title: Optimization of Correcting Molecules of Nonsense Mutations in Epithelial Cells of the Upper Airways of Patients With Cystic Fibrosis With Nonsense Mutations in the CFTR Gene

summary:
The presence of a nonsense mutation leads to the rapid degradation of the carrier mRNA mutation by a mechanism called NMD (nonsense-mediated mRNA decay) [6, 13]. There are currently 3 main strategies at least for correcting nonsense mutations: exon skipping, inhibition of NMD and nonsense mutation readthrough.

In the laboratory, we developed a strategy for correcting nonsense mutations combining inhibition of NMD and activation of translecture. For this purpose, we have constructed screening systems to identify NMD-inhibiting and/or readthrough enhancers. The molecules thus identified are then tested on cell lines and in murine models carrying a nonsense mutation.

One of our goals is to select a set of molecules that can correct effectively nonsense mutations. For this we have to test these molecules on a great diversity of nonsense mutations.

This work will:

determine if we can correct all the nonsense mutations tested with at least one of our molecules
determine what is common within a group of mutations corrected by a given molecule
be able to assign the parameters that make one mutation is corrected by one molecule and not or little by another.

This study will therefore improve our theoretical knowledge on the recognition of premature stop codons but also to propose therapeutic approaches for the correction of nonsense mutations of the CFTR gene in cystic fibrosis in a targeted way for a patient.

lead_sponsor: University Hospital, Lille

location_facility: Hu Paris Centre Site Cochin Aphp - Paris 14


title: Medico Economic Study, Randomized, Comparing Intraoperative Radiotherapy With Intrabeam® on Surgical Resection Bed Versus Conventional Surgery + EBRT in Postmenopausal Patients Operated by Conservative Surgery for Low Risk Breast Cancer

acronym: RIOP-SEIN

summary:
Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy.

This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with :

25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general);
16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence.

In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae.

Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation.

Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence.

The main advantages of IBRTare :

Improvement of the quality of life due to a single session of radiotherapy associated with surgical ;
Increased precision to deliver the necessary dose in tumour tissue;
Preservation of surrounding healthy tissue ;
Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions.

RIOP SEIN is a project supported by Institut National du Cancer (INCa)

, which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Institut Cancerologie de l'Ouest

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

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

acronym: DFG

summary: This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

ReferenceType: result

ReferenceCitation: Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8.

ReferenceCitation: Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. Review.

ReferenceCitation: Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):5289-94. doi: 10.3748/wjg.v17.i48.5289.

family: Hisa

full_name: Takeshi Hisa

given: Takeshi

sequence: first

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: World Journal of Gastroenterology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Baishideng Publishing Group Inc.

publisher_dissemination: Baishideng Publishing Group Inc.

publisher_group: Baishideng Publishing Group Inc.

publisher_normalized: Baishideng Publishing Group Inc.

ReferenceCitation: Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34.

ReferenceCitation: Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. Epub 2007 Jun 20.

ReferenceCitation: Cennamo V, Fuccio L, Repici A, Fabbri C, Grilli D, Conio M, D'Imperio N, Bazzoli F. Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):473-9. doi: 10.1016/j.gie.2008.09.037.

family: Cennamo

full_name: Vincenzo Cennamo

given: Vincenzo

family: Fuccio

full_name: Lorenzo Fuccio

given: Lorenzo

sequence: additional

family: Repici

full_name: Alessandro Repici

given: Alessandro

family: Fabbri

full_name: Carlo Fabbri

given: Carlo

family: Grilli

full_name: Diego Grilli

given: Diego

family: Conio

full_name: Massimo Conio

given: Massimo

family: D'Imperio

full_name: Nicola D'Imperio

given: Nicola

family: Bazzoli

full_name: Franco Bazzoli

given: Franco

journal_name: Gastrointestinal Endoscopy

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy. 2010 May;42(5):381-8. doi: 10.1055/s-0029-1243992. Epub 2010 Mar 19. Review.

full_name: V. Cennamo

given: V.

full_name: L. Fuccio

given: L.

family: Zagari

full_name: R. Zagari

given: R.

family: Eusebi

ReferenceCitation: Parlak E, Cicek B, Disibeyaz S, Kuran S, Sahin B. Early decision for precut sphincterotomy: is it a risky preference? Dig Dis Sci. 2007 Mar;52(3):845-51.

ReferenceCitation: Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636.

ReferenceCitation: Gotoh Y, Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Higashizawa T, Miyata T, Ido K, Sugano K. A new method for deep cannulation of the bile duct by straightening the pancreatic duct. Gastrointest Endosc. 2001 Jun;53(7):820-2.

ReferenceCitation: Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652-6.

ReferenceCitation: Caletti GC, Vandelli A, Bolondi L, Fontana G, Labò G. Endoscopic retrograde cholangiography (ERC) through artificial endoscopic choledocho-duodenal fistula. Endoscopy. 1978 Aug;10(3):203-6.

ReferenceCitation: Siegel JH. Precut papillotomy: a method to improve success of ERCP and papillotomy. Endoscopy. 1980 May;12(3):130-3.

ReferenceCitation: Osnes M, Kahrs T. Endoscopic choledochoduodenostomy for choledocholithiasis through choledochoduodenal fistula. Endoscopy. 1977 Aug;9(3):162-5.

ReferenceCitation: Dumonceau JM, Devière J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy. 1998 Sep;30(7):S80.

ReferenceCitation: Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Ponauthai Y, Kullavanijaya P. Success rate and cannulation time between precut sphincterotomy and double-guidewire technique in truly difficult biliary cannulation. J Gastroenterol Hepatol. 2012 Feb;27(2):356-61. doi: 10.1111/j.1440-1746.2011.06927.x.

journal_name: Journal of Gastroenterology and Hepatology

ReferenceCitation: Coté GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial. Dig Dis Sci. 2012 Dec;57(12):3271-8. doi: 10.1007/s10620-012-2269-2. Epub 2012 Jun 26.

title: Use of a Pancreatic Duct Stent or Guidewire Facilitates Bile Duct Access with Low Rates of Precut Sphincterotomy: A Randomized Clinical Trial

ReferenceCitation: Herreros de Tejada A, Calleja JL, Díaz G, Pertejo V, Espinel J, Cacho G, Jiménez J, Millán I, García F, Abreu L; UDOGUIA-04 Group. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc. 2009 Oct;70(4):700-9. doi: 10.1016/j.gie.2009.03.031. Epub 2009 Jun 27.

ReferenceCitation: Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108.

title: Double guidewire techniquevstranspancreatic precut sphincterotomy in difficult biliary cannulation

ReferenceCitation: Xinopoulos D, Bassioukas SP, Kypreos D, Korkolis D, Scorilas A, Mavridis K, Dimitroulopoulos D, Paraskevas E. Pancreatic duct guidewire placement for biliary cannulation in a single-session therapeutic ERCP. World J Gastroenterol. 2011 Apr 21;17(15):1989-95. doi: 10.3748/wjg.v17.i15.1989.

ReferenceCitation: Lee TH, Hwang SO, Choi HJ, Jung Y, Cha SW, Chung IK, Moon JH, Cho YD, Park SH, Kim SJ. Sequential algorithm analysis to facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study. BMC Gastroenterol. 2014 Feb 17;14:30. doi: 10.1186/1471-230X-14-30.

ReferenceCitation: Goff JS. Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy. Gastrointest Endosc. 1999 Nov;50(5):642-5.

ReferenceCitation: Tang SJ, Haber GB, Kortan P, Zanati S, Cirocco M, Ennis M, Elfant A, Scheider D, Ter H, Dorais J. Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial. Endoscopy. 2005 Jan;37(1):58-65.

ReferenceCitation: Laquière A, Privat J, Jacques J, Legros R, Urena-Campos R, Belkhodja H, Subtil C, Kanafi L, Lecomte L, Boustière C, Katsogiannou M, Karsenti D. Early double-guidewire versus repeated single-guidewire technique to facilitate selective bile duct cannulation: a randomized controlled trial. Endoscopy. 2021 Apr 15. doi: 10.1055/a-1395-7485. [Epub ahead of print]

name: Department of Gastroenterology, Saint Joseph Hospital, Marseille, France

name: Department of Gastroenterology, Jacques Lacarin Hospital, Vichy, France

name: Department of Endoscopy and Gastroenterology, Dupuytren Hospital, Limoges, France

name: Digestive Endoscopy Unit, University Hospital Lyon Sud, Lyon, France

name: Digestive Endoscopy Unit, University Hospital, Bordeaux, France

name: Department of Gastroenterology, Groupe Polyclinique Marzet-Navarre, Pau, France

name: Department of Clinical Research, Saint Joseph Hospital, Marseille, France

name: Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility: Groupe Hospitalier Diaconesses - La Croix Saint-Simon


type: Other Identifier

title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil on Demand Compared to Sildenafil Citrate on Demand on Treatment Discontinuation in Patients With Erectile Dysfunction Who Are naïve to PDE5 Inhibitors

summary: The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

ReferenceType: derived

ReferenceCitation: Buvat J, Büttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.

family: Buvat

full_name: Jacques Buvat

given: Jacques

family: Büttner

full_name: Hartwig Büttner

given: Hartwig

family: Hatzimouratidis

full_name: Konstantinos Hatzimouratidis

given: Konstantinos

family: Vendeira

full_name: Pedro A.S. Vendeira

given: Pedro A.S.

family: Moncada

full_name: Ignacio Moncada

given: Ignacio

family: Boehmer

full_name: Michael Boehmer

given: Michael

family: Henneges

full_name: Carsten Henneges

given: Carsten

family: Boess

full_name: Frank G. Boess

given: Frank G.

journal_name: The Journal of Sexual Medicine

title: Adherence to Initial PDE5 Inhibitor Treatment: Randomized OpenLabel Study Comparing Tadalafil Once a Day, Tadalafil on Demand, and Sildenafil on Demand in Patients with Erectile Dysfunction

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Poland
France
Greece
Romania
Portugal
Germany
United Kingdom

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

status_simplified: Completed


title: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

acronym: Resova

summary: The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up …) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility: Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

location_facility: CRLC de Bourgogne Georges François Leclerc

location_facility: Centre de Lutte Contre le Cancer Léon Bérard

lead_sponsor_type: academique

status_simplified: Unknown


title: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

acronym: ARIAPUMP

summary:
The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately

Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Bellot P, Welker MW, Soriano G, von Schaewen M, Appenrodt B, Wiest R, Whittaker S, Tzonev R, Handshiev S, Verslype C, Moench C, Zeuzem S, Sauerbruch T, Guarner C, Schott E, Johnson N, Petrov A, Katzarov K, Nevens F, Zapater P, Such J. Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study. J Hepatol. 2013 May;58(5):922-7. doi: 10.1016/j.jhep.2012.12.020. Epub 2013 Jan 11.

ReferenceCitation: Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum in: J Hepatol. 2018 Jan 29;:. J Hepatol. 2020 Mar;72(3):595-596.

family: Bureau

full_name: Christophe Bureau

given: Christophe

family: Adebayo

full_name: Danielle Adebayo

given: Danielle

family: Chalret de Rieu

full_name: Mael Chalret de Rieu

given: Mael

family: Elkrief

full_name: Laure Elkrief

given: Laure

family: Valla

full_name: Dominique Valla

given: Dominique

family: Peck-Radosavljevic

full_name: Markus Peck-Radosavljevic

given: Markus

family: McCune

full_name: Anne McCune

given: Anne

family: Vargas

full_name: Victor Vargas

given: Victor

family: Simon-Talero

full_name: Macarena Simon-Talero

given: Macarena

family: Cordoba

full_name: Juan Cordoba

given: Juan

family: Angeli

full_name: Paolo Angeli

given: Paolo

family: Rosi

full_name: Silvia Rosi

given: Silvia

family: MacDonald

full_name: Stewart MacDonald

given: Stewart

family: Malago

full_name: Massimo Malago

family: Stepanova

full_name: Maria Stepanova

given: Maria

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

family: Trepte

full_name: Claudia Trepte

given: Claudia

family: Watson

full_name: Randall Watson

given: Randall

family: Borisenko

full_name: Oleg Borisenko

given: Oleg

family: Sun

full_name: Sun Sun

given: Sun

family: Inhaber

full_name: Neil Inhaber

given: Neil

family: Jalan

full_name: Rajiv Jalan

given: Rajiv

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.

ReferenceCitation: Solà E, Solé C, Ginès P. Management of uninfected and infected ascites in cirrhosis. Liver Int. 2016 Jan;36 Suppl 1:109-15. doi: 10.1111/liv.13015. Review.

ReferenceCitation: Thomas MN, Sauter GH, Gerbes AL, Stangl M, Schiergens TS, Angele M, Werner J, Guba M. Automated low flow pump system for the treatment of refractory ascites: a single-center experience. Langenbecks Arch Surg. 2015 Dec;400(8):979-83. doi: 10.1007/s00423-015-1356-1. Epub 2015 Nov 13.

ReferenceCitation: Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.

location_facility:
Haut-Lévêque Hospital
Jean MINJOZ Univesity Hospital
Grenoble University Hospital
Amiens-Picardie University Hospital
Beaujon Hospital
LA PITIE SALPETRIERE Univesity Hospital
Chu Pontchaillou
Toulouse University Hospital


title: Randomized Controlled Multicenter Prospective Open-label Study of the Efficacy of the Percutaneous Cryotherapy Combined or Not With a Medical Analgesia in the Treatment of Patients With Uncontrolled Painful Musculoskeletal Metastasis

acronym: CRYO

summary: The primary objective of this trial is to compare the efficacy of 2 analgesic strategies, based on percutaneous cryotherapy plus medical supportive care versus medical supportive care alone in the treatment of cancer patients with painful musculoskeletal metastasis.

primary_purpose: Supportive Care

lead_sponsor: Centre Leon Berard

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

location_facility: Institut de Cancérologie de Montpellier-Val d'Aurelle

intervention_type: Other


title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™

acronym: ECRO

summary:
Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.

The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.

primary_purpose: Other

ReferenceCitation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9:CD013330. doi: 10.1002/14651858.CD013330.pub2. Review.

name: Department of Health Promotion and Human Behavior; Kyoto University Graduate School of Medicine / School of Public Health; Kyoto Japan

name: Department of Nephrology and Dialysis; Kyoritsu Hospital; Kawanishi Japan

name: Systematic Review Workshop Peer Support Group (SRWS-PSG); Osaka Japan

family: Tsujimoto

full_name: Yasushi Tsujimoto

given: Yasushi

name: Department of Nephrology; Sumitomo Hospital; Osaka Japan

family: Miki

full_name: Sho Miki

given: Sho

name: Department of Nephrology; Hyogo Prefectural Amagasaki General Medical Center; Amagasaki Japan

family: Shimada

full_name: Hiroki Shimada

given: Hiroki

name: Hospital Care Research Unit; Hyogo Prefectural Amagasaki General Medical Center; Hyogo Japan

full_name: Hiraku Tsujimoto

given: Hiraku

name: Department of Emergency and Critical Care Medicine; Jichi Medical University Saitama Medical Center; Saitama-shi Japan

family: Yasuda

full_name: Hideto Yasuda

given: Hideto

name: Department of Internal Medicine; Kyoto Min-Iren Asukai Hospital; Kyoto Japan

name: Department of Healthcare Epidemiology; Kyoto University Graduate School of Medicine / School of Public Health; Kyoto Japan

name: Section of Clinical Epidemiology, Department of Community Medicine; Kyoto University Graduate School of Medicine; Kyoto Japan

family: Kataoka

full_name: Yuki Kataoka

given: Yuki

name: Intensive Care Unit; Jikei University Hospital; Tokyo Japan

name: ANZIC-RC; Monash University School of Public Health and Preventive Medicine; Melbourne Australia

family: Fujii

full_name: Tomoko Fujii

given: Tomoko

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hospices Civils de Lyon

location_facility: L'Hôpital Nord-Ouest - Villefranche sur Saone

location_facility: Hôpital Pasteur 2 - Hôpital Universitaire de Nice

location_facility: Hopital Universitaire de Clermont Ferrand

location_facility: Anesthesia and Critical Care Medicine Department - Edouard Herriot Hospital

intervention_type: Device


title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study

acronym: EMMIE

summary: The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.

lead_sponsor: Symatese Aesthetics

location_facility:
Institut Gustave Roussy
Institut du Sein
Clinique BIZET
Chu Pasteur
Clinique Charcot
Centre F.X. Michelet Chu Bordeaux
Clinique des Champs Elysées
Hopital Tenon


title: Detection and Characteristic of Whipple Diseases in the Great Britany

acronym: WHO

summary:
Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma.

Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.

None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis.

As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
CH d'ORLEANS
CHU de Nantes
CHU de Tours
CHU de POITIERS
CHRU de Brest
CHU de Rennes
CH le MAns
CHU d'ANGERS


title: Interest of iRECIST Radiological Assessment for Disease Control Rate (DCR) for Evaluation of Patients With Metastatic Colorectal Cancer dMMR and / or MSI Treated With Nivolumab and Ipilimumab. A GERCOR Open-label Phase II Study NIPICOL C17-01

acronym: NIPICOL

summary:
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks.

Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators).

A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.

ReferenceCitation: Cohen R, Bennouna J, Meurisse A, Tournigand C, De La Fouchardière C, Tougeron D, Borg C, Mazard T, Chibaudel B, Garcia-Larnicol ML, Svrcek M, Vernerey D, Menu Y, André T. RECIST and iRECIST criteria for the evaluation of nivolumab plus ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the GERCOR NIPICOL phase II study. J Immunother Cancer. 2020 Nov;8(2). pii: e001499. doi: 10.1136/jitc-2020-001499.

family: Cohen

full_name: Romain Cohen

given: Romain

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Tournigand

full_name: Christophe Tournigand

given: Christophe

family: De La Fouchardière

full_name: Christelle De La Fouchardière

given: Christelle

family: Tougeron

full_name: David Tougeron

given: David

family: Borg

full_name: Christophe Borg

family: Mazard

full_name: Thibault Mazard

given: Thibault

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Garcia-Larnicol

full_name: Marie-Line Garcia-Larnicol

given: Marie-Line

family: Svrcek

full_name: Magali Svrcek

given: Magali

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Menu

full_name: Yves Menu

given: Yves

family: André

full_name: Thierry André

given: Thierry

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
IHFB
Hospital Saint Antoine
Henri Mondor Hospital
CHU Poitiers
CHRU Besançon
Institut Sainte Catherine
Centre Leon Berard
CHU Nantes - Hôtel Dieu


title: Observational Prospective Multicentered Study Evaluating Initial Clinical Presentation of Inflammatory Optic Neuritis (ON) Associated or Not With Autoantibodies Anti- Myelin-oligodendrocyte-glycoprotein (MOG-Ab)

acronym: MOG

summary: In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.

ReferenceCitation: Ramanathan S, Dale RC, Brilot F. Anti-MOG antibody: The history, clinical phenotype, and pathogenicity of a serum biomarker for demyelination. Autoimmun Rev. 2016 Apr;15(4):307-24. doi: 10.1016/j.autrev.2015.12.004. Epub 2015 Dec 17. Review.

ReferenceCitation: Akaishi T, Nakashima I, Takeshita T, Kaneko K, Mugikura S, Sato DK, Takahashi T, Nakazawa T, Aoki M, Fujihara K. Different etiologies and prognoses of optic neuritis in demyelinating diseases. J Neuroimmunol. 2016 Oct 15;299:152-157. doi: 10.1016/j.jneuroim.2016.09.007. Epub 2016 Sep 14.

ReferenceCitation: Ramanathan S, Reddel SW, Henderson A, Parratt JD, Barnett M, Gatt PN, Merheb V, Kumaran RY, Pathmanandavel K, Sinmaz N, Ghadiri M, Yiannikas C, Vucic S, Stewart G, Bleasel AF, Booth D, Fung VS, Dale RC, Brilot F. Antibodies to myelin oligodendrocyte glycoprotein in bilateral and recurrent optic neuritis. Neurol Neuroimmunol Neuroinflamm. 2014 Oct 29;1(4):e40. doi: 10.1212/NXI.0000000000000040. eCollection 2014 Dec.

ReferenceCitation: Havla J, Kümpfel T, Schinner R, Spadaro M, Schuh E, Meinl E, Hohlfeld R, Outteryck O. Myelin-oligodendrocyte-glycoprotein (MOG) autoantibodies as potential markers of severe optic neuritis and subclinical retinal axonal degeneration. J Neurol. 2017 Jan;264(1):139-151. doi: 10.1007/s00415-016-8333-7. Epub 2016 Nov 14.

ReferenceCitation: Sato DK, Callegaro D, Lana-Peixoto MA, Waters PJ, de Haidar Jorge FM, Takahashi T, Nakashima I, Apostolos-Pereira SL, Talim N, Simm RF, Lino AM, Misu T, Leite MI, Aoki M, Fujihara K. Distinction between MOG antibody-positive and AQP4 antibody-positive NMO spectrum disorders. Neurology. 2014 Feb 11;82(6):474-81. doi: 10.1212/WNL.0000000000000101. Epub 2014 Jan 10.

ReferenceCitation: Jarius S, Ruprecht K, Kleiter I, Borisow N, Asgari N, Pitarokoili K, Pache F, Stich O, Beume LA, Hümmert MW, Ringelstein M, Trebst C, Winkelmann A, Schwarz A, Buttmann M, Zimmermann H, Kuchling J, Franciotta D, Capobianco M, Siebert E, Lukas C, Korporal-Kuhnke M, Haas J, Fechner K, Brandt AU, Schanda K, Aktas O, Paul F, Reindl M, Wildemann B; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 2: Epidemiology, clinical presentation, radiological and laboratory features, treatment responses, and long-term outcome. J Neuroinflammation. 2016 Sep 27;13(1):280.

ReferenceCitation: Höftberger R, Sepulveda M, Armangue T, Blanco Y, Rostásy K, Calvo AC, Olascoaga J, Ramió-Torrentà L, Reindl M, Benito-León J, Casanova B, Arrambide G, Sabater L, Graus F, Dalmau J, Saiz A. Antibodies to MOG and AQP4 in adults with neuromyelitis optica and suspected limited forms of the disease. Mult Scler. 2015 Jun;21(7):866-874. doi: 10.1177/1352458514555785. Epub 2014 Oct 24.

ReferenceCitation: The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8.

ReferenceCitation: Stiebel-Kalish H, Lotan I, Brody J, Chodick G, Bialer O, Marignier R, Bach M, Hellmann MA. Retinal Nerve Fiber Layer May Be Better Preserved in MOG-IgG versus AQP4-IgG Optic Neuritis: A Cohort Study. PLoS One. 2017 Jan 26;12(1):e0170847. doi: 10.1371/journal.pone.0170847. eCollection 2017.

ReferenceCitation: Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8.

ReferenceCitation: Elsone L, Panicker J, Mutch K, Boggild M, Appleton R, Jacob A. Role of intravenous immunoglobulin in the treatment of acute relapses of neuromyelitis optica: experience in 10 patients. Mult Scler. 2014 Apr;20(4):501-4. doi: 10.1177/1352458513495938. Epub 2013 Aug 28.

ReferenceCitation: Optic Neuritis Study Group. Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology. 2008 Jun;115(6):1079-1082.e5. Epub 2007 Nov 5.

ReferenceCitation: Garcia-Martin E, Ara JR, Martin J, Almarcegui C, Dolz I, Vilades E, Gil-Arribas L, Fernandez FJ, Polo V, Larrosa JM, Pablo LE, Satue M. Retinal and Optic Nerve Degeneration in Patients with Multiple Sclerosis Followed up for 5 Years. Ophthalmology. 2017 May;124(5):688-696. doi: 10.1016/j.ophtha.2017.01.005. Epub 2017 Feb 7.

ReferenceCitation: Beck RW, Gal RL, Bhatti MT, Brodsky MC, Buckley EG, Chrousos GA, Corbett J, Eggenberger E, Goodwin JA, Katz B, Kaufman DI, Keltner JL, Kupersmith MJ, Miller NR, Moke PS, Nazarian S, Orengo-Nania S, Savino PJ, Shults WT, Smith CH, Trobe JD, Wall M, Xing D; Optic Neuritis Study Group. Visual function more than 10 years after optic neuritis: experience of the optic neuritis treatment trial. Am J Ophthalmol. 2004 Jan;137(1):77-83. Erratum in: Am J Ophthalmol. 2004 Apr;137(4):following 793. Am J Ophthalmol. 2004 Aug;138(2):following 321.

ReferenceCitation: Pache F, Zimmermann H, Mikolajczak J, Schumacher S, Lacheta A, Oertel FC, Bellmann-Strobl J, Jarius S, Wildemann B, Reindl M, Waldman A, Soelberg K, Asgari N, Ringelstein M, Aktas O, Gross N, Buttmann M, Ach T, Ruprecht K, Paul F, Brandt AU; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 4: Afferent visual system damage after optic neuritis in MOG-IgG-seropositive versus AQP4-IgG-seropositive patients. J Neuroinflammation. 2016 Nov 1;13(1):282.

location_facility:
Ch Cholet
Chu Angers
Chr Le Mans
Chd La Roche Sur Yon
CHU Nantes
Ch Saint Nazaire
Ch Laval
Ch Challans


title: Protection During Cardiac Surgery.

acronym: ProCCard

summary: This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

ReferenceCitation: Chiari P, Mewton N, Maucort-Boulch D, Desebbe O, Durand M, Fischer MO, Lena-Quintard D, Palao JC, Ovize M, Fellahi JL. Multimodal Strategy for Myocardial Protection During Cardiac Surgery: The ProCCard Study. J Am Coll Cardiol. 2021 Feb 16;77(6):827-829. doi: 10.1016/j.jacc.2020.12.020.

family: Chiari

full_name: Pascal Chiari

given: Pascal

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Desebbe

full_name: Olivier Desebbe

given: Olivier

family: Durand

full_name: Michel Durand

given: Michel

family: Fischer

full_name: Marc-Olivier Fischer

given: Marc-Olivier

family: Lena-Quintard

full_name: Diane Lena-Quintard

given: Diane

family: Palao

full_name: Jean-Charles Palao

given: Jean-Charles

family: Ovize

full_name: Michel Ovize

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Chiari P, Durand M, Desebbe O, Fischer MO, Lena-Quintard D, Palao JC, Mercier C, Samson G, Varillon Y, Pozzi M, Mewton N, Maucort-Boulch D, Ovize M, Fellahi JL. Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial. Trials. 2019 Sep 11;20(1):560. doi: 10.1186/s13063-019-3638-3.

apc_source: openAPC

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Samson

full_name: Géraldine Samson

given: Géraldine

family: Varillon

full_name: Yvonne Varillon

given: Yvonne

family: Pozzi

full_name: Matteo Pozzi

given: Matteo

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

location_facility: Institut Arnault Tzanck - Saint-Laurent du Var

location_facility: Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel

location_facility: Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

location_facility: service de Chirurgie Cardiaque CHU Gabriel Montpied


title: Non Invasive Prenatal Diagnosis on Isolated Circulating Fetal Trophoblastic Cells (CFTC) for Triplet Repeat Diseases

acronym: DIACCIMEX

summary: The purpose of this study is to develop and validate an analytical and clinical NIPD test for triplet repeat diseases by isolated circulating fetal trophoblastic cells (CFTC) analysis from maternal blood, searching for the familial mutation in families at risk of having one of the following triplet repeat diseases: Huntington's disease, Steinert Myotonic dystrophy, Fragile X syndrome, spinocerebellar ataxia (SCA) 1, 2 and 3.

primary_purpose: Diagnostic

ReferenceCitation: Cayrefourcq L, Vincent MC, Pierredon S, Moutou C, Imbert-Bouteille M, Haquet E, Puechberty J, Willems M, Liautard-Haag C, Molinari N, Zordan C, Dorian V, Rooryck-Thambo C, Goizet C, Chaussenot A, Rouzier C, Boureau-Wirth A, Monteil L, Calvas P, Miry C, Favre R, Petrov Y, Khau Van Kien P, Le Boette E, Fradin M, Alix-Panabières C, Guissart C. Single Circulating Fetal Trophoblastic Cells Eligible for Non Invasive Prenatal Diagnosis: the Exception Rather than the Rule. Sci Rep. 2020 Jun 17;10(1):9861. doi: 10.1038/s41598-020-66923-9.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Strasbourg
CHU Toulouse
CHU Nîmes
CHU Bordeaux
CHU Montpellier
CH Saint Brieuc
CHU Nice
CHU Rennes

intervention_type: Genetic


title: Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months

acronym: DexEnceph

summary:
Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV).

HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. It is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with HSV encephalitis. The aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with HSV Encephalitis.

ReferenceCitation: Whitley RJ. Herpes simplex encephalitis: adolescents and adults. Antiviral Res. 2006 Sep;71(2-3):141-8. Epub 2006 Apr 25. Review.

ReferenceCitation: Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15. Erratum in: Lancet Infect Dis. 2011 Feb;11(2):79.

ReferenceCitation: Tunkel AR, Glaser CA, Bloch KC, Sejvar JJ, Marra CM, Roos KL, Hartman BJ, Kaplan SL, Scheld WM, Whitley RJ; Infectious Diseases Society of America. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2008 Aug 1;47(3):303-27. doi: 10.1086/589747.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Strasbourg
Hôpital Bichat-Claude Bernard, APHP
Hôpital Gui de Chauliac
Hôpital Delafontaine
CHU Hôtel-Dieu
Hôpital Charles Nicolle
CHU Rennes, Hôpital Pontchaillou
CHRU de Nancy, Hopitaux de Brabois


title: Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.

acronym: QUANARIE

summary:
Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL) assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival.

The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO).

Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.

status: Unknown status

ReferenceCitation: Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.

family: Mouillet

full_name: Guillaume Mouillet

given: Guillaume

family: Fritzsch

full_name: Joëlle Fritzsch

given: Joëlle

family: Paget-Bailly

full_name: Sophie Paget-Bailly

given: Sophie

family: Pozet

full_name: Astrid Pozet

given: Astrid

family: Es-Saad

full_name: Ikram Es-Saad

given: Ikram

family: Meurisse

full_name: Aurelia Meurisse

given: Aurelia

family: Vernerey

full_name: Dewi Vernerey

family: Mouyabi

full_name: Kristina Mouyabi

given: Kristina

family: Berthod

full_name: Diane Berthod

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Anota

full_name: Amélie Anota

given: Amélie

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

given: Antoine

currency_apc_doaj: GBP

journal_name: Health and Quality of Life Outcomes

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine

location_facility: Centre de lutte contre le cancer Georges François Leclerc

location_facility: Centre de lutte contre le cancer Jean Godinot


title: Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

summary:
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.

The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.

lead_sponsor: Oticon Medical

location_facility:
CHU Lyon Hôpital Edouard Herriot
APHM - Hôpital Nord Marseille
CHU Rennes Pontchaillou
CHRU de Nancy hôpital Central
APHP Pitie salpetriere
IUFC - CHU Nice
CHRU Lille Hôpital Roger Salengro
CHU Bordeaux Pellegrin


lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Germany France Switzerland

acronym: PROMET

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: EOC-Istituto Oncologico della Svizzera Italiana

location_facility: Centre de lutte contre le cancer Léon Bérard

location_facility: Clinique Pasteur - Centre finistérien de radiothérapie et d'oncologie

location_facility: Centre Hospitalier Régional Universitaire (CHRU) Jean Minjoz

location_facility: Institut de Cancérologie de L'Ouest René Gauducheau

type: EudraCT Number

source: euctr

title: SAKK 08/15 - PROMET - Multicenter, Randomized Phase II Trial of Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy

summary: The main objective of the trial is to explore the efficacy of salvage radiotherapy (SRT) plus metformin compared to SRT in the endpoint of time to progression after prostatectomy failure.


title: An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)

summary: The purpose of the study is to assess the sensibility of the ISL questionnaire.

design_allocation: Non-Randomized

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


title: Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

summary: Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

ReferenceCitation: Cadranel J, Lavolé A, Gounant V, Wislez M. [Bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features: a clinico-pathological spectrum]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S165-70. Review. French.

ReferenceCitation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77.

ReferenceCitation: Garfield DH, Cadranel JL, Wislez M, Franklin WA, Hirsch FR. The bronchioloalveolar carcinoma and peripheral adenocarcinoma spectrum of diseases. J Thorac Oncol. 2006 May;1(4):344-59. Review. Erratum in: J Thorac Oncol. 2006 Jun;1(5):405.

ReferenceCitation: Cadranel J, Quoix E, Baudrin L, Mourlanette P, Moro-Sibilot D, Morere JF, Souquet PJ, Soria JC, Morin F, Milleron B; IFCT-0401 Trial Group. IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. J Thorac Oncol. 2009 Sep;4(9):1126-35. doi: 10.1097/JTO.0b013e3181abeb5d.

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Baudrin

full_name: Laurence Baudrin

given: Laurence

family: Mourlanette

full_name: Pierre Mourlanette

given: Pierre

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Morere

full_name: Jean-François Morere

given: Jean-François

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Soria

full_name: Jean-Charles Soria

family: Morin

full_name: Franck Morin

family: Milleron

full_name: Bernard Milleron

given: Bernard

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: IFCT-0401 Trial: A Phase II Study of Gefitinib Administered as First-Line Treatment in Advanced Adenocarcinoma with Bronchioloalveolar Carcinoma Subtype

ReferenceCitation: Wislez M, Antoine M, Baudrin L, Poulot V, Neuville A, Pradere M, Longchampt E, Isaac-Sibille S, Lebitasy MP, Cadranel J. Non-mucinous and mucinous subtypes of adenocarcinoma with bronchioloalveolar carcinoma features differ by biomarker expression and in the response to gefitinib. Lung Cancer. 2010 May;68(2):185-91. doi: 10.1016/j.lungcan.2009.05.021. Epub 2009 Jul 5.

family: Wislez

full_name: Marie Wislez

given: Marie

family: Antoine

full_name: Martine Antoine

given: Martine

family: Poulot

full_name: Virginie Poulot

given: Virginie

family: Neuville

full_name: Agnes Neuville

given: Agnes

family: Pradere

full_name: Maryvonne Pradere

given: Maryvonne

family: Longchampt

full_name: Elisabeth Longchampt

family: Isaac-Sibille

full_name: Sylvie Isaac-Sibille

given: Sylvie

family: Lebitasy

full_name: Marie-Paule Lebitasy

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: APHP - CHU Avicenne - Oncologie Medicale


title: Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

acronym: PRINGEN

summary:
Despite a large diffusion for generic anti-hypertensive, they are not currently used.

Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only.

A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria.

The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH d'ANNONAY
CH de FEURS
CHU de SAINT-ETIENNE
CH du PUY EN VELAY
CH de SAINT-CHAMOND
CH de FIRMINY
CH de ROANNE
CH de MONTBRISON


title: Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .

lead_sponsor: UNICANCER

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

location_facility: Centre Hospitalier General de Saint Nazaire


title: Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.

ReferenceCitation: Bensadoun RJ, Bénézery K, Dassonville O, Magné N, Poissonnet G, Ramaïoli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Géry B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):983-94. Epub 2006 Jan 10.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

summary:
Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.

Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.

HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.

Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.

To investigators knowledge, SRS and HSRT have not been prospectively compared.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Eugène Marquis
Centre Antoine Lacassagne
Centre François Baclesse
Centre Guillaume le Conquérant
Centre Oscar Lambret
La Pitié Salpétrière
Gustave Roussy
Centre Henri Becquerel
CHU


title: Genetic Study on the Familial Forms of Intracranial Aneurysm

acronym: GAÏA

summary:
Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death.

Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of an IA in a given individual. Also, there is no pharmacological drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the management of patients with IA remains extremely challenging and still controversial.

Although the pathogenesis of IA has been the subject of many studies for the last decade, the mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant animal models of IA are not available.

Familial history of IA predisposes to IA formation and rupture and increasing evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance and penetrance.

This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and predictive tools of risk of IA.

The investigators propose to identify IA-causing variants by whole-exome sequencing in familial forms of the disease.

The investigators hypothesises that the functional analysis of the causal / susceptibility variants thus identified will provide clues to understanding the pathological mechanisms of IA formation, and the bases for developing diagnostic tools. This project aims at meeting this challenge. Based on preliminary data that already allowed to identify such a variant, and the combination of genetic and functional investigations, the specific objectives of this project are: - To identify IA-causing variants in familial forms of the disease by whole-exome sequencing; - To understand the function of these genes/ variants in the formation and rupture of IA by molecular and cellular approaches and generation of relevant animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.

ReferenceCitation: Canham PB, Finlay HM. Morphometry of medial gaps of human brain artery branches. Stroke. 2004 May;35(5):1153-7. Epub 2004 Mar 11.

ReferenceCitation: Rhoton AL Jr. Aneurysms. Neurosurgery. 2002 Oct;51(4 Suppl):S121-58. Review.

ReferenceCitation: Rinkel GJ, Djibuti M, Algra A, van Gijn J. Prevalence and risk of rupture of intracranial aneurysms: a systematic review. Stroke. 1998 Jan;29(1):251-6.

ReferenceCitation: Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0. Review.

ReferenceCitation: Ronkainen A, Hernesniemi J, Ryynänen M. Familial subarachnoid hemorrhage in east Finland, 1977-1990. Neurosurgery. 1993 Nov;33(5):787-96; discussion 796-97. Review.

ReferenceCitation: Bakker MK, van der Spek RAA, van Rheenen W, Morel S, Bourcier R, Hostettler IC, Alg VS, van Eijk KR, Koido M, Akiyama M, Terao C, Matsuda K, Walters RG, Lin K, Li L, Millwood IY, Chen Z, Rouleau GA, Zhou S, Rannikmäe K, Sudlow CLM, Houlden H, van den Berg LH, Dina C, Naggara O, Gentric JC, Shotar E, Eugène F, Desal H, Winsvold BS, Børte S, Johnsen MB, Brumpton BM, Sandvei MS, Willer CJ, Hveem K, Zwart JA, Verschuren WMM, Friedrich CM, Hirsch S, Schilling S, Dauvillier J, Martin O; HUNT All-In Stroke; China Kadoorie Biobank Collaborative Group; BioBank Japan Project Consortium; ICAN Study Group; CADISP Group; Genetics and Observational Subarachnoid Haemorrhage (GOSH) Study investigators; International Stroke Genetics Consortium (ISGC), Jones GT, Bown MJ, Ko NU, Kim H, Coleman JRI, Breen G, Zaroff JG, Klijn CJM, Malik R, Dichgans M, Sargurupremraj M, Tatlisumak T, Amouyel P, Debette S, Rinkel GJE, Worrall BB, Pera J, Slowik A, Gaál-Paavola EI, Niemelä M, Jääskeläinen JE, von Und Zu Fraunberg M, Lindgren A, Broderick JP, Werring DJ, Woo D, Redon R, Bijlenga P, Kamatani Y, Veldink JH, Ruigrok YM. Genome-wide association study of intracranial aneurysms identifies 17 risk loci and genetic overlap with clinical risk factors. Nat Genet. 2020 Dec;52(12):1303-1313. doi: 10.1038/s41588-020-00725-7. Epub 2020 Nov 16. Erratum in: Nat Genet. 2020 Dec 22;:.

family: Bakker

full_name: Mark K. Bakker

given: Mark K.

family: van der Spek

full_name: Rick A. A. van der Spek

given: Rick A. A.

family: van Rheenen

full_name: Wouter van Rheenen

given: Wouter

family: Morel

full_name: Sandrine Morel

given: Sandrine

family: Bourcier

full_name: Romain Bourcier

given: Romain

family: Hostettler

full_name: Isabel C. Hostettler

given: Isabel C.

family: Alg

full_name: Varinder S. Alg

given: Varinder S.

family: van Eijk

full_name: Kristel R. van Eijk

given: Kristel R.

family: Koido

full_name: Masaru Koido

given: Masaru

family: Akiyama

full_name: Masato Akiyama

given: Masato

family: Terao

full_name: Chikashi Terao

given: Chikashi

family: Matsuda

full_name: Koichi Matsuda

given: Koichi

family: Walters

full_name: Robin G. Walters

given: Robin G.

family: Lin

full_name: Kuang Lin

given: Kuang

family: Li

full_name: Liming Li

given: Liming

family: Millwood

full_name: Iona Y. Millwood

given: Iona Y.

family: Chen

full_name: Zhengming Chen

given: Zhengming

family: Rouleau

full_name: Guy A. Rouleau

given: Guy A.

family: Zhou

full_name: Sirui Zhou

given: Sirui

family: Rannikmäe

full_name: Kristiina Rannikmäe

given: Kristiina

family: Sudlow

full_name: Cathie L. M. Sudlow

given: Cathie L. M.

family: Houlden

full_name: Henry Houlden

repository_institution: University of Oslo - Duo Research Archive

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Bourcier R, Le Scouarnec S, Bonnaud S, Karakachoff M, Bourcereau E, Heurtebise-Chrétien S, Menguy C, Dina C, Simonet F, Moles A, Lenoble C, Lindenbaum P, Chatel S, Isidor B, Génin E, Deleuze JF, Schott JJ, Le Marec H; ICAN Study Group, Loirand G, Desal H, Redon R. Rare Coding Variants in ANGPTL6 Are Associated with Familial Forms of Intracranial Aneurysm. Am J Hum Genet. 2018 Jan 4;102(1):133-141. doi: 10.1016/j.ajhg.2017.12.006.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

location_facility:
University Hospital Poitiers
AP-HP, Henri Mondor hospital
Rouen University Hospital
Tours University Hospital
University Hospital Rennes
Nantes University Hospital
Bordeaux University Hospital
CHD La Roche sur YON


title: Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

summary: Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric emergency departments. So as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient observation are prescribed. Ultimately, the majority of these measures could be avoided and a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as the S100B protein, has the potential to reduce the number of these unnecessary measures.

ReferenceCitation: Bouvier D, Fournier M, Dauphin JB, Amat F, Ughetto S, Labbé A, Sapin V. Serum S100B determination in the management of pediatric mild traumatic brain injury. Clin Chem. 2012 Jul;58(7):1116-22. doi: 10.1373/clinchem.2011.180828. Epub 2012 Apr 23.

ReferenceCitation: The management of minor closed head injury in children. Committee on Quality Improvement, American Academy of Pediatrics. Commission on Clinical Policies and Research, American Academy of Family Physicians. Pediatrics. 1999 Dec;104(6):1407-15. Review.

ReferenceCitation: Bouvier D, Balayssac D, Durif J, Mourgues C, Sarret C, Pereira B, Sapin V. Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury-PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial. BMJ Open. 2019 May 24;9(5):e027365. doi: 10.1136/bmjopen-2018-027365.

family: Bouvier

full_name: Damien Bouvier

given: Damien

family: Balayssac

full_name: David Balayssac

given: David

family: Durif

full_name: Julie Durif

given: Julie

family: Mourgues

full_name: Charline Mourgues

given: Charline

family: Sarret

full_name: Catherine Sarret

given: Catherine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Sapin

full_name: Vincent Sapin

given: Vincent

journal_name: BMJ Open

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

title: Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury—PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique des Hôpitaux de Marseille

intervention_type: Procedure


title: Follow-up of a Cohort of Patients With Myasthenic Syndrome and COVID-19 Infection: Consequences on the Severity of Myasthenic Syndrome and Reciprocal Impact of the Two Pathologies on Their Respective Treatments

acronym: CO-MY-COVID

summary:
Coronavirus disease 2019 (COVID-19), declared by the World Health Organization (WHO) as a "public health emergency of international concern" (January 31, 2020), has posed a significant threat to global health. This infectious disease, caused by the 'severe acute respiratory syndrome coronavirus-2'(SARS-CoV-2), was first reported in China at the end of 2019. As other coronaviruses, SARS-CoV-2 primarily targets the human respiratory system. The most common symptoms are fever, fatigue, and dry cough. During the second week of the disease, part of patients may progress to shortness of breath, then hypoxemia and severe pneumonia. Acute respiratory distress syndrome (ARDS), linked to some risk factors such as advanced age and underlying comorbidities (hypertension, diabetes, cardiovascular disease, and cerebrovascular disease), may be fatal and needs early supportive therapy and monitoring.

Some patients with COVID-19 experienced neurological complications including headache, dizziness, hypogeusia and/or anosmia, altered level of consciousness, strokes, seizures, and ataxia, less frequently neuromuscular disorders (NMD) such as acute inflammatory polyradiculoneuropathy. Among NMD, myasthenia gravis (MG) patients, particularly susceptible to infections causing crises, could be of special risk of COVID-19 ARDS. Some general recommendations were established for the management of NMD during the COVID-19 pandemic,with also specific recommendations for MG. However, only data on a small number of patients who were managed in hospital are currently available;in addition, only two cases of myasthenic crisis following COVID-19 were reported. For this reason, the French neuromuscular rare disease network (FILNEMUS: 'FILière NEuroMUSculaire') has created the 'CO-MY-COVID register' to describe the clinical course and prognosis of patients with COVID-19 and pre-existing myasthenic syndrome.

lead_sponsor: University Hospital, Bordeaux

location_facility: Assistance Publique Hôpitaux de Marseille


title: PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

acronym: PRODIGIOUS

summary: To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
<CHU de Poitiers
CH des Pays de Morlaix
CH Le Mans
CHU de Nantes
CHR d'Orléans
CHU d'Angers
CHU de Tours
CHIC Quimper
CHRU de Brest
CHD Vendée


title: Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face - Study PICAMEL

acronym: PICAMEL

summary:
Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma cells, limited to the epidermis. It is found most commonly on the head and neck of elderly persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin. However, the lesions can be large, and conventional surgery can be difficult, particularly on the face.

Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis and superficial dermis.

Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or a prolonged remission of non-invasive LM.

Because of the exploratory phase of this study (no case report and no clinical trial at the early phase of designing this study, only one case report at the time of submission of this form) the investigators will conduct an open label study limited to patients who are not eligible to, or who refuse surgical treatment of their LM.

The main objective of this study is to determine the proportion of patients with complete response (CR) obtained 2 months after one or two cycles (for patients who did not respond to the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head and neck).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
AP-HP Hôpital Ambroise Paré
AP-HP Hopital Avicenne
CHU de Nantes
CHRU de Lille
Hôpital Pontchaillou
CHU de Nice
Hôpital du Morvan
CHU de Saint Etienne


title: Impact of Telemonitoring for the Management of Side Effects in Patients With Melanoma, Lung or Renal Cancer, Treated With Immunotherapy Combination of Nivolumab and Ipilimumab.

acronym: MONITOR

summary:
The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.

The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Louis Pradel - Department of Pneumology

location_facility: Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute

location_facility: Hôpital de la Croix Rousse - Department of Pneumology

location_facility: University hospital of Grenoble Alpes - Department of dermatology

location_facility: Hôpital Edouard Herriot - Department of urology

location_facility: Groupement hospitalier Est - Multidisciplinary oncological platform

location_facility: University hospital of Grenoble Alpes - Department of Medical Oncology

location_facility: Hôpital Lyon Sud - Department of pneumology,Thoracic oncology

location_facility: University hospital of Saint-Etienne - Department of dermatology

location_facility: Centre Hospitalier Lyon Sud - Department of Medical Oncology

intervention_type: Behavioral


title: A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

acronym: PROTRACH

summary: The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

ReferenceCitation: Guitton C, Ehrmann S, Volteau C, Colin G, Maamar A, Jean-Michel V, Mahe PJ, Landais M, Brule N, Bretonnière C, Zambon O, Vourc'h M. Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial. Intensive Care Med. 2019 Apr;45(4):447-458. doi: 10.1007/s00134-019-05529-w. Epub 2019 Jan 21.

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Maamar

full_name: Adel Maamar

given: Adel

family: Jean-Michel

full_name: Vanessa Jean-Michel

given: Vanessa

family: Mahe

full_name: Pierre-Joachim Mahe

given: Pierre-Joachim

family: Landais

full_name: Mickael Landais

given: Mickael

family: Brule

full_name: Noelle Brule

given: Noelle

family: Bretonnière

full_name: Cedric Bretonnière

given: Cedric

family: Zambon

full_name: Olivier Zambon

given: Olivier

family: Vourc’h

full_name: Mickael Vourc’h

journal_name: Intensive Care Medicine

evidence: open (via free pdf)

lead_sponsor: Nantes University Hospital

location_facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

location_facility: Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit

location_facility: CHD LES OUDOUAIRIES Service de réanimation polyvalente

location_facility: Brest hospital, CHU La cavale Blanche, medical intensive care unit

location_facility: Tours university hospital, hôpital Bretonneau, medical intensive care unit

location_facility: Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit

location_facility: Nantes University hospital, Hôpital Laennec, pneumology intensive care unit


title: Evaluation of Treatment Response With CHOI and RECIST Criteria and CT Texture Analysis in Patients With Metastatic Colorectal Cancer Treated With Regorafenib. A GERCOR Phase II Study

acronym: TEXCAN

summary:
The purpose of the study is to evaluate the performance of various tumor response criteria (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.

Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic texture analysis (CTTA)

ReferenceCitation: Lucidarme O, Wagner M, Gillard P, Kim S, Bachet JB, Rousseau B, Mazard T, Louvet C, Chibaudel B, Cohen R, Garcia-Larnicol ML, Gobert A, Henriques J, André T. RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study. Cancer Imaging. 2019 Dec 9;19(1):85. doi: 10.1186/s40644-019-0271-z.

family: Lucidarme

full_name: Olivier Lucidarme

family: Wagner

full_name: Mathilde Wagner

given: Mathilde

family: Gillard

full_name: Paul Gillard

given: Paul

family: Kim

full_name: Stefano Kim

given: Stefano

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Rousseau

full_name: Benoit Rousseau

given: Benoit

family: Mazard

full_name: Thibault Mazard

given: Thibault

family: Louvet

full_name: Christophe Louvet

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Cohen

full_name: Romain Cohen

given: Romain

family: Garcia-Larnicol

full_name: Marie-Line Garcia-Larnicol

given: Marie-Line

family: Gobert

full_name: Aurelien Gobert

given: Aurelien

family: Henriques

full_name: Julie Henriques

family: André

full_name: Thierry André

given: Thierry

journal_name: Cancer Imaging

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

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

location_facility:
Hôpital Saint Antoine
Insitut Mutualiste Montouris
Institut Hospitalier Franco-Britannique
CHU Jean Minjoz
ICM Val D'Aurelle
Hôpital Pitié Salpêtrière
CHRU Claude Huriez
Hôpitlal Henri Mondor


title: Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

acronym: E-PENEPA

summary: Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

location_facility: CIC, Hospital University, Clermont Ferrand

location_facility: University Hospital Lyon sud - Pierre Bénite


title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial

acronym: G-PACTS

summary: The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

ReferenceCitation: Chaïb LS, Lopez-Castroman J, Abbar M. Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial. Trials. 2020 Oct 27;21(1):889. doi: 10.1186/s13063-020-04816-y.

family: Chaïb

full_name: Laurent S. Chaïb

given: Laurent S.

family: Lopez-Castroman

full_name: Jorge Lopez-Castroman

given: Jorge

family: Abbar

full_name: Mocrane Abbar

given: Mocrane

journal_name: Trials

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Tours - Clinique Psychiatrique Universitaire

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied


title: Evaluation of the Circulating Concentration of Olfactomédine 4 (OLFM4) in Women With a BRCA1 or 2 Gene Mutation or at High Risk of Developing Breast Cancer, According to the Imaging

summary: Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

primary_purpose: Screening

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
CH
CHU La Mileterie
Instit de Cancérologie de l'Ouest
CHBA Hopital Chubert
CHU Morvan
CHU Bretonneau
Institut de Cancerologie de l'Ouest

intervention_type: Biological


title: Assessment of Food Practices by Residents in Nursing Homes, Study of Relationship Between Food Intake and Nutritional Status.

summary:
Nutrition is an essential component of health and a key determinant of aging and quality of life of individuals. Malnutrition in the elderly is now recognized as a public health problem affecting nearly half of residents in nursing homes. The fight against malnutrition requires to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve practices of care at the elderly, the impact of environmental and social aspects of food in nursing homes has been assessed. The social environment and interactions during the meals are now identified as effective ways to stimulate food intake and increase feelings of well-being in the elderly.

The objectives of the study are to characterize the appreciation of food and social interactions during the meals and to study the relationships between the quality of food practices and nutritional status of the residents in nursing homes to improve their quality of life.

location_facility:
La Vérandine
Les Acanthes
Les Cristallines
Les Althéas
Les Volubilis
Les Alizés
Les Amandines
Castellane


acronym: ConstiCAPE

summary: The investigators' study aims to compare the results of percutaneous endoscopic caecostomie (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to medical treatment. The primary endpoint will be the quality of life assessed by the Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible complications. The patients included must meet the classification criteria of Rome III, have an elongated colonic transit time, have had a complete colonoscopy and be refractory to medical treatment including at least one stimulant laxative or suppositories or enemas retrograde.

location_facility:
CHD Vannes
CHU de Nantes
CHU Clermont Ferrand
CHU de Bordeaux
CMRRF de Kerpape
CHD Vendée
CHU de Rennes
CHU de Rouen


title: Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism. The DEBRIEF-VTE Study

acronym: DEBRIEF-VTE

summary:
Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated.

In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.

lead_sponsor: University Hospital, Brest

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: CHU de Grenoble - Hôpital Nord Michallon


title: Concordance and Accuracy of Magnetic Resonance Imaging in the Detection of Meningiomas: Optimizing Sequences With Low Doses of Gadolinium

acronym: CAMOMILLE

summary:
Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series.

The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis.

Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects.

New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent.

These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population.

Patients presenting for brain MRI screening or meningioma follow-up will have the usual MRI sequences for their management, and the sequences performed at 1/6th of the standard dose of Gadolinium that are added for research. These new sequences will add approximately 6 minutes of additional examination time.

ipd_sharing: Undecided

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild