title: EVALUATION OF THE IMPACT OF A THERAPY MANAGEMENT PLATFORM ON THE MANAGEMENT OF PATIENTS SUFFERING FROM ADVANCED/METASTATIC RENAL CELL CARCINOMA AND RECEIVING FIRST LINE TREATMENT WITH SUNITINIB, VERSUS STANDARD FOLLOW-UP

acronym: RENACALL

summary:
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center

Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

lead_sponsor: Pfizer

location_facility: Hopital Jean BERNARD - Tours - 7eme etage

location_facility: CHI de Cornouailles - Oncologie hospitalisation

location_facility: Polyclinique de Gentilly Service Oncologie Médicale

location_facility: Clinique Claude Bernard Chimiotherapie Ambulatoire


title: Prospective, Multicenter, Randomized Controlled Study Evaluating the Efficacy of Parenteral Nutrition on the Quality of Life and Overall Survival in Patients in the Palliative Phase of Cancer.

acronym: ALIM-K

summary:
In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible.

Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives.

And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences.

We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer.

To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated.

The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Pazart L, Cretin E, Grodard G, Cornet C, Mathieu-Nicot F, Bonnetain F, Mercier M, Cuynet P, Bouleuc C, Aubry R; ALIM-K study investigational group. Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial. Trials. 2014 Sep 24;15:370. doi: 10.1186/1745-6215-15-370.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Georges François Leclerc
Centre Paul Strauss
Hopital de la Timone
Centre de cancérologie de Lorraine
Centre Léon Bérard
Centre Oscar Lambret
Institut Paoli calmettes
Insitut Jean Godinot
Palliative Care Unit - CHU Jean Minjoz
Institut Gustave Roussy
Centre François Baclesse
Institut Curie
Centre hospitalier Henri Mondor

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

summary:
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

primary_purpose: Treatment

lead_sponsor: Actelion

location_country: France Spain Italy

location_facility: UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica

location_facility: Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare

location_facility: Hospital Universitario Insular Gran Canarias

intervention_type: Drug

lead_sponsor_type: industriel


title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency

summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

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

ReferenceCitation: Berrouiguet S, Larsen ME, Mesmeur C, Gravey M, Billot R, Walter M; HUGOPSY Network, Lemey C, Lenca P. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 10;6(1):e8. doi: 10.2196/mhealth.7780.

ReferenceCitation: Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-García E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.

lead_sponsor: University Hospital, Brest

location_facility:
CHU Nantes
CHU St Nazaire
CHU Tours
CH Quimperlé
CHU Caen
CHU de Lyon
CHU Angers
CHU Rennes
CHRU de Brest
CH Vannes
CHU de Saint-Etienne, Hôpital Nord
CH St Malo
CHRU Lille

intervention_type: Device

status_simplified: Unknown


type: EudraCT Number

type: Other Identifier

title: Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

acronym: Nebuadom

summary: Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).

lead_sponsor: University Hospital, Tours


type: Other Grant/Funding Number

title: Evaluate the Long-term (3 Months) Efficacy of L-threo DOPS (DroxiDopa) on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With Multiple System Atrophy (MSA). Comparative Study Versus Placebo

acronym: DOPS-AMS

summary: Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following randomization to continued therapy with droxidopa or placebo.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de Rouen
Hôpital La Timone
CHRU de lille
CHU Pontchaillou
CHU de limoges
CHU de Clermont-Ferrand
CHU de Dijon
CHU bordeaux
Hôpital Pitié-Salpétrière
CHU de Poitiers
chu de Strasbourg
Centre hospitalier d'Angers
Hôpital G. & R. Laennec


title: Double Blind Randomized Study, Comparing Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

acronym: PRPET

summary: TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

ReferenceCitation: Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrié N, Carbonell N, Rousseau V, Sommet A, Péron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10.7326/M20-0202. Epub 2021 Feb 2.

ipd_sharing: Undecided

location_facility:
CHU Nantes
CHU Beaujon Clichy
CHU Tours
UHToulouse
CHU Poitiers
CHU Angers
CHU Bordeaux
CHU Rennes
Pitié Salpêtrière
Hôpital Jean Verdier
CHU Marseille
CHU Saint-Antoine
CHRU Lille


title: Specific Cognitive Remediation for Schizophrenia (RECOS) and Sheltered Employment: a Multicentre Controlled Randomized Trial.

acronym: RemedRehab

summary:
This study, driven on schizophrenic patients, is aimed at :

Measuring the efficiency of the cognitive remediation program RECOS (COgnitive REmediation in Schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (ESAT and EA).
Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on integration in sheltered employment of patients suffering from schizophrenia.

Realizing a comparative analysis, in both arms, of :

the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment)
the duration of such employments in sheltered areas.
Estimating the impact of RECOS on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6 months later (month M9), and looking for a correlation between the improvement of these parameters and sheltered employment.
Estimating the impact of cognitive remediation on integration in sheltered employment.

ReferenceCitation: Deppen P, Sarrasin Bruchez P, Dukes R, Pellanda V, Vianin P. [Cognitive remediation program for individuals living with schizophrenia (Recos): preliminary results]. Encephale. 2011 Sep;37(4):314-21. doi: 10.1016/j.encep.2011.02.002. Epub 2011 Apr 9. French.

ReferenceCitation: Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network, Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.

lead_sponsor: Hôpital le Vinatier

location_facility: Centre de Santé Mentale Angevin (CESAME)

intervention_type: Behavioral


acronym:
PAZOTHYR

 PAZOTHYR

title: A Randomized, Multicenter, Open-label, Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

lead_sponsor: Centre Leon Berard

source: euctr

ReferenceCitation: Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM, Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. doi: 10.1016/S1470-2045(10)70203-5. Epub 2010 Sep 17.

ReferenceCitation: Altorki N, Lane ME, Bauer T, Lee PC, Guarino MJ, Pass H, Felip E, Peylan-Ramu N, Gurpide A, Grannis FW, Mitchell JD, Tachdjian S, Swann RS, Huff A, Roychowdhury DF, Reeves A, Ottesen LH, Yankelevitz DF. Phase II proof-of-concept study of pazopanib monotherapy in treatment-naive patients with stage I/II resectable non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3131-7. doi: 10.1200/JCO.2009.23.9749. Epub 2010 Jun 1.

ReferenceCitation: Billemont B, Medioni J, Taillade L, Helley D, Meric JB, Rixe O, Oudard S. Blood glucose levels in patients with metastatic renal cell carcinoma treated with sunitinib. Br J Cancer. 2008 Nov 4;99(9):1380-2. doi: 10.1038/sj.bjc.6604709. Epub 2008 Oct 7.

ReferenceCitation: Borson-Chazot F, Bardet S, Bournaud C, Conte-Devolx B, Corone C, D'Herbomez M, Henry JF, Leenhardt L, Peix JL, Schlumberger M, Wemeau JL; Expert Group for French Recommendations for the Management of Differentiated Thyroid Carcinomas of Vesicular Origin, Baudin E, Berger N, Bernard MH, Calzada-Nocaudie M, Caron P, Catargi B, Chabrier G, Charrie A, Franc B, Hartl D, Helal B, Kerlan V, Kraimps JL, Leboulleux S, Le Clech G, Menegaux F, Orgiazzi J, Perié S, Raingeard I, Rodien P, Rohmer V, Sadoul JL, Schwartz C, Tenenbaum F, Toubert ME, Tramalloni J, Travagli JP, Vaudrey C. Guidelines for the management of differentiated thyroid carcinomas of vesicular origin. Ann Endocrinol (Paris). 2008 Dec;69(6):472-86. Review.

ReferenceCitation: Brose M. S., et al. Effect of BRAFV600E on response to sorafenib in advanced thyroid cancer patients. J Clin Oncol (meeting Abstracts) 27.15S (2009) : 6002.

ReferenceCitation: Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. doi: 10.1158/1078-0432.CCR-10-0994. Epub 2010 Sep 16.

ReferenceCitation: de la Fouchardiere C, Droz JP. Targeted therapies and thyroid cancer: an update. Anticancer Drugs. 2011 Aug;22(7):688-99. doi: 10.1097/CAD.0b013e32834319c7. Review.

ReferenceCitation: Fagin JA, Tuttle RM, Pfister DG. Harvesting the low-hanging fruit: kinase inhibitors for therapy of advanced medullary and nonmedullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2621-4. doi: 10.1210/jc.2010-0800.

ReferenceCitation: GSK Laboratories. Investigator's Brochure of pazopanib, version 09 dated 25 Jan. 2012.Ref Type: Unpublished Work

ReferenceCitation: Gupta-Abramson V, Troxel AB, Nellore A, Puttaswamy K, Redlinger M, Ransone K, Mandel SJ, Flaherty KT, Loevner LA, O'Dwyer PJ, Brose MS. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol. 2008 Oct 10;26(29):4714-9. doi: 10.1200/JCO.2008.16.3279. Epub 2008 Jun 9.

ReferenceCitation: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

ReferenceCitation: Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9.

ReferenceCitation: Jebreel A, England J, Bedford K, Murphy J, Karsai L, Atkin S. Vascular endothelial growth factor (VEGF), VEGF receptors expression and microvascular density in benign and malignant thyroid diseases. Int J Exp Pathol. 2007 Aug;88(4):271-7.

ReferenceCitation: Iwamoto FM, Lamborn KR, Robins HI, Mehta MP, Chang SM, Butowski NA, Deangelis LM, Abrey LE, Zhang WT, Prados MD, Fine HA. Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). Neuro Oncol. 2010 Aug;12(8):855-61. doi: 10.1093/neuonc/noq025. Epub 2010 Mar 3.

ReferenceCitation: Kaplan, E. L and P. Meier. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958): 457-81.

ReferenceCitation: Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21.

ReferenceCitation: Lan, K. K. G. and D. L. De Mets. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983): 659-63

ReferenceCitation: Leboulleux, S., Bastholt, L., and Krause TM. Vandetanib in locally advanced or metastatic differentiated thyroid cancer (papillary or follicular; DTC): a randomized, double-blind phase II trial. International Thyroid Conference;Paris, France; [ Sept 11.16, 2009. Abstr 0C.023.]. 2010. Ref Type: Abstract

ReferenceCitation: Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.

ReferenceCitation: Nikiforov YE. Thyroid carcinoma: molecular pathways and therapeutic targets. Mod Pathol. 2008 May;21 Suppl 2:S37-43. doi: 10.1038/modpathol.2008.10. Review.

ReferenceCitation: Pacini F, Castagna MG, Brilli L, Pentheroudakis G; ESMO Guidelines Working Group. Differentiated thyroid cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:143-6. doi: 10.1093/annonc/mdp156. Review.

ReferenceCitation: Prince HM, Hönemann D, Spencer A, Rizzieri DA, Stadtmauer EA, Roberts AW, Bahlis N, Tricot G, Bell B, Demarini DJ, Benjamin Suttle A, Baker KL, Pandite LN. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009 May 7;113(19):4819-20. doi: 10.1182/blood-2009-02-207209.

ReferenceCitation: Ravaud, A., et al. Sunitinib in patients with refractory advanced thyroid cancer: the THYSU phase II trial. J Clin Oncol (Meeting Abstracts) 26.15_suppl (2008): 6058.

ReferenceCitation: Ricarte-Filho JC, Ryder M, Chitale DA, Rivera M, Heguy A, Ladanyi M, Janakiraman M, Solit D, Knauf JA, Tuttle RM, Ghossein RA, Fagin JA. Mutational profile of advanced primary and metastatic radioactive iodine-refractory thyroid cancers reveals distinct pathogenetic roles for BRAF, PIK3CA, and AKT1. Cancer Res. 2009 Jun 1;69(11):4885-93. doi: 10.1158/0008-5472.CAN-09-0727.

ReferenceCitation: Schlumberger M. [Papillary and follicular thyroid carcinoma]. Ann Endocrinol (Paris). 2007 Jun;68(2-3):120-8. Epub 2007 Jun 19. Review. French.

ReferenceCitation: Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ; Motesanib Thyroid Cancer Study Group. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008 Jul 3;359(1):31-42. doi: 10.1056/NEJMoa075853.

ReferenceCitation: Slamon D,. et al. Pazopanib + Lapatinib is more active than Lapatinib alone : Updated results from a randomized study in patients with first-line ErbB2-positive advanced or metastatic breast cancer [ESMO abstract 139P]. Ann Oncol. 2008c ;19 (supp 8) : viii 64-65.

ReferenceCitation: Sleijfer, S., et al. Phase II study of pazopanib (GW786034) in patients (pts) with relapsed or refractory soft tissue sarcoma (STS): EORTC 62043. ASCO Meeting Abstracts 25.18_suppl (2007): 10031.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Soh EY, Duh QY, Sobhi SA, Young DM, Epstein HD, Wong MG, Garcia YK, Min YD, Grossman RF, Siperstein AE, Clark OH. Vascular endothelial growth factor expression is higher in differentiated thyroid cancer than in normal or benign thyroid. J Clin Endocrinol Metab. 1997 Nov;82(11):3741-7.

ReferenceCitation: Volante M, Rapa I, Gandhi M, Bussolati G, Giachino D, Papotti M, Nikiforov YE. RAS mutations are the predominant molecular alteration in poorly differentiated thyroid carcinomas and bear prognostic impact. J Clin Endocrinol Metab. 2009 Dec;94(12):4735-41. doi: 10.1210/jc.2009-1233. Epub 2009 Oct 16.

ReferenceCitation: de la Fouchardière C, Godbert Y, Dalban C, Illouz F, Wassermann J, Do Cao C, Bardet S, Zerdoud S, Chougnet CN, Zalzali M, Benisvy D, Niccoli P, Digue L, Lamartina L, Schwartz P, Borson Chazot F, Gautier J, Pérol D, Leboulleux S; PAZOTHYR investigators. Intermittent versus continuous administration of pazopanib in progressive radioiodine refractory thyroid carcinoma: Final results of the randomised, multicenter, open-label phase II trial PAZOTHYR. Eur J Cancer. 2021 Nov;157:153-164. doi: 10.1016/j.ejca.2021.07.029. Epub 2021 Sep 9.

location_facility:
Institut Bergonié
Institut Jean Godinot
CHRU Lille Hôpital Claude Huriez
Hôpital de la Timone APHM
Hôpital de la Pitié Salpêtrière APHP
Centre Antoine Lacassagne
CHU Angers
CHU Bordeaux
Hôpital Saint-Louis APHP
Institut Claudius Régaud
Institut Gustave Roussy
Centre Leon Berard
Centre François Baclesse

summary: The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.


title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy

acronym: EDIEMHYPER

summary:
MAIN OBJECTIVE :

To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years

SECONDARY OBJECTIVES :

To assess the consequences of a maternal hyperthyroïd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.

To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:

the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid versus disease of Basedow),
the use or not of a anti-thyroid treatment,
the rate of TSH néonatal (measured with the blotter by tracking with J3 at all the new born ones).

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Reims
University Hospital of Lille
Civil Hospices of Lyon
University Hospital of Angers
University Hospital of Amiens
University Hospital of Nantes
University Hospital of Kremlin Bicetre
University Hospital of Cochin
University Hospital of Toulouse
Hospital of Saint Antoine
University Hospital of Poitiers
University Hospital of Marseille
University Hospital of Strasbourg


title: Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65

acronym: FerHem

summary:
The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a common disorder in the elderly. Indeed, in 1996, in a French study, the median age of patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in the studies reported in English the median age was 71. If epidemiological data concerning lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved, whereas anaemia related to a bleeding episode remains a frequent complication of gastrointestinal bleeding in elderly patients.

Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on the criteria used and populations studied. The occurrence of a bleeding episode can either induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal bleeding are often unaware of anaemic consequences in the elderly patients which can often be serious. Various studies have shown that anaemia increases morbidity and mortality rates in the elderly. Life expectancy is independently significantly lower for anaemic patients over 65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of cardiovascular and neurological complications, impairment in cognitive function and increased risk of falling.

Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for upper or lower gastrointestinal bleeding should be corrected rapidly and effectively. Currently, the cost and risks of infection or cardiovascular-related complications of transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL haemoglobin. It is also necessary to develop alternatives to massive transfusions. The correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.

In clinical practice, the effectiveness of iron intake by the oral route is limited by the frequent occurrence of significant gastrointestinal side effects that limit patient compliance and limited absorption necessitating prolonged treatment to correct iron deficiency.

The black colour of stools caused by taking oral iron supplements also makes it difficult to detect a possible recurrence of bleeding after hospitalization.

The prescription of intravenous iron seems more suitable for a rapid and complete correction of iron deficiency after gastrointestinal bleeding. The main objective of our study is to evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron supplementation, the rate of re-hospitalization within 6 months after discharge and patients quality of life. This is a prospective multicenter randomized study versus placebo. After obtaining informed consent, all patients aged over 65 admitted with upper or lower gastrointestinal bleeding, with successful outcome, not related to portal hypertension, responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will be included in the study. Patients will be treated for their bleeding event in the usual manner of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of bleeding.

Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1 included: obtaining informed consent of the patient, determination of iron and ferritin blood levels and complete blood count. and randomization intravenous iron injection , (Ferinject) versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6 and at month 6 to obtain related intercurrent events and assess their quality of life.

The results of this study could lead to changes in the care of older patients hospitalized for gastrointestinal bleeding.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU d'Amiens
CH de Valenciennes
CHU de Caen
CHU de Rouen
CHU de Nice
CHI le Raincy Montfermeil
CHU de Pau
CH de Vendée
CH Le Mans
CH de Montélimar
GH du havre
CH d'Orléans
CHU de Rennes


summary: Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric, non randomized and with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.

lead_sponsor: Poitiers University Hospital

location_facility:
Orléans Hospital
Poitiers University Hospital
Saintes Hospital
Tours University Hospital
Angoulême Hospital
Cochin University Hospital
Limoges University Hospital
La Rochelle Hospital
Rennes University Hospital
Nice University Hospital
La Roche sur Yon Hospital
Angers University Hospital
Nantes University Hospital

intervention_type: Procedure


title: Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

summary: The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

ReferenceCitation: Allegre L, Debodinance P, Demattei C, Fabbro Peray P, Cayrac M, Fritel X, Courtieu C, Fatton B, de Tayrac R. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. Neurourol Urodyn. 2019 Nov;38(8):2242-2249. doi: 10.1002/nau.24125. Epub 2019 Jul 29.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: CHRU de Lyon - Hôpital de la Croix Rousse

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Clermont Ferrand - Hôpital Estaing


title: Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)

acronym: ALS-TOX

summary: Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie, Hôpital Central, CHU de Nancy

location_facility: Service de Neurologie, CHU de Saint-Etienne

location_facility: Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

location_facility: Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers

location_facility: Fédération des Maladies du Système Nerveux, Groupement Hospitalier Pitié Salpêtrière, AP-HP

location_facility: Service de Neurologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand

location_facility: Service de Neurologie, Hôpital Dupuytren, CHU de Limoges

location_facility: Département de Neurologie, Hôpital de Hautepierre, CHRU de Strasbourg

location_facility: Service d'Explorations Fonctionelles Neuro-Musculaires, Hôpital Rangueil, CHU de Toulouse

location_facility: Centre SLA, Service de Neurologie A et pathologies du mouvement, Hôpital Roger Salengro, CHU de Lille

location_facility: Service de Neurologie Vastel, Hôpital Côte de Nacre, CHU de Caen

location_facility: Centre de Référence maladies Neuromusculaires, Service de Médecine Physique et Réadaptation, Hôpital de l'Archet 1, CHU de Nice

location_facility: Service de Neurologie, Hôpital de la Timone, CHU de Marseille


title: Antibiotic Concentrations Among Critically Ill Patients

acronym: DALI

summary: The primary objective of the DALI study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams and glycopeptides.

study_type: Observational

time_perspective: Cross-Sectional

intervention_type: Biological


title: Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.

acronym: ANGIO-TAX+

summary: Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma

ReferenceCitation: Lebellec L, Bertucci F, Tresch-Bruneel E, Ray-Coquard I, Le Cesne A, Bompas E, Blay JY, Italiano A, Mir O, Ryckewaert T, Toiron Y, Camoin L, Goncalves A, Penel N, Le Deley MC. Prognostic and predictive factors for angiosarcoma patients receiving paclitaxel once weekly plus or minus bevacizumab: an ancillary study derived from a randomized clinical trial. BMC Cancer. 2018 Oct 11;18(1):963. doi: 10.1186/s12885-018-4828-1.

lead_sponsor: Centre Oscar Lambret

location_facility:
Institut Bergonié
Centre René Gauducheau
Centre Georges François Leclerc
Centre Jean Perrin
Centre Antoine Lacassagne
Institut de Cancérologie de la Loire
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
Institut Claudius Regaud
Institut Curie
Centre François Baclesse
Centre Val d'Aurelle


type: Registry Identifier

title: Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

acronym: CURDYS

summary: Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

ReferenceType: result

ReferenceCitation: Hascoët JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.

ReferenceCitation: Hascoët JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22. Review.

lead_sponsor: Jean Michel Hascoet

location_facility:
CHU Hopital Nord
Centre Hospitalier
AP-HP Hopital Port Royal
CHU Hopital Gatien de Clocheville
CHU hopital d'enfants
CHU
APHM hopital de la conception
CHI Andre Gregoire
Maternite Regionale Universitaire
CHU Hopital Jeanne de Flandre
CHU Hopital de la Croix Rousse
CHU Hopital Clemenceau


title: Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma

acronym: SAPORO

summary: The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.

location_facility:
Lille University Hospital
Strasbourg University Hospital
Besançon University Hospital
Marseille University Hospital
Paris XI University Hospital
Angers University Hospital
Toulouse Universtiy Hospital
Bordeaux University Hospital
Lyon University Hospital
Caen University Hospital
Grenoble University Hospital
University Hospital of Limoges
Rouen University Hospital


title: Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer

acronym: COLOCROSS

summary:
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.

Another objective of the trial is to assess and compare the safety of each treatment.

location_facility:
Clinique des Dentellieres
Centre Hospitalier
Centre Hospitalier de CHOLET
Polyclinique du Bois
Centre Hospitalier de Béthune
Centre Oscar Lambret
Centre Joliot-Curie
Centre Paul Papin
Centre Hospitalier Regional
Centre Leonard de Vinci
Hopital Saint Vincent de Paul


title: Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.

acronym: HAA-NAC

summary: 35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

ReferenceCitation: Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire Pitié-Salpétrière

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Besançon


title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

acronym: TRANSCIAL

summary: Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).

ReferenceCitation: Vanlemmens C, Di Martino V, Milan C, Messner M, Minello A, Duvoux C, Poynard T, Perarnau JM, Piquet MA, Pageaux GP, Dharancy S, Silvain C, Hillaire S, Thiefin G, Vinel JP, Hillon P, Collin E, Mantion G, Miguet JP; TRANSCIAL Study Group. Immediate listing for liver transplantation versus standard care for Child-Pugh stage B alcoholic cirrhosis: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):153-61.

location_facility: Clinique des maladies du foie Hôpital Pontchailloux

location_facility: CHRU CAEN - Service d'hépato-gastroentérologie

location_facility: Centre d'épidémiologie de population EPI 106

location_facility: Hôpital Bon secours - Hépato-gastroentérologie

location_facility: Hôpital Saint-Eloi - Hépato-gastroentérologie

location_facility: Hôpital Pitié-Salpétrière - Hépato-gastroentérologie

location_facility: CHU Henri Mondor - Hépato-gastroentérologie

location_facility: Hôpital Purpan - Hépato-gastroentérologie

location_facility: Hôpital Beaujon - Hépato-gastroentérologie


title: Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospital Universitaire Hop Huriez

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


title: A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t).

summary: In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.

status: Terminated

ReferenceCitation: Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terré C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.

ReferenceCitation: Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terré C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

ReferenceCitation: Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terré C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

ReferenceCitation: Malfuson JV, Etienne A, Turlure P, de Revel T, Thomas X, Contentin N, Terré C, Rigaudeau S, Bordessoule D, Vey N, Gardin C, Dombret H; Acute Leukemia French Association (ALFA). Risk factors and decision criteria for intensive chemotherapy in older patients with acute myeloid leukemia. Haematologica. 2008 Dec;93(12):1806-13. doi: 10.3324/haematol.13309. Epub 2008 Oct 6.

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Edouard Herriot
IGR
Hopital Henri Mondor
Hopital Saint-Louis
Hopital Avicenne
CHU
CNLCC
CH
Hopital Pitie-Salpetriere
Hopital Percy


title: National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)

summary:
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the primary objective of the treatment in this context. The symptomatic treatment of the ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is not significantly improved by the current standard of care, including early revascularisation and intra-aortic balloon counterpulsation.

In order to improve the immediate prognosis, it seems necessary to limit the irreversible myocardial lesions and the systemic inflammatory response induced by an extended myocardial infarction (complement activation, cytokines production, iNOS expression, etc.). These objectives may be reached by a more extended utilization and availability of circulatory assistance methods.

The investigators propose to compare, in a randomised multicenter study, two treatments of the myocardial infarction with cardiogenic shock among 44 patients:

Standard Treatment versus ECLS-Impella +/- standard treatment.

In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic pump.

This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new amendment has been approved by the EC. This amendment allowed to revise the number of patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint : variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level obtained before the randomization).Showing a more important BNP levels decrease in the experimental group compared to standard treatment group, the investigators obtain an indirect argument to show a superior efficacy of the tested strategy.

lead_sponsor: University Hospital, Caen

location_facility:
Cochin Hospital
Hôpital de la Timone
Pitié-Salpétrière Hospital
Centre Cardiologique du Nord
Paris Sud Cardiovascular Institute
Clermont-Ferrand University Hospital
Hôpital Haut-Lévèque
Brest University Hospital
Hôpital Charles Nicolle
Toulouse University Hospital
Hôpital de la Croix Rousse
Caen University Hospital
Mulhouse Hospital


title: Phase 2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor

acronym: MetroWilms

summary: This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Hôpital pour Enfants " La Timone " AP-HM

location_facility: CHRU Strasbourg - Hôpital de Hautepierre

location_facility: CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

status_simplified: Ongoing


title: Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial

acronym: pc-ASTER

summary:
Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis.

Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population .

Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).

First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome.

Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients .

However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT.

In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.

lead_sponsor: Hopital Foch

location_facility:
Fondation Adolphe de Rothschild
Chru Nancy
APHP - Pitié Salpêtrière
CHU Caen
Chu Bordeaux
CHU Montpellier
CHU Rennes
CHU de Tours
CHU Limoges
Chu Nantes
Hôpital FOCH
CHU de Reims


title: Validation of Ultrasonic Positive Diagnosis Criteria of Ipsilateral Deep Vein Thrombosis Recurrence of the Lower Limbs Based on Thrombosis Evolution at a 3-month Follow-up Under Anticoagulation: The ULTREC Project Ancillary Study

acronym: ULTRECAncillar

summary:
The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.

The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.

In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.

The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)

status: Recruiting

time_perspective: Prospective

ReferenceCitation: Ageno W, Squizzato A, Wells PS, Büller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301.

ReferenceCitation: Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4.

ReferenceCitation: Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.

ReferenceCitation: Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98.

ReferenceCitation: Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340. Review.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


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

location_facility: Institut de Cancerologie de Lorraine - Alexis Vautrin


title: Outcomes of Adjuvant "Polymer Cerclage System "OrthoLoop" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.

acronym: SERRE

summary:
The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population.

Whether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip/shoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.

The "Sterile Self Locking Polymer Cerclage System" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications.

Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care.

SERRE is a 36 months follow up study in two arms :

Experimental group: "OrthoLoop cercalge"
Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.

The main objective of this study is to assess the role of "OrthoLoop cerclage" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.

ReferenceCitation: Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. doi: 10.1016/j.injury.2007.02.048. Epub 2007 May 2.

ReferenceCitation: Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. doi: 10.1177/112070001002000402.

ReferenceCitation: Tsiridis E, Pavlou G, Venkatesh R, Bobak P, Gie G. Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management. Hip Int. 2009 Apr-Jun;19(2):75-86. doi: 10.1177/112070000901900201.

ReferenceCitation: Ferbert T, Jaber A, Gress N, Schmidmaier G, Gotterbarm T, Merle C. Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up. Hip Int. 2020 Sep;30(5):544-551. doi: 10.1177/1120700019849911. Epub 2019 May 17.

ReferenceCitation: Ebraheim NA, Sochacki KR, Liu X, Hirschfeld AG, Liu J. Locking plate fixation of periprosthetic femur fractures with and without cerclage wires. Orthop Surg. 2013 Aug;5(3):183-7. doi: 10.1111/os.12052.

ReferenceCitation: Angelini A, Battiato C. Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures. Eur J Orthop Surg Traumatol. 2016 May;26(4):397-406. doi: 10.1007/s00590-016-1761-3. Epub 2016 Mar 17.

ReferenceCitation: Gordon K, Winkler M, Hofstadter T, Dorn U, Augat P. Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study. Injury. 2016 Jun;47 Suppl 2:S51-7. doi: 10.1016/S0020-1383(16)47009-9.

ReferenceCitation: Angelini A, Battiato C. Past and present of the use of cerclage wires in orthopedics. Eur J Orthop Surg Traumatol. 2015 May;25(4):623-35. doi: 10.1007/s00590-014-1520-2. Epub 2014 Sep 4.

ReferenceCitation: Altenburg AJ, Callaghan JJ, Yehyawi TM, Pedersen DR, Liu SS, Leinen JA, Dahl KA, Goetz DD, Brown TD, Johnston RC. Cemented total hip replacement cable debris and acetabular construct durability. J Bone Joint Surg Am. 2009 Jul;91(7):1664-70. doi: 10.2106/JBJS.G.00428.

ReferenceCitation: Silverton CD, Jacobs JJ, Rosenberg AG, Kull L, Conley A, Galante JO. Complications of a cable grip system. J Arthroplasty. 1996 Jun;11(4):400-4. doi: 10.1016/s0883-5403(96)80029-5.

ReferenceCitation: Peeters I, Depover A, Van Tongel A, De Wilde L. A review of metallic and non-metallic cerclage in orthopaedic surgery: Is there still a place for metallic cerclage? Injury. 2019 Oct;50(10):1627-1633. doi: 10.1016/j.injury.2019.06.034. Epub 2019 Jul 13.

lead_sponsor: Quanta Medical

location_facility:
CH Libourne
Ch Metz - Thionville
CH Valenciennes
Clinique de Saint Omer
CH Agen
CHRU Nancy
CHU Lille
CH Le Mans
CHU Toulouse
Polyclinique Du Parc
CH Arcachon
CHU Nimes


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

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

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

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

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

location_facility: Institut de Cancérologie Lucien NEUWIRTH


title: 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: Institut Daniel Hollard, Groupe Hospitalier Mutualiste de Grenoble


title: A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia

acronym: ENDOBARRETT

summary:
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.

A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

location_facility:
University Hospital of Nice
University Hospital of Brest
University Hospital of Lille
University Hospital of Nantes
Cochin Hospital
University Hospital of Rennes
University Hospital of Tours
Edouard Herriot Hospital
University Hospital of Poitiers
Georges Pompidou European Hospital
University Hospital of Bordeaux
University Hospital of Limoges


title: Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO

acronym: DISCO-SET

summary:
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.

Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.

Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.

The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.

The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.

location_facility:
Romain NIFENECKER
Marieke SALACROUP
Béatrice NEGARET
Hoël CHARBONNEL
Laurent LENOBLE
Anna JARNO-JOSSE
Marie BROSSET
Jean-Philippe DUGUEY
Lucie MURGALE
Emmanuelle FOURE-AMELOT
Antoine MOUTEL
Lucie DELATTE


acronym: GYNET

title: A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Carboplatin Plus Paclitaxel and/or Pembrolizumab in Patients With Locally Advanced/Metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/Relapsing After at Least One Prior Systemic Chemotherapy.

lead_sponsor: NETRIS Pharma

location_facility:
Institut Bergonié
ICM - Val d'Aurelle
Insitut de cancérologie de l'ouest
Hopital de la Croix Saint Simon
Primary Completion Date
Centre Léon Bérard
Institut Curie (Site Saint Cloud)
Institut Gustave Roussy
Institut claudius Regaud
Centre Eugène Marquis
Centre François Baclesse

summary: The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).


title: Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease

acronym: PREPCOV

summary: There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.

ReferenceCitation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

lead_sponsor: University Hospital, Toulouse

location_facility: Joseph Ducuing Hospital - Médecine interne

location_facility: University Hospital of Toulouse - Rangueil Médecine interne

location_facility: Haut-Lévêque Hospital - Gastro-entérologie

location_facility: University hospital Toulouse - Purpan Médecine interne

location_facility: Pitié Salpêtrière Hospital - Hépatologie

location_facility: Toulouse university Hospital - Larrey Dermatologie

location_facility: Haut-Lévêque Hospital - Médecine interne

location_facility: Toulouse University Hospital - Rhumatologie

location_facility: Pitié Salpêtrière Hospital - Médecine interne


title: KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

acronym: KETACANCER

summary:
The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication).

The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression.

In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin


title: Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

acronym: DOCTORS-LM

summary: The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

status: Active, not recruiting

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier de Chartres - Hôpital Louis Pasteur


title: Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

summary:
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.

In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.

In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

location_facility: Centre Hospitalo-Universitaire de Grenoble


title: Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial

acronym: EMPROTECT

summary: Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital d'instruction des armées de Percy


acronym: IMMUNONCOVID

title: A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

summary:
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit.

According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts:

COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1).
COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).


title: Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.

acronym: GREPH

summary: The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.

ReferenceCitation: Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salamé E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w. Erratum in: Trials. 2022 May 24;23(1):438.

lead_sponsor: University Hospital, Tours

location_facility: APHM Service Pharmacie- Hôpital de la Conception

location_facility: APHM - Service de Pharmacie Clinique; Hôpital de la Timone

location_facility: CHU-REIMS Service de Pharmacie -Robert Debré

location_facility: CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre

location_facility: CHU-BREST - Pharmacie clinique La Cavale Blanche

location_facility: CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique

location_facility: CHU-Montpellier Service Pharmacie Lapeyronie


title: Ocular Surface in Patients With Soft Contact Lenses

summary:
Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre hospitalier national d'ophtalmologie des Quinze-Vingts


title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

acronym: BRAINI

summary: Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

ReferenceCitation: Richard M, Lagares A, Bondanese V, de la Cruz J, Mejan O, Pavlov V, Payen JF; BRAINI investigators. Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.

lead_sponsor: University Hospital, Grenoble

location_country: France Spain

location_facility: Hôpital Nord Ouest de Villefranche sur Saône


title: "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases

acronym: CEREMET-LR

summary: The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

ReferenceCitation: Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.

ReferenceCitation: Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007. Review.

ReferenceCitation: Smedby KE, Brandt L, Bäcklund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.

ReferenceCitation: Kocher M, Soffietti R, Abacioglu U, Villà S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

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

location_facility: Laboratoire d'anatomo-pathologie de Nîmes

location_facility: Centre hospitalier régional et universitaire de Nîmes

location_facility: Centre d'Anatomie et Cytologie Pathologiques de Grabels

location_facility: Centre hospitalier régional et universitaire de Montpellier


title: Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

acronym: EDHITO

summary: The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Centre D'Oncologie Et de Radiotherapie 37


title: Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale

acronym: REDRESS

summary:
Major Depressive Disorder (MDD) is a debilitating disease characterized by a depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD occurs about twice as often in women than it does in men and affects about 6% of the adult population worldwide each year.

Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale, the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression (TRD) occurrence. In parallel, patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression. The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements. It has been demonstrated that an early response to an AntiDepressant (AD) treatment can be seen as early as week 2 and is not related to a placebo-effect. While there is no consensus on the exact cut-off values, several factors emerge as early predictors of a later treatment response, such as:

Improvement in emotional processing of happy facial expressions after 1 week of treatment,
Circa 20% improvement in Hamilton Depression Rating Scale-17 item (HDRS-17) at week 2. The hypothesis is therefore that repeated, systematic and real-time, contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment.

REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority, augmented with digital active and passive activity monitoring, speech analysis and emotional processing assessment. Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution.

To test this assumption, the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response.

The response to treatment at week 6 will be studied (end of Phase 1). Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase (Phase 2). Non-responders will receive another treatment course (Other AD, combination, etc.). Responders will just be followed up and will keep the same treatment. The REDRESS scores will be analysed in this population and will allow us to test the investigator's assumption in people with treatment resistant depression. This study will also allow to assess patients' quality of life at the end of each phase of treatment and to compare results with REDRESS scores.

lead_sponsor: Ad scientiam

location_facility:
Centre hospitalier Henri Laborit
Hôpital de la Pitié Salpêtrière
CHU Clermont-Ferrand
CH Cholet
CHRU Tours
CHU Nantes - CAPPA Jacques Prévet
Centre hospitalier Saint-Antoine
CHU Toulouse
Centre Hospitalier Guillaume Régnier
CHU Grenoble
Cabinet de ville
Centre Hospitalier Saint-Anne


title: MELROSE: Phase 2 Study Evaluating MEchanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtinib Until and Beyond Radiological Progression : the MELROSE Trial

acronym: MELROSE

summary:
Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer.

The AURA 3 study (T790M-positive advanced non-small-cell lung cancer in progression after first-line EGFR-TKI therapy, shown that the median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months p<0.001).

In addition, clinical data show that patients with mutated EGFR NSCLC receiving osimertinib in first line, presented an objective response rate of 77 % with a disease control rate of 98 % and a median PFS was 19.3 months.

Finally, The FLAURA study randomized phase 3 study clearly demonstrated the superiority of osimertinib compared with erlotinib or gefitinib in EGFR mutated nonpretreated NSCLC (median PFS of 18.9 months versus 10.2 months).

However, several issues remain unknown or debated :

What are the mechanisms of resistance to osimertinib prescribed in first-line?
What are the consequences of prolonged exposure to osimertinib on the expression of markers of response to immunotherapy?
Is there an association between kinetic parameters of ctDNA (circulating tumor DNA) and prediction of response to osimertinib and/ or and prediction of therapeutic escape under osimertinib? In order to respond to all these questions, this phase II trial will be the first to systemically analyze the mechanisms of resistance to Osimertinib based on the analysis of biopsy, and collection of plasma from all patients during the course of treatment.

ReferenceCitation: Bennouna J, Girard N, Audigier-Valette C, le Thuaut A, Gervais R, Masson P, Marcq M, Molinier O, Cortot A, Debieuvre D, Cadranel J, Lena H, Moro-Sibilot D, Chouaid C, Mennecier B, Urban T, Sagan C, Perrier L, Barlesi F, Denis MG. Phase II Study Evaluating the Mechanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR-mutated Non-pretreated Advanced Lung Cancer Receiving Osimertinib Until and Beyond Radiologic Progression: The MELROSE Trial. Clin Lung Cancer. 2020 Jan;21(1):e10-e14. doi: 10.1016/j.cllc.2019.09.007. Epub 2019 Oct 1.

lead_sponsor: Nantes University Hospital

location_facility: CH DU MOENCHSBERG - Hôpital Emile Muller

intervention_type: Genetic


title: Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial

summary: The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

ReferenceCitation: Deshayes E, Piron L, Bouvier A, Lapuyade B, Lermite E, Vervueren L, Laurent C, Pinaquy JB, Chevallier P, Dohan A, Rode A, Sengel C, Guillot C, Quenet F, Guiu B. Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases. BMC Cancer. 2020 Jun 19;20(1):574. doi: 10.1186/s12885-020-07065-z.

lead_sponsor: University Hospital, Montpellier

location_facility:
Centre Léon Berard
CHU de Nice
APHP - Cochin hospital
CHU de Grenoble
CHU d'Angers
CHU de Poitiers
CHU de Dijon
Institut Gustave Roussy
Bordeaux University Hospital
Hospices Civils de Lyon
CHU de Montpellier
Hôpital Paul Brousse


title: Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care

acronym: AdoDesP

summary:
Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care.

In children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. It is regularly reported that 30% of adolescents of depressed parents have depression themselves. General Practitioners (GP) have significant access to the depression of adults, potentially parents of teenagers. In fact, 20% of patients in the regular active file of one GP have depression. The primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents.

The difficulties of articulation between primary care (PC) and mental health devices are demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and may even disturb early detection of depression. An organized joint between the PC and a specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in PC.

In addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. They vary by age and sex of the child but also the sex of the parent. A concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors.

AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group of adolescent with PC articulated with mental health service (MDA) and an other group without articulation (routine cares).

A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.

primary_purpose: Diagnostic

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Dr Le Grignou
Dr Phan
Dr Ac'h
Dr PITMAN
Dr NABBE
Dr CHIRON
Dr Coat-Gourio
Dr Wauters
Dr Cazuguel
Dr Volant-Le-Berre
Dr AUGUSTIN
Dr CONNAN


title: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.

acronym: DISCO

summary:
The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy.

This is a 3 years medico-economics study with 1 year follow-up period involving patients with 1 or 2 depression treatment(s) failed.

Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).

ReferenceCitation: Sauvaget A, Lagalice L, Schirr-Bonnans S, Volteau C, Péré M, Dert C, Rivalland A, Tessier F, Lepage A, Tostivint A, Deschamps T, Thomas-Ollivier V, Robin A, Pineau N, Cabelguen C, Bukowski N, Guitteny M, Beslot A, Simons L, Network H, Vanelle JM, D'Urso G, Bulteau S, Riche VP; DISCO investigators group. Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol. BMJ Open. 2020 Jan 13;10(1):e033376. doi: 10.1136/bmjopen-2019-033376.

location_facility: Centre hospitalier Guillaume Regnier Rennes


title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study

summary: This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

lead_sponsor: Theraclion

location_facility:
Polyclinique de l'Atlantique
Groupe Hospitaliler Diaconesses
Clinique Mutualiste LA SAGESSE
CHU Strasbourg
Centre Hospitalier
Polyclinique Majorelle
American Hospital of Paris
Hopital Pitié-salpêtrière
Hopital TENON
Hopital Saint Louis
CHU de Montpellier
Hopital Européen


title: Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?

acronym: TCAP

summary:
At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner.

However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

location_facility:
CH Bretagne Atlantique
CH Chartres
CHU de Nantes
CHU Brest
CH Le Mans
CHU d'Angers
CHU de Poitiers
CH de Saint Malo
CH Bretagne Sud - Quimperlé
CH Bretagne Sud, Lorient
CH de Saint Brieuc
CHU de Rennes

intervention_type: Radiation


title: Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM)

summary:
The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.

For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.

location_facility:
CHU de Caen
Institut Paoli Calmettes
CHU de Nantes
CHU Bordeaux
CHU de Grenoble
CHRU de Nancy
CHU de Tours
CHU de Dijon
University Hosptial Toulouse
Hospices Civils de Lyon
CHRU de Lille
CHU de Rennes


title: Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis

summary:
The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age.

FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

location_facility: La-Roche-Sur-Yon, Departmental Hospital Center