name: Jean Luc Bosson

given: Jean Luc

family: Bouzat

full_name: Pierre Bouzat

given: Pierre

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

location_facility: University Hospital of Paris-Salpetriere


title: Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

acronym: Stress-PR

summary: Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.

location_facility: CH de Libourne - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie


title: Impact of a Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis

acronym: KITE

summary:
The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.

This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.

Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.

ReferenceCitation: Dusseux E, Albano L, Fafin C, Hourmant M, Guérin O, Couchoud C, Moranne O. A simple clinical tool to inform the decision-making process to refer elderly incident dialysis patients for kidney transplant evaluation. Kidney Int. 2015 Jul;88(1):121-9. doi: 10.1038/ki.2015.25. Epub 2015 Feb 11.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Centre d'Hemodialyse Languedoc Méditérranéen

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context

acronym: SMURIDS

summary: In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

location_facility: Aphp, Hopital Raymond Poincare - Samu-Smur 92

location_facility: CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33


title: A Prospective Randomized Clinical Trial, in Open-label, Multicenter, Estimating the Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery

acronym: BARIATHYPNOSE

summary: The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.

location_facility: CHR Saint Pierre - maladies métaboliques


title: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

acronym: CLINALK

summary: Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

ReferenceCitation: Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Jänne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

family: Shaw

full_name: Alice T. Shaw

given: Alice T.

family: Kim

full_name: Dong-Wan Kim

given: Dong-Wan

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Seto

full_name: Takashi Seto

given: Takashi

family: Crinó

full_name: Lucio Crinó

given: Lucio

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: De Pas

full_name: Tommaso De Pas

given: Tommaso

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Solomon

full_name: Benjamin J. Solomon

given: Benjamin J.

family: Blackhall

full_name: Fiona Blackhall

given: Fiona

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Thomas

full_name: Michael Thomas

given: Michael

family: O'Byrne

full_name: Kenneth J. O'Byrne

given: Kenneth J.

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Camidge

full_name: D. Ross Camidge

given: D. Ross

family: Mok

full_name: Tony Mok

given: Tony

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Riely

full_name: Gregory J. Riely

given: Gregory J.

family: Iyer

full_name: Shrividya Iyer

given: Shrividya

family: Tassell

full_name: Vanessa Tassell

given: Vanessa

family: Polli

full_name: Anna Polli

given: Anna

family: Wilner

full_name: Keith D. Wilner

given: Keith D.

family: Jänne

full_name: Pasi A. Jänne

given: Pasi A.

repository_institution: The University of Manchester - Research Explorer

title: Crizotinib versus Chemotherapy in AdvancedALK-Positive Lung Cancer

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Paris - Hôpital Européen Georges Pompidou

location_facility: Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud

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

location_facility: Vannes - Centre Hospitalier Bretagne Atlantique


title: Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer

summary: This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.


title: Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer

acronym: ACE-Lung

summary:
Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.

Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.

Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.

Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.

location_facility: Montpellier - GCS Centre de Cancérologie du Grand Montpellier


title: National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection

acronym: IDENTIFY

summary: Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

lead_sponsor: Pathoquest

location_facility:
Hospital Salpétrière
Hospital Robert Debré
Hosptial Saint Louis
Hospital Necker
Hospital Trousseau


type: Registry Identifier

title: Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis

acronym: AcceptVoice

summary: The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.

lead_sponsor: University Hospital, Toulouse

location_facility:
Lannemezan Hospital
Lavaur Hospital
Ariège-Couserans Hospital
Sainte-Marie de Rodez Hospital
Gérard Marchand Hospital


title: HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor

acronym: HYPNOS

summary:
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:

Detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone

The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.

The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.

Another objective of the study is to verify the safety of the PASITHEA system.

lead_sponsor: LivaNova

location_facility: Laboratoire du sommeil et d'EFCR; Hopital Michallon


title: Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units

summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis. Datas will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

status: Withdrawn

lead_sponsor: Nantes University Hospital

location_facility:
Rennes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Nantes University Hospital


title: A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated

summary:
The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis.

Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.


title: Experience of the Father Following the Announcement of a First Pregnancy

summary: Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?


title: Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

acronym: GOLILOR

summary: It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Amiens-Picardie
Chu Saint Etienne
CHU Nice
CHU Montpellier - St Eloi
CHU Lyon Sud


title: Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors

acronym: EXPRESS

summary: Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

primary_purpose: Other

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

location_facility: CHU de Poitiers - Pôle régional de Cancérologie

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Hôpitaux Drôme-Nord- Site de Romans sur Isère

location_facility: Institut de Cancérologie de l'Ouest (site René Gauducheau)

location_facility: Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy

location_facility: Institut de Cancérologie de l'Ouest (site Paul Papin)


lead_sponsor: Centre Leon Berard

acronym: CHEMOIMMUNE

location_facility: Institut de cancérologie Lucien Neuwirth

title: CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide

summary:
The investigators hypothesize that the administration of pembrolizumab combined to metronomic cyclophosphamide may be an interesting therapeutic option for female patients breast cancer with lymphopenia.

Include only patients with breast cancer with lymphopenia is based on the particularly poor prognosis of these patients. The approach suggested here is to deplete and active the immune response of these immunosuppressed patients. The combination of pembrolizumab and cyclophosphamide would provide a higher gain in anti-tumor response in these patients than in those without lymphopenia and in chemotherapy alone.

The investigators proposal is to conduct a multicentric, non-comparative, single arm, two-stage, Phase II trial in lymphopenic patients with metastatic breast cancer.

The study is divided in 2 parts:

a safety run-in Phase aiming to evaluate the safety of the combination therapy pembrolizumab + metronomic cyclophosphamide based on the occurrence of severe toxicities.
a two-stage Phase II aiming to evaluate the clinical activity of the combination therapy pembrolizumab + metronomic cyclophosphamide.

In both parts of the study, patients will receive cyclophosphamide (50 mg/day, daily, per os) and pembrolizumab (200 mg every 3 weeks, intravenously [IV]). The adverse events of the two drugs are well known.


title: Interventional Multicentre Pharmacokinetic Study of Adoport® (Tacrolimus) in Patients With de Novo Kidney Transplantation

acronym: IMPAKT

summary:
Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic index and large inter-individual pharmacokinetic variability. Adoport® is an immediate-release formulation of tacrolimus, to be administered twice daily. Because of a narrow therapeutic window and a better correlation between pre-dose level and effects than between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity).

As reported in a consensus document from a consortium of European experts on tacrolimus TDM, the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in routine, due to clinical constraints and the necessity of multiple samples. Calculation of the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood samples collected during the early phase post-dose would represent an elegant solution, as already done for other tacrolimus formulations.

Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation. Although this polymorphism showed no impact on the performance of the Bayesian estimators previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will be considered in this pharmacokinetic study as a potential covariate in, or confounding factor of, the PK model. Specifically, owing to a 12% frequency in the White European population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the performance of the PK model and Bayesian estimator developed will be specifically evaluated in this subgroup.

location_facility:
CHU de ROUEN
Limoges University Hospital
Tours University Hospital
Amiens Picardie University Hospital
Poitiers University Hospital


title: Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

summary: This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Hôpital Cochin (APHP)
Institut de Cancérologie de Lorraine
Chru Lille
Hôpital Beaujon
Institut du Cancer de Montpellier
CHP Saint Grégoire
Chu Colmar
CHU Reims
Chu Nantes
Hopital européen Marseille
Centre Eugène Marquis
CH Bicêtre (APHP)
Chu Rouen
Hôpital Henri Mondor (APHP)
Institut Paoli CALMETTES
Institut Bergonié
Chru Nancy
Institut Mutualiste Montsouris
Hôpital Haut-Lévêque
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Hôpital La Timone
Pitié Salpêtrière (APHP)
Chru Tours
CHU Morvan
Polyclinique Bordeaux Nord
Infirmerie Protestante de Lyon

intervention_type: Radiation


title: TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

summary: This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay

ReferenceCitation: Ben Hamou A, Kipnis E, Elbaz A, Bignon A, Nseir S, Tamion F, Du Cheyron D, Jaillette E, Voisin B, Robriquet L, Vanbaelinghem C, Thellier D, Abi Rached H, Jannin A, Duhamel A, Behal H, Machuron F, Espiard S, Preiser JC, Preau S, Pattou F, Jourdain M. Association of transcription factor 7-like 2 gene (TCF7L2) polymorphisms with stress-related hyperglycaemia (SRH) in intensive care and resulting outcomes: The READIAB study. Diabetes Metab. 2020 Jun;46(3):243-247. doi: 10.1016/j.diabet.2019.05.001. Epub 2019 May 20.

family: Ben Hamou

full_name: A. Ben Hamou

given: A.

family: Kipnis

full_name: E. Kipnis

given: E.

family: Elbaz

full_name: A. Elbaz

family: Bignon

full_name: A. Bignon

family: Nseir

full_name: S. Nseir

given: S.

family: Tamion

full_name: F. Tamion

given: F.

family: Du Cheyron

full_name: D. Du Cheyron

given: D.

family: jaillette

full_name: E. jaillette

family: Voisin

full_name: B. Voisin

given: B.

family: Robriquet

full_name: L. Robriquet

given: L.

family: Vanbaelinghem

full_name: C. Vanbaelinghem

given: C.

family: Thellier

full_name: D. Thellier

family: Abi Rached

full_name: H. Abi Rached

given: H.

family: Jannin

full_name: A. Jannin

family: Duhamel

full_name: A. Duhamel

family: Behal

full_name: H. Behal

family: Machuron

full_name: F. Machuron

family: Espiard

full_name: S. Espiard

family: Preiser

full_name: J.-C. Preiser

family: Preau

full_name: S. Preau

family: Pattou

full_name: F. Pattou

family: Jourdain

full_name: M. Jourdain

given: M.

journal_name: Diabetes & Metabolism

location_facility:
CH Victor Provot
CHU Cote de Nâcre
CHU Charles Nicolle
CH Tourcoing
Hôpital Roger Salengro, CHRU de Lille


title: Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years

acronym: BIOWELL

summary: A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpital J. Monod - Pavillon Femme Mère Enfant - Le Havre

intervention_type: Dietary Supplement


title: InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

acronym: OSIRIS

summary:
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.

As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.

MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.

To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.

Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.

lead_sponsor: MaaT Pharma

location_facility:
CHU de Nantes
HCL Croix-Rousse
GH Diaconesses-Croix Saint Simon
CHU Bordeaux
CH Tourcoing


title: Evaluation of Efficacy and Safety of Rituximab in Association With Mycophenolate Mofetil Versus Mycophenolate Mofetil Alone in Patients With Interstitial Lung Diseases (ILD) Non-responders to a First-line Immunosuppressive Treatment

acronym: EvER-ILD

summary: The purpose of the study is to evaluate the efficacy on lung function 6 months after one course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one course of placebo and 6 months of MMF treatment in a broad range of patients with Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.

ReferenceCitation: Bejan-Angoulvant T, Naccache JM, Caille A, Borie R, Nunes H, Ferreira M, Cadranel J, Crestani B, Cottin V, Marchand-Adam S; OrphaLung. Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial. Respir Med Res. 2020 Nov;78:100770. doi: 10.1016/j.resmer.2020.100770. Epub 2020 May 23.

family: Bejan-Angoulvant

full_name: T. Bejan-Angoulvant

given: T.

family: Naccache

full_name: J.-Marc Naccache

family: Caille

full_name: A. Caille

family: Borie

full_name: R. Borie

given: R.

family: Nunes

full_name: H. Nunes

family: Ferreira

full_name: M. Ferreira

family: Cadranel

full_name: J. Cadranel

given: J.

family: Crestani

full_name: B. Crestani

family: Cottin

full_name: V. Cottin

given: V.

family: Marchand-Adam

full_name: S. Marchand-Adam

journal_name: Respiratory Medicine and Research

oa_host_type: publisher

evidence: open (author manuscript)

version: acceptedVersion

lead_sponsor: University Hospital, Tours

location_facility:
Chu Rennes
Chu Besancon
AP-HM Hôpital NORD
Chu Dijon
CHRU Tours