title: Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study

acronym: THERMA-SAS

summary: The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

status: Withdrawn

ReferenceCitation: Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG. Review.

ReferenceCitation: Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8.

ReferenceCitation: Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.

ReferenceCitation: Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.

ReferenceCitation: Terán-Santos J, Jiménez-Gómez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51.

ReferenceCitation: Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41.

ReferenceCitation: Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503.

ReferenceCitation: Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. Review. Erratum in: Physiol Rev.2010 Apr;90(2):797-8.

ReferenceCitation: Lévy P, Pépin JL, Dematteis M. Pharyngeal neuropathy in obstructive sleep apnea: where are we going? Am J Respir Crit Care Med. 2012 Feb 1;185(3):241-3. doi: 10.1164/rccm.201111-1992ED.

ReferenceCitation: Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8.

ReferenceCitation: Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. J Card Fail. 2009 May;15(4):279-85. doi: 10.1016/j.cardfail.2008.11.015. Epub 2009 Jan 21.

ReferenceCitation: de Oliveira Rodrigues CJ, Marson O, Tufic S, Kohlmann O Jr, Guimarães SM, Togeiro P, Ribeiro AB, Tavares A. Relationship among end-stage renal disease, hypertension, and sleep apnea in nondiabetic dialysis patients. Am J Hypertens. 2005 Feb;18(2 Pt 1):152-7.

ReferenceCitation: Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7.

ReferenceCitation: Yumino D, Redolfi S, Ruttanaumpawan P, Su MC, Smith S, Newton GE, Mak S, Bradley TD. Nocturnal rostral fluid shift: a unifying concept for the pathogenesis of obstructive and central sleep apnea in men with heart failure. Circulation. 2010 Apr 13;121(14):1598-605. doi: 10.1161/CIRCULATIONAHA.109.902452. Epub 2010 Mar 29.

ReferenceCitation: Friedman O, Bradley TD, Chan CT, Parkes R, Logan AG. Relationship between overnight rostral fluid shift and obstructive sleep apnea in drug-resistant hypertension. Hypertension. 2010 Dec;56(6):1077-82. doi: 10.1161/HYPERTENSIONAHA.110.154427. Epub 2010 Nov 8.

ReferenceCitation: Elias RM, Bradley TD, Kasai T, Motwani SS, Chan CT. Rostral overnight fluid shift in end-stage renal disease: relationship with obstructive sleep apnea. Nephrol Dial Transplant. 2012 Apr;27(4):1569-73. doi: 10.1093/ndt/gfr605. Epub 2011 Nov 5.

ReferenceCitation: Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

ReferenceCitation: Rapoport DM, Garay SM, Epstein H, Goldring RM. Hypercapnia in the obstructive sleep apnea syndrome. A reevaluation of the "Pickwickian syndrome". Chest. 1986 May;89(5):627-35.

ReferenceCitation: Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981 Apr 18;1(8225):862-5.

ReferenceCitation: Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001106. Review.

ReferenceCitation: Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64.

ReferenceCitation: Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbé F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.

family: Marin

full_name: José M. Marin

given: José M.

family: Agusti

full_name: Alvar Agusti

given: Alvar

family: Villar

full_name: Isabel Villar

given: Isabel

family: Forner

full_name: Marta Forner

given: Marta

family: Nieto

full_name: David Nieto

given: David

family: Carrizo

full_name: Santiago J. Carrizo

given: Santiago J.

family: Barbé

full_name: Ferran Barbé

given: Ferran

family: Vicente

full_name: Eugenio Vicente

given: Eugenio

family: Wei

full_name: Ying Wei

given: Ying

full_name: F. Javier Nieto

given: F. Javier

family: Jelic

full_name: Sanja Jelic

given: Sanja

journal_name: JAMA

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

title: Association Between Treated and Untreated Obstructive Sleep Apnea and Risk of Hypertension

ReferenceCitation: Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. CPAP for the metabolic syndrome in patients with obstructive sleep apnea. N Engl J Med. 2011 Dec 15;365(24):2277-86. doi: 10.1056/NEJMoa1103944. Retraction in: Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. N Engl J Med. 2013 Oct 31;369(18):1770.

ReferenceCitation: Papandreou C, Schiza SE, Bouloukaki I, Hatzis CM, Kafatos AG, Siafakas NM, Tzanakis NE. Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomised trial. Eur Respir J. 2012 Jun;39(6):1398-404. doi: 10.1183/09031936.00103411. Epub 2011 Oct 27.

ReferenceCitation: Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.

ReferenceCitation: Mirrakhimov AE. Physical exercise related improvement in obstructive sleep apnea. Look for the rostral fluid shift. Med Hypotheses. 2013 Feb;80(2):125-8. doi: 10.1016/j.mehy.2012.11.007. Epub 2012 Dec 3.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.

ReferenceCitation: Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

title: Upper-Airway Stimulation for Obstructive Sleep Apnea

ReferenceCitation: Chan AS, Sutherland K, Schwab RJ, Zeng B, Petocz P, Lee RW, Darendeliler MA, Cistulli PA. The effect of mandibular advancement on upper airway structure in obstructive sleep apnoea. Thorax. 2010 Aug;65(8):726-32. doi: 10.1136/thx.2009.131094.

ReferenceCitation: Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. Review.

ReferenceCitation: Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost. 2009 May;7(5):879-83. doi: 10.1111/j.1538-7836.2009.03294.x. Epub 2009 Jan 19.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
University Hospital Grenoble
Medical practice (angiology)
Clinic Beau Soleil
Medical pratice (angiology)


title: Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

acronym: DESTIN

summary: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panés J, Schölmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lémann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

family: Cosnes

full_name: Jacques Cosnes

given: Jacques

sequence: first

family: Bourrier

full_name: Anne Bourrier

given: Anne

sequence: additional

family: Laharie

full_name: David Laharie

family: Nahon

full_name: Stéphane Nahon

given: Stéphane

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Dupas

full_name: Jean–Louis Dupas

given: Jean–Louis

family: Reimund

full_name: Jean–Marie Reimund

given: Jean–Marie

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Jouet

full_name: Pauline Jouet

given: Pauline

family: Moreau

full_name: Jacques Moreau

family: Mary

full_name: Jean–Yves Mary

given: Jean–Yves

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: A Randomized Controlled Trial

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
CHU Bordeaux - Pessac
CHRU Lille
Hopital Saint Louis
Hopital Saint-Antoine
Hopital Beaujon
IMM
CHU NICE
Chu Toulouse
Chu Clermont-Ferrand

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms

summary:
This study aims to evaluate the impact of financial support on improving the management of prenatal care in pregnant women with low incomes. The judgment criterion is clinically pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this approach through a qualitative survey.

It is planned to include 4000 women distributed into two arms of 2000 each. One group will receive financial support (prepaid payment card credited for each consultation attended according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the other group will not. The management of the pregnancy for both groups will not be modified.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Bardou M, Crépon B, Bertaux AC, Godard-Marceaux A, Eckman-Lacroix A, Thellier E, Falchier F, Deruelle P, Doret M, Carcopino-Tusoli X, Schmitz T, Barjat T, Morin M, Perrotin F, Hatem G, Deneux-Tharaux C, Fournel I, Laforet L, Meunier-Beillard N, Duflo E, Le Ray I; NAITRE Study Group. NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France. BMJ Open. 2017 Oct 30;7(10):e017321. doi: 10.1136/bmjopen-2017-017321.

family: Bardou

full_name: Marc Bardou

given: Marc

family: Crépon

full_name: Bruno Crépon

given: Bruno

family: Bertaux

full_name: Anne-Claire Bertaux

given: Anne-Claire

family: Godard-Marceaux

full_name: Aurélie Godard-Marceaux

given: Aurélie

family: Eckman-Lacroix

full_name: Astrid Eckman-Lacroix

given: Astrid

family: Thellier

full_name: Elise Thellier

given: Elise

family: Falchier

full_name: Frédérique Falchier

given: Frédérique

family: Deruelle

full_name: Philippe Deruelle

given: Philippe

family: Doret

full_name: Muriel Doret

given: Muriel

family: Carcopino-Tusoli

full_name: Xavier Carcopino-Tusoli

given: Xavier

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

family: Barjat

full_name: Thiphaine Barjat

given: Thiphaine

family: Morin

full_name: Mathieu Morin

given: Mathieu

family: Perrotin

full_name: Franck Perrotin

family: Hatem

full_name: Ghada Hatem

given: Ghada

family: Deneux-Tharaux

full_name: Catherine Deneux-Tharaux

given: Catherine

family: Fournel

full_name: Isabelle Fournel

given: Isabelle

family: Laforet

full_name: Laurent Laforet

given: Laurent

family: Meunier-Beillard

full_name: Nicolas Meunier-Beillard

given: Nicolas

family: Duflo

full_name: Esther Duflo

given: Esther

family: Le Ray

full_name: Isabelle Le Ray

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: Massachusetts Institute of Technology - DSpace@MIT

location_facility:
APHP maternité Kremlin Bicêtre
CHRU de LILLE
APHM Hôpital Nord
APHP Hopital Robert Debré
Chu Tours
CHRU de BESANCON
Chu Saint Etienne
CHU de DIJON
CHRU de BREST


type: Other Identifier

title: Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)

acronym: SENTINEL

summary: This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.

primary_purpose: Diagnostic

lead_sponsor: Weprom

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

location_facility: Institut de Cancerologie de l'Ouest - site Paul Papin

intervention_type: Other


title: Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children

acronym: EVEACE

summary:
Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.

Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.

The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospiatlier Départemental de Vendée

lead_sponsor_type: academique


title: A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

acronym: EVERCMV

summary: Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Edouard Herriot
APHP - Kremlin Bicetre
CHU de Bordeaux
APHP - Hôpital Necker
CHU La Cavale Blanche
CHRU Caen - Hôpital de Caen
CHRU Strasbourg
CHU de Toulouse - Hôpital Rangueil
CHU de Limoges - Hôpital Dupuytren

intervention_type: Drug


title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

acronym: PREDICORT

summary: The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Limoges

status_simplified: Unknown


title: A Multicentre, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis and Early Stage Acute Liver Failure

summary:
Acute liver failure is a rare but dramatic disease, often affecting young people, marked by the sudden loss of liver function in a person without preexisting liver disease.

ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this dramatic disease with high unmet medical need, a future therapy for the treatment of patients suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due to acetaminophen overdose, where liver transplantation is the sole treatment in the absence of spontaneous recovery.

The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.

A minimum of 60 patients will be recruited into the study in the following two treatment groups:

Group A: approximately 30 patients will receive ALF-5755
Group B: approximately 30 patients will receive placebo (physiological saline solution: 0.9% NaCl)

Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow intravenous infusions over 10 minutes using automatic syringes.

ReferenceCitation: Christa L, Felin M, Morali O, Simon MT, Lasserre C, Brechot C, Sève AP. The human HIP gene, overexpressed in primary liver cancer encodes for a C-type carbohydrate binding protein with lactose binding activity. FEBS Lett. 1994 Jan 3;337(1):114-8.

ReferenceCitation: Hoofnagle JH, Carithers RL Jr, Shapiro C, Ascher N. Fulminant hepatic failure: summary of a workshop. Hepatology. 1995 Jan;21(1):240-52. Review.

ReferenceCitation: Iovanna JL, Dagorn JC. The multifunctional family of secreted proteins containing a C-type lectin-like domain linked to a short N-terminal peptide. Biochim Biophys Acta. 2005 May 25;1723(1-3):8-18. Epub 2005 Jan 21. Review.

ReferenceCitation: Kondo T, Suda T, Fukuyama H, Adachi M, Nagata S. Essential roles of the Fas ligand in the development of hepatitis. Nat Med. 1997 Apr;3(4):409-13.

ReferenceCitation: Lasserre C, Christa L, Simon MT, Vernier P, Bréchot C. A novel gene (HIP) activated in human primary liver cancer. Cancer Res. 1992 Sep 15;52(18):5089-95.

ReferenceCitation: Lieu HT, Batteux F, Simon MT, Cortes A, Nicco C, Zavala F, Pauloin A, Tralhao JG, Soubrane O, Weill B, Bréchot C, Christa L. HIP/PAP accelerates liver regeneration and protects against acetaminophen injury in mice. Hepatology. 2005 Sep;42(3):618-26.

ReferenceCitation: Lieu HT, Simon MT, Nguyen-Khoa T, Kebede M, Cortes A, Tebar L, Smith AJ, Bayne R, Hunt SP, Bréchot C, Christa L. Reg2 inactivation increases sensitivity to Fas hepatotoxicity and delays liver regeneration post-hepatectomy in mice. Hepatology. 2006 Dec;44(6):1452-64.

ReferenceCitation: Polson J, Lee WM; American Association for the Study of Liver Disease. AASLD position paper: the management of acute liver failure. Hepatology. 2005 May;41(5):1179-97.

ReferenceCitation: Simon MT, Pauloin A, Normand G, Lieu HT, Mouly H, Pivert G, Carnot F, Tralhao JG, Brechot C, Christa L. HIP/PAP stimulates liver regeneration after partial hepatectomy and combines mitogenic and anti-apoptotic functions through the PKA signaling pathway. FASEB J. 2003 Aug;17(11):1441-50.

ReferenceCitation: Nalpas B, Ichaï P, Jamot L, Carbonell N, Rudler M, Mathurin P, Durand F, Gerken G, Manns M, Trautwein C, Larrey D, Radenne S, Duvoux C, Leroy V, Bernuau J, Faivre J, Moniaux N, Bréchot C, Amouyal G, Amouyal P, Samuel D. A Proof of Concept, Phase II Randomized European Trial, on the Efficacy of ALF-5755, a Novel Extracellular Matrix-Targeted Antioxidant in Patients with Acute Liver Diseases. PLoS One. 2016 Mar 16;11(3):e0150733. doi: 10.1371/journal.pone.0150733. eCollection 2016.

family: Nalpas

full_name: Bertrand Nalpas

given: Bertrand

family: Ichaï

full_name: Philippe Ichaï

family: Jamot

full_name: Laure Jamot

given: Laure

family: Carbonell

full_name: Nicolas Carbonell

family: Rudler

full_name: Marika Rudler

given: Marika

family: Mathurin

full_name: Philippe Mathurin

family: Durand

full_name: François Durand

given: François

family: Gerken

full_name: Guido Gerken

given: Guido

family: Manns

full_name: Michael Manns

given: Michael

family: Trautwein

full_name: Christian Trautwein

given: Christian

family: Larrey

full_name: Dominique Larrey

given: Dominique

family: Radenne

full_name: Sylvie Radenne

given: Sylvie

family: Duvoux

full_name: Christophe Duvoux

given: Christophe

family: Leroy

full_name: Vincent Leroy

given: Vincent

family: Bernuau

full_name: Jacques Bernuau

given: Jacques

family: Faivre

full_name: Jamila Faivre

given: Jamila

family: Moniaux

full_name: Nicolas Moniaux

family: Bréchot

full_name: Christian Bréchot

family: Amouyal

full_name: Gilles Amouyal

given: Gilles

full_name: Paul Amouyal

given: Paul

family: Samuel

full_name: Didier Samuel

given: Didier

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

location_facility:
Hôpital La Pitié Salpétrière
Hôpital Saint-Eloi
Hôpital Saint Antoine
Hôpital Claude Huriez
Hôpital Conception
CHU Clermont-Ferrand
Hôpital Croix-Rousse
CHU de Grenoble
Hôpital de l'Archet 2
Centre Hépatobiliaire Paul Brousse
CHU de Besançon
Hôpital Beaujon


title: Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus

acronym: NNNB

summary:
Background and Rationale

Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.

Hypothesis

Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.

lead_sponsor: Association Pour la Recherche en Infectiologie

location_facility:
Edourad Herriot hospital
Hopital l'Archet 1
Pitie Salpetriere Hospital
Nord Hospital
Hotel Dieu hospital
Cannes hosipital
St Louis Hospital
Frejus hospital
Ste MArguerite Hospital
Croix Rousse hospital
Conception hospital
CHU


title: An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

summary:
Primary objectives:

To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

Secondary objectives:

•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

•Secondary safety objective: To describe the safety profile after vaccination in each group

primary_purpose: Prevention

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Germany France

intervention_type: Biological


title: A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy

summary: This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche


title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

summary: This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

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

location_facility:
Centre Oscar Lambret
Institut Sainte catherine
Hopital Saint Andre
Hotel Dieu
Centre Rene Gauducheau
Centre Paul Strauss
Institut Paoli Calmettes
Hopital Saint Eloi
CRLC Val d'Aurelle
Institut Gustave Roussy
Hopital Michallon
CAC Léon Bérard

intervention_type: Radiation


title: Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study

acronym: TVA

summary: The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".

ReferenceCitation: Nabholtz JM, Abrial C, Mouret-Reynier MA, Dauplat MM, Weber B, Gligorov J, Forest AM, Tredan O, Vanlemmens L, Petit T, Guiu S, Van Praagh I, Jouannaud C, Dubray-Longeras P, Tubiana-Mathieu N, Benmammar KE, Kullab S, Bahadoor MR, Radosevic-Robin N, Kwiatkowski F, Desrichard A, Cayre A, Uhrhammer N, Chalabi N, Chollet P, Penault-Llorca F. Multicentric neoadjuvant phase II study of panitumumab combined with an anthracycline/taxane-based chemotherapy in operable triple-negative breast cancer: identification of biologically defined signatures predicting treatment impact. Ann Oncol. 2014 Aug;25(8):1570-7. doi: 10.1093/annonc/mdu183. Epub 2014 May 14.

family: Nabholtz

full_name: J.M. Nabholtz

family: Abrial

full_name: C. Abrial

given: C.

family: Mouret-Reynier

full_name: M.A. Mouret-Reynier

family: Dauplat

full_name: M.M. Dauplat

family: Weber

full_name: B. Weber

given: B.

family: Gligorov

full_name: J. Gligorov

given: J.

family: Forest

full_name: A.M. Forest

family: Tredan

full_name: O. Tredan

given: O.

family: Vanlemmens

full_name: L. Vanlemmens

given: L.

family: Petit

full_name: T. Petit

given: T.

family: Guiu

full_name: S. Guiu

given: S.

family: Van Praagh

full_name: I. Van Praagh

given: I.

family: Jouannaud

full_name: C. Jouannaud

family: Dubray-Longeras

full_name: P. Dubray-Longeras

given: P.

family: Tubiana-Mathieu

full_name: N. Tubiana-Mathieu

given: N.

family: Benmammar

full_name: K.E. Benmammar

family: Kullab

full_name: S. Kullab

family: Bahadoor

full_name: M.R.K. Bahadoor

family: Radosevic-Robin

full_name: N. Radosevic-Robin

family: Kwiatkowski

full_name: F. Kwiatkowski

given: F.

family: Desrichard

full_name: A. Desrichard

given: A.

family: Cayre

full_name: A. Cayre

family: Uhrhammer

full_name: N. Uhrhammer

family: Chalabi

full_name: N. Chalabi

family: Chollet

full_name: P. Chollet

location_facility:
Centre Léon Bérard
Centre Alexis Vautrin
Centre Oscar Lambret
Hôpital Tenon
Centre Hospitalier
CHU Dupuytren
Centre Jean Perrin
Pole Santé République
Centre Georges François Leclerc
Institut Jean Godinot
Centre Paul Strauss
Institut de Cancérologie de la Loire


title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

summary: The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.

lead_sponsor: Sodilac

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)


title: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

acronym: SENAT

summary:
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.

The objectives of this study are:

Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
to evaluate adverse events.
Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.

ReferenceCitation: Leung CH, Poon WS, Yu LM; International Subarachnoid Aneurysm Trial. The ISAT trial. Lancet. 2003 Feb 1;361(9355):430-1; author reply 432.

ReferenceCitation: Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol. 2005 May;26(5):1223-31.

ReferenceCitation: Alfke K, Straube T, Dörner L, Mehdorn HM, Jansen O. Treatment of intracranial broad-neck aneurysms with a new self-expanding stent and coil embolization. AJNR Am J Neuroradiol. 2004 Apr;25(4):584-91.

ReferenceCitation: Baráth K, Cassot F, Rüfenacht DA, Fasel JH. Anatomically shaped internal carotid artery aneurysm in vitro model for flow analysis to evaluate stent effect. AJNR Am J Neuroradiol. 2004 Nov-Dec;25(10):1750-9.

ReferenceCitation: Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery. 2004 Jun;54(6):1359-67; discussion 1368.

ReferenceCitation: Byrne JV, Bashiri M, Pasco A, Morris JH. A novel flexible endovascular stent for use in small and tortuous vessels. Neuroradiology. 2000 Jan;42(1):56-61.

ReferenceCitation: Cantón G, Levy DI, Lasheras JC, Nelson PK. Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms. J Neurosurg. 2005 Nov;103(5):891-902.

ReferenceCitation: dos Santos Souza MP, Agid R, Willinsky RA, Cusimano M, Montanera W, Wallace MC, terBrugge KG, Marotta TR. Microstent-assisted coiling for wide-necked intracranial aneurysms. Can J Neurol Sci. 2005 Feb;32(1):71-81.

ReferenceCitation: Fiorella D, Albuquerque FC, Han P, McDougall CG. Preliminary experience using the Neuroform stent for the treatment of cerebral aneurysms. Neurosurgery. 2004 Jan;54(1):6-16; discussion 16-7.

ReferenceCitation: Howington JU, Hanel RA, Harrigan MR, Levy EI, Guterman LR, Hopkins LN. The Neuroform stent, the first microcatheter-delivered stent for use in the intracranial circulation. Neurosurgery. 2004 Jan;54(1):2-5.

ReferenceCitation: Lylyk P, Ferrario A, Pasbón B, Miranda C, Doroszuk G. Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. J Neurosurg. 2005 Feb;102(2):235-41.

ReferenceCitation: Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Viñuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66.

ReferenceCitation: Wakhloo AK, Lanzino G, Lieber BB, Hopkins LN. Stents for intracranial aneurysms: the beginning of a new endovascular era? Neurosurgery. 1998 Aug;43(2):377-9.

lead_sponsor: Stryker Neurovascular

location_facility:
CHU Hôpital de la Côte de Nacre
Groupe Hospitalier Pitié-Salpétrière
CHU Limoges
Hôpital Saint-Roch
Hôpital Gui de Chauliac
Fondation Rotschild
Hôpital Lariboisière
Centre Hospitalier pellegrin
CHU Nancy
CHRU Salengro
CHU Hôpital Guillaume et René Laënnec
Hôpital Neurologique

intervention_type: Device


title: Efficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib: A Phase 2 Study

acronym: CYCLIGIST

summary:
The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with both imatinib and sunitinib, treatment remains controversial.

Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al. 2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A, CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to the overexpression of CINSARC genes, which in turn induce chromosome instability and ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009). Considering our molecular data, we believed that PD-0332991 warrants clinical investigation in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is detectable by comparative genomic hybridization which is a technique highly manageable in the context of routine clinical care and clinical trial.

Main objective was to assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after centralized review) in patients with documented disease progression while on therapy with imatinib and sunitinib for unresectable and/or metastatic GIST.

ReferenceType: result

ReferenceCitation: Toulmonde M, Blay JY, Bouche O, Mir O, Penel N, Isambert N, Duffaud F, Bompas E, Esnaud T, Boidot R, Geneste D, Ghiringhelli F, Lucchesi C, Bellera CA, Le Loarer F, Italiano A. Activity and Safety of Palbociclib in Patients with Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib: A Biomarker-driven Phase II Study. Clin Cancer Res. 2019 Aug 1;25(15):4611-4615. doi: 10.1158/1078-0432.CCR-18-3127. Epub 2019 Apr 12. Erratum in: Clin Cancer Res. 2019 Aug 1;25(15):4859.

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Bouche

full_name: Olivier Bouche

given: Olivier

family: Mir

full_name: Olivier Mir

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Isambert

full_name: Nicolas Isambert

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Esnaud

full_name: Thomas Esnaud

given: Thomas

family: Boidot

full_name: Romain Boidot

given: Romain

family: Geneste

full_name: Damien Geneste

given: Damien

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Lucchesi

full_name: Carlo Lucchesi

given: Carlo

family: Bellera

full_name: Carine A. Bellera

given: Carine A.

family: Le Loarer

full_name: François Le Loarer

family: Italiano

full_name: Antoine Italiano

given: Antoine

journal_name: Clinical Cancer Research

oa_host_type: publisher

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Association for Cancer Research (AACR)

ipd_sharing: No

lead_sponsor: Institut Bergonié

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
CHU de REIMS - Hôpital Robert Debré
Hôpital de la Timone - AP-HM
Hôpital Saint-Antoine (AP-HP)
Centre René Gauducheau
Institut Bergonié
Centre Georges-Francois Leclerc
Institut Gustave Roussy


title: Multicentre, Open Study for the Setting up of Population Pharmacokinetic Models and Bayesian Estimators for Individual Dose Adjustment of Immunosuppressive Drugs (Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Everolimus) During the First Year Post-grafting in Adult Heart Transplant Recipients.

acronym: PIGREC

summary:
The main objective is to develop pharmacokinetic methods for individual dose adjustment of the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and everolimus, taking into account the pharmacokinetic interactions), in order to optimise the efficiency and reduce the potentially severe sides effects of these drugs.

Forty five heart-transplant patients are to be included in this phase IV study to obtain a minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.

Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient and the immunosuppressive drug concentrations will be measured by LC-MS/MS.

The pharmacokinetic models and Bayesian estimators thus developed will provide tools for individual dose adjustment of immunosuppressive drugs simultaneously, at different post-transplant periods, using the area under the concentration-time curve (AUC) estimated using a limited number of time-points (2 or 3).

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de NANCY
CHU de Nantes
CHU de Strasbourg
CHU de Limoges
CHU de Bordeaux
CHU de Lille
CHU de Clermont-Ferrand
CHU de Rouen
Hôpital Pitié-Salpêtrière
Hôpital Européen Georges Pompidou
Hôpital Louis Pradel - CHU de Lyon
CHU de Rennes


title: Multicentric Evaluation of IMACTIS-CT Navigation System

summary: Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level.

ReferenceCitation: Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.

family: Rouchy

full_name: RC. Rouchy

given: RC.

family: Moreau-Gaudry

full_name: A. Moreau-Gaudry

family: Chipon

full_name: E. Chipon

given: E.

family: Aubry

full_name: S. Aubry

given: S.

family: Pazart

full_name: L. Pazart

given: L.

family: Lapuyade

full_name: B. Lapuyade

given: B.

family: Durand

full_name: M. Durand

given: M.

family: Hajjam

full_name: M. Hajjam

family: Pottier

full_name: S. Pottier

family: Renard

full_name: B. Renard

family: Logier

full_name: R. Logier

given: R.

family: Orry

full_name: X. Orry

given: X.

family: Cherifi

full_name: A. Cherifi

family: Quehen

full_name: E. Quehen

family: Kervio

full_name: G. Kervio

given: G.

family: Favelle

full_name: O. Favelle

given: O.

family: Patat

full_name: F. Patat

family: De Kerviler

full_name: E. De Kerviler

family: Hughes

full_name: C. Hughes

given: C.

family: Medici

full_name: M. Medici

family: Ghelfi

full_name: J. Ghelfi

given: J.

family: Mounier

full_name: A. Mounier

family: Bricault

full_name: I. Bricault

given: I.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

location_facility:
University Hospital
University Hospital of Saint-Louis
Ambroise Paré University Hospital


title: Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study

summary:
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.

Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.

Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.

The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.

ReferenceCitation: Pernot S, Pellerin O, Artru P, Montérymard C, Smith D, Raoul JL, De La Fouchardière C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8.

family: Pernot

full_name: Simon Pernot

given: Simon

family: Pellerin

full_name: Olivier Pellerin

given: Olivier

family: Artru

full_name: Pascal Artru

given: Pascal

family: Montérymard

full_name: Carole Montérymard

given: Carole

family: Smith

full_name: Denis Smith

given: Denis

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: De La Fouchardière

full_name: Christelle De La Fouchardière

given: Christelle

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Sefrioui

full_name: David Sefrioui

given: David

family: Jouve

full_name: Jean-Louis Jouve

given: Jean-Louis

family: Lepage

full_name: Côme Lepage

given: Côme

family: Tougeron

full_name: David Tougeron

family: Taieb

full_name: Julien Taieb

given: Julien

journal_name: British Journal of Cancer

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Centre Léon Berard
Hôpital Europeen G Pompidou
Hôpital Prive Jean Mermoz
Hôpital Rangueil
CHU Charles Nicolle
Institut Paoli Calmette
CHU - Hôpital François Mitterand
Hopital Saint André
CHU de la TIMONE


title: Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer

acronym: VESTOR

summary: In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.

ReferenceCitation: Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houédé N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5.

family: Pulido

full_name: Marina Pulido

given: Marina

family: Roubaud

full_name: Guilhem Roubaud

given: Guilhem

family: Cazeau

full_name: Anne-Laure Cazeau

given: Anne-Laure

family: Mahammedi

full_name: Hakim Mahammedi

given: Hakim

family: Vedrine

full_name: Lionel Vedrine

given: Lionel

family: Joly

full_name: Florence Joly

given: Florence

family: Mourey

full_name: Loic Mourey

given: Loic

family: Pfister

full_name: Christian Pfister

given: Christian

family: Goberna

full_name: Alejandro Goberna

given: Alejandro

family: Lortal

full_name: Barbara Lortal

given: Barbara

family: Bellera

full_name: Carine Bellera

given: Carine

family: Pourquier

full_name: Philippe Pourquier

given: Philippe

family: Houédé

full_name: Nadine Houédé

given: Nadine

journal_name: BMC Cancer

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repository_normalized: HAL

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

location_facility: Hôpital d'instruction des armées du Val-de-Grâce


title: Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

acronym: STICREVOLENS

summary:
BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.

ReferenceCitation: Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French.

ReferenceCitation: Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.

family: Perotin

full_name: Jeanne Marie Perotin

given: Jeanne Marie

family: Leroy

full_name: Sylvie Leroy

given: Sylvie

family: Marquette

full_name: Charles Hugo Marquette

given: Charles Hugo

family: Mal

full_name: Hervé Mal

given: Hervé

family: Dutau

full_name: Hervé Dutau

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Vergnon

full_name: Jean Michel Vergnon

given: Jean Michel

family: Pison

full_name: Christophe Pison

given: Christophe

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Deslee

full_name: Gaëtan Deslee

given: Gaëtan

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

license: cc-by-nc

license_normalized: cc-by-nc

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

evidence: oa repository (semantic scholar lookup)

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

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaün M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x.

family: Bulsei

full_name: Julie Bulsei

given: Julie

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

ReferenceCitation: Deslée G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaün M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6). pii: 1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

ReferenceCitation: Deslée G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.

name: Service de Pneumologie, INSERM U903, Hôpital Universitaire de Reims, Reims, France

name: Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France

name: Service d’Oncologie Thoracique, Maladies de la Plèvre, Pneumologie Interventionnelle, Hôpital Universitaire de Marseille, Marseille, France

name: Département de Pneumologie et Addictologie, PhyMedExp, Inserm U1046, CNRS UMR, Hôpital Universitaire de Montpellier, Montpellier, France

name: Service de Pneumologie, Hôpital Universitaire de Saint-Étienne, Saint-Étienne, France

name: Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Inserm 1055, Hôpital Universitaire de Grenoble Alpes, Grenoble, France

name: Service de Pneumologie, Hôpital Universitaire de Strasbourg, Strasbourg, France

name: Service de Pneumologie, Hôpital Universitaire d’Amiens, Amiens, France

name: Service de Pneumologie, Hôpital Universitaire de Rouen, Rouen, France

name: Service de Pneumologie, IRCAN, UMR CNRS 7284/Inserm U1081, Team 3, Hôpital Universitaire de Nice Sophia Antipolis, Nice, France

name: Département de Pharmacovigilance, Hôpital Universitaire de Reims, Reims, France

name: Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire de Reims, Reims, France

name: URC Eco IdF, Unité de Recherche Clinique en Économie de la Santé d’Ile de France, AP-HP Paris, Paris, France

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

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

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

location_facility:
AP-HM
CHU de Saint-Etienne
Hôpitaux Universitaires de Strasbourg
CHU d'Amiens
CHU de Nice
CHU de Montpellier
CHU de Grenoble
CHU de Rouen
AP-HP - Hôpital Bichat


type: EudraCT Number

title: Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled

acronym: DBMZol

summary:
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.

Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.

No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.

status: Terminated

location_facility:
Centre de l'Arche
Hôpital Rangueil CHU
CHU
Institut Régional de Réadaptation Nancy
Centre Bouffard - Vercelli CAP Cerbère
Centre Mutualiste Neurologique Propara
CRMPR Les Herbiers
Hôpital R. Poincaré
University hospital of Nantes


title: A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,

acronym: ASSESS

summary: This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

lead_sponsor: AstraZeneca

location_country:
Italy
Sweden
Netherlands
France
Japan
Spain
Germany
United Kingdom


type: Other Grant/Funding Number

title: Evaluation of the Efficiency and Indications of IMSI in Comparison With ICSI in Case of Male Infertility

acronym: PHRC-IMSI

summary: Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in ICSI. The purpose of this study is to evaluate the efficiency and the indications of IMSI through a multicentric randomised trial.

lead_sponsor: University Hospital, Toulouse

location_facility: Laboratoire de Biologie de la Reproduction, Hôpital Jeanne de Flandre

location_facility: Service de génétique et Biologie de la Reproduction CECOS, Hôpital Maison Blanche

location_facility: Laboratoire de Biologie de la Reproduction CECOS


title: Evaluation du Stent Multicouches Dans le Traitement Des anévrismes de l'Aorte Thoraco-abdominale

acronym: STRATO

summary:
Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm Repair.

The objectives of the study is to determine the efficacy, safety and performance of the MFM and its delivery system in patients at high surgical risk presenting with a type II, III thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation, according to the Crawford classification.

ReferenceCitation: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial. J Endovasc Ther. 2014 Feb;21(1):85-95. doi: 10.1583/13-4553R.1.

family: Vaislic

full_name: Claude D. Vaislic

given: Claude D.

family: Fabiani

full_name: Jean Noël Fabiani

given: Jean Noël

family: Chocron

full_name: Sidney Chocron

given: Sidney

family: Robin

full_name: Jacques Robin

given: Jacques

family: Costache

full_name: Victor S. Costache

given: Victor S.

family: Villemot

full_name: Jean-Pierre Villemot

given: Jean-Pierre

family: Alsac

full_name: Jean Marc Alsac

given: Jean Marc

family: Leprince

full_name: Pascal N. Leprince

given: Pascal N.

family: Unterseeh

full_name: Thierry Unterseeh

given: Thierry

family: Portocarrero

full_name: Eric Portocarrero

given: Eric

family: Glock

full_name: Yves Glock

given: Yves

family: Rousseau

full_name: Hervé Rousseau

name: on behalf of the STRATO Investigators Group

journal_name: Journal of Endovascular Therapy

publisher: International Society of Endovascular Specialists

title: One-Year Outcomes Following Repair of Thoracoabdominal Aneurysms With the Multilayer Flow Modulator: Report From the STRATO Trial

ReferenceCitation: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. Three-Year Outcomes With the Multilayer Flow Modulator for Repair of Thoracoabdominal Aneurysms: A Follow-up Report From the STRATO Trial. J Endovasc Ther. 2016 Oct;23(5):762-72. doi: 10.1177/1526602816653095. Epub 2016 Jun 8.

name: Department of Cardiac, Vascular, and Thoracic Surgery, Centre Hospitalier Privé Parly 2, Le Chesnay, France

name: Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France

name: Department of Thoracic and Cardiovascular Surgery, Hôpital Jean Minjoz, Besançon, France

name: Department of Cardiovascular Surgery, Hôpital Louis Pradel, Lyon-Bron, France

name: Department of Cardiac Surgery, Centre Hospitalier de la Région d’Annecy, Metz-Tessy, France

name: Department of Cardiovascular Surgery and Transplantation, CHU-Nancy, Hôpital d’adultes de Brabois, Nancy, France

name: Department of Thoracic and Cardiovascular Surgery, Hôpital Pitié-Salpétrière, Paris, France

name: Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Hôpital Privé Claude Galien, Quincy-sous-Sénart, France

name: Department of Cardiovascular Surgery, CHU Toulouse, Hôpital Rangueil, Toulouse, France

name: Department of Radiology, CHU Toulouse, Hôpital Rangueil, Toulouse, France

location_facility: Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy

location_facility: Centre Hospitalier de La Région D'Annecy


ReferenceCitation: Samalin E, Fouchardière C, Thézenas S, Boige V, Senellart H, Guimbaud R, Taïeb J, François E, Galais MP, Lièvre A, Seitz JF, Metges JP, Bouché O, Boissière-Michot F, Lopez-Crapez E, Bibeau F, Ho-Pun-Cheung A, Ychou M, Adenis A, Di Fiore F, Mazard T. Sorafenib Plus Irinotecan Combination in Patients With RAS-mutated Metastatic Colorectal Cancer Refractory To Standard Combined Chemotherapies: A Multicenter, Randomized Phase 2 Trial (NEXIRI-2/PRODIGE 27). Clin Colorectal Cancer. 2020 Dec;19(4):301-310.e1. doi: 10.1016/j.clcc.2020.04.008. Epub 2020 May 15.

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle de la

family: Thézenas

full_name: Simon Thézenas

given: Simon

family: Boige

full_name: Valérie Boige

given: Valérie

family: Senellart

full_name: Hélène Senellart

given: Hélène

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Taïeb

full_name: Julien Taïeb

given: Julien

family: François

full_name: Eric François

family: Galais

full_name: Marie-Pierre Galais

given: Marie-Pierre

family: Lièvre

full_name: Astrid Lièvre

given: Astrid

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Metges

full_name: Jean-Philippe Metges

given: Jean-Philippe

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Boissière-Michot

full_name: Florence Boissière-Michot

given: Florence

family: Lopez-Crapez

full_name: Evelyne Lopez-Crapez

given: Evelyne

family: Bibeau

full_name: Frédéric Bibeau

given: Frédéric

family: Ho-Pun-Cheung

full_name: Alexandre Ho-Pun-Cheung

given: Alexandre

family: Ychou

full_name: Marc Ychou

given: Marc

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Di Fiore

full_name: Frédéric Di Fiore

family: Mazard

full_name: Thibault Mazard

given: Thibault

journal_name: Clinical Colorectal Cancer

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

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

title: A Randomized Phase II Trial Assessing Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors After Failure of All Drugs Known to be Effective

summary: The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.


title: Clinical Evaluation on Advanced Resynchronization

summary:
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.

PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.

lead_sponsor: LivaNova

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

location_facility:
CHU Poitiers
Isala Klinieken
CHU Montpellier
CH Albi
Hosp. Clinico
Osp. Univ. Careggi
General Hospital
CH Yves le Foll
Diaconessenhuis
Univ Saarland
Osp. Niguarda
CH Lomme
Vlietland Ziekenhuis
Medisch Centrum Rijnmond-Zuid
InParys Cardiology
Saint Peter's Hospital
UKB Unfallkrankenhaus
University Hospital
CHU Bordeaux
Osp. B. Ramazzini
St.Adolfstift
CHR Cardiologie A
Stiftsklinikum Augustinum
Osp. Civile
Osp. S. Filippo Neri
NC Nantaises
CHU Angers
CH Pau
H. General Universit.
Royal Hospital
Osp. S. Maria Nuova
CHU Rouen
Nothern General
H. Virgen de las Nieves


title: A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Combination With Melphalan and Dexamethasone in Subjects With Newly-diagnosed Light-chain (AL)-Amyloidosis

summary: Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid protein progressively disrupts normal tissue structure and ultimately leads to organ failure, most frequently in the kidneys, heart, liver and peripheral nervous system. A recently completed French prospective randomized trial, in patients presenting with newly AL-amyloidosis, compared two treatment regimens at the time of diagnosis: Melphalan-dexamethasone (conventional oral treatment), versus high dose of Melphalan followed by autologous stem cell transplantation (ASCT) (1). High-dose therapy was not associated with a better outcome. Melphalan-dex given monthly can be considered as the current standard of care, with a median survival of 56 months. The use of a combination of lenalidomide and dexamethasone has already been tested in patients with AL-amyloidosis (2). The initial dose of lenalidomide at 25 mg/day was poorly tolerated. However, a 15 mg/day dose regimen was well tolerated and effective, with an overall hematologic response rate of 67%. Hematologic responses were associated with clinical responses. Dispenzieri et al confirmed that the combination of Lenalidomide + dexamethasone achieved a 75% hematologic response rate, with a 42% organ response, and a median follow-up of 17 months in patients still receiving treatment (2006). These authors also recommended a lower dose of 15mg/day. The rationale for the present investigation is that addition of lenalidomide to the current standard of care (Melphalan-dexamethasone) might improve the hematologic response rate and the organ response rates both associated with a prolonged survival in patients with AL-amyloidosis. As the toxicity of the combination of M-dex + lenalidomide is unknown in patients with AL-amyloidosis, the dose of lenalidomide will start from the lowest one available, i.e., 5 mg/day and increased from 5 to 5 mg up to a maximum dose of 15 mg in combination with M-dex in 3 consecutive cohorts of patients, according to toxicity. When the optimal dose of lenalidomide will be defined, 9 additional patients will be included in the trial at the recommended dose-level to assess the feasibility of the combination M-dex-lenalidomide.

ReferenceCitation: Moreau P, Jaccard A, Benboubker L, Royer B, Leleu X, Bridoux F, Salles G, Leblond V, Roussel M, Alakl M, Hermine O, Planche L, Harousseau JL, Fermand JP. Lenalidomide in combination with melphalan and dexamethasone in patients with newly diagnosed AL amyloidosis: a multicenter phase 1/2 dose-escalation study. Blood. 2010 Dec 2;116(23):4777-82. doi: 10.1182/blood-2010-07-294405. Epub 2010 Aug 19.

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: University Hospital, Centre National de Référence de l'Amylose, Limoges, France;

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Royer

full_name: Bruno Royer

given: Bruno

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Bridoux

full_name: Franck Bridoux

given: Franck

family: Salles

full_name: Gilles Salles

given: Gilles

name: University Hospital, Pitié-Salpétrière, Paris, France;

family: Leblond

full_name: Veronique Leblond

given: Veronique

family: Roussel

full_name: Murielle Roussel

given: Murielle

family: Alakl

full_name: May Alakl

given: May

name: University Hospital, Necker, Paris, France;

family: Hermine

full_name: Olivier Hermine

family: Planche

full_name: Lucie Planche

given: Lucie

name: Centre René Gauducheau, Saint-Herblain, France; and

family: Harousseau

full_name: Jean-Luc Harousseau

given: Jean-Luc

name: University Hospital, Saint-Louis, Paris, France

family: Fermand

full_name: Jean-Paul Fermand

given: Jean-Paul

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_facility:
CHRU d'Amiens
CHU de Nantes
CHRU de Lille
CHU de Limoges
Hôpitaux Civils de Lyon
CHU de Poitiers
CHRU deTours
Hôpital Pitié Salpetrière
Hôpital necker
CHU de Toulouse
Hôpital Saint-Louis
CHU de Rennes


title: Randomized Study With Medico-economic Evaluation Comparing the Use of PTFE Covered Stents vs Naked Stent in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

summary:
Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.

The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.

The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.

Population concerned: Patients with a cirrhotic portal hypertension responsible for:

recurrent variceal bleeding
refractory ascite (or hydrothorax)

ReferenceCitation: Perarnau JM, Noeldge G, Rössle M. [Intrahepatic portacaval anastomosis by the transjugular approach. Use of the Palmaz endoprosthesis]. Presse Med. 1991 Nov 9;20(36):1770-2. French.

ReferenceCitation: Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Péron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75.

ReferenceCitation: Nishimine K, Saxon RR, Kichikawa K, Mendel-Hartvig J, Timmermans HA, Shim HJ, Uchida BT, Barton RE, Keller FS, Rösch J. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology. 1995 Aug;196(2):341-7.

ReferenceCitation: Angermayr B, Cejna M, Koenig F, Karnel F, Hackl F, Gangl A, Peck-Radosavljevic M; Vienna TIPS Study Group. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology. 2003 Oct;38(4):1043-50.

ReferenceCitation: Charon JP, Alaeddin FH, Pimpalwar SA, Fay DM, Olliff SP, Jackson RW, Edwards RD, Robertson IR, Rose JD, Moss JG. Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol. 2004 Nov;15(11):1219-30.

ReferenceCitation: Barrio J, Ripoll C, Bañares R, Echenagusia A, Catalina MV, Camúñez F, Simó G, Santos L. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol. 2005 Jul;55(1):120-4.

ReferenceCitation: Vignali C, Bargellini I, Grosso M, Passalacqua G, Maglione F, Pedrazzini F, Filauri P, Niola R, Cioni R, Petruzzi P. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol. 2005 Aug;185(2):472-80.

ReferenceCitation: Rössle M, Siegerstetter V, Euringer W, Olschewski M, Kromeier J, Kurz K, Langer M. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol. 2006 Sep;47(7):660-6.

ReferenceCitation: Gandini R, Konda D, Simonetti G. Transjugular intrahepatic portosystemic shunt patency and clinical outcome in patients with Budd-Chiari syndrome: covered versus uncovered stents. Radiology. 2006 Oct;241(1):298-305. Epub 2006 Aug 14.

ReferenceCitation: Tripathi D, Redhead D. Transjugular intrahepatic portosystemic stent-shunt: technical factors and new developments. Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1127-33. Review.

ReferenceCitation: Riggio O, Angeloni S, Nicolao F, Ridola L, Salvatori FM et al. Hepatic Encephalopathy is more frequent and severe after Transjugular intrahepatic portosystemeic Shunt (TIPS) with PTFE-coveted stent-grafts. Hepatology 2006;44, suppl 1, 232

lead_sponsor: University Hospital, Tours

location_facility: CHRU NANTES / Hôpital Guillaume et René Laënnec


lead_sponsor: Pierre Fabre Dermatology

location_country: Spain France Poland

location_facility: CHU Lyon Est Hôpital mère enfant - Consultation des angiomes

location_facility: CHU Necker enfants malades - Service de dermatologie

location_facility: Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique

location_facility: Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique

location_facility: CHU Saint-Etienne Hôpital Nord - Service de dermatologie

location_facility: Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed

location_facility: Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii

location_facility: Hospital General Universitario de Valencia

location_facility: CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique

location_facility: Hôpital de Clocheville - Centre de Pédiatrie Gatien

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique

source: euctr

title: A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

summary:
There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.


ReferenceCitation: Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

name: Inserm U1171, Memory clinic of CHU and University of Lille, Lille, France

family: Pasquier

full_name: Florence Pasquier

given: Florence

name: Premiere Research Institute, Palm Beach Neurology, Nova SE University, West Palm Beach, FL, USA

family: Sadowsky

full_name: Carl Sadowsky

given: Carl

name: Pfizer Vaccine R&D, Collegeville, PA, USA

family: Holstein

full_name: Ann Holstein

given: Ann

name: Pfizer Global Research and Development, Paris cedex 14 – France

family: Leterme

full_name: Ghislaine Le Prince Leterme

given: Ghislaine Le Prince

family: Peng

full_name: Yahong Peng

given: Yahong

family: Jackson

full_name: Nicholas Jackson

given: Nicholas

name: Dementia Research Centre, Department of Neurodegeneration, UCL Institute of Neurology, London, UK

family: Fox

full_name: Nick C. Fox

given: Nick C.

name: Janssen Research and Development, San Diego, CA, USA

family: Ketter

full_name: Nzeera Ketter

given: Nzeera

family: Liu

full_name: Enchi Liu

given: Enchi

family: Ryan

full_name: J. Michael Ryan

given: J. Michael

journal_name: Journal of Alzheimer's Disease

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Two Phase 2 Multiple Ascending–Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer’s Disease

lead_sponsor: Pfizer

location_country: Germany France Spain

location_facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources

location_facility: Technische Universitaet Muenchen, Klinikum rechts der Isar

title: A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease

summary: To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.


title: IFM2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

summary: The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.

ReferenceCitation: Roussel M, Lauwers-Cances V, Robillard N, Hulin C, Leleu X, Benboubker L, Marit G, Moreau P, Pegourie B, Caillot D, Fruchart C, Stoppa AM, Gentil C, Wuilleme S, Huynh A, Hebraud B, Corre J, Chretien ML, Facon T, Avet-Loiseau H, Attal M. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myélome. J Clin Oncol. 2014 Sep 1;32(25):2712-7. doi: 10.1200/JCO.2013.54.8164. Epub 2014 Jul 14.

name: Murielle Roussel, Valérie Lauwers-Cances, Catherine Gentil, Anne Huynh, Benjamin Hebraud, Jill Corre, and Hervé Avet-Loiseau, Hopitaux de Toulouse; Michel Attal, Institut Claudius Regaud, Toulouse; Nelly Robillard, Philippe Moreau, and Soraya Wuilleme, Hôtel Dieu, Nantes; Cyrille Hulin, Centre Hospitalier Brabois, Nancy; Xavier Leleu and Thierry Facon, Hôpital Claude Huriez, Lille; Lotfi Benboubker, Hôpital Bretonneau, Tours; Gérald Marit, Hôpital Haut-Lévêque, Bordeaux Pessac; Brigitte Pegourie, Hôpital...

family: Lauwers-Cances

full_name: Valérie Lauwers-Cances

given: Valérie

family: Robillard

full_name: Nelly Robillard

given: Nelly

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Marit

full_name: Gérald Marit

given: Gérald

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

family: Caillot

full_name: Denis Caillot

given: Denis

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

family: Stoppa

full_name: Anne-Marie Stoppa

given: Anne-Marie

family: Gentil

full_name: Catherine Gentil

given: Catherine

family: Wuilleme

full_name: Soraya Wuilleme

given: Soraya

family: Huynh

full_name: Anne Huynh

given: Anne

family: Hebraud

full_name: Benjamin Hebraud

given: Benjamin

family: Corre

full_name: Jill Corre

given: Jill

family: Chretien

full_name: Marie-Lorraine Chretien

given: Marie-Lorraine

family: Facon

full_name: Thierry Facon

given: Thierry

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

family: Attal

full_name: Michel Attal

given: Michel

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Front-Line Transplantation Program With Lenalidomide, Bortezomib, and Dexamethasone Combination As Induction and Consolidation Followed by Lenalidomide Maintenance in Patients With Multiple Myeloma: A Phase II Study by the Intergroupe Francophone du Myélome

location_facility: University Hospital of Bordeaux, "Hôpital du Haut Lévêque "

location_facility: University Hospital of Dijon, Hôpital des Enfants

location_facility: University Hospital Of Lille, Hôpital Claude Huriez

location_facility: University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X


title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.

summary: The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.

ReferenceCitation: Evrard S, Rivoire M, Arnaud J-, Lermite E, Bellera C, Fonck M, Becouarn Y, Lalet C, Puildo M, Mathoulin-Pelissier S. Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection. Br J Surg. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724.

name: Department of Surgery, VU University Medical Centre, De Boelelaan 1117, 1007 MB Amsterdam, The Netherlands

family: Kazemier

full_name: G Kazemier

given: G

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection (Br J Surg 2012; 99: 558–565)

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

location_facility: Centre de Radiothérapie et d'Oncologie Médicale


title: Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d. Multicenter, Randomised Trial of Equivalence.

summary:
The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.

The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.

ReferenceCitation: Sannier N, Le Masne A, Sayegh N, Gaillard JL, Chéron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3.

ReferenceCitation: Leroy S, Marc E, Adamsbaum C, Gendrel D, Bréart G, Chalumeau M. Prediction of vesicoureteral reflux after a first febrile urinary tract infection in children: validation of a clinical decision rule. Arch Dis Child. 2006 Mar;91(3):241-4. Epub 2005 May 12.

ReferenceCitation: Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Bréart G, Chalumeau M. Procalcitonin as a predictor of vesicoureteral reflux in children with a first febrile urinary tract infection. Pediatrics. 2005 Jun;115(6):e706-9. Epub 2005 May 2.

ReferenceCitation: Marc E, Ménager C, Moulin F, Stos B, Chalumeau M, Guérin S, Lebon P, Brunet F, Raymond J, Gendrel D. [Procalcitonin and viral meningitis: reduction of unnecessary antibiotics by measurement during an outbreak]. Arch Pediatr. 2002 Apr;9(4):358-64. French.

ReferenceCitation: Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Chéron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.

family: Bocquet

full_name: N. Bocquet

given: N.

family: Sergent Alaoui

full_name: A. Sergent Alaoui

given: A.

family: Jais

full_name: J.-P. Jais

family: Gajdos

full_name: V. Gajdos

given: V.

family: Guigonis

full_name: V. Guigonis

family: Lacour

full_name: B. Lacour

given: B.

family: Cheron

full_name: G. Cheron

given: G.

journal_name: PEDIATRICS

publisher: American Academy of Pediatrics (AAP)

publisher_dissemination: American Academy of Pediatrics (AAP)

publisher_group: American Academy of Pediatrics (AAP)

publisher_normalized: American Academy of Pediatrics (AAP)

title: Randomized Trial of Oral Versus Sequential IV/Oral Antibiotic for Acute Pyelonephritis in Children

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Pellegrin
Necker Enfants Malades
La Timone
Chu de Limoges
Robert Debre
Saint Vincent de Paul
Hopital Andre Mignot
CHU NICE
Hôpital Armand Trousseau
Hopital de Bicetre
Hôpital Antoine Beclere
Hôpital Ambroise Pare


title: Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy

acronym: REMYKIR

summary: This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.

lead_sponsor: Innate Pharma

location_facility:
CHRU Lille
Hôpital Saint Antoine
Hôpital Dupuytren
Hopital Saint Louis
C.H.R.U. de Caen - Hôpital Bretonneau
Institut Paoli Calmettes
CHU Dijon
C.H.R.U. de Tours
CHU Nancy


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

acronym: PAXIPEM

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancerologie de Lorraine - Alexis Vautrin

status_simplified: Ongoing


title: Interest of Relaxation From Patients With Pain Due to Migraine

acronym: MIGREL

summary: The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Consultation de la douleur - CH Emile Roux

location_facility: Consultation de la douleur du CHU d'Amiens

intervention_type: Behavioral


acronym: INFILTHERA

summary:
Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:

neuropathic pains treatment
specific kinesitherapy
Alcock's canal and sacrospinal ligament infiltrations under scan
with diagnostic block
local steroids injections
and surgical decompression of pudendal nerve with transrectal approach.

Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.

The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:

group A: only local anesthetic (control arm)
group B: local anesthetics associated with local steroids
group C: local anesthetics associated with local steroids and important volumes of physiological serum

lead_sponsor: Nantes University Hospital

location_facility:
Hospices Civils de Lyon
Catherine de Sienne
CHU de Nantes
Hôpital Rothschild
Hôpital Charles Nicolle
CHU Clermont-Ferrand
Centre MARIENIA
Scanner Saint Hilaire
CH de la Côte Basque


title: Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia

acronym: ARTOME

summary:
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.

Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.

ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.

ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.

time_perspective: Retrospective

lead_sponsor: Center Eugene Marquis

location_facility:
Centre Léon Bérard
Centre Eugene Marquis
CRLCC Henri Becquerel
CRLCC Oscar Lambret
Clinique Claude Bernard
Clinique Pasteur Lanroze
CHU Tours - Hôpital Bretonneau
CHU de la Milétrie
CRLCC Baclesse
Centre Paul Strauss
CRLCC Antoine Lacassagne


title: A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine

summary: The purpose of this study is to assess of incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain in the adjuvant, or metastatic setting due to fluoropyrimidines

status: Recruiting

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Saint Antoine
CHU Tours Hôpital Trousseau
Chu Dijon
CHU Poitiers
CHU Pontchaillou
CHU Jean Minjoz
Hôpital Robert Debré
Hôptial Henri Mondor
Hôpital Privé Jean Mermoz
GH Pitié Salpêtrière
Centre Hospitalier Boulogne/ Mer


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

acronym: RePERSO

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

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

lead_sponsor: Rennes University Hospital

location_facility:
Centre Eugène Marquis
CHU Poitiers
AP-HP Henri Mondor
CHU Caen
AP-HP La Pitié-Salpétrière
CHU Tours
AP-HP St Antoine
CHU Nantes
CHU Rennes
CHU Rouen
CHU Brest